Steven R. Smith, MS, JD

CASE Young woman with family history of breast cancer detects lump

Two weeks after noting a lump on her breast when her cat happened to jump on her in that spot, a 28-year-old woman (G0) went to her primary care provider. She was referred to her gynecologist; breast imaging, ultrasonography, and mammography were obtained, with microcalcifications noted. A fine needle aspiration diagnosed intraductal malignancy. The surgical breast tissue specimen was estrogen receptor (ER)- and progestogen receptor (PR)-positive and HER2-negative. Other tumor markers were obtained, including carcinoembryonic antigen, and tissue polypeptide specific antigen, p53, cathepsin D, cyclin E, and nestin, but results were not available.

With regard to family history, the woman’s mother and maternal grandmother had a history of breast cancer. The patient and her family underwent gene testing. The patient was found to be BRCA1- and BRCA2-positive; her mother was BRCA1-positive, an older sister was BRCA2-positive, and her grandmother was not tested.

The question arose in light of her family history as to why she was not tested for BRCA and appropriately counseled by her gynecologist prior to the cancer diagnosis. Litigation was initiated. While the case did not go forward regarding litigation, it is indeed a case in point. (Please note that this is a hypothetical case. It is based on a composite of several cases.)
 

Medical considerations

Breast cancer is the most common type of cancer affecting women in the Western world.¹ Advances in clinical testing for gene mutations have escalated and allowed for identification of patients at increased risk for breast and ovarian cancer. Along with these advances come professional liability risk. After looking at the medical considerations for BRCA1 and 2 testing, we will consider a number of important legal issues. In the view of some commentators, the failure to diagnose genetic mutations in patients predisposed to cancer is “poised to become the next wave of medical professional liability lawsuits.”²

BRCA1 and BRCA2 genes provide tumor suppressor proteins, and assessment for mutations is recommended for individuals at high risk for breast and/or ovarian cancer; mutations in BRCA genes cause DNA damage, which increases the chance of developing cancer. The other way to look at it is, BRCA1 and 2 are tumor suppressor genes that are integrally involved with DNA damage control. Once there is a mutation, it adversely affects the beneficial effects of the gene. Mutations in these genes account for 5% to 10% of all hereditary breast cancers.³ Of note, men with BRCA2 are at increased risk for prostate cancer.

A patient who presents to her gynecologist stating that there is a family history of breast cancer, without knowledge of genetic components, presents a challenge (and a medicolegal risk) for the provider to assess. Prediction models have been used to determine specific patient risk for carrying a genetic mutation with resultant breast cancer development.⁴ Risk prediction models do not appear to be a good answer to predicting who is more likely to develop breast or ovarian cancer, however. A Mayo model may assist (FIGURE).⁵ Clinicians should also be aware of other models of risk assessment, including the Gail Model (TABLE 1).⁶

Continue to: Guidelines for genetic testing...

Guidelines for genetic testing

The American College of Obstetricians and Gynecologists states that patient medical history and family history are paramount in obtaining information regarding risk for breast and ovarian cancer. First- and second-degree relatives are allocated to this category. Information regarding age of diagnosis, maternal and paternal lineage, and ethnic background can imply a need for genetic testing (TABLE 2).^7,8 A number of genetics national organizations have participated in recommendations and include the American College of Medical Genetics and Genomics, the National Society for Genetic Counselors, and the Society of Gynecologic Oncology.⁷

The question always surfaces, could the clinical outcome of the cancer when diagnosed have been changed if screening were undertaken, with earlier diagnosis, or prevented with prophylactic mastectomy, and changed the end result. In addition, it is well known that breast augmentation mammoplasty alters the ability to accurately evaluate mammograms. Patients considering this type of plastic surgery, ideally, should be counselled accordingly.⁹

Bottom line, we as clinicians must be cognizant of both ACOG and United States Preventive Services Task Force (USPSTF) recommendations regarding screening and gene testing for women considered high risk for breast cancer based on family history.⁷

Legal considerations

The case presented demonstrates that the discovery of the BRCA1 and BRCA2 genes, and reliable tests for determining the existence of the genes, brought with them legal issues as well as medical advantages. We look at professional liability (malpractice) questions this technology raises, and then consider the outcome of the hypothetical case. (BRCA is used here to apply broadly—not only to BRCA1 and 2 but also to PALB2, CHEK2, and similar genetic abnormalities.)

To date, the most visible BRCA legal issues covered in cases and law reviews have focused more on patent law than malpractice. The most important of these was a decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics.¹⁰ The US Patent Office was granting patents to companies finding useful, naturally occurring segments of human DNA, and had granted Myriad several patents on BRCA1 and BRCA2 genes. This patent policy had the potential to seriously interfere with broad scientific use of these genes.¹¹ Fortunately, the Supreme Court stepped in and unanimously invalidated such patents. It held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court noted, “Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible ‘new . . . composition[s] of matter.’”⁸ The Court did allow the patenting of tests for specific gene structures, and artificial changes in naturally occurring genes.

Malpractice and BRCA

While the BRCA patent wars have lingered, the potential for a significant increase in BRCA-related malpractice cases is of increasing concern. Like most malpractice liability, these new claims are based on very old principles of negligence.¹² To prevail, the plaintiff (ordinarily, an injured patient) must demonstrate 4 things:

• A duty. That is, the physician owed a duty to the injured party. Usually (but not always) that requires a professional relationship between the physician and the person injured.
• A breach of that duty. Malpractice liability is based on the fact that the physician did something that a reasonably careful physician (generally, of the same specialty) would not have done, or that the physician failed to do something that a reasonable physician would have done. This usually means that the profession itself sees what the physician did (or did not do) as medically inappropriate. In medical malpractice cases, that is ordinarily measured by what the usual or common practice is among prudent physicians. In rare circumstances, courts have found the standard practice of a profession to be negligent. Where, for example, it was custom for a professional not to give an eye pressure test to anyone under age 40, a court found that common standard to be inappropriate.¹³ In the words of Judge Learned Hand (speaking about a different case), “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests.”¹⁴ Underlying negligence is a cost-benefit analysis (discussed below).
• Damages. There must have been some damage that courts recognize, usually loss of money or opportunity to work, the cost of care, pain and suffering, or loss of enjoyment/quality of life. In malpractice, many states now recognize the “loss of chance” or the “loss of a chance.” That means, if a “physician negligently fails to diagnose a curable disease, and the patient is harmed by the disease, the physician should be liable for causing the ‘loss of a chance of a cure.’”¹⁵ (Delay in diagnosis is the most common reason for claims in breast cancer care.)¹⁶
• Causation. The breach of duty (negligence) must have caused the damages. The causation must have been reasonably close. If a driver drives through a stop sign, or a physician misreads a test, and someone is injured but there is no connection between the negligence and the injury, there is not tort liability.

The 4 elements of malpractice just described are raised in some way in the possible liability associated with BRCA testing. We next look at the ways in which liability may arise from that testing (or lack of it).

Underlying much of the following discussion is the “cost-benefit” consideration noted above. This concept is that the total cost (financial and health) of testing should be compared with the value of the benefits of testing, taking into account the probabilities that the testing will result in better health outcomes. BRCA testing, for example, is essentially cost-free in terms of physical risk. Its financial cost, while not trivial, is not great, and it is commonly covered by health insurance.¹⁷ In terms of benefits, the testing has the potential for providing critical information in making treatment decisions for a meaningful percentage of patients and their families. There are many ways of analyzing the liability risks of genetic malpractice,^7,18 and the following is intended to discuss some of the greatest risks related to BRCA testing.

Continue to: Areas of liability...

The failure to recommend a test. The circumstances in which BRCA testing should be undertaken are set out by professional organizations (noted above). These recommendations are not static, however. They change from time to time. Given the potential harm caused by the failure to test in relevant circumstances, malpractice liability is certainly a possibility when the failure to recommend a test to a patient results in a cancer that might have been prevented had the genetic problem been identified in a timely manner. The circumstances in which testing should be considered continue to change, placing an obligation on clinicians to stay well informed of changing genetic understandings. Another risk is that one specialist may assume that it is the job of another specialist to order the test. Whatever the cause of the failure to test, or unnecessary delay in testing, it appears to be the primary basis for BRCA liability.

The failure to properly interpret a test. Any test that is misinterpreted may lead to harm for the patient. A false negative, of course, may mean that preventive treatment that could have been undertaken will be foregone, as a “loss of a chance.” On the other hand, a false positive can lead to radical, unnecessary surgery or treatment. If a misinterpretation occurred because of carelessness by the testing organization, or confusion by a practitioner, there is a likelihood of negligence.¹⁹

A different form of “misinterpretation” could be reasonable—and not negligent. Advances in scientific-medical understanding may result in the outcome of tests being reconsidered and changed. That has been the case with genetic testing and breast cancer. The availability of multiple breast cancer SNPs (single nucleotide polymorphisms), and combining this information with other risk factors for example, results in a polygenic risk score that may be at odds with the level of risk from earlier testing.^20,21 This naturally leads to the question of when later, updated testing should be recommended to look for a better current interpretation.^22,23

The failure to act on BRCA test results. Testing is of no value, of course, if the results are not used properly. Test results or analyses that are not sent to the proper physicians, or are somehow ignored when properly directed, is a “never” event—it should never happen. It almost always would be considered negligence, and if the patient were injured, could lead to liability. Amazingly, one study found that, in genetic testing liability cases, nearly 20% of the claims arose from failure to return test results to patients.²⁴ In addition, when a patient is found to be BRCA-positive, there is an obligation to discuss the options for dealing with the increased risk associated with the gene mutation(s), as well as to recommend the prudent course of action or to refer the patient to someone who will have that discussion.

Informed consent to the patient. BRCA testing requires informed consent. The physical risks of the testing process are minimal, of course, but it carries a number of other emotional and family risks. The informed consent process is an invitation to an honest discussion between clinicians and patients. It should be an opportunity to discuss what the testing is, and is not, and what the test may mean for treatment. It may also be an opportunity to discuss the implications for other members of the patient’s family (noted below).

One element of informed consent is a discussion of the consequences of failure to consent, or to undertake one of the alternatives. In the case of BRCA testing, this is especially important in cases in which a patient expresses a hesitancy to be tested with an “I’d rather not know philosophy.” Although clinicians should not practice law, some patient concerns about discrimination may be addressed by the protection that the federal Genetic Information Nondiscrimination Act (GINA) and other laws provide (which prohibit insurance and employment discrimination based on genetic information). A good source of information about GINA and related nondiscrimination laws is provided by the National Human Genome Research Institute.²⁵ In addition, the National Institutes of Health has a website that may be helpful to many patients²⁶ (and a much more complex site for health professionals).²⁷ At the same time, courts have resisted plaintiffs/patients who have tried to use informed consent as a way of suing for failure to offer genetic testing.^28,29

The failure to refer. In some cases, a patient should be formally referred for genetics consultation. The considerations here are similar to other circumstances in modern, fast developing medical practice that require special sensitivity to those occasions in which a patient will benefit from additional expertise. It is a principle that the AMA Council on Ethical and Judicial Affairs has expressed this way: “In the absence of adequate expertise in pretest and posttest counseling, a physician should refer the patient to an appropriate specialist.”³⁰ The failure to refer, when that deviates from acceptable practice, may result in liability.

Informing others. BRCA testing is an area of medicine in which results may be of great significance not only to the patient but also to the patient’s family.³¹ Physicians should counsel patients on the importance of informing relatives about relevant results and “should make themselves available to assist patients in communicating with relatives to discuss opportunities for counseling and testing, as appropriate.”³⁰ The question may arise, however, of whether in some circumstances physicians should go a step further in ensuring relatives receive important information regarding their loved one’s health.³² The law has been reluctant to impose liability to “third parties” (someone not a patient). Duties usually arise through the physician-patient relationship. There are exceptions. Perhaps the best known has been the obligation of mental health professionals to take action to protect third parties from patients who have made believable threats against identifiable victims.³³ There are indications that some courts could find, in extreme circumstances, a “duty to warn” nonpatients in some instances where it is essential to inform third parties that they should receive a specific form of genetic testing.^34,35 Such a duty would, of course, have to protect the privacy rights of the patient to the maximum extent possible. A general duty of this type has not been established widely, but may be part of the future.

Continue to: Was there liability in our example case?...

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

• the clinical implementation of genetic science has been slower than expected
• the lack of expertise of many physicians in genetic science
• expert witnesses have sometimes been hard to find
• the lack of understanding by plaintiffs’ attorneys of genetic malpractice
• potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

CASE Young woman with family history of breast cancer detects lump

Two weeks after noting a lump on her breast when her cat happened to jump on her in that spot, a 28-year-old woman (G0) went to her primary care provider. She was referred to her gynecologist; breast imaging, ultrasonography, and mammography were obtained, with microcalcifications noted. A fine needle aspiration diagnosed intraductal malignancy. The surgical breast tissue specimen was estrogen receptor (ER)- and progestogen receptor (PR)-positive and HER2-negative. Other tumor markers were obtained, including carcinoembryonic antigen, and tissue polypeptide specific antigen, p53, cathepsin D, cyclin E, and nestin, but results were not available.

With regard to family history, the woman’s mother and maternal grandmother had a history of breast cancer. The patient and her family underwent gene testing. The patient was found to be BRCA1- and BRCA2-positive; her mother was BRCA1-positive, an older sister was BRCA2-positive, and her grandmother was not tested.

The question arose in light of her family history as to why she was not tested for BRCA and appropriately counseled by her gynecologist prior to the cancer diagnosis. Litigation was initiated. While the case did not go forward regarding litigation, it is indeed a case in point. (Please note that this is a hypothetical case. It is based on a composite of several cases.)
 

Medical considerations

Breast cancer is the most common type of cancer affecting women in the Western world.¹ Advances in clinical testing for gene mutations have escalated and allowed for identification of patients at increased risk for breast and ovarian cancer. Along with these advances come professional liability risk. After looking at the medical considerations for BRCA1 and 2 testing, we will consider a number of important legal issues. In the view of some commentators, the failure to diagnose genetic mutations in patients predisposed to cancer is “poised to become the next wave of medical professional liability lawsuits.”²

BRCA1 and BRCA2 genes provide tumor suppressor proteins, and assessment for mutations is recommended for individuals at high risk for breast and/or ovarian cancer; mutations in BRCA genes cause DNA damage, which increases the chance of developing cancer. The other way to look at it is, BRCA1 and 2 are tumor suppressor genes that are integrally involved with DNA damage control. Once there is a mutation, it adversely affects the beneficial effects of the gene. Mutations in these genes account for 5% to 10% of all hereditary breast cancers.³ Of note, men with BRCA2 are at increased risk for prostate cancer.

A patient who presents to her gynecologist stating that there is a family history of breast cancer, without knowledge of genetic components, presents a challenge (and a medicolegal risk) for the provider to assess. Prediction models have been used to determine specific patient risk for carrying a genetic mutation with resultant breast cancer development.⁴ Risk prediction models do not appear to be a good answer to predicting who is more likely to develop breast or ovarian cancer, however. A Mayo model may assist (FIGURE).⁵ Clinicians should also be aware of other models of risk assessment, including the Gail Model (TABLE 1).⁶

Continue to: Guidelines for genetic testing...

Guidelines for genetic testing

The American College of Obstetricians and Gynecologists states that patient medical history and family history are paramount in obtaining information regarding risk for breast and ovarian cancer. First- and second-degree relatives are allocated to this category. Information regarding age of diagnosis, maternal and paternal lineage, and ethnic background can imply a need for genetic testing (TABLE 2).^7,8 A number of genetics national organizations have participated in recommendations and include the American College of Medical Genetics and Genomics, the National Society for Genetic Counselors, and the Society of Gynecologic Oncology.⁷

The question always surfaces, could the clinical outcome of the cancer when diagnosed have been changed if screening were undertaken, with earlier diagnosis, or prevented with prophylactic mastectomy, and changed the end result. In addition, it is well known that breast augmentation mammoplasty alters the ability to accurately evaluate mammograms. Patients considering this type of plastic surgery, ideally, should be counselled accordingly.⁹

Bottom line, we as clinicians must be cognizant of both ACOG and United States Preventive Services Task Force (USPSTF) recommendations regarding screening and gene testing for women considered high risk for breast cancer based on family history.⁷

Legal considerations

The case presented demonstrates that the discovery of the BRCA1 and BRCA2 genes, and reliable tests for determining the existence of the genes, brought with them legal issues as well as medical advantages. We look at professional liability (malpractice) questions this technology raises, and then consider the outcome of the hypothetical case. (BRCA is used here to apply broadly—not only to BRCA1 and 2 but also to PALB2, CHEK2, and similar genetic abnormalities.)

To date, the most visible BRCA legal issues covered in cases and law reviews have focused more on patent law than malpractice. The most important of these was a decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics.¹⁰ The US Patent Office was granting patents to companies finding useful, naturally occurring segments of human DNA, and had granted Myriad several patents on BRCA1 and BRCA2 genes. This patent policy had the potential to seriously interfere with broad scientific use of these genes.¹¹ Fortunately, the Supreme Court stepped in and unanimously invalidated such patents. It held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court noted, “Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible ‘new . . . composition[s] of matter.’”⁸ The Court did allow the patenting of tests for specific gene structures, and artificial changes in naturally occurring genes.

Malpractice and BRCA

While the BRCA patent wars have lingered, the potential for a significant increase in BRCA-related malpractice cases is of increasing concern. Like most malpractice liability, these new claims are based on very old principles of negligence.¹² To prevail, the plaintiff (ordinarily, an injured patient) must demonstrate 4 things:

• A duty. That is, the physician owed a duty to the injured party. Usually (but not always) that requires a professional relationship between the physician and the person injured.
• A breach of that duty. Malpractice liability is based on the fact that the physician did something that a reasonably careful physician (generally, of the same specialty) would not have done, or that the physician failed to do something that a reasonable physician would have done. This usually means that the profession itself sees what the physician did (or did not do) as medically inappropriate. In medical malpractice cases, that is ordinarily measured by what the usual or common practice is among prudent physicians. In rare circumstances, courts have found the standard practice of a profession to be negligent. Where, for example, it was custom for a professional not to give an eye pressure test to anyone under age 40, a court found that common standard to be inappropriate.¹³ In the words of Judge Learned Hand (speaking about a different case), “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests.”¹⁴ Underlying negligence is a cost-benefit analysis (discussed below).
• Damages. There must have been some damage that courts recognize, usually loss of money or opportunity to work, the cost of care, pain and suffering, or loss of enjoyment/quality of life. In malpractice, many states now recognize the “loss of chance” or the “loss of a chance.” That means, if a “physician negligently fails to diagnose a curable disease, and the patient is harmed by the disease, the physician should be liable for causing the ‘loss of a chance of a cure.’”¹⁵ (Delay in diagnosis is the most common reason for claims in breast cancer care.)¹⁶
• Causation. The breach of duty (negligence) must have caused the damages. The causation must have been reasonably close. If a driver drives through a stop sign, or a physician misreads a test, and someone is injured but there is no connection between the negligence and the injury, there is not tort liability.

The 4 elements of malpractice just described are raised in some way in the possible liability associated with BRCA testing. We next look at the ways in which liability may arise from that testing (or lack of it).

Underlying much of the following discussion is the “cost-benefit” consideration noted above. This concept is that the total cost (financial and health) of testing should be compared with the value of the benefits of testing, taking into account the probabilities that the testing will result in better health outcomes. BRCA testing, for example, is essentially cost-free in terms of physical risk. Its financial cost, while not trivial, is not great, and it is commonly covered by health insurance.¹⁷ In terms of benefits, the testing has the potential for providing critical information in making treatment decisions for a meaningful percentage of patients and their families. There are many ways of analyzing the liability risks of genetic malpractice,^7,18 and the following is intended to discuss some of the greatest risks related to BRCA testing.

Continue to: Areas of liability...

The failure to recommend a test. The circumstances in which BRCA testing should be undertaken are set out by professional organizations (noted above). These recommendations are not static, however. They change from time to time. Given the potential harm caused by the failure to test in relevant circumstances, malpractice liability is certainly a possibility when the failure to recommend a test to a patient results in a cancer that might have been prevented had the genetic problem been identified in a timely manner. The circumstances in which testing should be considered continue to change, placing an obligation on clinicians to stay well informed of changing genetic understandings. Another risk is that one specialist may assume that it is the job of another specialist to order the test. Whatever the cause of the failure to test, or unnecessary delay in testing, it appears to be the primary basis for BRCA liability.

The failure to properly interpret a test. Any test that is misinterpreted may lead to harm for the patient. A false negative, of course, may mean that preventive treatment that could have been undertaken will be foregone, as a “loss of a chance.” On the other hand, a false positive can lead to radical, unnecessary surgery or treatment. If a misinterpretation occurred because of carelessness by the testing organization, or confusion by a practitioner, there is a likelihood of negligence.¹⁹

A different form of “misinterpretation” could be reasonable—and not negligent. Advances in scientific-medical understanding may result in the outcome of tests being reconsidered and changed. That has been the case with genetic testing and breast cancer. The availability of multiple breast cancer SNPs (single nucleotide polymorphisms), and combining this information with other risk factors for example, results in a polygenic risk score that may be at odds with the level of risk from earlier testing.^20,21 This naturally leads to the question of when later, updated testing should be recommended to look for a better current interpretation.^22,23

The failure to act on BRCA test results. Testing is of no value, of course, if the results are not used properly. Test results or analyses that are not sent to the proper physicians, or are somehow ignored when properly directed, is a “never” event—it should never happen. It almost always would be considered negligence, and if the patient were injured, could lead to liability. Amazingly, one study found that, in genetic testing liability cases, nearly 20% of the claims arose from failure to return test results to patients.²⁴ In addition, when a patient is found to be BRCA-positive, there is an obligation to discuss the options for dealing with the increased risk associated with the gene mutation(s), as well as to recommend the prudent course of action or to refer the patient to someone who will have that discussion.

Informed consent to the patient. BRCA testing requires informed consent. The physical risks of the testing process are minimal, of course, but it carries a number of other emotional and family risks. The informed consent process is an invitation to an honest discussion between clinicians and patients. It should be an opportunity to discuss what the testing is, and is not, and what the test may mean for treatment. It may also be an opportunity to discuss the implications for other members of the patient’s family (noted below).

One element of informed consent is a discussion of the consequences of failure to consent, or to undertake one of the alternatives. In the case of BRCA testing, this is especially important in cases in which a patient expresses a hesitancy to be tested with an “I’d rather not know philosophy.” Although clinicians should not practice law, some patient concerns about discrimination may be addressed by the protection that the federal Genetic Information Nondiscrimination Act (GINA) and other laws provide (which prohibit insurance and employment discrimination based on genetic information). A good source of information about GINA and related nondiscrimination laws is provided by the National Human Genome Research Institute.²⁵ In addition, the National Institutes of Health has a website that may be helpful to many patients²⁶ (and a much more complex site for health professionals).²⁷ At the same time, courts have resisted plaintiffs/patients who have tried to use informed consent as a way of suing for failure to offer genetic testing.^28,29

The failure to refer. In some cases, a patient should be formally referred for genetics consultation. The considerations here are similar to other circumstances in modern, fast developing medical practice that require special sensitivity to those occasions in which a patient will benefit from additional expertise. It is a principle that the AMA Council on Ethical and Judicial Affairs has expressed this way: “In the absence of adequate expertise in pretest and posttest counseling, a physician should refer the patient to an appropriate specialist.”³⁰ The failure to refer, when that deviates from acceptable practice, may result in liability.

Informing others. BRCA testing is an area of medicine in which results may be of great significance not only to the patient but also to the patient’s family.³¹ Physicians should counsel patients on the importance of informing relatives about relevant results and “should make themselves available to assist patients in communicating with relatives to discuss opportunities for counseling and testing, as appropriate.”³⁰ The question may arise, however, of whether in some circumstances physicians should go a step further in ensuring relatives receive important information regarding their loved one’s health.³² The law has been reluctant to impose liability to “third parties” (someone not a patient). Duties usually arise through the physician-patient relationship. There are exceptions. Perhaps the best known has been the obligation of mental health professionals to take action to protect third parties from patients who have made believable threats against identifiable victims.³³ There are indications that some courts could find, in extreme circumstances, a “duty to warn” nonpatients in some instances where it is essential to inform third parties that they should receive a specific form of genetic testing.^34,35 Such a duty would, of course, have to protect the privacy rights of the patient to the maximum extent possible. A general duty of this type has not been established widely, but may be part of the future.

Continue to: Was there liability in our example case?...

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

• the clinical implementation of genetic science has been slower than expected
• the lack of expertise of many physicians in genetic science
• expert witnesses have sometimes been hard to find
• the lack of understanding by plaintiffs’ attorneys of genetic malpractice
• potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

CASE Young woman with family history of breast cancer detects lump

Two weeks after noting a lump on her breast when her cat happened to jump on her in that spot, a 28-year-old woman (G0) went to her primary care provider. She was referred to her gynecologist; breast imaging, ultrasonography, and mammography were obtained, with microcalcifications noted. A fine needle aspiration diagnosed intraductal malignancy. The surgical breast tissue specimen was estrogen receptor (ER)- and progestogen receptor (PR)-positive and HER2-negative. Other tumor markers were obtained, including carcinoembryonic antigen, and tissue polypeptide specific antigen, p53, cathepsin D, cyclin E, and nestin, but results were not available.

With regard to family history, the woman’s mother and maternal grandmother had a history of breast cancer. The patient and her family underwent gene testing. The patient was found to be BRCA1- and BRCA2-positive; her mother was BRCA1-positive, an older sister was BRCA2-positive, and her grandmother was not tested.

The question arose in light of her family history as to why she was not tested for BRCA and appropriately counseled by her gynecologist prior to the cancer diagnosis. Litigation was initiated. While the case did not go forward regarding litigation, it is indeed a case in point. (Please note that this is a hypothetical case. It is based on a composite of several cases.)
 

Medical considerations

Breast cancer is the most common type of cancer affecting women in the Western world.¹ Advances in clinical testing for gene mutations have escalated and allowed for identification of patients at increased risk for breast and ovarian cancer. Along with these advances come professional liability risk. After looking at the medical considerations for BRCA1 and 2 testing, we will consider a number of important legal issues. In the view of some commentators, the failure to diagnose genetic mutations in patients predisposed to cancer is “poised to become the next wave of medical professional liability lawsuits.”²

BRCA1 and BRCA2 genes provide tumor suppressor proteins, and assessment for mutations is recommended for individuals at high risk for breast and/or ovarian cancer; mutations in BRCA genes cause DNA damage, which increases the chance of developing cancer. The other way to look at it is, BRCA1 and 2 are tumor suppressor genes that are integrally involved with DNA damage control. Once there is a mutation, it adversely affects the beneficial effects of the gene. Mutations in these genes account for 5% to 10% of all hereditary breast cancers.³ Of note, men with BRCA2 are at increased risk for prostate cancer.

A patient who presents to her gynecologist stating that there is a family history of breast cancer, without knowledge of genetic components, presents a challenge (and a medicolegal risk) for the provider to assess. Prediction models have been used to determine specific patient risk for carrying a genetic mutation with resultant breast cancer development.⁴ Risk prediction models do not appear to be a good answer to predicting who is more likely to develop breast or ovarian cancer, however. A Mayo model may assist (FIGURE).⁵ Clinicians should also be aware of other models of risk assessment, including the Gail Model (TABLE 1).⁶

Continue to: Guidelines for genetic testing...

Guidelines for genetic testing

The American College of Obstetricians and Gynecologists states that patient medical history and family history are paramount in obtaining information regarding risk for breast and ovarian cancer. First- and second-degree relatives are allocated to this category. Information regarding age of diagnosis, maternal and paternal lineage, and ethnic background can imply a need for genetic testing (TABLE 2).^7,8 A number of genetics national organizations have participated in recommendations and include the American College of Medical Genetics and Genomics, the National Society for Genetic Counselors, and the Society of Gynecologic Oncology.⁷

The question always surfaces, could the clinical outcome of the cancer when diagnosed have been changed if screening were undertaken, with earlier diagnosis, or prevented with prophylactic mastectomy, and changed the end result. In addition, it is well known that breast augmentation mammoplasty alters the ability to accurately evaluate mammograms. Patients considering this type of plastic surgery, ideally, should be counselled accordingly.⁹

Bottom line, we as clinicians must be cognizant of both ACOG and United States Preventive Services Task Force (USPSTF) recommendations regarding screening and gene testing for women considered high risk for breast cancer based on family history.⁷

Legal considerations

The case presented demonstrates that the discovery of the BRCA1 and BRCA2 genes, and reliable tests for determining the existence of the genes, brought with them legal issues as well as medical advantages. We look at professional liability (malpractice) questions this technology raises, and then consider the outcome of the hypothetical case. (BRCA is used here to apply broadly—not only to BRCA1 and 2 but also to PALB2, CHEK2, and similar genetic abnormalities.)

To date, the most visible BRCA legal issues covered in cases and law reviews have focused more on patent law than malpractice. The most important of these was a decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics.¹⁰ The US Patent Office was granting patents to companies finding useful, naturally occurring segments of human DNA, and had granted Myriad several patents on BRCA1 and BRCA2 genes. This patent policy had the potential to seriously interfere with broad scientific use of these genes.¹¹ Fortunately, the Supreme Court stepped in and unanimously invalidated such patents. It held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court noted, “Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible ‘new . . . composition[s] of matter.’”⁸ The Court did allow the patenting of tests for specific gene structures, and artificial changes in naturally occurring genes.

Malpractice and BRCA

While the BRCA patent wars have lingered, the potential for a significant increase in BRCA-related malpractice cases is of increasing concern. Like most malpractice liability, these new claims are based on very old principles of negligence.¹² To prevail, the plaintiff (ordinarily, an injured patient) must demonstrate 4 things:

• A duty. That is, the physician owed a duty to the injured party. Usually (but not always) that requires a professional relationship between the physician and the person injured.
• A breach of that duty. Malpractice liability is based on the fact that the physician did something that a reasonably careful physician (generally, of the same specialty) would not have done, or that the physician failed to do something that a reasonable physician would have done. This usually means that the profession itself sees what the physician did (or did not do) as medically inappropriate. In medical malpractice cases, that is ordinarily measured by what the usual or common practice is among prudent physicians. In rare circumstances, courts have found the standard practice of a profession to be negligent. Where, for example, it was custom for a professional not to give an eye pressure test to anyone under age 40, a court found that common standard to be inappropriate.¹³ In the words of Judge Learned Hand (speaking about a different case), “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests.”¹⁴ Underlying negligence is a cost-benefit analysis (discussed below).
• Damages. There must have been some damage that courts recognize, usually loss of money or opportunity to work, the cost of care, pain and suffering, or loss of enjoyment/quality of life. In malpractice, many states now recognize the “loss of chance” or the “loss of a chance.” That means, if a “physician negligently fails to diagnose a curable disease, and the patient is harmed by the disease, the physician should be liable for causing the ‘loss of a chance of a cure.’”¹⁵ (Delay in diagnosis is the most common reason for claims in breast cancer care.)¹⁶
• Causation. The breach of duty (negligence) must have caused the damages. The causation must have been reasonably close. If a driver drives through a stop sign, or a physician misreads a test, and someone is injured but there is no connection between the negligence and the injury, there is not tort liability.

The 4 elements of malpractice just described are raised in some way in the possible liability associated with BRCA testing. We next look at the ways in which liability may arise from that testing (or lack of it).

Underlying much of the following discussion is the “cost-benefit” consideration noted above. This concept is that the total cost (financial and health) of testing should be compared with the value of the benefits of testing, taking into account the probabilities that the testing will result in better health outcomes. BRCA testing, for example, is essentially cost-free in terms of physical risk. Its financial cost, while not trivial, is not great, and it is commonly covered by health insurance.¹⁷ In terms of benefits, the testing has the potential for providing critical information in making treatment decisions for a meaningful percentage of patients and their families. There are many ways of analyzing the liability risks of genetic malpractice,^7,18 and the following is intended to discuss some of the greatest risks related to BRCA testing.

