S.Y. Tan, MD, JD

Question: A patient who is a commercial truck driver has a long history of snoring and daytime sleepiness. His physical exam was remarkable for obesity, prominent extremities, a large tongue, and a prominent jaw. The treating doctor did not pursue additional work-up or treatment.

One day, the patient fell asleep while driving his truck and hit an oncoming vehicle, resulting in injuries to both patient and the other driver.

In this hypothetical scenario, which of the following statements is best?

A. The doctor may be found negligent for missing the diagnosis of acromegaly and accompanying sleep apnea, and for failing to treat and warn about driving risks.

B. The doctor may be liable to both his patient and the other injured driver.

C. The patient may be terminated from his job as a commercial truck driver, because he poses a danger to himself and the public.

D. Both A and B are correct.

E. All are correct.

Answer: D. Sleep apnea, an underdiagnosed and undertreated disabling condition, places the patient at substantial risk for injuries, chronic hypoxemia, and respiratory arrest. Excessive daytime sleepiness and fatigue may prove hazardous, particularly in those whose undivided attention is a requirement of their jobs, such as with truck drivers.

Diagnosis is established with a formal sleep study (polysomnography), and treatment with a continuous positive airway pressure (CPAP) device is usually effective. In severe or recalcitrant cases, surgical intervention (that is, uvulopalatopharyngoplasty) may be necessary.

In a recent study, Dr. Peter F. Svider of Rutgers New Jersey Medical School, Newark, and his colleagues analyzed 54 litigated sleep apnea cases, of which 33 (61%) were resolved in favor of the defendants (Otolaryngol Head Neck Surg. 2013 Dec;149[6]:947-53). Most of the cases (47) stemmed from patients who underwent surgery with perioperative complications, including death. Inadequate informed consent and monitoring, as well as inappropriate medications, were other findings.

Obstructive sleep apnea is a well-recognized complication of acromegaly with its bony and soft-tissue hypertrophy. The hypothetical situation described above is substantially modified from an actual case in which a 39-year-old man with acromegaly and sleep apnea died from cardiorespiratory arrest (Cornett v. W.O. Moss Regional Hospital, 614 So.2d 189 [La. 1993]). He had presented over the course of several years with repeated complaints of daytime sleepiness and sleeping while driving. Falling asleep in the examination room and abnormal blood gases were giveaway signs. Unfortunately, sleep apnea was left untreated.

Other litigated cases have included anoxic encephalopathy from a lost airway and inappropriate fentanyl dosing during and following aggressive surgery for mild/moderate obstructive sleep apnea, as well as cardiac arrest in a retired sailor during a routine endoscopic procedure. In the latter instance, the plaintiff alleged that there was a failure to take proper precautions in protecting the airway, given that the patient had a known case of obstructive sleep apnea.

What about other liabilities for injuries that are proximately caused by a failure to diagnose and treat?

A doctor is usually liable for negligent care only to his or her own patient, because the duty of care grows out of the doctor-patient relationship and is normally owed to the patient and no one else. However, in very limited circumstances, the duty may extend to other individuals who are family members or even total strangers.

Sleep apnea, by virtue of its sleep disturbances and resulting daytime sleepiness, poses a foreseeable risk of harm. Nonpatient third parties have successfully sued doctors for driving injuries arising out of the failure to diagnose, treat, or warn in a variety of medical conditions.

For example, the Iowa Supreme Court has held that a physician must warn a patient with newly diagnosed seizure disorder about the risks of driving (Freese v. Lemmon, 210 N.W.2d 576 [Iowa 1973]). In that case, a patient with a history of a single seizure injured a woman when he suffered a second seizure while driving.

By analogy, it seems reasonable to assume that the facts given in our hypothetical scenario may give rise to an action against the doctor not only by the patient, but by the injured nonpatient third party as well.

In many jurisdictions, sleep apnea has been accepted as a disability for purposes of the Americans with Disabilities Act (ADA). A disability is defined as a condition evincing substantial interference with a major life activity. Under the ADA, employers are required to make “reasonable accommodation” for disabled employees and cannot simply dismiss them by sole virtue of that disability.

However, qualification for the job must still be shown. One court ruled that a plaintiff with sleep apnea had failed to show that he was a qualified employee even if given his proposed “two-nap-a-day” accommodation (Jackson v. Boise Cascade Corp., 941 F. Supp. 1122 [Ala. 1996]).

Another interesting case involved an anesthesiologist who suffered from sleep apnea and who was snoring and sleeping during surgery. The hospital terminated his contract, and the anesthesiologist filed suit claiming disability discrimination. The 6th U.S. Circuit Court of Appeals affirmed the lower court’s decision in favor of the hospital, finding that the anesthesiologist was fired not because he had a disability, but because he had slept during surgical procedures (Brohm v. JH Properties, 149 F.3d 517 [6th Cir. 1998]).

Distinguishing between discharging someone for unacceptable conduct and discharging someone because of the disability, the court reasoned: “One suffering from chronic sleep deprivation may well be so tired that he cannot stay awake. But such sleep deprivation did not compel Brohm [the anesthesiologist defendant] to administer anesthetics during surgical procedures when he knew he was tired.”

On the other hand, a federal court in 2014 ordered the city of McPherson, Kan., to pay $920,000 in damages to a dismissed police officer suffering from sleep apnea. Although the city cited other factors for the termination, such as insubordination and conduct unbecoming an officer, it had focused on “sleeping on the job” as the basis for the termination. The officer reportedly experienced no further difficulties after he received medical treatment, and the city did not offer the officer an alternative to his graveyard shift or an opportunity to explain his medical condition.

Finally, a discussion of the legal aspects of sleep apnea is incomplete without noting that conducting and billing for sleep studies may occasionally be subject to abuse and/or fraud. The U.S. Department of Health & Human Services Office of Inspector General (OIG) has underscored the high utilization of sleep testing by sleep disorder clinics; in 2010 alone, Medicare reimbursement totaled some $410 million.

The OIG is targeting questionable billing practices under the False Claims Act (31 U.S.C. §§3729-3733) and for self-referrals (Stark Law). Medicare and Medicaid will only reimburse sleep studies that are reasonable and necessary. In addition, there are strict rules such as the mandatory use of properly trained and credentialed sleep technicians, and appropriate level of general physician supervision.

In its most recent prosecution, the federal government is going after the owners of a chain of sleep clinics in the San Francisco Bay area for sleep tests that were conducted in unapproved locations and/or by unlicensed technicians. In addition, the lawsuit alleges a Stark Law violation for self-referrals. The action is being taken in conjunction with a lawsuit filed by a former employee in a whistle-blower action. Under the False Claims Act, whistle-blowers who are private citizens, such as former employees, can file a qui tam action alone or in concert with the government, and they stand to collect a significant (e.g., 25%) portion of any recovery.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: A patient who is a commercial truck driver has a long history of snoring and daytime sleepiness. His physical exam was remarkable for obesity, prominent extremities, a large tongue, and a prominent jaw. The treating doctor did not pursue additional work-up or treatment.

One day, the patient fell asleep while driving his truck and hit an oncoming vehicle, resulting in injuries to both patient and the other driver.

In this hypothetical scenario, which of the following statements is best?

A. The doctor may be found negligent for missing the diagnosis of acromegaly and accompanying sleep apnea, and for failing to treat and warn about driving risks.

B. The doctor may be liable to both his patient and the other injured driver.

C. The patient may be terminated from his job as a commercial truck driver, because he poses a danger to himself and the public.

D. Both A and B are correct.

E. All are correct.

Answer: D. Sleep apnea, an underdiagnosed and undertreated disabling condition, places the patient at substantial risk for injuries, chronic hypoxemia, and respiratory arrest. Excessive daytime sleepiness and fatigue may prove hazardous, particularly in those whose undivided attention is a requirement of their jobs, such as with truck drivers.

Diagnosis is established with a formal sleep study (polysomnography), and treatment with a continuous positive airway pressure (CPAP) device is usually effective. In severe or recalcitrant cases, surgical intervention (that is, uvulopalatopharyngoplasty) may be necessary.

In a recent study, Dr. Peter F. Svider of Rutgers New Jersey Medical School, Newark, and his colleagues analyzed 54 litigated sleep apnea cases, of which 33 (61%) were resolved in favor of the defendants (Otolaryngol Head Neck Surg. 2013 Dec;149[6]:947-53). Most of the cases (47) stemmed from patients who underwent surgery with perioperative complications, including death. Inadequate informed consent and monitoring, as well as inappropriate medications, were other findings.

Obstructive sleep apnea is a well-recognized complication of acromegaly with its bony and soft-tissue hypertrophy. The hypothetical situation described above is substantially modified from an actual case in which a 39-year-old man with acromegaly and sleep apnea died from cardiorespiratory arrest (Cornett v. W.O. Moss Regional Hospital, 614 So.2d 189 [La. 1993]). He had presented over the course of several years with repeated complaints of daytime sleepiness and sleeping while driving. Falling asleep in the examination room and abnormal blood gases were giveaway signs. Unfortunately, sleep apnea was left untreated.

Other litigated cases have included anoxic encephalopathy from a lost airway and inappropriate fentanyl dosing during and following aggressive surgery for mild/moderate obstructive sleep apnea, as well as cardiac arrest in a retired sailor during a routine endoscopic procedure. In the latter instance, the plaintiff alleged that there was a failure to take proper precautions in protecting the airway, given that the patient had a known case of obstructive sleep apnea.

What about other liabilities for injuries that are proximately caused by a failure to diagnose and treat?

A doctor is usually liable for negligent care only to his or her own patient, because the duty of care grows out of the doctor-patient relationship and is normally owed to the patient and no one else. However, in very limited circumstances, the duty may extend to other individuals who are family members or even total strangers.

Sleep apnea, by virtue of its sleep disturbances and resulting daytime sleepiness, poses a foreseeable risk of harm. Nonpatient third parties have successfully sued doctors for driving injuries arising out of the failure to diagnose, treat, or warn in a variety of medical conditions.

For example, the Iowa Supreme Court has held that a physician must warn a patient with newly diagnosed seizure disorder about the risks of driving (Freese v. Lemmon, 210 N.W.2d 576 [Iowa 1973]). In that case, a patient with a history of a single seizure injured a woman when he suffered a second seizure while driving.

By analogy, it seems reasonable to assume that the facts given in our hypothetical scenario may give rise to an action against the doctor not only by the patient, but by the injured nonpatient third party as well.

In many jurisdictions, sleep apnea has been accepted as a disability for purposes of the Americans with Disabilities Act (ADA). A disability is defined as a condition evincing substantial interference with a major life activity. Under the ADA, employers are required to make “reasonable accommodation” for disabled employees and cannot simply dismiss them by sole virtue of that disability.

However, qualification for the job must still be shown. One court ruled that a plaintiff with sleep apnea had failed to show that he was a qualified employee even if given his proposed “two-nap-a-day” accommodation (Jackson v. Boise Cascade Corp., 941 F. Supp. 1122 [Ala. 1996]).

Another interesting case involved an anesthesiologist who suffered from sleep apnea and who was snoring and sleeping during surgery. The hospital terminated his contract, and the anesthesiologist filed suit claiming disability discrimination. The 6th U.S. Circuit Court of Appeals affirmed the lower court’s decision in favor of the hospital, finding that the anesthesiologist was fired not because he had a disability, but because he had slept during surgical procedures (Brohm v. JH Properties, 149 F.3d 517 [6th Cir. 1998]).

Distinguishing between discharging someone for unacceptable conduct and discharging someone because of the disability, the court reasoned: “One suffering from chronic sleep deprivation may well be so tired that he cannot stay awake. But such sleep deprivation did not compel Brohm [the anesthesiologist defendant] to administer anesthetics during surgical procedures when he knew he was tired.”

On the other hand, a federal court in 2014 ordered the city of McPherson, Kan., to pay $920,000 in damages to a dismissed police officer suffering from sleep apnea. Although the city cited other factors for the termination, such as insubordination and conduct unbecoming an officer, it had focused on “sleeping on the job” as the basis for the termination. The officer reportedly experienced no further difficulties after he received medical treatment, and the city did not offer the officer an alternative to his graveyard shift or an opportunity to explain his medical condition.

Finally, a discussion of the legal aspects of sleep apnea is incomplete without noting that conducting and billing for sleep studies may occasionally be subject to abuse and/or fraud. The U.S. Department of Health & Human Services Office of Inspector General (OIG) has underscored the high utilization of sleep testing by sleep disorder clinics; in 2010 alone, Medicare reimbursement totaled some $410 million.

The OIG is targeting questionable billing practices under the False Claims Act (31 U.S.C. §§3729-3733) and for self-referrals (Stark Law). Medicare and Medicaid will only reimburse sleep studies that are reasonable and necessary. In addition, there are strict rules such as the mandatory use of properly trained and credentialed sleep technicians, and appropriate level of general physician supervision.

In its most recent prosecution, the federal government is going after the owners of a chain of sleep clinics in the San Francisco Bay area for sleep tests that were conducted in unapproved locations and/or by unlicensed technicians. In addition, the lawsuit alleges a Stark Law violation for self-referrals. The action is being taken in conjunction with a lawsuit filed by a former employee in a whistle-blower action. Under the False Claims Act, whistle-blowers who are private citizens, such as former employees, can file a qui tam action alone or in concert with the government, and they stand to collect a significant (e.g., 25%) portion of any recovery.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: A patient who is a commercial truck driver has a long history of snoring and daytime sleepiness. His physical exam was remarkable for obesity, prominent extremities, a large tongue, and a prominent jaw. The treating doctor did not pursue additional work-up or treatment.

One day, the patient fell asleep while driving his truck and hit an oncoming vehicle, resulting in injuries to both patient and the other driver.

In this hypothetical scenario, which of the following statements is best?

A. The doctor may be found negligent for missing the diagnosis of acromegaly and accompanying sleep apnea, and for failing to treat and warn about driving risks.

B. The doctor may be liable to both his patient and the other injured driver.

C. The patient may be terminated from his job as a commercial truck driver, because he poses a danger to himself and the public.

D. Both A and B are correct.

E. All are correct.

Answer: D. Sleep apnea, an underdiagnosed and undertreated disabling condition, places the patient at substantial risk for injuries, chronic hypoxemia, and respiratory arrest. Excessive daytime sleepiness and fatigue may prove hazardous, particularly in those whose undivided attention is a requirement of their jobs, such as with truck drivers.

Diagnosis is established with a formal sleep study (polysomnography), and treatment with a continuous positive airway pressure (CPAP) device is usually effective. In severe or recalcitrant cases, surgical intervention (that is, uvulopalatopharyngoplasty) may be necessary.

In a recent study, Dr. Peter F. Svider of Rutgers New Jersey Medical School, Newark, and his colleagues analyzed 54 litigated sleep apnea cases, of which 33 (61%) were resolved in favor of the defendants (Otolaryngol Head Neck Surg. 2013 Dec;149[6]:947-53). Most of the cases (47) stemmed from patients who underwent surgery with perioperative complications, including death. Inadequate informed consent and monitoring, as well as inappropriate medications, were other findings.

Obstructive sleep apnea is a well-recognized complication of acromegaly with its bony and soft-tissue hypertrophy. The hypothetical situation described above is substantially modified from an actual case in which a 39-year-old man with acromegaly and sleep apnea died from cardiorespiratory arrest (Cornett v. W.O. Moss Regional Hospital, 614 So.2d 189 [La. 1993]). He had presented over the course of several years with repeated complaints of daytime sleepiness and sleeping while driving. Falling asleep in the examination room and abnormal blood gases were giveaway signs. Unfortunately, sleep apnea was left untreated.

Other litigated cases have included anoxic encephalopathy from a lost airway and inappropriate fentanyl dosing during and following aggressive surgery for mild/moderate obstructive sleep apnea, as well as cardiac arrest in a retired sailor during a routine endoscopic procedure. In the latter instance, the plaintiff alleged that there was a failure to take proper precautions in protecting the airway, given that the patient had a known case of obstructive sleep apnea.

What about other liabilities for injuries that are proximately caused by a failure to diagnose and treat?

A doctor is usually liable for negligent care only to his or her own patient, because the duty of care grows out of the doctor-patient relationship and is normally owed to the patient and no one else. However, in very limited circumstances, the duty may extend to other individuals who are family members or even total strangers.

Sleep apnea, by virtue of its sleep disturbances and resulting daytime sleepiness, poses a foreseeable risk of harm. Nonpatient third parties have successfully sued doctors for driving injuries arising out of the failure to diagnose, treat, or warn in a variety of medical conditions.

For example, the Iowa Supreme Court has held that a physician must warn a patient with newly diagnosed seizure disorder about the risks of driving (Freese v. Lemmon, 210 N.W.2d 576 [Iowa 1973]). In that case, a patient with a history of a single seizure injured a woman when he suffered a second seizure while driving.

By analogy, it seems reasonable to assume that the facts given in our hypothetical scenario may give rise to an action against the doctor not only by the patient, but by the injured nonpatient third party as well.

In many jurisdictions, sleep apnea has been accepted as a disability for purposes of the Americans with Disabilities Act (ADA). A disability is defined as a condition evincing substantial interference with a major life activity. Under the ADA, employers are required to make “reasonable accommodation” for disabled employees and cannot simply dismiss them by sole virtue of that disability.

However, qualification for the job must still be shown. One court ruled that a plaintiff with sleep apnea had failed to show that he was a qualified employee even if given his proposed “two-nap-a-day” accommodation (Jackson v. Boise Cascade Corp., 941 F. Supp. 1122 [Ala. 1996]).

Another interesting case involved an anesthesiologist who suffered from sleep apnea and who was snoring and sleeping during surgery. The hospital terminated his contract, and the anesthesiologist filed suit claiming disability discrimination. The 6th U.S. Circuit Court of Appeals affirmed the lower court’s decision in favor of the hospital, finding that the anesthesiologist was fired not because he had a disability, but because he had slept during surgical procedures (Brohm v. JH Properties, 149 F.3d 517 [6th Cir. 1998]).

Distinguishing between discharging someone for unacceptable conduct and discharging someone because of the disability, the court reasoned: “One suffering from chronic sleep deprivation may well be so tired that he cannot stay awake. But such sleep deprivation did not compel Brohm [the anesthesiologist defendant] to administer anesthetics during surgical procedures when he knew he was tired.”

On the other hand, a federal court in 2014 ordered the city of McPherson, Kan., to pay $920,000 in damages to a dismissed police officer suffering from sleep apnea. Although the city cited other factors for the termination, such as insubordination and conduct unbecoming an officer, it had focused on “sleeping on the job” as the basis for the termination. The officer reportedly experienced no further difficulties after he received medical treatment, and the city did not offer the officer an alternative to his graveyard shift or an opportunity to explain his medical condition.

Finally, a discussion of the legal aspects of sleep apnea is incomplete without noting that conducting and billing for sleep studies may occasionally be subject to abuse and/or fraud. The U.S. Department of Health & Human Services Office of Inspector General (OIG) has underscored the high utilization of sleep testing by sleep disorder clinics; in 2010 alone, Medicare reimbursement totaled some $410 million.

