Law & Medicine

Question: A 60-year-old postmenopausal woman was placed on 2.5 mg of prednisone daily for rheumatoid arthritis. Six months later, she developed back pain and was found to have an L4 vertebral fracture. She had not been warned that steroids could cause osteoporosis, and was not placed on supplemental calcium, vitamin D, or a bisphosphonate. In a lawsuit for negligence, which of the following is best?

A. Osteoporosis is an uncommon complication of glucocorticoid therapy, so there is no need to warn of this complication.

B. The incidence of glucocorticoid-induced osteoporosis can be reduced by decreasing the dose and/or duration of therapy, but not by adding a bisphosphonate.

C. To prevail in her lawsuit, the patient must show that it is the standard of care to use a bisphosphonate to treat all osteoporotic women.

D. The doctor’s defense may be to show that the vertebral fracture was caused by postmenopausal osteoporosis or rheumatoid arthritis rather than prednisone, as her steroid dose was not excessive and the period of exposure relatively short.

E. If she had been given alendronate and developed osteonecrosis of the jaw, she would have a cause of action against the doctor irrespective of whether she had been informed of this risk.

Answer: D. Osteoporotic fractures are a surprisingly common malpractice issue, with cases arising from failure to diagnose, warn, or treat. Postmenopausal women are at particular risk, but the condition can also affect men and certain patient groups such as those with rheumatoid arthritis or hypogonadism, or those taking long-term glucocorticoids. Pharmacologic doses of steroids can lead to bone loss and fractures, and can aggravate or cause other serious complications such as aseptic necrosis, diabetes, hypertension, and cataracts.

Fracture risk rises with increasingly higher steroid doses (equivalent of greater than 5-10 mg of prednisone daily) and duration of therapy (greater than 3-6 months). Recent studies indicate that a bisphosphonate added to oral calcium and vitamin D can significantly attenuate this risk, and its use has therefore been recommended in patients requiring long-term steroids.

In the above hypothetical, the plaintiff need not prove that it is the standard practice to treat all women at risk of osteoporosis with a bisphosphonate, just those on steroids. However, she received a relatively low dose, and there are other risk factors in her case. As a result, her doctor may be able to mount a defense.

In Weil v. Seltzer, a 1989 D.C. decision, Dr. Seltzer treated his patient, Dr. Weil, for more than 20 years with steroids, telling the patient that it was an antihistamine. The patient developed steroid complications, including blood pressure changes, infections, and hip and vertebral fractures. He died suddenly at age 54 from a saddle block embolism, which contained bone marrow fragments believed to have arisen from osteoporotic bone. Dr. Seltzer had ordered 1.3 million tablets of cortisone from 1980 to 1984. The defense raised legal arguments of contributory negligence, assumption of risk, and intervening cause, but was unsuccessful.

In Fuller v. Merten, a 2001 Oregon case, a patient taking steroids for arthritis developed osteoporosis of the cervical spine, which fractured after an automobile accident. The court applied the "eggshell skull" rule for the serious injuries as the tortfeasor "takes the victim as he finds him."

In yet another case, a mechanic who was allergic to petroleum-based solvents developed severe contact dermatitis and required parenteral treatment for more than 20 years with adrenocorticotropic hormone, Kenalog, and oral steroids. He developed cataracts and osteoporosis, but lost the lawsuit against the doctor and the manufacturer because he did not have expert witnesses to testify to the standard of care and adequacy of the warning label.

The most dramatic osteoporosis case is probably Warren v. Schecter, where the plaintiff won a $9.6 million judgment against her surgeon for his failure to disclose a remote risk of osteoporosis. Her surgeon did not believe osteoporosis, osteomalacia, and bone pain were risks of peptic ulcer surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had the doctor warned her of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken after she developed postop dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. The plaintiff subsequently developed severe osteoporotic fractures, and won a malpractice lawsuit under an informed consent theory.

A physician is obligated to warn patients of the side effects of a prescribed drug. All drugs can have serious adverse effects, and anti-osteoporosis drugs are no exception. A rare but serious complication associated with bisphosphonates is osteonecrosis of the jaw. This complication is particularly apt to occur in bisphosphonate-treated patients undergoing dental procedures or in those with an underlying malignancy who had received radiation to the head and neck. Predictably, lawsuits including class-action suits have targeted the drug manufacturers, but physicians may also be roped in on the basis of lack of informed consent and failure to warn. Similarly, doctors would do well to inform patients of the more recent concern over atypical femur fractures allegedly linked to alendronate.

Finally, it is important to recognize the compelling evidence showing that treating postmenopausal osteoporosis can significantly reduce fracture risk. Fracture of the hip is a very serious disability, especially in the elderly, so the failure to diagnose and treat osteoporosis may amount to a negligent omission – with implications for legal liability.

Dr. Tan is an emeritus professor at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 60-year-old postmenopausal woman was placed on 2.5 mg of prednisone daily for rheumatoid arthritis. Six months later, she developed back pain and was found to have an L4 vertebral fracture. She had not been warned that steroids could cause osteoporosis, and was not placed on supplemental calcium, vitamin D, or a bisphosphonate. In a lawsuit for negligence, which of the following is best?

A. Osteoporosis is an uncommon complication of glucocorticoid therapy, so there is no need to warn of this complication.

B. The incidence of glucocorticoid-induced osteoporosis can be reduced by decreasing the dose and/or duration of therapy, but not by adding a bisphosphonate.

C. To prevail in her lawsuit, the patient must show that it is the standard of care to use a bisphosphonate to treat all osteoporotic women.

D. The doctor’s defense may be to show that the vertebral fracture was caused by postmenopausal osteoporosis or rheumatoid arthritis rather than prednisone, as her steroid dose was not excessive and the period of exposure relatively short.

E. If she had been given alendronate and developed osteonecrosis of the jaw, she would have a cause of action against the doctor irrespective of whether she had been informed of this risk.

Answer: D. Osteoporotic fractures are a surprisingly common malpractice issue, with cases arising from failure to diagnose, warn, or treat. Postmenopausal women are at particular risk, but the condition can also affect men and certain patient groups such as those with rheumatoid arthritis or hypogonadism, or those taking long-term glucocorticoids. Pharmacologic doses of steroids can lead to bone loss and fractures, and can aggravate or cause other serious complications such as aseptic necrosis, diabetes, hypertension, and cataracts.

Fracture risk rises with increasingly higher steroid doses (equivalent of greater than 5-10 mg of prednisone daily) and duration of therapy (greater than 3-6 months). Recent studies indicate that a bisphosphonate added to oral calcium and vitamin D can significantly attenuate this risk, and its use has therefore been recommended in patients requiring long-term steroids.

In the above hypothetical, the plaintiff need not prove that it is the standard practice to treat all women at risk of osteoporosis with a bisphosphonate, just those on steroids. However, she received a relatively low dose, and there are other risk factors in her case. As a result, her doctor may be able to mount a defense.