Continue to: Areas of liability...

The failure to recommend a test. The circumstances in which BRCA testing should be undertaken are set out by professional organizations (noted above). These recommendations are not static, however. They change from time to time. Given the potential harm caused by the failure to test in relevant circumstances, malpractice liability is certainly a possibility when the failure to recommend a test to a patient results in a cancer that might have been prevented had the genetic problem been identified in a timely manner. The circumstances in which testing should be considered continue to change, placing an obligation on clinicians to stay well informed of changing genetic understandings. Another risk is that one specialist may assume that it is the job of another specialist to order the test. Whatever the cause of the failure to test, or unnecessary delay in testing, it appears to be the primary basis for BRCA liability.

The failure to properly interpret a test. Any test that is misinterpreted may lead to harm for the patient. A false negative, of course, may mean that preventive treatment that could have been undertaken will be foregone, as a “loss of a chance.” On the other hand, a false positive can lead to radical, unnecessary surgery or treatment. If a misinterpretation occurred because of carelessness by the testing organization, or confusion by a practitioner, there is a likelihood of negligence.¹⁹

A different form of “misinterpretation” could be reasonable—and not negligent. Advances in scientific-medical understanding may result in the outcome of tests being reconsidered and changed. That has been the case with genetic testing and breast cancer. The availability of multiple breast cancer SNPs (single nucleotide polymorphisms), and combining this information with other risk factors for example, results in a polygenic risk score that may be at odds with the level of risk from earlier testing.^20,21 This naturally leads to the question of when later, updated testing should be recommended to look for a better current interpretation.^22,23

The failure to act on BRCA test results. Testing is of no value, of course, if the results are not used properly. Test results or analyses that are not sent to the proper physicians, or are somehow ignored when properly directed, is a “never” event—it should never happen. It almost always would be considered negligence, and if the patient were injured, could lead to liability. Amazingly, one study found that, in genetic testing liability cases, nearly 20% of the claims arose from failure to return test results to patients.²⁴ In addition, when a patient is found to be BRCA-positive, there is an obligation to discuss the options for dealing with the increased risk associated with the gene mutation(s), as well as to recommend the prudent course of action or to refer the patient to someone who will have that discussion.

Informed consent to the patient. BRCA testing requires informed consent. The physical risks of the testing process are minimal, of course, but it carries a number of other emotional and family risks. The informed consent process is an invitation to an honest discussion between clinicians and patients. It should be an opportunity to discuss what the testing is, and is not, and what the test may mean for treatment. It may also be an opportunity to discuss the implications for other members of the patient’s family (noted below).

One element of informed consent is a discussion of the consequences of failure to consent, or to undertake one of the alternatives. In the case of BRCA testing, this is especially important in cases in which a patient expresses a hesitancy to be tested with an “I’d rather not know philosophy.” Although clinicians should not practice law, some patient concerns about discrimination may be addressed by the protection that the federal Genetic Information Nondiscrimination Act (GINA) and other laws provide (which prohibit insurance and employment discrimination based on genetic information). A good source of information about GINA and related nondiscrimination laws is provided by the National Human Genome Research Institute.²⁵ In addition, the National Institutes of Health has a website that may be helpful to many patients²⁶ (and a much more complex site for health professionals).²⁷ At the same time, courts have resisted plaintiffs/patients who have tried to use informed consent as a way of suing for failure to offer genetic testing.^28,29

The failure to refer. In some cases, a patient should be formally referred for genetics consultation. The considerations here are similar to other circumstances in modern, fast developing medical practice that require special sensitivity to those occasions in which a patient will benefit from additional expertise. It is a principle that the AMA Council on Ethical and Judicial Affairs has expressed this way: “In the absence of adequate expertise in pretest and posttest counseling, a physician should refer the patient to an appropriate specialist.”³⁰ The failure to refer, when that deviates from acceptable practice, may result in liability.

Informing others. BRCA testing is an area of medicine in which results may be of great significance not only to the patient but also to the patient’s family.³¹ Physicians should counsel patients on the importance of informing relatives about relevant results and “should make themselves available to assist patients in communicating with relatives to discuss opportunities for counseling and testing, as appropriate.”³⁰ The question may arise, however, of whether in some circumstances physicians should go a step further in ensuring relatives receive important information regarding their loved one’s health.³² The law has been reluctant to impose liability to “third parties” (someone not a patient). Duties usually arise through the physician-patient relationship. There are exceptions. Perhaps the best known has been the obligation of mental health professionals to take action to protect third parties from patients who have made believable threats against identifiable victims.³³ There are indications that some courts could find, in extreme circumstances, a “duty to warn” nonpatients in some instances where it is essential to inform third parties that they should receive a specific form of genetic testing.^34,35 Such a duty would, of course, have to protect the privacy rights of the patient to the maximum extent possible. A general duty of this type has not been established widely, but may be part of the future.

Continue to: Was there liability in our example case?...

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

• the clinical implementation of genetic science has been slower than expected
• the lack of expertise of many physicians in genetic science
• expert witnesses have sometimes been hard to find
• the lack of understanding by plaintiffs’ attorneys of genetic malpractice
• potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

CASE Unidentified ectopic pregnancy leads to rupture*

A 33-year-old woman (G1 P0010) with 2 positive home pregnancy tests presents to the emergency department (ED) reporting intermittent vaginal bleeding for 3 days. Her last menstrual period was 10 weeks ago, but she reports that her menses are always irregular. She has a history of asymptomatic chlamydia, as well as spontaneous abortion 2 years prior. At present, she denies abdominal pain or vaginal discharge.

Upon examination her vital signs are: temperature, 98.3 °F; pulse, 112 bpm, with a resting rate of 16 bpm; blood pressure (BP), 142/91 mm Hg; pulse O2, 99%; height, 4’ 3”; weight, 115 lb. Her labs are: hemoglobin, 12.1 g/dL; hematocrit, 38%; serum human chorionic gonadotropin (hCG) 236 mIU/mL. Upon pelvic examination, no active bleeding is noted. She agrees to be followed up by her gynecologist and is given a prescription for serum hCG in 2 days. She is instructed to return to the ED should she have pain or increased vaginal bleeding.

Three days later, the patient follows up with her gynecologist reporting mild cramping. She notes having had an episode of heavy vaginal bleeding and a “weakly positive” home pregnancy test. Transvaginal ultrasonography notes endometrial thickness 0.59 mm and unremarkable adnexa. A urine pregnancy test performed in the office is positive; urinalysis is positive for nitrites. With the bleeding slowed, the gynecologist’s overall impression is that the patient has undergone complete spontaneous abortion. She prescribes Macrobid for the urinary tract infection. She does not obtain the ED-prescribed serum HCG levels, as she feels, since complete spontaneous abortion has occurred there is no need to obtain a follow-up serum HCG.

Five days later, the patient returns to the ED reporting abdominal pain after eating. Fever and productive cough of 2 days are noted. The patient states that she had a recent miscarriage. The overall impression of the patient’s condition is bronchitis, and it is noted on the patient’s record, “unlikely ectopic pregnancy and pregnancy test may be false positive,” hence a pregnancy test is not ordered. Examination reveals mild suprapubic tenderness with no rebound; no pelvic exam is performed. The patient is instructed to follow up with a health care clinic within a week, and to return to the ED with severe abdominal pain, higher fever, or any new concerning symptoms. A Zithromax Z-pak is prescribed.

Four days later, the patient is brought by ambulance to the ED of the local major medical center with severe abdominal pain involving the right lower quadrant. She states that she had a miscarriage 3 weeks prior and was recently treated for bronchitis. She has dizziness when standing. Her vital signs are: temperature, 97.8 °F; heart rate, 95 bpm; BP, 72/48 mm Hg; pulse O2, 100%. She reports her abdominal pain to be 6/10.

The patient is given a Lactated Ringer’s bolus of 1,000 mL for a hypotensive episode. Computed tomography is obtained and notes, “low attenuation in the left adnexa with a dilated fallopian tube.” A large heterogeneous collection of fluid in the pelvis is noted with active extravasation, consistent with an “acute bleed.”

The patient is brought to the operating room with a diagnosis of probable ruptured ectopic pregnancy. Intraoperatively she is noted to have a right ruptured ectopic and left tubo-ovarian abscess. The surgeon proceeds with right salpingectomy and left salpingo-oophorectomy. Three liters of hemoperitoneum is found.

She is followed postoperatively with serum hCG until levels are negative. Her postoperative course is uneventful. Her only future option for pregnancy is through assisted reproductive technology (ART) with in vitro fertilization (IVF). The patient sues the gynecologist and second ED physician for presumed inappropriate assessment for ectopic pregnancy.

*The “facts” of this case are a composite, drawn from several cases to illustrate medical and legal issues. The statement of facts should be considered hypothetical.

Continue to: WHAT’S THE VERDICT?...

WHAT’S THE VERDICT?

A defense verdict is returned.

Medical considerations

The incidence of ectopic pregnancy is 2% of all pregnancies, with a higher incidence (about 4%) among infertility patients.¹ Up to 10% of ectopic pregnancies have no symptoms.²

Clinical presentations. Classic signs of ectopic pregnancy include:

• abdominal pain
• vaginal bleeding
• late menses (often noted).

A recent case of ectopic pregnancy presenting with chest pain was reported.³ Clinicians must never lose site of the fact that ectopic pregnancy is the most common cause of maternal mortality in the first trimester, with an incidence of 1% to 10% of all first-trimester deaths.⁴

Risk factors include pelvic inflammatory disease, as demonstrated in the opening case. “The silent epidemic of chlamydia” comes to mind, and tobacco smoking can adversely affect tubal cilia, as can pelvic adhesions and/or prior tubal surgery. All of these factors can predispose a patient to ectopic pregnancy; in addition, intrauterine devices, endometriosis, tubal ligation (or ligation reversal), all can set the stage for an ectopic pregnancy.⁵ Appropriate serum hCG monitoring during early pregnancy can assist in sorting out pregnancies of unknown location (PUL; FIGURE). First trimester ultrasonography, at 5 weeks gestation, usually identifies early intrauterine gestation.

Heterotopic pregnancy includes an intrauterine gestation and an ectopic pregnancy. This presentation includes the presence of a “pseudosac” in the endometrial cavity plus an extrauterine gestation. Heterotopic pregnancies have become somewhat more common as ART/IVF has unfolded, especially prior to the predominance of single embryo transfer.

Managing ectopic pregnancy

For cases of early pregnancy complicated by intermittent bleeding and/or pain, monitoring with serum hCG levels at 48-hour intervals to distinguish a viable IUP from an abnormal IUP or an ectopic is appropriate. The “discriminatory zone” collates serum hCG levels with findings on ultrasonography. Specific lower limits of serum hCG levels are not clear cut, with recommendations of 3,500 mIU/mL to provide sonographic evidence of an intrauterine gestation “to avoid misdiagnosis and possible interruption of intrauterine pregnancy,” as conveyed in the American College of Obstetricians and Gynecologists 2018 practice bulletin.⁸ Serum progesterone levels also have been suggested to complement hCG levels; a progesterone level of <20 nmol/L is consistent with an abnormal pregnancy, whereas levels >25 nmol/L are suggestive of a viable pregnancy.² Inhibin A levels also have been suggested to be helpful, but they are not an ideal monitoring tool.

While most ectopic pregnancies are located in the fallopian tube, other locations also can be abdominal or ovarian. In addition, cesarean scar ectopic pregnancy can occur and often is associated with delay in diagnosis and greater morbidity due to such delay.⁹ With regard to ovarian ectopic, Spiegelberg criteria are established for diagnosis (TABLE 1).¹⁰

Appropriate management of an ectopic pregnancy is dependent upon the gestational age, serum hCG levels, and imaging findings, as well as the patient’s symptoms and exam findings. Treatment is established in large part on a case-by-case basis and includes, for early pregnancy, expectant management and use of methotrexate (TABLE 2).¹¹ Dilation and curettage may be used to identify the pregnancy’s location when the serum hCG level is below 2,000 mIU/mL and there is no evidence of an IUP on ultrasound. Surgical treatment can include minimally invasive salpingostomy or salpingectomy and, depending on circumstance, laparotomy may be indicated.

Continue to: Legal perspective...

Legal perspective

Lawsuits related to ectopic pregnancy are not a new phenomenon. In fact, in 1897, a physician in Ohio who misdiagnosed an “extrauterine pregnancy” as appendicitis was the center of a malpractice lawsuit.¹³ Unrecognized or mishandled ectopic pregnancy can result in serious injuries—in the range of 1% to 10% (see above) of maternal deaths are related to ectopic pregnancy.¹⁴ Ectopic pregnancy cases, therefore, have been the subject of substantial litigation over the years. An informal, noncomprehensive review of malpractice lawsuits brought from 2000 to 2019, found more than 300 ectopic pregnancy cases. Given the large number of malpractice claims against ObGyns,¹⁵ ectopic pregnancy cases are only a small portion of all ObGyn malpractice cases.¹⁶

A common claim: negligent diagnosis or treatment

The most common basis for lawsuits in cases of ectopic pregnancy is the clinician’s negligent failure to properly diagnose the ectopic nature of the pregnancy. There are also a number of cases claiming negligent treatment of an identified ectopic pregnancy. Not every missed diagnosis, or unsuccessful treatment, leads to liability, of course. It is only when a diagnosis or treatment fails to meet the standard of care within the profession that there should be liability. That standard of care is generally defined by what a reasonably prudent physician would do under the circumstances. Expert witnesses, who are familiar with the standard of practice within the specialty, are usually necessary to establish what that practice is. Both the plaintiff and the defense obtain experts, the former to prove what the standard of care is and that the standard was not met in the case at hand. The defense experts are usually arguing that the standard of care was met.¹⁷ Inadequate diagnosis of ectopic pregnancy or other condition may arise from a failure to take a sufficient history, conduct an appropriately thorough physical examination, recognize any of the symptoms that would suggest it is present, use and conduct ultrasound correctly, or follow-up appropriately with additional testing.¹⁸

A malpractice claim of negligent treatment can involve any the following circumstances¹⁹:

• failure to establish an appropriate treatment plan
• prescribing inappropriate medications for the patient (eg, methotrexate, when it is contraindicated)
• delivering the wrong medication or the wrong amount of the right medication
• performing a procedure badly
• undertaking a new treatment without adequate instruction and preparation.

Given the nature and risks of ectopic pregnancy, ongoing, frequent contact with the patient is essential from the point at which the condition is suspected. The greater the risk of harm (probability or consequence), the more careful any professional ought to be. Because ectopic pregnancy is not an uncommon occurrence, and because it can have devastating effects, including death, a reasonably prudent practitioner would be especially aware of the clinical presentations discussed above.²⁰ In the opening case, the treatment plan was not well documented.

Negligence must lead to patient harm. In addition to negligence (proving that the physician did not act in accordance with the standard of care), to prevail in a malpractice case, the plaintiff-patient must prove that the negligence caused the injury, or worsened it. If the failure to make a diagnosis would not have made any difference in a harm the patient suffered, there are no damages and no liability. Suppose, for example, that a physician negligently failed to diagnose ectopic pregnancy, but performed surgery expecting to find the misdiagnosed condition. In the course of the surgery, however, the surgeon discovered and appropriately treated the ectopic pregnancy. (A version of this happened in the old 19th century case mentioned above.) The negligence of the physician did not cause harm, so there are no damages and no liability.

Continue to: Informed consent is vital...

Informed consent is vital

A part of malpractice is informed consent (or the absence of it)—issues that can arise in any medical care.²¹ It is wise to pay particular attention in cases where the nature of the illness is unknown, and where there are significant uncertainties and the nature of testing and treatment may change substantially over a period of a few days or few weeks. As always, informed consent should include a discussion of what process or procedure is proposed, its risks and benefits, alternative approaches that might be available, and the risk of doing nothing. Frequently, the uncertainty of ectopic pregnancy complicates the informed consent process.²²

Because communication with the patient is an essential function of informed consent, the consent process should productively be used in PUL and similar cases to inform the patient about the uncertainty, and the testing and (nonsurgical) treatment that will occur. This is an opportunity to reinforce the message that the patient must maintain ongoing communication with the physician’s office about changes in her condition, and appear for each appointment scheduled. If more invasive procedures—notably surgery—become required, a separate consent process should be completed, because the risks and considerations are now meaningfully different than when treatment began. As a general matter, any possible treatment that may result in infertility or reduced reproductive capacity should specifically be included in the consent process.

In the hypothetical case, the gynecologist failed to obtain a follow-up serum hCG level. In addition, the record did not reflect ectopic pregnancy in the differential diagnosis. As noted above, the patient had predisposing factors for an ectopic pregnancy. The physician should have acknowledged the history of sexually transmitted disease predisposing her to an ectopic pregnancy. Monitoring of serum hCG levels until they are negative is appropriate with ectopic, or presumed ectopic, pregnancy management. Appropriate monitoring did not occur in this case. Each of these errors (following up on serum hCG levels and the inadequacy of notations about the possibility of ectopic pregnancy) seem inconsistent with the usual standard of care. Furthermore, as a result of the outcome, the only future option for the patient to pursue pregnancy was IVF.

Other legal issues

There are a number of other legal issues that are associated with the topic of ectopic pregnancy. There is evidence, for example, that Catholic and non-Catholic hospitals treat ectopic pregnancies differently,²³ which may reflect different views on taking a life or the use of methotrexate and its association with abortion.²⁴ In addition, the possibility of an increase in future ectopic pregnancies is one of the “risks” of abortion that pro-life organizations have pushed to see included in abortion informed consent.²⁵ This has led some commentators to conclude that some Catholic hospitals violate federal law in managing ectopic pregnancy. There is also evidence of “overwhelming rates of medical misinformation on pregnancy center websites, including a link between abortion and ectopic pregnancy.”²⁶

The fact that cesarean deliveries are related to an increased risk for ectopic pregnancy (because of the risk of cesarean scar ectopic pregnancy) also has been cited as information that should play a role in the consent process for cesarean delivery.²⁷ In terms of liability, failed tubal ligation leads to a 33% risk of ectopic pregnancy.²⁸ The risk of ectopic pregnancy is also commonly included in surrogacy contracts.²⁹

Why the outcome was for the defense

The opening hypothetical case illustrates some of the uncertainties of medical malpractice cases. As noted, there appeared a deviation from the usual standard of care, particularly the failure to follow up on the serum hCG level. The weakness in the medical record, failing to note the possibility of ectopic pregnancy, also was probably an error but, apparently, the court felt that this did not result in any harm to the patient.

The question arises of how there would be a defense verdict in light of the failure to track consecutive serum hCG levels. A speculative explanation is that there are many uncertainties in most lawsuits. Procedural problems may result in a case being limited, expert witnesses are essential to both the plaintiff and defense, with the quality of their review and testimony possibly uneven. Judges and juries may rely on one expert witness rather than another, juries vary, and the quality of advocacy differs. Any of these situations can contribute to the unpredictability of the outcome of a case. In the case above, the liability was somewhat uncertain, and the various other factors tipped in favor of a defense verdict. ●

CASE Unidentified ectopic pregnancy leads to rupture*

A 33-year-old woman (G1 P0010) with 2 positive home pregnancy tests presents to the emergency department (ED) reporting intermittent vaginal bleeding for 3 days. Her last menstrual period was 10 weeks ago, but she reports that her menses are always irregular. She has a history of asymptomatic chlamydia, as well as spontaneous abortion 2 years prior. At present, she denies abdominal pain or vaginal discharge.

Upon examination her vital signs are: temperature, 98.3 °F; pulse, 112 bpm, with a resting rate of 16 bpm; blood pressure (BP), 142/91 mm Hg; pulse O2, 99%; height, 4’ 3”; weight, 115 lb. Her labs are: hemoglobin, 12.1 g/dL; hematocrit, 38%; serum human chorionic gonadotropin (hCG) 236 mIU/mL. Upon pelvic examination, no active bleeding is noted. She agrees to be followed up by her gynecologist and is given a prescription for serum hCG in 2 days. She is instructed to return to the ED should she have pain or increased vaginal bleeding.

Three days later, the patient follows up with her gynecologist reporting mild cramping. She notes having had an episode of heavy vaginal bleeding and a “weakly positive” home pregnancy test. Transvaginal ultrasonography notes endometrial thickness 0.59 mm and unremarkable adnexa. A urine pregnancy test performed in the office is positive; urinalysis is positive for nitrites. With the bleeding slowed, the gynecologist’s overall impression is that the patient has undergone complete spontaneous abortion. She prescribes Macrobid for the urinary tract infection. She does not obtain the ED-prescribed serum HCG levels, as she feels, since complete spontaneous abortion has occurred there is no need to obtain a follow-up serum HCG.

Five days later, the patient returns to the ED reporting abdominal pain after eating. Fever and productive cough of 2 days are noted. The patient states that she had a recent miscarriage. The overall impression of the patient’s condition is bronchitis, and it is noted on the patient’s record, “unlikely ectopic pregnancy and pregnancy test may be false positive,” hence a pregnancy test is not ordered. Examination reveals mild suprapubic tenderness with no rebound; no pelvic exam is performed. The patient is instructed to follow up with a health care clinic within a week, and to return to the ED with severe abdominal pain, higher fever, or any new concerning symptoms. A Zithromax Z-pak is prescribed.

Four days later, the patient is brought by ambulance to the ED of the local major medical center with severe abdominal pain involving the right lower quadrant. She states that she had a miscarriage 3 weeks prior and was recently treated for bronchitis. She has dizziness when standing. Her vital signs are: temperature, 97.8 °F; heart rate, 95 bpm; BP, 72/48 mm Hg; pulse O2, 100%. She reports her abdominal pain to be 6/10.

The patient is given a Lactated Ringer’s bolus of 1,000 mL for a hypotensive episode. Computed tomography is obtained and notes, “low attenuation in the left adnexa with a dilated fallopian tube.” A large heterogeneous collection of fluid in the pelvis is noted with active extravasation, consistent with an “acute bleed.”

The patient is brought to the operating room with a diagnosis of probable ruptured ectopic pregnancy. Intraoperatively she is noted to have a right ruptured ectopic and left tubo-ovarian abscess. The surgeon proceeds with right salpingectomy and left salpingo-oophorectomy. Three liters of hemoperitoneum is found.

She is followed postoperatively with serum hCG until levels are negative. Her postoperative course is uneventful. Her only future option for pregnancy is through assisted reproductive technology (ART) with in vitro fertilization (IVF). The patient sues the gynecologist and second ED physician for presumed inappropriate assessment for ectopic pregnancy.

*The “facts” of this case are a composite, drawn from several cases to illustrate medical and legal issues. The statement of facts should be considered hypothetical.

Continue to: WHAT’S THE VERDICT?...

WHAT’S THE VERDICT?

A defense verdict is returned.

Medical considerations

The incidence of ectopic pregnancy is 2% of all pregnancies, with a higher incidence (about 4%) among infertility patients.¹ Up to 10% of ectopic pregnancies have no symptoms.²

Clinical presentations. Classic signs of ectopic pregnancy include:

• abdominal pain
• vaginal bleeding
• late menses (often noted).

A recent case of ectopic pregnancy presenting with chest pain was reported.³ Clinicians must never lose site of the fact that ectopic pregnancy is the most common cause of maternal mortality in the first trimester, with an incidence of 1% to 10% of all first-trimester deaths.⁴

Risk factors include pelvic inflammatory disease, as demonstrated in the opening case. “The silent epidemic of chlamydia” comes to mind, and tobacco smoking can adversely affect tubal cilia, as can pelvic adhesions and/or prior tubal surgery. All of these factors can predispose a patient to ectopic pregnancy; in addition, intrauterine devices, endometriosis, tubal ligation (or ligation reversal), all can set the stage for an ectopic pregnancy.⁵ Appropriate serum hCG monitoring during early pregnancy can assist in sorting out pregnancies of unknown location (PUL; FIGURE). First trimester ultrasonography, at 5 weeks gestation, usually identifies early intrauterine gestation.

Heterotopic pregnancy includes an intrauterine gestation and an ectopic pregnancy. This presentation includes the presence of a “pseudosac” in the endometrial cavity plus an extrauterine gestation. Heterotopic pregnancies have become somewhat more common as ART/IVF has unfolded, especially prior to the predominance of single embryo transfer.

Managing ectopic pregnancy

For cases of early pregnancy complicated by intermittent bleeding and/or pain, monitoring with serum hCG levels at 48-hour intervals to distinguish a viable IUP from an abnormal IUP or an ectopic is appropriate. The “discriminatory zone” collates serum hCG levels with findings on ultrasonography. Specific lower limits of serum hCG levels are not clear cut, with recommendations of 3,500 mIU/mL to provide sonographic evidence of an intrauterine gestation “to avoid misdiagnosis and possible interruption of intrauterine pregnancy,” as conveyed in the American College of Obstetricians and Gynecologists 2018 practice bulletin.⁸ Serum progesterone levels also have been suggested to complement hCG levels; a progesterone level of <20 nmol/L is consistent with an abnormal pregnancy, whereas levels >25 nmol/L are suggestive of a viable pregnancy.² Inhibin A levels also have been suggested to be helpful, but they are not an ideal monitoring tool.

While most ectopic pregnancies are located in the fallopian tube, other locations also can be abdominal or ovarian. In addition, cesarean scar ectopic pregnancy can occur and often is associated with delay in diagnosis and greater morbidity due to such delay.⁹ With regard to ovarian ectopic, Spiegelberg criteria are established for diagnosis (TABLE 1).¹⁰

Appropriate management of an ectopic pregnancy is dependent upon the gestational age, serum hCG levels, and imaging findings, as well as the patient’s symptoms and exam findings. Treatment is established in large part on a case-by-case basis and includes, for early pregnancy, expectant management and use of methotrexate (TABLE 2).¹¹ Dilation and curettage may be used to identify the pregnancy’s location when the serum hCG level is below 2,000 mIU/mL and there is no evidence of an IUP on ultrasound. Surgical treatment can include minimally invasive salpingostomy or salpingectomy and, depending on circumstance, laparotomy may be indicated.

Continue to: Legal perspective...

Legal perspective

Lawsuits related to ectopic pregnancy are not a new phenomenon. In fact, in 1897, a physician in Ohio who misdiagnosed an “extrauterine pregnancy” as appendicitis was the center of a malpractice lawsuit.¹³ Unrecognized or mishandled ectopic pregnancy can result in serious injuries—in the range of 1% to 10% (see above) of maternal deaths are related to ectopic pregnancy.¹⁴ Ectopic pregnancy cases, therefore, have been the subject of substantial litigation over the years. An informal, noncomprehensive review of malpractice lawsuits brought from 2000 to 2019, found more than 300 ectopic pregnancy cases. Given the large number of malpractice claims against ObGyns,¹⁵ ectopic pregnancy cases are only a small portion of all ObGyn malpractice cases.¹⁶

A common claim: negligent diagnosis or treatment

The most common basis for lawsuits in cases of ectopic pregnancy is the clinician’s negligent failure to properly diagnose the ectopic nature of the pregnancy. There are also a number of cases claiming negligent treatment of an identified ectopic pregnancy. Not every missed diagnosis, or unsuccessful treatment, leads to liability, of course. It is only when a diagnosis or treatment fails to meet the standard of care within the profession that there should be liability. That standard of care is generally defined by what a reasonably prudent physician would do under the circumstances. Expert witnesses, who are familiar with the standard of practice within the specialty, are usually necessary to establish what that practice is. Both the plaintiff and the defense obtain experts, the former to prove what the standard of care is and that the standard was not met in the case at hand. The defense experts are usually arguing that the standard of care was met.¹⁷ Inadequate diagnosis of ectopic pregnancy or other condition may arise from a failure to take a sufficient history, conduct an appropriately thorough physical examination, recognize any of the symptoms that would suggest it is present, use and conduct ultrasound correctly, or follow-up appropriately with additional testing.¹⁸

A malpractice claim of negligent treatment can involve any the following circumstances¹⁹:

• failure to establish an appropriate treatment plan
• prescribing inappropriate medications for the patient (eg, methotrexate, when it is contraindicated)
• delivering the wrong medication or the wrong amount of the right medication
• performing a procedure badly
• undertaking a new treatment without adequate instruction and preparation.

Given the nature and risks of ectopic pregnancy, ongoing, frequent contact with the patient is essential from the point at which the condition is suspected. The greater the risk of harm (probability or consequence), the more careful any professional ought to be. Because ectopic pregnancy is not an uncommon occurrence, and because it can have devastating effects, including death, a reasonably prudent practitioner would be especially aware of the clinical presentations discussed above.²⁰ In the opening case, the treatment plan was not well documented.

Negligence must lead to patient harm. In addition to negligence (proving that the physician did not act in accordance with the standard of care), to prevail in a malpractice case, the plaintiff-patient must prove that the negligence caused the injury, or worsened it. If the failure to make a diagnosis would not have made any difference in a harm the patient suffered, there are no damages and no liability. Suppose, for example, that a physician negligently failed to diagnose ectopic pregnancy, but performed surgery expecting to find the misdiagnosed condition. In the course of the surgery, however, the surgeon discovered and appropriately treated the ectopic pregnancy. (A version of this happened in the old 19th century case mentioned above.) The negligence of the physician did not cause harm, so there are no damages and no liability.

Continue to: Informed consent is vital...

Informed consent is vital

A part of malpractice is informed consent (or the absence of it)—issues that can arise in any medical care.²¹ It is wise to pay particular attention in cases where the nature of the illness is unknown, and where there are significant uncertainties and the nature of testing and treatment may change substantially over a period of a few days or few weeks. As always, informed consent should include a discussion of what process or procedure is proposed, its risks and benefits, alternative approaches that might be available, and the risk of doing nothing. Frequently, the uncertainty of ectopic pregnancy complicates the informed consent process.²²

Because communication with the patient is an essential function of informed consent, the consent process should productively be used in PUL and similar cases to inform the patient about the uncertainty, and the testing and (nonsurgical) treatment that will occur. This is an opportunity to reinforce the message that the patient must maintain ongoing communication with the physician’s office about changes in her condition, and appear for each appointment scheduled. If more invasive procedures—notably surgery—become required, a separate consent process should be completed, because the risks and considerations are now meaningfully different than when treatment began. As a general matter, any possible treatment that may result in infertility or reduced reproductive capacity should specifically be included in the consent process.

In the hypothetical case, the gynecologist failed to obtain a follow-up serum hCG level. In addition, the record did not reflect ectopic pregnancy in the differential diagnosis. As noted above, the patient had predisposing factors for an ectopic pregnancy. The physician should have acknowledged the history of sexually transmitted disease predisposing her to an ectopic pregnancy. Monitoring of serum hCG levels until they are negative is appropriate with ectopic, or presumed ectopic, pregnancy management. Appropriate monitoring did not occur in this case. Each of these errors (following up on serum hCG levels and the inadequacy of notations about the possibility of ectopic pregnancy) seem inconsistent with the usual standard of care. Furthermore, as a result of the outcome, the only future option for the patient to pursue pregnancy was IVF.

Other legal issues

There are a number of other legal issues that are associated with the topic of ectopic pregnancy. There is evidence, for example, that Catholic and non-Catholic hospitals treat ectopic pregnancies differently,²³ which may reflect different views on taking a life or the use of methotrexate and its association with abortion.²⁴ In addition, the possibility of an increase in future ectopic pregnancies is one of the “risks” of abortion that pro-life organizations have pushed to see included in abortion informed consent.²⁵ This has led some commentators to conclude that some Catholic hospitals violate federal law in managing ectopic pregnancy. There is also evidence of “overwhelming rates of medical misinformation on pregnancy center websites, including a link between abortion and ectopic pregnancy.”²⁶

The fact that cesarean deliveries are related to an increased risk for ectopic pregnancy (because of the risk of cesarean scar ectopic pregnancy) also has been cited as information that should play a role in the consent process for cesarean delivery.²⁷ In terms of liability, failed tubal ligation leads to a 33% risk of ectopic pregnancy.²⁸ The risk of ectopic pregnancy is also commonly included in surrogacy contracts.²⁹

Why the outcome was for the defense

The opening hypothetical case illustrates some of the uncertainties of medical malpractice cases. As noted, there appeared a deviation from the usual standard of care, particularly the failure to follow up on the serum hCG level. The weakness in the medical record, failing to note the possibility of ectopic pregnancy, also was probably an error but, apparently, the court felt that this did not result in any harm to the patient.