The OIG is targeting questionable billing practices under the False Claims Act (31 U.S.C. §§3729-3733) and for self-referrals (Stark Law). Medicare and Medicaid will only reimburse sleep studies that are reasonable and necessary. In addition, there are strict rules such as the mandatory use of properly trained and credentialed sleep technicians, and appropriate level of general physician supervision.

In its most recent prosecution, the federal government is going after the owners of a chain of sleep clinics in the San Francisco Bay area for sleep tests that were conducted in unapproved locations and/or by unlicensed technicians. In addition, the lawsuit alleges a Stark Law violation for self-referrals. The action is being taken in conjunction with a lawsuit filed by a former employee in a whistle-blower action. Under the False Claims Act, whistle-blowers who are private citizens, such as former employees, can file a qui tam action alone or in concert with the government, and they stand to collect a significant (e.g., 25%) portion of any recovery.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Driving home after a demanding 24 hours on call, the sleepy and fatigued first-year medical resident momentarily dozed off at the wheel, ran a stop sign, and struck an oncoming car, injuring its driver. In a lawsuit by the injured victim, which of the following answers is best?

A. The residency program is definitely liable, being in violation of Accreditation Council for Graduate Medical Education rules on consecutive work hours.

B. The resident is solely liable, because he’s the one who owed the duty of due care.

C. The hospital may be a named codefendant, because it knew or should have known that sleep deprivation can impair a person’s driving ability.

D. A and C are correct.

E. Only B and C are correct.

Answer: E. Residency training programs face many potential liabilities, such as those arising from disciplinary actions, employer-employee disputes, sexual harassment, and so on. But one issue deserving attention is auto accidents in overfatigued trainees. The incidence of falling asleep at the wheel is very high – in some surveys, close to 50% – and accidents are more likely to occur in the immediate post-call period.

The two main research papers documenting a relationship between extended work duty and auto accidents are from Laura K. Barger, Ph.D., and Dr. Colin P. West.

In the Barger study, the authors conducted a nationwide Web-based survey of 2,737 interns (N. Engl. J. Med. 2005;352:125-34). They found that an extended work shift (greater than 24 hours) was 2.3 times as likely for a motor vehicle crash, and 5.9 times for a near-miss accident. The researchers calculated that every extended shift in the month increased the crash risk by 9.1% and near-miss risk by 16.2%.

In the West study, the authors performed a prospective, 5-year longitudinal study of a cohort of 340 first-year Mayo Clinic residents in internal medicine (Mayo Clin. Proc. 2012;87:1138-44). In self-generated quarterly filings, 11.3% reported a motor vehicle crash and 43.3% a near-miss accident. Sleepiness (as well as other variables such as depression, burnout, diminished quality of life, and fatigue) significantly increased the odds of a motor vehicle incident in the subsequent 3-month period. Each 1-point increase in fatigue or Epworth Sleepiness Scale score was associated with a 52% and 12% respective increase in a motor vehicle crash.

The Accreditation Council for Graduate Medical Education (ACGME) has formulated rules, which have undergone recent changes, regarding consecutive work-duty hours. Its latest edict in June 2014 can be found on its website and stipulates that “Duty periods of PGY-1 residents must not exceed 16 hours in duration,” and “Duty periods of PGY-2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital.”

Furthermore, programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m., was a strong suggestion.

In a 2005 lawsuit naming Chicago’s Rush Presbyterian-St. Luke’s Medical Center as a defendant, an Illinois court faced the issue of whether a hospital owed a duty to a plaintiff injured by an off-duty resident doctor allegedly suffering from sleep deprivation as a result of a hospital’s policy on working hours (Brewster v. Rush Presbyterian-St. Luke’s Medical Center (836 N.E.2d 635 (Il. App. 2005)). The doctor was an intern who had worked 34 hours of a 36-hour work shift, and fell asleep behind the wheel of her car, striking and seriously injuring the driver of an oncoming car.

In its decision, the court noted the plaintiff’s argument that it was reasonably foreseeable and likely that drivers who were sleep deprived would cause traffic accidents resulting in injuries. For public policy reasons, the plaintiff also maintained that such injuries could be prevented if hospitals either changed work schedules of their residents or provided them with additional rest periods.

However, the court held that there was no liability imputed to health care providers for injuries to nonpatient third parties absent the existence of a “special relationship” between the parties.

Thus, training programs or hospitals may or may not be found liable in future such cases or in other jurisdictions – but the new, stricter ACGME rules suggest that they will, at a minimum, be a named defendant.

Note that in some jurisdictions, injured nonpatient third parties have successfully sued doctors for failing to warn their patients that certain medications can adversely affect their driving ability, and for failing to warn about medical conditions, e.g., syncope, that can adversely impact driving.

Court decisions in analogous factual circumstances have sometimes favored the accident victim.

In Robertson v. LeMaster (301 S.E.2d 563 (W. Va. 1983)), the West Virginia Supreme Court of Appeals noted that the defendant’s employer, Norfolk & Western Railway Company, “could have reasonably foreseen that its exhausted employee, who had been required to work 27 hours without rest, would pose a risk of harm to other motorists^.”

In Faverty v. McDonald’s Restaurants of Oregon (892 P.2d 703 (Ore. Ct. App.1995)), an Oregon appeals court held that the defendant corporation (McDonald’s Restaurants of Oregon) knew or should have known that its employee was a hazard to himself and others when he drove home from the workplace after working multiple shifts in a 24-hour period.

On the other hand, in Barclay v. Briscoe (47 A.3d 560 (Md. 2012)), a longshoreman employed by Ports America Baltimore fell asleep at the wheel while traveling home after working a 22-hour shift and caused a head-on collision resulting in catastrophic injuries. Ports America Baltimore contended that it could not be held primarily liable, because it owed no duty to the public to ensure that an employee was fit to drive his personal vehicle home. The trial court agreed, and the Maryland Court of Appeals affirmed.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Driving home after a demanding 24 hours on call, the sleepy and fatigued first-year medical resident momentarily dozed off at the wheel, ran a stop sign, and struck an oncoming car, injuring its driver. In a lawsuit by the injured victim, which of the following answers is best?

A. The residency program is definitely liable, being in violation of Accreditation Council for Graduate Medical Education rules on consecutive work hours.

B. The resident is solely liable, because he’s the one who owed the duty of due care.

C. The hospital may be a named codefendant, because it knew or should have known that sleep deprivation can impair a person’s driving ability.

D. A and C are correct.

E. Only B and C are correct.

Answer: E. Residency training programs face many potential liabilities, such as those arising from disciplinary actions, employer-employee disputes, sexual harassment, and so on. But one issue deserving attention is auto accidents in overfatigued trainees. The incidence of falling asleep at the wheel is very high – in some surveys, close to 50% – and accidents are more likely to occur in the immediate post-call period.

The two main research papers documenting a relationship between extended work duty and auto accidents are from Laura K. Barger, Ph.D., and Dr. Colin P. West.

In the Barger study, the authors conducted a nationwide Web-based survey of 2,737 interns (N. Engl. J. Med. 2005;352:125-34). They found that an extended work shift (greater than 24 hours) was 2.3 times as likely for a motor vehicle crash, and 5.9 times for a near-miss accident. The researchers calculated that every extended shift in the month increased the crash risk by 9.1% and near-miss risk by 16.2%.

In the West study, the authors performed a prospective, 5-year longitudinal study of a cohort of 340 first-year Mayo Clinic residents in internal medicine (Mayo Clin. Proc. 2012;87:1138-44). In self-generated quarterly filings, 11.3% reported a motor vehicle crash and 43.3% a near-miss accident. Sleepiness (as well as other variables such as depression, burnout, diminished quality of life, and fatigue) significantly increased the odds of a motor vehicle incident in the subsequent 3-month period. Each 1-point increase in fatigue or Epworth Sleepiness Scale score was associated with a 52% and 12% respective increase in a motor vehicle crash.

The Accreditation Council for Graduate Medical Education (ACGME) has formulated rules, which have undergone recent changes, regarding consecutive work-duty hours. Its latest edict in June 2014 can be found on its website and stipulates that “Duty periods of PGY-1 residents must not exceed 16 hours in duration,” and “Duty periods of PGY-2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital.”

Furthermore, programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m., was a strong suggestion.

In a 2005 lawsuit naming Chicago’s Rush Presbyterian-St. Luke’s Medical Center as a defendant, an Illinois court faced the issue of whether a hospital owed a duty to a plaintiff injured by an off-duty resident doctor allegedly suffering from sleep deprivation as a result of a hospital’s policy on working hours (Brewster v. Rush Presbyterian-St. Luke’s Medical Center (836 N.E.2d 635 (Il. App. 2005)). The doctor was an intern who had worked 34 hours of a 36-hour work shift, and fell asleep behind the wheel of her car, striking and seriously injuring the driver of an oncoming car.

In its decision, the court noted the plaintiff’s argument that it was reasonably foreseeable and likely that drivers who were sleep deprived would cause traffic accidents resulting in injuries. For public policy reasons, the plaintiff also maintained that such injuries could be prevented if hospitals either changed work schedules of their residents or provided them with additional rest periods.

However, the court held that there was no liability imputed to health care providers for injuries to nonpatient third parties absent the existence of a “special relationship” between the parties.

Thus, training programs or hospitals may or may not be found liable in future such cases or in other jurisdictions – but the new, stricter ACGME rules suggest that they will, at a minimum, be a named defendant.

Note that in some jurisdictions, injured nonpatient third parties have successfully sued doctors for failing to warn their patients that certain medications can adversely affect their driving ability, and for failing to warn about medical conditions, e.g., syncope, that can adversely impact driving.

Court decisions in analogous factual circumstances have sometimes favored the accident victim.

In Robertson v. LeMaster (301 S.E.2d 563 (W. Va. 1983)), the West Virginia Supreme Court of Appeals noted that the defendant’s employer, Norfolk & Western Railway Company, “could have reasonably foreseen that its exhausted employee, who had been required to work 27 hours without rest, would pose a risk of harm to other motorists^.”

In Faverty v. McDonald’s Restaurants of Oregon (892 P.2d 703 (Ore. Ct. App.1995)), an Oregon appeals court held that the defendant corporation (McDonald’s Restaurants of Oregon) knew or should have known that its employee was a hazard to himself and others when he drove home from the workplace after working multiple shifts in a 24-hour period.

On the other hand, in Barclay v. Briscoe (47 A.3d 560 (Md. 2012)), a longshoreman employed by Ports America Baltimore fell asleep at the wheel while traveling home after working a 22-hour shift and caused a head-on collision resulting in catastrophic injuries. Ports America Baltimore contended that it could not be held primarily liable, because it owed no duty to the public to ensure that an employee was fit to drive his personal vehicle home. The trial court agreed, and the Maryland Court of Appeals affirmed.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Driving home after a demanding 24 hours on call, the sleepy and fatigued first-year medical resident momentarily dozed off at the wheel, ran a stop sign, and struck an oncoming car, injuring its driver. In a lawsuit by the injured victim, which of the following answers is best?

A. The residency program is definitely liable, being in violation of Accreditation Council for Graduate Medical Education rules on consecutive work hours.

B. The resident is solely liable, because he’s the one who owed the duty of due care.

C. The hospital may be a named codefendant, because it knew or should have known that sleep deprivation can impair a person’s driving ability.

D. A and C are correct.

E. Only B and C are correct.

Answer: E. Residency training programs face many potential liabilities, such as those arising from disciplinary actions, employer-employee disputes, sexual harassment, and so on. But one issue deserving attention is auto accidents in overfatigued trainees. The incidence of falling asleep at the wheel is very high – in some surveys, close to 50% – and accidents are more likely to occur in the immediate post-call period.

The two main research papers documenting a relationship between extended work duty and auto accidents are from Laura K. Barger, Ph.D., and Dr. Colin P. West.

In the Barger study, the authors conducted a nationwide Web-based survey of 2,737 interns (N. Engl. J. Med. 2005;352:125-34). They found that an extended work shift (greater than 24 hours) was 2.3 times as likely for a motor vehicle crash, and 5.9 times for a near-miss accident. The researchers calculated that every extended shift in the month increased the crash risk by 9.1% and near-miss risk by 16.2%.

In the West study, the authors performed a prospective, 5-year longitudinal study of a cohort of 340 first-year Mayo Clinic residents in internal medicine (Mayo Clin. Proc. 2012;87:1138-44). In self-generated quarterly filings, 11.3% reported a motor vehicle crash and 43.3% a near-miss accident. Sleepiness (as well as other variables such as depression, burnout, diminished quality of life, and fatigue) significantly increased the odds of a motor vehicle incident in the subsequent 3-month period. Each 1-point increase in fatigue or Epworth Sleepiness Scale score was associated with a 52% and 12% respective increase in a motor vehicle crash.

The Accreditation Council for Graduate Medical Education (ACGME) has formulated rules, which have undergone recent changes, regarding consecutive work-duty hours. Its latest edict in June 2014 can be found on its website and stipulates that “Duty periods of PGY-1 residents must not exceed 16 hours in duration,” and “Duty periods of PGY-2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital.”

Furthermore, programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m., was a strong suggestion.

In a 2005 lawsuit naming Chicago’s Rush Presbyterian-St. Luke’s Medical Center as a defendant, an Illinois court faced the issue of whether a hospital owed a duty to a plaintiff injured by an off-duty resident doctor allegedly suffering from sleep deprivation as a result of a hospital’s policy on working hours (Brewster v. Rush Presbyterian-St. Luke’s Medical Center (836 N.E.2d 635 (Il. App. 2005)). The doctor was an intern who had worked 34 hours of a 36-hour work shift, and fell asleep behind the wheel of her car, striking and seriously injuring the driver of an oncoming car.

In its decision, the court noted the plaintiff’s argument that it was reasonably foreseeable and likely that drivers who were sleep deprived would cause traffic accidents resulting in injuries. For public policy reasons, the plaintiff also maintained that such injuries could be prevented if hospitals either changed work schedules of their residents or provided them with additional rest periods.

However, the court held that there was no liability imputed to health care providers for injuries to nonpatient third parties absent the existence of a “special relationship” between the parties.

Thus, training programs or hospitals may or may not be found liable in future such cases or in other jurisdictions – but the new, stricter ACGME rules suggest that they will, at a minimum, be a named defendant.

Note that in some jurisdictions, injured nonpatient third parties have successfully sued doctors for failing to warn their patients that certain medications can adversely affect their driving ability, and for failing to warn about medical conditions, e.g., syncope, that can adversely impact driving.

Court decisions in analogous factual circumstances have sometimes favored the accident victim.

In Robertson v. LeMaster (301 S.E.2d 563 (W. Va. 1983)), the West Virginia Supreme Court of Appeals noted that the defendant’s employer, Norfolk & Western Railway Company, “could have reasonably foreseen that its exhausted employee, who had been required to work 27 hours without rest, would pose a risk of harm to other motorists^.”

In Faverty v. McDonald’s Restaurants of Oregon (892 P.2d 703 (Ore. Ct. App.1995)), an Oregon appeals court held that the defendant corporation (McDonald’s Restaurants of Oregon) knew or should have known that its employee was a hazard to himself and others when he drove home from the workplace after working multiple shifts in a 24-hour period.

On the other hand, in Barclay v. Briscoe (47 A.3d 560 (Md. 2012)), a longshoreman employed by Ports America Baltimore fell asleep at the wheel while traveling home after working a 22-hour shift and caused a head-on collision resulting in catastrophic injuries. Ports America Baltimore contended that it could not be held primarily liable, because it owed no duty to the public to ensure that an employee was fit to drive his personal vehicle home. The trial court agreed, and the Maryland Court of Appeals affirmed.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Grandma finally checked into a skilled nursing facility (SNF), a member of a national chain of for-profit SNFs, after her progressive dementia prevented her from performing the basic activities of daily living. Unfortunately, the staffing was inadequate, and there were lapses in attention toward her nutrition, medications, and body hygiene. She even fell from her bed on a couple of occasions. Other residents have registered similar complaints. Which of the following legal recourses is available?

A. A lawsuit against the SNF, alleging neglect and abuse.
B. A class action suit against the SNF and its corporate owners.
C. A lawsuit against the attending physician and/or the medical director.
D. A, B, and C.
E. Only A and B.

Answer: D. According to the Wall Street Journal, more than 1.4 million people live in U.S. nursing homes, 69% of which are run by for-profit entities.¹ In contrast to a malpractice complaint, lawsuits against nursing homes and SNFs typically involve allegations of a pattern of neglect and abuse rather than any single incident of negligence. The terms nursing home and SNF are often used interchangeably, but do differ somewhat in that the former deals with non-Medicare regulated custodial care, whereas Medicare regulates and certifies all SNFs, which provide both custodial and medical care. Federal and state statutes, e.g., 42 CFR §483 and Centers for Medicare and Medicaid Services guidelines in the State Operations Manual, prescribe the requisite standards. Collectively referred to as the OBRA standards, their violations are frequently at the heart of a plaintiff’s allegations. These may include short staffing, inattention to body hygiene, skin infections, pressure ulcers, improper use of restraints, poor nutrition and hydration, and failure to monitor or supervise, including failure to administer prescription medications and prevention of falls and violent acts from other residents.

In the past 2 decades, nursing homes and SNFs have experienced soaring numbers of lawsuits, with Texas and Florida being especially vulnerable.² Runaway jury verdicts can result even where the elderly victim has incurred little or no economic loss. Noneconomic losses such as pain and suffering as well as punitive damages explain these huge awards. A recent widely publicized case is illustrative: On Sept. 4, 2009, 87-year-old Dorothy Douglas, an Alzheimer’s patient, was admitted to Heartland Nursing Home in Charleston, W.Va. Still cognitive, she was able to ambulate with an assistive device and was well nourished. However, within 19 days of admission, she became barely responsive, dehydrated, and bedridden, and had fallen numerous times, injuring her head. She died shortly thereafter. Her son sued the owner of Heartland and those responsible for its operations, claiming, among other things, medical and corporate negligence. A jury found in his favor, awarding $11.5 million in compensatory damages and $80 million in punitive damages. On appeal, the West Virginia Supreme Court affirmed in part the trial court’s order, although it reduced the punitive damages from $80 million to $32 million (termed a remittitur).³

There are other sizable verdicts, such as a $29 million lawsuit against a Rocklin, Calif., facility in 2010. Another, possibly the largest on record, was a 2013 Florida jury award of $110 million in compensatory damages and $1.0 billion in punitive damages against Auburndale Oaks Healthcare Center. However, this may not have been the final negotiated amount. Increasingly popular is the use of class action lawsuits, where representative plaintiffs assert claims on behalf of a large class of similarly injured members. Typically, they allege grossly substandard care and understaffing in violation of Medicare and/or other statutory rules. New York’s first nursing home class action suit,⁴ which dragged on for some 9 years, ended up with a settlement sum of only $950,000 for its 22 class members. The suit alleged, among other things, inedible food, inadequate heat, and squalid conditions. A more recent example: In 2010, a Humboldt County, Calif., jury returned a $677 million verdict (Lavender v. Skilled Healthcare Group Inc.) against one of the nation’s largest nursing home chains for violating California’s Health and Safety Code in its 22 statewide facilities. The case later settled for $62.8 million on behalf of the 32,000 residents.