In Weil v. Seltzer, a 1989 D.C. decision, Dr. Seltzer treated his patient, Dr. Weil, for more than 20 years with steroids, telling the patient that it was an antihistamine. The patient developed steroid complications, including blood pressure changes, infections, and hip and vertebral fractures. He died suddenly at age 54 from a saddle block embolism, which contained bone marrow fragments believed to have arisen from osteoporotic bone. Dr. Seltzer had ordered 1.3 million tablets of cortisone from 1980 to 1984. The defense raised legal arguments of contributory negligence, assumption of risk, and intervening cause, but was unsuccessful.

In Fuller v. Merten, a 2001 Oregon case, a patient taking steroids for arthritis developed osteoporosis of the cervical spine, which fractured after an automobile accident. The court applied the "eggshell skull" rule for the serious injuries as the tortfeasor "takes the victim as he finds him."

In yet another case, a mechanic who was allergic to petroleum-based solvents developed severe contact dermatitis and required parenteral treatment for more than 20 years with adrenocorticotropic hormone, Kenalog, and oral steroids. He developed cataracts and osteoporosis, but lost the lawsuit against the doctor and the manufacturer because he did not have expert witnesses to testify to the standard of care and adequacy of the warning label.

The most dramatic osteoporosis case is probably Warren v. Schecter, where the plaintiff won a $9.6 million judgment against her surgeon for his failure to disclose a remote risk of osteoporosis. Her surgeon did not believe osteoporosis, osteomalacia, and bone pain were risks of peptic ulcer surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had the doctor warned her of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken after she developed postop dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. The plaintiff subsequently developed severe osteoporotic fractures, and won a malpractice lawsuit under an informed consent theory.

A physician is obligated to warn patients of the side effects of a prescribed drug. All drugs can have serious adverse effects, and anti-osteoporosis drugs are no exception. A rare but serious complication associated with bisphosphonates is osteonecrosis of the jaw. This complication is particularly apt to occur in bisphosphonate-treated patients undergoing dental procedures or in those with an underlying malignancy who had received radiation to the head and neck. Predictably, lawsuits including class-action suits have targeted the drug manufacturers, but physicians may also be roped in on the basis of lack of informed consent and failure to warn. Similarly, doctors would do well to inform patients of the more recent concern over atypical femur fractures allegedly linked to alendronate.

Finally, it is important to recognize the compelling evidence showing that treating postmenopausal osteoporosis can significantly reduce fracture risk. Fracture of the hip is a very serious disability, especially in the elderly, so the failure to diagnose and treat osteoporosis may amount to a negligent omission – with implications for legal liability.

Dr. Tan is an emeritus professor at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 60-year-old postmenopausal woman was placed on 2.5 mg of prednisone daily for rheumatoid arthritis. Six months later, she developed back pain and was found to have an L4 vertebral fracture. She had not been warned that steroids could cause osteoporosis, and was not placed on supplemental calcium, vitamin D, or a bisphosphonate. In a lawsuit for negligence, which of the following is best?

A. Osteoporosis is an uncommon complication of glucocorticoid therapy, so there is no need to warn of this complication.

B. The incidence of glucocorticoid-induced osteoporosis can be reduced by decreasing the dose and/or duration of therapy, but not by adding a bisphosphonate.

C. To prevail in her lawsuit, the patient must show that it is the standard of care to use a bisphosphonate to treat all osteoporotic women.

D. The doctor’s defense may be to show that the vertebral fracture was caused by postmenopausal osteoporosis or rheumatoid arthritis rather than prednisone, as her steroid dose was not excessive and the period of exposure relatively short.

E. If she had been given alendronate and developed osteonecrosis of the jaw, she would have a cause of action against the doctor irrespective of whether she had been informed of this risk.

Answer: D. Osteoporotic fractures are a surprisingly common malpractice issue, with cases arising from failure to diagnose, warn, or treat. Postmenopausal women are at particular risk, but the condition can also affect men and certain patient groups such as those with rheumatoid arthritis or hypogonadism, or those taking long-term glucocorticoids. Pharmacologic doses of steroids can lead to bone loss and fractures, and can aggravate or cause other serious complications such as aseptic necrosis, diabetes, hypertension, and cataracts.

Fracture risk rises with increasingly higher steroid doses (equivalent of greater than 5-10 mg of prednisone daily) and duration of therapy (greater than 3-6 months). Recent studies indicate that a bisphosphonate added to oral calcium and vitamin D can significantly attenuate this risk, and its use has therefore been recommended in patients requiring long-term steroids.

In the above hypothetical, the plaintiff need not prove that it is the standard practice to treat all women at risk of osteoporosis with a bisphosphonate, just those on steroids. However, she received a relatively low dose, and there are other risk factors in her case. As a result, her doctor may be able to mount a defense.

In Weil v. Seltzer, a 1989 D.C. decision, Dr. Seltzer treated his patient, Dr. Weil, for more than 20 years with steroids, telling the patient that it was an antihistamine. The patient developed steroid complications, including blood pressure changes, infections, and hip and vertebral fractures. He died suddenly at age 54 from a saddle block embolism, which contained bone marrow fragments believed to have arisen from osteoporotic bone. Dr. Seltzer had ordered 1.3 million tablets of cortisone from 1980 to 1984. The defense raised legal arguments of contributory negligence, assumption of risk, and intervening cause, but was unsuccessful.

In Fuller v. Merten, a 2001 Oregon case, a patient taking steroids for arthritis developed osteoporosis of the cervical spine, which fractured after an automobile accident. The court applied the "eggshell skull" rule for the serious injuries as the tortfeasor "takes the victim as he finds him."

In yet another case, a mechanic who was allergic to petroleum-based solvents developed severe contact dermatitis and required parenteral treatment for more than 20 years with adrenocorticotropic hormone, Kenalog, and oral steroids. He developed cataracts and osteoporosis, but lost the lawsuit against the doctor and the manufacturer because he did not have expert witnesses to testify to the standard of care and adequacy of the warning label.

The most dramatic osteoporosis case is probably Warren v. Schecter, where the plaintiff won a $9.6 million judgment against her surgeon for his failure to disclose a remote risk of osteoporosis. Her surgeon did not believe osteoporosis, osteomalacia, and bone pain were risks of peptic ulcer surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had the doctor warned her of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken after she developed postop dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. The plaintiff subsequently developed severe osteoporotic fractures, and won a malpractice lawsuit under an informed consent theory.

A physician is obligated to warn patients of the side effects of a prescribed drug. All drugs can have serious adverse effects, and anti-osteoporosis drugs are no exception. A rare but serious complication associated with bisphosphonates is osteonecrosis of the jaw. This complication is particularly apt to occur in bisphosphonate-treated patients undergoing dental procedures or in those with an underlying malignancy who had received radiation to the head and neck. Predictably, lawsuits including class-action suits have targeted the drug manufacturers, but physicians may also be roped in on the basis of lack of informed consent and failure to warn. Similarly, doctors would do well to inform patients of the more recent concern over atypical femur fractures allegedly linked to alendronate.