The question arises of how there would be a defense verdict in light of the failure to track consecutive serum hCG levels. A speculative explanation is that there are many uncertainties in most lawsuits. Procedural problems may result in a case being limited, expert witnesses are essential to both the plaintiff and defense, with the quality of their review and testimony possibly uneven. Judges and juries may rely on one expert witness rather than another, juries vary, and the quality of advocacy differs. Any of these situations can contribute to the unpredictability of the outcome of a case. In the case above, the liability was somewhat uncertain, and the various other factors tipped in favor of a defense verdict. ●

CASE Unidentified ectopic pregnancy leads to rupture*

A 33-year-old woman (G1 P0010) with 2 positive home pregnancy tests presents to the emergency department (ED) reporting intermittent vaginal bleeding for 3 days. Her last menstrual period was 10 weeks ago, but she reports that her menses are always irregular. She has a history of asymptomatic chlamydia, as well as spontaneous abortion 2 years prior. At present, she denies abdominal pain or vaginal discharge.

Upon examination her vital signs are: temperature, 98.3 °F; pulse, 112 bpm, with a resting rate of 16 bpm; blood pressure (BP), 142/91 mm Hg; pulse O2, 99%; height, 4’ 3”; weight, 115 lb. Her labs are: hemoglobin, 12.1 g/dL; hematocrit, 38%; serum human chorionic gonadotropin (hCG) 236 mIU/mL. Upon pelvic examination, no active bleeding is noted. She agrees to be followed up by her gynecologist and is given a prescription for serum hCG in 2 days. She is instructed to return to the ED should she have pain or increased vaginal bleeding.

Three days later, the patient follows up with her gynecologist reporting mild cramping. She notes having had an episode of heavy vaginal bleeding and a “weakly positive” home pregnancy test. Transvaginal ultrasonography notes endometrial thickness 0.59 mm and unremarkable adnexa. A urine pregnancy test performed in the office is positive; urinalysis is positive for nitrites. With the bleeding slowed, the gynecologist’s overall impression is that the patient has undergone complete spontaneous abortion. She prescribes Macrobid for the urinary tract infection. She does not obtain the ED-prescribed serum HCG levels, as she feels, since complete spontaneous abortion has occurred there is no need to obtain a follow-up serum HCG.

Five days later, the patient returns to the ED reporting abdominal pain after eating. Fever and productive cough of 2 days are noted. The patient states that she had a recent miscarriage. The overall impression of the patient’s condition is bronchitis, and it is noted on the patient’s record, “unlikely ectopic pregnancy and pregnancy test may be false positive,” hence a pregnancy test is not ordered. Examination reveals mild suprapubic tenderness with no rebound; no pelvic exam is performed. The patient is instructed to follow up with a health care clinic within a week, and to return to the ED with severe abdominal pain, higher fever, or any new concerning symptoms. A Zithromax Z-pak is prescribed.

Four days later, the patient is brought by ambulance to the ED of the local major medical center with severe abdominal pain involving the right lower quadrant. She states that she had a miscarriage 3 weeks prior and was recently treated for bronchitis. She has dizziness when standing. Her vital signs are: temperature, 97.8 °F; heart rate, 95 bpm; BP, 72/48 mm Hg; pulse O2, 100%. She reports her abdominal pain to be 6/10.

The patient is given a Lactated Ringer’s bolus of 1,000 mL for a hypotensive episode. Computed tomography is obtained and notes, “low attenuation in the left adnexa with a dilated fallopian tube.” A large heterogeneous collection of fluid in the pelvis is noted with active extravasation, consistent with an “acute bleed.”

The patient is brought to the operating room with a diagnosis of probable ruptured ectopic pregnancy. Intraoperatively she is noted to have a right ruptured ectopic and left tubo-ovarian abscess. The surgeon proceeds with right salpingectomy and left salpingo-oophorectomy. Three liters of hemoperitoneum is found.

She is followed postoperatively with serum hCG until levels are negative. Her postoperative course is uneventful. Her only future option for pregnancy is through assisted reproductive technology (ART) with in vitro fertilization (IVF). The patient sues the gynecologist and second ED physician for presumed inappropriate assessment for ectopic pregnancy.

*The “facts” of this case are a composite, drawn from several cases to illustrate medical and legal issues. The statement of facts should be considered hypothetical.

Continue to: WHAT’S THE VERDICT?...

WHAT’S THE VERDICT?

A defense verdict is returned.

Medical considerations

The incidence of ectopic pregnancy is 2% of all pregnancies, with a higher incidence (about 4%) among infertility patients.¹ Up to 10% of ectopic pregnancies have no symptoms.²

Clinical presentations. Classic signs of ectopic pregnancy include:

• abdominal pain
• vaginal bleeding
• late menses (often noted).

A recent case of ectopic pregnancy presenting with chest pain was reported.³ Clinicians must never lose site of the fact that ectopic pregnancy is the most common cause of maternal mortality in the first trimester, with an incidence of 1% to 10% of all first-trimester deaths.⁴

Risk factors include pelvic inflammatory disease, as demonstrated in the opening case. “The silent epidemic of chlamydia” comes to mind, and tobacco smoking can adversely affect tubal cilia, as can pelvic adhesions and/or prior tubal surgery. All of these factors can predispose a patient to ectopic pregnancy; in addition, intrauterine devices, endometriosis, tubal ligation (or ligation reversal), all can set the stage for an ectopic pregnancy.⁵ Appropriate serum hCG monitoring during early pregnancy can assist in sorting out pregnancies of unknown location (PUL; FIGURE). First trimester ultrasonography, at 5 weeks gestation, usually identifies early intrauterine gestation.

Heterotopic pregnancy includes an intrauterine gestation and an ectopic pregnancy. This presentation includes the presence of a “pseudosac” in the endometrial cavity plus an extrauterine gestation. Heterotopic pregnancies have become somewhat more common as ART/IVF has unfolded, especially prior to the predominance of single embryo transfer.

Managing ectopic pregnancy

For cases of early pregnancy complicated by intermittent bleeding and/or pain, monitoring with serum hCG levels at 48-hour intervals to distinguish a viable IUP from an abnormal IUP or an ectopic is appropriate. The “discriminatory zone” collates serum hCG levels with findings on ultrasonography. Specific lower limits of serum hCG levels are not clear cut, with recommendations of 3,500 mIU/mL to provide sonographic evidence of an intrauterine gestation “to avoid misdiagnosis and possible interruption of intrauterine pregnancy,” as conveyed in the American College of Obstetricians and Gynecologists 2018 practice bulletin.⁸ Serum progesterone levels also have been suggested to complement hCG levels; a progesterone level of <20 nmol/L is consistent with an abnormal pregnancy, whereas levels >25 nmol/L are suggestive of a viable pregnancy.² Inhibin A levels also have been suggested to be helpful, but they are not an ideal monitoring tool.

While most ectopic pregnancies are located in the fallopian tube, other locations also can be abdominal or ovarian. In addition, cesarean scar ectopic pregnancy can occur and often is associated with delay in diagnosis and greater morbidity due to such delay.⁹ With regard to ovarian ectopic, Spiegelberg criteria are established for diagnosis (TABLE 1).¹⁰

Appropriate management of an ectopic pregnancy is dependent upon the gestational age, serum hCG levels, and imaging findings, as well as the patient’s symptoms and exam findings. Treatment is established in large part on a case-by-case basis and includes, for early pregnancy, expectant management and use of methotrexate (TABLE 2).¹¹ Dilation and curettage may be used to identify the pregnancy’s location when the serum hCG level is below 2,000 mIU/mL and there is no evidence of an IUP on ultrasound. Surgical treatment can include minimally invasive salpingostomy or salpingectomy and, depending on circumstance, laparotomy may be indicated.

Continue to: Legal perspective...

Legal perspective

Lawsuits related to ectopic pregnancy are not a new phenomenon. In fact, in 1897, a physician in Ohio who misdiagnosed an “extrauterine pregnancy” as appendicitis was the center of a malpractice lawsuit.¹³ Unrecognized or mishandled ectopic pregnancy can result in serious injuries—in the range of 1% to 10% (see above) of maternal deaths are related to ectopic pregnancy.¹⁴ Ectopic pregnancy cases, therefore, have been the subject of substantial litigation over the years. An informal, noncomprehensive review of malpractice lawsuits brought from 2000 to 2019, found more than 300 ectopic pregnancy cases. Given the large number of malpractice claims against ObGyns,¹⁵ ectopic pregnancy cases are only a small portion of all ObGyn malpractice cases.¹⁶

A common claim: negligent diagnosis or treatment

The most common basis for lawsuits in cases of ectopic pregnancy is the clinician’s negligent failure to properly diagnose the ectopic nature of the pregnancy. There are also a number of cases claiming negligent treatment of an identified ectopic pregnancy. Not every missed diagnosis, or unsuccessful treatment, leads to liability, of course. It is only when a diagnosis or treatment fails to meet the standard of care within the profession that there should be liability. That standard of care is generally defined by what a reasonably prudent physician would do under the circumstances. Expert witnesses, who are familiar with the standard of practice within the specialty, are usually necessary to establish what that practice is. Both the plaintiff and the defense obtain experts, the former to prove what the standard of care is and that the standard was not met in the case at hand. The defense experts are usually arguing that the standard of care was met.¹⁷ Inadequate diagnosis of ectopic pregnancy or other condition may arise from a failure to take a sufficient history, conduct an appropriately thorough physical examination, recognize any of the symptoms that would suggest it is present, use and conduct ultrasound correctly, or follow-up appropriately with additional testing.¹⁸

A malpractice claim of negligent treatment can involve any the following circumstances¹⁹:

• failure to establish an appropriate treatment plan
• prescribing inappropriate medications for the patient (eg, methotrexate, when it is contraindicated)
• delivering the wrong medication or the wrong amount of the right medication
• performing a procedure badly
• undertaking a new treatment without adequate instruction and preparation.

Given the nature and risks of ectopic pregnancy, ongoing, frequent contact with the patient is essential from the point at which the condition is suspected. The greater the risk of harm (probability or consequence), the more careful any professional ought to be. Because ectopic pregnancy is not an uncommon occurrence, and because it can have devastating effects, including death, a reasonably prudent practitioner would be especially aware of the clinical presentations discussed above.²⁰ In the opening case, the treatment plan was not well documented.

Negligence must lead to patient harm. In addition to negligence (proving that the physician did not act in accordance with the standard of care), to prevail in a malpractice case, the plaintiff-patient must prove that the negligence caused the injury, or worsened it. If the failure to make a diagnosis would not have made any difference in a harm the patient suffered, there are no damages and no liability. Suppose, for example, that a physician negligently failed to diagnose ectopic pregnancy, but performed surgery expecting to find the misdiagnosed condition. In the course of the surgery, however, the surgeon discovered and appropriately treated the ectopic pregnancy. (A version of this happened in the old 19th century case mentioned above.) The negligence of the physician did not cause harm, so there are no damages and no liability.

Continue to: Informed consent is vital...

Informed consent is vital

A part of malpractice is informed consent (or the absence of it)—issues that can arise in any medical care.²¹ It is wise to pay particular attention in cases where the nature of the illness is unknown, and where there are significant uncertainties and the nature of testing and treatment may change substantially over a period of a few days or few weeks. As always, informed consent should include a discussion of what process or procedure is proposed, its risks and benefits, alternative approaches that might be available, and the risk of doing nothing. Frequently, the uncertainty of ectopic pregnancy complicates the informed consent process.²²

Because communication with the patient is an essential function of informed consent, the consent process should productively be used in PUL and similar cases to inform the patient about the uncertainty, and the testing and (nonsurgical) treatment that will occur. This is an opportunity to reinforce the message that the patient must maintain ongoing communication with the physician’s office about changes in her condition, and appear for each appointment scheduled. If more invasive procedures—notably surgery—become required, a separate consent process should be completed, because the risks and considerations are now meaningfully different than when treatment began. As a general matter, any possible treatment that may result in infertility or reduced reproductive capacity should specifically be included in the consent process.

In the hypothetical case, the gynecologist failed to obtain a follow-up serum hCG level. In addition, the record did not reflect ectopic pregnancy in the differential diagnosis. As noted above, the patient had predisposing factors for an ectopic pregnancy. The physician should have acknowledged the history of sexually transmitted disease predisposing her to an ectopic pregnancy. Monitoring of serum hCG levels until they are negative is appropriate with ectopic, or presumed ectopic, pregnancy management. Appropriate monitoring did not occur in this case. Each of these errors (following up on serum hCG levels and the inadequacy of notations about the possibility of ectopic pregnancy) seem inconsistent with the usual standard of care. Furthermore, as a result of the outcome, the only future option for the patient to pursue pregnancy was IVF.

Other legal issues

There are a number of other legal issues that are associated with the topic of ectopic pregnancy. There is evidence, for example, that Catholic and non-Catholic hospitals treat ectopic pregnancies differently,²³ which may reflect different views on taking a life or the use of methotrexate and its association with abortion.²⁴ In addition, the possibility of an increase in future ectopic pregnancies is one of the “risks” of abortion that pro-life organizations have pushed to see included in abortion informed consent.²⁵ This has led some commentators to conclude that some Catholic hospitals violate federal law in managing ectopic pregnancy. There is also evidence of “overwhelming rates of medical misinformation on pregnancy center websites, including a link between abortion and ectopic pregnancy.”²⁶

The fact that cesarean deliveries are related to an increased risk for ectopic pregnancy (because of the risk of cesarean scar ectopic pregnancy) also has been cited as information that should play a role in the consent process for cesarean delivery.²⁷ In terms of liability, failed tubal ligation leads to a 33% risk of ectopic pregnancy.²⁸ The risk of ectopic pregnancy is also commonly included in surrogacy contracts.²⁹

Why the outcome was for the defense

The opening hypothetical case illustrates some of the uncertainties of medical malpractice cases. As noted, there appeared a deviation from the usual standard of care, particularly the failure to follow up on the serum hCG level. The weakness in the medical record, failing to note the possibility of ectopic pregnancy, also was probably an error but, apparently, the court felt that this did not result in any harm to the patient.

The question arises of how there would be a defense verdict in light of the failure to track consecutive serum hCG levels. A speculative explanation is that there are many uncertainties in most lawsuits. Procedural problems may result in a case being limited, expert witnesses are essential to both the plaintiff and defense, with the quality of their review and testimony possibly uneven. Judges and juries may rely on one expert witness rather than another, juries vary, and the quality of advocacy differs. Any of these situations can contribute to the unpredictability of the outcome of a case. In the case above, the liability was somewhat uncertain, and the various other factors tipped in favor of a defense verdict. ●

The 2019-2020 term of the US Supreme Court was remarkable by any standard. An extraordinary number of important cases made it “a buffet of blockbusters.”¹ 

We look first at several cases that will be of particular interest to ObGyns. Then we look briefly at a number of other important cases that affect the medical profession as a whole and the direction of the country (see “Other significant US Supreme Court decisions”), and finally we conclude with an analysis of this term and a forecast for the next. 

We chose cases in which specialty organizations, such as the American College of Obstetricians and Gynecologists (ACOG), or organized medicine (the American Medical Association [AMA], the Association of American Medical Colleges [AAMC], or the American Hospital Association [AHA]), took a special interest by filing “amicus curiae” (friend of the court) briefs with the Supreme Court. These briefs are filed by an organization or person who is not a party to the case but who may have important information to convey to the Court. Because these briefs represent a significant commitment of money, time, and effort, they are usually not undertaken lightly. 

Decisions concerning abortion

June v Russo

Decided June 29, 2020, June v Russo involved a Louisiana statute that required abortion providers have “active admitting privileges at a hospital” within 30 miles of where the abortion is performed.² The Court decided a case in 2016 (from Texas) that involved almost the same statutory provision, so it might seem like an easy ruling.³ But Justice Kennedy (the deciding vote in 2016) has been replaced by Justice Gorsuch, so the outcome was uncertain. It was a difficult case, with a total of 5 opinions covering 138 pages and a “surprise” from the Chief Justice. 

The Court, in a 5-4 decision, struck down the Louisiana law, but there was no majority opinion. Four justices in the plurality emphasized that the Louisiana law (like the Texas law) substantially burdened the right to abortion without any corresponding benefit to the health of the women seeking abortions. (Under earlier Court precedents, “undue burdens” on abortion are unconstitutional.⁴) Justice Breyer noted that the state could not present even one example in which a woman would have had better treatment if her doctor had admitting privileges. For a variety of reasons, admitting privileges were cumbersome for abortion providers to obtain; therefore, enforcing the law had little or no benefit, but significant risk of reduced availability of abortion services.

In June v Russo, Chief Justice Roberts literally became the “swing vote”—the fifth vote to strike down the Louisiana law. In 2016, he had voted the other way—to uphold essentially the same law (in Texas) that he struck down here. He attributed his switch to precedent (the general obligation of courts to follow prior decisions). He disagreed with the earlier decision, but felt bound by it. 

This should be the end of the abortion provider “hospital privileges requirements” that a number of states have passed. States seeking to nibble away at abortion rights will undoubtedly look elsewhere. Beyond that, it is difficult, from this case, to discern the future of abortion rights. 

ACOG was the lead in amicus briefs urging the Court to strike down the Louisiana law. ACOG (with others) was one of only a handful of organizations filing a brief urging the Court to agree to hear the case.⁵ When the Court did agree to hear the case (“granted certiorari”), ACOG and a number of other medical organizations filed a formal amicus brief on the merits of the case.⁶ The brief made 2 arguments: First, that this case was essentially decided in Whole Woman’s Health in 2016 (the Texas case) and, second, that “an admitting privileges requirement is not medically necessary” and “clinicians who provide abortions are unable to obtain admitting privileges for reasons unrelated to their ability to safely and competently perform abortions.” Justice Breyer cited the ACOG brief twice.

The American Association of Pro-Life Obstetricians and Gynecologists also filed an amicus brief.⁷ The brief was directed solely at arguing that ACOG was not presenting reliable science. It summarized, “The American College of Obstetricians and Gynecologists has always presented itself to the Court as a source of objective medical knowledge. However, when it comes to abortion, the College today is primarily a pro-abortion political advocacy organization.” That brief concluded that the “Court should read ACOG’s amicus brief not as an authoritative recitation of settled science, but as a partisan advocacy paper on behalf of a mere subset of American obstetricians and gynecologists.” 

The Association of American Physicians and Surgeons (which should not be confused with the “National Board of Physicians and Surgeons”) also filed an amicus brief. The brief argued, “Abortion, like other outpatient surgical procedures, sometimes results in patient hospitalization. Requiring abortion providers to maintain admitting privileges will improve communication between physicians in the transfer of patients to the hospital and allow them to participate in the care of their patients while in the hospital, in line with their ethical duty to ensure their patients’ continuity of care.”⁸

Continue to: Ultrasonography requirement for abortion...

In another abortion case, the Court was asked to review a Kentucky abortion statute requiring that an ultrasound image be shown to the woman as part of informed consent for an abortion.⁹ ACOG filed an amicus brief in favor of a review, but the Court declined to hear the case.^10,11 

Contraception considerations

The Affordable Care Act (ACA) has an ambiguous provision regarding no-cost “preventive care and screenings” for women. The ACA does not, however, specify contraceptive coverage.¹² Several departments and the Health Resources and Services Administration (collectively referred to as “HRSA”) interpreted the provision to include contraception, but from the start there were religious objections. HRSA eventually provided an exemption regarding contraception for employers (nonprofits and for-profits with no publicly traded components) that had “sincerely held moral” objections to providing forms of contraceptive coverage. That regulation was again before the Court this term in Little Sisters of the Poor Saints Peter and Paul Home v Pennsylvania.¹³ 

In a 7-2 decision, the Court held that the ACA gave HRSA authority to adopt regulations related to the undefined term “preventive care.” Therefore, it found that HRSA could exempt those with religious objections from participation in providing contraceptive coverage. ACOG and other medical groups filed an amicus brief arguing that contraception is an essential preventive service. “Contraception not only helps to prevent unintended pregnancy, but also helps to protect the health and well-being of women and their children.”¹⁴ It was cited only by Justice Ginsburg in her dissent.¹⁵ 

Deferred Action for Childhood Arrivals (DACA)

The AAMC, ACOG, AMA, and many other organizations filed an amicus brief¹⁶ in Department of Homeland Security v Regents of University of California.¹⁷ The case raised the question of whether a decision to end the DACA program followed the appropriate administrative procedures. In 2012, the Obama administration issued a “memorandum” establishing DACA (without congressional approval or formal rulemaking). A lower court decision barring implementation of DACA was upheld by the Supreme Court in 2016 on a 4-4 vote.¹⁸ In 2017, the Trump administration moved to end DACA. 

In a 5-4 decision, the Court held that the explanation for ending DACA was inadequate, and violated the Administrative Procedures Act, so DACA could continue until the administration redid the repeal, following the proper procedures. The decision of the Court dealt solely with the process by which the rescission took place—there was general agreement that the administration had the right to rescind it if the procedure (with legitimate reasons) was proper.

The brief for the medical groups argued that the failure of the regulation to consider “reliance interests” would have especially difficult consequences in the medical fields. It noted, “At this moment, an estimated 27,000 health care workers and support staff depend on DACA for their authorization to work in the United States. Among those 27,000 are nurses, dentists, pharmacists, physician assistants, home health aides, technicians, and others. The number also includes nearly 200 medical students, medical residents, and physicians who depend on DACA for their eligibility to practice medicine.”¹⁶ The brief was not cited by the Court, but the reliance interest the brief spoke about was an important part of the case.

Continue to: Employment discrimination against gay and transgender employees...

Federal law (“Title VII”) makes it illegal for an employer to “discriminate against any individual because of race, color, religion, sex, or national origin.”¹⁹ The question this term was whether discrimination based on sexual orientation or sexual identity is within the statute’s meaning of “sex.” By a 6-3 majority, the Court held that Title VII applies both to orientation and identity. (This was an interpretation of the statute, not a broad constitutional ruling.)

The majority reasoned that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex. Consider, for example, an employer with 2 employees, both of whom are attracted to men.” If the employer fires the gay employee, “the employer discriminates against him for traits or actions it tolerates in his female colleague.”²⁰ 

AMA and a number of other medical organizations filed an amicus brief in the case.²¹ The core of the argument of the brief was, “Employment discrimination against transgender people frustrates the treatment of gender dysphoria by preventing transgender individuals from living openly in accordance with their true gender identity and impeding access to needed medical care. Experiencing discrimination in one of the most important aspects of adult life—employment—makes it nearly impossible to live in full congruence with one’s gender identity. The fear of facing such discrimination alone can prompt transgender individuals to hide their gender identity, directly thwarting the goal of social transition…. Lack of treatment, in turn, increases the rate of negative mental health outcomes, substance abuse, and suicide.” The brief was not cited in the opinions in the case.

This decision is likely to have great impact on many aspects of American life. In the employment area, it is now a matter of course that employers may not discriminate based on orientation or identity in any employment decisions including hiring, firing, compensation, fringe benefits, etc. Harassment based on identity or orientation may similarly be an employment law violation. The decision also likely means that giving employment preferences to gay employees would now be as illegal as would be giving preferences to straight employees. (Limited exceptions, notably to some religious organization employees, are not included in anti-discrimination laws.)²² 

The importance of the decision goes well beyond employment, however. More than 100 federal statutes are in place that prohibit “discrimination because of sex.” It is now likely that these statutes will be interpreted as prohibiting discrimination related to sexual orientation and identification. 

Additional cases of interest 

HIV/AIDS International Program

A major US program fighting HIV/AIDS worldwide—the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (aka the Leadership Act)—has provided billions of dollars to agencies abroad.²³ Nongovernmental organizations (NGOs) receiving funds under the program must agree to have a “policy explicitly opposing prostitution and sex trafficking” (known as the “Policy Requirement”). Some grant recipients in foreign countries, generally affiliates of US NGOs, do not want to have such a policy and challenged the policy requirement as a violation of First Amendment right of free speech. The Court held that it is a well-settled principle that “foreign citizens outside US territory do not possess rights under the US Constitution.”²⁴ Nor do organizations become entitled to such rights as a result of an affiliation with US organizations. This decision means that foreign organizations are free not to have the required policies, but they will be ineligible for funds under the Leadership Act. 

Continue to: ACA government debts edition...

The ACA was before the Court, yet again. To encourage private insurers to participate in online health insurance exchanges, the ACA provided that the federal government would share in insurance company losses for 3 years.²⁵ The Act, however, did not appropriate any money for these “risk corridors,” and insurance companies  lost $12 billion. 

Congress (after the 2010 election) prohibited any appropriated funds from being used to pay insurance companies for their risk corridor losses. Four insurance companies sued the United States, seeking reimbursements for their losses. This term the Court held that the government must pay for their losses under the ACA.²⁶ The Court said that Congress could have expressly repealed the risk corridor obligation (in the appropriation bill), but instead had only prohibited the expenditure of the money, which the Court said did not amount to an implied repeal of the obligation. We will see that ACA will be back before the Court again next term in California v Texas (discussed below).

Child custody and international abduction

The Hague Convention on the Civil Aspects of International Child Abduction (to which the United States is a party) provides that the courts of the country where the child has “habitual residence” have jurisdiction to decide custody.²⁷ If a parent takes the child to another country, that country is obligated to return the child to the country of “habitual residence.” 

This term the Court was called upon to define “habitual residence.” The Court held that determining habitual residence depends on the “totality of the circumstances,” and that “locating a child’s home is a fact-driven inquiry,” and that “courts must be sensitive to the unique circumstances of the case and informed by common sense.”²⁸ An exception to the Convention’s obligation to return a child to the country of habitual residence is where “there is a grave risk that [the] return would expose the child to physical or psychological harm or otherwise place the child in an intolerable situation.”²⁹ Who the parent is can affect many aspects of legal authority over the child, including consent to medical care, and the right to receive information concerning care. 

Analysis of the term

The term began October 7, 2019, and adjourned July 9, 2020, somewhat later than usual because of coronavirus disease 2019 (COVID-19). During the term, the Court decided 60 cases, including 53 “signed” merit opinions after oral argument—the lowest number of decided cases in many years.30 Of those 60 cases, 22 (35%) were unanimous, and 13 (22%) resulted in a 5-4 split.³⁰ Ten-year averages are 48% unanimous and 20% with 5-4 decisions.³⁰

Chief Justice Roberts was the central focus of the term. He presided over the impeachment trial of President Trump in the Senate early in the term. He also presided over the Court’s accommodations of the COVID-19 pandemic. He is the “median,” or “swing,” justice. He was in the majority in 12 of the 13 cases with 5-4 decisions.³⁰ He was in the majority in 97% of all cases and in 95% of “divided cases”—the highest of any of the justices this term.³⁰ In some of the most critical decisions, Chief Justice Roberts sided with the “liberal” wing, including on cases concerning abortion, gay and transgender employment, DACA, and 2 Presidential subpoena cases. More often (in 9 of the 5-4 decisions), however, he sided with the more conservative justices.³⁰ Justice Kavanaugh agreed with Chief Justice Roberts most often (in 93% of all cases).³⁰ Among the others, these justices agreed with each other 90% or more of the time: Justices Ginsburg and Breyer (93%), Justices Alito and Thomas (92%), and Justices Breyer and Kagan (90%).³⁰

Continue to: COVID-19 and the Court...

Some of the biggest news of the term came not from the law, but from medicine in the form of  COVID-19. The Court was in the process of preparing a final period of important arguments when, on March 16, it announced that it was postponing further arguments. The Court rescheduled 10 oral arguments that were held by telephone (other cases were held over to the next term). The phone arguments, during the first 2 weeks of May, necessitated a change in format. Each justice was called on (in order of seniority) by the Chief Justice to ask questions. This was in contrast to the free-for-all questions that usually characterize in-person arguments. These arguments were broadcast live—something that had never been done before. Public access was, on balance, a good thing. There were a couple failures to unmute, and there was “the flush heard round the world” in the middle of one argument, but otherwise the arguments went off with few hitches.³¹

Looking ahead

By the end of the term, no justice had announced an intention to retire from the Court. On September 18, however, Justice Ruth Bader Ginsburg passed away. In 2009, she had been diagnosed with early-stage pancreatic cancer. This term she had been hospitalized twice, and at the end of the term, she announced a recurrence of pancreatic cancer, which was being treated with chemotherapy. See “RBG: The woman, the legacy” for a tribute to this remarkable woman, lawyer, and justice.

Justice Ginsburg’s death, occurring in the middle of a presidential campaign, ignited a political firestorm concerning her successor. The outcome of selecting and confirming her successor and the political fallout were not immediately apparent. Justice Ginsburg was confirmed just 7 weeks after her nomination by President Clinton, by a vote of 96-3. But those days of Senate consensus are not the current norm.

The next term (called the “October 2020 Term”) will begin on October 5, 2020. The Court will begin with 8 justices and, depending on the nomination process, may operate with 8 justices for some time. When there is a “tie” vote in the Court, the lower court decision is upheld. The Court has been short-handed several times in the past and, with few exceptions, has managed the cases successfully.

The Court has announced that initial arguments will be telephonic. It already has taken a number of cases. The constitutionality of the individual mandate (coverage) in the ACA will once again be before the Court, and that already has produced a flood of amicus briefs from health-related organizations.³² Among other upcoming issues are cases related to state regulation of pharmacy benefit managers, gay rights and foster care, sentencing of juveniles to life in prison without the possibility of parole, a face-off between Google and Oracle on software copyrights, and arbitration. In addition, some of the issues we saw this term will reappear, with more on robocalls, religious freedom and Catholic charities, and immigration and removal cases.
 

The 2019-2020 term of the US Supreme Court was remarkable by any standard. An extraordinary number of important cases made it “a buffet of blockbusters.”¹ 

We look first at several cases that will be of particular interest to ObGyns. Then we look briefly at a number of other important cases that affect the medical profession as a whole and the direction of the country (see “Other significant US Supreme Court decisions”), and finally we conclude with an analysis of this term and a forecast for the next. 

We chose cases in which specialty organizations, such as the American College of Obstetricians and Gynecologists (ACOG), or organized medicine (the American Medical Association [AMA], the Association of American Medical Colleges [AAMC], or the American Hospital Association [AHA]), took a special interest by filing “amicus curiae” (friend of the court) briefs with the Supreme Court. These briefs are filed by an organization or person who is not a party to the case but who may have important information to convey to the Court. Because these briefs represent a significant commitment of money, time, and effort, they are usually not undertaken lightly. 

Decisions concerning abortion

June v Russo

Decided June 29, 2020, June v Russo involved a Louisiana statute that required abortion providers have “active admitting privileges at a hospital” within 30 miles of where the abortion is performed.² The Court decided a case in 2016 (from Texas) that involved almost the same statutory provision, so it might seem like an easy ruling.³ But Justice Kennedy (the deciding vote in 2016) has been replaced by Justice Gorsuch, so the outcome was uncertain. It was a difficult case, with a total of 5 opinions covering 138 pages and a “surprise” from the Chief Justice. 

The Court, in a 5-4 decision, struck down the Louisiana law, but there was no majority opinion. Four justices in the plurality emphasized that the Louisiana law (like the Texas law) substantially burdened the right to abortion without any corresponding benefit to the health of the women seeking abortions. (Under earlier Court precedents, “undue burdens” on abortion are unconstitutional.⁴) Justice Breyer noted that the state could not present even one example in which a woman would have had better treatment if her doctor had admitting privileges. For a variety of reasons, admitting privileges were cumbersome for abortion providers to obtain; therefore, enforcing the law had little or no benefit, but significant risk of reduced availability of abortion services.

In June v Russo, Chief Justice Roberts literally became the “swing vote”—the fifth vote to strike down the Louisiana law. In 2016, he had voted the other way—to uphold essentially the same law (in Texas) that he struck down here. He attributed his switch to precedent (the general obligation of courts to follow prior decisions). He disagreed with the earlier decision, but felt bound by it. 