What about physician liability? Many doctors attend to SNF patients and a number act as medical directors. Liability exists in both roles. The first is governed by the usual tort action of malpractice. The latter is infinitely trickier. Medicare mandates all SNFs to have a medical director, and federal law [42 CFR 483.75 (i)] requires the medical director to be responsible for implementation of resident care policies and the coordination of medical care in the facility. Although their duties are administrative in nature, medical directors are not infrequently named as codefendants in SNF lawsuits. Allegations against the medical director may include negligent supervision of staff, and/or the failure to set standards, policies, and procedures, especially if they have been made aware of citations by auditing agencies. Because a doctor’s professional liability policy typically excludes coverage for such work, it behooves all medical directors to insist on being a named insured in the institution’s general liability policy (to include tail coverage), and to be informed in a timely fashion should there be a relevant change or cancellation of coverage. Their contract should stipulate that the facility would indemnify them for all lawsuits arising out of their work. More and more nursing homes are dropping their insurance to bypass legal exposure, leaving the attending physician and/or medical director at increased risk. To avoid a serious gap in coverage, medical directors should consider purchasing a specific medical director policy.⁵ Medical directors should also be aware of potential Stark Law violations, such as treating private patients without paying fair rent or receiving compensation in exchange for referrals.

Importantly, elder abuse judgments, as opposed to malpractice awards, may negate restrictions on attorney fees and noneconomic damages such as California’s $250,000 cap. The jury may also levy punitive damages, which are not covered by professional insurance. The plaintiff will need to prove, by clear and convincing evidence, something more than simple or gross negligence such as malice, fraud, oppression, or recklessness.⁶ Under California’s elder abuse and dependent Adult Civil Protection Act, an appellate court has held that a plaintiff may mount an elder abuse claim directed at physicians and not just facilities with “custodial” duties.⁷This important issue is currently under appeal before the California Supreme Court.

References

1. The Wall Street Journal, Oct. 3, 2014.

2. Stevenson, DG and DM Studdert, The Rise Of Nursing Home Litigation: Findings From A National Survey Of Attorneys. Health Affairs 2003; 22:219-29.

3. Manor Care Inc. v. Douglas, 763 N.E.2d 73 (W. Va. 2014).

4. Fleming v. Barnwell Nursing Hone and Health Facilities Inc., 309 A.D.2d 1132 (N.Y. App. Div. 2003).

5. See the American Medical Directors Association’s (AMDA) offering at http://locktonmedicalliabilityinsurance.com/amda/.

6. Delaney v. Baker, 20 Cal. 4th 23 (1999).

7. Winn v. Pioneer Medical Group Inc., 216 Cal. App. 4th 875 (2013).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs The St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: Grandma finally checked into a skilled nursing facility (SNF), a member of a national chain of for-profit SNFs, after her progressive dementia prevented her from performing the basic activities of daily living. Unfortunately, the staffing was inadequate, and there were lapses in attention toward her nutrition, medications, and body hygiene. She even fell from her bed on a couple of occasions. Other residents have registered similar complaints. Which of the following legal recourses is available?

A. A lawsuit against the SNF, alleging neglect and abuse.
B. A class action suit against the SNF and its corporate owners.
C. A lawsuit against the attending physician and/or the medical director.
D. A, B, and C.
E. Only A and B.

Answer: D. According to the Wall Street Journal, more than 1.4 million people live in U.S. nursing homes, 69% of which are run by for-profit entities.¹ In contrast to a malpractice complaint, lawsuits against nursing homes and SNFs typically involve allegations of a pattern of neglect and abuse rather than any single incident of negligence. The terms nursing home and SNF are often used interchangeably, but do differ somewhat in that the former deals with non-Medicare regulated custodial care, whereas Medicare regulates and certifies all SNFs, which provide both custodial and medical care. Federal and state statutes, e.g., 42 CFR §483 and Centers for Medicare and Medicaid Services guidelines in the State Operations Manual, prescribe the requisite standards. Collectively referred to as the OBRA standards, their violations are frequently at the heart of a plaintiff’s allegations. These may include short staffing, inattention to body hygiene, skin infections, pressure ulcers, improper use of restraints, poor nutrition and hydration, and failure to monitor or supervise, including failure to administer prescription medications and prevention of falls and violent acts from other residents.

In the past 2 decades, nursing homes and SNFs have experienced soaring numbers of lawsuits, with Texas and Florida being especially vulnerable.² Runaway jury verdicts can result even where the elderly victim has incurred little or no economic loss. Noneconomic losses such as pain and suffering as well as punitive damages explain these huge awards. A recent widely publicized case is illustrative: On Sept. 4, 2009, 87-year-old Dorothy Douglas, an Alzheimer’s patient, was admitted to Heartland Nursing Home in Charleston, W.Va. Still cognitive, she was able to ambulate with an assistive device and was well nourished. However, within 19 days of admission, she became barely responsive, dehydrated, and bedridden, and had fallen numerous times, injuring her head. She died shortly thereafter. Her son sued the owner of Heartland and those responsible for its operations, claiming, among other things, medical and corporate negligence. A jury found in his favor, awarding $11.5 million in compensatory damages and $80 million in punitive damages. On appeal, the West Virginia Supreme Court affirmed in part the trial court’s order, although it reduced the punitive damages from $80 million to $32 million (termed a remittitur).³

There are other sizable verdicts, such as a $29 million lawsuit against a Rocklin, Calif., facility in 2010. Another, possibly the largest on record, was a 2013 Florida jury award of $110 million in compensatory damages and $1.0 billion in punitive damages against Auburndale Oaks Healthcare Center. However, this may not have been the final negotiated amount. Increasingly popular is the use of class action lawsuits, where representative plaintiffs assert claims on behalf of a large class of similarly injured members. Typically, they allege grossly substandard care and understaffing in violation of Medicare and/or other statutory rules. New York’s first nursing home class action suit,⁴ which dragged on for some 9 years, ended up with a settlement sum of only $950,000 for its 22 class members. The suit alleged, among other things, inedible food, inadequate heat, and squalid conditions. A more recent example: In 2010, a Humboldt County, Calif., jury returned a $677 million verdict (Lavender v. Skilled Healthcare Group Inc.) against one of the nation’s largest nursing home chains for violating California’s Health and Safety Code in its 22 statewide facilities. The case later settled for $62.8 million on behalf of the 32,000 residents.

What about physician liability? Many doctors attend to SNF patients and a number act as medical directors. Liability exists in both roles. The first is governed by the usual tort action of malpractice. The latter is infinitely trickier. Medicare mandates all SNFs to have a medical director, and federal law [42 CFR 483.75 (i)] requires the medical director to be responsible for implementation of resident care policies and the coordination of medical care in the facility. Although their duties are administrative in nature, medical directors are not infrequently named as codefendants in SNF lawsuits. Allegations against the medical director may include negligent supervision of staff, and/or the failure to set standards, policies, and procedures, especially if they have been made aware of citations by auditing agencies. Because a doctor’s professional liability policy typically excludes coverage for such work, it behooves all medical directors to insist on being a named insured in the institution’s general liability policy (to include tail coverage), and to be informed in a timely fashion should there be a relevant change or cancellation of coverage. Their contract should stipulate that the facility would indemnify them for all lawsuits arising out of their work. More and more nursing homes are dropping their insurance to bypass legal exposure, leaving the attending physician and/or medical director at increased risk. To avoid a serious gap in coverage, medical directors should consider purchasing a specific medical director policy.⁵ Medical directors should also be aware of potential Stark Law violations, such as treating private patients without paying fair rent or receiving compensation in exchange for referrals.

Importantly, elder abuse judgments, as opposed to malpractice awards, may negate restrictions on attorney fees and noneconomic damages such as California’s $250,000 cap. The jury may also levy punitive damages, which are not covered by professional insurance. The plaintiff will need to prove, by clear and convincing evidence, something more than simple or gross negligence such as malice, fraud, oppression, or recklessness.⁶ Under California’s elder abuse and dependent Adult Civil Protection Act, an appellate court has held that a plaintiff may mount an elder abuse claim directed at physicians and not just facilities with “custodial” duties.⁷This important issue is currently under appeal before the California Supreme Court.

References

1. The Wall Street Journal, Oct. 3, 2014.

2. Stevenson, DG and DM Studdert, The Rise Of Nursing Home Litigation: Findings From A National Survey Of Attorneys. Health Affairs 2003; 22:219-29.

3. Manor Care Inc. v. Douglas, 763 N.E.2d 73 (W. Va. 2014).

4. Fleming v. Barnwell Nursing Hone and Health Facilities Inc., 309 A.D.2d 1132 (N.Y. App. Div. 2003).

5. See the American Medical Directors Association’s (AMDA) offering at http://locktonmedicalliabilityinsurance.com/amda/.

6. Delaney v. Baker, 20 Cal. 4th 23 (1999).

7. Winn v. Pioneer Medical Group Inc., 216 Cal. App. 4th 875 (2013).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs The St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: Grandma finally checked into a skilled nursing facility (SNF), a member of a national chain of for-profit SNFs, after her progressive dementia prevented her from performing the basic activities of daily living. Unfortunately, the staffing was inadequate, and there were lapses in attention toward her nutrition, medications, and body hygiene. She even fell from her bed on a couple of occasions. Other residents have registered similar complaints. Which of the following legal recourses is available?

A. A lawsuit against the SNF, alleging neglect and abuse.
B. A class action suit against the SNF and its corporate owners.
C. A lawsuit against the attending physician and/or the medical director.
D. A, B, and C.
E. Only A and B.

Answer: D. According to the Wall Street Journal, more than 1.4 million people live in U.S. nursing homes, 69% of which are run by for-profit entities.¹ In contrast to a malpractice complaint, lawsuits against nursing homes and SNFs typically involve allegations of a pattern of neglect and abuse rather than any single incident of negligence. The terms nursing home and SNF are often used interchangeably, but do differ somewhat in that the former deals with non-Medicare regulated custodial care, whereas Medicare regulates and certifies all SNFs, which provide both custodial and medical care. Federal and state statutes, e.g., 42 CFR §483 and Centers for Medicare and Medicaid Services guidelines in the State Operations Manual, prescribe the requisite standards. Collectively referred to as the OBRA standards, their violations are frequently at the heart of a plaintiff’s allegations. These may include short staffing, inattention to body hygiene, skin infections, pressure ulcers, improper use of restraints, poor nutrition and hydration, and failure to monitor or supervise, including failure to administer prescription medications and prevention of falls and violent acts from other residents.

In the past 2 decades, nursing homes and SNFs have experienced soaring numbers of lawsuits, with Texas and Florida being especially vulnerable.² Runaway jury verdicts can result even where the elderly victim has incurred little or no economic loss. Noneconomic losses such as pain and suffering as well as punitive damages explain these huge awards. A recent widely publicized case is illustrative: On Sept. 4, 2009, 87-year-old Dorothy Douglas, an Alzheimer’s patient, was admitted to Heartland Nursing Home in Charleston, W.Va. Still cognitive, she was able to ambulate with an assistive device and was well nourished. However, within 19 days of admission, she became barely responsive, dehydrated, and bedridden, and had fallen numerous times, injuring her head. She died shortly thereafter. Her son sued the owner of Heartland and those responsible for its operations, claiming, among other things, medical and corporate negligence. A jury found in his favor, awarding $11.5 million in compensatory damages and $80 million in punitive damages. On appeal, the West Virginia Supreme Court affirmed in part the trial court’s order, although it reduced the punitive damages from $80 million to $32 million (termed a remittitur).³

There are other sizable verdicts, such as a $29 million lawsuit against a Rocklin, Calif., facility in 2010. Another, possibly the largest on record, was a 2013 Florida jury award of $110 million in compensatory damages and $1.0 billion in punitive damages against Auburndale Oaks Healthcare Center. However, this may not have been the final negotiated amount. Increasingly popular is the use of class action lawsuits, where representative plaintiffs assert claims on behalf of a large class of similarly injured members. Typically, they allege grossly substandard care and understaffing in violation of Medicare and/or other statutory rules. New York’s first nursing home class action suit,⁴ which dragged on for some 9 years, ended up with a settlement sum of only $950,000 for its 22 class members. The suit alleged, among other things, inedible food, inadequate heat, and squalid conditions. A more recent example: In 2010, a Humboldt County, Calif., jury returned a $677 million verdict (Lavender v. Skilled Healthcare Group Inc.) against one of the nation’s largest nursing home chains for violating California’s Health and Safety Code in its 22 statewide facilities. The case later settled for $62.8 million on behalf of the 32,000 residents.

What about physician liability? Many doctors attend to SNF patients and a number act as medical directors. Liability exists in both roles. The first is governed by the usual tort action of malpractice. The latter is infinitely trickier. Medicare mandates all SNFs to have a medical director, and federal law [42 CFR 483.75 (i)] requires the medical director to be responsible for implementation of resident care policies and the coordination of medical care in the facility. Although their duties are administrative in nature, medical directors are not infrequently named as codefendants in SNF lawsuits. Allegations against the medical director may include negligent supervision of staff, and/or the failure to set standards, policies, and procedures, especially if they have been made aware of citations by auditing agencies. Because a doctor’s professional liability policy typically excludes coverage for such work, it behooves all medical directors to insist on being a named insured in the institution’s general liability policy (to include tail coverage), and to be informed in a timely fashion should there be a relevant change or cancellation of coverage. Their contract should stipulate that the facility would indemnify them for all lawsuits arising out of their work. More and more nursing homes are dropping their insurance to bypass legal exposure, leaving the attending physician and/or medical director at increased risk. To avoid a serious gap in coverage, medical directors should consider purchasing a specific medical director policy.⁵ Medical directors should also be aware of potential Stark Law violations, such as treating private patients without paying fair rent or receiving compensation in exchange for referrals.

Importantly, elder abuse judgments, as opposed to malpractice awards, may negate restrictions on attorney fees and noneconomic damages such as California’s $250,000 cap. The jury may also levy punitive damages, which are not covered by professional insurance. The plaintiff will need to prove, by clear and convincing evidence, something more than simple or gross negligence such as malice, fraud, oppression, or recklessness.⁶ Under California’s elder abuse and dependent Adult Civil Protection Act, an appellate court has held that a plaintiff may mount an elder abuse claim directed at physicians and not just facilities with “custodial” duties.⁷This important issue is currently under appeal before the California Supreme Court.

References

1. The Wall Street Journal, Oct. 3, 2014.

2. Stevenson, DG and DM Studdert, The Rise Of Nursing Home Litigation: Findings From A National Survey Of Attorneys. Health Affairs 2003; 22:219-29.

3. Manor Care Inc. v. Douglas, 763 N.E.2d 73 (W. Va. 2014).

4. Fleming v. Barnwell Nursing Hone and Health Facilities Inc., 309 A.D.2d 1132 (N.Y. App. Div. 2003).

5. See the American Medical Directors Association’s (AMDA) offering at http://locktonmedicalliabilityinsurance.com/amda/.

6. Delaney v. Baker, 20 Cal. 4th 23 (1999).

7. Winn v. Pioneer Medical Group Inc., 216 Cal. App. 4th 875 (2013).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs The St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: A patient who is a school bus driver is also an alcoholic, but he continues to drive despite his physician’s warning against drinking and driving. He already has had one prior driving under the influence (DUI) conviction. Fearing a potential vehicular accident with injuries to the schoolchildren, the physician, with permission, informed the patient’s wife of the situation; but that did not make a difference.

Under the circumstances, which of the following is best?

A. The physician has discharged his professional duty by warning the patient and informing his wife.

B. It is unethical for the physician to report this to the employer, because it violates the principle of confidentiality.

C. The physician may have an ethical and legal duty to report, because the risk of harm to the school children is foreseeable and outweighs other considerations.

D. A and B.

E. A and C.

Answer: C. The issue in this hypothetical revolves around the failure to warn and report when a doctor has determined that his or her patient poses a significant societal risk. It places the health care provider in a dilemma, because it pits patient confidentiality against the public interest in safety.

There does not appear to be an appellate case precisely on point, but the well known case of Tarasoff¹ offers useful insight.

In Tarasoff, a California court imposed a legal duty on a college psychologist to warn an intended victim of harm, even though that meant breaching confidentiality in a professional relationship. A jilted patient had confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, the girlfriend, whom the patient stabbed to death 2 months later.

The California court found the psychologist and the University of California (as the psychologist’s employer) liable, reasoning that the protection of public safety was more important than the sanctity of the doctor-patient confidentiality relationship.

The court wrote: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault. ... In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal.”

However, the duty to warn a third party may not be as clear cut where there is no readily identifiable victim.²

Further, the law is unsettled regarding a physician’s duty to report negligent conduct that poses a significant risk to public safety, e.g., where a patient insists on operating a vehicle against medical advice. Obviously, the doctor should spare no effort in trying to persuade such a patient to discontinue driving. When this fails, however, and depending on the circumstances, the physician should seriously consider breaching patent confidentiality by notifying the driving licensing bureau.

This opinion is in accord with the AMA Code of Medical Ethics: “Physicians should use their best judgment when determining when to report impairments that could limit a patient’s ability to drive safely. In situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the department of motor vehicles.”³

What about informing the patient’s employer if the risk of harm arises in the work setting?

The duty to report is clearer if the physician is a company doctor specifically charged with the task of determining whether an employee is fit for work. However, a patient’s personal physician may be a different matter, because he or she does not share the same contractual obligation as a company employed doctor.

Still, the circumstances may well dictate the need to report. In the hypothetical scenario posed above, the patient is refusing to heed the advice of physician and spouse, and given the history of a DUI, can be said to be placing innocent children and others at risk. The physician may need to go beyond warning the patient and wife, even though revealing a patient’s diagnosis violates the principle of confidentiality.

Arguably controversial, the physician’s justification is that there is a higher ethical and legal duty to report, as the risk of harm to the school children is both unreasonable and foreseeable, outweighing other considerations.

The same analysis concerning reporting may be applied in uncooperative patients with certain medical diagnoses (e.g., uncontrolled epilepsy, serious mental illness, or disabling cardiac or cerebrovascular disease, to name a few) and in those taking mind-altering prescription medications or illicit drugs.

A key inquiry is whether the patient’s work activity is potentially hazardous, as in those who are entrusted with public transportation, e.g., bus drivers, pilots and train/ship engineers, or those who operate heavy machinery.

The most familiar example of the failure to warn (as opposed to report) is of course in informed consent litigation, where the physician is faulted for not warning the patient of the risk of harm and the patient in fact suffers that harm. It is framed as the failure to disclose material risks. The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject the recommended medical procedure”; that “a (material) fact must also be one which is not commonly appreciated”; and the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures.”⁴ There is, however, no legal requirement to deliver a “mini-course in medical science.”⁵

Another situation where there may have been a failure to warn is in medical products liability. Here, the plaintiff alleges that the defective product has caused injuries because the manufacturer has issued no prior warning to the health care provider or end user. A prime example is the current Lipitor and diabetes class action lawsuit against Pfizer.

