Law & Medicine

Echocardiograms were done, but who was reading them?

A 67-YEAR-OLD MAN had been under the care of his primary care physician for aortic stenosis. The physician was aware of this diagnosis and did periodic echocardiograms to monitor the patient’s heart. The patient was sent to a cardiologist for additional care. Over the next year and a half, the decedent’s condition worsened, and he died of heart failure.

PLAINTIFF’S CLAIM The defendants deviated from the standard of care in not reading the echocardiograms. If they had, they could have treated him and extended his life.

THE DEFENSE The cardiologist said it was not up to him to read the echocardiogram. The primary care physician acknowledged that he deviated from the standard of care.

VERDICT $3 million Connecticut verdict.

Don't assume the specialist has taken charge; verify or manage the patient yourself.

COMMENT This is a clear case of failure to take responsibility. I suspect the failure was based on the assumption by both physicians that the other physician was monitoring the patient’s status.

This happened to me with a patient who gradually drifted into acute heart failure while I assumed the nephrologist was managing his diuretics. A phone call and more furosemide would have prevented that hospital admission. (Luckily, my patient recovered uneventfully.)

Don’t assume the specialist has taken charge; verify or manage the patient yourself.

Third call to help line finally leads to office visit, but it’s too late

A 42-YEAR-OLD WOMAN called a phone help line and told a nurse that she had a fever, chills, sore throat, and severe chest pain. The next day she called again and spoke with a nurse who routed her call to a physician. The physician diagnosed the woman with influenza during their 4-minute conversation. She called again the next day and was told to come in for examination. The woman did so and was admitted. One day later, she died of sepsis secondary to pneumonia.

PLAINTIFF’S CLAIM The standard of care required immediate examination by the time of the second call.

THE DEFENSE The plaintiff did not actually report chest pain until the second call, and she contracted an unusually fast-acting strain of pneumonia.

VERDICT $3.5 million California arbitration award.

COMMENT Delayed diagnosis is one of the main reasons family physicians are successfully sued. Management of this patient may have been reasonable the first day. The second call should have prompted a same day visit or instructions to go to the emergency department or at least an urgent care facility. The third call was too late.

Echocardiograms were done, but who was reading them?

A 67-YEAR-OLD MAN had been under the care of his primary care physician for aortic stenosis. The physician was aware of this diagnosis and did periodic echocardiograms to monitor the patient’s heart. The patient was sent to a cardiologist for additional care. Over the next year and a half, the decedent’s condition worsened, and he died of heart failure.

PLAINTIFF’S CLAIM The defendants deviated from the standard of care in not reading the echocardiograms. If they had, they could have treated him and extended his life.

THE DEFENSE The cardiologist said it was not up to him to read the echocardiogram. The primary care physician acknowledged that he deviated from the standard of care.

VERDICT $3 million Connecticut verdict.

Don't assume the specialist has taken charge; verify or manage the patient yourself.

COMMENT This is a clear case of failure to take responsibility. I suspect the failure was based on the assumption by both physicians that the other physician was monitoring the patient’s status.

This happened to me with a patient who gradually drifted into acute heart failure while I assumed the nephrologist was managing his diuretics. A phone call and more furosemide would have prevented that hospital admission. (Luckily, my patient recovered uneventfully.)

Don’t assume the specialist has taken charge; verify or manage the patient yourself.

Third call to help line finally leads to office visit, but it’s too late

A 42-YEAR-OLD WOMAN called a phone help line and told a nurse that she had a fever, chills, sore throat, and severe chest pain. The next day she called again and spoke with a nurse who routed her call to a physician. The physician diagnosed the woman with influenza during their 4-minute conversation. She called again the next day and was told to come in for examination. The woman did so and was admitted. One day later, she died of sepsis secondary to pneumonia.

PLAINTIFF’S CLAIM The standard of care required immediate examination by the time of the second call.

THE DEFENSE The plaintiff did not actually report chest pain until the second call, and she contracted an unusually fast-acting strain of pneumonia.

VERDICT $3.5 million California arbitration award.

COMMENT Delayed diagnosis is one of the main reasons family physicians are successfully sued. Management of this patient may have been reasonable the first day. The second call should have prompted a same day visit or instructions to go to the emergency department or at least an urgent care facility. The third call was too late.

Echocardiograms were done, but who was reading them?

A 67-YEAR-OLD MAN had been under the care of his primary care physician for aortic stenosis. The physician was aware of this diagnosis and did periodic echocardiograms to monitor the patient’s heart. The patient was sent to a cardiologist for additional care. Over the next year and a half, the decedent’s condition worsened, and he died of heart failure.

PLAINTIFF’S CLAIM The defendants deviated from the standard of care in not reading the echocardiograms. If they had, they could have treated him and extended his life.

THE DEFENSE The cardiologist said it was not up to him to read the echocardiogram. The primary care physician acknowledged that he deviated from the standard of care.

VERDICT $3 million Connecticut verdict.

Don't assume the specialist has taken charge; verify or manage the patient yourself.

COMMENT This is a clear case of failure to take responsibility. I suspect the failure was based on the assumption by both physicians that the other physician was monitoring the patient’s status.

This happened to me with a patient who gradually drifted into acute heart failure while I assumed the nephrologist was managing his diuretics. A phone call and more furosemide would have prevented that hospital admission. (Luckily, my patient recovered uneventfully.)

Don’t assume the specialist has taken charge; verify or manage the patient yourself.

Third call to help line finally leads to office visit, but it’s too late

A 42-YEAR-OLD WOMAN called a phone help line and told a nurse that she had a fever, chills, sore throat, and severe chest pain. The next day she called again and spoke with a nurse who routed her call to a physician. The physician diagnosed the woman with influenza during their 4-minute conversation. She called again the next day and was told to come in for examination. The woman did so and was admitted. One day later, she died of sepsis secondary to pneumonia.

PLAINTIFF’S CLAIM The standard of care required immediate examination by the time of the second call.

THE DEFENSE The plaintiff did not actually report chest pain until the second call, and she contracted an unusually fast-acting strain of pneumonia.

VERDICT $3.5 million California arbitration award.

COMMENT Delayed diagnosis is one of the main reasons family physicians are successfully sued. Management of this patient may have been reasonable the first day. The second call should have prompted a same day visit or instructions to go to the emergency department or at least an urgent care facility. The third call was too late.

Question: Which of the following statements regarding artificial nutrition and hydration (ANH) is least supported in ethics and/or law?

A. One may invoke medical futility and discontinue ANH in noncognitive, terminally ill patients.

B. Forgoing ANH at the end of life is part of good palliative care.

C. Tube feeding is a way to provide food and sustenance and does not constitute medical treatment.

D. Many state statutes allow for the discontinuation of ANH under specified conditions.

E. Discontinuing ANH is most contentious when it affects a young, otherwise healthy person in a persistent vegetative state.

Answer: C.

Only a few decades ago, litigation over end-of-life care took the form of surrogates demanding to stop treatment, e.g., mechanical ventilation, against the orders of the hospital and doctors.¹ The parties now tend to reverse their positions, with some families insisting on continuing all treatment modalities, especially artificial nutrition and hydration (ANH) such as tube feedings. Medical futility has been variously defined as an intervention that has no pathophysiologic rationale, where such intervention had already failed in the patient, where maximal treatment is already failing, or where the intervention will not achieve the goals of care. The AMA Code of Medical Ethics advises: “Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them.”² The AMA Code also clarifies that “life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition” and “may include … artificial nutrition and hydration.”³

Although many palliative care specialists have deemed ANH to be of dubious medical benefit at the end of life,⁴ forgoing ANH nonetheless poses a particularly contentious dilemma. Opponents assert that ANH is a form of feeding rather than medical treatment, denial of which amounts to “starving” the patient to death. However in 1990, the U.S. Supreme Court in Cruzan v. Director⁵ declared that ANH could not be readily distinguished from other forms of medical treatment. The case involved a 25-year-old woman who lapsed into a persistent vegetative state (PVS) following an automobile accident. Her parents sought a court order to withdraw ANH when it became apparent that she had virtually no chance of recovering her cognitive faculties. Writing for a unanimous Supreme Court, Justice O’Connor opined: “Whether or not the techniques used to pass food and water into the patient’s alimentary tract are termed ‘medical treatment,’ it is clear they all involve some degree of intrusion and restraint. … Feeding a patient by means of a nasogastric tube requires a physician to pass a long flexible tube through the patient’s nose, throat, and esophagus and into the stomach. Because of the discomfort such a tube causes, ‘many patients need to be restrained forcibly and their hands put into large mittens to prevent them from removing the tube.’ A gastrostomy tube … or jejunostomy tube must be surgically implanted into the stomach or small intestine. … Requiring a competent adult to endure such procedures against her will burdens the patient’s liberty, dignity, and freedom to determine the course of her own treatment.”

The English High Court has likewise adopted this position in Airedale NHS Trust v. Bland.⁶ Tony Bland, a young man, was crushed in a Hillsborough football melee in 1989, which caused him to develop PVS. The court wrote: “The question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of medical treatment or care. The correct formulation of the question is of particular importance in a case such as the present, where the patient is totally unconscious or where there is no hope whatsoever of any amelioration of his condition.”

In 2005, the United States witnessed its most public and highly politicized case regarding the withdrawal of ANH.⁷ In 1990, Terri Schiavo, then age 26, sustained a cardiac arrest, possibly caused by an eating disorder and hypokalemia. Her husband, Michael, filed a malpractice suit and won damages of $1.5 million, but the arrest left her in a PVS. Terri had left no advance directive, and her husband said she would rather die than be kept alive artificially, and therefore directed that her tube feeding be stopped. On the other hand, her parents Bob and Mary Schindler wished to keep her alive, and volunteered to take care of her. After a long and bitter legal battle, an appellate court finally agreed to stop Terri’s tube feeding, as it found clear and convincing evidence that she would not have wanted to live in that manner. The U.S. Supreme Court refused to review the case. On Oct. 15, 2003, with the discontinuation of her tube feeding, Terri’s parents appealed to then Florida Gov. Jeb Bush, calling into question the diagnosis of PVS. They insisted Terri’s eyes were open, and she appeared to respond with smiles to the sound of her mother’s voice. Despite contrary expert opinion, 15 doctors testified she could and would improve. Both the Florida legislature and the U.S. Congress intervened but to no avail. Terri died at 10 a.m. on March 31, 2005, 13 days after tube withdrawal. An autopsy revealed severe brain atrophy.