Finally, it is important to recognize the compelling evidence showing that treating postmenopausal osteoporosis can significantly reduce fracture risk. Fracture of the hip is a very serious disability, especially in the elderly, so the failure to diagnose and treat osteoporosis may amount to a negligent omission – with implications for legal liability.

Dr. Tan is an emeritus professor at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A patient in his 30s presented to Dr. C with atypical substernal chest pain. There was no family history of heart disease, he had no cardiac risk factors, and the examination was normal. Although the clinical picture was not that of myocardial ischemia, Dr. C obtained an EKG and serum creatine phosphokinase (CPK) and troponin levels, all of which were normal. In recent years, Dr. C, a cardiologist, has given up doing invasive procedures to reduce malpractice exposure. Which of the following is best?

A. The work-up of chest pain in this patient can be considered defensive medicine if it’s done primarily out of malpractice fear.

B. Questionnaire surveys generally conclude that virtually all doctors practice defensive medicine.

C. Giving up "high-risk" procedures purely for medicolegal reasons (malpractice concerns) is a form of defensive medicine.

D. There is controversy over what constitutes defensive medicine, how much it costs, and whether it is in fact widely practiced.

E. All are correct.

Answer: E. Almost all doctors admit they practice defensive medicine, which has been defined as "deviation from sound medical practice that is induced primarily by a threat of liability" (JAMA 2005;293:2609-17). Positive defensive medicine, centering on assurance behavior, provides additional services that are of no medical value. An example is obtaining a head CT in all cases of headaches. Negative defensive medicine speaks to avoidance behavior, with the doctor foregoing interventions that he or she perceives as increased malpractice risk, such as performing invasive procedures.

A 2003 survey of specialists in Pennsylvania found that 93% practiced defensive medicine. Assurance behavior – such as ordering tests, performing diagnostic procedures, and referring patients for consultation – was very common (92%). A particularly widespread defensive act was the use of imaging technology in clinically unnecessary circumstances. Avoidance of litigation-prone procedures and patients was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years including avoiding trauma surgery as well as patients with complex medical problems or who were perceived as litigious.

In a 2005 study, emergency physicians in the upper tertile of malpractice fear were found to use more diagnostic tests and were more likely to hospitalize patients at low risk for coronary artery disease (Ann. Emerg. Med. 2005;46:525-33).

Defensive medicine also was found to be widespread (83%) among 900 doctors in a survey recently conducted by the Massachusetts Medical Society.

It is widely believed that defensive medicine adds to the nation’s medical bill. By correlating professional liability insurance with cost of services, the AMA estimated that in the 1980s, defensive medicine cost $12.1-$13.7 billion each year (JAMA 1987;257:2776-81).

In an oft-cited study by Kessler and McClellan (Q. J. Econ. 1996;111:353-90), the authors measured the effects of malpractice liability reforms using data on elderly Medicare beneficiaries treated for serious heart disease and 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 total annual savings would amount to $50 billion. A more conservative study estimated that system-wide savings from aggressive malpractice reform would approach $41 billion over 5 years (J. Am. Health Policy 1994;4:7-15).

Skeptics, however, question the way the profession defines defensive medicine, pointing out that malpractice concerns may be one, but not the only or even the primary reason as most interventions add some marginal value to patient care. Besides, physicians in low litigious jurisdictions display similar behavior, for example, in Japan, where 98% of 131 gastroenterologists in Hiroshima admitted to the practice although only three (2%) respondents had been sued and most respondents (96%) had liability insurance (World J. Gastro. 2006;12:7671-5).

Above all, skeptics argue that there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.

Several reports challenge the belief that the practice of defensive medicine is widespread and therefore adds hugely to health care costs (J. Health Polit. Policy Law 1996;21:267-88).

The Klingman study used simulated clinical scenarios and concluded that the extent of defensive medicine was at most 8%. The study by Glassman et al. found no correlation between individual malpractice claims experience to use of resources among 835 physicians including internists. Nor did they find a correlation between malpractice claims experience and an individual physician’s concern about malpractice, tolerance for uncertainty or perception of risk.

Finally, in an interview of 29 physicians and 17 administrators about their use of the more expensive low-osmolar contrast agent and the cheaper high-osmolar agent, investigators found that clinical and cost concerns were more important than were the legal factors (J. Health Polit. Policy Law 1996;21:243-66).

They concluded that "clinical factors dominate the decision-making process, making it unlikely that a policy focus on reducing incentives for defensive medicine will substantially reduce health care costs."

Dr. Tan is an emeritus professor of medicine at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A patient in his 30s presented to Dr. C with atypical substernal chest pain. There was no family history of heart disease, he had no cardiac risk factors, and the examination was normal. Although the clinical picture was not that of myocardial ischemia, Dr. C obtained an EKG and serum creatine phosphokinase (CPK) and troponin levels, all of which were normal. In recent years, Dr. C, a cardiologist, has given up doing invasive procedures to reduce malpractice exposure. Which of the following is best?

A. The work-up of chest pain in this patient can be considered defensive medicine if it’s done primarily out of malpractice fear.

B. Questionnaire surveys generally conclude that virtually all doctors practice defensive medicine.

C. Giving up "high-risk" procedures purely for medicolegal reasons (malpractice concerns) is a form of defensive medicine.

D. There is controversy over what constitutes defensive medicine, how much it costs, and whether it is in fact widely practiced.

E. All are correct.

Answer: E. Almost all doctors admit they practice defensive medicine, which has been defined as "deviation from sound medical practice that is induced primarily by a threat of liability" (JAMA 2005;293:2609-17). Positive defensive medicine, centering on assurance behavior, provides additional services that are of no medical value. An example is obtaining a head CT in all cases of headaches. Negative defensive medicine speaks to avoidance behavior, with the doctor foregoing interventions that he or she perceives as increased malpractice risk, such as performing invasive procedures.

A 2003 survey of specialists in Pennsylvania found that 93% practiced defensive medicine. Assurance behavior – such as ordering tests, performing diagnostic procedures, and referring patients for consultation – was very common (92%). A particularly widespread defensive act was the use of imaging technology in clinically unnecessary circumstances. Avoidance of litigation-prone procedures and patients was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years including avoiding trauma surgery as well as patients with complex medical problems or who were perceived as litigious.

In a 2005 study, emergency physicians in the upper tertile of malpractice fear were found to use more diagnostic tests and were more likely to hospitalize patients at low risk for coronary artery disease (Ann. Emerg. Med. 2005;46:525-33).

Defensive medicine also was found to be widespread (83%) among 900 doctors in a survey recently conducted by the Massachusetts Medical Society.

It is widely believed that defensive medicine adds to the nation’s medical bill. By correlating professional liability insurance with cost of services, the AMA estimated that in the 1980s, defensive medicine cost $12.1-$13.7 billion each year (JAMA 1987;257:2776-81).