In failing to warn a patient, a doctor may incur liability not only for injuries to the patient but also to nonpatient third parties.

In a 2002 Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter.⁶ The driver alleged that the prescription medication prazosin caused him to develop hypotension and lose control of the car, and that the treating physician was negligent in failing to warn of this potential side effect.

The Hawaii Supreme Court held that physicians have a duty to their patients to warn of potential adverse effects, and this responsibility should therefore extend to third parties.

Court decisions elsewhere have also found liability where, for public policy reasons, a “special relationship” is deemed to exist between the doctor and the injured third party. Foreseeability is one important factor in construing its existence, notwithstanding the absence of the traditional doctor-patient relationship.

References

1. Tarasoff v. Regents of University of California, 551 P.2d 334 (Cal. 1976).

2. Furr v. Spring Grove State Hospital, 454 A.2d 414 (Md. 1983).

3. AMA Code of Medical Ethics [2.24 (3), 2012-2013 ed.].

4. Truman v. Thomas, 27 Cal.3d 285 (1980).

5. Cobbs v. Grant, 8 Cal.3d 229 (1972).

6. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: A patient who is a school bus driver is also an alcoholic, but he continues to drive despite his physician’s warning against drinking and driving. He already has had one prior driving under the influence (DUI) conviction. Fearing a potential vehicular accident with injuries to the schoolchildren, the physician, with permission, informed the patient’s wife of the situation; but that did not make a difference.

Under the circumstances, which of the following is best?

A. The physician has discharged his professional duty by warning the patient and informing his wife.

B. It is unethical for the physician to report this to the employer, because it violates the principle of confidentiality.

C. The physician may have an ethical and legal duty to report, because the risk of harm to the school children is foreseeable and outweighs other considerations.

D. A and B.

E. A and C.

Answer: C. The issue in this hypothetical revolves around the failure to warn and report when a doctor has determined that his or her patient poses a significant societal risk. It places the health care provider in a dilemma, because it pits patient confidentiality against the public interest in safety.

There does not appear to be an appellate case precisely on point, but the well known case of Tarasoff¹ offers useful insight.

In Tarasoff, a California court imposed a legal duty on a college psychologist to warn an intended victim of harm, even though that meant breaching confidentiality in a professional relationship. A jilted patient had confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, the girlfriend, whom the patient stabbed to death 2 months later.

The California court found the psychologist and the University of California (as the psychologist’s employer) liable, reasoning that the protection of public safety was more important than the sanctity of the doctor-patient confidentiality relationship.

The court wrote: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault. ... In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal.”

However, the duty to warn a third party may not be as clear cut where there is no readily identifiable victim.²

Further, the law is unsettled regarding a physician’s duty to report negligent conduct that poses a significant risk to public safety, e.g., where a patient insists on operating a vehicle against medical advice. Obviously, the doctor should spare no effort in trying to persuade such a patient to discontinue driving. When this fails, however, and depending on the circumstances, the physician should seriously consider breaching patent confidentiality by notifying the driving licensing bureau.

This opinion is in accord with the AMA Code of Medical Ethics: “Physicians should use their best judgment when determining when to report impairments that could limit a patient’s ability to drive safely. In situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the department of motor vehicles.”³

What about informing the patient’s employer if the risk of harm arises in the work setting?

The duty to report is clearer if the physician is a company doctor specifically charged with the task of determining whether an employee is fit for work. However, a patient’s personal physician may be a different matter, because he or she does not share the same contractual obligation as a company employed doctor.

Still, the circumstances may well dictate the need to report. In the hypothetical scenario posed above, the patient is refusing to heed the advice of physician and spouse, and given the history of a DUI, can be said to be placing innocent children and others at risk. The physician may need to go beyond warning the patient and wife, even though revealing a patient’s diagnosis violates the principle of confidentiality.

Arguably controversial, the physician’s justification is that there is a higher ethical and legal duty to report, as the risk of harm to the school children is both unreasonable and foreseeable, outweighing other considerations.

The same analysis concerning reporting may be applied in uncooperative patients with certain medical diagnoses (e.g., uncontrolled epilepsy, serious mental illness, or disabling cardiac or cerebrovascular disease, to name a few) and in those taking mind-altering prescription medications or illicit drugs.

A key inquiry is whether the patient’s work activity is potentially hazardous, as in those who are entrusted with public transportation, e.g., bus drivers, pilots and train/ship engineers, or those who operate heavy machinery.

The most familiar example of the failure to warn (as opposed to report) is of course in informed consent litigation, where the physician is faulted for not warning the patient of the risk of harm and the patient in fact suffers that harm. It is framed as the failure to disclose material risks. The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject the recommended medical procedure”; that “a (material) fact must also be one which is not commonly appreciated”; and the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures.”⁴ There is, however, no legal requirement to deliver a “mini-course in medical science.”⁵

Another situation where there may have been a failure to warn is in medical products liability. Here, the plaintiff alleges that the defective product has caused injuries because the manufacturer has issued no prior warning to the health care provider or end user. A prime example is the current Lipitor and diabetes class action lawsuit against Pfizer.

In failing to warn a patient, a doctor may incur liability not only for injuries to the patient but also to nonpatient third parties.

In a 2002 Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter.⁶ The driver alleged that the prescription medication prazosin caused him to develop hypotension and lose control of the car, and that the treating physician was negligent in failing to warn of this potential side effect.

The Hawaii Supreme Court held that physicians have a duty to their patients to warn of potential adverse effects, and this responsibility should therefore extend to third parties.

Court decisions elsewhere have also found liability where, for public policy reasons, a “special relationship” is deemed to exist between the doctor and the injured third party. Foreseeability is one important factor in construing its existence, notwithstanding the absence of the traditional doctor-patient relationship.

References

1. Tarasoff v. Regents of University of California, 551 P.2d 334 (Cal. 1976).

2. Furr v. Spring Grove State Hospital, 454 A.2d 414 (Md. 1983).

3. AMA Code of Medical Ethics [2.24 (3), 2012-2013 ed.].

4. Truman v. Thomas, 27 Cal.3d 285 (1980).

5. Cobbs v. Grant, 8 Cal.3d 229 (1972).

6. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: A patient who is a school bus driver is also an alcoholic, but he continues to drive despite his physician’s warning against drinking and driving. He already has had one prior driving under the influence (DUI) conviction. Fearing a potential vehicular accident with injuries to the schoolchildren, the physician, with permission, informed the patient’s wife of the situation; but that did not make a difference.

Under the circumstances, which of the following is best?

A. The physician has discharged his professional duty by warning the patient and informing his wife.

B. It is unethical for the physician to report this to the employer, because it violates the principle of confidentiality.

C. The physician may have an ethical and legal duty to report, because the risk of harm to the school children is foreseeable and outweighs other considerations.

D. A and B.

E. A and C.

Answer: C. The issue in this hypothetical revolves around the failure to warn and report when a doctor has determined that his or her patient poses a significant societal risk. It places the health care provider in a dilemma, because it pits patient confidentiality against the public interest in safety.

There does not appear to be an appellate case precisely on point, but the well known case of Tarasoff¹ offers useful insight.

In Tarasoff, a California court imposed a legal duty on a college psychologist to warn an intended victim of harm, even though that meant breaching confidentiality in a professional relationship. A jilted patient had confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, the girlfriend, whom the patient stabbed to death 2 months later.

The California court found the psychologist and the University of California (as the psychologist’s employer) liable, reasoning that the protection of public safety was more important than the sanctity of the doctor-patient confidentiality relationship.

The court wrote: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault. ... In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal.”

However, the duty to warn a third party may not be as clear cut where there is no readily identifiable victim.²

Further, the law is unsettled regarding a physician’s duty to report negligent conduct that poses a significant risk to public safety, e.g., where a patient insists on operating a vehicle against medical advice. Obviously, the doctor should spare no effort in trying to persuade such a patient to discontinue driving. When this fails, however, and depending on the circumstances, the physician should seriously consider breaching patent confidentiality by notifying the driving licensing bureau.

This opinion is in accord with the AMA Code of Medical Ethics: “Physicians should use their best judgment when determining when to report impairments that could limit a patient’s ability to drive safely. In situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the department of motor vehicles.”³

What about informing the patient’s employer if the risk of harm arises in the work setting?

The duty to report is clearer if the physician is a company doctor specifically charged with the task of determining whether an employee is fit for work. However, a patient’s personal physician may be a different matter, because he or she does not share the same contractual obligation as a company employed doctor.

Still, the circumstances may well dictate the need to report. In the hypothetical scenario posed above, the patient is refusing to heed the advice of physician and spouse, and given the history of a DUI, can be said to be placing innocent children and others at risk. The physician may need to go beyond warning the patient and wife, even though revealing a patient’s diagnosis violates the principle of confidentiality.

Arguably controversial, the physician’s justification is that there is a higher ethical and legal duty to report, as the risk of harm to the school children is both unreasonable and foreseeable, outweighing other considerations.

The same analysis concerning reporting may be applied in uncooperative patients with certain medical diagnoses (e.g., uncontrolled epilepsy, serious mental illness, or disabling cardiac or cerebrovascular disease, to name a few) and in those taking mind-altering prescription medications or illicit drugs.

A key inquiry is whether the patient’s work activity is potentially hazardous, as in those who are entrusted with public transportation, e.g., bus drivers, pilots and train/ship engineers, or those who operate heavy machinery.

The most familiar example of the failure to warn (as opposed to report) is of course in informed consent litigation, where the physician is faulted for not warning the patient of the risk of harm and the patient in fact suffers that harm. It is framed as the failure to disclose material risks. The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject the recommended medical procedure”; that “a (material) fact must also be one which is not commonly appreciated”; and the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures.”⁴ There is, however, no legal requirement to deliver a “mini-course in medical science.”⁵

Another situation where there may have been a failure to warn is in medical products liability. Here, the plaintiff alleges that the defective product has caused injuries because the manufacturer has issued no prior warning to the health care provider or end user. A prime example is the current Lipitor and diabetes class action lawsuit against Pfizer.

In failing to warn a patient, a doctor may incur liability not only for injuries to the patient but also to nonpatient third parties.

In a 2002 Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter.⁶ The driver alleged that the prescription medication prazosin caused him to develop hypotension and lose control of the car, and that the treating physician was negligent in failing to warn of this potential side effect.

The Hawaii Supreme Court held that physicians have a duty to their patients to warn of potential adverse effects, and this responsibility should therefore extend to third parties.

Court decisions elsewhere have also found liability where, for public policy reasons, a “special relationship” is deemed to exist between the doctor and the injured third party. Foreseeability is one important factor in construing its existence, notwithstanding the absence of the traditional doctor-patient relationship.

References

1. Tarasoff v. Regents of University of California, 551 P.2d 334 (Cal. 1976).

2. Furr v. Spring Grove State Hospital, 454 A.2d 414 (Md. 1983).

3. AMA Code of Medical Ethics [2.24 (3), 2012-2013 ed.].

4. Truman v. Thomas, 27 Cal.3d 285 (1980).

5. Cobbs v. Grant, 8 Cal.3d 229 (1972).

6. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: C, age 17 years, was diagnosed with Hodgkin’s lymphoma. According to her oncologists, chemotherapy would offer an 80% chance of cure, whereas death within 2 years was almost a certainty without treatment. C refused treatment, a decision supported by her mother. Under these facts, which of the following is best?

A. C has a constitutional right to forgo medical treatment.

B. C is a minor and needs parental consent regarding all medical intervention.

C. The mother’s refusal to give consent means the doctors have no recourse but to accept the joint decision of mother and daughter.

D. If C can show she is a mature minor or an emancipated minor, she can then decide for herself.

E. In life-and-death matters, the state has the authority to compel lifesaving beneficial treatment without prior judicial approval.

Answer: D. The above scenario raises the issue of doing what’s best when a minor refuses clearly beneficial medical treatment. It is taken from a very recent case wherein the Connecticut Supreme Court held that the state could force treatment in a minor with Hodgkin’s lymphoma. The patient, a 17-year-old teenager, knowingly and with full information, objected to receiving treatment, a decision supported by her mother. There was no finding of mental incompetence or deficiency in either mother or daughter. Can the daughter, against her will, be forced to receive treatment?

The teenager, known as Cassandra, was diagnosed with Hodgkin’s lymphoma, which her oncologists believed had an 80% chance of remission if treated with chemotherapy. Cassandra refused, a decision supported by her mother with whom she lives. Placed under the jurisdiction of Connecticut’s Department of Children and Families (DCF), she initially agreed to a trial of medication if the state allowed her to stay at home with her mother, but she ran away. The case is reminiscent of Billy Best, a 16-year-old diagnosed with Hodgkin’s disease in August 1994, who ran away from his Massachusetts home after 2½ months of chemotherapy because he felt the medicine was killing him instead of helping him.¹

In order to compel treatment, DCF had to obtain judicial approval, which the lower court granted notwithstanding arguments that forcing Cassandra to undergo unwanted medical treatment against her will violated her constitutional substantive due process rights. Also, as there was no competency hearing, so the litigants asserted that this was also a violation of her procedural due process rights. On appeal, the Supreme Court of Connecticut found that Cassandra was not a mature minor, and thus had no constitutional claim to the right of medical decision-making autonomy.² The Court unanimously ruled that the state could compel treatment. Its final opinion is yet to be published, but in its preliminary order, the Court wrote: “… Cassandra is suffering from Hodgkin’s lymphoma, a cancer that has a high rate of cure if treated and that will certainly kill Cassandra if not treated … Cassandra represented, under oath … that she would undergo treatment for her cancer if she were allowed to return home, and then was allowed to do so, she ran away from home and stopped treatment. Thus, … Cassandra either intentionally misrepresented her intentions to the trial court or she changed her mind on this issue of life and death. In either case, her conduct amply supports Judge Quinn’s finding that the respondents have failed to prove that Cassandra was a mature minor under any standard.”

Whereas all adults of sound mind are presumed to be competent to give informed consent, the doctor typically needs permission from the parents or guardian for a minor unless emancipated, i.e., conducting himself or herself as an adult and is no longer under the support or control of the parents. Another exception is the “mature minor,” a term used to describe the minor who is able to understand the nature and consequences of treatment. In 1987, the Tennessee Supreme Court was the first to recognize a mature minor exception to the common law rule that requires a physician to obtain parental consent.³ The issue there was whether Sandra, an alleged malpractice victim 5 months shy of her 18th birthday, was capable of giving consent for an osteopathic treatment. The court acknowledged that for well over a century, the common law recognized that minors achieved varying degrees of maturity and responsibility, and referenced the common law rule of capacity, known as “The Rule of Sevens.” The Rule presumes differing levels of capacity depending on whether the individual is less than 7 years old, between the ages of 7 and 14, or older than 14 years. The youngest group lacks capacity, but a rebuttable presumption of lack of capacity exists for children between the ages of 7 and 14, and one presuming capacity exists for children between the ages of 14 and 21. In Commonwealth jurisdictions, the term “Gillick competence” is used to describe a minor under the age of 16 years who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications, and consequences of treatment.

Two years later in a landmark case,⁴ the Illinois Supreme Court specifically recognized the right of some minors to refuse medical treatment. The litigant was a 17-year-old girl with leukemia who needed life-sustaining blood transfusions. Both the minor and her mother were Jehovah’s Witnesses, and withheld consent to the blood transfusion because of their religious beliefs. The Court opined that the age of majority, “is not an impenetrable barrier that magically precludes a minor from possessing and exercising certain rights normally associated with adulthood,” and that if clear and convincing evidence was presented regarding maturity, then the “mature minor doctrine affords [the minor] the common law right to consent to or refuse medical treatment.” The following year, the Maine Supreme Judicial Court held that a minor’s clear and convincing decision not to be maintained by life-sustaining procedures must be respected.⁵ In that instance, Chad, a minor just under 18, had lapsed into a persistent vegetative state following an auto accident.

Other court decisions favoring the minor abound.⁶ For example, a court held that a 14-year-old boy could decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one. On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

In addressing the right of mature minors to refuse life-sustaining treatment, the 1985 New York Task Force on Life and the Law acknowledged the need to balance “the developing rights of the minor and parental rights,” and society’s interest “in promoting the autonomy and well-being of minors.” The Task Force recognized that some minors have the maturity and capacity to participate in medical decisions, and recommended that the treating physician assess the minor’s maturity, conceptual ability and life’s experience in order for the minor to assume a substantial, though not exclusive, role in decisions to refuse life-sustaining treatment.

Notes

1. Joan-Margaret Kun, Rejecting the Adage Children Should Be Seen and Not Heard – The Mature Minor Doctrine, 16 Pace L. Rev. 423 (1996). Available at http://digitalcommons.pace.edu/plr/vol16/iss2/13.

2. In re Cassandra C., Supreme Court, State of Connecticut, No. 19426, Jan. 8, 2015.

3. Cardwell v. Bechtol, 724 S.W. 2d 739 (Tenn. 1987)

4. In re E.G., 549 N.E. 2d 322 (Ill. 1990).

5. In re Swan, 569 A. 2d 1202 (Me. 1990).

6. Weir RF and Peters C. Affirming the Decisions Adolescents Make about Life and Death. Hastings Center Report 1997; 27:29-40.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu, and currently directs the St. Francis International Center for Healthcare Ethics, also in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: C, age 17 years, was diagnosed with Hodgkin’s lymphoma. According to her oncologists, chemotherapy would offer an 80% chance of cure, whereas death within 2 years was almost a certainty without treatment. C refused treatment, a decision supported by her mother. Under these facts, which of the following is best?

A. C has a constitutional right to forgo medical treatment.

B. C is a minor and needs parental consent regarding all medical intervention.

C. The mother’s refusal to give consent means the doctors have no recourse but to accept the joint decision of mother and daughter.

D. If C can show she is a mature minor or an emancipated minor, she can then decide for herself.

E. In life-and-death matters, the state has the authority to compel lifesaving beneficial treatment without prior judicial approval.

Answer: D. The above scenario raises the issue of doing what’s best when a minor refuses clearly beneficial medical treatment. It is taken from a very recent case wherein the Connecticut Supreme Court held that the state could force treatment in a minor with Hodgkin’s lymphoma. The patient, a 17-year-old teenager, knowingly and with full information, objected to receiving treatment, a decision supported by her mother. There was no finding of mental incompetence or deficiency in either mother or daughter. Can the daughter, against her will, be forced to receive treatment?