In Cruzan, the U.S. Supreme Court had held that the liberty guaranteed by the Due Process Clause must protect an individual’s deeply personal decision to reject medical treatment, including the artificial delivery of food and water. However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment. In a 6-0 decision, the California Supreme Court ruled that a patient’s tube feedings could not be discontinued under the circumstances of the Wendland case.⁸ Robert Wendland regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, the county ombudsman, and a court-appointed counsel all agreed with the decision. Robert did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state. But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.

In some jurisdictions, a patient’s advance medical directive to discontinue ANH may require a specific opt-in or opt-out choice. And although medical directives typically spring into effect when a patient is terminally ill, many jurisdictions allow their applicability in nonterminal conditions such as irreversible unconscious states or where the likely risks and burdens of treatment would outweigh any expected benefits (Hawaii is such a state under HRS §327E-16). Physicians are legally bound to respect a patient’s wish regarding forgoing or continuing therapy including ANH. Given the wide variations in legal requirements governing this emotional matter, physicians must look closely at their individual state statute to determine the proper course of action under the circumstances.

References

1. In re Quinlan, 70 N.J. 10 (1976).

2. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.035.

3. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.20.

4. Danis M. Stopping artificial nutrition and hydration at the end of life. UpToDate, Nov 2, 2015.

5. Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990).

6. Airedale NHS Trust v. Bland (1993) A.C. 789.

7. Available at https://en.wikipedia.org/wiki/Terri_Schiavo_case.

8. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).

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 artificial nutrition and hydration (ANH) is least supported in ethics and/or law?

A. One may invoke medical futility and discontinue ANH in noncognitive, terminally ill patients.

B. Forgoing ANH at the end of life is part of good palliative care.

C. Tube feeding is a way to provide food and sustenance and does not constitute medical treatment.

D. Many state statutes allow for the discontinuation of ANH under specified conditions.

E. Discontinuing ANH is most contentious when it affects a young, otherwise healthy person in a persistent vegetative state.

Answer: C.

Only a few decades ago, litigation over end-of-life care took the form of surrogates demanding to stop treatment, e.g., mechanical ventilation, against the orders of the hospital and doctors.¹ The parties now tend to reverse their positions, with some families insisting on continuing all treatment modalities, especially artificial nutrition and hydration (ANH) such as tube feedings. Medical futility has been variously defined as an intervention that has no pathophysiologic rationale, where such intervention had already failed in the patient, where maximal treatment is already failing, or where the intervention will not achieve the goals of care. The AMA Code of Medical Ethics advises: “Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them.”² The AMA Code also clarifies that “life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition” and “may include … artificial nutrition and hydration.”³

Although many palliative care specialists have deemed ANH to be of dubious medical benefit at the end of life,⁴ forgoing ANH nonetheless poses a particularly contentious dilemma. Opponents assert that ANH is a form of feeding rather than medical treatment, denial of which amounts to “starving” the patient to death. However in 1990, the U.S. Supreme Court in Cruzan v. Director⁵ declared that ANH could not be readily distinguished from other forms of medical treatment. The case involved a 25-year-old woman who lapsed into a persistent vegetative state (PVS) following an automobile accident. Her parents sought a court order to withdraw ANH when it became apparent that she had virtually no chance of recovering her cognitive faculties. Writing for a unanimous Supreme Court, Justice O’Connor opined: “Whether or not the techniques used to pass food and water into the patient’s alimentary tract are termed ‘medical treatment,’ it is clear they all involve some degree of intrusion and restraint. … Feeding a patient by means of a nasogastric tube requires a physician to pass a long flexible tube through the patient’s nose, throat, and esophagus and into the stomach. Because of the discomfort such a tube causes, ‘many patients need to be restrained forcibly and their hands put into large mittens to prevent them from removing the tube.’ A gastrostomy tube … or jejunostomy tube must be surgically implanted into the stomach or small intestine. … Requiring a competent adult to endure such procedures against her will burdens the patient’s liberty, dignity, and freedom to determine the course of her own treatment.”

The English High Court has likewise adopted this position in Airedale NHS Trust v. Bland.⁶ Tony Bland, a young man, was crushed in a Hillsborough football melee in 1989, which caused him to develop PVS. The court wrote: “The question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of medical treatment or care. The correct formulation of the question is of particular importance in a case such as the present, where the patient is totally unconscious or where there is no hope whatsoever of any amelioration of his condition.”

In 2005, the United States witnessed its most public and highly politicized case regarding the withdrawal of ANH.⁷ In 1990, Terri Schiavo, then age 26, sustained a cardiac arrest, possibly caused by an eating disorder and hypokalemia. Her husband, Michael, filed a malpractice suit and won damages of $1.5 million, but the arrest left her in a PVS. Terri had left no advance directive, and her husband said she would rather die than be kept alive artificially, and therefore directed that her tube feeding be stopped. On the other hand, her parents Bob and Mary Schindler wished to keep her alive, and volunteered to take care of her. After a long and bitter legal battle, an appellate court finally agreed to stop Terri’s tube feeding, as it found clear and convincing evidence that she would not have wanted to live in that manner. The U.S. Supreme Court refused to review the case. On Oct. 15, 2003, with the discontinuation of her tube feeding, Terri’s parents appealed to then Florida Gov. Jeb Bush, calling into question the diagnosis of PVS. They insisted Terri’s eyes were open, and she appeared to respond with smiles to the sound of her mother’s voice. Despite contrary expert opinion, 15 doctors testified she could and would improve. Both the Florida legislature and the U.S. Congress intervened but to no avail. Terri died at 10 a.m. on March 31, 2005, 13 days after tube withdrawal. An autopsy revealed severe brain atrophy.

In Cruzan, the U.S. Supreme Court had held that the liberty guaranteed by the Due Process Clause must protect an individual’s deeply personal decision to reject medical treatment, including the artificial delivery of food and water. However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment. In a 6-0 decision, the California Supreme Court ruled that a patient’s tube feedings could not be discontinued under the circumstances of the Wendland case.⁸ Robert Wendland regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, the county ombudsman, and a court-appointed counsel all agreed with the decision. Robert did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state. But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.

In some jurisdictions, a patient’s advance medical directive to discontinue ANH may require a specific opt-in or opt-out choice. And although medical directives typically spring into effect when a patient is terminally ill, many jurisdictions allow their applicability in nonterminal conditions such as irreversible unconscious states or where the likely risks and burdens of treatment would outweigh any expected benefits (Hawaii is such a state under HRS §327E-16). Physicians are legally bound to respect a patient’s wish regarding forgoing or continuing therapy including ANH. Given the wide variations in legal requirements governing this emotional matter, physicians must look closely at their individual state statute to determine the proper course of action under the circumstances.

References

1. In re Quinlan, 70 N.J. 10 (1976).

2. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.035.

3. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.20.

4. Danis M. Stopping artificial nutrition and hydration at the end of life. UpToDate, Nov 2, 2015.

5. Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990).

6. Airedale NHS Trust v. Bland (1993) A.C. 789.

7. Available at https://en.wikipedia.org/wiki/Terri_Schiavo_case.

8. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).

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 artificial nutrition and hydration (ANH) is least supported in ethics and/or law?

A. One may invoke medical futility and discontinue ANH in noncognitive, terminally ill patients.

B. Forgoing ANH at the end of life is part of good palliative care.

C. Tube feeding is a way to provide food and sustenance and does not constitute medical treatment.

D. Many state statutes allow for the discontinuation of ANH under specified conditions.

E. Discontinuing ANH is most contentious when it affects a young, otherwise healthy person in a persistent vegetative state.

Answer: C.

Only a few decades ago, litigation over end-of-life care took the form of surrogates demanding to stop treatment, e.g., mechanical ventilation, against the orders of the hospital and doctors.¹ The parties now tend to reverse their positions, with some families insisting on continuing all treatment modalities, especially artificial nutrition and hydration (ANH) such as tube feedings. Medical futility has been variously defined as an intervention that has no pathophysiologic rationale, where such intervention had already failed in the patient, where maximal treatment is already failing, or where the intervention will not achieve the goals of care. The AMA Code of Medical Ethics advises: “Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them.”² The AMA Code also clarifies that “life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition” and “may include … artificial nutrition and hydration.”³

Although many palliative care specialists have deemed ANH to be of dubious medical benefit at the end of life,⁴ forgoing ANH nonetheless poses a particularly contentious dilemma. Opponents assert that ANH is a form of feeding rather than medical treatment, denial of which amounts to “starving” the patient to death. However in 1990, the U.S. Supreme Court in Cruzan v. Director⁵ declared that ANH could not be readily distinguished from other forms of medical treatment. The case involved a 25-year-old woman who lapsed into a persistent vegetative state (PVS) following an automobile accident. Her parents sought a court order to withdraw ANH when it became apparent that she had virtually no chance of recovering her cognitive faculties. Writing for a unanimous Supreme Court, Justice O’Connor opined: “Whether or not the techniques used to pass food and water into the patient’s alimentary tract are termed ‘medical treatment,’ it is clear they all involve some degree of intrusion and restraint. … Feeding a patient by means of a nasogastric tube requires a physician to pass a long flexible tube through the patient’s nose, throat, and esophagus and into the stomach. Because of the discomfort such a tube causes, ‘many patients need to be restrained forcibly and their hands put into large mittens to prevent them from removing the tube.’ A gastrostomy tube … or jejunostomy tube must be surgically implanted into the stomach or small intestine. … Requiring a competent adult to endure such procedures against her will burdens the patient’s liberty, dignity, and freedom to determine the course of her own treatment.”

The English High Court has likewise adopted this position in Airedale NHS Trust v. Bland.⁶ Tony Bland, a young man, was crushed in a Hillsborough football melee in 1989, which caused him to develop PVS. The court wrote: “The question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of medical treatment or care. The correct formulation of the question is of particular importance in a case such as the present, where the patient is totally unconscious or where there is no hope whatsoever of any amelioration of his condition.”

In 2005, the United States witnessed its most public and highly politicized case regarding the withdrawal of ANH.⁷ In 1990, Terri Schiavo, then age 26, sustained a cardiac arrest, possibly caused by an eating disorder and hypokalemia. Her husband, Michael, filed a malpractice suit and won damages of $1.5 million, but the arrest left her in a PVS. Terri had left no advance directive, and her husband said she would rather die than be kept alive artificially, and therefore directed that her tube feeding be stopped. On the other hand, her parents Bob and Mary Schindler wished to keep her alive, and volunteered to take care of her. After a long and bitter legal battle, an appellate court finally agreed to stop Terri’s tube feeding, as it found clear and convincing evidence that she would not have wanted to live in that manner. The U.S. Supreme Court refused to review the case. On Oct. 15, 2003, with the discontinuation of her tube feeding, Terri’s parents appealed to then Florida Gov. Jeb Bush, calling into question the diagnosis of PVS. They insisted Terri’s eyes were open, and she appeared to respond with smiles to the sound of her mother’s voice. Despite contrary expert opinion, 15 doctors testified she could and would improve. Both the Florida legislature and the U.S. Congress intervened but to no avail. Terri died at 10 a.m. on March 31, 2005, 13 days after tube withdrawal. An autopsy revealed severe brain atrophy.

