Osteoporosis Malpractice

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].