The teenager, known as Cassandra, was diagnosed with Hodgkin’s lymphoma, which her oncologists believed had an 80% chance of remission if treated with chemotherapy. Cassandra refused, a decision supported by her mother with whom she lives. Placed under the jurisdiction of Connecticut’s Department of Children and Families (DCF), she initially agreed to a trial of medication if the state allowed her to stay at home with her mother, but she ran away. The case is reminiscent of Billy Best, a 16-year-old diagnosed with Hodgkin’s disease in August 1994, who ran away from his Massachusetts home after 2½ months of chemotherapy because he felt the medicine was killing him instead of helping him.¹

In order to compel treatment, DCF had to obtain judicial approval, which the lower court granted notwithstanding arguments that forcing Cassandra to undergo unwanted medical treatment against her will violated her constitutional substantive due process rights. Also, as there was no competency hearing, so the litigants asserted that this was also a violation of her procedural due process rights. On appeal, the Supreme Court of Connecticut found that Cassandra was not a mature minor, and thus had no constitutional claim to the right of medical decision-making autonomy.² The Court unanimously ruled that the state could compel treatment. Its final opinion is yet to be published, but in its preliminary order, the Court wrote: “… Cassandra is suffering from Hodgkin’s lymphoma, a cancer that has a high rate of cure if treated and that will certainly kill Cassandra if not treated … Cassandra represented, under oath … that she would undergo treatment for her cancer if she were allowed to return home, and then was allowed to do so, she ran away from home and stopped treatment. Thus, … Cassandra either intentionally misrepresented her intentions to the trial court or she changed her mind on this issue of life and death. In either case, her conduct amply supports Judge Quinn’s finding that the respondents have failed to prove that Cassandra was a mature minor under any standard.”

Whereas all adults of sound mind are presumed to be competent to give informed consent, the doctor typically needs permission from the parents or guardian for a minor unless emancipated, i.e., conducting himself or herself as an adult and is no longer under the support or control of the parents. Another exception is the “mature minor,” a term used to describe the minor who is able to understand the nature and consequences of treatment. In 1987, the Tennessee Supreme Court was the first to recognize a mature minor exception to the common law rule that requires a physician to obtain parental consent.³ The issue there was whether Sandra, an alleged malpractice victim 5 months shy of her 18th birthday, was capable of giving consent for an osteopathic treatment. The court acknowledged that for well over a century, the common law recognized that minors achieved varying degrees of maturity and responsibility, and referenced the common law rule of capacity, known as “The Rule of Sevens.” The Rule presumes differing levels of capacity depending on whether the individual is less than 7 years old, between the ages of 7 and 14, or older than 14 years. The youngest group lacks capacity, but a rebuttable presumption of lack of capacity exists for children between the ages of 7 and 14, and one presuming capacity exists for children between the ages of 14 and 21. In Commonwealth jurisdictions, the term “Gillick competence” is used to describe a minor under the age of 16 years who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications, and consequences of treatment.

Two years later in a landmark case,⁴ the Illinois Supreme Court specifically recognized the right of some minors to refuse medical treatment. The litigant was a 17-year-old girl with leukemia who needed life-sustaining blood transfusions. Both the minor and her mother were Jehovah’s Witnesses, and withheld consent to the blood transfusion because of their religious beliefs. The Court opined that the age of majority, “is not an impenetrable barrier that magically precludes a minor from possessing and exercising certain rights normally associated with adulthood,” and that if clear and convincing evidence was presented regarding maturity, then the “mature minor doctrine affords [the minor] the common law right to consent to or refuse medical treatment.” The following year, the Maine Supreme Judicial Court held that a minor’s clear and convincing decision not to be maintained by life-sustaining procedures must be respected.⁵ In that instance, Chad, a minor just under 18, had lapsed into a persistent vegetative state following an auto accident.

Other court decisions favoring the minor abound.⁶ For example, a court held that a 14-year-old boy could decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one. On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

In addressing the right of mature minors to refuse life-sustaining treatment, the 1985 New York Task Force on Life and the Law acknowledged the need to balance “the developing rights of the minor and parental rights,” and society’s interest “in promoting the autonomy and well-being of minors.” The Task Force recognized that some minors have the maturity and capacity to participate in medical decisions, and recommended that the treating physician assess the minor’s maturity, conceptual ability and life’s experience in order for the minor to assume a substantial, though not exclusive, role in decisions to refuse life-sustaining treatment.

Notes

1. Joan-Margaret Kun, Rejecting the Adage Children Should Be Seen and Not Heard – The Mature Minor Doctrine, 16 Pace L. Rev. 423 (1996). Available at http://digitalcommons.pace.edu/plr/vol16/iss2/13.

2. In re Cassandra C., Supreme Court, State of Connecticut, No. 19426, Jan. 8, 2015.

3. Cardwell v. Bechtol, 724 S.W. 2d 739 (Tenn. 1987)

4. In re E.G., 549 N.E. 2d 322 (Ill. 1990).

5. In re Swan, 569 A. 2d 1202 (Me. 1990).

6. Weir RF and Peters C. Affirming the Decisions Adolescents Make about Life and Death. Hastings Center Report 1997; 27:29-40.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu, and currently directs the St. Francis International Center for Healthcare Ethics, also in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: C, age 17 years, was diagnosed with Hodgkin’s lymphoma. According to her oncologists, chemotherapy would offer an 80% chance of cure, whereas death within 2 years was almost a certainty without treatment. C refused treatment, a decision supported by her mother. Under these facts, which of the following is best?

A. C has a constitutional right to forgo medical treatment.

B. C is a minor and needs parental consent regarding all medical intervention.

C. The mother’s refusal to give consent means the doctors have no recourse but to accept the joint decision of mother and daughter.

D. If C can show she is a mature minor or an emancipated minor, she can then decide for herself.

E. In life-and-death matters, the state has the authority to compel lifesaving beneficial treatment without prior judicial approval.

Answer: D. The above scenario raises the issue of doing what’s best when a minor refuses clearly beneficial medical treatment. It is taken from a very recent case wherein the Connecticut Supreme Court held that the state could force treatment in a minor with Hodgkin’s lymphoma. The patient, a 17-year-old teenager, knowingly and with full information, objected to receiving treatment, a decision supported by her mother. There was no finding of mental incompetence or deficiency in either mother or daughter. Can the daughter, against her will, be forced to receive treatment?

The teenager, known as Cassandra, was diagnosed with Hodgkin’s lymphoma, which her oncologists believed had an 80% chance of remission if treated with chemotherapy. Cassandra refused, a decision supported by her mother with whom she lives. Placed under the jurisdiction of Connecticut’s Department of Children and Families (DCF), she initially agreed to a trial of medication if the state allowed her to stay at home with her mother, but she ran away. The case is reminiscent of Billy Best, a 16-year-old diagnosed with Hodgkin’s disease in August 1994, who ran away from his Massachusetts home after 2½ months of chemotherapy because he felt the medicine was killing him instead of helping him.¹

In order to compel treatment, DCF had to obtain judicial approval, which the lower court granted notwithstanding arguments that forcing Cassandra to undergo unwanted medical treatment against her will violated her constitutional substantive due process rights. Also, as there was no competency hearing, so the litigants asserted that this was also a violation of her procedural due process rights. On appeal, the Supreme Court of Connecticut found that Cassandra was not a mature minor, and thus had no constitutional claim to the right of medical decision-making autonomy.² The Court unanimously ruled that the state could compel treatment. Its final opinion is yet to be published, but in its preliminary order, the Court wrote: “… Cassandra is suffering from Hodgkin’s lymphoma, a cancer that has a high rate of cure if treated and that will certainly kill Cassandra if not treated … Cassandra represented, under oath … that she would undergo treatment for her cancer if she were allowed to return home, and then was allowed to do so, she ran away from home and stopped treatment. Thus, … Cassandra either intentionally misrepresented her intentions to the trial court or she changed her mind on this issue of life and death. In either case, her conduct amply supports Judge Quinn’s finding that the respondents have failed to prove that Cassandra was a mature minor under any standard.”

Whereas all adults of sound mind are presumed to be competent to give informed consent, the doctor typically needs permission from the parents or guardian for a minor unless emancipated, i.e., conducting himself or herself as an adult and is no longer under the support or control of the parents. Another exception is the “mature minor,” a term used to describe the minor who is able to understand the nature and consequences of treatment. In 1987, the Tennessee Supreme Court was the first to recognize a mature minor exception to the common law rule that requires a physician to obtain parental consent.³ The issue there was whether Sandra, an alleged malpractice victim 5 months shy of her 18th birthday, was capable of giving consent for an osteopathic treatment. The court acknowledged that for well over a century, the common law recognized that minors achieved varying degrees of maturity and responsibility, and referenced the common law rule of capacity, known as “The Rule of Sevens.” The Rule presumes differing levels of capacity depending on whether the individual is less than 7 years old, between the ages of 7 and 14, or older than 14 years. The youngest group lacks capacity, but a rebuttable presumption of lack of capacity exists for children between the ages of 7 and 14, and one presuming capacity exists for children between the ages of 14 and 21. In Commonwealth jurisdictions, the term “Gillick competence” is used to describe a minor under the age of 16 years who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications, and consequences of treatment.

Two years later in a landmark case,⁴ the Illinois Supreme Court specifically recognized the right of some minors to refuse medical treatment. The litigant was a 17-year-old girl with leukemia who needed life-sustaining blood transfusions. Both the minor and her mother were Jehovah’s Witnesses, and withheld consent to the blood transfusion because of their religious beliefs. The Court opined that the age of majority, “is not an impenetrable barrier that magically precludes a minor from possessing and exercising certain rights normally associated with adulthood,” and that if clear and convincing evidence was presented regarding maturity, then the “mature minor doctrine affords [the minor] the common law right to consent to or refuse medical treatment.” The following year, the Maine Supreme Judicial Court held that a minor’s clear and convincing decision not to be maintained by life-sustaining procedures must be respected.⁵ In that instance, Chad, a minor just under 18, had lapsed into a persistent vegetative state following an auto accident.

Other court decisions favoring the minor abound.⁶ For example, a court held that a 14-year-old boy could decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one. On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

In addressing the right of mature minors to refuse life-sustaining treatment, the 1985 New York Task Force on Life and the Law acknowledged the need to balance “the developing rights of the minor and parental rights,” and society’s interest “in promoting the autonomy and well-being of minors.” The Task Force recognized that some minors have the maturity and capacity to participate in medical decisions, and recommended that the treating physician assess the minor’s maturity, conceptual ability and life’s experience in order for the minor to assume a substantial, though not exclusive, role in decisions to refuse life-sustaining treatment.

Notes

1. Joan-Margaret Kun, Rejecting the Adage Children Should Be Seen and Not Heard – The Mature Minor Doctrine, 16 Pace L. Rev. 423 (1996). Available at http://digitalcommons.pace.edu/plr/vol16/iss2/13.

2. In re Cassandra C., Supreme Court, State of Connecticut, No. 19426, Jan. 8, 2015.

3. Cardwell v. Bechtol, 724 S.W. 2d 739 (Tenn. 1987)

4. In re E.G., 549 N.E. 2d 322 (Ill. 1990).

5. In re Swan, 569 A. 2d 1202 (Me. 1990).

6. Weir RF and Peters C. Affirming the Decisions Adolescents Make about Life and Death. Hastings Center Report 1997; 27:29-40.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu, and currently directs the St. Francis International Center for Healthcare Ethics, also in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Developments in medical tort reform include:

A. Continued constitutional challenges to caps on damages.

B. An emphasis on patient safety.

C. Hillary Clinton’s Senate bill.

D. Linking medical tort reform to error reduction.

E. All of the above.

Answer: E. Recent years have witnessed a stabilizing environment for medical liability, although insurance premiums continue to vary greatly by specialty and geographic location.

Recent statistics from the American Medical Association show that 2014 ob.gyn. insurance rates range from less than $50,000 in some areas of California to a high of $215,000 in Nassau and Suffolk counties in New York. The highest average expense in 2013, around a quarter of a million dollars, was for those claims that resulted in plaintiff verdicts, while defendant verdicts were substantially lower and averaged $140,000.

As in the past, most claims were dropped, dismissed, or withdrawn. About one-quarter of claims were settled, with only 2% decided by an alternative dispute resolution. Less than 8% were decided by trial verdict, with the vast majority won by the defendant.

The plaintiff bar continues to mount constitutional challenges to caps on damages. The California Supreme Court had previously ruled that reforms under California’s historic Medical Injury Compensation Reform Act (MICRA)¹, which limits noneconomic recovery to $250,000, are constitutional, because they are rationally related to the legitimate legislative goal of reducing medical costs.

However, the statute has again come under challenge, only to be reaffirmed by a California state appeals court. In November 2014, California voters rejected Proposition 46, which sought to increase the cap from $250,000 to $1.1 million.

Texas, another pro-reform state, sides with California, and Mississippi also ruled that its damage cap is constitutional. However, Florida and Oklahoma recently joined jurisdictions such as Georgia, Illinois, and Missouri in ruling that damage caps are unconstitutional.

Asserting that the current health care liability system has been an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice, then-U.S. senators Hillary Clinton (D-N.Y.) and Barack Obama (D-Ill.) in 2005 jointly sponsored legislation (S. 1784) to establish a National Medical Error Disclosure and Compensation Program (National MEDiC Act). Although the bill was killed in Senate committee, its key provisions were subsequently published in the New England Journal of Medicine (2006;354:2205-8).

The senators noted that the liability system has failed to the extent that only one medical malpractice claim is filed for every eight medical injuries, that it takes 4-8 years to resolve a claim, and that “solutions to the patient safety, litigation, and medical liability insurance problems have been elusive.”

Accordingly, the bill’s purpose was to promote the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, there would be negotiations for compensation and proposals to prevent a recurrence of the problem that led to the patient’s injury. However, the patient would retain the right to counsel during negotiations, as well as access to the courts if no agreement were reached. The bill was entirely silent on traditional tort reform measures.

Nearly 4 decades earlier, a no-fault proposal by Professor Jeffrey O’Connell made some of these points, but with sharper focus and specificity, especially regarding damages.²

In marked contrast to the Clinton-Obama bill, his proposal gave the medical provider the exclusive option to tender payment, which would completely foreclose future tort action by the victim. Compensation benefits included net economic loss such as 100% of lost wages, replacement service loss, medical treatment expenses, and reasonable attorney’s fees. But noneconomic losses, such as pain and suffering, were not reimbursable, and payment was net of any benefits from collateral sources.

This proposal elegantly combined efficiency and fairness, and would have ameliorated the financial and emotional toll that comes with litigating injuries arising out of health care. Legislation in the House of Representatives, the Alternative Medical Liability Act (H.R. 5400), incorporated many of these features, and came before the 98th U.S. Congress in 1984. It, too, died in committee.

There may be something to the current trend toward pairing tort reform with error reduction. Thoughtful observers point to “disclosure and offer” programs such as the one at the Lexington (Ky.) Veterans Affairs Medical Center, which boasts average settlements of approximately $15,000 per claim – compared with more than $98,000 at other VA institutions. Its policy has also decreased the average duration of cases, previously 2-4 years, to 2-4 months, as well as reduced costs for legal defense.

Likewise, the program at the University of Michigan Health System has reduced both the frequency and severity of claims, duration of cases, and litigation costs. Aware of these developments, some private insurers, such as the COPIC Insurance Company in Colorado, are adopting a similar approach.

In its updated 2014 tort reform position paper, the American College of Physicians continues to endorse caps on noneconomic and punitive damages, as well as other tort reform measures.

However, it now acknowledges that “improving patient safety and preventing errors must be at the fore of the medical liability reform discussion.” The ACP correctly asserts that “emphasizing patient safety, promoting a culture of quality improvement and coordinated care, and training physicians in best practices to avoid errors and reduce risk will prevent harm and reduce the waste associated with defensive medicine.”

This hybrid approach combining traditional tort reforms with a renewed attention to patient safety through medical error reduction may yet yield additional practical benefits.

Here, the experience in anesthesiology bears recounting: Its dramatic progress in risk management has cut patient death rate from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of 20 years, and this has been associated with a concurrent 37% fall in insurance premiums.

References

1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).

2. O’Connell, J. No-Fault Insurance for Injuries Arising from Medical Treatment: A Proposal for Elective Coverage. Emory L. J. 1975;24:21.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. Currently, he directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Developments in medical tort reform include:

A. Continued constitutional challenges to caps on damages.

B. An emphasis on patient safety.

C. Hillary Clinton’s Senate bill.

D. Linking medical tort reform to error reduction.

E. All of the above.

Answer: E. Recent years have witnessed a stabilizing environment for medical liability, although insurance premiums continue to vary greatly by specialty and geographic location.

Recent statistics from the American Medical Association show that 2014 ob.gyn. insurance rates range from less than $50,000 in some areas of California to a high of $215,000 in Nassau and Suffolk counties in New York. The highest average expense in 2013, around a quarter of a million dollars, was for those claims that resulted in plaintiff verdicts, while defendant verdicts were substantially lower and averaged $140,000.

As in the past, most claims were dropped, dismissed, or withdrawn. About one-quarter of claims were settled, with only 2% decided by an alternative dispute resolution. Less than 8% were decided by trial verdict, with the vast majority won by the defendant.

The plaintiff bar continues to mount constitutional challenges to caps on damages. The California Supreme Court had previously ruled that reforms under California’s historic Medical Injury Compensation Reform Act (MICRA)¹, which limits noneconomic recovery to $250,000, are constitutional, because they are rationally related to the legitimate legislative goal of reducing medical costs.

However, the statute has again come under challenge, only to be reaffirmed by a California state appeals court. In November 2014, California voters rejected Proposition 46, which sought to increase the cap from $250,000 to $1.1 million.

Texas, another pro-reform state, sides with California, and Mississippi also ruled that its damage cap is constitutional. However, Florida and Oklahoma recently joined jurisdictions such as Georgia, Illinois, and Missouri in ruling that damage caps are unconstitutional.

Asserting that the current health care liability system has been an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice, then-U.S. senators Hillary Clinton (D-N.Y.) and Barack Obama (D-Ill.) in 2005 jointly sponsored legislation (S. 1784) to establish a National Medical Error Disclosure and Compensation Program (National MEDiC Act). Although the bill was killed in Senate committee, its key provisions were subsequently published in the New England Journal of Medicine (2006;354:2205-8).

The senators noted that the liability system has failed to the extent that only one medical malpractice claim is filed for every eight medical injuries, that it takes 4-8 years to resolve a claim, and that “solutions to the patient safety, litigation, and medical liability insurance problems have been elusive.”

Accordingly, the bill’s purpose was to promote the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, there would be negotiations for compensation and proposals to prevent a recurrence of the problem that led to the patient’s injury. However, the patient would retain the right to counsel during negotiations, as well as access to the courts if no agreement were reached. The bill was entirely silent on traditional tort reform measures.

Nearly 4 decades earlier, a no-fault proposal by Professor Jeffrey O’Connell made some of these points, but with sharper focus and specificity, especially regarding damages.²

In marked contrast to the Clinton-Obama bill, his proposal gave the medical provider the exclusive option to tender payment, which would completely foreclose future tort action by the victim. Compensation benefits included net economic loss such as 100% of lost wages, replacement service loss, medical treatment expenses, and reasonable attorney’s fees. But noneconomic losses, such as pain and suffering, were not reimbursable, and payment was net of any benefits from collateral sources.

This proposal elegantly combined efficiency and fairness, and would have ameliorated the financial and emotional toll that comes with litigating injuries arising out of health care. Legislation in the House of Representatives, the Alternative Medical Liability Act (H.R. 5400), incorporated many of these features, and came before the 98th U.S. Congress in 1984. It, too, died in committee.