In Cruzan, the U.S. Supreme Court had held that the liberty guaranteed by the Due Process Clause must protect an individual’s deeply personal decision to reject medical treatment, including the artificial delivery of food and water. However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment. In a 6-0 decision, the California Supreme Court ruled that a patient’s tube feedings could not be discontinued under the circumstances of the Wendland case.⁸ Robert Wendland regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, the county ombudsman, and a court-appointed counsel all agreed with the decision. Robert did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state. But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.

In some jurisdictions, a patient’s advance medical directive to discontinue ANH may require a specific opt-in or opt-out choice. And although medical directives typically spring into effect when a patient is terminally ill, many jurisdictions allow their applicability in nonterminal conditions such as irreversible unconscious states or where the likely risks and burdens of treatment would outweigh any expected benefits (Hawaii is such a state under HRS §327E-16). Physicians are legally bound to respect a patient’s wish regarding forgoing or continuing therapy including ANH. Given the wide variations in legal requirements governing this emotional matter, physicians must look closely at their individual state statute to determine the proper course of action under the circumstances.

References

1. In re Quinlan, 70 N.J. 10 (1976).

2. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.035.

3. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.20.

4. Danis M. Stopping artificial nutrition and hydration at the end of life. UpToDate, Nov 2, 2015.

5. Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990).

6. Airedale NHS Trust v. Bland (1993) A.C. 789.

7. Available at https://en.wikipedia.org/wiki/Terri_Schiavo_case.

8. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).

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: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

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: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

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: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

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 choices is best?

A. Controversy exists over whether defensive medicine is widely practiced and whether it raises health care costs.

B. Everyone agrees that defensive medicine is widely practiced.

C. Doctors who spend more for their hospitalized patients have been reported to face a lower malpractice risk.

D. A and C.

E. B and C.

Answer: D. Virtually all doctors admit they practice defensive medicine, which describes medical care specifically directed to attenuate the threat of malpractice liability rather than for a proper medical indication. Survey studies generally put the prevalence at greater than 90%, but what separates true defensive medicine from careful practice or patient expectation/demand remains controversial.

A mail survey of 824 physicians in high-risk specialties in Pennsylvania, a state where doctors pay high malpractice premiums, revealed that nearly all reported practicing defensive medicine. The respondents admitted to both assurance behavior – such as ordering more tests, especially imaging studies – as well as avoidance behavior – that is, restricting or eliminating complex procedures or perceived litigious patients.¹

In another study, emergency physicians in the upper third of “malpractice fear” used more diagnostic tests and were more likely to hospitalize patients at low risk for coronary artery disease.²

On the other hand, a report using simulated clinical scenarios concluded that the extent of defensive medicine was at most 8%, and another found no correlation between individual malpractice claims experience and resource use, physician concern about malpractice, tolerance for uncertainty, or perception of risk.³

Another area of contention is whether some of our soaring health care costs may reflect defensive medicine at play.

A recent survey of 2,000 U.S. orthopedic surgeons found that 96% admitted practicing defensive medicine, with 24% of all ordered tests being for defensive reasons. The authors estimated that this amounted to about $100,000 per surgeon per year, or a total annual sum of $2 billion for the 20,400 orthopedic surgeons in the U.S.⁴

By correlating professional liability insurance with cost of services, the AMA estimated that in the 1980s, defensive medicine cost $12.1 billion to $13.7 billion each year.⁵ In an oft-cited study by Kessler and McClellan, the authors measured the effects of malpractice liability reforms using data from elderly Medicare beneficiaries treated for serious heart disease.⁶ They found that reforms that directly reduced provider liability pressure led to reductions of 5%-9% in medical expenditures. If such Medicare savings, which amounted to $600 million per year for cardiac disease, were extrapolated across the health care system, the annual savings would total $50 billion.

A more conservative study estimated that systemwide savings from aggressive malpractice reform would approach $41 billion over 5 years.⁷

Dr. Anupam B. Jena and his coauthors are the latest investigators seeking to clarify the correlation between defensive medicine and health care costs.⁸ Using Florida hospital admission data from 2000-2009, which covered some 24,000 physicians in seven separate specialties, the authors found that higher spending by physicians was associated with reduced malpractice claims the following year. This pattern held true for six of the seven specialties, family practitioners being the sole exception.

For example, among internists, the malpractice risk probability was reduced from 1.5% in the bottom spending fifth ($19,725 per admission) to 0.3% in the top fifth ($39,379 per admission). Among obstetricians, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth. These results comport with previous reports of higher C-section rates in obstetricians who perceived themselves at higher malpractice risk, although other studies have found no correlation or an actual lower rate.

In concluding that higher resource use by physicians was associated with fewer malpractice claims, the authors acknowledged that a principal limitation of the study was the lack of information on illness severity. Importantly, they were unable to state whether higher spending was defensively motivated. A companion editorial questioned whether increased resource expenditure was a bona fide reflection of defensive medicine or may simply have resulted in fewer errors and adverse events.⁹

Unfortunately, the past malpractice experience of the doctors, which could provide insight into more defensive postures, better communication, etc., was not measured in the study. In addition, claims made just 1 year after an incident may not accurately reflect the real-world situation, where the filing of a lawsuit may lag any alleged negligence by a much longer period, especially in obstetric cases.

Worryingly, the results of this timely study may be used to imply that the more doctors spend, the less likely they are to be sued – a troubling notion in our current race to stem rising health care costs.

References

1. JAMA. 2005 Jun 1;293(21):2609-17.

2. Ann Emerg Med. 2005 Dec;46(6):525-33.

3. J Health Polit Policy Law. 1996 Summer;21(2):267-88.

4. Am J Orthop (Belle Mead NJ). 2012 Feb;41(2):69-73.

5. JAMA. 1987 May 22-29;257(20):2776-81.

6. Q J Econ. 1996 May; 111(2):353-90.

7. J Am Health Policy. 1994 Jul-Aug;4(4):7-15.

8. BMJ. 2015 Nov 4;351:h5516.

9. BMJ. 2015 Nov 4;351:h5786.

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 choices is best?

A. Controversy exists over whether defensive medicine is widely practiced and whether it raises health care costs.

B. Everyone agrees that defensive medicine is widely practiced.

C. Doctors who spend more for their hospitalized patients have been reported to face a lower malpractice risk.

D. A and C.

E. B and C.

Answer: D. Virtually all doctors admit they practice defensive medicine, which describes medical care specifically directed to attenuate the threat of malpractice liability rather than for a proper medical indication. Survey studies generally put the prevalence at greater than 90%, but what separates true defensive medicine from careful practice or patient expectation/demand remains controversial.

A mail survey of 824 physicians in high-risk specialties in Pennsylvania, a state where doctors pay high malpractice premiums, revealed that nearly all reported practicing defensive medicine. The respondents admitted to both assurance behavior – such as ordering more tests, especially imaging studies – as well as avoidance behavior – that is, restricting or eliminating complex procedures or perceived litigious patients.¹

In another study, emergency physicians in the upper third of “malpractice fear” used more diagnostic tests and were more likely to hospitalize patients at low risk for coronary artery disease.²

On the other hand, a report using simulated clinical scenarios concluded that the extent of defensive medicine was at most 8%, and another found no correlation between individual malpractice claims experience and resource use, physician concern about malpractice, tolerance for uncertainty, or perception of risk.³

Another area of contention is whether some of our soaring health care costs may reflect defensive medicine at play.

A recent survey of 2,000 U.S. orthopedic surgeons found that 96% admitted practicing defensive medicine, with 24% of all ordered tests being for defensive reasons. The authors estimated that this amounted to about $100,000 per surgeon per year, or a total annual sum of $2 billion for the 20,400 orthopedic surgeons in the U.S.⁴

By correlating professional liability insurance with cost of services, the AMA estimated that in the 1980s, defensive medicine cost $12.1 billion to $13.7 billion each year.⁵ In an oft-cited study by Kessler and McClellan, the authors measured the effects of malpractice liability reforms using data from elderly Medicare beneficiaries treated for serious heart disease.⁶ They found that reforms that directly reduced provider liability pressure led to reductions of 5%-9% in medical expenditures. If such Medicare savings, which amounted to $600 million per year for cardiac disease, were extrapolated across the health care system, the annual savings would total $50 billion.

A more conservative study estimated that systemwide savings from aggressive malpractice reform would approach $41 billion over 5 years.⁷

Dr. Anupam B. Jena and his coauthors are the latest investigators seeking to clarify the correlation between defensive medicine and health care costs.⁸ Using Florida hospital admission data from 2000-2009, which covered some 24,000 physicians in seven separate specialties, the authors found that higher spending by physicians was associated with reduced malpractice claims the following year. This pattern held true for six of the seven specialties, family practitioners being the sole exception.

For example, among internists, the malpractice risk probability was reduced from 1.5% in the bottom spending fifth ($19,725 per admission) to 0.3% in the top fifth ($39,379 per admission). Among obstetricians, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth. These results comport with previous reports of higher C-section rates in obstetricians who perceived themselves at higher malpractice risk, although other studies have found no correlation or an actual lower rate.

In concluding that higher resource use by physicians was associated with fewer malpractice claims, the authors acknowledged that a principal limitation of the study was the lack of information on illness severity. Importantly, they were unable to state whether higher spending was defensively motivated. A companion editorial questioned whether increased resource expenditure was a bona fide reflection of defensive medicine or may simply have resulted in fewer errors and adverse events.⁹

Unfortunately, the past malpractice experience of the doctors, which could provide insight into more defensive postures, better communication, etc., was not measured in the study. In addition, claims made just 1 year after an incident may not accurately reflect the real-world situation, where the filing of a lawsuit may lag any alleged negligence by a much longer period, especially in obstetric cases.

Worryingly, the results of this timely study may be used to imply that the more doctors spend, the less likely they are to be sued – a troubling notion in our current race to stem rising health care costs.