In an oft-cited study by Kessler and McClellan (Q. J. Econ. 1996;111:353-90), the authors measured the effects of malpractice liability reforms using data on elderly Medicare beneficiaries treated for serious heart disease and 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 total annual savings would amount to $50 billion. A more conservative study estimated that system-wide savings from aggressive malpractice reform would approach $41 billion over 5 years (J. Am. Health Policy 1994;4:7-15).

Skeptics, however, question the way the profession defines defensive medicine, pointing out that malpractice concerns may be one, but not the only or even the primary reason as most interventions add some marginal value to patient care. Besides, physicians in low litigious jurisdictions display similar behavior, for example, in Japan, where 98% of 131 gastroenterologists in Hiroshima admitted to the practice although only three (2%) respondents had been sued and most respondents (96%) had liability insurance (World J. Gastro. 2006;12:7671-5).

Above all, skeptics argue that there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.

Several reports challenge the belief that the practice of defensive medicine is widespread and therefore adds hugely to health care costs (J. Health Polit. Policy Law 1996;21:267-88).

The Klingman study used simulated clinical scenarios and concluded that the extent of defensive medicine was at most 8%. The study by Glassman et al. found no correlation between individual malpractice claims experience to use of resources among 835 physicians including internists. Nor did they find a correlation between malpractice claims experience and an individual physician’s concern about malpractice, tolerance for uncertainty or perception of risk.

Finally, in an interview of 29 physicians and 17 administrators about their use of the more expensive low-osmolar contrast agent and the cheaper high-osmolar agent, investigators found that clinical and cost concerns were more important than were the legal factors (J. Health Polit. Policy Law 1996;21:243-66).

They concluded that "clinical factors dominate the decision-making process, making it unlikely that a policy focus on reducing incentives for defensive medicine will substantially reduce health care costs."

Dr. Tan is an emeritus professor of medicine at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A patient in his 30s presented to Dr. C with atypical substernal chest pain. There was no family history of heart disease, he had no cardiac risk factors, and the examination was normal. Although the clinical picture was not that of myocardial ischemia, Dr. C obtained an EKG and serum creatine phosphokinase (CPK) and troponin levels, all of which were normal. In recent years, Dr. C, a cardiologist, has given up doing invasive procedures to reduce malpractice exposure. Which of the following is best?

A. The work-up of chest pain in this patient can be considered defensive medicine if it’s done primarily out of malpractice fear.

B. Questionnaire surveys generally conclude that virtually all doctors practice defensive medicine.

C. Giving up "high-risk" procedures purely for medicolegal reasons (malpractice concerns) is a form of defensive medicine.

D. There is controversy over what constitutes defensive medicine, how much it costs, and whether it is in fact widely practiced.

E. All are correct.

Answer: E. Almost all doctors admit they practice defensive medicine, which has been defined as "deviation from sound medical practice that is induced primarily by a threat of liability" (JAMA 2005;293:2609-17). Positive defensive medicine, centering on assurance behavior, provides additional services that are of no medical value. An example is obtaining a head CT in all cases of headaches. Negative defensive medicine speaks to avoidance behavior, with the doctor foregoing interventions that he or she perceives as increased malpractice risk, such as performing invasive procedures.

A 2003 survey of specialists in Pennsylvania found that 93% practiced defensive medicine. Assurance behavior – such as ordering tests, performing diagnostic procedures, and referring patients for consultation – was very common (92%). A particularly widespread defensive act was the use of imaging technology in clinically unnecessary circumstances. Avoidance of litigation-prone procedures and patients was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years including avoiding trauma surgery as well as patients with complex medical problems or who were perceived as litigious.

In a 2005 study, emergency physicians in the upper tertile of malpractice fear were found to use more diagnostic tests and were more likely to hospitalize patients at low risk for coronary artery disease (Ann. Emerg. Med. 2005;46:525-33).

Defensive medicine also was found to be widespread (83%) among 900 doctors in a survey recently conducted by the Massachusetts Medical Society.

It is widely believed that defensive medicine adds to the nation’s medical bill. By correlating professional liability insurance with cost of services, the AMA estimated that in the 1980s, defensive medicine cost $12.1-$13.7 billion each year (JAMA 1987;257:2776-81).

In an oft-cited study by Kessler and McClellan (Q. J. Econ. 1996;111:353-90), the authors measured the effects of malpractice liability reforms using data on elderly Medicare beneficiaries treated for serious heart disease and 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 total annual savings would amount to $50 billion. A more conservative study estimated that system-wide savings from aggressive malpractice reform would approach $41 billion over 5 years (J. Am. Health Policy 1994;4:7-15).

Skeptics, however, question the way the profession defines defensive medicine, pointing out that malpractice concerns may be one, but not the only or even the primary reason as most interventions add some marginal value to patient care. Besides, physicians in low litigious jurisdictions display similar behavior, for example, in Japan, where 98% of 131 gastroenterologists in Hiroshima admitted to the practice although only three (2%) respondents had been sued and most respondents (96%) had liability insurance (World J. Gastro. 2006;12:7671-5).

Above all, skeptics argue that there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.

Several reports challenge the belief that the practice of defensive medicine is widespread and therefore adds hugely to health care costs (J. Health Polit. Policy Law 1996;21:267-88).

The Klingman study used simulated clinical scenarios and concluded that the extent of defensive medicine was at most 8%. The study by Glassman et al. found no correlation between individual malpractice claims experience to use of resources among 835 physicians including internists. Nor did they find a correlation between malpractice claims experience and an individual physician’s concern about malpractice, tolerance for uncertainty or perception of risk.

Finally, in an interview of 29 physicians and 17 administrators about their use of the more expensive low-osmolar contrast agent and the cheaper high-osmolar agent, investigators found that clinical and cost concerns were more important than were the legal factors (J. Health Polit. Policy Law 1996;21:243-66).

They concluded that "clinical factors dominate the decision-making process, making it unlikely that a policy focus on reducing incentives for defensive medicine will substantially reduce health care costs."

Dr. Tan is an emeritus professor of medicine at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: Dr. X is a member of a rural group practice with no other doctor or doctor groups in the area. One of his patients has been noncompliant with medical advice and has refused to pay his bills on time. Additionally, there are style differences that have caused their interactions to be confrontational at times. Eventually, the doctor decided he’d had enough and unilaterally terminated the relationship. In a lawsuit that followed based on patient abandonment in this hypothetical, which of the following is incorrect?