There may be something to the current trend toward pairing tort reform with error reduction. Thoughtful observers point to “disclosure and offer” programs such as the one at the Lexington (Ky.) Veterans Affairs Medical Center, which boasts average settlements of approximately $15,000 per claim – compared with more than $98,000 at other VA institutions. Its policy has also decreased the average duration of cases, previously 2-4 years, to 2-4 months, as well as reduced costs for legal defense.

Likewise, the program at the University of Michigan Health System has reduced both the frequency and severity of claims, duration of cases, and litigation costs. Aware of these developments, some private insurers, such as the COPIC Insurance Company in Colorado, are adopting a similar approach.

In its updated 2014 tort reform position paper, the American College of Physicians continues to endorse caps on noneconomic and punitive damages, as well as other tort reform measures.

However, it now acknowledges that “improving patient safety and preventing errors must be at the fore of the medical liability reform discussion.” The ACP correctly asserts that “emphasizing patient safety, promoting a culture of quality improvement and coordinated care, and training physicians in best practices to avoid errors and reduce risk will prevent harm and reduce the waste associated with defensive medicine.”

This hybrid approach combining traditional tort reforms with a renewed attention to patient safety through medical error reduction may yet yield additional practical benefits.

Here, the experience in anesthesiology bears recounting: Its dramatic progress in risk management has cut patient death rate from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of 20 years, and this has been associated with a concurrent 37% fall in insurance premiums.

References

1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).

2. O’Connell, J. No-Fault Insurance for Injuries Arising from Medical Treatment: A Proposal for Elective Coverage. Emory L. J. 1975;24:21.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. Currently, he directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Developments in medical tort reform include:

A. Continued constitutional challenges to caps on damages.

B. An emphasis on patient safety.

C. Hillary Clinton’s Senate bill.

D. Linking medical tort reform to error reduction.

E. All of the above.

Answer: E. Recent years have witnessed a stabilizing environment for medical liability, although insurance premiums continue to vary greatly by specialty and geographic location.

Recent statistics from the American Medical Association show that 2014 ob.gyn. insurance rates range from less than $50,000 in some areas of California to a high of $215,000 in Nassau and Suffolk counties in New York. The highest average expense in 2013, around a quarter of a million dollars, was for those claims that resulted in plaintiff verdicts, while defendant verdicts were substantially lower and averaged $140,000.

As in the past, most claims were dropped, dismissed, or withdrawn. About one-quarter of claims were settled, with only 2% decided by an alternative dispute resolution. Less than 8% were decided by trial verdict, with the vast majority won by the defendant.

The plaintiff bar continues to mount constitutional challenges to caps on damages. The California Supreme Court had previously ruled that reforms under California’s historic Medical Injury Compensation Reform Act (MICRA)¹, which limits noneconomic recovery to $250,000, are constitutional, because they are rationally related to the legitimate legislative goal of reducing medical costs.

However, the statute has again come under challenge, only to be reaffirmed by a California state appeals court. In November 2014, California voters rejected Proposition 46, which sought to increase the cap from $250,000 to $1.1 million.

Texas, another pro-reform state, sides with California, and Mississippi also ruled that its damage cap is constitutional. However, Florida and Oklahoma recently joined jurisdictions such as Georgia, Illinois, and Missouri in ruling that damage caps are unconstitutional.

Asserting that the current health care liability system has been an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice, then-U.S. senators Hillary Clinton (D-N.Y.) and Barack Obama (D-Ill.) in 2005 jointly sponsored legislation (S. 1784) to establish a National Medical Error Disclosure and Compensation Program (National MEDiC Act). Although the bill was killed in Senate committee, its key provisions were subsequently published in the New England Journal of Medicine (2006;354:2205-8).

The senators noted that the liability system has failed to the extent that only one medical malpractice claim is filed for every eight medical injuries, that it takes 4-8 years to resolve a claim, and that “solutions to the patient safety, litigation, and medical liability insurance problems have been elusive.”

Accordingly, the bill’s purpose was to promote the confidential disclosure to patients of medical errors in an effort to improve patient-safety systems. At the time of disclosure, there would be negotiations for compensation and proposals to prevent a recurrence of the problem that led to the patient’s injury. However, the patient would retain the right to counsel during negotiations, as well as access to the courts if no agreement were reached. The bill was entirely silent on traditional tort reform measures.

Nearly 4 decades earlier, a no-fault proposal by Professor Jeffrey O’Connell made some of these points, but with sharper focus and specificity, especially regarding damages.²

In marked contrast to the Clinton-Obama bill, his proposal gave the medical provider the exclusive option to tender payment, which would completely foreclose future tort action by the victim. Compensation benefits included net economic loss such as 100% of lost wages, replacement service loss, medical treatment expenses, and reasonable attorney’s fees. But noneconomic losses, such as pain and suffering, were not reimbursable, and payment was net of any benefits from collateral sources.

This proposal elegantly combined efficiency and fairness, and would have ameliorated the financial and emotional toll that comes with litigating injuries arising out of health care. Legislation in the House of Representatives, the Alternative Medical Liability Act (H.R. 5400), incorporated many of these features, and came before the 98th U.S. Congress in 1984. It, too, died in committee.

There may be something to the current trend toward pairing tort reform with error reduction. Thoughtful observers point to “disclosure and offer” programs such as the one at the Lexington (Ky.) Veterans Affairs Medical Center, which boasts average settlements of approximately $15,000 per claim – compared with more than $98,000 at other VA institutions. Its policy has also decreased the average duration of cases, previously 2-4 years, to 2-4 months, as well as reduced costs for legal defense.

Likewise, the program at the University of Michigan Health System has reduced both the frequency and severity of claims, duration of cases, and litigation costs. Aware of these developments, some private insurers, such as the COPIC Insurance Company in Colorado, are adopting a similar approach.

In its updated 2014 tort reform position paper, the American College of Physicians continues to endorse caps on noneconomic and punitive damages, as well as other tort reform measures.

However, it now acknowledges that “improving patient safety and preventing errors must be at the fore of the medical liability reform discussion.” The ACP correctly asserts that “emphasizing patient safety, promoting a culture of quality improvement and coordinated care, and training physicians in best practices to avoid errors and reduce risk will prevent harm and reduce the waste associated with defensive medicine.”

This hybrid approach combining traditional tort reforms with a renewed attention to patient safety through medical error reduction may yet yield additional practical benefits.

Here, the experience in anesthesiology bears recounting: Its dramatic progress in risk management has cut patient death rate from 1 in 5,000 to 1 in 200,000 to 300,000 in the space of 20 years, and this has been associated with a concurrent 37% fall in insurance premiums.

References

1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).

2. O’Connell, J. No-Fault Insurance for Injuries Arising from Medical Treatment: A Proposal for Elective Coverage. Emory L. J. 1975;24:21.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. Currently, he directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Charges of homicide have been successfully brought against doctors in the following situations except:

A. Withholding life-sustaining treatment.

B. Euthanasia.

C. Negligent treatment of a patient.

D. Overprescription of controlled substances.

Answer: A. Homicideis any act that causes the death of a human being with criminal intent and without legal justification. It comprises several crimes of varying severity, with murder being the most serious (requiring “malice aforethought”). Depending on the intent of the perpetrator and/or the presence of mitigating/aggravating circumstances, jurisdictions have subdivided homicide into categories such as first- and second-degree murder, voluntary and involuntary manslaughter, negligent homicide, and others.

Discontinuing futile medical treatment that ends with patient demise raises the specter of criminal prosecution for homicide. However, prosecution of doctors under such circumstances has failed. The seminal case is Barber v. Superior Court (147 Cal. App. 3d 1006 (1983)), in which the state of California brought murder charges against two doctors for discontinuing intravenous fluids and nutrition in a comatose patient.

The patient, a 55-year-old security guard, sustained a cardiopulmonary arrest following surgery for intestinal obstruction. Irreversible brain damage resulted, leaving him in a vegetative state. His family allegedly requested that life support measures and intravenous fluids be discontinued, to which the doctors complied, and the patient died 6 days later.

After a preliminary pretrial hearing, the magistrate dismissed the charges; but a trial court reinstated them. The court of appeals, however, viewed the defendant’s conduct in discontinuing intravenous fluids as an omission rather than an affirmative action, and found that a physician has no duty to continue treatment once it is proven to be ineffective.

The appeals court recognized that “a physician is authorized under the standards of medical practice to discontinue a form of therapy which in his medical judgment is useless. … If the treating physicians have determined that continued use of a respirator is useless, then they may decide to discontinue it without fear of civil or criminal liability.”

In rejecting the distinction between ordinary and extraordinary care, the court dismissed the prosecutor’s contention that unlike the respirator, fluids and nutrition represented ordinary care and therefore should never be withheld.

It concluded that “the petitioners’ omission to continue treatment under the circumstances, though intentional and with knowledge that the patient would die, was not an unlawful failure to perform a legal duty.” And because no criminal liability attaches for failure to act (i.e., an omission) unless there is a legal duty to act affirmatively, it issued a writ of prohibition restraining the lower court from taking any further action on the matter.

The U.S. Supreme Court has since validated the distinction between “letting die” and an affirmative action taken with the intention to cause death, such as the administration of a lethal injection. The former is ethical and legal, conforming to medical norms, while the latter amounts to murder (Vacco v. Quill (117 S. Ct. 2293 (1997)).

With these developments, physicians therefore need not worry about criminal prosecution for carrying out Barber-like noneuthanasia, end-of-life actions that result in the death of their patients.

On the other hand, those who act directly to end the life of a patient, even one who freely requests death, may face criminal prosecution.

The most notorious example is that of retired Michigan pathologist Dr. Jack Kevorkian, who was found guilty of the second-degree murder of Thomas Youk, a 52-year-old race-car driver with terminal Lou Gehrig’s disease. Dr. Kevorkian injected a lethal mixture of Seconal, Anectine, and potassium chloride to end the patient’s life.

At trial, Dr. Kevorkian dismissed his lawyer and served ineffectively in his own defense, never taking the witness stand. Found guilty by a jury and sentenced to 10-25 years in prison, he served just more than 8 years until 2007, when he was released for good behavior. Previous charges by the state of Michigan against Dr. Kevorkian for assisting in the suicide of some 130 patients had proven unsuccessful.

This case spawned a nationwide debate on physician-directed deaths, with a few states now legalizing physician-assisted suicide, although euthanasia remains illegal throughout the nation.

In general, the remedy sought in a medical wrongful death case lies in a malpractice civil lawsuit against the negligent doctor. Sometimes, the plaintiff may assert that there was gross negligence where the conduct was particularly blameworthy, and if proven, the jury may award punitive damages.

Rarely, however, does the level of misconduct rise to that of criminal negligence. Here, the burden of proof for a conviction requires evidence beyond reasonable doubt, rather than the lower “more probable than not” evidentiary standard required in a civil lawsuit.

However, in cases where the physician’s conduct has markedly deviated from the standard of care, doctors have been successfully prosecuted for their “criminal” conduct.

For example, in an English case, an anesthesiologist was convicted of manslaughter in the death of a patient undergoing surgery for a detached retina. During surgery, the patient’s ventilation was interrupted because of accidental disconnection of the endotracheal tube for 4 minutes, leading to a cardiac arrest. An alarm had apparently sounded but was not noticed. The injury would not have occurred had the doctor attended to the patient instead of being away from the operating room.

The tragic death of pop star Michael Jackson in 2009 is another example. Dr. Conrad Murray, a cardiologist who was Jackson’s personal physician, had used the surgical anesthetic propofol to treat Jackson’s insomnia in a bedroom setting without monitoring or resuscitation equipment. Concurrent use of the sedative lorazepam exacerbated the effect of propofol. The prosecution characterized Dr. Murray’s conduct as “egregious, unethical, and unconscionable,” which violated medical standards and amounted to criminal negligence. He was found guilty of involuntary manslaughter, and the state sentenced him to a 4-year prison term.

A new trend appears to be developing toward prosecuting doctors whose overprescription of controlled substances results in patient deaths.

According to a recent news report, New York for the first time convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and Xanax.¹ Some of the patients were reportedly prescribed as many as 500-800 pills over a 5-6 week period. Dr. Stan Li, an anesthesiologist and pain management specialist, allegedly saw up to 90 patients a day in his Queens, N.Y., weekend storefront clinic, charging them on a per-prescription basis. In his defense, Dr. Li claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).

Meanwhile, a similar scenario played out in Oklahoma.² There, Dr. William Valuck, a pain management doctor, pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths. He entered into a plea bargain with Oklahoma prosecutors and will serve 8 years in prison. Dr. Valuck had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma, which included hydrocodone, oxycodone, alprazolam, Valium, and Soma, sometimes as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.

Most physicians are unlikely to ever face the specter of criminal prosecution based on their medical performance. Only in the most egregious of circumstances have physicians been successfully prosecuted for homicide.

As requests for physicians to withhold or withdraw life-sustaining treatments grow, physicians may find themselves questioning what acts or omissions they may legally perform. Unless the legal landscape changes, however, it appears that the forgoing of life-sustaining treatments in the typical clinical context will not subject physicians to criminal prosecution.

References

1. “NY doctor convicted of manslaughter in 2 overdoses,” July 18, 2014 (http://bigstory.ap.org/article/ny-doctor-convicted-2-patients-overdose-deaths).

2. “Ex-doctor pleads guilty in overdose deaths,” Aug. 13, 2014 (www.usatoday.com/story/news/nation/2014/08/13/ex-doctor-guilty-deaths/14022735).

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Charges of homicide have been successfully brought against doctors in the following situations except:

A. Withholding life-sustaining treatment.

B. Euthanasia.

C. Negligent treatment of a patient.

D. Overprescription of controlled substances.

Answer: A. Homicideis any act that causes the death of a human being with criminal intent and without legal justification. It comprises several crimes of varying severity, with murder being the most serious (requiring “malice aforethought”). Depending on the intent of the perpetrator and/or the presence of mitigating/aggravating circumstances, jurisdictions have subdivided homicide into categories such as first- and second-degree murder, voluntary and involuntary manslaughter, negligent homicide, and others.

Discontinuing futile medical treatment that ends with patient demise raises the specter of criminal prosecution for homicide. However, prosecution of doctors under such circumstances has failed. The seminal case is Barber v. Superior Court (147 Cal. App. 3d 1006 (1983)), in which the state of California brought murder charges against two doctors for discontinuing intravenous fluids and nutrition in a comatose patient.

The patient, a 55-year-old security guard, sustained a cardiopulmonary arrest following surgery for intestinal obstruction. Irreversible brain damage resulted, leaving him in a vegetative state. His family allegedly requested that life support measures and intravenous fluids be discontinued, to which the doctors complied, and the patient died 6 days later.

After a preliminary pretrial hearing, the magistrate dismissed the charges; but a trial court reinstated them. The court of appeals, however, viewed the defendant’s conduct in discontinuing intravenous fluids as an omission rather than an affirmative action, and found that a physician has no duty to continue treatment once it is proven to be ineffective.

The appeals court recognized that “a physician is authorized under the standards of medical practice to discontinue a form of therapy which in his medical judgment is useless. … If the treating physicians have determined that continued use of a respirator is useless, then they may decide to discontinue it without fear of civil or criminal liability.”

In rejecting the distinction between ordinary and extraordinary care, the court dismissed the prosecutor’s contention that unlike the respirator, fluids and nutrition represented ordinary care and therefore should never be withheld.

It concluded that “the petitioners’ omission to continue treatment under the circumstances, though intentional and with knowledge that the patient would die, was not an unlawful failure to perform a legal duty.” And because no criminal liability attaches for failure to act (i.e., an omission) unless there is a legal duty to act affirmatively, it issued a writ of prohibition restraining the lower court from taking any further action on the matter.

The U.S. Supreme Court has since validated the distinction between “letting die” and an affirmative action taken with the intention to cause death, such as the administration of a lethal injection. The former is ethical and legal, conforming to medical norms, while the latter amounts to murder (Vacco v. Quill (117 S. Ct. 2293 (1997)).

With these developments, physicians therefore need not worry about criminal prosecution for carrying out Barber-like noneuthanasia, end-of-life actions that result in the death of their patients.

On the other hand, those who act directly to end the life of a patient, even one who freely requests death, may face criminal prosecution.

The most notorious example is that of retired Michigan pathologist Dr. Jack Kevorkian, who was found guilty of the second-degree murder of Thomas Youk, a 52-year-old race-car driver with terminal Lou Gehrig’s disease. Dr. Kevorkian injected a lethal mixture of Seconal, Anectine, and potassium chloride to end the patient’s life.

At trial, Dr. Kevorkian dismissed his lawyer and served ineffectively in his own defense, never taking the witness stand. Found guilty by a jury and sentenced to 10-25 years in prison, he served just more than 8 years until 2007, when he was released for good behavior. Previous charges by the state of Michigan against Dr. Kevorkian for assisting in the suicide of some 130 patients had proven unsuccessful.

This case spawned a nationwide debate on physician-directed deaths, with a few states now legalizing physician-assisted suicide, although euthanasia remains illegal throughout the nation.

In general, the remedy sought in a medical wrongful death case lies in a malpractice civil lawsuit against the negligent doctor. Sometimes, the plaintiff may assert that there was gross negligence where the conduct was particularly blameworthy, and if proven, the jury may award punitive damages.

Rarely, however, does the level of misconduct rise to that of criminal negligence. Here, the burden of proof for a conviction requires evidence beyond reasonable doubt, rather than the lower “more probable than not” evidentiary standard required in a civil lawsuit.

However, in cases where the physician’s conduct has markedly deviated from the standard of care, doctors have been successfully prosecuted for their “criminal” conduct.

For example, in an English case, an anesthesiologist was convicted of manslaughter in the death of a patient undergoing surgery for a detached retina. During surgery, the patient’s ventilation was interrupted because of accidental disconnection of the endotracheal tube for 4 minutes, leading to a cardiac arrest. An alarm had apparently sounded but was not noticed. The injury would not have occurred had the doctor attended to the patient instead of being away from the operating room.

The tragic death of pop star Michael Jackson in 2009 is another example. Dr. Conrad Murray, a cardiologist who was Jackson’s personal physician, had used the surgical anesthetic propofol to treat Jackson’s insomnia in a bedroom setting without monitoring or resuscitation equipment. Concurrent use of the sedative lorazepam exacerbated the effect of propofol. The prosecution characterized Dr. Murray’s conduct as “egregious, unethical, and unconscionable,” which violated medical standards and amounted to criminal negligence. He was found guilty of involuntary manslaughter, and the state sentenced him to a 4-year prison term.

A new trend appears to be developing toward prosecuting doctors whose overprescription of controlled substances results in patient deaths.

According to a recent news report, New York for the first time convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and Xanax.¹ Some of the patients were reportedly prescribed as many as 500-800 pills over a 5-6 week period. Dr. Stan Li, an anesthesiologist and pain management specialist, allegedly saw up to 90 patients a day in his Queens, N.Y., weekend storefront clinic, charging them on a per-prescription basis. In his defense, Dr. Li claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).