This should be the end of the abortion provider “hospital privileges requirements” that a number of states have passed. States seeking to nibble away at abortion rights will undoubtedly look elsewhere. Beyond that, it is difficult, from this case, to discern the future of abortion rights. 

ACOG was the lead in amicus briefs urging the Court to strike down the Louisiana law. ACOG (with others) was one of only a handful of organizations filing a brief urging the Court to agree to hear the case.⁵ When the Court did agree to hear the case (“granted certiorari”), ACOG and a number of other medical organizations filed a formal amicus brief on the merits of the case.⁶ The brief made 2 arguments: First, that this case was essentially decided in Whole Woman’s Health in 2016 (the Texas case) and, second, that “an admitting privileges requirement is not medically necessary” and “clinicians who provide abortions are unable to obtain admitting privileges for reasons unrelated to their ability to safely and competently perform abortions.” Justice Breyer cited the ACOG brief twice.

The American Association of Pro-Life Obstetricians and Gynecologists also filed an amicus brief.⁷ The brief was directed solely at arguing that ACOG was not presenting reliable science. It summarized, “The American College of Obstetricians and Gynecologists has always presented itself to the Court as a source of objective medical knowledge. However, when it comes to abortion, the College today is primarily a pro-abortion political advocacy organization.” That brief concluded that the “Court should read ACOG’s amicus brief not as an authoritative recitation of settled science, but as a partisan advocacy paper on behalf of a mere subset of American obstetricians and gynecologists.” 

The Association of American Physicians and Surgeons (which should not be confused with the “National Board of Physicians and Surgeons”) also filed an amicus brief. The brief argued, “Abortion, like other outpatient surgical procedures, sometimes results in patient hospitalization. Requiring abortion providers to maintain admitting privileges will improve communication between physicians in the transfer of patients to the hospital and allow them to participate in the care of their patients while in the hospital, in line with their ethical duty to ensure their patients’ continuity of care.”⁸

Continue to: Ultrasonography requirement for abortion...

In another abortion case, the Court was asked to review a Kentucky abortion statute requiring that an ultrasound image be shown to the woman as part of informed consent for an abortion.⁹ ACOG filed an amicus brief in favor of a review, but the Court declined to hear the case.^10,11 

Contraception considerations

The Affordable Care Act (ACA) has an ambiguous provision regarding no-cost “preventive care and screenings” for women. The ACA does not, however, specify contraceptive coverage.¹² Several departments and the Health Resources and Services Administration (collectively referred to as “HRSA”) interpreted the provision to include contraception, but from the start there were religious objections. HRSA eventually provided an exemption regarding contraception for employers (nonprofits and for-profits with no publicly traded components) that had “sincerely held moral” objections to providing forms of contraceptive coverage. That regulation was again before the Court this term in Little Sisters of the Poor Saints Peter and Paul Home v Pennsylvania.¹³ 

In a 7-2 decision, the Court held that the ACA gave HRSA authority to adopt regulations related to the undefined term “preventive care.” Therefore, it found that HRSA could exempt those with religious objections from participation in providing contraceptive coverage. ACOG and other medical groups filed an amicus brief arguing that contraception is an essential preventive service. “Contraception not only helps to prevent unintended pregnancy, but also helps to protect the health and well-being of women and their children.”¹⁴ It was cited only by Justice Ginsburg in her dissent.¹⁵ 

Deferred Action for Childhood Arrivals (DACA)

The AAMC, ACOG, AMA, and many other organizations filed an amicus brief¹⁶ in Department of Homeland Security v Regents of University of California.¹⁷ The case raised the question of whether a decision to end the DACA program followed the appropriate administrative procedures. In 2012, the Obama administration issued a “memorandum” establishing DACA (without congressional approval or formal rulemaking). A lower court decision barring implementation of DACA was upheld by the Supreme Court in 2016 on a 4-4 vote.¹⁸ In 2017, the Trump administration moved to end DACA. 

In a 5-4 decision, the Court held that the explanation for ending DACA was inadequate, and violated the Administrative Procedures Act, so DACA could continue until the administration redid the repeal, following the proper procedures. The decision of the Court dealt solely with the process by which the rescission took place—there was general agreement that the administration had the right to rescind it if the procedure (with legitimate reasons) was proper.

The brief for the medical groups argued that the failure of the regulation to consider “reliance interests” would have especially difficult consequences in the medical fields. It noted, “At this moment, an estimated 27,000 health care workers and support staff depend on DACA for their authorization to work in the United States. Among those 27,000 are nurses, dentists, pharmacists, physician assistants, home health aides, technicians, and others. The number also includes nearly 200 medical students, medical residents, and physicians who depend on DACA for their eligibility to practice medicine.”¹⁶ The brief was not cited by the Court, but the reliance interest the brief spoke about was an important part of the case.

Continue to: Employment discrimination against gay and transgender employees...

Federal law (“Title VII”) makes it illegal for an employer to “discriminate against any individual because of race, color, religion, sex, or national origin.”¹⁹ The question this term was whether discrimination based on sexual orientation or sexual identity is within the statute’s meaning of “sex.” By a 6-3 majority, the Court held that Title VII applies both to orientation and identity. (This was an interpretation of the statute, not a broad constitutional ruling.)

The majority reasoned that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex. Consider, for example, an employer with 2 employees, both of whom are attracted to men.” If the employer fires the gay employee, “the employer discriminates against him for traits or actions it tolerates in his female colleague.”²⁰ 

AMA and a number of other medical organizations filed an amicus brief in the case.²¹ The core of the argument of the brief was, “Employment discrimination against transgender people frustrates the treatment of gender dysphoria by preventing transgender individuals from living openly in accordance with their true gender identity and impeding access to needed medical care. Experiencing discrimination in one of the most important aspects of adult life—employment—makes it nearly impossible to live in full congruence with one’s gender identity. The fear of facing such discrimination alone can prompt transgender individuals to hide their gender identity, directly thwarting the goal of social transition…. Lack of treatment, in turn, increases the rate of negative mental health outcomes, substance abuse, and suicide.” The brief was not cited in the opinions in the case.

This decision is likely to have great impact on many aspects of American life. In the employment area, it is now a matter of course that employers may not discriminate based on orientation or identity in any employment decisions including hiring, firing, compensation, fringe benefits, etc. Harassment based on identity or orientation may similarly be an employment law violation. The decision also likely means that giving employment preferences to gay employees would now be as illegal as would be giving preferences to straight employees. (Limited exceptions, notably to some religious organization employees, are not included in anti-discrimination laws.)²² 

The importance of the decision goes well beyond employment, however. More than 100 federal statutes are in place that prohibit “discrimination because of sex.” It is now likely that these statutes will be interpreted as prohibiting discrimination related to sexual orientation and identification. 

Additional cases of interest 

HIV/AIDS International Program

A major US program fighting HIV/AIDS worldwide—the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (aka the Leadership Act)—has provided billions of dollars to agencies abroad.²³ Nongovernmental organizations (NGOs) receiving funds under the program must agree to have a “policy explicitly opposing prostitution and sex trafficking” (known as the “Policy Requirement”). Some grant recipients in foreign countries, generally affiliates of US NGOs, do not want to have such a policy and challenged the policy requirement as a violation of First Amendment right of free speech. The Court held that it is a well-settled principle that “foreign citizens outside US territory do not possess rights under the US Constitution.”²⁴ Nor do organizations become entitled to such rights as a result of an affiliation with US organizations. This decision means that foreign organizations are free not to have the required policies, but they will be ineligible for funds under the Leadership Act. 

Continue to: ACA government debts edition...

The ACA was before the Court, yet again. To encourage private insurers to participate in online health insurance exchanges, the ACA provided that the federal government would share in insurance company losses for 3 years.²⁵ The Act, however, did not appropriate any money for these “risk corridors,” and insurance companies  lost $12 billion. 

Congress (after the 2010 election) prohibited any appropriated funds from being used to pay insurance companies for their risk corridor losses. Four insurance companies sued the United States, seeking reimbursements for their losses. This term the Court held that the government must pay for their losses under the ACA.²⁶ The Court said that Congress could have expressly repealed the risk corridor obligation (in the appropriation bill), but instead had only prohibited the expenditure of the money, which the Court said did not amount to an implied repeal of the obligation. We will see that ACA will be back before the Court again next term in California v Texas (discussed below).

Child custody and international abduction

The Hague Convention on the Civil Aspects of International Child Abduction (to which the United States is a party) provides that the courts of the country where the child has “habitual residence” have jurisdiction to decide custody.²⁷ If a parent takes the child to another country, that country is obligated to return the child to the country of “habitual residence.” 

This term the Court was called upon to define “habitual residence.” The Court held that determining habitual residence depends on the “totality of the circumstances,” and that “locating a child’s home is a fact-driven inquiry,” and that “courts must be sensitive to the unique circumstances of the case and informed by common sense.”²⁸ An exception to the Convention’s obligation to return a child to the country of habitual residence is where “there is a grave risk that [the] return would expose the child to physical or psychological harm or otherwise place the child in an intolerable situation.”²⁹ Who the parent is can affect many aspects of legal authority over the child, including consent to medical care, and the right to receive information concerning care. 

Analysis of the term

The term began October 7, 2019, and adjourned July 9, 2020, somewhat later than usual because of coronavirus disease 2019 (COVID-19). During the term, the Court decided 60 cases, including 53 “signed” merit opinions after oral argument—the lowest number of decided cases in many years.30 Of those 60 cases, 22 (35%) were unanimous, and 13 (22%) resulted in a 5-4 split.³⁰ Ten-year averages are 48% unanimous and 20% with 5-4 decisions.³⁰

Chief Justice Roberts was the central focus of the term. He presided over the impeachment trial of President Trump in the Senate early in the term. He also presided over the Court’s accommodations of the COVID-19 pandemic. He is the “median,” or “swing,” justice. He was in the majority in 12 of the 13 cases with 5-4 decisions.³⁰ He was in the majority in 97% of all cases and in 95% of “divided cases”—the highest of any of the justices this term.³⁰ In some of the most critical decisions, Chief Justice Roberts sided with the “liberal” wing, including on cases concerning abortion, gay and transgender employment, DACA, and 2 Presidential subpoena cases. More often (in 9 of the 5-4 decisions), however, he sided with the more conservative justices.³⁰ Justice Kavanaugh agreed with Chief Justice Roberts most often (in 93% of all cases).³⁰ Among the others, these justices agreed with each other 90% or more of the time: Justices Ginsburg and Breyer (93%), Justices Alito and Thomas (92%), and Justices Breyer and Kagan (90%).³⁰

Continue to: COVID-19 and the Court...

Some of the biggest news of the term came not from the law, but from medicine in the form of  COVID-19. The Court was in the process of preparing a final period of important arguments when, on March 16, it announced that it was postponing further arguments. The Court rescheduled 10 oral arguments that were held by telephone (other cases were held over to the next term). The phone arguments, during the first 2 weeks of May, necessitated a change in format. Each justice was called on (in order of seniority) by the Chief Justice to ask questions. This was in contrast to the free-for-all questions that usually characterize in-person arguments. These arguments were broadcast live—something that had never been done before. Public access was, on balance, a good thing. There were a couple failures to unmute, and there was “the flush heard round the world” in the middle of one argument, but otherwise the arguments went off with few hitches.³¹

Looking ahead

By the end of the term, no justice had announced an intention to retire from the Court. On September 18, however, Justice Ruth Bader Ginsburg passed away. In 2009, she had been diagnosed with early-stage pancreatic cancer. This term she had been hospitalized twice, and at the end of the term, she announced a recurrence of pancreatic cancer, which was being treated with chemotherapy. See “RBG: The woman, the legacy” for a tribute to this remarkable woman, lawyer, and justice.

Justice Ginsburg’s death, occurring in the middle of a presidential campaign, ignited a political firestorm concerning her successor. The outcome of selecting and confirming her successor and the political fallout were not immediately apparent. Justice Ginsburg was confirmed just 7 weeks after her nomination by President Clinton, by a vote of 96-3. But those days of Senate consensus are not the current norm.

The next term (called the “October 2020 Term”) will begin on October 5, 2020. The Court will begin with 8 justices and, depending on the nomination process, may operate with 8 justices for some time. When there is a “tie” vote in the Court, the lower court decision is upheld. The Court has been short-handed several times in the past and, with few exceptions, has managed the cases successfully.

The Court has announced that initial arguments will be telephonic. It already has taken a number of cases. The constitutionality of the individual mandate (coverage) in the ACA will once again be before the Court, and that already has produced a flood of amicus briefs from health-related organizations.³² Among other upcoming issues are cases related to state regulation of pharmacy benefit managers, gay rights and foster care, sentencing of juveniles to life in prison without the possibility of parole, a face-off between Google and Oracle on software copyrights, and arbitration. In addition, some of the issues we saw this term will reappear, with more on robocalls, religious freedom and Catholic charities, and immigration and removal cases.
 

The 2019-2020 term of the US Supreme Court was remarkable by any standard. An extraordinary number of important cases made it “a buffet of blockbusters.”¹ 

We look first at several cases that will be of particular interest to ObGyns. Then we look briefly at a number of other important cases that affect the medical profession as a whole and the direction of the country (see “Other significant US Supreme Court decisions”), and finally we conclude with an analysis of this term and a forecast for the next. 

We chose cases in which specialty organizations, such as the American College of Obstetricians and Gynecologists (ACOG), or organized medicine (the American Medical Association [AMA], the Association of American Medical Colleges [AAMC], or the American Hospital Association [AHA]), took a special interest by filing “amicus curiae” (friend of the court) briefs with the Supreme Court. These briefs are filed by an organization or person who is not a party to the case but who may have important information to convey to the Court. Because these briefs represent a significant commitment of money, time, and effort, they are usually not undertaken lightly. 

Decisions concerning abortion

June v Russo

Decided June 29, 2020, June v Russo involved a Louisiana statute that required abortion providers have “active admitting privileges at a hospital” within 30 miles of where the abortion is performed.² The Court decided a case in 2016 (from Texas) that involved almost the same statutory provision, so it might seem like an easy ruling.³ But Justice Kennedy (the deciding vote in 2016) has been replaced by Justice Gorsuch, so the outcome was uncertain. It was a difficult case, with a total of 5 opinions covering 138 pages and a “surprise” from the Chief Justice. 

The Court, in a 5-4 decision, struck down the Louisiana law, but there was no majority opinion. Four justices in the plurality emphasized that the Louisiana law (like the Texas law) substantially burdened the right to abortion without any corresponding benefit to the health of the women seeking abortions. (Under earlier Court precedents, “undue burdens” on abortion are unconstitutional.⁴) Justice Breyer noted that the state could not present even one example in which a woman would have had better treatment if her doctor had admitting privileges. For a variety of reasons, admitting privileges were cumbersome for abortion providers to obtain; therefore, enforcing the law had little or no benefit, but significant risk of reduced availability of abortion services.

In June v Russo, Chief Justice Roberts literally became the “swing vote”—the fifth vote to strike down the Louisiana law. In 2016, he had voted the other way—to uphold essentially the same law (in Texas) that he struck down here. He attributed his switch to precedent (the general obligation of courts to follow prior decisions). He disagreed with the earlier decision, but felt bound by it. 

This should be the end of the abortion provider “hospital privileges requirements” that a number of states have passed. States seeking to nibble away at abortion rights will undoubtedly look elsewhere. Beyond that, it is difficult, from this case, to discern the future of abortion rights. 

ACOG was the lead in amicus briefs urging the Court to strike down the Louisiana law. ACOG (with others) was one of only a handful of organizations filing a brief urging the Court to agree to hear the case.⁵ When the Court did agree to hear the case (“granted certiorari”), ACOG and a number of other medical organizations filed a formal amicus brief on the merits of the case.⁶ The brief made 2 arguments: First, that this case was essentially decided in Whole Woman’s Health in 2016 (the Texas case) and, second, that “an admitting privileges requirement is not medically necessary” and “clinicians who provide abortions are unable to obtain admitting privileges for reasons unrelated to their ability to safely and competently perform abortions.” Justice Breyer cited the ACOG brief twice.

The American Association of Pro-Life Obstetricians and Gynecologists also filed an amicus brief.⁷ The brief was directed solely at arguing that ACOG was not presenting reliable science. It summarized, “The American College of Obstetricians and Gynecologists has always presented itself to the Court as a source of objective medical knowledge. However, when it comes to abortion, the College today is primarily a pro-abortion political advocacy organization.” That brief concluded that the “Court should read ACOG’s amicus brief not as an authoritative recitation of settled science, but as a partisan advocacy paper on behalf of a mere subset of American obstetricians and gynecologists.” 

The Association of American Physicians and Surgeons (which should not be confused with the “National Board of Physicians and Surgeons”) also filed an amicus brief. The brief argued, “Abortion, like other outpatient surgical procedures, sometimes results in patient hospitalization. Requiring abortion providers to maintain admitting privileges will improve communication between physicians in the transfer of patients to the hospital and allow them to participate in the care of their patients while in the hospital, in line with their ethical duty to ensure their patients’ continuity of care.”⁸

Continue to: Ultrasonography requirement for abortion...

In another abortion case, the Court was asked to review a Kentucky abortion statute requiring that an ultrasound image be shown to the woman as part of informed consent for an abortion.⁹ ACOG filed an amicus brief in favor of a review, but the Court declined to hear the case.^10,11 

Contraception considerations

The Affordable Care Act (ACA) has an ambiguous provision regarding no-cost “preventive care and screenings” for women. The ACA does not, however, specify contraceptive coverage.¹² Several departments and the Health Resources and Services Administration (collectively referred to as “HRSA”) interpreted the provision to include contraception, but from the start there were religious objections. HRSA eventually provided an exemption regarding contraception for employers (nonprofits and for-profits with no publicly traded components) that had “sincerely held moral” objections to providing forms of contraceptive coverage. That regulation was again before the Court this term in Little Sisters of the Poor Saints Peter and Paul Home v Pennsylvania.¹³ 

In a 7-2 decision, the Court held that the ACA gave HRSA authority to adopt regulations related to the undefined term “preventive care.” Therefore, it found that HRSA could exempt those with religious objections from participation in providing contraceptive coverage. ACOG and other medical groups filed an amicus brief arguing that contraception is an essential preventive service. “Contraception not only helps to prevent unintended pregnancy, but also helps to protect the health and well-being of women and their children.”¹⁴ It was cited only by Justice Ginsburg in her dissent.¹⁵ 

Deferred Action for Childhood Arrivals (DACA)

The AAMC, ACOG, AMA, and many other organizations filed an amicus brief¹⁶ in Department of Homeland Security v Regents of University of California.¹⁷ The case raised the question of whether a decision to end the DACA program followed the appropriate administrative procedures. In 2012, the Obama administration issued a “memorandum” establishing DACA (without congressional approval or formal rulemaking). A lower court decision barring implementation of DACA was upheld by the Supreme Court in 2016 on a 4-4 vote.¹⁸ In 2017, the Trump administration moved to end DACA. 

In a 5-4 decision, the Court held that the explanation for ending DACA was inadequate, and violated the Administrative Procedures Act, so DACA could continue until the administration redid the repeal, following the proper procedures. The decision of the Court dealt solely with the process by which the rescission took place—there was general agreement that the administration had the right to rescind it if the procedure (with legitimate reasons) was proper.

The brief for the medical groups argued that the failure of the regulation to consider “reliance interests” would have especially difficult consequences in the medical fields. It noted, “At this moment, an estimated 27,000 health care workers and support staff depend on DACA for their authorization to work in the United States. Among those 27,000 are nurses, dentists, pharmacists, physician assistants, home health aides, technicians, and others. The number also includes nearly 200 medical students, medical residents, and physicians who depend on DACA for their eligibility to practice medicine.”¹⁶ The brief was not cited by the Court, but the reliance interest the brief spoke about was an important part of the case.

Continue to: Employment discrimination against gay and transgender employees...

Federal law (“Title VII”) makes it illegal for an employer to “discriminate against any individual because of race, color, religion, sex, or national origin.”¹⁹ The question this term was whether discrimination based on sexual orientation or sexual identity is within the statute’s meaning of “sex.” By a 6-3 majority, the Court held that Title VII applies both to orientation and identity. (This was an interpretation of the statute, not a broad constitutional ruling.)

The majority reasoned that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex. Consider, for example, an employer with 2 employees, both of whom are attracted to men.” If the employer fires the gay employee, “the employer discriminates against him for traits or actions it tolerates in his female colleague.”²⁰ 

AMA and a number of other medical organizations filed an amicus brief in the case.²¹ The core of the argument of the brief was, “Employment discrimination against transgender people frustrates the treatment of gender dysphoria by preventing transgender individuals from living openly in accordance with their true gender identity and impeding access to needed medical care. Experiencing discrimination in one of the most important aspects of adult life—employment—makes it nearly impossible to live in full congruence with one’s gender identity. The fear of facing such discrimination alone can prompt transgender individuals to hide their gender identity, directly thwarting the goal of social transition…. Lack of treatment, in turn, increases the rate of negative mental health outcomes, substance abuse, and suicide.” The brief was not cited in the opinions in the case.

This decision is likely to have great impact on many aspects of American life. In the employment area, it is now a matter of course that employers may not discriminate based on orientation or identity in any employment decisions including hiring, firing, compensation, fringe benefits, etc. Harassment based on identity or orientation may similarly be an employment law violation. The decision also likely means that giving employment preferences to gay employees would now be as illegal as would be giving preferences to straight employees. (Limited exceptions, notably to some religious organization employees, are not included in anti-discrimination laws.)²² 

The importance of the decision goes well beyond employment, however. More than 100 federal statutes are in place that prohibit “discrimination because of sex.” It is now likely that these statutes will be interpreted as prohibiting discrimination related to sexual orientation and identification. 

Additional cases of interest 

HIV/AIDS International Program

A major US program fighting HIV/AIDS worldwide—the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (aka the Leadership Act)—has provided billions of dollars to agencies abroad.²³ Nongovernmental organizations (NGOs) receiving funds under the program must agree to have a “policy explicitly opposing prostitution and sex trafficking” (known as the “Policy Requirement”). Some grant recipients in foreign countries, generally affiliates of US NGOs, do not want to have such a policy and challenged the policy requirement as a violation of First Amendment right of free speech. The Court held that it is a well-settled principle that “foreign citizens outside US territory do not possess rights under the US Constitution.”²⁴ Nor do organizations become entitled to such rights as a result of an affiliation with US organizations. This decision means that foreign organizations are free not to have the required policies, but they will be ineligible for funds under the Leadership Act. 

Continue to: ACA government debts edition...

The ACA was before the Court, yet again. To encourage private insurers to participate in online health insurance exchanges, the ACA provided that the federal government would share in insurance company losses for 3 years.²⁵ The Act, however, did not appropriate any money for these “risk corridors,” and insurance companies  lost $12 billion. 

Congress (after the 2010 election) prohibited any appropriated funds from being used to pay insurance companies for their risk corridor losses. Four insurance companies sued the United States, seeking reimbursements for their losses. This term the Court held that the government must pay for their losses under the ACA.²⁶ The Court said that Congress could have expressly repealed the risk corridor obligation (in the appropriation bill), but instead had only prohibited the expenditure of the money, which the Court said did not amount to an implied repeal of the obligation. We will see that ACA will be back before the Court again next term in California v Texas (discussed below).

Child custody and international abduction

The Hague Convention on the Civil Aspects of International Child Abduction (to which the United States is a party) provides that the courts of the country where the child has “habitual residence” have jurisdiction to decide custody.²⁷ If a parent takes the child to another country, that country is obligated to return the child to the country of “habitual residence.” 

This term the Court was called upon to define “habitual residence.” The Court held that determining habitual residence depends on the “totality of the circumstances,” and that “locating a child’s home is a fact-driven inquiry,” and that “courts must be sensitive to the unique circumstances of the case and informed by common sense.”²⁸ An exception to the Convention’s obligation to return a child to the country of habitual residence is where “there is a grave risk that [the] return would expose the child to physical or psychological harm or otherwise place the child in an intolerable situation.”²⁹ Who the parent is can affect many aspects of legal authority over the child, including consent to medical care, and the right to receive information concerning care. 

Analysis of the term

The term began October 7, 2019, and adjourned July 9, 2020, somewhat later than usual because of coronavirus disease 2019 (COVID-19). During the term, the Court decided 60 cases, including 53 “signed” merit opinions after oral argument—the lowest number of decided cases in many years.30 Of those 60 cases, 22 (35%) were unanimous, and 13 (22%) resulted in a 5-4 split.³⁰ Ten-year averages are 48% unanimous and 20% with 5-4 decisions.³⁰

Chief Justice Roberts was the central focus of the term. He presided over the impeachment trial of President Trump in the Senate early in the term. He also presided over the Court’s accommodations of the COVID-19 pandemic. He is the “median,” or “swing,” justice. He was in the majority in 12 of the 13 cases with 5-4 decisions.³⁰ He was in the majority in 97% of all cases and in 95% of “divided cases”—the highest of any of the justices this term.³⁰ In some of the most critical decisions, Chief Justice Roberts sided with the “liberal” wing, including on cases concerning abortion, gay and transgender employment, DACA, and 2 Presidential subpoena cases. More often (in 9 of the 5-4 decisions), however, he sided with the more conservative justices.³⁰ Justice Kavanaugh agreed with Chief Justice Roberts most often (in 93% of all cases).³⁰ Among the others, these justices agreed with each other 90% or more of the time: Justices Ginsburg and Breyer (93%), Justices Alito and Thomas (92%), and Justices Breyer and Kagan (90%).³⁰

Continue to: COVID-19 and the Court...

Some of the biggest news of the term came not from the law, but from medicine in the form of  COVID-19. The Court was in the process of preparing a final period of important arguments when, on March 16, it announced that it was postponing further arguments. The Court rescheduled 10 oral arguments that were held by telephone (other cases were held over to the next term). The phone arguments, during the first 2 weeks of May, necessitated a change in format. Each justice was called on (in order of seniority) by the Chief Justice to ask questions. This was in contrast to the free-for-all questions that usually characterize in-person arguments. These arguments were broadcast live—something that had never been done before. Public access was, on balance, a good thing. There were a couple failures to unmute, and there was “the flush heard round the world” in the middle of one argument, but otherwise the arguments went off with few hitches.³¹

Looking ahead

By the end of the term, no justice had announced an intention to retire from the Court. On September 18, however, Justice Ruth Bader Ginsburg passed away. In 2009, she had been diagnosed with early-stage pancreatic cancer. This term she had been hospitalized twice, and at the end of the term, she announced a recurrence of pancreatic cancer, which was being treated with chemotherapy. See “RBG: The woman, the legacy” for a tribute to this remarkable woman, lawyer, and justice.

Justice Ginsburg’s death, occurring in the middle of a presidential campaign, ignited a political firestorm concerning her successor. The outcome of selecting and confirming her successor and the political fallout were not immediately apparent. Justice Ginsburg was confirmed just 7 weeks after her nomination by President Clinton, by a vote of 96-3. But those days of Senate consensus are not the current norm.

The next term (called the “October 2020 Term”) will begin on October 5, 2020. The Court will begin with 8 justices and, depending on the nomination process, may operate with 8 justices for some time. When there is a “tie” vote in the Court, the lower court decision is upheld. The Court has been short-handed several times in the past and, with few exceptions, has managed the cases successfully.

The Court has announced that initial arguments will be telephonic. It already has taken a number of cases. The constitutionality of the individual mandate (coverage) in the ACA will once again be before the Court, and that already has produced a flood of amicus briefs from health-related organizations.³² Among other upcoming issues are cases related to state regulation of pharmacy benefit managers, gay rights and foster care, sentencing of juveniles to life in prison without the possibility of parole, a face-off between Google and Oracle on software copyrights, and arbitration. In addition, some of the issues we saw this term will reappear, with more on robocalls, religious freedom and Catholic charities, and immigration and removal cases.
 

This is the third and final article in a series focusing on malpractice, liability, and reform. In the first article, we looked at the background on malpractice and reasons malpractice rates have been so high—including large verdicts and lawsuit-prone physicians. In the second article we considered recent experience and developments in malpractice exposure, who is sued and why. Finally, in this third article, we focus on apologies, apology laws, and liability.

“I’m sorry”

In childhood we are all taught the basic courtesies: “please” and “thank you,” and “I’m sorry,” when harm has occurred. Should we as adult health care providers fear the consequences of apologizing? Apologies are a way for clinicians to express empathy; they also serve as a tool to reduce medical malpractice claims.¹

Apologies, ethics, and care

The American Medical Association takes the position that a physician has an ethical duty to disclose a harmful error to a patient.^2,3 Indeed this approach has been an impetus for states to enact apology laws, which we discuss below. As pointed out in this 2013 article title, “Dealing with a medical mistake: Should physicians apologize to patients?”,⁴ the legal benefits of any apology are an issue. It is a controversial area in medicine still today, including in obstetrics and gynecology.

“Ethical codes for both M.D.s and D.O.s suggest providers should display honesty and empathy following adverse events and errors.”^1,3,5 In addition, the American Medical Association states, “a physician should at all times deal honestly and openly with patients.”² Concerns about liability that may result from truthful disclosure should not affect the physician’s honesty (TABLE). Increasingly, the law has sided with that principle through apology laws.

Continue to: Legal issues and medical apologies...

Legal issues and medical apologies

From a legal standpoint, traditionally, an apology from a physician to a patient could be used against a physician in a medical liability (malpractice) case as proof of negligence.

Statements of interest. Such out-of-court statements ordinarily would be “hearsay” and excluded from evidence; there is, however, an exception to this hearsay rule that allows “confessions” or “statements against interest” to be admissible against the party making the statement. The theory is that when a statement is harmful to the person making it, the person likely thought that it was true, and the statement should be admissible at trial. We do not generally go around confessing to things that are not true. Following an auto crash, if one driver jumps out of the car saying, “I am so sorry I hit you. I was using my cell phone and did not see you stop,” the statement is against the interest of the driver and could be used in court.

As a matter of general legal principle, the same issue can arise in medical practice. Suppose a physician says, “I am so sorry for your injury. We made a mistake in interpreting the data from the monitors.” That sounds a lot like not just an apology but a statement against interest. Malpractice cases generally are based on the claim that a “doctor failed to do what a reasonable provider in the same specialty would have done in a similar situation.”¹³ An apology may be little more than general sympathy (“I’m sorry to tell you that we have not cured the infection. Unfortunately, that will mean more time in the hospital.”), but it can include a confession of error (“I’m sorry we got the x-ray backward and removed the wrong kidney.”). In the latter kind of apology, courts traditionally have found a “statement against interest.”

The legal consequence of a statement against interest is that the statement may be admitted in court. Such statements do not automatically establish negligence, but they can be powerful evidence when presented to a jury.

Courts have struggled with medical apologies. General sympathy or feelings of regret or compassion do not generally rise to the level of an admission that the physician did not use reasonable care under the circumstances and ordinarily are not admissible. (For further details, we refer you to the case of Cobbs v. Grant.¹⁴ Even if a physician said to the patient that he “blamed himself for [the patient] being back in the hospital for a second time,…the statement signifies compassion, or at most, a feeling of remorse, for plaintiff’s ordeal.”) On the other hand, in cases in which a physician in an apology referred to a “careless” mistake or even a “negligent” mistake, courts have allowed it admitted at trial as a statement against interest. (A 1946 case, Woronka v. Sewall, is an example.¹⁵ In that case, the physician said to the patient, “My God, what a mess…she had a very hard delivery, and it was a burning shame to get [an injury] on top of it, and it was because of negligence when they were upstairs.”) Some of these cases come down to the provider’s use of a single word: fault, careless, or negligence.

The ambiguity over the legal place of medical apologies in medicine led attorneys to urge medical providers to avoid statements that might even remotely be taken as statements against interest, including real apologies. The confusion over the admissibility of medical apologies led state legislatures to adopt apology laws. These laws essentially limit what statements against interest may be introduced in professional liability cases when a provider has issued a responsibility or apologized.