References

1. JAMA. 2005 Jun 1;293(21):2609-17.

2. Ann Emerg Med. 2005 Dec;46(6):525-33.

3. J Health Polit Policy Law. 1996 Summer;21(2):267-88.

4. Am J Orthop (Belle Mead NJ). 2012 Feb;41(2):69-73.

5. JAMA. 1987 May 22-29;257(20):2776-81.

6. Q J Econ. 1996 May; 111(2):353-90.

7. J Am Health Policy. 1994 Jul-Aug;4(4):7-15.

8. BMJ. 2015 Nov 4;351:h5516.

9. BMJ. 2015 Nov 4;351:h5786.

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 choices is best?

A. Controversy exists over whether defensive medicine is widely practiced and whether it raises health care costs.

B. Everyone agrees that defensive medicine is widely practiced.

C. Doctors who spend more for their hospitalized patients have been reported to face a lower malpractice risk.

D. A and C.

E. B and C.

Answer: D. Virtually all doctors admit they practice defensive medicine, which describes medical care specifically directed to attenuate the threat of malpractice liability rather than for a proper medical indication. Survey studies generally put the prevalence at greater than 90%, but what separates true defensive medicine from careful practice or patient expectation/demand remains controversial.

A mail survey of 824 physicians in high-risk specialties in Pennsylvania, a state where doctors pay high malpractice premiums, revealed that nearly all reported practicing defensive medicine. The respondents admitted to both assurance behavior – such as ordering more tests, especially imaging studies – as well as avoidance behavior – that is, restricting or eliminating complex procedures or perceived litigious patients.¹

In another study, emergency physicians in the upper third of “malpractice fear” used more diagnostic tests and were more likely to hospitalize patients at low risk for coronary artery disease.²

On the other hand, a report using simulated clinical scenarios concluded that the extent of defensive medicine was at most 8%, and another found no correlation between individual malpractice claims experience and resource use, physician concern about malpractice, tolerance for uncertainty, or perception of risk.³

Another area of contention is whether some of our soaring health care costs may reflect defensive medicine at play.

A recent survey of 2,000 U.S. orthopedic surgeons found that 96% admitted practicing defensive medicine, with 24% of all ordered tests being for defensive reasons. The authors estimated that this amounted to about $100,000 per surgeon per year, or a total annual sum of $2 billion for the 20,400 orthopedic surgeons in the U.S.⁴

By correlating professional liability insurance with cost of services, the AMA estimated that in the 1980s, defensive medicine cost $12.1 billion to $13.7 billion each year.⁵ In an oft-cited study by Kessler and McClellan, the authors measured the effects of malpractice liability reforms using data from elderly Medicare beneficiaries treated for serious heart disease.⁶ They found that reforms that directly reduced provider liability pressure led to reductions of 5%-9% in medical expenditures. If such Medicare savings, which amounted to $600 million per year for cardiac disease, were extrapolated across the health care system, the annual savings would total $50 billion.

A more conservative study estimated that systemwide savings from aggressive malpractice reform would approach $41 billion over 5 years.⁷

Dr. Anupam B. Jena and his coauthors are the latest investigators seeking to clarify the correlation between defensive medicine and health care costs.⁸ Using Florida hospital admission data from 2000-2009, which covered some 24,000 physicians in seven separate specialties, the authors found that higher spending by physicians was associated with reduced malpractice claims the following year. This pattern held true for six of the seven specialties, family practitioners being the sole exception.

For example, among internists, the malpractice risk probability was reduced from 1.5% in the bottom spending fifth ($19,725 per admission) to 0.3% in the top fifth ($39,379 per admission). Among obstetricians, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth. These results comport with previous reports of higher C-section rates in obstetricians who perceived themselves at higher malpractice risk, although other studies have found no correlation or an actual lower rate.

In concluding that higher resource use by physicians was associated with fewer malpractice claims, the authors acknowledged that a principal limitation of the study was the lack of information on illness severity. Importantly, they were unable to state whether higher spending was defensively motivated. A companion editorial questioned whether increased resource expenditure was a bona fide reflection of defensive medicine or may simply have resulted in fewer errors and adverse events.⁹

Unfortunately, the past malpractice experience of the doctors, which could provide insight into more defensive postures, better communication, etc., was not measured in the study. In addition, claims made just 1 year after an incident may not accurately reflect the real-world situation, where the filing of a lawsuit may lag any alleged negligence by a much longer period, especially in obstetric cases.

Worryingly, the results of this timely study may be used to imply that the more doctors spend, the less likely they are to be sued – a troubling notion in our current race to stem rising health care costs.

References

1. JAMA. 2005 Jun 1;293(21):2609-17.

2. Ann Emerg Med. 2005 Dec;46(6):525-33.

3. J Health Polit Policy Law. 1996 Summer;21(2):267-88.

4. Am J Orthop (Belle Mead NJ). 2012 Feb;41(2):69-73.

5. JAMA. 1987 May 22-29;257(20):2776-81.

6. Q J Econ. 1996 May; 111(2):353-90.

7. J Am Health Policy. 1994 Jul-Aug;4(4):7-15.

8. BMJ. 2015 Nov 4;351:h5516.

9. BMJ. 2015 Nov 4;351:h5786.

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: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

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: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

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: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

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 doctor may owe a duty of care in the setting of:

A. A cyber relationship.

B. A special relationship.

C. Both A and B.

D. Neither A nor B.

Answer: C. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries.

Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

Duty in the context of medical negligence is not usually in dispute, as it is plainly owed by a doctor to his or her patient. It arises out of the doctor-patient relationship. Whether a relationship has been formed in the first place is a threshold inquiry. Where a doctor accepts a patient who is seeking his or her services, the relationship is readily evident. Duty is also established when the doctor begins the evaluation process in a typical encounter.

However, a phone inquiry by a potential patient, without more, may be insufficient to create this relationship, although this may depend on the nature of the phone conversation and the doctor’s response.

Likewise, a “curbside” consultation sought by a colleague does not normally translate into a duty for the doctor offering the opinion. Presumably casual advice given freely and understood as such at social gatherings does not add up to a doctor-patient relationship, and courts will look to reasonableness as the touchstone in deciding whether such a relationship was ever formed.

Still, there are some medical situations where a legitimate question of duty can be raised. With the growth of electronic medical records and communication, medical encounters in cyberspace will emerge as an increasing source of litigation.

Internet liability can be far reaching. In addition to risks governing negligence, informed consent, and privacy/confidentiality, there are additional issues of product liability, cross-border jurisdictional conflicts, and others.

The threshold question when assessing cyberspace liability arising, for example, from the use of doctor-operated medical websites concerns duty, because its existence or denial will determine whether the case can go forward in the first place. Although not the typical office or hospital patient, a plaintiff may argue successfully that a doctor-patient relationship had nonetheless been formed in cyberspace.

It is possible that such a relationship will be found in some circumstances, relevant factors being knowledge of names of subscribers, frequency of interactions, specificity of queries, and so on. In particular, a subscription fee is likely to be construed as evidence of soliciting and accepting a more committed interaction, so it places the operator of the website at greater legal risk. A specific disclaimer is a standard precaution but may not be enough to definitively protect against a lawsuit.

Courts have ruled in favor of plaintiffs despite the absence of face-to-face interaction with a physician. In one case, a doctor speaking to a patient from the emergency department was deemed to have formed a doctor-patient relationship (O’Neill v. Montefiore Hospital, 11 A.D.2d 132 (N.Y.A.D. 1 Dept. 1960). In another, an on-call neurologist’s telephone advice to the treating doctor likewise raised the issue of legal duty (Lection v. Dyll, 65 S.W.3d 696 (Tex. App. Dallas 2001).

The state of Hawaii now permits telehealth services to be reimbursable, notwithstanding the absence of face-to-face contact (HI Rev Stat § 431:10A-116.3[a]). With this law, an online encounter will likely translate into a professional relationship – with corresponding legal duty of due care.

In the case of a Good Samaritan physician – i.e., one who offers gratuitous aid to a stranger in need of medical assistance – courts are unlikely to find a professional relationship, because there is no common law duty to help a stranger.

However, once treatment has begun, there is a duty not to make matters worse. So, all 50 states have enacted Good Samaritan statutes, which protect against liability arising out of negligent rescue. Note that statutory protection is generally excluded for Good Samaritan acts performed within a hospital setting, under the theory that doctors have an ongoing relationship with the hospital and are already obligated to provide emergency care within its walls.

Another category of legal duty concerns nonpatient third parties. The complaint may relate to a failure to warn family members of a patient’s contagious disease, or the transmissible condition may have been missed and an innocent third party was injured as a result.

Another situation where duty to a third party might arise is the learning of a credible threat of harm directed at a named individual. This is famously known as the Tarasoff doctrine, after a California case in which the court imposed a duty on a college psychologist to directly warn an intended victim of harm by his patient – even though that meant breaching confidentiality of a professional relationship, and the victim was a nonpatient third party (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

A doctor may also incur liability for automobile injuries sustained by one other than his or her own patient. In a Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old bystander. The driver alleged that the prescription medication prazosin caused him to lose control of the car.

In ruling that the health care provider was liable to the injured bystander, the Hawaii Supreme Court held that physicians have a duty to warn their patients of potential adverse medication effects, and this responsibility should extend to third parties (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]).

A foreseeable and unreasonable risk of harm is an important factor, but not the only decisive factor, in construing the existence of a legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of “existing social values, customs, and considerations of policy.”

In a Massachusetts case, a family practitioner had failed to warn his patient of the risk of diabetic drugs when operating a vehicle. Just 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court used the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist (Arsenault v. McConarty, 21 Mass. L. Rptr. 500 [2006]).

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 doctor may owe a duty of care in the setting of:

A. A cyber relationship.

B. A special relationship.

C. Both A and B.

D. Neither A nor B.

Answer: C. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries.

Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

Duty in the context of medical negligence is not usually in dispute, as it is plainly owed by a doctor to his or her patient. It arises out of the doctor-patient relationship. Whether a relationship has been formed in the first place is a threshold inquiry. Where a doctor accepts a patient who is seeking his or her services, the relationship is readily evident. Duty is also established when the doctor begins the evaluation process in a typical encounter.

However, a phone inquiry by a potential patient, without more, may be insufficient to create this relationship, although this may depend on the nature of the phone conversation and the doctor’s response.

Likewise, a “curbside” consultation sought by a colleague does not normally translate into a duty for the doctor offering the opinion. Presumably casual advice given freely and understood as such at social gatherings does not add up to a doctor-patient relationship, and courts will look to reasonableness as the touchstone in deciding whether such a relationship was ever formed.

Still, there are some medical situations where a legitimate question of duty can be raised. With the growth of electronic medical records and communication, medical encounters in cyberspace will emerge as an increasing source of litigation.

Internet liability can be far reaching. In addition to risks governing negligence, informed consent, and privacy/confidentiality, there are additional issues of product liability, cross-border jurisdictional conflicts, and others.