Meanwhile, a similar scenario played out in Oklahoma.² There, Dr. William Valuck, a pain management doctor, pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths. He entered into a plea bargain with Oklahoma prosecutors and will serve 8 years in prison. Dr. Valuck had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma, which included hydrocodone, oxycodone, alprazolam, Valium, and Soma, sometimes as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.

Most physicians are unlikely to ever face the specter of criminal prosecution based on their medical performance. Only in the most egregious of circumstances have physicians been successfully prosecuted for homicide.

As requests for physicians to withhold or withdraw life-sustaining treatments grow, physicians may find themselves questioning what acts or omissions they may legally perform. Unless the legal landscape changes, however, it appears that the forgoing of life-sustaining treatments in the typical clinical context will not subject physicians to criminal prosecution.

References

1. “NY doctor convicted of manslaughter in 2 overdoses,” July 18, 2014 (http://bigstory.ap.org/article/ny-doctor-convicted-2-patients-overdose-deaths).

2. “Ex-doctor pleads guilty in overdose deaths,” Aug. 13, 2014 (www.usatoday.com/story/news/nation/2014/08/13/ex-doctor-guilty-deaths/14022735).

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Charges of homicide have been successfully brought against doctors in the following situations except:

A. Withholding life-sustaining treatment.

B. Euthanasia.

C. Negligent treatment of a patient.

D. Overprescription of controlled substances.

Answer: A. Homicideis any act that causes the death of a human being with criminal intent and without legal justification. It comprises several crimes of varying severity, with murder being the most serious (requiring “malice aforethought”). Depending on the intent of the perpetrator and/or the presence of mitigating/aggravating circumstances, jurisdictions have subdivided homicide into categories such as first- and second-degree murder, voluntary and involuntary manslaughter, negligent homicide, and others.

Discontinuing futile medical treatment that ends with patient demise raises the specter of criminal prosecution for homicide. However, prosecution of doctors under such circumstances has failed. The seminal case is Barber v. Superior Court (147 Cal. App. 3d 1006 (1983)), in which the state of California brought murder charges against two doctors for discontinuing intravenous fluids and nutrition in a comatose patient.

The patient, a 55-year-old security guard, sustained a cardiopulmonary arrest following surgery for intestinal obstruction. Irreversible brain damage resulted, leaving him in a vegetative state. His family allegedly requested that life support measures and intravenous fluids be discontinued, to which the doctors complied, and the patient died 6 days later.

After a preliminary pretrial hearing, the magistrate dismissed the charges; but a trial court reinstated them. The court of appeals, however, viewed the defendant’s conduct in discontinuing intravenous fluids as an omission rather than an affirmative action, and found that a physician has no duty to continue treatment once it is proven to be ineffective.

The appeals court recognized that “a physician is authorized under the standards of medical practice to discontinue a form of therapy which in his medical judgment is useless. … If the treating physicians have determined that continued use of a respirator is useless, then they may decide to discontinue it without fear of civil or criminal liability.”

In rejecting the distinction between ordinary and extraordinary care, the court dismissed the prosecutor’s contention that unlike the respirator, fluids and nutrition represented ordinary care and therefore should never be withheld.

It concluded that “the petitioners’ omission to continue treatment under the circumstances, though intentional and with knowledge that the patient would die, was not an unlawful failure to perform a legal duty.” And because no criminal liability attaches for failure to act (i.e., an omission) unless there is a legal duty to act affirmatively, it issued a writ of prohibition restraining the lower court from taking any further action on the matter.

The U.S. Supreme Court has since validated the distinction between “letting die” and an affirmative action taken with the intention to cause death, such as the administration of a lethal injection. The former is ethical and legal, conforming to medical norms, while the latter amounts to murder (Vacco v. Quill (117 S. Ct. 2293 (1997)).

With these developments, physicians therefore need not worry about criminal prosecution for carrying out Barber-like noneuthanasia, end-of-life actions that result in the death of their patients.

On the other hand, those who act directly to end the life of a patient, even one who freely requests death, may face criminal prosecution.

The most notorious example is that of retired Michigan pathologist Dr. Jack Kevorkian, who was found guilty of the second-degree murder of Thomas Youk, a 52-year-old race-car driver with terminal Lou Gehrig’s disease. Dr. Kevorkian injected a lethal mixture of Seconal, Anectine, and potassium chloride to end the patient’s life.

At trial, Dr. Kevorkian dismissed his lawyer and served ineffectively in his own defense, never taking the witness stand. Found guilty by a jury and sentenced to 10-25 years in prison, he served just more than 8 years until 2007, when he was released for good behavior. Previous charges by the state of Michigan against Dr. Kevorkian for assisting in the suicide of some 130 patients had proven unsuccessful.

This case spawned a nationwide debate on physician-directed deaths, with a few states now legalizing physician-assisted suicide, although euthanasia remains illegal throughout the nation.

In general, the remedy sought in a medical wrongful death case lies in a malpractice civil lawsuit against the negligent doctor. Sometimes, the plaintiff may assert that there was gross negligence where the conduct was particularly blameworthy, and if proven, the jury may award punitive damages.

Rarely, however, does the level of misconduct rise to that of criminal negligence. Here, the burden of proof for a conviction requires evidence beyond reasonable doubt, rather than the lower “more probable than not” evidentiary standard required in a civil lawsuit.

However, in cases where the physician’s conduct has markedly deviated from the standard of care, doctors have been successfully prosecuted for their “criminal” conduct.

For example, in an English case, an anesthesiologist was convicted of manslaughter in the death of a patient undergoing surgery for a detached retina. During surgery, the patient’s ventilation was interrupted because of accidental disconnection of the endotracheal tube for 4 minutes, leading to a cardiac arrest. An alarm had apparently sounded but was not noticed. The injury would not have occurred had the doctor attended to the patient instead of being away from the operating room.

The tragic death of pop star Michael Jackson in 2009 is another example. Dr. Conrad Murray, a cardiologist who was Jackson’s personal physician, had used the surgical anesthetic propofol to treat Jackson’s insomnia in a bedroom setting without monitoring or resuscitation equipment. Concurrent use of the sedative lorazepam exacerbated the effect of propofol. The prosecution characterized Dr. Murray’s conduct as “egregious, unethical, and unconscionable,” which violated medical standards and amounted to criminal negligence. He was found guilty of involuntary manslaughter, and the state sentenced him to a 4-year prison term.

A new trend appears to be developing toward prosecuting doctors whose overprescription of controlled substances results in patient deaths.

According to a recent news report, New York for the first time convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and Xanax.¹ Some of the patients were reportedly prescribed as many as 500-800 pills over a 5-6 week period. Dr. Stan Li, an anesthesiologist and pain management specialist, allegedly saw up to 90 patients a day in his Queens, N.Y., weekend storefront clinic, charging them on a per-prescription basis. In his defense, Dr. Li claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).

Meanwhile, a similar scenario played out in Oklahoma.² There, Dr. William Valuck, a pain management doctor, pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths. He entered into a plea bargain with Oklahoma prosecutors and will serve 8 years in prison. Dr. Valuck had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma, which included hydrocodone, oxycodone, alprazolam, Valium, and Soma, sometimes as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.

Most physicians are unlikely to ever face the specter of criminal prosecution based on their medical performance. Only in the most egregious of circumstances have physicians been successfully prosecuted for homicide.

As requests for physicians to withhold or withdraw life-sustaining treatments grow, physicians may find themselves questioning what acts or omissions they may legally perform. Unless the legal landscape changes, however, it appears that the forgoing of life-sustaining treatments in the typical clinical context will not subject physicians to criminal prosecution.

References

1. “NY doctor convicted of manslaughter in 2 overdoses,” July 18, 2014 (http://bigstory.ap.org/article/ny-doctor-convicted-2-patients-overdose-deaths).

2. “Ex-doctor pleads guilty in overdose deaths,” Aug. 13, 2014 (www.usatoday.com/story/news/nation/2014/08/13/ex-doctor-guilty-deaths/14022735).

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: A patient alleges that an ophthalmologist was negligent in performing blepharoplasty. The surgical site became infected and left the patient with a disfigured eye. An infectious disease specialist was to testify as plaintiff’s expert, but the defense, relying on a state statute, objected that the expert-to-be had no specialized training in ophthalmology.

Correct statements about expert medical testimony include the following, except:

A. The federal Rules of Evidence require that an expert possess the relevant knowledge, skill, education, training, or experience.

B. Only a few states have enacted statutes specifying that an expert must be in the same or similar specialty as the defendant.

C. Advocates contend that such statutes reduce frivolous lawsuits by limiting expert shopping and the use of “hired guns.”

D. It is the sitting judge, not the jury, who interprets the statute and decides whether a witness qualifies as an expert.

E. In some cases, a nondoctor such as a nurse or pharmacist may be allowed to offer expert testimony against a doctor.

Answer: B. Lay testimony is usually insufficient to define the standard of care in a claim of medical malpractice, and “the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony” (Craft v. Peebles, 893 P.2d 138 [Haw.1995]). Court rules of evidence dictate that the expert must possess the knowledge, skill, experience, training, or education for establishing that standard.

In coming to an opinion, the expert may rely on external evidence in the form of a book, treatise, or article; and although these sources represent hearsay evidence, they are admissible to enable the expert witness to form his/her opinion.

The facts of the multiple-choice question above are taken from a recent case (Edwards v. Sunrise Ophthalmology ASC, LLC, 134 So. 3d 1056 [Fla. 4th DCA 2013]), whose appeal is yet to be heard by the Florida Supreme Court. The plaintiff alleged that the surgical site was infected with nocardia during a lower-lid blepharoplasty, which caused her to undergo additional surgery with resulting disfigurement of the eye.

A lower court disqualified the plaintiff’s expert, an infectious disease specialist, based on a Florida statute stipulating that expert medical opinion can be offered only by one in the “same or similar specialty” (Section 766.102, Florida Statutes (2009)). In the words of the court, “Simply put, the infectious disease doctor is not an eye surgeon, nor is the ophthalmologist an infectious disease doctor.”

More than half of all the states have a medical-expert law, many with language comparable to the Florida statute. The idea behind such a statute, frequently enacted as part of a state’s tort reform, is to limit expert shopping and the use of hired guns and “junk science.”

Unsurprisingly, litigation abounds over the statutory language.

For example, a Maryland court ruled that a vascular surgeon was qualified to set the standard of care when an orthopedic surgeon’s alleged negligence caused a patient to lose a leg following knee surgery. The court found the two specialties to be “related,” because the orthopedic complication was vascular in origin.

In some jurisdictions without strict statutory requirements, doctors are more likely to be allowed to testify outside their specialty.

Instances of professionals of unlike specialties qualifying as experts include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores. Georgia requires only that an expert show significant familiarity with the area of practice in which the expert opinion is to be given. Still, in a sleep apnea case (Nathans v. Diamond, 654 S.E.2d 121 [Ga. 2007]), the court held that a pulmonologist was not qualified to testify on the standard of surgical care provided by an otolaryngologist.

Besides arguing over the statutory language, litigants have also raised questions of constitutionality. For example, Arizona’s statute ARS §12-2604 (A) requires a medical expert to be a specialist who is actively practicing or teaching in that area of medicine. The state court of appeals held that this violated the separation of powers doctrine (conflicting with Arizona Rule of Evidence 702), but the Supreme Court of Arizona subsequently reversed and reinstated the law (Seisinger v. Siebel, 203 P.3d 483 [Ariz. 2009]).

More recently, the same court upheld the constitutionality of the requirement that an expert share “the same specialty” as the treating physician, and disqualified an adult hematologist from serving as an expert because the defendant was a pediatric hematologist, not an adult hematologist (Baker v. University Physicians Healthcare, 296 P.3d 42 [Ariz. 2013]).

Another issue deals with the locality rule. In an Illinois case, the court accepted an out-of-state plaintiff expert based on his qualifications, competency, and familiarity with standards in the defendant’s community. The case dealt with the development of a rectovaginal fistula that complicated an episiotomy during delivery (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]).

The defense attempted to exclude the expert, alleging the lack of familiarity with the standards in the community (Rantoul, Ill.). However, the expert stated that he was familiar with the minimum standards of medical practice in relation to the diagnosis and treatment of rectovaginal fistulae, and those minimum standards were uniform throughout the country.

It is not necessary that the expert witness has the highest possible qualifications to testify about a particular matter. Still, in Domingo v. T.K. (289 F.3d 600 [9th Cir. 2002]), a federal court excluded the testimony of the plaintiff’s expert witness, because it lacked reliability. The plaintiff developed brain damage from fat embolism following hip surgery, and alleged that prolonged malleting of a hip prosthesis was the cause of the fat embolism syndrome (FES).

The court found that “there was no evidence of widespread acceptance of Dr. Harrington’s theory linking extended malleting to FES; indeed, no theory linking extensive malleting to FES had ever been published.” It also noted the lack of any objective source, peer review, clinical tests, establishment of an error rate or other evidence to show that Dr. Harrington followed a valid, scientific method in developing his theory.

Being disqualified as an expert is one thing, but a recent case goes further. In addition to dismissing an expert’s testimony, a state judge barred the expert from ever testifying in his courtroom after it was determined that the testimony was untruthful.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected]

Question: A patient alleges that an ophthalmologist was negligent in performing blepharoplasty. The surgical site became infected and left the patient with a disfigured eye. An infectious disease specialist was to testify as plaintiff’s expert, but the defense, relying on a state statute, objected that the expert-to-be had no specialized training in ophthalmology.

Correct statements about expert medical testimony include the following, except:

A. The federal Rules of Evidence require that an expert possess the relevant knowledge, skill, education, training, or experience.

B. Only a few states have enacted statutes specifying that an expert must be in the same or similar specialty as the defendant.

C. Advocates contend that such statutes reduce frivolous lawsuits by limiting expert shopping and the use of “hired guns.”

D. It is the sitting judge, not the jury, who interprets the statute and decides whether a witness qualifies as an expert.

E. In some cases, a nondoctor such as a nurse or pharmacist may be allowed to offer expert testimony against a doctor.

Answer: B. Lay testimony is usually insufficient to define the standard of care in a claim of medical malpractice, and “the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony” (Craft v. Peebles, 893 P.2d 138 [Haw.1995]). Court rules of evidence dictate that the expert must possess the knowledge, skill, experience, training, or education for establishing that standard.

In coming to an opinion, the expert may rely on external evidence in the form of a book, treatise, or article; and although these sources represent hearsay evidence, they are admissible to enable the expert witness to form his/her opinion.

The facts of the multiple-choice question above are taken from a recent case (Edwards v. Sunrise Ophthalmology ASC, LLC, 134 So. 3d 1056 [Fla. 4th DCA 2013]), whose appeal is yet to be heard by the Florida Supreme Court. The plaintiff alleged that the surgical site was infected with nocardia during a lower-lid blepharoplasty, which caused her to undergo additional surgery with resulting disfigurement of the eye.

A lower court disqualified the plaintiff’s expert, an infectious disease specialist, based on a Florida statute stipulating that expert medical opinion can be offered only by one in the “same or similar specialty” (Section 766.102, Florida Statutes (2009)). In the words of the court, “Simply put, the infectious disease doctor is not an eye surgeon, nor is the ophthalmologist an infectious disease doctor.”

More than half of all the states have a medical-expert law, many with language comparable to the Florida statute. The idea behind such a statute, frequently enacted as part of a state’s tort reform, is to limit expert shopping and the use of hired guns and “junk science.”

Unsurprisingly, litigation abounds over the statutory language.

For example, a Maryland court ruled that a vascular surgeon was qualified to set the standard of care when an orthopedic surgeon’s alleged negligence caused a patient to lose a leg following knee surgery. The court found the two specialties to be “related,” because the orthopedic complication was vascular in origin.

In some jurisdictions without strict statutory requirements, doctors are more likely to be allowed to testify outside their specialty.

Instances of professionals of unlike specialties qualifying as experts include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores. Georgia requires only that an expert show significant familiarity with the area of practice in which the expert opinion is to be given. Still, in a sleep apnea case (Nathans v. Diamond, 654 S.E.2d 121 [Ga. 2007]), the court held that a pulmonologist was not qualified to testify on the standard of surgical care provided by an otolaryngologist.

Besides arguing over the statutory language, litigants have also raised questions of constitutionality. For example, Arizona’s statute ARS §12-2604 (A) requires a medical expert to be a specialist who is actively practicing or teaching in that area of medicine. The state court of appeals held that this violated the separation of powers doctrine (conflicting with Arizona Rule of Evidence 702), but the Supreme Court of Arizona subsequently reversed and reinstated the law (Seisinger v. Siebel, 203 P.3d 483 [Ariz. 2009]).

More recently, the same court upheld the constitutionality of the requirement that an expert share “the same specialty” as the treating physician, and disqualified an adult hematologist from serving as an expert because the defendant was a pediatric hematologist, not an adult hematologist (Baker v. University Physicians Healthcare, 296 P.3d 42 [Ariz. 2013]).

Another issue deals with the locality rule. In an Illinois case, the court accepted an out-of-state plaintiff expert based on his qualifications, competency, and familiarity with standards in the defendant’s community. The case dealt with the development of a rectovaginal fistula that complicated an episiotomy during delivery (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]).

The defense attempted to exclude the expert, alleging the lack of familiarity with the standards in the community (Rantoul, Ill.). However, the expert stated that he was familiar with the minimum standards of medical practice in relation to the diagnosis and treatment of rectovaginal fistulae, and those minimum standards were uniform throughout the country.

It is not necessary that the expert witness has the highest possible qualifications to testify about a particular matter. Still, in Domingo v. T.K. (289 F.3d 600 [9th Cir. 2002]), a federal court excluded the testimony of the plaintiff’s expert witness, because it lacked reliability. The plaintiff developed brain damage from fat embolism following hip surgery, and alleged that prolonged malleting of a hip prosthesis was the cause of the fat embolism syndrome (FES).

The court found that “there was no evidence of widespread acceptance of Dr. Harrington’s theory linking extended malleting to FES; indeed, no theory linking extensive malleting to FES had ever been published.” It also noted the lack of any objective source, peer review, clinical tests, establishment of an error rate or other evidence to show that Dr. Harrington followed a valid, scientific method in developing his theory.

Being disqualified as an expert is one thing, but a recent case goes further. In addition to dismissing an expert’s testimony, a state judge barred the expert from ever testifying in his courtroom after it was determined that the testimony was untruthful.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected]

Question: A patient alleges that an ophthalmologist was negligent in performing blepharoplasty. The surgical site became infected and left the patient with a disfigured eye. An infectious disease specialist was to testify as plaintiff’s expert, but the defense, relying on a state statute, objected that the expert-to-be had no specialized training in ophthalmology.

Correct statements about expert medical testimony include the following, except:

A. The federal Rules of Evidence require that an expert possess the relevant knowledge, skill, education, training, or experience.

B. Only a few states have enacted statutes specifying that an expert must be in the same or similar specialty as the defendant.

C. Advocates contend that such statutes reduce frivolous lawsuits by limiting expert shopping and the use of “hired guns.”