Continue to: Apology statutes...

Apology statutes

Massachusetts was the first state to enact an apology law—in 1986.¹ As of 2019, a clear majority of states have some form of apology statute. “Apology laws are gaining traction,” was the first sentence in a 2012 review on the subject by Saitta and colleagues.³ Only a few (5 states) have “strong” statutes that have broad protection for statements of fault, error, and negligence, as well as sympathy. The other 33 states have statutes that only protect against statements of sympathy.^4,16 FIGURE 1 is a US map showing the apology laws by state.¹

Do apology statutes and apologies reduce liability?

The positive aspects of apology include personal, psychological, and emotional benefits to both the one apologizing and the one receiving the apology. It also may have financial benefits to health care providers.⁴ The assumption has been, and there has been some evidence for the proposition, that apologies reduce the possibility of malpractice claims. That is one of the reasons that institutions may have formal apology policies. Indeed, there is evidence that apologies reduce financial awards to patients, as manifest in the states of Pennsylvania and Kentucky.⁴ Apologies appear to reduce patient anger and can open the door to better communication with the provider. There is evidence that some kinds of apologies tend to diminish blame and make the injured patient less likely to pursue litigation.¹⁰ The conclusion from these studies might be that honest and open communication serves to decrease the incidence of medical malpractice lawsuit initiation and that honesty is the best policy.

It is important to note the difference, however, between apologies (or institutional apology policies) and apology laws. There is some evidence that apology and institutional apology policies may reduce malpractice claims or losses.^17,18 On the other hand, the studies of apology laws have not found that these laws have much impact on malpractice rates. An especially good and thorough study of the effect of apology laws nationwide, using insurance claims data, essentially found little net effect of the apology laws.^19,20 One other study could find no evidence that apology statutes reduce defensive medicine (so no reduction in provider concerns over liability).²¹

It should be noted that most studies on medical apology and its effects on malpractice claims generally have looked at the narrow or limited apology statutes (that do not cover expressions of fault or negligence). Few states have the broader statutes, and it is possible that those broader statutes would be more effective in reducing liability. Removing the disincentives to medical apologies is a good thing, but in and of itself it is probably not a liability game changer.

Continue to: Institutional policy and apology...

Institutional policy and apology

Some institutions have established an “inclusion of apology” strategy for medical errors. These policies appear to have a meaningful effect on reducing medical malpractice costs. These programs commonly include a proactive investigation, disclosure of error, and apologies. Such policies have been studied at the University of Michigan and the Veterans Affairs (VA) Hospital in Lexington, Kentucky. The University of Michigan program resulted in a 60% reduction in compensation costs for medical errors.²² It also cut litigation costs by half.²³ The review of the Kentucky VA program also was positive.¹⁷ FIGURE 2 illustrates the key features of the Michigan program.²⁴

Conclusions: Effective apologies

Our conclusions, first, are that apologies are important from all perspectives: ethical, medical, and legal. On the other hand, all of the attention given in recent years to apology statutes may have been misplaced, at least if they were intended to be malpractice reform.¹⁷

Institutional apology and response programs are likely successful because they are thoughtfully put together, generally based on the best understanding of how injured patients respond to apologies and what it takes to be sincere, and communicate that sincerity, in the apology. What is an effective apology?, “The acceptance of responsibility for having caused harm.” It may, for example, mean accepting some financial responsibility for the harm. It is also important that the apology is conveyed in such a way that it includes an element of self-critical expression.²⁵ Although there are many formulations of the elements of an effective apology, one example is, “(1) acknowledging and accepting responsibility for the offense; (2) expressing remorse with forbearance, sincerity, and honesty; (3) explaining the understanding of the offense; and (4) willingness to make reparations.”²⁶

At the other extreme is a medical professional, after a bad event, trying to engage in a half-hearted, awkward, or insincere apology on an ad hoc and poorly planned basis. Worse still, “when victims perceive apologies to be insincere and designed simply to cool them off, they react with more rather than less indignation.”²⁷ Of course, the “forced apology” may be the worst of all. An instance of this was addressed in a New Zealand study in which providers were “forced” to provide a written apology to a couple (Mr. and Mrs. B) and a separate written apology to Baby B when there was failure to discuss vitamin K administration during the antenatal period when it was indicated.²⁸ Rather than emphasizing required apology in such a case, which can seem hollow and disingenuous, emphasis was placed on the apology providing a “positive-physiological” effect for those harmed, and on strategies that “nurture the development of the moral maturity required for authentic apology.”

The great advantage of institutional or practice-wide policies is that they can be developed in the calm of planning, with good foresight and careful consideration. This is much different from having to come up with some approach in the heat of something having gone wrong. Ultimately, however, apologies are not about liability. They are about caring for, respecting, and communicating with those who are harmed. Apologizing is often the right and professional thing to do.

This is the third and final article in a series focusing on malpractice, liability, and reform. In the first article, we looked at the background on malpractice and reasons malpractice rates have been so high—including large verdicts and lawsuit-prone physicians. In the second article we considered recent experience and developments in malpractice exposure, who is sued and why. Finally, in this third article, we focus on apologies, apology laws, and liability.

“I’m sorry”

In childhood we are all taught the basic courtesies: “please” and “thank you,” and “I’m sorry,” when harm has occurred. Should we as adult health care providers fear the consequences of apologizing? Apologies are a way for clinicians to express empathy; they also serve as a tool to reduce medical malpractice claims.¹

Apologies, ethics, and care

The American Medical Association takes the position that a physician has an ethical duty to disclose a harmful error to a patient.^2,3 Indeed this approach has been an impetus for states to enact apology laws, which we discuss below. As pointed out in this 2013 article title, “Dealing with a medical mistake: Should physicians apologize to patients?”,⁴ the legal benefits of any apology are an issue. It is a controversial area in medicine still today, including in obstetrics and gynecology.

“Ethical codes for both M.D.s and D.O.s suggest providers should display honesty and empathy following adverse events and errors.”^1,3,5 In addition, the American Medical Association states, “a physician should at all times deal honestly and openly with patients.”² Concerns about liability that may result from truthful disclosure should not affect the physician’s honesty (TABLE). Increasingly, the law has sided with that principle through apology laws.

Continue to: Legal issues and medical apologies...

Legal issues and medical apologies

From a legal standpoint, traditionally, an apology from a physician to a patient could be used against a physician in a medical liability (malpractice) case as proof of negligence.

Statements of interest. Such out-of-court statements ordinarily would be “hearsay” and excluded from evidence; there is, however, an exception to this hearsay rule that allows “confessions” or “statements against interest” to be admissible against the party making the statement. The theory is that when a statement is harmful to the person making it, the person likely thought that it was true, and the statement should be admissible at trial. We do not generally go around confessing to things that are not true. Following an auto crash, if one driver jumps out of the car saying, “I am so sorry I hit you. I was using my cell phone and did not see you stop,” the statement is against the interest of the driver and could be used in court.

As a matter of general legal principle, the same issue can arise in medical practice. Suppose a physician says, “I am so sorry for your injury. We made a mistake in interpreting the data from the monitors.” That sounds a lot like not just an apology but a statement against interest. Malpractice cases generally are based on the claim that a “doctor failed to do what a reasonable provider in the same specialty would have done in a similar situation.”¹³ An apology may be little more than general sympathy (“I’m sorry to tell you that we have not cured the infection. Unfortunately, that will mean more time in the hospital.”), but it can include a confession of error (“I’m sorry we got the x-ray backward and removed the wrong kidney.”). In the latter kind of apology, courts traditionally have found a “statement against interest.”

The legal consequence of a statement against interest is that the statement may be admitted in court. Such statements do not automatically establish negligence, but they can be powerful evidence when presented to a jury.

Courts have struggled with medical apologies. General sympathy or feelings of regret or compassion do not generally rise to the level of an admission that the physician did not use reasonable care under the circumstances and ordinarily are not admissible. (For further details, we refer you to the case of Cobbs v. Grant.¹⁴ Even if a physician said to the patient that he “blamed himself for [the patient] being back in the hospital for a second time,…the statement signifies compassion, or at most, a feeling of remorse, for plaintiff’s ordeal.”) On the other hand, in cases in which a physician in an apology referred to a “careless” mistake or even a “negligent” mistake, courts have allowed it admitted at trial as a statement against interest. (A 1946 case, Woronka v. Sewall, is an example.¹⁵ In that case, the physician said to the patient, “My God, what a mess…she had a very hard delivery, and it was a burning shame to get [an injury] on top of it, and it was because of negligence when they were upstairs.”) Some of these cases come down to the provider’s use of a single word: fault, careless, or negligence.

The ambiguity over the legal place of medical apologies in medicine led attorneys to urge medical providers to avoid statements that might even remotely be taken as statements against interest, including real apologies. The confusion over the admissibility of medical apologies led state legislatures to adopt apology laws. These laws essentially limit what statements against interest may be introduced in professional liability cases when a provider has issued a responsibility or apologized.

Continue to: Apology statutes...

Apology statutes

Massachusetts was the first state to enact an apology law—in 1986.¹ As of 2019, a clear majority of states have some form of apology statute. “Apology laws are gaining traction,” was the first sentence in a 2012 review on the subject by Saitta and colleagues.³ Only a few (5 states) have “strong” statutes that have broad protection for statements of fault, error, and negligence, as well as sympathy. The other 33 states have statutes that only protect against statements of sympathy.^4,16 FIGURE 1 is a US map showing the apology laws by state.¹

Do apology statutes and apologies reduce liability?

The positive aspects of apology include personal, psychological, and emotional benefits to both the one apologizing and the one receiving the apology. It also may have financial benefits to health care providers.⁴ The assumption has been, and there has been some evidence for the proposition, that apologies reduce the possibility of malpractice claims. That is one of the reasons that institutions may have formal apology policies. Indeed, there is evidence that apologies reduce financial awards to patients, as manifest in the states of Pennsylvania and Kentucky.⁴ Apologies appear to reduce patient anger and can open the door to better communication with the provider. There is evidence that some kinds of apologies tend to diminish blame and make the injured patient less likely to pursue litigation.¹⁰ The conclusion from these studies might be that honest and open communication serves to decrease the incidence of medical malpractice lawsuit initiation and that honesty is the best policy.

It is important to note the difference, however, between apologies (or institutional apology policies) and apology laws. There is some evidence that apology and institutional apology policies may reduce malpractice claims or losses.^17,18 On the other hand, the studies of apology laws have not found that these laws have much impact on malpractice rates. An especially good and thorough study of the effect of apology laws nationwide, using insurance claims data, essentially found little net effect of the apology laws.^19,20 One other study could find no evidence that apology statutes reduce defensive medicine (so no reduction in provider concerns over liability).²¹

It should be noted that most studies on medical apology and its effects on malpractice claims generally have looked at the narrow or limited apology statutes (that do not cover expressions of fault or negligence). Few states have the broader statutes, and it is possible that those broader statutes would be more effective in reducing liability. Removing the disincentives to medical apologies is a good thing, but in and of itself it is probably not a liability game changer.

Continue to: Institutional policy and apology...

Institutional policy and apology

Some institutions have established an “inclusion of apology” strategy for medical errors. These policies appear to have a meaningful effect on reducing medical malpractice costs. These programs commonly include a proactive investigation, disclosure of error, and apologies. Such policies have been studied at the University of Michigan and the Veterans Affairs (VA) Hospital in Lexington, Kentucky. The University of Michigan program resulted in a 60% reduction in compensation costs for medical errors.²² It also cut litigation costs by half.²³ The review of the Kentucky VA program also was positive.¹⁷ FIGURE 2 illustrates the key features of the Michigan program.²⁴

Conclusions: Effective apologies

Our conclusions, first, are that apologies are important from all perspectives: ethical, medical, and legal. On the other hand, all of the attention given in recent years to apology statutes may have been misplaced, at least if they were intended to be malpractice reform.¹⁷

Institutional apology and response programs are likely successful because they are thoughtfully put together, generally based on the best understanding of how injured patients respond to apologies and what it takes to be sincere, and communicate that sincerity, in the apology. What is an effective apology?, “The acceptance of responsibility for having caused harm.” It may, for example, mean accepting some financial responsibility for the harm. It is also important that the apology is conveyed in such a way that it includes an element of self-critical expression.²⁵ Although there are many formulations of the elements of an effective apology, one example is, “(1) acknowledging and accepting responsibility for the offense; (2) expressing remorse with forbearance, sincerity, and honesty; (3) explaining the understanding of the offense; and (4) willingness to make reparations.”²⁶

At the other extreme is a medical professional, after a bad event, trying to engage in a half-hearted, awkward, or insincere apology on an ad hoc and poorly planned basis. Worse still, “when victims perceive apologies to be insincere and designed simply to cool them off, they react with more rather than less indignation.”²⁷ Of course, the “forced apology” may be the worst of all. An instance of this was addressed in a New Zealand study in which providers were “forced” to provide a written apology to a couple (Mr. and Mrs. B) and a separate written apology to Baby B when there was failure to discuss vitamin K administration during the antenatal period when it was indicated.²⁸ Rather than emphasizing required apology in such a case, which can seem hollow and disingenuous, emphasis was placed on the apology providing a “positive-physiological” effect for those harmed, and on strategies that “nurture the development of the moral maturity required for authentic apology.”

The great advantage of institutional or practice-wide policies is that they can be developed in the calm of planning, with good foresight and careful consideration. This is much different from having to come up with some approach in the heat of something having gone wrong. Ultimately, however, apologies are not about liability. They are about caring for, respecting, and communicating with those who are harmed. Apologizing is often the right and professional thing to do.

This is the third and final article in a series focusing on malpractice, liability, and reform. In the first article, we looked at the background on malpractice and reasons malpractice rates have been so high—including large verdicts and lawsuit-prone physicians. In the second article we considered recent experience and developments in malpractice exposure, who is sued and why. Finally, in this third article, we focus on apologies, apology laws, and liability.

“I’m sorry”

In childhood we are all taught the basic courtesies: “please” and “thank you,” and “I’m sorry,” when harm has occurred. Should we as adult health care providers fear the consequences of apologizing? Apologies are a way for clinicians to express empathy; they also serve as a tool to reduce medical malpractice claims.¹

Apologies, ethics, and care

The American Medical Association takes the position that a physician has an ethical duty to disclose a harmful error to a patient.^2,3 Indeed this approach has been an impetus for states to enact apology laws, which we discuss below. As pointed out in this 2013 article title, “Dealing with a medical mistake: Should physicians apologize to patients?”,⁴ the legal benefits of any apology are an issue. It is a controversial area in medicine still today, including in obstetrics and gynecology.

“Ethical codes for both M.D.s and D.O.s suggest providers should display honesty and empathy following adverse events and errors.”^1,3,5 In addition, the American Medical Association states, “a physician should at all times deal honestly and openly with patients.”² Concerns about liability that may result from truthful disclosure should not affect the physician’s honesty (TABLE). Increasingly, the law has sided with that principle through apology laws.

Continue to: Legal issues and medical apologies...

Legal issues and medical apologies

From a legal standpoint, traditionally, an apology from a physician to a patient could be used against a physician in a medical liability (malpractice) case as proof of negligence.

Statements of interest. Such out-of-court statements ordinarily would be “hearsay” and excluded from evidence; there is, however, an exception to this hearsay rule that allows “confessions” or “statements against interest” to be admissible against the party making the statement. The theory is that when a statement is harmful to the person making it, the person likely thought that it was true, and the statement should be admissible at trial. We do not generally go around confessing to things that are not true. Following an auto crash, if one driver jumps out of the car saying, “I am so sorry I hit you. I was using my cell phone and did not see you stop,” the statement is against the interest of the driver and could be used in court.

As a matter of general legal principle, the same issue can arise in medical practice. Suppose a physician says, “I am so sorry for your injury. We made a mistake in interpreting the data from the monitors.” That sounds a lot like not just an apology but a statement against interest. Malpractice cases generally are based on the claim that a “doctor failed to do what a reasonable provider in the same specialty would have done in a similar situation.”¹³ An apology may be little more than general sympathy (“I’m sorry to tell you that we have not cured the infection. Unfortunately, that will mean more time in the hospital.”), but it can include a confession of error (“I’m sorry we got the x-ray backward and removed the wrong kidney.”). In the latter kind of apology, courts traditionally have found a “statement against interest.”

The legal consequence of a statement against interest is that the statement may be admitted in court. Such statements do not automatically establish negligence, but they can be powerful evidence when presented to a jury.

Courts have struggled with medical apologies. General sympathy or feelings of regret or compassion do not generally rise to the level of an admission that the physician did not use reasonable care under the circumstances and ordinarily are not admissible. (For further details, we refer you to the case of Cobbs v. Grant.¹⁴ Even if a physician said to the patient that he “blamed himself for [the patient] being back in the hospital for a second time,…the statement signifies compassion, or at most, a feeling of remorse, for plaintiff’s ordeal.”) On the other hand, in cases in which a physician in an apology referred to a “careless” mistake or even a “negligent” mistake, courts have allowed it admitted at trial as a statement against interest. (A 1946 case, Woronka v. Sewall, is an example.¹⁵ In that case, the physician said to the patient, “My God, what a mess…she had a very hard delivery, and it was a burning shame to get [an injury] on top of it, and it was because of negligence when they were upstairs.”) Some of these cases come down to the provider’s use of a single word: fault, careless, or negligence.

The ambiguity over the legal place of medical apologies in medicine led attorneys to urge medical providers to avoid statements that might even remotely be taken as statements against interest, including real apologies. The confusion over the admissibility of medical apologies led state legislatures to adopt apology laws. These laws essentially limit what statements against interest may be introduced in professional liability cases when a provider has issued a responsibility or apologized.

Continue to: Apology statutes...

Apology statutes

Massachusetts was the first state to enact an apology law—in 1986.¹ As of 2019, a clear majority of states have some form of apology statute. “Apology laws are gaining traction,” was the first sentence in a 2012 review on the subject by Saitta and colleagues.³ Only a few (5 states) have “strong” statutes that have broad protection for statements of fault, error, and negligence, as well as sympathy. The other 33 states have statutes that only protect against statements of sympathy.^4,16 FIGURE 1 is a US map showing the apology laws by state.¹

Do apology statutes and apologies reduce liability?

The positive aspects of apology include personal, psychological, and emotional benefits to both the one apologizing and the one receiving the apology. It also may have financial benefits to health care providers.⁴ The assumption has been, and there has been some evidence for the proposition, that apologies reduce the possibility of malpractice claims. That is one of the reasons that institutions may have formal apology policies. Indeed, there is evidence that apologies reduce financial awards to patients, as manifest in the states of Pennsylvania and Kentucky.⁴ Apologies appear to reduce patient anger and can open the door to better communication with the provider. There is evidence that some kinds of apologies tend to diminish blame and make the injured patient less likely to pursue litigation.¹⁰ The conclusion from these studies might be that honest and open communication serves to decrease the incidence of medical malpractice lawsuit initiation and that honesty is the best policy.

It is important to note the difference, however, between apologies (or institutional apology policies) and apology laws. There is some evidence that apology and institutional apology policies may reduce malpractice claims or losses.^17,18 On the other hand, the studies of apology laws have not found that these laws have much impact on malpractice rates. An especially good and thorough study of the effect of apology laws nationwide, using insurance claims data, essentially found little net effect of the apology laws.^19,20 One other study could find no evidence that apology statutes reduce defensive medicine (so no reduction in provider concerns over liability).²¹

It should be noted that most studies on medical apology and its effects on malpractice claims generally have looked at the narrow or limited apology statutes (that do not cover expressions of fault or negligence). Few states have the broader statutes, and it is possible that those broader statutes would be more effective in reducing liability. Removing the disincentives to medical apologies is a good thing, but in and of itself it is probably not a liability game changer.

Continue to: Institutional policy and apology...

Institutional policy and apology

Some institutions have established an “inclusion of apology” strategy for medical errors. These policies appear to have a meaningful effect on reducing medical malpractice costs. These programs commonly include a proactive investigation, disclosure of error, and apologies. Such policies have been studied at the University of Michigan and the Veterans Affairs (VA) Hospital in Lexington, Kentucky. The University of Michigan program resulted in a 60% reduction in compensation costs for medical errors.²² It also cut litigation costs by half.²³ The review of the Kentucky VA program also was positive.¹⁷ FIGURE 2 illustrates the key features of the Michigan program.²⁴

Conclusions: Effective apologies

Our conclusions, first, are that apologies are important from all perspectives: ethical, medical, and legal. On the other hand, all of the attention given in recent years to apology statutes may have been misplaced, at least if they were intended to be malpractice reform.¹⁷

Institutional apology and response programs are likely successful because they are thoughtfully put together, generally based on the best understanding of how injured patients respond to apologies and what it takes to be sincere, and communicate that sincerity, in the apology. What is an effective apology?, “The acceptance of responsibility for having caused harm.” It may, for example, mean accepting some financial responsibility for the harm. It is also important that the apology is conveyed in such a way that it includes an element of self-critical expression.²⁵ Although there are many formulations of the elements of an effective apology, one example is, “(1) acknowledging and accepting responsibility for the offense; (2) expressing remorse with forbearance, sincerity, and honesty; (3) explaining the understanding of the offense; and (4) willingness to make reparations.”²⁶

At the other extreme is a medical professional, after a bad event, trying to engage in a half-hearted, awkward, or insincere apology on an ad hoc and poorly planned basis. Worse still, “when victims perceive apologies to be insincere and designed simply to cool them off, they react with more rather than less indignation.”²⁷ Of course, the “forced apology” may be the worst of all. An instance of this was addressed in a New Zealand study in which providers were “forced” to provide a written apology to a couple (Mr. and Mrs. B) and a separate written apology to Baby B when there was failure to discuss vitamin K administration during the antenatal period when it was indicated.²⁸ Rather than emphasizing required apology in such a case, which can seem hollow and disingenuous, emphasis was placed on the apology providing a “positive-physiological” effect for those harmed, and on strategies that “nurture the development of the moral maturity required for authentic apology.”

The great advantage of institutional or practice-wide policies is that they can be developed in the calm of planning, with good foresight and careful consideration. This is much different from having to come up with some approach in the heat of something having gone wrong. Ultimately, however, apologies are not about liability. They are about caring for, respecting, and communicating with those who are harmed. Apologizing is often the right and professional thing to do.

In this second in a series of 3 articles discussing medical malpractice and the ObGyn we look at the reasons for malpractice claims and liability, what happens to malpractice claims, and the direction and future of medical malpractice. The first article dealt with 2 sources of major malpractice damages: the “big verdict” and physicians with multiple malpractice paid claims. Next month we look at the place of apology in medicine, in cases in which error, including negligence, may have caused a patient injury.

CASE 1 Long-term brachial plexus injury

Right upper extremity injury occurs in the neonate at delivery with sequela of long-term brachial plexus injury (which is diagnosed around 6 months of age). Physical therapy and orthopedic assessment are rendered. Despite continued treatment, discrepancy in arm lengths (ie, affected side arm is noticeably shorter than opposite side) remains. The child cannot play basketball with his older brother and is the victim of ridicule, the plaintiff’s attorney emphasizes. He is unable to properly pronate or supinate the affected arm.

The defendant ObGyn maintains that there was “no shoulder dystocia [at delivery] and the shoulder did not get obstructed in the pelvis; shoulder was delivered 15 seconds after delivery of the head.” The nursing staff testifies that if shoulder dystocia had been the problem they would have launched upon a series of procedures to address such, in accord with the delivering obstetrician. The defense expert witness testifies that a brachial plexus injury can happen without shoulder dystocia.

A defense verdict is rendered by the Florida jury.¹
 

CASE 2 Shoulder dystocia

During delivery, the obstetrician notes a shoulder dystocia (“turtle sign”). After initial attempts to release the shoulder were unsuccessful, the physician applies traction several times to the head of the child, and the baby is delivered. There is permanent injury to the right brachial plexus. The defendant ObGyn says that traction was necessary to dislodge the shoulder, and that the injury was the result of the forces of labor (not the traction). The expert witness for the plaintiff testifies that the medical standard of care did not permit traction under these circumstances, and that the traction was the likely cause of the injury.

The Virginia jury awards $2.32 million in damages.²

Note: The above vignettes are drawn from actual cases but are only outlines of those cases and are not complete descriptions of the claims in the cases. Because the information comes from informal sources, not formal court records, the facts may be inaccurate and incomplete. They should be viewed as illustrations only.

The trend in malpractice

It has been clear for many years that medical malpractice claims are not randomly or evenly distributed among physicians. Notably, the variation among specialties has, and continues to be, substantial (FIGURE 1).³ Recent data suggest that, although paid claims per “1,000 physician-years” averages 14 paid claims per 1,000 physician years, it ranges from 4 or 5 in 1,000 (psychiatry and pediatrics) to 53 and 49 claims per 1,000 (neurology and plastic surgery, respectively). Obstetrics and gynecology has the fourth highest rate at 42.5 paid claims per 1,000 physician years.⁴ (These data are for the years 1992–2014.)

Continue to: The number of ObGyn paid malpractice claims has decreased over time...

The number of ObGyn paid malpractice claims has decreased over time. Although large verdicts and physicians with multiple paid malpractice claims receive a good deal of attention (as we noted in part 1 of our series), in fact, paid medical malpractice claims have trended downward in recent decades.⁵ When the data above are disaggregated by 5-year periods, for example, in obstetrics and gynecology, there has been a consistent reduction in paid malpractice claims from 1992 to 2014. Paid claims went from 58 per 1,000 physician-years in 1992–1996 to 25 per 1,000 in 2009–2014 (FIGURE 2).^4,6 In short, the rate dropped by half over approximately 20 years.⁴

It is reasonable to expect that such a decline in the cost of malpractice insurance premiums would follow. Robert L. Barbieri, MD, who practices in Boston, Massachusetts, in his excellent recent editorial in OBG Management⁶ reported that his professional liability insurance premiums decreased 18% from 2014 to 2019, and his colleague reported a 22% reduction during the same time period.⁶ An American Medical Association report of 7 states or metropolitan areas for 2008 to 2017 found considerable variance. The study looked at the rates and the trend of rates for malpractice insurance in several areas of the United States (FIGURE 3).⁷ For ObGyns, one of these jurisdictions experienced increased rates; in one other, rates stayed the same, and in 5 jurisdictions, the rates went down. The premiums varied across the country, however. In 2017, Los Angeles/Orange had an average rate of $49,804, and in Nassau and Suffolk counties, New York, the rate was $214,999. The median rate was approximately $170,000.⁷

Why have malpractice payouts declined overall?

Have medical errors declined?

It would be wonderful if the reduction in malpractice claims represented a significant decrease in medical errors. Attention to medical errors was driven by the first widely noticed study of medical error deaths. The Institute of Medicine (IOM) study in 2000, put the number of deaths annually at 44,000 to 98,000.⁸ There have been many efforts to reduce such errors, and it is possible that those efforts have indeed reduced errors somewhat.⁴ Barbieri provided a helpful digest of many of the error-reduction suggestions for ObGyn practice (TABLE 1).⁶ But the number of medical errors remains high. More recent studies have suggested that the IOM’s reported number of injuries may have been low.⁹ In 2013, one study suggested that 210,000 deaths annually were “associated with preventable harm” in hospitals. Because of how the data were gathered the authors estimated that the actual number of preventable deaths was closer to 400,000 annually. Serious harm to patients was estimated at 10 to 20 times the IOM rate.⁹

Therefore, a dramatic reduction in preventable medical errors does not appear to explain the reduction in malpractice claims. Some portion of it may be explained by malpractice reforms—see "The medical reform factor" section below.

The collective accountability factor

The way malpractice claims are paid (FIGURE 4),¹⁰ reported, and handled may explain some of the apparent reduction in overall paid claims. Perhaps the advent of “collective accountability,” in which patient care is rendered by teams and responsibility accepted at a team level, can alleviate a significant amount of individual physician medical malpractice claims.¹¹ This “enterprise liability” may shift the burden of medical error from physicians to health care organizations.¹² Collective accountability may, therefore, focus on institutional responsibility rather than individual physician negligence.^11,13 Institutions frequently hire multiple specialists and cover their medical malpractice costs as well as stand to be named in suits.

Continue to: The institutional involvement in malpractice cases also may affect...

The institutional involvement in malpractice cases also may affect apparent malpractice rates in another way. The National Practitioner Data Bank, which is the source of information for many malpractice studies, only requires reporting about individual physicians, not institutions.¹⁴ If, therefore, claims are settled on behalf of an institution, without implicating the physician, the number of physician malpractice cases may appear to decline without any real change in malpractice rates.¹⁴ In addition, institutions have taken the lead in informal resolution of injuries that occur in the institution, and these programs may reduce the direct malpractice claims against physicians. (These “disclosure, apology, and offer,” and similar programs, are discussed in the upcoming third part of this series.)

The medical reform factor

As noted, annual rates paid for medical malpractice in our specialty are trending downward. Many commentators look to malpractice reforms as the reason for the drop in malpractice rates.^15-17 Because medical malpractice is essentially a matter of state law, the medical malpractice reform has occurred primarily at the state level.¹⁸ There have been many different reforms tried—limits on expert witnesses, review panels, and a variety of procedural limitations.¹⁹ Perhaps the most effective reform has been caps being placed on noneconomic damages (generally pain and suffering).²⁰ These caps vary by state (FIGURE 5)^21,22 and, of course, affect the “big verdict” cases. (As we saw in the second case scenario above, Virginia is an example of a state with a cap on malpractice awards.) They also have the secondary effect of reducing the number of malpractice cases. They make malpractice cases less attractive to some attorneys because they reduce the opportunity of large contingency fees from large verdicts. (Virtually all medical malpractice cases in the United States are tried on a contingency-fee basis, meaning that the plaintiff does not pay the attorney handling the case but rather the attorney takes a percentage of any recovery—typically in the neighborhood of 35%.) The reform process continues, although, presently, there is less pressure to act on the malpractice crisis.

Medical malpractice cases are emotional and costly

Another reason for the relatively low rate of paid claims is that medical malpractice cases are difficult, emotionally challenging, time consuming, and expensive to pursue.²³ They typically drag on for years, require extensive and expensive expert consultants as well as witnesses, and face stiff defense (compared with many other torts). The settlement of medical malpractice cases, for example, is less likely than other kinds of personal injury cases.

The contingency-fee basis does mean that injured patients do not have to pay attorney fees up front; however, plaintiffs may have to pay substantial costs along the way. The other side of this coin is that lawyers can be reluctant to take malpractice cases in which the damages are likely to be small, or where the legal uncertainty reduces the odds of achieving any damages. Thus, many potential malpractice cases are never filed.

A word of caution

The news of a reduction in malpractice paid claims may not be permanent. The numbers can conceivably be cyclical, and political reforms achieved can be changed. In addition, new technology will likely bring new kinds of malpractice claims. That appears to be the case, for example, with electronic health records (EHRs). One insurer reports that EHR malpractice claims have increased over the last 8 years.²⁴ The most common injury in these claims was death (25%), as well as a magnitude of less serious injuries. EHR-related claims result from system failures, copy-paste inaccuracies, faulty drop-down menu use, and uncorrected “auto-populated” fields. Obstetrics is tied for fifth on the list of 14 specialties with claims related to EHRs, and gynecology is tied for eighth place.²⁴

Continue to: A federal court ruled that a hospital that changed from...

A federal court ruled that a hospital that changed from paper records to EHRs for test results had a duty to “‘implement a reasonable procedure during the transition phase’ to ensure the timely delivery of test results” to health care providers.²⁵ We will address this in a future “What’s the Verdict?”.

Rates of harm, malpractice cases, and the disposition of cases

There are many surprises when looking at medical malpractice claims data generally. The first surprise is how few claims are filed relative to the number of error-related injuries. Given the estimate of 210,000 to 400,000 deaths “associated with preventable harm” in hospitals, plus 10 to 20 times that number of serious injuries, it would be reasonable to expect claims of many hundreds of thousands per year. Compare the probability of a malpractice claim from an error-related injury, for example, with the probability of other personal injuries—eg, of traffic deaths associated with preventable harm.