A. One may terminate a doctor-patient relationship with patient consent.

B. One may unilaterally terminate a doctor-patient relationship without patient consent.

C. In terminating care, a doctor is required to give notice and forward all relevant records to the new provider.

D. The original doctor is still responsible for all care until the patient finds a new doctor.

E. Given the above fact situation, the entire group practice may terminate the relationship.

Answer: E. A doctor is permitted to terminate the professional relationship with a patient with or without his consent in situations such as irreconcilable disagreements over treatment plans, loss of rapport or trust, or patient refusal to pay the doctor’s bill. However, before terminating care, the doctor is required to give sufficient notice and arrange to transfer all medical records to the new treating doctor. In addition, the original physician must continue to provide ongoing care until the patient has established contact with the new doctor. In other words, it is the affirmative obligation of the physician to ensure that no interim harm comes to the patient.

A not uncommon scenario is where a group practice collectively refuses to treat a patient or group of patients. In Leach v. Drummond Medical Group, the plaintiffs complained to the State licensing board about some members in a group practice, and the entire group then attempted to terminate its professional relationship with those patients. The California appellate court held that whereas one member may decline to treat, the entire group may not exercise the same option, as there were no similar services within a hundred miles.

The American Medical Association’s Code of Medical Ethics (§8.115) emphasizes that physicians "have an obligation to support continuity of care for their patients. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured."

Merely making a referral may not be enough. In a dental malpractice case where the patient was simply referred to his family physician after oral surgery was complicated by an infection, an Illinois court held the dentist liable for the postop complications. Furthermore, civil rights laws prohibit discrimination based on race, gender, religion, or ethnic origin in places of public accommodation, which include a doctor’s office. Additionally, the Americans with Disabilities Act (ADA) prohibits discriminating against the disabled. Obviously, care for patients should not be terminated or refused for these reasons.

The tort of abandonment may be intentional or negligent. In the former instance, the deliberateness of the defendant’s action is a key element, and the aggrieved party may not need expert testimony to prevail. Still, in a 2007 Wisconsin case where a surgeon canceled an elective surgery after the patient had sued the employer surgical center, the appeals court overruled the trial court and held that expert testimony was required to prove the plaintiff’s case. However, negligent abandonment, for example, premature discharge of a patient from the hospital or emergency department, is simply a form of medical negligence, which will require expert testimony at trial to set the standard of care.

Rarely, the facts are so outrageous the courts have ruled that the health care providers owed no further duty to provide treatment. The best known case is that of Payton v. Weaver, where a physician and hospital refused to provide dialysis to a patient because of persistent uncooperative and antisocial behavior. In lamenting that "occasionally a case will challenge the ability of the law, and society, to cope effectively and sensitively with fundamental problems of human existence," the court affirmed the trial court’s judgment that the healthcare providers had no legal obligation to continue providing regular dialysis treatment.

The facts of the case are as vivid as they are tragic. Ms. Brenda Payton was a 35-year-old woman with end-stage-renal disease on dialysis. An active user of alcohol, heroin, and barbiturates, she was non-compliant with dialysis and medical therapy. She continued to buy barbiturates from pushers on the street at least twice a week, failed to restrict her diet, sometimes gaining 15 kg between dialysis, and frequently missed dialysis, resulting in 30 hospitalizations in the 11 months before trial. She would come to dialysis drugged or drunk, use profane and vulgar language, cuss at staff, and expose her genitals in a lewd fashion. At times, she would scream for dialysis to be terminated and pull the dialysis needle from the shunt causing blood to spew.

The court found her behavior to be "knowing and intentional" and described Dr. Weaver as "one of the most sensitive and honest physicians that I have been exposed to either in a courtroom or out of a courtroom." It held that "there exists no basis in law or in equity to saddle him with a continuing sole obligation for Brenda’s welfare."

In another refusal-to-treat case, an abusive and disruptive patient missed scheduled dialysis sessions, and threatened to kill his nephrologists, Dr. John Bower, and shoot the hospital administrator at the University of Mississippi Medical Center. The court ruled that to compel Dr. Bower to proffer dialysis was tantamount to involuntary servitude, and this would violate the 13th amendment which prohibits slavery. However, it ordered the medical center to continue to provide dialysis because there was no other facility in the region.

Dr. S. Y. Tan is an emeritus professor of medicine at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].

Question: Dr. X is a member of a rural group practice with no other doctor or doctor groups in the area. One of his patients has been noncompliant with medical advice and has refused to pay his bills on time. Additionally, there are style differences that have caused their interactions to be confrontational at times. Eventually, the doctor decided he’d had enough and unilaterally terminated the relationship. In a lawsuit that followed based on patient abandonment in this hypothetical, which of the following is incorrect?

A. One may terminate a doctor-patient relationship with patient consent.

B. One may unilaterally terminate a doctor-patient relationship without patient consent.

C. In terminating care, a doctor is required to give notice and forward all relevant records to the new provider.

D. The original doctor is still responsible for all care until the patient finds a new doctor.

E. Given the above fact situation, the entire group practice may terminate the relationship.

Answer: E. A doctor is permitted to terminate the professional relationship with a patient with or without his consent in situations such as irreconcilable disagreements over treatment plans, loss of rapport or trust, or patient refusal to pay the doctor’s bill. However, before terminating care, the doctor is required to give sufficient notice and arrange to transfer all medical records to the new treating doctor. In addition, the original physician must continue to provide ongoing care until the patient has established contact with the new doctor. In other words, it is the affirmative obligation of the physician to ensure that no interim harm comes to the patient.

A not uncommon scenario is where a group practice collectively refuses to treat a patient or group of patients. In Leach v. Drummond Medical Group, the plaintiffs complained to the State licensing board about some members in a group practice, and the entire group then attempted to terminate its professional relationship with those patients. The California appellate court held that whereas one member may decline to treat, the entire group may not exercise the same option, as there were no similar services within a hundred miles.

The American Medical Association’s Code of Medical Ethics (§8.115) emphasizes that physicians "have an obligation to support continuity of care for their patients. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured."

Merely making a referral may not be enough. In a dental malpractice case where the patient was simply referred to his family physician after oral surgery was complicated by an infection, an Illinois court held the dentist liable for the postop complications. Furthermore, civil rights laws prohibit discrimination based on race, gender, religion, or ethnic origin in places of public accommodation, which include a doctor’s office. Additionally, the Americans with Disabilities Act (ADA) prohibits discriminating against the disabled. Obviously, care for patients should not be terminated or refused for these reasons.

The tort of abandonment may be intentional or negligent. In the former instance, the deliberateness of the defendant’s action is a key element, and the aggrieved party may not need expert testimony to prevail. Still, in a 2007 Wisconsin case where a surgeon canceled an elective surgery after the patient had sued the employer surgical center, the appeals court overruled the trial court and held that expert testimony was required to prove the plaintiff’s case. However, negligent abandonment, for example, premature discharge of a patient from the hospital or emergency department, is simply a form of medical negligence, which will require expert testimony at trial to set the standard of care.

Rarely, the facts are so outrageous the courts have ruled that the health care providers owed no further duty to provide treatment. The best known case is that of Payton v. Weaver, where a physician and hospital refused to provide dialysis to a patient because of persistent uncooperative and antisocial behavior. In lamenting that "occasionally a case will challenge the ability of the law, and society, to cope effectively and sensitively with fundamental problems of human existence," the court affirmed the trial court’s judgment that the healthcare providers had no legal obligation to continue providing regular dialysis treatment.