The threshold question when assessing cyberspace liability arising, for example, from the use of doctor-operated medical websites concerns duty, because its existence or denial will determine whether the case can go forward in the first place. Although not the typical office or hospital patient, a plaintiff may argue successfully that a doctor-patient relationship had nonetheless been formed in cyberspace.

It is possible that such a relationship will be found in some circumstances, relevant factors being knowledge of names of subscribers, frequency of interactions, specificity of queries, and so on. In particular, a subscription fee is likely to be construed as evidence of soliciting and accepting a more committed interaction, so it places the operator of the website at greater legal risk. A specific disclaimer is a standard precaution but may not be enough to definitively protect against a lawsuit.

Courts have ruled in favor of plaintiffs despite the absence of face-to-face interaction with a physician. In one case, a doctor speaking to a patient from the emergency department was deemed to have formed a doctor-patient relationship (O’Neill v. Montefiore Hospital, 11 A.D.2d 132 (N.Y.A.D. 1 Dept. 1960). In another, an on-call neurologist’s telephone advice to the treating doctor likewise raised the issue of legal duty (Lection v. Dyll, 65 S.W.3d 696 (Tex. App. Dallas 2001).

The state of Hawaii now permits telehealth services to be reimbursable, notwithstanding the absence of face-to-face contact (HI Rev Stat § 431:10A-116.3[a]). With this law, an online encounter will likely translate into a professional relationship – with corresponding legal duty of due care.

In the case of a Good Samaritan physician – i.e., one who offers gratuitous aid to a stranger in need of medical assistance – courts are unlikely to find a professional relationship, because there is no common law duty to help a stranger.

However, once treatment has begun, there is a duty not to make matters worse. So, all 50 states have enacted Good Samaritan statutes, which protect against liability arising out of negligent rescue. Note that statutory protection is generally excluded for Good Samaritan acts performed within a hospital setting, under the theory that doctors have an ongoing relationship with the hospital and are already obligated to provide emergency care within its walls.

Another category of legal duty concerns nonpatient third parties. The complaint may relate to a failure to warn family members of a patient’s contagious disease, or the transmissible condition may have been missed and an innocent third party was injured as a result.

Another situation where duty to a third party might arise is the learning of a credible threat of harm directed at a named individual. This is famously known as the Tarasoff doctrine, after a California case in which the court imposed a duty on a college psychologist to directly warn an intended victim of harm by his patient – even though that meant breaching confidentiality of a professional relationship, and the victim was a nonpatient third party (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

A doctor may also incur liability for automobile injuries sustained by one other than his or her own patient. In a Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old bystander. The driver alleged that the prescription medication prazosin caused him to lose control of the car.

In ruling that the health care provider was liable to the injured bystander, the Hawaii Supreme Court held that physicians have a duty to warn their patients of potential adverse medication effects, and this responsibility should extend to third parties (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]).

A foreseeable and unreasonable risk of harm is an important factor, but not the only decisive factor, in construing the existence of a legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of “existing social values, customs, and considerations of policy.”

In a Massachusetts case, a family practitioner had failed to warn his patient of the risk of diabetic drugs when operating a vehicle. Just 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court used the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist (Arsenault v. McConarty, 21 Mass. L. Rptr. 500 [2006]).

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 doctor may owe a duty of care in the setting of:

A. A cyber relationship.

B. A special relationship.

C. Both A and B.

D. Neither A nor B.

Answer: C. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries.

Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

Duty in the context of medical negligence is not usually in dispute, as it is plainly owed by a doctor to his or her patient. It arises out of the doctor-patient relationship. Whether a relationship has been formed in the first place is a threshold inquiry. Where a doctor accepts a patient who is seeking his or her services, the relationship is readily evident. Duty is also established when the doctor begins the evaluation process in a typical encounter.

However, a phone inquiry by a potential patient, without more, may be insufficient to create this relationship, although this may depend on the nature of the phone conversation and the doctor’s response.

Likewise, a “curbside” consultation sought by a colleague does not normally translate into a duty for the doctor offering the opinion. Presumably casual advice given freely and understood as such at social gatherings does not add up to a doctor-patient relationship, and courts will look to reasonableness as the touchstone in deciding whether such a relationship was ever formed.

Still, there are some medical situations where a legitimate question of duty can be raised. With the growth of electronic medical records and communication, medical encounters in cyberspace will emerge as an increasing source of litigation.

Internet liability can be far reaching. In addition to risks governing negligence, informed consent, and privacy/confidentiality, there are additional issues of product liability, cross-border jurisdictional conflicts, and others.

The threshold question when assessing cyberspace liability arising, for example, from the use of doctor-operated medical websites concerns duty, because its existence or denial will determine whether the case can go forward in the first place. Although not the typical office or hospital patient, a plaintiff may argue successfully that a doctor-patient relationship had nonetheless been formed in cyberspace.

It is possible that such a relationship will be found in some circumstances, relevant factors being knowledge of names of subscribers, frequency of interactions, specificity of queries, and so on. In particular, a subscription fee is likely to be construed as evidence of soliciting and accepting a more committed interaction, so it places the operator of the website at greater legal risk. A specific disclaimer is a standard precaution but may not be enough to definitively protect against a lawsuit.

Courts have ruled in favor of plaintiffs despite the absence of face-to-face interaction with a physician. In one case, a doctor speaking to a patient from the emergency department was deemed to have formed a doctor-patient relationship (O’Neill v. Montefiore Hospital, 11 A.D.2d 132 (N.Y.A.D. 1 Dept. 1960). In another, an on-call neurologist’s telephone advice to the treating doctor likewise raised the issue of legal duty (Lection v. Dyll, 65 S.W.3d 696 (Tex. App. Dallas 2001).

The state of Hawaii now permits telehealth services to be reimbursable, notwithstanding the absence of face-to-face contact (HI Rev Stat § 431:10A-116.3[a]). With this law, an online encounter will likely translate into a professional relationship – with corresponding legal duty of due care.

In the case of a Good Samaritan physician – i.e., one who offers gratuitous aid to a stranger in need of medical assistance – courts are unlikely to find a professional relationship, because there is no common law duty to help a stranger.

However, once treatment has begun, there is a duty not to make matters worse. So, all 50 states have enacted Good Samaritan statutes, which protect against liability arising out of negligent rescue. Note that statutory protection is generally excluded for Good Samaritan acts performed within a hospital setting, under the theory that doctors have an ongoing relationship with the hospital and are already obligated to provide emergency care within its walls.

Another category of legal duty concerns nonpatient third parties. The complaint may relate to a failure to warn family members of a patient’s contagious disease, or the transmissible condition may have been missed and an innocent third party was injured as a result.

Another situation where duty to a third party might arise is the learning of a credible threat of harm directed at a named individual. This is famously known as the Tarasoff doctrine, after a California case in which the court imposed a duty on a college psychologist to directly warn an intended victim of harm by his patient – even though that meant breaching confidentiality of a professional relationship, and the victim was a nonpatient third party (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

A doctor may also incur liability for automobile injuries sustained by one other than his or her own patient. In a Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old bystander. The driver alleged that the prescription medication prazosin caused him to lose control of the car.

In ruling that the health care provider was liable to the injured bystander, the Hawaii Supreme Court held that physicians have a duty to warn their patients of potential adverse medication effects, and this responsibility should extend to third parties (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]).

A foreseeable and unreasonable risk of harm is an important factor, but not the only decisive factor, in construing the existence of a legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of “existing social values, customs, and considerations of policy.”

In a Massachusetts case, a family practitioner had failed to warn his patient of the risk of diabetic drugs when operating a vehicle. Just 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court used the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist (Arsenault v. McConarty, 21 Mass. L. Rptr. 500 [2006]).

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].

Was this CT with contrast unnecessary—and harmful?

A 52-YEAR-OLD WOMAN presented to the emergency department (ED) with leg pain and vaginal bleeding. The ED physicians ordered a computed tomography (CT) scan with contrast. Following the administration of the contrast dye, the patient’s blood pressure spiked and a brain aneurysm ruptured. The patient immediately underwent cranial surgery and recovered well. However, she still suffers from paralysis, cognitive issues, and weakness in her left arm and leg. She has been unable to return to her job.

PLAINTIFF’S CLAIM The doctors ran several unnecessary tests, including the CT scan, which caused her to have an allergic reaction.

THE DEFENSE The CT scan was necessary to rule out a stomach abscess, and the ruptured aneurysm was caused by her medical condition and not the dye.

VERDICT $3.62 million New Jersey verdict.

This is a sober reminder that doing more tests does not protect one from litigation.

COMMENT Here is a sober reminder that doing more tests does not protect one from litigation. We are not told enough in this short report to know if there was a legitimate indication for a CT scan, but the large award suggests there was not. The Choosing Wisely campaign (http://www.choosingwisely.org), which has a goal of “advancing a national dialogue on avoiding wasteful or unnecessary medical tests, treatments and procedures,” is not just about saving money—it is about practicing medicine appropriately.

Patient dies after being prescribed opioids right after detoxification

A 52-YEAR-OLD WOMAN had been going to the same physician for 17 years. While she was under his care, she had been prescribed various narcotics, benzodiazepines, and barbiturates, and she had become addicted to them. The patient suffered a fall at home that was allegedly caused by an overdose of these medications. During a 3-week hospitalization after her fall, the woman went through a detoxification protocol to ease her dependence on the drugs. During her next appointment with her physician, he prescribed alprazolam and morphine sulfate daily. A week later, the woman died, allegedly due to an overdose of the alprazolam and morphine sulfate.

PLAINTIFF’S CLAIM The defendant’s failure to investigate the reason for the decedent’s hospitalization violated the standard of care. If the physician had inquired about his patient’s recent hospitalization, he would have been told about her detoxification, and wouldn’t have prescribed her any potentially addictive drugs.

THE DEFENSE The physician admitted that if he had known about his patient’s detoxification, he would not have prescribed her any medication. However, the doctor in charge of overseeing the detoxification told the patient not to see the defendant again, and not to take any prescriptions from him.

VERDICT $156,853 Illinois verdict.

COMMENT There is good reason to be wary of prescribing strong opioids and benzodiazepines for chronic pain in primary care practice. With the sharp increase in overdose deaths from opioids and the marginal evidence, at best, that supports the use of opioids for chronic, nonmalignant pain, such patients should—in my opinion—be managed directly in a pain/addiction program, or in close collaboration with one.

State Boards of Medicine are becoming appropriately stringent about opioids, so don’t risk losing your medical license or being sued. Use narcotic-use contracts, random drug testing, and co-management, and check your state narcotic prescribing database regularly if you treat chronic pain patients.