The second key observation is how many of the claims filed are not successful—even when there was evidence in the record of errors associated with the injury. Studies slice the data in different ways but collectively suggest that only a small proportion of malpractice claims filed (a claim is generally regarded as some written demand for compensation for injuries) result in payments, either through settlement or by trial. A 2006 study by Studdert and colleagues determined that 63% of formal malpractice claims filed did involve injuries resulting from errors.²⁶ The study found that in 16% of the claims (not injuries) there was no payment even though there was error. In 10% of the claims there was payment, even in the absence of error.

Overall, in this study, 56% of the claims received some compensation.²⁶ That is higher than a more recent study by Jena and others, which found only 22% of claims resulted in compensation.³

How malpractice claims are decided is also interesting. Jena and colleagues found that only 55% of claims resulted in litigation.²⁷ Presumably, the other 45% may have resulted in the plaintiff dropping the case, or in some form of settlement. Of the claims that were litigated, 54% were dismissed by the court, and another 35% were settled before a trial verdict. The cases that went to trial (about 10%), overwhelmingly (80%) resulted in verdicts for the defense.^3,27 A different study found that only 9% of cases went to trial, and 87% were a defense verdict.²⁸ The high level of defense verdicts may suggest that malpractice defense lawyers, and their client physicians, do a good job of assessing cases they are likely to lose, and settling them before trial.

ObGyns generally have larger numbers of claims and among the largest payment amounts when there is payment. Fewer of their cases are dismissed by the courts, so more go to trial. At trial, however, ObGyns prevail at a remarkably high rate.²⁷ As for the probability of payment of a malpractice claim for ObGyns, one study suggested that there is approximately a 16% annual probability of a claim being filed, but only a 3% annual probability of a payment being made (suggesting about a 20% probability of payment per claim).³

Continue to: The purposes and effects of the medical malpractice system...

The purposes and effects of the medical malpractice system

The essential goals of tort law (including medical malpractice) include compensation for those who are injured and deterrence of future injuries (TABLE 2). What are the overall effects to the medical malpractice system? Unfortunately, the answer is that the law delivers disappointing results at best. It has a fairly high error rate. Many people who deserve some compensation for their injuries never seek compensation, and many deserving injured patients fail in efforts to receive compensation. At the same time, a few of the injured receive huge recoveries (even windfalls), and at least a small fraction receive compensation when there was no medical error. In addition to the high error rate, the system is inefficient and very expensive. Both defendants (through their insurance carriers) and plaintiffs spend a lot of money, years of time, and untold emotional pain dealing with these cases. The system also exacts high emotional and personal costs on plaintiffs and defendants.

Malpractice reform has not really addressed these issues—it has generally been focused on ways to reduce the cost of malpractice insurance. The most effective reform in reducing rates—caps—has had the effect of compensating the most seriously injured as though they were more modestly injured, and dissuading attorneys from taking the cases of those less seriously injured.

The medical and legal professions exist to help patients (the public). It does not seem that we have arrived at a system that does that very fairly or efficiently when a patient is injured because of preventable medical error.

Watch for the third and final article in this series next month, as we are going to look at “apology in medicine and a proactive response” to communication regarding a complication.

In this second in a series of 3 articles discussing medical malpractice and the ObGyn we look at the reasons for malpractice claims and liability, what happens to malpractice claims, and the direction and future of medical malpractice. The first article dealt with 2 sources of major malpractice damages: the “big verdict” and physicians with multiple malpractice paid claims. Next month we look at the place of apology in medicine, in cases in which error, including negligence, may have caused a patient injury.

CASE 1 Long-term brachial plexus injury

Right upper extremity injury occurs in the neonate at delivery with sequela of long-term brachial plexus injury (which is diagnosed around 6 months of age). Physical therapy and orthopedic assessment are rendered. Despite continued treatment, discrepancy in arm lengths (ie, affected side arm is noticeably shorter than opposite side) remains. The child cannot play basketball with his older brother and is the victim of ridicule, the plaintiff’s attorney emphasizes. He is unable to properly pronate or supinate the affected arm.

The defendant ObGyn maintains that there was “no shoulder dystocia [at delivery] and the shoulder did not get obstructed in the pelvis; shoulder was delivered 15 seconds after delivery of the head.” The nursing staff testifies that if shoulder dystocia had been the problem they would have launched upon a series of procedures to address such, in accord with the delivering obstetrician. The defense expert witness testifies that a brachial plexus injury can happen without shoulder dystocia.

A defense verdict is rendered by the Florida jury.¹
 

CASE 2 Shoulder dystocia

During delivery, the obstetrician notes a shoulder dystocia (“turtle sign”). After initial attempts to release the shoulder were unsuccessful, the physician applies traction several times to the head of the child, and the baby is delivered. There is permanent injury to the right brachial plexus. The defendant ObGyn says that traction was necessary to dislodge the shoulder, and that the injury was the result of the forces of labor (not the traction). The expert witness for the plaintiff testifies that the medical standard of care did not permit traction under these circumstances, and that the traction was the likely cause of the injury.

The Virginia jury awards $2.32 million in damages.²

Note: The above vignettes are drawn from actual cases but are only outlines of those cases and are not complete descriptions of the claims in the cases. Because the information comes from informal sources, not formal court records, the facts may be inaccurate and incomplete. They should be viewed as illustrations only.

The trend in malpractice

It has been clear for many years that medical malpractice claims are not randomly or evenly distributed among physicians. Notably, the variation among specialties has, and continues to be, substantial (FIGURE 1).³ Recent data suggest that, although paid claims per “1,000 physician-years” averages 14 paid claims per 1,000 physician years, it ranges from 4 or 5 in 1,000 (psychiatry and pediatrics) to 53 and 49 claims per 1,000 (neurology and plastic surgery, respectively). Obstetrics and gynecology has the fourth highest rate at 42.5 paid claims per 1,000 physician years.⁴ (These data are for the years 1992–2014.)

Continue to: The number of ObGyn paid malpractice claims has decreased over time...

The number of ObGyn paid malpractice claims has decreased over time. Although large verdicts and physicians with multiple paid malpractice claims receive a good deal of attention (as we noted in part 1 of our series), in fact, paid medical malpractice claims have trended downward in recent decades.⁵ When the data above are disaggregated by 5-year periods, for example, in obstetrics and gynecology, there has been a consistent reduction in paid malpractice claims from 1992 to 2014. Paid claims went from 58 per 1,000 physician-years in 1992–1996 to 25 per 1,000 in 2009–2014 (FIGURE 2).^4,6 In short, the rate dropped by half over approximately 20 years.⁴

It is reasonable to expect that such a decline in the cost of malpractice insurance premiums would follow. Robert L. Barbieri, MD, who practices in Boston, Massachusetts, in his excellent recent editorial in OBG Management⁶ reported that his professional liability insurance premiums decreased 18% from 2014 to 2019, and his colleague reported a 22% reduction during the same time period.⁶ An American Medical Association report of 7 states or metropolitan areas for 2008 to 2017 found considerable variance. The study looked at the rates and the trend of rates for malpractice insurance in several areas of the United States (FIGURE 3).⁷ For ObGyns, one of these jurisdictions experienced increased rates; in one other, rates stayed the same, and in 5 jurisdictions, the rates went down. The premiums varied across the country, however. In 2017, Los Angeles/Orange had an average rate of $49,804, and in Nassau and Suffolk counties, New York, the rate was $214,999. The median rate was approximately $170,000.⁷

Why have malpractice payouts declined overall?

Have medical errors declined?

It would be wonderful if the reduction in malpractice claims represented a significant decrease in medical errors. Attention to medical errors was driven by the first widely noticed study of medical error deaths. The Institute of Medicine (IOM) study in 2000, put the number of deaths annually at 44,000 to 98,000.⁸ There have been many efforts to reduce such errors, and it is possible that those efforts have indeed reduced errors somewhat.⁴ Barbieri provided a helpful digest of many of the error-reduction suggestions for ObGyn practice (TABLE 1).⁶ But the number of medical errors remains high. More recent studies have suggested that the IOM’s reported number of injuries may have been low.⁹ In 2013, one study suggested that 210,000 deaths annually were “associated with preventable harm” in hospitals. Because of how the data were gathered the authors estimated that the actual number of preventable deaths was closer to 400,000 annually. Serious harm to patients was estimated at 10 to 20 times the IOM rate.⁹

Therefore, a dramatic reduction in preventable medical errors does not appear to explain the reduction in malpractice claims. Some portion of it may be explained by malpractice reforms—see "The medical reform factor" section below.

The collective accountability factor

The way malpractice claims are paid (FIGURE 4),¹⁰ reported, and handled may explain some of the apparent reduction in overall paid claims. Perhaps the advent of “collective accountability,” in which patient care is rendered by teams and responsibility accepted at a team level, can alleviate a significant amount of individual physician medical malpractice claims.¹¹ This “enterprise liability” may shift the burden of medical error from physicians to health care organizations.¹² Collective accountability may, therefore, focus on institutional responsibility rather than individual physician negligence.^11,13 Institutions frequently hire multiple specialists and cover their medical malpractice costs as well as stand to be named in suits.

Continue to: The institutional involvement in malpractice cases also may affect...

The institutional involvement in malpractice cases also may affect apparent malpractice rates in another way. The National Practitioner Data Bank, which is the source of information for many malpractice studies, only requires reporting about individual physicians, not institutions.¹⁴ If, therefore, claims are settled on behalf of an institution, without implicating the physician, the number of physician malpractice cases may appear to decline without any real change in malpractice rates.¹⁴ In addition, institutions have taken the lead in informal resolution of injuries that occur in the institution, and these programs may reduce the direct malpractice claims against physicians. (These “disclosure, apology, and offer,” and similar programs, are discussed in the upcoming third part of this series.)

The medical reform factor

As noted, annual rates paid for medical malpractice in our specialty are trending downward. Many commentators look to malpractice reforms as the reason for the drop in malpractice rates.^15-17 Because medical malpractice is essentially a matter of state law, the medical malpractice reform has occurred primarily at the state level.¹⁸ There have been many different reforms tried—limits on expert witnesses, review panels, and a variety of procedural limitations.¹⁹ Perhaps the most effective reform has been caps being placed on noneconomic damages (generally pain and suffering).²⁰ These caps vary by state (FIGURE 5)^21,22 and, of course, affect the “big verdict” cases. (As we saw in the second case scenario above, Virginia is an example of a state with a cap on malpractice awards.) They also have the secondary effect of reducing the number of malpractice cases. They make malpractice cases less attractive to some attorneys because they reduce the opportunity of large contingency fees from large verdicts. (Virtually all medical malpractice cases in the United States are tried on a contingency-fee basis, meaning that the plaintiff does not pay the attorney handling the case but rather the attorney takes a percentage of any recovery—typically in the neighborhood of 35%.) The reform process continues, although, presently, there is less pressure to act on the malpractice crisis.

Medical malpractice cases are emotional and costly

Another reason for the relatively low rate of paid claims is that medical malpractice cases are difficult, emotionally challenging, time consuming, and expensive to pursue.²³ They typically drag on for years, require extensive and expensive expert consultants as well as witnesses, and face stiff defense (compared with many other torts). The settlement of medical malpractice cases, for example, is less likely than other kinds of personal injury cases.

The contingency-fee basis does mean that injured patients do not have to pay attorney fees up front; however, plaintiffs may have to pay substantial costs along the way. The other side of this coin is that lawyers can be reluctant to take malpractice cases in which the damages are likely to be small, or where the legal uncertainty reduces the odds of achieving any damages. Thus, many potential malpractice cases are never filed.

A word of caution

The news of a reduction in malpractice paid claims may not be permanent. The numbers can conceivably be cyclical, and political reforms achieved can be changed. In addition, new technology will likely bring new kinds of malpractice claims. That appears to be the case, for example, with electronic health records (EHRs). One insurer reports that EHR malpractice claims have increased over the last 8 years.²⁴ The most common injury in these claims was death (25%), as well as a magnitude of less serious injuries. EHR-related claims result from system failures, copy-paste inaccuracies, faulty drop-down menu use, and uncorrected “auto-populated” fields. Obstetrics is tied for fifth on the list of 14 specialties with claims related to EHRs, and gynecology is tied for eighth place.²⁴

Continue to: A federal court ruled that a hospital that changed from...

A federal court ruled that a hospital that changed from paper records to EHRs for test results had a duty to “‘implement a reasonable procedure during the transition phase’ to ensure the timely delivery of test results” to health care providers.²⁵ We will address this in a future “What’s the Verdict?”.

Rates of harm, malpractice cases, and the disposition of cases

There are many surprises when looking at medical malpractice claims data generally. The first surprise is how few claims are filed relative to the number of error-related injuries. Given the estimate of 210,000 to 400,000 deaths “associated with preventable harm” in hospitals, plus 10 to 20 times that number of serious injuries, it would be reasonable to expect claims of many hundreds of thousands per year. Compare the probability of a malpractice claim from an error-related injury, for example, with the probability of other personal injuries—eg, of traffic deaths associated with preventable harm.

The second key observation is how many of the claims filed are not successful—even when there was evidence in the record of errors associated with the injury. Studies slice the data in different ways but collectively suggest that only a small proportion of malpractice claims filed (a claim is generally regarded as some written demand for compensation for injuries) result in payments, either through settlement or by trial. A 2006 study by Studdert and colleagues determined that 63% of formal malpractice claims filed did involve injuries resulting from errors.²⁶ The study found that in 16% of the claims (not injuries) there was no payment even though there was error. In 10% of the claims there was payment, even in the absence of error.

Overall, in this study, 56% of the claims received some compensation.²⁶ That is higher than a more recent study by Jena and others, which found only 22% of claims resulted in compensation.³

How malpractice claims are decided is also interesting. Jena and colleagues found that only 55% of claims resulted in litigation.²⁷ Presumably, the other 45% may have resulted in the plaintiff dropping the case, or in some form of settlement. Of the claims that were litigated, 54% were dismissed by the court, and another 35% were settled before a trial verdict. The cases that went to trial (about 10%), overwhelmingly (80%) resulted in verdicts for the defense.^3,27 A different study found that only 9% of cases went to trial, and 87% were a defense verdict.²⁸ The high level of defense verdicts may suggest that malpractice defense lawyers, and their client physicians, do a good job of assessing cases they are likely to lose, and settling them before trial.

ObGyns generally have larger numbers of claims and among the largest payment amounts when there is payment. Fewer of their cases are dismissed by the courts, so more go to trial. At trial, however, ObGyns prevail at a remarkably high rate.²⁷ As for the probability of payment of a malpractice claim for ObGyns, one study suggested that there is approximately a 16% annual probability of a claim being filed, but only a 3% annual probability of a payment being made (suggesting about a 20% probability of payment per claim).³

Continue to: The purposes and effects of the medical malpractice system...

The purposes and effects of the medical malpractice system

The essential goals of tort law (including medical malpractice) include compensation for those who are injured and deterrence of future injuries (TABLE 2). What are the overall effects to the medical malpractice system? Unfortunately, the answer is that the law delivers disappointing results at best. It has a fairly high error rate. Many people who deserve some compensation for their injuries never seek compensation, and many deserving injured patients fail in efforts to receive compensation. At the same time, a few of the injured receive huge recoveries (even windfalls), and at least a small fraction receive compensation when there was no medical error. In addition to the high error rate, the system is inefficient and very expensive. Both defendants (through their insurance carriers) and plaintiffs spend a lot of money, years of time, and untold emotional pain dealing with these cases. The system also exacts high emotional and personal costs on plaintiffs and defendants.

Malpractice reform has not really addressed these issues—it has generally been focused on ways to reduce the cost of malpractice insurance. The most effective reform in reducing rates—caps—has had the effect of compensating the most seriously injured as though they were more modestly injured, and dissuading attorneys from taking the cases of those less seriously injured.

The medical and legal professions exist to help patients (the public). It does not seem that we have arrived at a system that does that very fairly or efficiently when a patient is injured because of preventable medical error.

Watch for the third and final article in this series next month, as we are going to look at “apology in medicine and a proactive response” to communication regarding a complication.

In this second in a series of 3 articles discussing medical malpractice and the ObGyn we look at the reasons for malpractice claims and liability, what happens to malpractice claims, and the direction and future of medical malpractice. The first article dealt with 2 sources of major malpractice damages: the “big verdict” and physicians with multiple malpractice paid claims. Next month we look at the place of apology in medicine, in cases in which error, including negligence, may have caused a patient injury.

CASE 1 Long-term brachial plexus injury

Right upper extremity injury occurs in the neonate at delivery with sequela of long-term brachial plexus injury (which is diagnosed around 6 months of age). Physical therapy and orthopedic assessment are rendered. Despite continued treatment, discrepancy in arm lengths (ie, affected side arm is noticeably shorter than opposite side) remains. The child cannot play basketball with his older brother and is the victim of ridicule, the plaintiff’s attorney emphasizes. He is unable to properly pronate or supinate the affected arm.

The defendant ObGyn maintains that there was “no shoulder dystocia [at delivery] and the shoulder did not get obstructed in the pelvis; shoulder was delivered 15 seconds after delivery of the head.” The nursing staff testifies that if shoulder dystocia had been the problem they would have launched upon a series of procedures to address such, in accord with the delivering obstetrician. The defense expert witness testifies that a brachial plexus injury can happen without shoulder dystocia.

A defense verdict is rendered by the Florida jury.¹
 

CASE 2 Shoulder dystocia

During delivery, the obstetrician notes a shoulder dystocia (“turtle sign”). After initial attempts to release the shoulder were unsuccessful, the physician applies traction several times to the head of the child, and the baby is delivered. There is permanent injury to the right brachial plexus. The defendant ObGyn says that traction was necessary to dislodge the shoulder, and that the injury was the result of the forces of labor (not the traction). The expert witness for the plaintiff testifies that the medical standard of care did not permit traction under these circumstances, and that the traction was the likely cause of the injury.

The Virginia jury awards $2.32 million in damages.²

Note: The above vignettes are drawn from actual cases but are only outlines of those cases and are not complete descriptions of the claims in the cases. Because the information comes from informal sources, not formal court records, the facts may be inaccurate and incomplete. They should be viewed as illustrations only.

The trend in malpractice

It has been clear for many years that medical malpractice claims are not randomly or evenly distributed among physicians. Notably, the variation among specialties has, and continues to be, substantial (FIGURE 1).³ Recent data suggest that, although paid claims per “1,000 physician-years” averages 14 paid claims per 1,000 physician years, it ranges from 4 or 5 in 1,000 (psychiatry and pediatrics) to 53 and 49 claims per 1,000 (neurology and plastic surgery, respectively). Obstetrics and gynecology has the fourth highest rate at 42.5 paid claims per 1,000 physician years.⁴ (These data are for the years 1992–2014.)

Continue to: The number of ObGyn paid malpractice claims has decreased over time...

The number of ObGyn paid malpractice claims has decreased over time. Although large verdicts and physicians with multiple paid malpractice claims receive a good deal of attention (as we noted in part 1 of our series), in fact, paid medical malpractice claims have trended downward in recent decades.⁵ When the data above are disaggregated by 5-year periods, for example, in obstetrics and gynecology, there has been a consistent reduction in paid malpractice claims from 1992 to 2014. Paid claims went from 58 per 1,000 physician-years in 1992–1996 to 25 per 1,000 in 2009–2014 (FIGURE 2).^4,6 In short, the rate dropped by half over approximately 20 years.⁴

It is reasonable to expect that such a decline in the cost of malpractice insurance premiums would follow. Robert L. Barbieri, MD, who practices in Boston, Massachusetts, in his excellent recent editorial in OBG Management⁶ reported that his professional liability insurance premiums decreased 18% from 2014 to 2019, and his colleague reported a 22% reduction during the same time period.⁶ An American Medical Association report of 7 states or metropolitan areas for 2008 to 2017 found considerable variance. The study looked at the rates and the trend of rates for malpractice insurance in several areas of the United States (FIGURE 3).⁷ For ObGyns, one of these jurisdictions experienced increased rates; in one other, rates stayed the same, and in 5 jurisdictions, the rates went down. The premiums varied across the country, however. In 2017, Los Angeles/Orange had an average rate of $49,804, and in Nassau and Suffolk counties, New York, the rate was $214,999. The median rate was approximately $170,000.⁷

Why have malpractice payouts declined overall?

Have medical errors declined?

It would be wonderful if the reduction in malpractice claims represented a significant decrease in medical errors. Attention to medical errors was driven by the first widely noticed study of medical error deaths. The Institute of Medicine (IOM) study in 2000, put the number of deaths annually at 44,000 to 98,000.⁸ There have been many efforts to reduce such errors, and it is possible that those efforts have indeed reduced errors somewhat.⁴ Barbieri provided a helpful digest of many of the error-reduction suggestions for ObGyn practice (TABLE 1).⁶ But the number of medical errors remains high. More recent studies have suggested that the IOM’s reported number of injuries may have been low.⁹ In 2013, one study suggested that 210,000 deaths annually were “associated with preventable harm” in hospitals. Because of how the data were gathered the authors estimated that the actual number of preventable deaths was closer to 400,000 annually. Serious harm to patients was estimated at 10 to 20 times the IOM rate.⁹

Therefore, a dramatic reduction in preventable medical errors does not appear to explain the reduction in malpractice claims. Some portion of it may be explained by malpractice reforms—see "The medical reform factor" section below.

The collective accountability factor

The way malpractice claims are paid (FIGURE 4),¹⁰ reported, and handled may explain some of the apparent reduction in overall paid claims. Perhaps the advent of “collective accountability,” in which patient care is rendered by teams and responsibility accepted at a team level, can alleviate a significant amount of individual physician medical malpractice claims.¹¹ This “enterprise liability” may shift the burden of medical error from physicians to health care organizations.¹² Collective accountability may, therefore, focus on institutional responsibility rather than individual physician negligence.^11,13 Institutions frequently hire multiple specialists and cover their medical malpractice costs as well as stand to be named in suits.

Continue to: The institutional involvement in malpractice cases also may affect...

The institutional involvement in malpractice cases also may affect apparent malpractice rates in another way. The National Practitioner Data Bank, which is the source of information for many malpractice studies, only requires reporting about individual physicians, not institutions.¹⁴ If, therefore, claims are settled on behalf of an institution, without implicating the physician, the number of physician malpractice cases may appear to decline without any real change in malpractice rates.¹⁴ In addition, institutions have taken the lead in informal resolution of injuries that occur in the institution, and these programs may reduce the direct malpractice claims against physicians. (These “disclosure, apology, and offer,” and similar programs, are discussed in the upcoming third part of this series.)

The medical reform factor

As noted, annual rates paid for medical malpractice in our specialty are trending downward. Many commentators look to malpractice reforms as the reason for the drop in malpractice rates.^15-17 Because medical malpractice is essentially a matter of state law, the medical malpractice reform has occurred primarily at the state level.¹⁸ There have been many different reforms tried—limits on expert witnesses, review panels, and a variety of procedural limitations.¹⁹ Perhaps the most effective reform has been caps being placed on noneconomic damages (generally pain and suffering).²⁰ These caps vary by state (FIGURE 5)^21,22 and, of course, affect the “big verdict” cases. (As we saw in the second case scenario above, Virginia is an example of a state with a cap on malpractice awards.) They also have the secondary effect of reducing the number of malpractice cases. They make malpractice cases less attractive to some attorneys because they reduce the opportunity of large contingency fees from large verdicts. (Virtually all medical malpractice cases in the United States are tried on a contingency-fee basis, meaning that the plaintiff does not pay the attorney handling the case but rather the attorney takes a percentage of any recovery—typically in the neighborhood of 35%.) The reform process continues, although, presently, there is less pressure to act on the malpractice crisis.

Medical malpractice cases are emotional and costly

Another reason for the relatively low rate of paid claims is that medical malpractice cases are difficult, emotionally challenging, time consuming, and expensive to pursue.²³ They typically drag on for years, require extensive and expensive expert consultants as well as witnesses, and face stiff defense (compared with many other torts). The settlement of medical malpractice cases, for example, is less likely than other kinds of personal injury cases.

The contingency-fee basis does mean that injured patients do not have to pay attorney fees up front; however, plaintiffs may have to pay substantial costs along the way. The other side of this coin is that lawyers can be reluctant to take malpractice cases in which the damages are likely to be small, or where the legal uncertainty reduces the odds of achieving any damages. Thus, many potential malpractice cases are never filed.

A word of caution

The news of a reduction in malpractice paid claims may not be permanent. The numbers can conceivably be cyclical, and political reforms achieved can be changed. In addition, new technology will likely bring new kinds of malpractice claims. That appears to be the case, for example, with electronic health records (EHRs). One insurer reports that EHR malpractice claims have increased over the last 8 years.²⁴ The most common injury in these claims was death (25%), as well as a magnitude of less serious injuries. EHR-related claims result from system failures, copy-paste inaccuracies, faulty drop-down menu use, and uncorrected “auto-populated” fields. Obstetrics is tied for fifth on the list of 14 specialties with claims related to EHRs, and gynecology is tied for eighth place.²⁴

Continue to: A federal court ruled that a hospital that changed from...

A federal court ruled that a hospital that changed from paper records to EHRs for test results had a duty to “‘implement a reasonable procedure during the transition phase’ to ensure the timely delivery of test results” to health care providers.²⁵ We will address this in a future “What’s the Verdict?”.

Rates of harm, malpractice cases, and the disposition of cases

There are many surprises when looking at medical malpractice claims data generally. The first surprise is how few claims are filed relative to the number of error-related injuries. Given the estimate of 210,000 to 400,000 deaths “associated with preventable harm” in hospitals, plus 10 to 20 times that number of serious injuries, it would be reasonable to expect claims of many hundreds of thousands per year. Compare the probability of a malpractice claim from an error-related injury, for example, with the probability of other personal injuries—eg, of traffic deaths associated with preventable harm.

The second key observation is how many of the claims filed are not successful—even when there was evidence in the record of errors associated with the injury. Studies slice the data in different ways but collectively suggest that only a small proportion of malpractice claims filed (a claim is generally regarded as some written demand for compensation for injuries) result in payments, either through settlement or by trial. A 2006 study by Studdert and colleagues determined that 63% of formal malpractice claims filed did involve injuries resulting from errors.²⁶ The study found that in 16% of the claims (not injuries) there was no payment even though there was error. In 10% of the claims there was payment, even in the absence of error.

Overall, in this study, 56% of the claims received some compensation.²⁶ That is higher than a more recent study by Jena and others, which found only 22% of claims resulted in compensation.³

How malpractice claims are decided is also interesting. Jena and colleagues found that only 55% of claims resulted in litigation.²⁷ Presumably, the other 45% may have resulted in the plaintiff dropping the case, or in some form of settlement. Of the claims that were litigated, 54% were dismissed by the court, and another 35% were settled before a trial verdict. The cases that went to trial (about 10%), overwhelmingly (80%) resulted in verdicts for the defense.^3,27 A different study found that only 9% of cases went to trial, and 87% were a defense verdict.²⁸ The high level of defense verdicts may suggest that malpractice defense lawyers, and their client physicians, do a good job of assessing cases they are likely to lose, and settling them before trial.

ObGyns generally have larger numbers of claims and among the largest payment amounts when there is payment. Fewer of their cases are dismissed by the courts, so more go to trial. At trial, however, ObGyns prevail at a remarkably high rate.²⁷ As for the probability of payment of a malpractice claim for ObGyns, one study suggested that there is approximately a 16% annual probability of a claim being filed, but only a 3% annual probability of a payment being made (suggesting about a 20% probability of payment per claim).³

Continue to: The purposes and effects of the medical malpractice system...

The purposes and effects of the medical malpractice system

The essential goals of tort law (including medical malpractice) include compensation for those who are injured and deterrence of future injuries (TABLE 2). What are the overall effects to the medical malpractice system? Unfortunately, the answer is that the law delivers disappointing results at best. It has a fairly high error rate. Many people who deserve some compensation for their injuries never seek compensation, and many deserving injured patients fail in efforts to receive compensation. At the same time, a few of the injured receive huge recoveries (even windfalls), and at least a small fraction receive compensation when there was no medical error. In addition to the high error rate, the system is inefficient and very expensive. Both defendants (through their insurance carriers) and plaintiffs spend a lot of money, years of time, and untold emotional pain dealing with these cases. The system also exacts high emotional and personal costs on plaintiffs and defendants.

Malpractice reform has not really addressed these issues—it has generally been focused on ways to reduce the cost of malpractice insurance. The most effective reform in reducing rates—caps—has had the effect of compensating the most seriously injured as though they were more modestly injured, and dissuading attorneys from taking the cases of those less seriously injured.

The medical and legal professions exist to help patients (the public). It does not seem that we have arrived at a system that does that very fairly or efficiently when a patient is injured because of preventable medical error.

Watch for the third and final article in this series next month, as we are going to look at “apology in medicine and a proactive response” to communication regarding a complication.

Medical malpractice (more formally, professional liability, but we will use the term malpractice) has been of concern to ObGyns for many years, and for good reasons. This specialty has some of the highest incidents of malpractice claims, some of the largest verdicts, and some of the highest malpractice insurance rates. We look more closely at ObGyn malpractice issues in a 3-part “What’s the Verdict” series over the next few months.

In part 1, we discuss the background on malpractice and reasons why malpractice rates have been so high—including large verdicts and lawsuit-prone physicians. In the second part we will look at recent experience and developments in malpractice exposure—who is sued and why. Finally, in the third part we will consider suggestions for reducing the likelihood of a malpractice lawsuit, with a special focus on recent research regarding apologies.

Two reports of recent trials involving ObGyn care illustrate the risk of “the big verdict.”^1,2 (Note that the following vignettes are drawn from actual cases but are outlines of those cases and not complete descriptions of the claims. Because the information does not come from formal court records, the facts may be inaccurate and are incomplete; they should be viewed as illustrations only.)

CASE 1 Delayed delivery, $19M verdict

At 39 weeks’ gestation, a woman was admitted to the hospital in spontaneous labor. Artificial rupture of membranes with clear amniotic fluid was noted. Active contractions occurred for 11 hours. Oxytocin was then initiated, and 17 minutes later, profound fetal bradycardia was detected. There was recurrent evidence of fetal distress with meconium. After a nursing staff change a second nurse restarted oxytocin for a prolonged period. The physician allowed labor to continue despite fetal distress, and performed a cesarean delivery (CD) 4.5 hours later. Five hours postdelivery the neonate was noted to have a pneumothorax, lung damage, and respiratory failure. The infant died at 18 days of age.

The jury felt that there was negligence—failure to timely diagnose fetal distress and failure to timely perform CD, all of which resulted in a verdict for the plaintiff. The jury awarded in excess of $19 million.¹

CASE 2 An undiagnosed tumor, $20M verdict

A patient underwent bilateral mastectomy. Following surgery, she reported pain and swelling at the surgical site for 2 years, and the defendant physician “dismissed” her complaint, refusing to evaluate it as the provider felt it was related to scar tissue. Three years after the mastectomies, the patient underwent surgical exploration and removal of 3 ribs and sternum secondary to a desmoid tumor. Surgical mesh and chest reconstruction was required, necessitating long-term opioids and sleeping medications that “will slow her wits, dull her senses and limit activities of daily living.” Of note, discrepancies were found in the medical records maintained by the defendant. (There was, for example, no report in the record of the plaintiff’s pain until late in the process.) The plaintiff based her claim on the fact that her pain and lump were neither evaluated nor discovered until it was too late.

The jury awarded $20 million. The verdict was reduced to $2 million by the court based on state statutory limits on malpractice damages.^2,3

Continue to: Medical malpractice: Evolution of a standard of care...