D. It is the sitting judge, not the jury, who interprets the statute and decides whether a witness qualifies as an expert.

E. In some cases, a nondoctor such as a nurse or pharmacist may be allowed to offer expert testimony against a doctor.

Answer: B. Lay testimony is usually insufficient to define the standard of care in a claim of medical malpractice, and “the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony” (Craft v. Peebles, 893 P.2d 138 [Haw.1995]). Court rules of evidence dictate that the expert must possess the knowledge, skill, experience, training, or education for establishing that standard.

In coming to an opinion, the expert may rely on external evidence in the form of a book, treatise, or article; and although these sources represent hearsay evidence, they are admissible to enable the expert witness to form his/her opinion.

The facts of the multiple-choice question above are taken from a recent case (Edwards v. Sunrise Ophthalmology ASC, LLC, 134 So. 3d 1056 [Fla. 4th DCA 2013]), whose appeal is yet to be heard by the Florida Supreme Court. The plaintiff alleged that the surgical site was infected with nocardia during a lower-lid blepharoplasty, which caused her to undergo additional surgery with resulting disfigurement of the eye.

A lower court disqualified the plaintiff’s expert, an infectious disease specialist, based on a Florida statute stipulating that expert medical opinion can be offered only by one in the “same or similar specialty” (Section 766.102, Florida Statutes (2009)). In the words of the court, “Simply put, the infectious disease doctor is not an eye surgeon, nor is the ophthalmologist an infectious disease doctor.”

More than half of all the states have a medical-expert law, many with language comparable to the Florida statute. The idea behind such a statute, frequently enacted as part of a state’s tort reform, is to limit expert shopping and the use of hired guns and “junk science.”

Unsurprisingly, litigation abounds over the statutory language.

For example, a Maryland court ruled that a vascular surgeon was qualified to set the standard of care when an orthopedic surgeon’s alleged negligence caused a patient to lose a leg following knee surgery. The court found the two specialties to be “related,” because the orthopedic complication was vascular in origin.

In some jurisdictions without strict statutory requirements, doctors are more likely to be allowed to testify outside their specialty.

Instances of professionals of unlike specialties qualifying as experts include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores. Georgia requires only that an expert show significant familiarity with the area of practice in which the expert opinion is to be given. Still, in a sleep apnea case (Nathans v. Diamond, 654 S.E.2d 121 [Ga. 2007]), the court held that a pulmonologist was not qualified to testify on the standard of surgical care provided by an otolaryngologist.

Besides arguing over the statutory language, litigants have also raised questions of constitutionality. For example, Arizona’s statute ARS §12-2604 (A) requires a medical expert to be a specialist who is actively practicing or teaching in that area of medicine. The state court of appeals held that this violated the separation of powers doctrine (conflicting with Arizona Rule of Evidence 702), but the Supreme Court of Arizona subsequently reversed and reinstated the law (Seisinger v. Siebel, 203 P.3d 483 [Ariz. 2009]).

More recently, the same court upheld the constitutionality of the requirement that an expert share “the same specialty” as the treating physician, and disqualified an adult hematologist from serving as an expert because the defendant was a pediatric hematologist, not an adult hematologist (Baker v. University Physicians Healthcare, 296 P.3d 42 [Ariz. 2013]).

Another issue deals with the locality rule. In an Illinois case, the court accepted an out-of-state plaintiff expert based on his qualifications, competency, and familiarity with standards in the defendant’s community. The case dealt with the development of a rectovaginal fistula that complicated an episiotomy during delivery (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]).

The defense attempted to exclude the expert, alleging the lack of familiarity with the standards in the community (Rantoul, Ill.). However, the expert stated that he was familiar with the minimum standards of medical practice in relation to the diagnosis and treatment of rectovaginal fistulae, and those minimum standards were uniform throughout the country.

It is not necessary that the expert witness has the highest possible qualifications to testify about a particular matter. Still, in Domingo v. T.K. (289 F.3d 600 [9th Cir. 2002]), a federal court excluded the testimony of the plaintiff’s expert witness, because it lacked reliability. The plaintiff developed brain damage from fat embolism following hip surgery, and alleged that prolonged malleting of a hip prosthesis was the cause of the fat embolism syndrome (FES).

The court found that “there was no evidence of widespread acceptance of Dr. Harrington’s theory linking extended malleting to FES; indeed, no theory linking extensive malleting to FES had ever been published.” It also noted the lack of any objective source, peer review, clinical tests, establishment of an error rate or other evidence to show that Dr. Harrington followed a valid, scientific method in developing his theory.

Being disqualified as an expert is one thing, but a recent case goes further. In addition to dismissing an expert’s testimony, a state judge barred the expert from ever testifying in his courtroom after it was determined that the testimony was untruthful.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected]

Question: Your office assistant misfiled a critical laboratory report showing dangerous hyperkalemia of 6.5 mEq/L. Unaware of the abnormality, you failed to notify the end-stage renal patient to return for treatment. In the meantime, the patient collapsed and died, and an autopsy revealed a fresh transmural myocardial infarct.

Which of the following statements is best?

A. You are negligent, because the standard of care is to promptly contact the patient.

B. Your office assistant is negligent, because she was the one who misfiled the report.

C. Liability rests with the laboratory, because it should have called the office immediately with the critical value.

D. Your lawyer will defend you on the legal theory that hyperkalemia was not the proximate cause of death.

E. All of the above.

Answer: E. In any negligence action, the plaintiff bears the burden of proof, on a balance of probabilities, that the defendant owes him/her a duty of care, the breach of which proximately caused the plaintiff’s injuries.

One begins with an inquiry into whether a duty exists and whether a breach has occurred. Generally, doctors owe a legal duty of due care to their patients arising out of the doctor-patient relationship. By “missing” the laboratory report, especially one of urgency, and not immediately notifying the patient, the doctor has likely breached his/her duty. Another way of putting it is to ask whether the conduct has fallen below what is ordinarily expected of a practitioner in a similar situation.

The doctor will likely blame the office assistant for misfiling the report, and the assistant is indeed liable, as he/she also owes a direct legal duty to the patient. However, such liability will then fall upon the doctor under “respondeat superior” or “let the master answer,” which is the legal doctrine underpinning vicarious liability. This is characteristically seen in an employer-employee situation, where liability is imputed to the employer despite the tortious act being committed only by the employee.

The idea behind this rule is to ensure that the employer, as supervisor, will enforce proper work conditions to avoid risk of harm. The employer also is better able to shoulder the cost of compensating the victim.

For vicarious liability to arise, the employee’s act must have occurred during and within the scope of employment, and the risk of harm must be foreseeable. Under the facts of this hypothetical scenario, it is easy to see that the doctor will be vicariously liable for the negligent act of the assistant.

The clinical laboratory also owes an independent duty to the patient, which includes, among other things, assuring the proper standards in specimen collection and test performance. The duty extends to timely and accurate reporting of the results, including calling the physician when there is a critically high or low value if that is the standard of care in the community, as it generally is.

Thus, the laboratory in this case will likely be named as a codefendant. This is called joint and several liability, where more than one defendant has concurrently or successively caused a plaintiff’s indivisible injury, and the latter can recover all damages from any of the wrongdoers irrespective of degree of fault, as long as causation is proven. However, the plaintiff is not entitled to double recovery, and a defendant can proceed against the other liable parties for contribution.

Proving existence and breach of duty are necessary but insufficient steps toward winning the lawsuit. The plaintiff must also establish causation, i.e., that the substandard care caused the injury.

Causation inquires into both cause-in-fact and cause-in-law, and the term “proximate cause” is used to cover both of these aspects of causation. Cause-in-fact is established with the “but for” test – whether it can be said that had it not been for the defendant’s actions, the plaintiff would not have suffered the injury.

In this scenario, the doctor’s attorney will argue that the cause of death, a myocardial infarct, was preexisting atherosclerotic heart disease, rather than hyperkalemia. Besides, the chronic renal patient typically adapts to hyperkalemia and can tolerate elevated levels better than nonrenal patients. Of course, the counterargument is that the patient’s cardiac injury was a likely consequence of hyperkalemia-induced ventricular arrhythmia.

The doctor, the nurse, and the laboratory will all be named as codefendants. However, the laboratory will attempt to escape liability by arguing that its negligence, if any, was superseded by the doctor’s own negligent failure to read the report. Cause-in-law analysis examines whether a new independent event has intervened between the negligent act and the outcome, which may have been aggravated by the new event.

It naturally raises the question whether the original wrongdoer – in this case, the laboratory – continues to be liable, or whether the chain of causation has been broken by the intervening cause (the doctor’s negligence).

In a federal case, the Florida District Court of Appeals found several doctors liable for missing the diagnosis of tuberculous meningitis (Hadley v. Terwilleger, 873 So.2d 378 (Fl. 2004)). The doctors had seen the patient at various times in a sequential manner. The court held that the plaintiff was entitled to concurring-cause, rather than superseding-cause, jury instructions. The purpose of such instruction was to negate the idea that a defendant is excused from the consequences of his or her negligence by reason of some other cause concurring in time and contributing to the same injury.

Overlooked, misfiled, or otherwise “missed” laboratory or x-ray reports are commonly encountered in medical practice, and may lead in some instances to serious patient injury. They are typically systems errors rather than the fault of any single individual, and like most medical errors, largely preventable.

Physicians and health care institutions should put in place tested protocols that protect patients from risk of harm, and, as the Institute of Medicine stated in its 2000 report, “To Err Is Human: Building a Safer Health System,” move away from “a culture of blame to a culture of safety.”

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at s[email protected].

Question: Your office assistant misfiled a critical laboratory report showing dangerous hyperkalemia of 6.5 mEq/L. Unaware of the abnormality, you failed to notify the end-stage renal patient to return for treatment. In the meantime, the patient collapsed and died, and an autopsy revealed a fresh transmural myocardial infarct.

Which of the following statements is best?

A. You are negligent, because the standard of care is to promptly contact the patient.

B. Your office assistant is negligent, because she was the one who misfiled the report.

C. Liability rests with the laboratory, because it should have called the office immediately with the critical value.

D. Your lawyer will defend you on the legal theory that hyperkalemia was not the proximate cause of death.

E. All of the above.

Answer: E. In any negligence action, the plaintiff bears the burden of proof, on a balance of probabilities, that the defendant owes him/her a duty of care, the breach of which proximately caused the plaintiff’s injuries.

One begins with an inquiry into whether a duty exists and whether a breach has occurred. Generally, doctors owe a legal duty of due care to their patients arising out of the doctor-patient relationship. By “missing” the laboratory report, especially one of urgency, and not immediately notifying the patient, the doctor has likely breached his/her duty. Another way of putting it is to ask whether the conduct has fallen below what is ordinarily expected of a practitioner in a similar situation.

The doctor will likely blame the office assistant for misfiling the report, and the assistant is indeed liable, as he/she also owes a direct legal duty to the patient. However, such liability will then fall upon the doctor under “respondeat superior” or “let the master answer,” which is the legal doctrine underpinning vicarious liability. This is characteristically seen in an employer-employee situation, where liability is imputed to the employer despite the tortious act being committed only by the employee.

The idea behind this rule is to ensure that the employer, as supervisor, will enforce proper work conditions to avoid risk of harm. The employer also is better able to shoulder the cost of compensating the victim.

For vicarious liability to arise, the employee’s act must have occurred during and within the scope of employment, and the risk of harm must be foreseeable. Under the facts of this hypothetical scenario, it is easy to see that the doctor will be vicariously liable for the negligent act of the assistant.

The clinical laboratory also owes an independent duty to the patient, which includes, among other things, assuring the proper standards in specimen collection and test performance. The duty extends to timely and accurate reporting of the results, including calling the physician when there is a critically high or low value if that is the standard of care in the community, as it generally is.

Thus, the laboratory in this case will likely be named as a codefendant. This is called joint and several liability, where more than one defendant has concurrently or successively caused a plaintiff’s indivisible injury, and the latter can recover all damages from any of the wrongdoers irrespective of degree of fault, as long as causation is proven. However, the plaintiff is not entitled to double recovery, and a defendant can proceed against the other liable parties for contribution.

Proving existence and breach of duty are necessary but insufficient steps toward winning the lawsuit. The plaintiff must also establish causation, i.e., that the substandard care caused the injury.

Causation inquires into both cause-in-fact and cause-in-law, and the term “proximate cause” is used to cover both of these aspects of causation. Cause-in-fact is established with the “but for” test – whether it can be said that had it not been for the defendant’s actions, the plaintiff would not have suffered the injury.

In this scenario, the doctor’s attorney will argue that the cause of death, a myocardial infarct, was preexisting atherosclerotic heart disease, rather than hyperkalemia. Besides, the chronic renal patient typically adapts to hyperkalemia and can tolerate elevated levels better than nonrenal patients. Of course, the counterargument is that the patient’s cardiac injury was a likely consequence of hyperkalemia-induced ventricular arrhythmia.

The doctor, the nurse, and the laboratory will all be named as codefendants. However, the laboratory will attempt to escape liability by arguing that its negligence, if any, was superseded by the doctor’s own negligent failure to read the report. Cause-in-law analysis examines whether a new independent event has intervened between the negligent act and the outcome, which may have been aggravated by the new event.

It naturally raises the question whether the original wrongdoer – in this case, the laboratory – continues to be liable, or whether the chain of causation has been broken by the intervening cause (the doctor’s negligence).

In a federal case, the Florida District Court of Appeals found several doctors liable for missing the diagnosis of tuberculous meningitis (Hadley v. Terwilleger, 873 So.2d 378 (Fl. 2004)). The doctors had seen the patient at various times in a sequential manner. The court held that the plaintiff was entitled to concurring-cause, rather than superseding-cause, jury instructions. The purpose of such instruction was to negate the idea that a defendant is excused from the consequences of his or her negligence by reason of some other cause concurring in time and contributing to the same injury.

Overlooked, misfiled, or otherwise “missed” laboratory or x-ray reports are commonly encountered in medical practice, and may lead in some instances to serious patient injury. They are typically systems errors rather than the fault of any single individual, and like most medical errors, largely preventable.

Physicians and health care institutions should put in place tested protocols that protect patients from risk of harm, and, as the Institute of Medicine stated in its 2000 report, “To Err Is Human: Building a Safer Health System,” move away from “a culture of blame to a culture of safety.”

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at s[email protected].

Question: Your office assistant misfiled a critical laboratory report showing dangerous hyperkalemia of 6.5 mEq/L. Unaware of the abnormality, you failed to notify the end-stage renal patient to return for treatment. In the meantime, the patient collapsed and died, and an autopsy revealed a fresh transmural myocardial infarct.

Which of the following statements is best?

A. You are negligent, because the standard of care is to promptly contact the patient.

B. Your office assistant is negligent, because she was the one who misfiled the report.

C. Liability rests with the laboratory, because it should have called the office immediately with the critical value.

D. Your lawyer will defend you on the legal theory that hyperkalemia was not the proximate cause of death.

E. All of the above.

Answer: E. In any negligence action, the plaintiff bears the burden of proof, on a balance of probabilities, that the defendant owes him/her a duty of care, the breach of which proximately caused the plaintiff’s injuries.

One begins with an inquiry into whether a duty exists and whether a breach has occurred. Generally, doctors owe a legal duty of due care to their patients arising out of the doctor-patient relationship. By “missing” the laboratory report, especially one of urgency, and not immediately notifying the patient, the doctor has likely breached his/her duty. Another way of putting it is to ask whether the conduct has fallen below what is ordinarily expected of a practitioner in a similar situation.

The doctor will likely blame the office assistant for misfiling the report, and the assistant is indeed liable, as he/she also owes a direct legal duty to the patient. However, such liability will then fall upon the doctor under “respondeat superior” or “let the master answer,” which is the legal doctrine underpinning vicarious liability. This is characteristically seen in an employer-employee situation, where liability is imputed to the employer despite the tortious act being committed only by the employee.

The idea behind this rule is to ensure that the employer, as supervisor, will enforce proper work conditions to avoid risk of harm. The employer also is better able to shoulder the cost of compensating the victim.

For vicarious liability to arise, the employee’s act must have occurred during and within the scope of employment, and the risk of harm must be foreseeable. Under the facts of this hypothetical scenario, it is easy to see that the doctor will be vicariously liable for the negligent act of the assistant.

The clinical laboratory also owes an independent duty to the patient, which includes, among other things, assuring the proper standards in specimen collection and test performance. The duty extends to timely and accurate reporting of the results, including calling the physician when there is a critically high or low value if that is the standard of care in the community, as it generally is.

Thus, the laboratory in this case will likely be named as a codefendant. This is called joint and several liability, where more than one defendant has concurrently or successively caused a plaintiff’s indivisible injury, and the latter can recover all damages from any of the wrongdoers irrespective of degree of fault, as long as causation is proven. However, the plaintiff is not entitled to double recovery, and a defendant can proceed against the other liable parties for contribution.

Proving existence and breach of duty are necessary but insufficient steps toward winning the lawsuit. The plaintiff must also establish causation, i.e., that the substandard care caused the injury.

Causation inquires into both cause-in-fact and cause-in-law, and the term “proximate cause” is used to cover both of these aspects of causation. Cause-in-fact is established with the “but for” test – whether it can be said that had it not been for the defendant’s actions, the plaintiff would not have suffered the injury.

In this scenario, the doctor’s attorney will argue that the cause of death, a myocardial infarct, was preexisting atherosclerotic heart disease, rather than hyperkalemia. Besides, the chronic renal patient typically adapts to hyperkalemia and can tolerate elevated levels better than nonrenal patients. Of course, the counterargument is that the patient’s cardiac injury was a likely consequence of hyperkalemia-induced ventricular arrhythmia.

The doctor, the nurse, and the laboratory will all be named as codefendants. However, the laboratory will attempt to escape liability by arguing that its negligence, if any, was superseded by the doctor’s own negligent failure to read the report. Cause-in-law analysis examines whether a new independent event has intervened between the negligent act and the outcome, which may have been aggravated by the new event.

It naturally raises the question whether the original wrongdoer – in this case, the laboratory – continues to be liable, or whether the chain of causation has been broken by the intervening cause (the doctor’s negligence).

In a federal case, the Florida District Court of Appeals found several doctors liable for missing the diagnosis of tuberculous meningitis (Hadley v. Terwilleger, 873 So.2d 378 (Fl. 2004)). The doctors had seen the patient at various times in a sequential manner. The court held that the plaintiff was entitled to concurring-cause, rather than superseding-cause, jury instructions. The purpose of such instruction was to negate the idea that a defendant is excused from the consequences of his or her negligence by reason of some other cause concurring in time and contributing to the same injury.

Overlooked, misfiled, or otherwise “missed” laboratory or x-ray reports are commonly encountered in medical practice, and may lead in some instances to serious patient injury. They are typically systems errors rather than the fault of any single individual, and like most medical errors, largely preventable.

Physicians and health care institutions should put in place tested protocols that protect patients from risk of harm, and, as the Institute of Medicine stated in its 2000 report, “To Err Is Human: Building a Safer Health System,” move away from “a culture of blame to a culture of safety.”

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at s[email protected].