Was this CT with contrast unnecessary—and harmful?

A 52-YEAR-OLD WOMAN presented to the emergency department (ED) with leg pain and vaginal bleeding. The ED physicians ordered a computed tomography (CT) scan with contrast. Following the administration of the contrast dye, the patient’s blood pressure spiked and a brain aneurysm ruptured. The patient immediately underwent cranial surgery and recovered well. However, she still suffers from paralysis, cognitive issues, and weakness in her left arm and leg. She has been unable to return to her job.

PLAINTIFF’S CLAIM The doctors ran several unnecessary tests, including the CT scan, which caused her to have an allergic reaction.

THE DEFENSE The CT scan was necessary to rule out a stomach abscess, and the ruptured aneurysm was caused by her medical condition and not the dye.

VERDICT $3.62 million New Jersey verdict.

This is a sober reminder that doing more tests does not protect one from litigation.

COMMENT Here is a sober reminder that doing more tests does not protect one from litigation. We are not told enough in this short report to know if there was a legitimate indication for a CT scan, but the large award suggests there was not. The Choosing Wisely campaign (http://www.choosingwisely.org), which has a goal of “advancing a national dialogue on avoiding wasteful or unnecessary medical tests, treatments and procedures,” is not just about saving money—it is about practicing medicine appropriately.

Patient dies after being prescribed opioids right after detoxification

A 52-YEAR-OLD WOMAN had been going to the same physician for 17 years. While she was under his care, she had been prescribed various narcotics, benzodiazepines, and barbiturates, and she had become addicted to them. The patient suffered a fall at home that was allegedly caused by an overdose of these medications. During a 3-week hospitalization after her fall, the woman went through a detoxification protocol to ease her dependence on the drugs. During her next appointment with her physician, he prescribed alprazolam and morphine sulfate daily. A week later, the woman died, allegedly due to an overdose of the alprazolam and morphine sulfate.

PLAINTIFF’S CLAIM The defendant’s failure to investigate the reason for the decedent’s hospitalization violated the standard of care. If the physician had inquired about his patient’s recent hospitalization, he would have been told about her detoxification, and wouldn’t have prescribed her any potentially addictive drugs.

THE DEFENSE The physician admitted that if he had known about his patient’s detoxification, he would not have prescribed her any medication. However, the doctor in charge of overseeing the detoxification told the patient not to see the defendant again, and not to take any prescriptions from him.

VERDICT $156,853 Illinois verdict.

COMMENT There is good reason to be wary of prescribing strong opioids and benzodiazepines for chronic pain in primary care practice. With the sharp increase in overdose deaths from opioids and the marginal evidence, at best, that supports the use of opioids for chronic, nonmalignant pain, such patients should—in my opinion—be managed directly in a pain/addiction program, or in close collaboration with one.

State Boards of Medicine are becoming appropriately stringent about opioids, so don’t risk losing your medical license or being sued. Use narcotic-use contracts, random drug testing, and co-management, and check your state narcotic prescribing database regularly if you treat chronic pain patients.

Was this CT with contrast unnecessary—and harmful?

A 52-YEAR-OLD WOMAN presented to the emergency department (ED) with leg pain and vaginal bleeding. The ED physicians ordered a computed tomography (CT) scan with contrast. Following the administration of the contrast dye, the patient’s blood pressure spiked and a brain aneurysm ruptured. The patient immediately underwent cranial surgery and recovered well. However, she still suffers from paralysis, cognitive issues, and weakness in her left arm and leg. She has been unable to return to her job.

PLAINTIFF’S CLAIM The doctors ran several unnecessary tests, including the CT scan, which caused her to have an allergic reaction.

THE DEFENSE The CT scan was necessary to rule out a stomach abscess, and the ruptured aneurysm was caused by her medical condition and not the dye.

VERDICT $3.62 million New Jersey verdict.

This is a sober reminder that doing more tests does not protect one from litigation.

COMMENT Here is a sober reminder that doing more tests does not protect one from litigation. We are not told enough in this short report to know if there was a legitimate indication for a CT scan, but the large award suggests there was not. The Choosing Wisely campaign (http://www.choosingwisely.org), which has a goal of “advancing a national dialogue on avoiding wasteful or unnecessary medical tests, treatments and procedures,” is not just about saving money—it is about practicing medicine appropriately.

Patient dies after being prescribed opioids right after detoxification

A 52-YEAR-OLD WOMAN had been going to the same physician for 17 years. While she was under his care, she had been prescribed various narcotics, benzodiazepines, and barbiturates, and she had become addicted to them. The patient suffered a fall at home that was allegedly caused by an overdose of these medications. During a 3-week hospitalization after her fall, the woman went through a detoxification protocol to ease her dependence on the drugs. During her next appointment with her physician, he prescribed alprazolam and morphine sulfate daily. A week later, the woman died, allegedly due to an overdose of the alprazolam and morphine sulfate.

PLAINTIFF’S CLAIM The defendant’s failure to investigate the reason for the decedent’s hospitalization violated the standard of care. If the physician had inquired about his patient’s recent hospitalization, he would have been told about her detoxification, and wouldn’t have prescribed her any potentially addictive drugs.

THE DEFENSE The physician admitted that if he had known about his patient’s detoxification, he would not have prescribed her any medication. However, the doctor in charge of overseeing the detoxification told the patient not to see the defendant again, and not to take any prescriptions from him.

VERDICT $156,853 Illinois verdict.

COMMENT There is good reason to be wary of prescribing strong opioids and benzodiazepines for chronic pain in primary care practice. With the sharp increase in overdose deaths from opioids and the marginal evidence, at best, that supports the use of opioids for chronic, nonmalignant pain, such patients should—in my opinion—be managed directly in a pain/addiction program, or in close collaboration with one.

State Boards of Medicine are becoming appropriately stringent about opioids, so don’t risk losing your medical license or being sued. Use narcotic-use contracts, random drug testing, and co-management, and check your state narcotic prescribing database regularly if you treat chronic pain patients.

Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.

Which of the following statements is correct?

A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.

B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.

C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.

D. Expect jurisdictional conflicts in the event there is a lawsuit.

E. All are correct.

Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”¹

In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.

Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.² The review also summarizes medical steps to be taken during midair medical emergencies.

Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.

In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.

Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”³

There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.⁴ An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.

However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.

The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.⁵

Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.

There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.⁶

For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.

In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.

References

1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.

2. N Engl J Med. 2015 Sep 3;373(10):939-45.

3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).

4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.

5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.

6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.

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: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.

Which of the following statements is correct?

A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.

B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.

C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.

D. Expect jurisdictional conflicts in the event there is a lawsuit.

E. All are correct.

Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”¹

In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.

Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.² The review also summarizes medical steps to be taken during midair medical emergencies.

Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.

In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.

Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”³

There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.⁴ An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.

However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.

The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.⁵

Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.

There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.⁶

For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.

In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.

References

1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.

2. N Engl J Med. 2015 Sep 3;373(10):939-45.

3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).

4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.

5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.

6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.

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: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.

Which of the following statements is correct?

A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.

B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.

C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.

D. Expect jurisdictional conflicts in the event there is a lawsuit.

E. All are correct.

Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”¹

In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.

Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.² The review also summarizes medical steps to be taken during midair medical emergencies.

Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.

In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.

Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”³

There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.⁴ An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.

However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.

The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.⁵

Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.

There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.⁶

For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.

In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.

References

1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.

2. N Engl J Med. 2015 Sep 3;373(10):939-45.

3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).

4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.

5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.

6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.

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].

The patient’s physical examination was unremarkable. His vital signs were normal, and there was no obvious external evidence of trauma. The posterior cervical spine was tender to palpation in the midline, but no step-off signs were appreciated. The neurological examination, including strength and sensation in all four extremities, was normal.

Since the patient’s only complaint was neck pain and his physical examination and history were otherwise normal, the emergency physician (EP) ordered radiographs of the cervical spine. The imaging studies were interpreted as showing advanced degenerative changes but no fractures, and the patient was prescribed an analgesic and discharged home.

When the patient woke up the next morning, he was unable to move his extremities, and returned to the same ED via EMS. He was placed in a cervical collar and found to have flaccid extremities on examination. A computed tomography (CT) scan of the cervical spine revealed a transverse fracture through the C6 vertebra. Radiology services also reviewed the cervical spine X-rays from the previous day, noting the presence of fracture.

The patient was taken to the operating room by neurosurgery services but remained paralyzed postoperatively. He never recovered from his injury and died 6 months later. His family sued the EP and the hospital for missed diagnosis of cervical spine fracture at the first ED presentation and the resulting paralysis. The case was settled for $1.3 million prior to trial.

Discussion

The evaluation of suspected cervical spine injury secondary to blunt trauma is a frequent and important skill practiced by EPs. Motor vehicle accidents are the most common cause of spinal cord injury in the United States (42%), followed by falls (27%), acts of violence (15%), and sports-related injuries (8%).¹ A review by Sekon and Fehlings² showed that 55% of all spinal injuries involve the cervical spine. Interestingly, the majority of cervical spine injuries occur at the upper or lower ends of the cervical spine; C2 vertebral fractures account for 33%, while C6 and C7 vertebral fractures account for approximately 50%.¹

There are two commonly used criteria to clinically clear the cervical spine (ie, no imaging studies necessary) in blunt-trauma patients. The first is the National Emergency X-Radiography Use Study (NEXUS), which has a sensitivity of 99.6% of identifying cervical spine fractures.¹ According to the NEXUS criteria, no imaging studies are required if: (1) there is no midline cervical spine tenderness; (2) there are no focal neurological deficits; (3) the patient exhibits a normal level of alertness; (4) the patient is not intoxicated; and (5) there is no distracting injury.¹

The other set of criteria used to clear the cervical spine is the Canadian Cervical Spine Rule. In these criteria, a patient is considered at very low risk for cervical spine fracture in the following cases: (1) the patient is fully alert with a Glasgow Coma scale of 15; (2) the patient has no high-risk factors (ie, age >65 years, dangerous mechanism of injury, fall greater than five stairs, axial load to the head, high-speed vehicular crash, bicycle or motorcycle crash, or the presence of paresthesias in the extremities); (3) the patient has low-risk factors (eg, simple vehicle crash, sitting position in the ED, ambulatory at any time, delayed onset of neck pain, and the absence of midline cervical tenderness); and (4) the patient can actively rotate his or her neck 45 degrees to the left and to the right. The Canadian group found the above criteria to have 100% sensitivity for predicting the absence of cervical spine injury.¹

The patient in this case failed both sets of criteria (ie, presence of cervical spine tenderness and age >65 years) and therefore required imaging. Historically, cervical spine X-ray (three views, anteroposterior, lateral, and odontoid; or five views, three views plus obliques) has been the imaging study of choice for such patients. Unfortunately, however, cervical spine radiographs have severe limitations in identifying spinal injury. In a large retrospective review, Woodring and Lee,³ found that the standard three-view cervical spine series failed to demonstrate 61% of all fractures and 36% of all subluxation and dislocations. Similarly, in a prospective study of 1,006 patients with 72 injuries, Diaz et al,⁴ found a 52.3% missed fracture rate when five-view radiographs were used to identify cervical spine injury. In addition, radiographic evaluation of elderly patients was found to be even more challenging in identifying cervical spine injury due to age-related degenerative changes.