The facts of the case are as vivid as they are tragic. Ms. Brenda Payton was a 35-year-old woman with end-stage-renal disease on dialysis. An active user of alcohol, heroin, and barbiturates, she was non-compliant with dialysis and medical therapy. She continued to buy barbiturates from pushers on the street at least twice a week, failed to restrict her diet, sometimes gaining 15 kg between dialysis, and frequently missed dialysis, resulting in 30 hospitalizations in the 11 months before trial. She would come to dialysis drugged or drunk, use profane and vulgar language, cuss at staff, and expose her genitals in a lewd fashion. At times, she would scream for dialysis to be terminated and pull the dialysis needle from the shunt causing blood to spew.

The court found her behavior to be "knowing and intentional" and described Dr. Weaver as "one of the most sensitive and honest physicians that I have been exposed to either in a courtroom or out of a courtroom." It held that "there exists no basis in law or in equity to saddle him with a continuing sole obligation for Brenda’s welfare."

In another refusal-to-treat case, an abusive and disruptive patient missed scheduled dialysis sessions, and threatened to kill his nephrologists, Dr. John Bower, and shoot the hospital administrator at the University of Mississippi Medical Center. The court ruled that to compel Dr. Bower to proffer dialysis was tantamount to involuntary servitude, and this would violate the 13th amendment which prohibits slavery. However, it ordered the medical center to continue to provide dialysis because there was no other facility in the region.

Dr. S. Y. Tan is an emeritus professor of medicine at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].

Question: Dr. X is a member of a rural group practice with no other doctor or doctor groups in the area. One of his patients has been noncompliant with medical advice and has refused to pay his bills on time. Additionally, there are style differences that have caused their interactions to be confrontational at times. Eventually, the doctor decided he’d had enough and unilaterally terminated the relationship. In a lawsuit that followed based on patient abandonment in this hypothetical, which of the following is incorrect?

A. One may terminate a doctor-patient relationship with patient consent.

B. One may unilaterally terminate a doctor-patient relationship without patient consent.

C. In terminating care, a doctor is required to give notice and forward all relevant records to the new provider.

D. The original doctor is still responsible for all care until the patient finds a new doctor.

E. Given the above fact situation, the entire group practice may terminate the relationship.

Answer: E. A doctor is permitted to terminate the professional relationship with a patient with or without his consent in situations such as irreconcilable disagreements over treatment plans, loss of rapport or trust, or patient refusal to pay the doctor’s bill. However, before terminating care, the doctor is required to give sufficient notice and arrange to transfer all medical records to the new treating doctor. In addition, the original physician must continue to provide ongoing care until the patient has established contact with the new doctor. In other words, it is the affirmative obligation of the physician to ensure that no interim harm comes to the patient.

A not uncommon scenario is where a group practice collectively refuses to treat a patient or group of patients. In Leach v. Drummond Medical Group, the plaintiffs complained to the State licensing board about some members in a group practice, and the entire group then attempted to terminate its professional relationship with those patients. The California appellate court held that whereas one member may decline to treat, the entire group may not exercise the same option, as there were no similar services within a hundred miles.

The American Medical Association’s Code of Medical Ethics (§8.115) emphasizes that physicians "have an obligation to support continuity of care for their patients. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured."

Merely making a referral may not be enough. In a dental malpractice case where the patient was simply referred to his family physician after oral surgery was complicated by an infection, an Illinois court held the dentist liable for the postop complications. Furthermore, civil rights laws prohibit discrimination based on race, gender, religion, or ethnic origin in places of public accommodation, which include a doctor’s office. Additionally, the Americans with Disabilities Act (ADA) prohibits discriminating against the disabled. Obviously, care for patients should not be terminated or refused for these reasons.

The tort of abandonment may be intentional or negligent. In the former instance, the deliberateness of the defendant’s action is a key element, and the aggrieved party may not need expert testimony to prevail. Still, in a 2007 Wisconsin case where a surgeon canceled an elective surgery after the patient had sued the employer surgical center, the appeals court overruled the trial court and held that expert testimony was required to prove the plaintiff’s case. However, negligent abandonment, for example, premature discharge of a patient from the hospital or emergency department, is simply a form of medical negligence, which will require expert testimony at trial to set the standard of care.

Rarely, the facts are so outrageous the courts have ruled that the health care providers owed no further duty to provide treatment. The best known case is that of Payton v. Weaver, where a physician and hospital refused to provide dialysis to a patient because of persistent uncooperative and antisocial behavior. In lamenting that "occasionally a case will challenge the ability of the law, and society, to cope effectively and sensitively with fundamental problems of human existence," the court affirmed the trial court’s judgment that the healthcare providers had no legal obligation to continue providing regular dialysis treatment.

The facts of the case are as vivid as they are tragic. Ms. Brenda Payton was a 35-year-old woman with end-stage-renal disease on dialysis. An active user of alcohol, heroin, and barbiturates, she was non-compliant with dialysis and medical therapy. She continued to buy barbiturates from pushers on the street at least twice a week, failed to restrict her diet, sometimes gaining 15 kg between dialysis, and frequently missed dialysis, resulting in 30 hospitalizations in the 11 months before trial. She would come to dialysis drugged or drunk, use profane and vulgar language, cuss at staff, and expose her genitals in a lewd fashion. At times, she would scream for dialysis to be terminated and pull the dialysis needle from the shunt causing blood to spew.

The court found her behavior to be "knowing and intentional" and described Dr. Weaver as "one of the most sensitive and honest physicians that I have been exposed to either in a courtroom or out of a courtroom." It held that "there exists no basis in law or in equity to saddle him with a continuing sole obligation for Brenda’s welfare."

In another refusal-to-treat case, an abusive and disruptive patient missed scheduled dialysis sessions, and threatened to kill his nephrologists, Dr. John Bower, and shoot the hospital administrator at the University of Mississippi Medical Center. The court ruled that to compel Dr. Bower to proffer dialysis was tantamount to involuntary servitude, and this would violate the 13th amendment which prohibits slavery. However, it ordered the medical center to continue to provide dialysis because there was no other facility in the region.

Dr. S. Y. Tan is an emeritus professor of medicine at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].

Question: A 60-year-old obese patient experiences episodic substernal discomfort over the past several months. He is a type 2 diabetic with associated hypertension and hypercholesterolemia, none treated to target. Recently, a sibling was diagnosed with coronary artery disease and underwent successful stenting. The physician is aware of his patient’s high coronary risk. The patient subsequently develops crushing chest pain, rapidly complicated by fatal cardiogenic shock. An autopsy was performed by the coroner. Which of the following best supports the plaintiff’s allegation of medical malpractice?