Medical malpractice: Evolution of a standard of care

Medical malpractice is not a modern invention. Some historians trace malpractice to the Code of Hammurabi (2030 BC), through Roman law,⁴ into English common law.⁵ It was sufficiently established by 1765 that the classic legal treatise of the century referred to medical malpractice.^6,7 Although medical malpractice existed for a long time, actual malpractice cases were relatively rare before the last half of the 20th century.⁸

Defensive medicine born out of necessity. The number of malpractice cases increased substantially—described as a “geometric increase”—after 1960, with a 300% rise between 1965 and 1970.^7,9 This “malpractice maelstrom of the 70s”⁷ resulted in dramatic increases in malpractice insurance costs and invited the practice of defensive medicine—medically unnecessary or unjustified tests and services.¹⁰Although there is controversy about what is defensive medicine and what is reasonably cautious medicine, the practice may account for 3% of total health care spending.¹¹ Mello and others have estimated that there may be a $55 billion annual cost related to the medical malpractice system.¹²

Several malpractice crises and waves of malpractice or tort reform ensued,¹³ beginning in the 1970s and extending into the 2000s.¹¹ Malpractice law is primarily a matter of state law, so reform essentially has been at the state level—as we will see in the second part in this series.

Defining a standard of care

Medical malpractice is the application of standard legal principles to medical practice. Those principles generally are torts (intentional torts and negligence), and sometimes contracts.¹⁴ Eventually, medical malpractice came to focus primarily on negligence. The legal purposes of imposing negligence liability are compensation (to repay the plaintiff the costs of the harm caused by the defendant) and deterrence (to discourage careless conduct that can harm others.)

Negligence is essentially carelessness that falls below the acceptable standard of care. Negligence may arise, for example, from¹⁵:

• doing something (giving a drug to a patient with a known allergy to it)
• not doing something (failing to test for a possible tumor, as in the second case above)
• not giving appropriate informed consent
• failing to conduct an adequate examination
• abandoning a patient
• failing to refer a patient to a specialist (or conduct a consultation).

(In recent years, law reforms directed specifically at medical malpractice have somewhat separated medical malpractice from other tort law.)

In malpractice cases, the core question is whether the provider did (or did not) do something that a reasonably careful physician would have done. It is axiomatic that not all bad outcomes are negligent. Indeed, not all mistakes are negligent—only the mistakes that were unreasonable given all of the circumstances. In the first case above, for example, given all of the facts that preceded it, the delay of the physician for 4.5 hours after the fetal distress started was, as seen by the jury, not just a mistake but an unreasonable mistake. Hence, it was negligent. In the second case, the failure to investigate the pain and swelling in the surgical site for 2 years (or failure to refer the patient to another physician) was seen by the jury as an unreasonable mistake—one that would not have been made by a reasonably careful practitioner.

Continue to: The big verdict...

The big verdict

Everyone—every professional providing service, every manufacturer, every driver—eventually will make an unreasonable mistake (ie, commit negligence). If that negligence results in harming someone else, our standard legal response is that the negligent person should be financially responsible for the harm to the other. So, a driver who fails to stop at a red light and hits another car is responsible for those damages. But the damages may vary—perhaps a banged-up fender, or, in another instance, with the same negligence, perhaps terrible personal injuries that will disable the other driver for life. Thus, the damages can vary for the same level of carelessness. The “big verdict” may therefore fall on someone who was not especially careless.

Big verdicts often involve long-term care. The opening case vignettes illustrate a concern of medical malpractice generally—especially for ObGyn practice—the very high verdict. Very high verdicts generally reflect catastrophic damages that will continue for a long time. Bixenstine and colleagues found, for example, that catastrophic payouts often involved “patient age less than 1 year, quadriplegia, brain damage, or lifelong care.”¹⁶ In the case of serious injuries during delivery, for example, the harm to the child may last a lifetime and require years and years of intensive medical services.

Million-dollar-plus payouts are on the rise. The percentage of paid claims (through settlement or trial) that are above $1 million is increasing. These million-dollar cases represent 36% of the total dollars paid in ObGyn malpractice claims, even though they represent only 8% of the number of claims paid.¹⁶ The increase in the big verdict cases (above $1 million) suggests that ObGyn practition­ers should consider their malpractice policy limits—a million dollars may not be enough.

In big verdict cases, the great harm to the plaintiff is often combined with facts that produce extraordinary sympathy for the plaintiff. Sometimes there is decidedly unsympathetic conduct by the defendant as well. In the second case, for example, the problems with the medical record may have suggested to the jury that the doctor was either trying to hide something or did not care enough about the patient even to note a serious complaint. In a case we reviewed in an earlier “What’s the Verdict” column, a physician left the room for several minutes during a critical time—to take a call from a stockbroker.^16-18

The big verdict does not necessarily suggest that the defendant was especially or grossly negligent.¹⁶ It was a bad injury that occurred, for instance. On the other hand, the physician with several malpractice judgments may suggest that this is a problem physician.

Physicians facing multiple lawsuits are the exceptions

A number of studies have demonstrated that only a small proportion of physicians are responsible for a disproportionate number of paid medical malpractice claims. (“Paid claims” are those in which the plaintiff receives money from the doctor’s insurance. “Filed claims” are all malpractice lawsuits filed. Many claims are filed, but few are paid.)

ObGyn has high number of paid claims and high risk of claim payment recurrence. Studdert and colleagues found that the probability of future paid malpractice climbed with each past paid claim.¹⁹ They also found that 1% of physicians accounted for 32% of all paid claims. The number of paid claims varied by specialty—obstetrics and gynecology accounted for the second largest number of paid claims (13%). The risk of recurrence (more than one paid claim) was highest among 4 surgical specialties and ObGyns (about double the recurrence rate in these specialties compared with internal medicine).¹⁹

A minority of physicians responsible for lion share of paid claims. Black and colleagues followed up the Studdert study. Although there were some differences in what they found, the results were very similar.²⁰ For example, they found that having even a single prior paid claim strongly predicted future claims over the next 5 years. They also found that some “outlier” physicians with multiple paid claims “are responsible for a significant share of paid claims.” They specifically found that, even for physicians in high-risk specialties in high-risk states, “bad luck is highly unlikely to explain” multiple claims within 5 years.

Continue to: Both of the studies just mentioned relied on...

Both of the studies just mentioned relied on the National Practitioner Data Bank for information about paid claims. This source has some limitations in capturing claims or payments made by hospitals or other institutions for the actions of its agent-physicians. Some of these limitations were resolved in another recent study that looked at Indiana state insurance and licensing discipline records (over a 41-year period).²¹ Not surprisingly, this study found that claims paid increase with more severe licensure discipline. On the other hand, although, the “frequent fliers” in terms of malpractice claims made and paid could be identified as a “small number of repeat defendants,” these physicians were not routinely disciplined by the state medical board. This was only a single state study, of course, but it also found that a few physicians accounted for a significant number of the claims. The state board was not taking licensing action against this small group, however.

Should the few bad apples be picked from the orchard?

Collectively, these studies are fairly overwhelming in demonstrating that there are some physicians who are “prone” to malpractice claims (for whom all physicians in the specialty are probably paying higher malpractice rates), but who do not attract the attention of licensing agencies for careful examination. In addition to its self-interest in eliminating physicians prone to malpractice claims and payments, the obligation of professions to protect the public interest suggests that state boards should be more aggressive in pursuing those physicians practicing risky medicine.

This medical malpractice series will continue next month with a look at how to reduce malpractice exposure.

Medical malpractice (more formally, professional liability, but we will use the term malpractice) has been of concern to ObGyns for many years, and for good reasons. This specialty has some of the highest incidents of malpractice claims, some of the largest verdicts, and some of the highest malpractice insurance rates. We look more closely at ObGyn malpractice issues in a 3-part “What’s the Verdict” series over the next few months.

In part 1, we discuss the background on malpractice and reasons why malpractice rates have been so high—including large verdicts and lawsuit-prone physicians. In the second part we will look at recent experience and developments in malpractice exposure—who is sued and why. Finally, in the third part we will consider suggestions for reducing the likelihood of a malpractice lawsuit, with a special focus on recent research regarding apologies.

Two reports of recent trials involving ObGyn care illustrate the risk of “the big verdict.”^1,2 (Note that the following vignettes are drawn from actual cases but are outlines of those cases and not complete descriptions of the claims. Because the information does not come from formal court records, the facts may be inaccurate and are incomplete; they should be viewed as illustrations only.)

CASE 1 Delayed delivery, $19M verdict

At 39 weeks’ gestation, a woman was admitted to the hospital in spontaneous labor. Artificial rupture of membranes with clear amniotic fluid was noted. Active contractions occurred for 11 hours. Oxytocin was then initiated, and 17 minutes later, profound fetal bradycardia was detected. There was recurrent evidence of fetal distress with meconium. After a nursing staff change a second nurse restarted oxytocin for a prolonged period. The physician allowed labor to continue despite fetal distress, and performed a cesarean delivery (CD) 4.5 hours later. Five hours postdelivery the neonate was noted to have a pneumothorax, lung damage, and respiratory failure. The infant died at 18 days of age.

The jury felt that there was negligence—failure to timely diagnose fetal distress and failure to timely perform CD, all of which resulted in a verdict for the plaintiff. The jury awarded in excess of $19 million.¹

CASE 2 An undiagnosed tumor, $20M verdict

A patient underwent bilateral mastectomy. Following surgery, she reported pain and swelling at the surgical site for 2 years, and the defendant physician “dismissed” her complaint, refusing to evaluate it as the provider felt it was related to scar tissue. Three years after the mastectomies, the patient underwent surgical exploration and removal of 3 ribs and sternum secondary to a desmoid tumor. Surgical mesh and chest reconstruction was required, necessitating long-term opioids and sleeping medications that “will slow her wits, dull her senses and limit activities of daily living.” Of note, discrepancies were found in the medical records maintained by the defendant. (There was, for example, no report in the record of the plaintiff’s pain until late in the process.) The plaintiff based her claim on the fact that her pain and lump were neither evaluated nor discovered until it was too late.

The jury awarded $20 million. The verdict was reduced to $2 million by the court based on state statutory limits on malpractice damages.^2,3

Continue to: Medical malpractice: Evolution of a standard of care...

Medical malpractice: Evolution of a standard of care

Medical malpractice is not a modern invention. Some historians trace malpractice to the Code of Hammurabi (2030 BC), through Roman law,⁴ into English common law.⁵ It was sufficiently established by 1765 that the classic legal treatise of the century referred to medical malpractice.^6,7 Although medical malpractice existed for a long time, actual malpractice cases were relatively rare before the last half of the 20th century.⁸

Defensive medicine born out of necessity. The number of malpractice cases increased substantially—described as a “geometric increase”—after 1960, with a 300% rise between 1965 and 1970.^7,9 This “malpractice maelstrom of the 70s”⁷ resulted in dramatic increases in malpractice insurance costs and invited the practice of defensive medicine—medically unnecessary or unjustified tests and services.¹⁰Although there is controversy about what is defensive medicine and what is reasonably cautious medicine, the practice may account for 3% of total health care spending.¹¹ Mello and others have estimated that there may be a $55 billion annual cost related to the medical malpractice system.¹²

Several malpractice crises and waves of malpractice or tort reform ensued,¹³ beginning in the 1970s and extending into the 2000s.¹¹ Malpractice law is primarily a matter of state law, so reform essentially has been at the state level—as we will see in the second part in this series.

Defining a standard of care

Medical malpractice is the application of standard legal principles to medical practice. Those principles generally are torts (intentional torts and negligence), and sometimes contracts.¹⁴ Eventually, medical malpractice came to focus primarily on negligence. The legal purposes of imposing negligence liability are compensation (to repay the plaintiff the costs of the harm caused by the defendant) and deterrence (to discourage careless conduct that can harm others.)

Negligence is essentially carelessness that falls below the acceptable standard of care. Negligence may arise, for example, from¹⁵:

• doing something (giving a drug to a patient with a known allergy to it)
• not doing something (failing to test for a possible tumor, as in the second case above)
• not giving appropriate informed consent
• failing to conduct an adequate examination
• abandoning a patient
• failing to refer a patient to a specialist (or conduct a consultation).

(In recent years, law reforms directed specifically at medical malpractice have somewhat separated medical malpractice from other tort law.)

In malpractice cases, the core question is whether the provider did (or did not) do something that a reasonably careful physician would have done. It is axiomatic that not all bad outcomes are negligent. Indeed, not all mistakes are negligent—only the mistakes that were unreasonable given all of the circumstances. In the first case above, for example, given all of the facts that preceded it, the delay of the physician for 4.5 hours after the fetal distress started was, as seen by the jury, not just a mistake but an unreasonable mistake. Hence, it was negligent. In the second case, the failure to investigate the pain and swelling in the surgical site for 2 years (or failure to refer the patient to another physician) was seen by the jury as an unreasonable mistake—one that would not have been made by a reasonably careful practitioner.

Continue to: The big verdict...

The big verdict

Everyone—every professional providing service, every manufacturer, every driver—eventually will make an unreasonable mistake (ie, commit negligence). If that negligence results in harming someone else, our standard legal response is that the negligent person should be financially responsible for the harm to the other. So, a driver who fails to stop at a red light and hits another car is responsible for those damages. But the damages may vary—perhaps a banged-up fender, or, in another instance, with the same negligence, perhaps terrible personal injuries that will disable the other driver for life. Thus, the damages can vary for the same level of carelessness. The “big verdict” may therefore fall on someone who was not especially careless.

Big verdicts often involve long-term care. The opening case vignettes illustrate a concern of medical malpractice generally—especially for ObGyn practice—the very high verdict. Very high verdicts generally reflect catastrophic damages that will continue for a long time. Bixenstine and colleagues found, for example, that catastrophic payouts often involved “patient age less than 1 year, quadriplegia, brain damage, or lifelong care.”¹⁶ In the case of serious injuries during delivery, for example, the harm to the child may last a lifetime and require years and years of intensive medical services.

Million-dollar-plus payouts are on the rise. The percentage of paid claims (through settlement or trial) that are above $1 million is increasing. These million-dollar cases represent 36% of the total dollars paid in ObGyn malpractice claims, even though they represent only 8% of the number of claims paid.¹⁶ The increase in the big verdict cases (above $1 million) suggests that ObGyn practition­ers should consider their malpractice policy limits—a million dollars may not be enough.

In big verdict cases, the great harm to the plaintiff is often combined with facts that produce extraordinary sympathy for the plaintiff. Sometimes there is decidedly unsympathetic conduct by the defendant as well. In the second case, for example, the problems with the medical record may have suggested to the jury that the doctor was either trying to hide something or did not care enough about the patient even to note a serious complaint. In a case we reviewed in an earlier “What’s the Verdict” column, a physician left the room for several minutes during a critical time—to take a call from a stockbroker.^16-18

The big verdict does not necessarily suggest that the defendant was especially or grossly negligent.¹⁶ It was a bad injury that occurred, for instance. On the other hand, the physician with several malpractice judgments may suggest that this is a problem physician.

Physicians facing multiple lawsuits are the exceptions

A number of studies have demonstrated that only a small proportion of physicians are responsible for a disproportionate number of paid medical malpractice claims. (“Paid claims” are those in which the plaintiff receives money from the doctor’s insurance. “Filed claims” are all malpractice lawsuits filed. Many claims are filed, but few are paid.)

ObGyn has high number of paid claims and high risk of claim payment recurrence. Studdert and colleagues found that the probability of future paid malpractice climbed with each past paid claim.¹⁹ They also found that 1% of physicians accounted for 32% of all paid claims. The number of paid claims varied by specialty—obstetrics and gynecology accounted for the second largest number of paid claims (13%). The risk of recurrence (more than one paid claim) was highest among 4 surgical specialties and ObGyns (about double the recurrence rate in these specialties compared with internal medicine).¹⁹

A minority of physicians responsible for lion share of paid claims. Black and colleagues followed up the Studdert study. Although there were some differences in what they found, the results were very similar.²⁰ For example, they found that having even a single prior paid claim strongly predicted future claims over the next 5 years. They also found that some “outlier” physicians with multiple paid claims “are responsible for a significant share of paid claims.” They specifically found that, even for physicians in high-risk specialties in high-risk states, “bad luck is highly unlikely to explain” multiple claims within 5 years.

Continue to: Both of the studies just mentioned relied on...

Both of the studies just mentioned relied on the National Practitioner Data Bank for information about paid claims. This source has some limitations in capturing claims or payments made by hospitals or other institutions for the actions of its agent-physicians. Some of these limitations were resolved in another recent study that looked at Indiana state insurance and licensing discipline records (over a 41-year period).²¹ Not surprisingly, this study found that claims paid increase with more severe licensure discipline. On the other hand, although, the “frequent fliers” in terms of malpractice claims made and paid could be identified as a “small number of repeat defendants,” these physicians were not routinely disciplined by the state medical board. This was only a single state study, of course, but it also found that a few physicians accounted for a significant number of the claims. The state board was not taking licensing action against this small group, however.

Should the few bad apples be picked from the orchard?

Collectively, these studies are fairly overwhelming in demonstrating that there are some physicians who are “prone” to malpractice claims (for whom all physicians in the specialty are probably paying higher malpractice rates), but who do not attract the attention of licensing agencies for careful examination. In addition to its self-interest in eliminating physicians prone to malpractice claims and payments, the obligation of professions to protect the public interest suggests that state boards should be more aggressive in pursuing those physicians practicing risky medicine.

This medical malpractice series will continue next month with a look at how to reduce malpractice exposure.

Medical malpractice (more formally, professional liability, but we will use the term malpractice) has been of concern to ObGyns for many years, and for good reasons. This specialty has some of the highest incidents of malpractice claims, some of the largest verdicts, and some of the highest malpractice insurance rates. We look more closely at ObGyn malpractice issues in a 3-part “What’s the Verdict” series over the next few months.

In part 1, we discuss the background on malpractice and reasons why malpractice rates have been so high—including large verdicts and lawsuit-prone physicians. In the second part we will look at recent experience and developments in malpractice exposure—who is sued and why. Finally, in the third part we will consider suggestions for reducing the likelihood of a malpractice lawsuit, with a special focus on recent research regarding apologies.

Two reports of recent trials involving ObGyn care illustrate the risk of “the big verdict.”^1,2 (Note that the following vignettes are drawn from actual cases but are outlines of those cases and not complete descriptions of the claims. Because the information does not come from formal court records, the facts may be inaccurate and are incomplete; they should be viewed as illustrations only.)

CASE 1 Delayed delivery, $19M verdict

At 39 weeks’ gestation, a woman was admitted to the hospital in spontaneous labor. Artificial rupture of membranes with clear amniotic fluid was noted. Active contractions occurred for 11 hours. Oxytocin was then initiated, and 17 minutes later, profound fetal bradycardia was detected. There was recurrent evidence of fetal distress with meconium. After a nursing staff change a second nurse restarted oxytocin for a prolonged period. The physician allowed labor to continue despite fetal distress, and performed a cesarean delivery (CD) 4.5 hours later. Five hours postdelivery the neonate was noted to have a pneumothorax, lung damage, and respiratory failure. The infant died at 18 days of age.

The jury felt that there was negligence—failure to timely diagnose fetal distress and failure to timely perform CD, all of which resulted in a verdict for the plaintiff. The jury awarded in excess of $19 million.¹

CASE 2 An undiagnosed tumor, $20M verdict

A patient underwent bilateral mastectomy. Following surgery, she reported pain and swelling at the surgical site for 2 years, and the defendant physician “dismissed” her complaint, refusing to evaluate it as the provider felt it was related to scar tissue. Three years after the mastectomies, the patient underwent surgical exploration and removal of 3 ribs and sternum secondary to a desmoid tumor. Surgical mesh and chest reconstruction was required, necessitating long-term opioids and sleeping medications that “will slow her wits, dull her senses and limit activities of daily living.” Of note, discrepancies were found in the medical records maintained by the defendant. (There was, for example, no report in the record of the plaintiff’s pain until late in the process.) The plaintiff based her claim on the fact that her pain and lump were neither evaluated nor discovered until it was too late.

The jury awarded $20 million. The verdict was reduced to $2 million by the court based on state statutory limits on malpractice damages.^2,3

Continue to: Medical malpractice: Evolution of a standard of care...

Medical malpractice: Evolution of a standard of care

Medical malpractice is not a modern invention. Some historians trace malpractice to the Code of Hammurabi (2030 BC), through Roman law,⁴ into English common law.⁵ It was sufficiently established by 1765 that the classic legal treatise of the century referred to medical malpractice.^6,7 Although medical malpractice existed for a long time, actual malpractice cases were relatively rare before the last half of the 20th century.⁸

Defensive medicine born out of necessity. The number of malpractice cases increased substantially—described as a “geometric increase”—after 1960, with a 300% rise between 1965 and 1970.^7,9 This “malpractice maelstrom of the 70s”⁷ resulted in dramatic increases in malpractice insurance costs and invited the practice of defensive medicine—medically unnecessary or unjustified tests and services.¹⁰Although there is controversy about what is defensive medicine and what is reasonably cautious medicine, the practice may account for 3% of total health care spending.¹¹ Mello and others have estimated that there may be a $55 billion annual cost related to the medical malpractice system.¹²

Several malpractice crises and waves of malpractice or tort reform ensued,¹³ beginning in the 1970s and extending into the 2000s.¹¹ Malpractice law is primarily a matter of state law, so reform essentially has been at the state level—as we will see in the second part in this series.

Defining a standard of care

Medical malpractice is the application of standard legal principles to medical practice. Those principles generally are torts (intentional torts and negligence), and sometimes contracts.¹⁴ Eventually, medical malpractice came to focus primarily on negligence. The legal purposes of imposing negligence liability are compensation (to repay the plaintiff the costs of the harm caused by the defendant) and deterrence (to discourage careless conduct that can harm others.)

Negligence is essentially carelessness that falls below the acceptable standard of care. Negligence may arise, for example, from¹⁵:

• doing something (giving a drug to a patient with a known allergy to it)
• not doing something (failing to test for a possible tumor, as in the second case above)
• not giving appropriate informed consent
• failing to conduct an adequate examination
• abandoning a patient
• failing to refer a patient to a specialist (or conduct a consultation).

(In recent years, law reforms directed specifically at medical malpractice have somewhat separated medical malpractice from other tort law.)

In malpractice cases, the core question is whether the provider did (or did not) do something that a reasonably careful physician would have done. It is axiomatic that not all bad outcomes are negligent. Indeed, not all mistakes are negligent—only the mistakes that were unreasonable given all of the circumstances. In the first case above, for example, given all of the facts that preceded it, the delay of the physician for 4.5 hours after the fetal distress started was, as seen by the jury, not just a mistake but an unreasonable mistake. Hence, it was negligent. In the second case, the failure to investigate the pain and swelling in the surgical site for 2 years (or failure to refer the patient to another physician) was seen by the jury as an unreasonable mistake—one that would not have been made by a reasonably careful practitioner.

Continue to: The big verdict...

The big verdict

Everyone—every professional providing service, every manufacturer, every driver—eventually will make an unreasonable mistake (ie, commit negligence). If that negligence results in harming someone else, our standard legal response is that the negligent person should be financially responsible for the harm to the other. So, a driver who fails to stop at a red light and hits another car is responsible for those damages. But the damages may vary—perhaps a banged-up fender, or, in another instance, with the same negligence, perhaps terrible personal injuries that will disable the other driver for life. Thus, the damages can vary for the same level of carelessness. The “big verdict” may therefore fall on someone who was not especially careless.

Big verdicts often involve long-term care. The opening case vignettes illustrate a concern of medical malpractice generally—especially for ObGyn practice—the very high verdict. Very high verdicts generally reflect catastrophic damages that will continue for a long time. Bixenstine and colleagues found, for example, that catastrophic payouts often involved “patient age less than 1 year, quadriplegia, brain damage, or lifelong care.”¹⁶ In the case of serious injuries during delivery, for example, the harm to the child may last a lifetime and require years and years of intensive medical services.

Million-dollar-plus payouts are on the rise. The percentage of paid claims (through settlement or trial) that are above $1 million is increasing. These million-dollar cases represent 36% of the total dollars paid in ObGyn malpractice claims, even though they represent only 8% of the number of claims paid.¹⁶ The increase in the big verdict cases (above $1 million) suggests that ObGyn practition­ers should consider their malpractice policy limits—a million dollars may not be enough.

In big verdict cases, the great harm to the plaintiff is often combined with facts that produce extraordinary sympathy for the plaintiff. Sometimes there is decidedly unsympathetic conduct by the defendant as well. In the second case, for example, the problems with the medical record may have suggested to the jury that the doctor was either trying to hide something or did not care enough about the patient even to note a serious complaint. In a case we reviewed in an earlier “What’s the Verdict” column, a physician left the room for several minutes during a critical time—to take a call from a stockbroker.^16-18

The big verdict does not necessarily suggest that the defendant was especially or grossly negligent.¹⁶ It was a bad injury that occurred, for instance. On the other hand, the physician with several malpractice judgments may suggest that this is a problem physician.

Physicians facing multiple lawsuits are the exceptions

A number of studies have demonstrated that only a small proportion of physicians are responsible for a disproportionate number of paid medical malpractice claims. (“Paid claims” are those in which the plaintiff receives money from the doctor’s insurance. “Filed claims” are all malpractice lawsuits filed. Many claims are filed, but few are paid.)

ObGyn has high number of paid claims and high risk of claim payment recurrence. Studdert and colleagues found that the probability of future paid malpractice climbed with each past paid claim.¹⁹ They also found that 1% of physicians accounted for 32% of all paid claims. The number of paid claims varied by specialty—obstetrics and gynecology accounted for the second largest number of paid claims (13%). The risk of recurrence (more than one paid claim) was highest among 4 surgical specialties and ObGyns (about double the recurrence rate in these specialties compared with internal medicine).¹⁹

A minority of physicians responsible for lion share of paid claims. Black and colleagues followed up the Studdert study. Although there were some differences in what they found, the results were very similar.²⁰ For example, they found that having even a single prior paid claim strongly predicted future claims over the next 5 years. They also found that some “outlier” physicians with multiple paid claims “are responsible for a significant share of paid claims.” They specifically found that, even for physicians in high-risk specialties in high-risk states, “bad luck is highly unlikely to explain” multiple claims within 5 years.

Continue to: Both of the studies just mentioned relied on...

Both of the studies just mentioned relied on the National Practitioner Data Bank for information about paid claims. This source has some limitations in capturing claims or payments made by hospitals or other institutions for the actions of its agent-physicians. Some of these limitations were resolved in another recent study that looked at Indiana state insurance and licensing discipline records (over a 41-year period).²¹ Not surprisingly, this study found that claims paid increase with more severe licensure discipline. On the other hand, although, the “frequent fliers” in terms of malpractice claims made and paid could be identified as a “small number of repeat defendants,” these physicians were not routinely disciplined by the state medical board. This was only a single state study, of course, but it also found that a few physicians accounted for a significant number of the claims. The state board was not taking licensing action against this small group, however.

Should the few bad apples be picked from the orchard?

Collectively, these studies are fairly overwhelming in demonstrating that there are some physicians who are “prone” to malpractice claims (for whom all physicians in the specialty are probably paying higher malpractice rates), but who do not attract the attention of licensing agencies for careful examination. In addition to its self-interest in eliminating physicians prone to malpractice claims and payments, the obligation of professions to protect the public interest suggests that state boards should be more aggressive in pursuing those physicians practicing risky medicine.

This medical malpractice series will continue next month with a look at how to reduce malpractice exposure.

CASE Adolescent seeks care without parent

A 15-year-old patient (G0) presents to the gynecology clinic requesting birth control. She reports being sexually active over the past 6 months and having several male partners over the past 2 years. She and her current male partner use condoms inconsistently. She reports being active in school sports, and her academic performance has been noteworthy. Her peers have encouraged her to seek out birth control; one of her good friends recently became pregnant and dropped out of school. She states that her best friend went to a similar clinic and received a “gynecologic encounter” that included information regarding safe sex and contraception, with no pelvic exam required for her to receive birth control pills.

The patient insists that her parents are not to know of her request for contraception due to sexual activity or that she is a patient at the clinic. The gynecologist covering the clinic is aware of the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care and their many publications. The patient is counseled regarding human papillomavirus (HPV) vaccination and screened for sexually transmitted infections. In addition, the gynecologist discusses contraceptive options with the patient, ranging from oral contraceptives, vaginal rings, subdermal implants, depomedroxyprogesterone acetate, as well as intrauterine devices (IUDs). The gynecologist emphasizes safe sex and advises that her partner consider use of condoms independent of her method of birth control. The patient asks for oral contraceptives and is given information about their use and risks, and she indicates that she understands.
 

A few months later the patient requests an IUD, as she would like to have lighter menses and not have to remember to take a pill every day. The provider obtains informed consent for the insertion procedure; the patient signs the appropriate forms.

The IUD is inserted, with difficulty, by a resident physician in the clinic. The patient experiences severe pelvic pain during and immediately following the insertion. She is sent home and told to contact the clinic or another health care provider or proceed to the local emergency department should pain persist or if fever develops.

The patient returns 72 hours later in pain. Pelvic ultrasonography shows the IUD out of place and at risk of perforating the fundus of the uterus. Later that day the patient’s mother calls the clinic, saying that she found a statement of service with the clinic’s number on it in her daughter’s bedroom. She wants to know if her daughter is there, what is going on, and what services have been or are being provided. In passing she remarks that she has no intention of paying (or allowing her insurance to pay for) any care that was provided.

What are the provider’s obligations at this point, both medically and legally?

Medical and legal considerations

One of the most difficult and important health law questions in adolescent medicine is the ability of minors to consent to treatment and to control the health care information resulting from treatment. (“Minor” describes a child or adolescent who has not obtained the age of legal consent, generally 18 years old, to lawfully enter into a legal transaction.)

Continue to: The consent of minor patients...

The consent of minor patients

The traditional legal rule is that parents or guardians (“parent” refers to both) must consent to medical treatment for minor children. There is an exception for emergency situations but generally minors do not provide consent for medical care, a parent does.¹ The parent typically is obliged to provide payment (often through insurance) for those services.

This traditional rule has some exceptions—the emergency exception already noted and the case of emancipated minors, notably an adolescent who is living almost entirely independent of her parents (for example, she is married or not relying on parents in a meaningful way). In recent times there has been increasing authority for “mature minors” to make some medical decisions.² A mature minor is one who has sufficient understanding and judgment to appreciate the consequences, benefits, and risks of accepting proposed medical intervention.

No circumstance involving adolescent treatment has been more contentious than services related to abortion and, to a lesser degree, contraception.³ Both the law of consent to services and the rights of parents to obtain information about contraceptive and abortion services have been a matter of strong, continuing debate. The law in these areas varies greatly from state-to-state, and includes a mix of state law (statutes and court decisions) with an overlay of federal constitutional law related to reproduction-related decisions of adolescents. In addition, the law in this area of consent and information changes relatively frequently.⁴ Clinicians, of course, must focus on the consent laws of the state in which they practice.

STI counseling and treatment

All states permit a minor patient to consent to treatment for an STI (TABLE 1).⁵ A number of states expressly permit, but do not require, health care providers to inform parents of treatment when a physician determines it would be in the best interest of the minor. Thus, the clinic would not be required to provide proactively the information to our case patient’s mother (regarding any STI issues) when she called.⁶

Contraception

Consent for contraception is more complicated. About half the states allow minors who have reached a certain age (12, 14, or 16 years) to consent to contraception. About 20 other states allow some minors to consent to contraceptive services, but the “allowed group” may be fairly narrow (eg, be married, have a health issue, or be “mature”). In 4 states there is currently no clear legal authority to provide contraceptive services to minors, yet those states do not specifically prohibit it. The US Supreme Court has held that a state cannot completely prohibit the availability of contraception to minors.⁷ The reach of that decision, however, is not clear and may not extend beyond what the states currently permit.

The ability of minors to consent to contraception services does not mean that there is a right to consent to all contraceptive options. As contraception becomes more irreversible, permanent, or risky, it is more problematic. For example, consent to sterilization would not ordinarily be within a minor’s recognized ability to consent. Standard, low risk, reversible contraception generally is covered by these state laws.⁸

In our case here, the patient likely was able to consent to contraception—initially to the oral contraception and later to the IUD. The risks and reversibility of both are probably within her ability to consent.^9,10 Of course, if the care was provided in a state that does not include the patient within the groups that can give consent to contraception, it is possible that she might not have the legal authority to consent.

Continue to: General requirements of consent...