Given the abovementioned limitations associated with radiographic imaging, CT scan of the cervical spine has become the imaging study of choice in moderate-to-severe risk patients with blunt cervical spine trauma. This modality has been shown to have a higher sensitivity and specificity for evaluating cervical spine injury compared to plain X-ray films, with CT detecting 97% to 100% of cervical spine fractures.⁵

In addition to demonstrating a higher sensitivity, CT also has the advantage of speed—especially when the patient is undergoing other CT studies (eg, head, abdomen, pelvis). While some clinicians criticize the higher cost of CT versus plain films, CT has been shown to decrease institutional costs (when settlement costs are taken into account) due to the reduction of the incidence of paralysis resulting from false-negative imaging studies.⁶

Forgotten Tourniquet

The patient’s vital signs were: blood pressure, 138/82 mm Hg; heart rate, 102 beats/minute; respiratory rate, 18 breaths/minute; temperature 98.6˚F. Oxygen saturation was 99% on room air.

The patient appeared uncomfortable overall. The physical examination was remarkable only for mild left-sided costovertebral angle tenderness. Her abdomen was soft, nontender, and without guarding or rebound.

The EP ordered the placement of an intravenous (IV) line, through which the patient was administered normal saline and morphine and promethazine, respectively, for pain and nausea. A complete blood count, basic metabolic panel, urinalysis, and urine pregnancy test were ordered. All of the laboratory bloodwork results were normal, and the urine pregnancy test was negative. The urinalysis was remarkable for 50 to 100 red blood cells.

A noncontrast CT scan of the abdomen and pelvis revealed a 3-mm ureteral stone on the left side. When the patient returned from radiology services, her pain was significantly decreased and she felt much improved. She was diagnosed with a kidney stone and discharged home with an analgesic and a strainer, along with instructions to follow-up with urology services. The patient was in the ED for a total of 5 hours.

The plaintiff sued the EP and hospital, claiming that the tourniquet used to start the IV line and draw blood was never removed, which in turn caused nerve damage resulting in reflex sympathetic dystrophy and complex regional pain syndrome. The defense denied all of these allegations, and the ED personnel testified that the tourniquet was removed as soon as the IV was established. The defense cited the plaintiff’s medical records, which contained documentation that the tourniquet had been removed. The defense further argued that if the tourniquet had been left on as the patient alleged, she would have experienced obvious physical signs, such as swelling, redness, infiltration of fluids, pain, and numbness. A defense verdict was returned.

Discussion

It is very tempting to simply dismiss this case as absurd, with nothing to be learned from it. It does defy common sense that no one would have noticed the tourniquet or, at the very least, that the patient would not have spoken up about it during her stay in the ED. While the jury clearly came to the correct conclusion,  it does highlight a real problem: forgotten tourniquets.

According to the Pennsylvania Patient Safety Advisory (PPSA), there were 125 reports of tourniquets being left on patients in Pennsylvania healthcare facilities in 1 year alone.¹ In 5% of these cases, the tourniquet was discovered within a half hour of application. In approximately 66% of cases, the tourniquet was left on for up to 2 hours, and the remaining were left in place for 2 to 18 hours.

Few locations within the hospital are without risk for this type of accident. The PPSA further noted that approximately 30% of retained tourniquets occurred on medical/surgical units, 14% in the ED, and 14% on inpatient and ambulatory surgical services departments. Approximately 19% were discovered when patients were transferred from one department to another.¹

In the analysis of these incidents, contributing factors to forgotten tourniquets included staff failing to follow proper procedures, inadequate staff proficiency, and staff distractions and/or interruptions.¹ In addition, some patients appeared to be at increased risk of having a retained tourniquet than others. Sixty percent of 125 patients with a forgotten tourniquet were aged 70 years or older, whereas some patients were younger than age 2 years.¹ Not surprisingly, patients who were unable to verbally communicate (eg, patients who were intubated, under anesthesia, had expressive aphasia, severe dementia), were at the highest risk.

In a review of recovery room incidents, Salman and Asfar² identified two cases of forgotten tourniquets out of approximately 7,000 patients. Potential strategies to avoid this mistake include: (1) only documenting procedures after they have been completed (eg, tourniquet removal); (2) double-checking that the tourniquet has been removed prior to leaving patient bedside; and (3) the use of extra-long tourniquets so the ends are more clearly visible.

The patient’s physical examination was unremarkable. His vital signs were normal, and there was no obvious external evidence of trauma. The posterior cervical spine was tender to palpation in the midline, but no step-off signs were appreciated. The neurological examination, including strength and sensation in all four extremities, was normal.

Since the patient’s only complaint was neck pain and his physical examination and history were otherwise normal, the emergency physician (EP) ordered radiographs of the cervical spine. The imaging studies were interpreted as showing advanced degenerative changes but no fractures, and the patient was prescribed an analgesic and discharged home.

When the patient woke up the next morning, he was unable to move his extremities, and returned to the same ED via EMS. He was placed in a cervical collar and found to have flaccid extremities on examination. A computed tomography (CT) scan of the cervical spine revealed a transverse fracture through the C6 vertebra. Radiology services also reviewed the cervical spine X-rays from the previous day, noting the presence of fracture.

The patient was taken to the operating room by neurosurgery services but remained paralyzed postoperatively. He never recovered from his injury and died 6 months later. His family sued the EP and the hospital for missed diagnosis of cervical spine fracture at the first ED presentation and the resulting paralysis. The case was settled for $1.3 million prior to trial.

Discussion

The evaluation of suspected cervical spine injury secondary to blunt trauma is a frequent and important skill practiced by EPs. Motor vehicle accidents are the most common cause of spinal cord injury in the United States (42%), followed by falls (27%), acts of violence (15%), and sports-related injuries (8%).¹ A review by Sekon and Fehlings² showed that 55% of all spinal injuries involve the cervical spine. Interestingly, the majority of cervical spine injuries occur at the upper or lower ends of the cervical spine; C2 vertebral fractures account for 33%, while C6 and C7 vertebral fractures account for approximately 50%.¹

There are two commonly used criteria to clinically clear the cervical spine (ie, no imaging studies necessary) in blunt-trauma patients. The first is the National Emergency X-Radiography Use Study (NEXUS), which has a sensitivity of 99.6% of identifying cervical spine fractures.¹ According to the NEXUS criteria, no imaging studies are required if: (1) there is no midline cervical spine tenderness; (2) there are no focal neurological deficits; (3) the patient exhibits a normal level of alertness; (4) the patient is not intoxicated; and (5) there is no distracting injury.¹

The other set of criteria used to clear the cervical spine is the Canadian Cervical Spine Rule. In these criteria, a patient is considered at very low risk for cervical spine fracture in the following cases: (1) the patient is fully alert with a Glasgow Coma scale of 15; (2) the patient has no high-risk factors (ie, age >65 years, dangerous mechanism of injury, fall greater than five stairs, axial load to the head, high-speed vehicular crash, bicycle or motorcycle crash, or the presence of paresthesias in the extremities); (3) the patient has low-risk factors (eg, simple vehicle crash, sitting position in the ED, ambulatory at any time, delayed onset of neck pain, and the absence of midline cervical tenderness); and (4) the patient can actively rotate his or her neck 45 degrees to the left and to the right. The Canadian group found the above criteria to have 100% sensitivity for predicting the absence of cervical spine injury.¹

The patient in this case failed both sets of criteria (ie, presence of cervical spine tenderness and age >65 years) and therefore required imaging. Historically, cervical spine X-ray (three views, anteroposterior, lateral, and odontoid; or five views, three views plus obliques) has been the imaging study of choice for such patients. Unfortunately, however, cervical spine radiographs have severe limitations in identifying spinal injury. In a large retrospective review, Woodring and Lee,³ found that the standard three-view cervical spine series failed to demonstrate 61% of all fractures and 36% of all subluxation and dislocations. Similarly, in a prospective study of 1,006 patients with 72 injuries, Diaz et al,⁴ found a 52.3% missed fracture rate when five-view radiographs were used to identify cervical spine injury. In addition, radiographic evaluation of elderly patients was found to be even more challenging in identifying cervical spine injury due to age-related degenerative changes.

Given the abovementioned limitations associated with radiographic imaging, CT scan of the cervical spine has become the imaging study of choice in moderate-to-severe risk patients with blunt cervical spine trauma. This modality has been shown to have a higher sensitivity and specificity for evaluating cervical spine injury compared to plain X-ray films, with CT detecting 97% to 100% of cervical spine fractures.⁵

In addition to demonstrating a higher sensitivity, CT also has the advantage of speed—especially when the patient is undergoing other CT studies (eg, head, abdomen, pelvis). While some clinicians criticize the higher cost of CT versus plain films, CT has been shown to decrease institutional costs (when settlement costs are taken into account) due to the reduction of the incidence of paralysis resulting from false-negative imaging studies.⁶

Forgotten Tourniquet

The patient’s vital signs were: blood pressure, 138/82 mm Hg; heart rate, 102 beats/minute; respiratory rate, 18 breaths/minute; temperature 98.6˚F. Oxygen saturation was 99% on room air.

The patient appeared uncomfortable overall. The physical examination was remarkable only for mild left-sided costovertebral angle tenderness. Her abdomen was soft, nontender, and without guarding or rebound.

The EP ordered the placement of an intravenous (IV) line, through which the patient was administered normal saline and morphine and promethazine, respectively, for pain and nausea. A complete blood count, basic metabolic panel, urinalysis, and urine pregnancy test were ordered. All of the laboratory bloodwork results were normal, and the urine pregnancy test was negative. The urinalysis was remarkable for 50 to 100 red blood cells.

A noncontrast CT scan of the abdomen and pelvis revealed a 3-mm ureteral stone on the left side. When the patient returned from radiology services, her pain was significantly decreased and she felt much improved. She was diagnosed with a kidney stone and discharged home with an analgesic and a strainer, along with instructions to follow-up with urology services. The patient was in the ED for a total of 5 hours.