A. Failure to refer to a cardiologist for evaluation of ischemic heart disease.

B. Failure to achieve strict control of his blood glucose and cholesterol.

C. Failure to control hypertension.

D. Failure to document that an exercise stress test was recommended, but declined by the patient.

E. Failure to obtain a chest CT to rule out a dissecting aortic aneurysm if that’s the cause of death.

Answer: E. All choices are plausible, but E is best. Misdiagnosis of an underlying cardiac condition such as a dissecting aneurysm in the setting of chest pain is a recurring malpractice allegation. Not treating risk factors where primary prevention is effective may constitute negligence, especially where there are national guidelines. An obvious example is in the diagnosis and treatment of hypertension. Not prescribing a low cholesterol diet in a hyperlipidemic patient has also been litigated as a negligent omission. Essentially, the plaintiff is asserting that the doctor deprived him or her of a chance of preventing the eventual injury ("loss of a chance" doctrine). Finally, whether and when to refer is to be judged by what a reasonably prudent doctor ought to do under the circumstances, and this requires expert testimony. For example, in Evanston Hospital v. Crane an Illinois court rejected the claim that it was common knowledge that someone should be referred to a cardiologist for a heart condition.

Failure to diagnose and treat myocardial infarction forms the basis of many lawsuits, including delay in or forgoing emergency heart catheterization in patients with acute chest pain. Another area of diagnosis-related liability is in exercise-induced sudden death, especially in professional athletes. Although many of the causes of sudden death in this young, healthy population (cardiomyopathy, valvular heart disease, coronary artery disease, and Marfan syndrome) may not be detectable by the usual screening tests, the physician should nonetheless heed the American Heart Association guidelines on what practices are customary in this setting.

Treatment negligence has been alleged over medications, invasive procedures, devices – and informed consent. Cardiac drugs like digitalis, anticoagulants, and antiarrhythmics are common examples of medication-related lawsuits. Prescription legibility may be at issue. In a highly publicized case of dispensing error, a cardiologist’s written prescription for Isordil was mistaken for Plendil, allegedly causing the patient to die from a heart attack. The family filed and won a lawsuit, with the jury awarding $450,000, equally apportioned between the cardiologist and pharmacist (State of Vasquez v. Albertsons). The invasive cardiologist or surgeon additionally faces lawsuits related to post-procedural or surgical complications such as perforation following angioplasty, postop strokes, hemorrhage, paralysis, and infection. Devices such as pacemakers can be defective and cause injuries. Improper indications, failure to warn of material risks, and post-procedure complications are the key issues when dealing with medical devices.

Remember, the plaintiff carries the burden of proving causation. Roskin v. Rosow is illustrative. The patient was being treated for hypercholesterolemia, and developed constipation and abdominal pain after taking cholestyramine and codeine. Her perforated colon was found to be distended with feces the size of tennis balls. The defendant-doctor contended that the plaintiff reported only mild constipation, and that the bowel was perforated during a barium enema study rather than from the use of medications. The case went to trial, and the jury found for the doctor. Reason: plaintiff failed to satisfy the causation element.

An emerging area of malpractice litigation affects patients who drive. Suppose a patient loses control of his or her car because of a cardiac arrhythmia or a drug reaction, and hits a pedestrian. The driver’s doctor may face a liability claim by the injured pedestrian. In a 2002 Hawaii case, such liability was held to attach "... where the physician has negligently failed to warn the patient that the medication may impair driving ability and where the circumstances are such that the reasonable patient could not have been expected to be aware of the risk without the physician’s warning."

According to MIEC, a medical professional liability insurance carrier, the quarterly premiums ($1 million/$3 million coverage) for an invasive and noninvasive cardiologist were $4,273 and $2,808 respectively, compared to $2,442 for a general internist (Hawaii, 2011). Of 230,624 closed claims from 1985 through 2007, 4,248 (1.8%) involved cardiologists. In all, 18% of these cardiovascular claims resulted in indemnity payments, averaging close to $250,000. The most common allegation was diagnostic error, especially regarding coronary artery disease. Coronary catheterization and angioplasty cases accounted for 12% and 7% respectively. Claims against cardiovascular and thoracic surgeons outnumber those against cardiologists, whose claims, in turn, outnumber other internists. These figures represent paid claims to the Physician Insurers Association of America, which collectively covers 60% of physicians in private practice.

Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].

Question: A 60-year-old obese patient experiences episodic substernal discomfort over the past several months. He is a type 2 diabetic with associated hypertension and hypercholesterolemia, none treated to target. Recently, a sibling was diagnosed with coronary artery disease and underwent successful stenting. The physician is aware of his patient’s high coronary risk. The patient subsequently develops crushing chest pain, rapidly complicated by fatal cardiogenic shock. An autopsy was performed by the coroner. Which of the following best supports the plaintiff’s allegation of medical malpractice?

A. Failure to refer to a cardiologist for evaluation of ischemic heart disease.

B. Failure to achieve strict control of his blood glucose and cholesterol.

C. Failure to control hypertension.

D. Failure to document that an exercise stress test was recommended, but declined by the patient.

E. Failure to obtain a chest CT to rule out a dissecting aortic aneurysm if that’s the cause of death.

Answer: E. All choices are plausible, but E is best. Misdiagnosis of an underlying cardiac condition such as a dissecting aneurysm in the setting of chest pain is a recurring malpractice allegation. Not treating risk factors where primary prevention is effective may constitute negligence, especially where there are national guidelines. An obvious example is in the diagnosis and treatment of hypertension. Not prescribing a low cholesterol diet in a hyperlipidemic patient has also been litigated as a negligent omission. Essentially, the plaintiff is asserting that the doctor deprived him or her of a chance of preventing the eventual injury ("loss of a chance" doctrine). Finally, whether and when to refer is to be judged by what a reasonably prudent doctor ought to do under the circumstances, and this requires expert testimony. For example, in Evanston Hospital v. Crane an Illinois court rejected the claim that it was common knowledge that someone should be referred to a cardiologist for a heart condition.

Failure to diagnose and treat myocardial infarction forms the basis of many lawsuits, including delay in or forgoing emergency heart catheterization in patients with acute chest pain. Another area of diagnosis-related liability is in exercise-induced sudden death, especially in professional athletes. Although many of the causes of sudden death in this young, healthy population (cardiomyopathy, valvular heart disease, coronary artery disease, and Marfan syndrome) may not be detectable by the usual screening tests, the physician should nonetheless heed the American Heart Association guidelines on what practices are customary in this setting.

Treatment negligence has been alleged over medications, invasive procedures, devices – and informed consent. Cardiac drugs like digitalis, anticoagulants, and antiarrhythmics are common examples of medication-related lawsuits. Prescription legibility may be at issue. In a highly publicized case of dispensing error, a cardiologist’s written prescription for Isordil was mistaken for Plendil, allegedly causing the patient to die from a heart attack. The family filed and won a lawsuit, with the jury awarding $450,000, equally apportioned between the cardiologist and pharmacist (State of Vasquez v. Albertsons). The invasive cardiologist or surgeon additionally faces lawsuits related to post-procedural or surgical complications such as perforation following angioplasty, postop strokes, hemorrhage, paralysis, and infection. Devices such as pacemakers can be defective and cause injuries. Improper indications, failure to warn of material risks, and post-procedure complications are the key issues when dealing with medical devices.