General requirements of consent

Even when adolescent consent is permitted for treatment, including in cases of contraception, it is essential that all of the legal and ethical requirements related to informed consent are met.

1. The adolescent has the capacity to consent. This means not only that the state-mandated requirements are met (age, for example) but also that the patient can and does understand the various elements of consent, and can make a sensible, informed decision.

The bottom line is “adolescent capacity is a complex process dependent upon the development of maturity of the adolescent, degree of intervention, expected benefit of the medical procedure, and the sociocultural context surrounding the decision.”¹¹ Other items of interest include the “evolving capacity” of the child,¹² which is the concept of increasing ability of the teen to process information and provide more appropriate informed consent. Central nervous system (CNS) maturation allows the adolescent to become increasingly more capable of decision making and has awareness of consequences of such decisions. Abstract thinking capabilities is a reflection of this CNS maturing process. If this competency is not established, the adolescent patient cannot give legitimate consent.

2. The patient must be given appropriate information (be “informed”). The discussion should include information relevant to the condition being treated (and the disease process if relevant). In addition, information about the treatment or intervention proposed and its risks and alternatives must be provided to the patient and in a way that is understandable.

3. As with all patients, consent must be voluntary and free of coercion or manipulation. These elements of informed consent are expanded on by the Joint Commission, which has established a number of components of informed consent (TABLE 2).^4,13

Confidentiality and release of information to parents and others

Similar to consent, parents historically have had the authority to obtain medical information about their minor children. This right generally continues today, with some limitations. The right to give consent generally carries with it the right to medical information. There are some times when parents may access medical information even if they have not given consent.

This right adds complexity to minor consent and is an important treatment issue and legal consideration because confidentiality for adolescents affects quality of care. Adolescents report that “confidentiality is an important factor in their decision to seek [medical] care.”¹⁴ Many parents are under the assumption that the health care provider will automatically inform them independent of whether or not the adolescent expressed precise instruction not to inform.^15,16

Of course if a minor patient authorizes the physician to provide information to her parents, that is consent and the health care provider may then provide the information. If the patient instructs the provider to convey the information, the practitioner would ordinarily be expected to be proactive in providing the information to the parent. The issue of “voluntariness” of the waiver of confidentiality can be a question, and the physician may discuss that question with the patient. Ordinarily, however, once a minor has authorized disclosure to the parent, the clinician has the authority to disclose the information to the parent, but not to others.

All of the usual considerations of confidentiality in health care apply to adolescent ObGyn services and care. This includes the general obligation not to disclose information without consent and to ensure that health care information is protected from accidental release as required by the Health Insurance Portability and Accountability Act (HIPAA) and other health information privacy laws.¹⁷

Continue to: How and when to protect minor confidentiality...

How and when to protect minor confidentiality

A clinician cannot assure minors of absolute confidentiality and should not agree to do so or imply that they are doing so.¹⁸ In our hypothetical case, when the patient told the physician that her parents were not to know of any of her treatment or communications, the provider should not have acquiesced by silence. He/she might have responded along these lines: “I have a strong commitment to confidentiality of your information, and we take many steps to protect that information. The law also allows some special protection of health care information. Despite the commitment to privacy, there are circumstances in which the law requires disclosure of information—and that might even be to parents. In addition, if you want any of your care covered by insurance, we would have to disclose that. While I expect that we can do as you ask about maintaining your confidentiality, no health care provider can absolutely guarantee it.”

Proactive vs reactive disclosure. There is “proactive” disclosure of information and “reactive” disclosure. Proactive is when the provider (without being asked) contacts a parent or others and provides information. Some states require proactive information about specific kinds of treatment (especially abortion services). For the most part, in states where a minor can legally consent to treatment, health care providers are not required to proactively disclose information.¹⁹

Clinicians may be required to respond to parental requests for information, which is reactive disclosure and is reflected in our case presentation. Even in such circumstances, however, the individual providing care may seek to avoid disclosure. In many states, the law would not require the release of this information (but would permit it if it is in the best interest of the patient). In addition, there are practical ways of avoiding the release of information. For example, the health care provider might acknowledge the interest and desire of the parent to have the information, but might humbly explain that in the experience of many clinicians protecting the confidentiality of patients is very important to successful treatment and it is the policy of the office/clinic not to breach the expectation of patient confidentiality except where that is clearly in the best interest of the patient or required by law.

In response to the likely question, “Well, isn’t that required by law?” the clinician can honestly reply, “I don’t know. There are many complex factors in the law regarding disclosure of medical information and as I am not an attorney I do not know how they all apply in this instance.” In some cases the parent may push the matter or take some kind of legal action. It is in this type of situation that an attorney familiar with health law and the clinician’s practice can be invaluable.

When parents are involved in the minor’s treatment (bringing the patient to the office/clinic, for example), there is an opportunity for an understanding, or agreement, among the patient, provider, and parent about what information the parent will receive. Ordinarily the agreement should not create the expectation of detailed information for the parent. Perhaps, for example, the physician will provide information only when he or she believes that doing so will be in the best interest of the patient. Even with parental agreement, complete confidentiality cannot be assured for minor patients. There may, for example, be another parent who will not feel bound by the established understanding, and the law requires some disclosures (in the case of child abuse or a court order).²⁰

Continue to: Accidental disclosure...

Accidental disclosure. Health care providers also should make sure that office procedures do not unnecessarily or accidentally disclose information about patients. For example, routinely gathering information about insurance coverage may well trigger the release of information to the policy holder (often a parent). Thus, there should be clear understandings about billing, insurance, and related issues before information is divulged by the patient. This should be part of the process of obtaining informed consent to treatment. It should be up front and honest. Developing a clear understanding of the legal requirements of the state is essential, so that assurance of confidentiality is on legal, solid ground.

Abuse reporting obligations

All states have mandatory child abuse reporting laws. These laws require medical professionals (and others) to report known, and often suspected, abuse of children. Abuse includes physical, sexual, or emotional, and generally also includes neglect that is harming a child. When there is apparent sexual or physical abuse, the health care provider is obligated to report it to designated state authorities, generally child protective services. Reporting laws vary from state to state based on the relationship between the suspected abuser and the minor, the nature of the harm, and how strong the suspicion of abuse needs to be. The failure to make required reports is a crime in most states and also may result in civil liability or licensure discipline. Criminal charges seldom result from the failure to report, but in some cases the failure to report may have serious consequences for the professional.

An ObGyn example of the complexity of reporting laws, and variation from state to state, is in the area of “statutory rape” reporting. Those state laws, which define serious criminal offenses, set out the age below which an individual is not legally capable of consenting to sexual activity. It varies among states, but may be an absolute age of consent, the age differential between the parties, or some combination of age and age differential.²¹ The question of reporting is further complicated by the issue of when statutory rape must be reported—for example, the circumstances when the harm to the underage person is sufficient to require reporting.²²

Laws are complex, as is practice navigation

It is apparent that navigating these issues makes it essential for an ObGyn practice to have clear policies and practices regarding reporting, yet the overall complexity is also why it is so difficult to develop those policies in the first place. Of course, they must be tailored to the state in which the practice resides. Once again, the need is clear for health care professionals to have an ongoing relationship with a health attorney who can help navigate ongoing questions.

CASE Adolescent seeks care without parent

A 15-year-old patient (G0) presents to the gynecology clinic requesting birth control. She reports being sexually active over the past 6 months and having several male partners over the past 2 years. She and her current male partner use condoms inconsistently. She reports being active in school sports, and her academic performance has been noteworthy. Her peers have encouraged her to seek out birth control; one of her good friends recently became pregnant and dropped out of school. She states that her best friend went to a similar clinic and received a “gynecologic encounter” that included information regarding safe sex and contraception, with no pelvic exam required for her to receive birth control pills.

The patient insists that her parents are not to know of her request for contraception due to sexual activity or that she is a patient at the clinic. The gynecologist covering the clinic is aware of the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care and their many publications. The patient is counseled regarding human papillomavirus (HPV) vaccination and screened for sexually transmitted infections. In addition, the gynecologist discusses contraceptive options with the patient, ranging from oral contraceptives, vaginal rings, subdermal implants, depomedroxyprogesterone acetate, as well as intrauterine devices (IUDs). The gynecologist emphasizes safe sex and advises that her partner consider use of condoms independent of her method of birth control. The patient asks for oral contraceptives and is given information about their use and risks, and she indicates that she understands.
 

A few months later the patient requests an IUD, as she would like to have lighter menses and not have to remember to take a pill every day. The provider obtains informed consent for the insertion procedure; the patient signs the appropriate forms.

The IUD is inserted, with difficulty, by a resident physician in the clinic. The patient experiences severe pelvic pain during and immediately following the insertion. She is sent home and told to contact the clinic or another health care provider or proceed to the local emergency department should pain persist or if fever develops.

The patient returns 72 hours later in pain. Pelvic ultrasonography shows the IUD out of place and at risk of perforating the fundus of the uterus. Later that day the patient’s mother calls the clinic, saying that she found a statement of service with the clinic’s number on it in her daughter’s bedroom. She wants to know if her daughter is there, what is going on, and what services have been or are being provided. In passing she remarks that she has no intention of paying (or allowing her insurance to pay for) any care that was provided.

What are the provider’s obligations at this point, both medically and legally?

Medical and legal considerations

One of the most difficult and important health law questions in adolescent medicine is the ability of minors to consent to treatment and to control the health care information resulting from treatment. (“Minor” describes a child or adolescent who has not obtained the age of legal consent, generally 18 years old, to lawfully enter into a legal transaction.)

Continue to: The consent of minor patients...

The consent of minor patients

The traditional legal rule is that parents or guardians (“parent” refers to both) must consent to medical treatment for minor children. There is an exception for emergency situations but generally minors do not provide consent for medical care, a parent does.¹ The parent typically is obliged to provide payment (often through insurance) for those services.

This traditional rule has some exceptions—the emergency exception already noted and the case of emancipated minors, notably an adolescent who is living almost entirely independent of her parents (for example, she is married or not relying on parents in a meaningful way). In recent times there has been increasing authority for “mature minors” to make some medical decisions.² A mature minor is one who has sufficient understanding and judgment to appreciate the consequences, benefits, and risks of accepting proposed medical intervention.

No circumstance involving adolescent treatment has been more contentious than services related to abortion and, to a lesser degree, contraception.³ Both the law of consent to services and the rights of parents to obtain information about contraceptive and abortion services have been a matter of strong, continuing debate. The law in these areas varies greatly from state-to-state, and includes a mix of state law (statutes and court decisions) with an overlay of federal constitutional law related to reproduction-related decisions of adolescents. In addition, the law in this area of consent and information changes relatively frequently.⁴ Clinicians, of course, must focus on the consent laws of the state in which they practice.

STI counseling and treatment

All states permit a minor patient to consent to treatment for an STI (TABLE 1).⁵ A number of states expressly permit, but do not require, health care providers to inform parents of treatment when a physician determines it would be in the best interest of the minor. Thus, the clinic would not be required to provide proactively the information to our case patient’s mother (regarding any STI issues) when she called.⁶

Contraception

Consent for contraception is more complicated. About half the states allow minors who have reached a certain age (12, 14, or 16 years) to consent to contraception. About 20 other states allow some minors to consent to contraceptive services, but the “allowed group” may be fairly narrow (eg, be married, have a health issue, or be “mature”). In 4 states there is currently no clear legal authority to provide contraceptive services to minors, yet those states do not specifically prohibit it. The US Supreme Court has held that a state cannot completely prohibit the availability of contraception to minors.⁷ The reach of that decision, however, is not clear and may not extend beyond what the states currently permit.

The ability of minors to consent to contraception services does not mean that there is a right to consent to all contraceptive options. As contraception becomes more irreversible, permanent, or risky, it is more problematic. For example, consent to sterilization would not ordinarily be within a minor’s recognized ability to consent. Standard, low risk, reversible contraception generally is covered by these state laws.⁸

In our case here, the patient likely was able to consent to contraception—initially to the oral contraception and later to the IUD. The risks and reversibility of both are probably within her ability to consent.^9,10 Of course, if the care was provided in a state that does not include the patient within the groups that can give consent to contraception, it is possible that she might not have the legal authority to consent.

Continue to: General requirements of consent...

General requirements of consent

Even when adolescent consent is permitted for treatment, including in cases of contraception, it is essential that all of the legal and ethical requirements related to informed consent are met.

1. The adolescent has the capacity to consent. This means not only that the state-mandated requirements are met (age, for example) but also that the patient can and does understand the various elements of consent, and can make a sensible, informed decision.

The bottom line is “adolescent capacity is a complex process dependent upon the development of maturity of the adolescent, degree of intervention, expected benefit of the medical procedure, and the sociocultural context surrounding the decision.”¹¹ Other items of interest include the “evolving capacity” of the child,¹² which is the concept of increasing ability of the teen to process information and provide more appropriate informed consent. Central nervous system (CNS) maturation allows the adolescent to become increasingly more capable of decision making and has awareness of consequences of such decisions. Abstract thinking capabilities is a reflection of this CNS maturing process. If this competency is not established, the adolescent patient cannot give legitimate consent.

2. The patient must be given appropriate information (be “informed”). The discussion should include information relevant to the condition being treated (and the disease process if relevant). In addition, information about the treatment or intervention proposed and its risks and alternatives must be provided to the patient and in a way that is understandable.

3. As with all patients, consent must be voluntary and free of coercion or manipulation. These elements of informed consent are expanded on by the Joint Commission, which has established a number of components of informed consent (TABLE 2).^4,13

Confidentiality and release of information to parents and others

Similar to consent, parents historically have had the authority to obtain medical information about their minor children. This right generally continues today, with some limitations. The right to give consent generally carries with it the right to medical information. There are some times when parents may access medical information even if they have not given consent.

This right adds complexity to minor consent and is an important treatment issue and legal consideration because confidentiality for adolescents affects quality of care. Adolescents report that “confidentiality is an important factor in their decision to seek [medical] care.”¹⁴ Many parents are under the assumption that the health care provider will automatically inform them independent of whether or not the adolescent expressed precise instruction not to inform.^15,16

Of course if a minor patient authorizes the physician to provide information to her parents, that is consent and the health care provider may then provide the information. If the patient instructs the provider to convey the information, the practitioner would ordinarily be expected to be proactive in providing the information to the parent. The issue of “voluntariness” of the waiver of confidentiality can be a question, and the physician may discuss that question with the patient. Ordinarily, however, once a minor has authorized disclosure to the parent, the clinician has the authority to disclose the information to the parent, but not to others.

All of the usual considerations of confidentiality in health care apply to adolescent ObGyn services and care. This includes the general obligation not to disclose information without consent and to ensure that health care information is protected from accidental release as required by the Health Insurance Portability and Accountability Act (HIPAA) and other health information privacy laws.¹⁷

Continue to: How and when to protect minor confidentiality...

How and when to protect minor confidentiality

A clinician cannot assure minors of absolute confidentiality and should not agree to do so or imply that they are doing so.¹⁸ In our hypothetical case, when the patient told the physician that her parents were not to know of any of her treatment or communications, the provider should not have acquiesced by silence. He/she might have responded along these lines: “I have a strong commitment to confidentiality of your information, and we take many steps to protect that information. The law also allows some special protection of health care information. Despite the commitment to privacy, there are circumstances in which the law requires disclosure of information—and that might even be to parents. In addition, if you want any of your care covered by insurance, we would have to disclose that. While I expect that we can do as you ask about maintaining your confidentiality, no health care provider can absolutely guarantee it.”

Proactive vs reactive disclosure. There is “proactive” disclosure of information and “reactive” disclosure. Proactive is when the provider (without being asked) contacts a parent or others and provides information. Some states require proactive information about specific kinds of treatment (especially abortion services). For the most part, in states where a minor can legally consent to treatment, health care providers are not required to proactively disclose information.¹⁹

Clinicians may be required to respond to parental requests for information, which is reactive disclosure and is reflected in our case presentation. Even in such circumstances, however, the individual providing care may seek to avoid disclosure. In many states, the law would not require the release of this information (but would permit it if it is in the best interest of the patient). In addition, there are practical ways of avoiding the release of information. For example, the health care provider might acknowledge the interest and desire of the parent to have the information, but might humbly explain that in the experience of many clinicians protecting the confidentiality of patients is very important to successful treatment and it is the policy of the office/clinic not to breach the expectation of patient confidentiality except where that is clearly in the best interest of the patient or required by law.

In response to the likely question, “Well, isn’t that required by law?” the clinician can honestly reply, “I don’t know. There are many complex factors in the law regarding disclosure of medical information and as I am not an attorney I do not know how they all apply in this instance.” In some cases the parent may push the matter or take some kind of legal action. It is in this type of situation that an attorney familiar with health law and the clinician’s practice can be invaluable.

When parents are involved in the minor’s treatment (bringing the patient to the office/clinic, for example), there is an opportunity for an understanding, or agreement, among the patient, provider, and parent about what information the parent will receive. Ordinarily the agreement should not create the expectation of detailed information for the parent. Perhaps, for example, the physician will provide information only when he or she believes that doing so will be in the best interest of the patient. Even with parental agreement, complete confidentiality cannot be assured for minor patients. There may, for example, be another parent who will not feel bound by the established understanding, and the law requires some disclosures (in the case of child abuse or a court order).²⁰

Continue to: Accidental disclosure...

Accidental disclosure. Health care providers also should make sure that office procedures do not unnecessarily or accidentally disclose information about patients. For example, routinely gathering information about insurance coverage may well trigger the release of information to the policy holder (often a parent). Thus, there should be clear understandings about billing, insurance, and related issues before information is divulged by the patient. This should be part of the process of obtaining informed consent to treatment. It should be up front and honest. Developing a clear understanding of the legal requirements of the state is essential, so that assurance of confidentiality is on legal, solid ground.

Abuse reporting obligations

All states have mandatory child abuse reporting laws. These laws require medical professionals (and others) to report known, and often suspected, abuse of children. Abuse includes physical, sexual, or emotional, and generally also includes neglect that is harming a child. When there is apparent sexual or physical abuse, the health care provider is obligated to report it to designated state authorities, generally child protective services. Reporting laws vary from state to state based on the relationship between the suspected abuser and the minor, the nature of the harm, and how strong the suspicion of abuse needs to be. The failure to make required reports is a crime in most states and also may result in civil liability or licensure discipline. Criminal charges seldom result from the failure to report, but in some cases the failure to report may have serious consequences for the professional.

An ObGyn example of the complexity of reporting laws, and variation from state to state, is in the area of “statutory rape” reporting. Those state laws, which define serious criminal offenses, set out the age below which an individual is not legally capable of consenting to sexual activity. It varies among states, but may be an absolute age of consent, the age differential between the parties, or some combination of age and age differential.²¹ The question of reporting is further complicated by the issue of when statutory rape must be reported—for example, the circumstances when the harm to the underage person is sufficient to require reporting.²²

Laws are complex, as is practice navigation

It is apparent that navigating these issues makes it essential for an ObGyn practice to have clear policies and practices regarding reporting, yet the overall complexity is also why it is so difficult to develop those policies in the first place. Of course, they must be tailored to the state in which the practice resides. Once again, the need is clear for health care professionals to have an ongoing relationship with a health attorney who can help navigate ongoing questions.

CASE Adolescent seeks care without parent

A 15-year-old patient (G0) presents to the gynecology clinic requesting birth control. She reports being sexually active over the past 6 months and having several male partners over the past 2 years. She and her current male partner use condoms inconsistently. She reports being active in school sports, and her academic performance has been noteworthy. Her peers have encouraged her to seek out birth control; one of her good friends recently became pregnant and dropped out of school. She states that her best friend went to a similar clinic and received a “gynecologic encounter” that included information regarding safe sex and contraception, with no pelvic exam required for her to receive birth control pills.

The patient insists that her parents are not to know of her request for contraception due to sexual activity or that she is a patient at the clinic. The gynecologist covering the clinic is aware of the American College of Obstetricians and Gynecologists Committee on Adolescent Health Care and their many publications. The patient is counseled regarding human papillomavirus (HPV) vaccination and screened for sexually transmitted infections. In addition, the gynecologist discusses contraceptive options with the patient, ranging from oral contraceptives, vaginal rings, subdermal implants, depomedroxyprogesterone acetate, as well as intrauterine devices (IUDs). The gynecologist emphasizes safe sex and advises that her partner consider use of condoms independent of her method of birth control. The patient asks for oral contraceptives and is given information about their use and risks, and she indicates that she understands.
 

A few months later the patient requests an IUD, as she would like to have lighter menses and not have to remember to take a pill every day. The provider obtains informed consent for the insertion procedure; the patient signs the appropriate forms.

The IUD is inserted, with difficulty, by a resident physician in the clinic. The patient experiences severe pelvic pain during and immediately following the insertion. She is sent home and told to contact the clinic or another health care provider or proceed to the local emergency department should pain persist or if fever develops.

The patient returns 72 hours later in pain. Pelvic ultrasonography shows the IUD out of place and at risk of perforating the fundus of the uterus. Later that day the patient’s mother calls the clinic, saying that she found a statement of service with the clinic’s number on it in her daughter’s bedroom. She wants to know if her daughter is there, what is going on, and what services have been or are being provided. In passing she remarks that she has no intention of paying (or allowing her insurance to pay for) any care that was provided.

What are the provider’s obligations at this point, both medically and legally?

Medical and legal considerations

One of the most difficult and important health law questions in adolescent medicine is the ability of minors to consent to treatment and to control the health care information resulting from treatment. (“Minor” describes a child or adolescent who has not obtained the age of legal consent, generally 18 years old, to lawfully enter into a legal transaction.)

Continue to: The consent of minor patients...

The consent of minor patients

The traditional legal rule is that parents or guardians (“parent” refers to both) must consent to medical treatment for minor children. There is an exception for emergency situations but generally minors do not provide consent for medical care, a parent does.¹ The parent typically is obliged to provide payment (often through insurance) for those services.

This traditional rule has some exceptions—the emergency exception already noted and the case of emancipated minors, notably an adolescent who is living almost entirely independent of her parents (for example, she is married or not relying on parents in a meaningful way). In recent times there has been increasing authority for “mature minors” to make some medical decisions.² A mature minor is one who has sufficient understanding and judgment to appreciate the consequences, benefits, and risks of accepting proposed medical intervention.

No circumstance involving adolescent treatment has been more contentious than services related to abortion and, to a lesser degree, contraception.³ Both the law of consent to services and the rights of parents to obtain information about contraceptive and abortion services have been a matter of strong, continuing debate. The law in these areas varies greatly from state-to-state, and includes a mix of state law (statutes and court decisions) with an overlay of federal constitutional law related to reproduction-related decisions of adolescents. In addition, the law in this area of consent and information changes relatively frequently.⁴ Clinicians, of course, must focus on the consent laws of the state in which they practice.

STI counseling and treatment

All states permit a minor patient to consent to treatment for an STI (TABLE 1).⁵ A number of states expressly permit, but do not require, health care providers to inform parents of treatment when a physician determines it would be in the best interest of the minor. Thus, the clinic would not be required to provide proactively the information to our case patient’s mother (regarding any STI issues) when she called.⁶

Contraception

Consent for contraception is more complicated. About half the states allow minors who have reached a certain age (12, 14, or 16 years) to consent to contraception. About 20 other states allow some minors to consent to contraceptive services, but the “allowed group” may be fairly narrow (eg, be married, have a health issue, or be “mature”). In 4 states there is currently no clear legal authority to provide contraceptive services to minors, yet those states do not specifically prohibit it. The US Supreme Court has held that a state cannot completely prohibit the availability of contraception to minors.⁷ The reach of that decision, however, is not clear and may not extend beyond what the states currently permit.

The ability of minors to consent to contraception services does not mean that there is a right to consent to all contraceptive options. As contraception becomes more irreversible, permanent, or risky, it is more problematic. For example, consent to sterilization would not ordinarily be within a minor’s recognized ability to consent. Standard, low risk, reversible contraception generally is covered by these state laws.⁸

In our case here, the patient likely was able to consent to contraception—initially to the oral contraception and later to the IUD. The risks and reversibility of both are probably within her ability to consent.^9,10 Of course, if the care was provided in a state that does not include the patient within the groups that can give consent to contraception, it is possible that she might not have the legal authority to consent.

Continue to: General requirements of consent...

General requirements of consent

Even when adolescent consent is permitted for treatment, including in cases of contraception, it is essential that all of the legal and ethical requirements related to informed consent are met.

1. The adolescent has the capacity to consent. This means not only that the state-mandated requirements are met (age, for example) but also that the patient can and does understand the various elements of consent, and can make a sensible, informed decision.

The bottom line is “adolescent capacity is a complex process dependent upon the development of maturity of the adolescent, degree of intervention, expected benefit of the medical procedure, and the sociocultural context surrounding the decision.”¹¹ Other items of interest include the “evolving capacity” of the child,¹² which is the concept of increasing ability of the teen to process information and provide more appropriate informed consent. Central nervous system (CNS) maturation allows the adolescent to become increasingly more capable of decision making and has awareness of consequences of such decisions. Abstract thinking capabilities is a reflection of this CNS maturing process. If this competency is not established, the adolescent patient cannot give legitimate consent.

2. The patient must be given appropriate information (be “informed”). The discussion should include information relevant to the condition being treated (and the disease process if relevant). In addition, information about the treatment or intervention proposed and its risks and alternatives must be provided to the patient and in a way that is understandable.

3. As with all patients, consent must be voluntary and free of coercion or manipulation. These elements of informed consent are expanded on by the Joint Commission, which has established a number of components of informed consent (TABLE 2).^4,13

Confidentiality and release of information to parents and others

Similar to consent, parents historically have had the authority to obtain medical information about their minor children. This right generally continues today, with some limitations. The right to give consent generally carries with it the right to medical information. There are some times when parents may access medical information even if they have not given consent.

This right adds complexity to minor consent and is an important treatment issue and legal consideration because confidentiality for adolescents affects quality of care. Adolescents report that “confidentiality is an important factor in their decision to seek [medical] care.”¹⁴ Many parents are under the assumption that the health care provider will automatically inform them independent of whether or not the adolescent expressed precise instruction not to inform.^15,16

Of course if a minor patient authorizes the physician to provide information to her parents, that is consent and the health care provider may then provide the information. If the patient instructs the provider to convey the information, the practitioner would ordinarily be expected to be proactive in providing the information to the parent. The issue of “voluntariness” of the waiver of confidentiality can be a question, and the physician may discuss that question with the patient. Ordinarily, however, once a minor has authorized disclosure to the parent, the clinician has the authority to disclose the information to the parent, but not to others.

All of the usual considerations of confidentiality in health care apply to adolescent ObGyn services and care. This includes the general obligation not to disclose information without consent and to ensure that health care information is protected from accidental release as required by the Health Insurance Portability and Accountability Act (HIPAA) and other health information privacy laws.¹⁷

Continue to: How and when to protect minor confidentiality...

How and when to protect minor confidentiality

A clinician cannot assure minors of absolute confidentiality and should not agree to do so or imply that they are doing so.¹⁸ In our hypothetical case, when the patient told the physician that her parents were not to know of any of her treatment or communications, the provider should not have acquiesced by silence. He/she might have responded along these lines: “I have a strong commitment to confidentiality of your information, and we take many steps to protect that information. The law also allows some special protection of health care information. Despite the commitment to privacy, there are circumstances in which the law requires disclosure of information—and that might even be to parents. In addition, if you want any of your care covered by insurance, we would have to disclose that. While I expect that we can do as you ask about maintaining your confidentiality, no health care provider can absolutely guarantee it.”

Proactive vs reactive disclosure. There is “proactive” disclosure of information and “reactive” disclosure. Proactive is when the provider (without being asked) contacts a parent or others and provides information. Some states require proactive information about specific kinds of treatment (especially abortion services). For the most part, in states where a minor can legally consent to treatment, health care providers are not required to proactively disclose information.¹⁹

Clinicians may be required to respond to parental requests for information, which is reactive disclosure and is reflected in our case presentation. Even in such circumstances, however, the individual providing care may seek to avoid disclosure. In many states, the law would not require the release of this information (but would permit it if it is in the best interest of the patient). In addition, there are practical ways of avoiding the release of information. For example, the health care provider might acknowledge the interest and desire of the parent to have the information, but might humbly explain that in the experience of many clinicians protecting the confidentiality of patients is very important to successful treatment and it is the policy of the office/clinic not to breach the expectation of patient confidentiality except where that is clearly in the best interest of the patient or required by law.

In response to the likely question, “Well, isn’t that required by law?” the clinician can honestly reply, “I don’t know. There are many complex factors in the law regarding disclosure of medical information and as I am not an attorney I do not know how they all apply in this instance.” In some cases the parent may push the matter or take some kind of legal action. It is in this type of situation that an attorney familiar with health law and the clinician’s practice can be invaluable.

When parents are involved in the minor’s treatment (bringing the patient to the office/clinic, for example), there is an opportunity for an understanding, or agreement, among the patient, provider, and parent about what information the parent will receive. Ordinarily the agreement should not create the expectation of detailed information for the parent. Perhaps, for example, the physician will provide information only when he or she believes that doing so will be in the best interest of the patient. Even with parental agreement, complete confidentiality cannot be assured for minor patients. There may, for example, be another parent who will not feel bound by the established understanding, and the law requires some disclosures (in the case of child abuse or a court order).²⁰

Continue to: Accidental disclosure...

Accidental disclosure. Health care providers also should make sure that office procedures do not unnecessarily or accidentally disclose information about patients. For example, routinely gathering information about insurance coverage may well trigger the release of information to the policy holder (often a parent). Thus, there should be clear understandings about billing, insurance, and related issues before information is divulged by the patient. This should be part of the process of obtaining informed consent to treatment. It should be up front and honest. Developing a clear understanding of the legal requirements of the state is essential, so that assurance of confidentiality is on legal, solid ground.

Abuse reporting obligations

All states have mandatory child abuse reporting laws. These laws require medical professionals (and others) to report known, and often suspected, abuse of children. Abuse includes physical, sexual, or emotional, and generally also includes neglect that is harming a child. When there is apparent sexual or physical abuse, the health care provider is obligated to report it to designated state authorities, generally child protective services. Reporting laws vary from state to state based on the relationship between the suspected abuser and the minor, the nature of the harm, and how strong the suspicion of abuse needs to be. The failure to make required reports is a crime in most states and also may result in civil liability or licensure discipline. Criminal charges seldom result from the failure to report, but in some cases the failure to report may have serious consequences for the professional.

An ObGyn example of the complexity of reporting laws, and variation from state to state, is in the area of “statutory rape” reporting. Those state laws, which define serious criminal offenses, set out the age below which an individual is not legally capable of consenting to sexual activity. It varies among states, but may be an absolute age of consent, the age differential between the parties, or some combination of age and age differential.²¹ The question of reporting is further complicated by the issue of when statutory rape must be reported—for example, the circumstances when the harm to the underage person is sufficient to require reporting.²²

Laws are complex, as is practice navigation

It is apparent that navigating these issues makes it essential for an ObGyn practice to have clear policies and practices regarding reporting, yet the overall complexity is also why it is so difficult to develop those policies in the first place. Of course, they must be tailored to the state in which the practice resides. Once again, the need is clear for health care professionals to have an ongoing relationship with a health attorney who can help navigate ongoing questions.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Failure to perform cesarean delivery^1–4

A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.

The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.

The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.

At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.

LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.

The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.

The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.

The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.

The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.

The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.

WHAT’S THE VERDICT?

Read about the verdict and medical considerations.

WHAT’S THE VERDICT?

The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.⁴

Medical considerations

Refusal of medical care

Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.⁵ There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.⁵ The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”⁵ There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate⁵:

• reliability and validity of evidence-based medicine
• severity of the prospective outcome
• degree of risk or burden placed on the patient
• patient understanding of the gravity of the situation and risks
• degree of urgency.

Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”⁶

Complications from vacuum-assisted vaginal delivery

Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.⁷

A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.⁸

Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.⁷ Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.⁹ Up to one-quarter of babies who require NICU admission for this condition die.¹⁰ This injury seldom occurs with forceps.

Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.¹¹

Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).¹²