The plaintiff sued the EP and hospital, claiming that the tourniquet used to start the IV line and draw blood was never removed, which in turn caused nerve damage resulting in reflex sympathetic dystrophy and complex regional pain syndrome. The defense denied all of these allegations, and the ED personnel testified that the tourniquet was removed as soon as the IV was established. The defense cited the plaintiff’s medical records, which contained documentation that the tourniquet had been removed. The defense further argued that if the tourniquet had been left on as the patient alleged, she would have experienced obvious physical signs, such as swelling, redness, infiltration of fluids, pain, and numbness. A defense verdict was returned.

Discussion

It is very tempting to simply dismiss this case as absurd, with nothing to be learned from it. It does defy common sense that no one would have noticed the tourniquet or, at the very least, that the patient would not have spoken up about it during her stay in the ED. While the jury clearly came to the correct conclusion,  it does highlight a real problem: forgotten tourniquets.

According to the Pennsylvania Patient Safety Advisory (PPSA), there were 125 reports of tourniquets being left on patients in Pennsylvania healthcare facilities in 1 year alone.¹ In 5% of these cases, the tourniquet was discovered within a half hour of application. In approximately 66% of cases, the tourniquet was left on for up to 2 hours, and the remaining were left in place for 2 to 18 hours.

Few locations within the hospital are without risk for this type of accident. The PPSA further noted that approximately 30% of retained tourniquets occurred on medical/surgical units, 14% in the ED, and 14% on inpatient and ambulatory surgical services departments. Approximately 19% were discovered when patients were transferred from one department to another.¹

In the analysis of these incidents, contributing factors to forgotten tourniquets included staff failing to follow proper procedures, inadequate staff proficiency, and staff distractions and/or interruptions.¹ In addition, some patients appeared to be at increased risk of having a retained tourniquet than others. Sixty percent of 125 patients with a forgotten tourniquet were aged 70 years or older, whereas some patients were younger than age 2 years.¹ Not surprisingly, patients who were unable to verbally communicate (eg, patients who were intubated, under anesthesia, had expressive aphasia, severe dementia), were at the highest risk.

In a review of recovery room incidents, Salman and Asfar² identified two cases of forgotten tourniquets out of approximately 7,000 patients. Potential strategies to avoid this mistake include: (1) only documenting procedures after they have been completed (eg, tourniquet removal); (2) double-checking that the tourniquet has been removed prior to leaving patient bedside; and (3) the use of extra-long tourniquets so the ends are more clearly visible.

The patient’s physical examination was unremarkable. His vital signs were normal, and there was no obvious external evidence of trauma. The posterior cervical spine was tender to palpation in the midline, but no step-off signs were appreciated. The neurological examination, including strength and sensation in all four extremities, was normal.

Since the patient’s only complaint was neck pain and his physical examination and history were otherwise normal, the emergency physician (EP) ordered radiographs of the cervical spine. The imaging studies were interpreted as showing advanced degenerative changes but no fractures, and the patient was prescribed an analgesic and discharged home.

When the patient woke up the next morning, he was unable to move his extremities, and returned to the same ED via EMS. He was placed in a cervical collar and found to have flaccid extremities on examination. A computed tomography (CT) scan of the cervical spine revealed a transverse fracture through the C6 vertebra. Radiology services also reviewed the cervical spine X-rays from the previous day, noting the presence of fracture.

The patient was taken to the operating room by neurosurgery services but remained paralyzed postoperatively. He never recovered from his injury and died 6 months later. His family sued the EP and the hospital for missed diagnosis of cervical spine fracture at the first ED presentation and the resulting paralysis. The case was settled for $1.3 million prior to trial.

Discussion

The evaluation of suspected cervical spine injury secondary to blunt trauma is a frequent and important skill practiced by EPs. Motor vehicle accidents are the most common cause of spinal cord injury in the United States (42%), followed by falls (27%), acts of violence (15%), and sports-related injuries (8%).¹ A review by Sekon and Fehlings² showed that 55% of all spinal injuries involve the cervical spine. Interestingly, the majority of cervical spine injuries occur at the upper or lower ends of the cervical spine; C2 vertebral fractures account for 33%, while C6 and C7 vertebral fractures account for approximately 50%.¹

There are two commonly used criteria to clinically clear the cervical spine (ie, no imaging studies necessary) in blunt-trauma patients. The first is the National Emergency X-Radiography Use Study (NEXUS), which has a sensitivity of 99.6% of identifying cervical spine fractures.¹ According to the NEXUS criteria, no imaging studies are required if: (1) there is no midline cervical spine tenderness; (2) there are no focal neurological deficits; (3) the patient exhibits a normal level of alertness; (4) the patient is not intoxicated; and (5) there is no distracting injury.¹

The other set of criteria used to clear the cervical spine is the Canadian Cervical Spine Rule. In these criteria, a patient is considered at very low risk for cervical spine fracture in the following cases: (1) the patient is fully alert with a Glasgow Coma scale of 15; (2) the patient has no high-risk factors (ie, age >65 years, dangerous mechanism of injury, fall greater than five stairs, axial load to the head, high-speed vehicular crash, bicycle or motorcycle crash, or the presence of paresthesias in the extremities); (3) the patient has low-risk factors (eg, simple vehicle crash, sitting position in the ED, ambulatory at any time, delayed onset of neck pain, and the absence of midline cervical tenderness); and (4) the patient can actively rotate his or her neck 45 degrees to the left and to the right. The Canadian group found the above criteria to have 100% sensitivity for predicting the absence of cervical spine injury.¹

The patient in this case failed both sets of criteria (ie, presence of cervical spine tenderness and age >65 years) and therefore required imaging. Historically, cervical spine X-ray (three views, anteroposterior, lateral, and odontoid; or five views, three views plus obliques) has been the imaging study of choice for such patients. Unfortunately, however, cervical spine radiographs have severe limitations in identifying spinal injury. In a large retrospective review, Woodring and Lee,³ found that the standard three-view cervical spine series failed to demonstrate 61% of all fractures and 36% of all subluxation and dislocations. Similarly, in a prospective study of 1,006 patients with 72 injuries, Diaz et al,⁴ found a 52.3% missed fracture rate when five-view radiographs were used to identify cervical spine injury. In addition, radiographic evaluation of elderly patients was found to be even more challenging in identifying cervical spine injury due to age-related degenerative changes.

Given the abovementioned limitations associated with radiographic imaging, CT scan of the cervical spine has become the imaging study of choice in moderate-to-severe risk patients with blunt cervical spine trauma. This modality has been shown to have a higher sensitivity and specificity for evaluating cervical spine injury compared to plain X-ray films, with CT detecting 97% to 100% of cervical spine fractures.⁵

In addition to demonstrating a higher sensitivity, CT also has the advantage of speed—especially when the patient is undergoing other CT studies (eg, head, abdomen, pelvis). While some clinicians criticize the higher cost of CT versus plain films, CT has been shown to decrease institutional costs (when settlement costs are taken into account) due to the reduction of the incidence of paralysis resulting from false-negative imaging studies.⁶

Forgotten Tourniquet

The patient’s vital signs were: blood pressure, 138/82 mm Hg; heart rate, 102 beats/minute; respiratory rate, 18 breaths/minute; temperature 98.6˚F. Oxygen saturation was 99% on room air.

The patient appeared uncomfortable overall. The physical examination was remarkable only for mild left-sided costovertebral angle tenderness. Her abdomen was soft, nontender, and without guarding or rebound.

The EP ordered the placement of an intravenous (IV) line, through which the patient was administered normal saline and morphine and promethazine, respectively, for pain and nausea. A complete blood count, basic metabolic panel, urinalysis, and urine pregnancy test were ordered. All of the laboratory bloodwork results were normal, and the urine pregnancy test was negative. The urinalysis was remarkable for 50 to 100 red blood cells.

A noncontrast CT scan of the abdomen and pelvis revealed a 3-mm ureteral stone on the left side. When the patient returned from radiology services, her pain was significantly decreased and she felt much improved. She was diagnosed with a kidney stone and discharged home with an analgesic and a strainer, along with instructions to follow-up with urology services. The patient was in the ED for a total of 5 hours.

The plaintiff sued the EP and hospital, claiming that the tourniquet used to start the IV line and draw blood was never removed, which in turn caused nerve damage resulting in reflex sympathetic dystrophy and complex regional pain syndrome. The defense denied all of these allegations, and the ED personnel testified that the tourniquet was removed as soon as the IV was established. The defense cited the plaintiff’s medical records, which contained documentation that the tourniquet had been removed. The defense further argued that if the tourniquet had been left on as the patient alleged, she would have experienced obvious physical signs, such as swelling, redness, infiltration of fluids, pain, and numbness. A defense verdict was returned.

Discussion

It is very tempting to simply dismiss this case as absurd, with nothing to be learned from it. It does defy common sense that no one would have noticed the tourniquet or, at the very least, that the patient would not have spoken up about it during her stay in the ED. While the jury clearly came to the correct conclusion,  it does highlight a real problem: forgotten tourniquets.

According to the Pennsylvania Patient Safety Advisory (PPSA), there were 125 reports of tourniquets being left on patients in Pennsylvania healthcare facilities in 1 year alone.¹ In 5% of these cases, the tourniquet was discovered within a half hour of application. In approximately 66% of cases, the tourniquet was left on for up to 2 hours, and the remaining were left in place for 2 to 18 hours.

Few locations within the hospital are without risk for this type of accident. The PPSA further noted that approximately 30% of retained tourniquets occurred on medical/surgical units, 14% in the ED, and 14% on inpatient and ambulatory surgical services departments. Approximately 19% were discovered when patients were transferred from one department to another.¹

In the analysis of these incidents, contributing factors to forgotten tourniquets included staff failing to follow proper procedures, inadequate staff proficiency, and staff distractions and/or interruptions.¹ In addition, some patients appeared to be at increased risk of having a retained tourniquet than others. Sixty percent of 125 patients with a forgotten tourniquet were aged 70 years or older, whereas some patients were younger than age 2 years.¹ Not surprisingly, patients who were unable to verbally communicate (eg, patients who were intubated, under anesthesia, had expressive aphasia, severe dementia), were at the highest risk.

In a review of recovery room incidents, Salman and Asfar² identified two cases of forgotten tourniquets out of approximately 7,000 patients. Potential strategies to avoid this mistake include: (1) only documenting procedures after they have been completed (eg, tourniquet removal); (2) double-checking that the tourniquet has been removed prior to leaving patient bedside; and (3) the use of extra-long tourniquets so the ends are more clearly visible.

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].