Remember, the plaintiff carries the burden of proving causation. Roskin v. Rosow is illustrative. The patient was being treated for hypercholesterolemia, and developed constipation and abdominal pain after taking cholestyramine and codeine. Her perforated colon was found to be distended with feces the size of tennis balls. The defendant-doctor contended that the plaintiff reported only mild constipation, and that the bowel was perforated during a barium enema study rather than from the use of medications. The case went to trial, and the jury found for the doctor. Reason: plaintiff failed to satisfy the causation element.

An emerging area of malpractice litigation affects patients who drive. Suppose a patient loses control of his or her car because of a cardiac arrhythmia or a drug reaction, and hits a pedestrian. The driver’s doctor may face a liability claim by the injured pedestrian. In a 2002 Hawaii case, such liability was held to attach "... where the physician has negligently failed to warn the patient that the medication may impair driving ability and where the circumstances are such that the reasonable patient could not have been expected to be aware of the risk without the physician’s warning."

According to MIEC, a medical professional liability insurance carrier, the quarterly premiums ($1 million/$3 million coverage) for an invasive and noninvasive cardiologist were $4,273 and $2,808 respectively, compared to $2,442 for a general internist (Hawaii, 2011). Of 230,624 closed claims from 1985 through 2007, 4,248 (1.8%) involved cardiologists. In all, 18% of these cardiovascular claims resulted in indemnity payments, averaging close to $250,000. The most common allegation was diagnostic error, especially regarding coronary artery disease. Coronary catheterization and angioplasty cases accounted for 12% and 7% respectively. Claims against cardiovascular and thoracic surgeons outnumber those against cardiologists, whose claims, in turn, outnumber other internists. These figures represent paid claims to the Physician Insurers Association of America, which collectively covers 60% of physicians in private practice.

Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].

Question: A 60-year-old obese patient experiences episodic substernal discomfort over the past several months. He is a type 2 diabetic with associated hypertension and hypercholesterolemia, none treated to target. Recently, a sibling was diagnosed with coronary artery disease and underwent successful stenting. The physician is aware of his patient’s high coronary risk. The patient subsequently develops crushing chest pain, rapidly complicated by fatal cardiogenic shock. An autopsy was performed by the coroner. Which of the following best supports the plaintiff’s allegation of medical malpractice?

A. Failure to refer to a cardiologist for evaluation of ischemic heart disease.

B. Failure to achieve strict control of his blood glucose and cholesterol.

C. Failure to control hypertension.

D. Failure to document that an exercise stress test was recommended, but declined by the patient.

E. Failure to obtain a chest CT to rule out a dissecting aortic aneurysm if that’s the cause of death.

Answer: E. All choices are plausible, but E is best. Misdiagnosis of an underlying cardiac condition such as a dissecting aneurysm in the setting of chest pain is a recurring malpractice allegation. Not treating risk factors where primary prevention is effective may constitute negligence, especially where there are national guidelines. An obvious example is in the diagnosis and treatment of hypertension. Not prescribing a low cholesterol diet in a hyperlipidemic patient has also been litigated as a negligent omission. Essentially, the plaintiff is asserting that the doctor deprived him or her of a chance of preventing the eventual injury ("loss of a chance" doctrine). Finally, whether and when to refer is to be judged by what a reasonably prudent doctor ought to do under the circumstances, and this requires expert testimony. For example, in Evanston Hospital v. Crane an Illinois court rejected the claim that it was common knowledge that someone should be referred to a cardiologist for a heart condition.

Failure to diagnose and treat myocardial infarction forms the basis of many lawsuits, including delay in or forgoing emergency heart catheterization in patients with acute chest pain. Another area of diagnosis-related liability is in exercise-induced sudden death, especially in professional athletes. Although many of the causes of sudden death in this young, healthy population (cardiomyopathy, valvular heart disease, coronary artery disease, and Marfan syndrome) may not be detectable by the usual screening tests, the physician should nonetheless heed the American Heart Association guidelines on what practices are customary in this setting.

Treatment negligence has been alleged over medications, invasive procedures, devices – and informed consent. Cardiac drugs like digitalis, anticoagulants, and antiarrhythmics are common examples of medication-related lawsuits. Prescription legibility may be at issue. In a highly publicized case of dispensing error, a cardiologist’s written prescription for Isordil was mistaken for Plendil, allegedly causing the patient to die from a heart attack. The family filed and won a lawsuit, with the jury awarding $450,000, equally apportioned between the cardiologist and pharmacist (State of Vasquez v. Albertsons). The invasive cardiologist or surgeon additionally faces lawsuits related to post-procedural or surgical complications such as perforation following angioplasty, postop strokes, hemorrhage, paralysis, and infection. Devices such as pacemakers can be defective and cause injuries. Improper indications, failure to warn of material risks, and post-procedure complications are the key issues when dealing with medical devices.

Remember, the plaintiff carries the burden of proving causation. Roskin v. Rosow is illustrative. The patient was being treated for hypercholesterolemia, and developed constipation and abdominal pain after taking cholestyramine and codeine. Her perforated colon was found to be distended with feces the size of tennis balls. The defendant-doctor contended that the plaintiff reported only mild constipation, and that the bowel was perforated during a barium enema study rather than from the use of medications. The case went to trial, and the jury found for the doctor. Reason: plaintiff failed to satisfy the causation element.

An emerging area of malpractice litigation affects patients who drive. Suppose a patient loses control of his or her car because of a cardiac arrhythmia or a drug reaction, and hits a pedestrian. The driver’s doctor may face a liability claim by the injured pedestrian. In a 2002 Hawaii case, such liability was held to attach "... where the physician has negligently failed to warn the patient that the medication may impair driving ability and where the circumstances are such that the reasonable patient could not have been expected to be aware of the risk without the physician’s warning."

According to MIEC, a medical professional liability insurance carrier, the quarterly premiums ($1 million/$3 million coverage) for an invasive and noninvasive cardiologist were $4,273 and $2,808 respectively, compared to $2,442 for a general internist (Hawaii, 2011). Of 230,624 closed claims from 1985 through 2007, 4,248 (1.8%) involved cardiologists. In all, 18% of these cardiovascular claims resulted in indemnity payments, averaging close to $250,000. The most common allegation was diagnostic error, especially regarding coronary artery disease. Coronary catheterization and angioplasty cases accounted for 12% and 7% respectively. Claims against cardiovascular and thoracic surgeons outnumber those against cardiologists, whose claims, in turn, outnumber other internists. These figures represent paid claims to the Physician Insurers Association of America, which collectively covers 60% of physicians in private practice.

Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.