Legal: Standard of care: My patient died from a side effect; will I be sued for millions?

September 1, 2008

Dr. Foot has, for years, been prescribing a highly effective oral medication for tinea pedis. One of the known and documented side effects of this oral agent is liver failure.

Key Points

Dr. Foot has, for years, been prescribing a highly effective oral medication for tinea pedis. One of the known and documented side effects of this oral agent is liver failure.

Although periodic blood test evaluations can lessen the likelihood of such problems, Dr. Foot, like all physicians, knows that even monthly blood tests cannot stop this rare event from occurring.

Two years ago, one of Dr. Foot's patients took this medication. Despite appropriate blood test evaluations, the patient - after only a short period of mildly elevated liver function tests - developed fulminant hepatic failure and died.

Dr. Foot is now worried that such a case will be brought against him. Certainly, he does not have enough medical malpractice coverage to protect him against such a verdict. Should he be worried? His concerns - at first thought, ridiculous - may not be unreasonable.

The jury is in

In the last two years, three large jury awards in lawsuits against an isotretinoin manufacturer have dermatologists wondering about the legal ramifications of prescribing the medication.

In May 2007, an Alabama jury awarded $2.6 million to a plaintiff who alleged that the medication caused irritable bowel disease. In October of the same year, another jury in Florida jury awarded $7 million in a similar lawsuit. Most recently, in April 2008, a New Jersey jury awarded a $10.5 million judgment to a 24-year-old woman who alleged that the drug had caused her inflammatory bowel disease.

All three verdicts are being appealed and are part of a stream of more than 400 suits against the manufacturer.

Standard of care

Although at first blush, Dr. Foot should be concerned, it should be noted that there is large difference between product liability cases brought against a drug manufacturer (as in the case of isotretinoin) and a medical malpractice case brought against a dermatologist for alleged negligence.

In contrast to product liability cases - which are brought against companies over allegedly defective products - negligence actions against physicians only succeed if that physician does not practice in accordance with the standard of care.

Product liability cases generally are filed against manufacturers based on a variety of issues, such as alleged misrepresentation and fraud. Physicians are generally not sued for these reasons. Physicians are generally sued for damage that occurs because they have breached the standard of care.

Just as the standard of care for dermatologists who prescribe isotretinoin is to be in compliance with the iPLEDGE system, the standard of care for a physician such as Dr. Foot is that he warn his patient about potential drug-induced liver problems and stress the need for periodic blood test evaluations.

If this is done and something goes awry, the suing plaintiff's expert will have to testify that the dermatologist did not practice in accordance with the standard of care - something the expert will not likely be able to do.

Dr. Foot's approach - just like the approach of a dermatologist who follows the iPLEDGE program - cannot stop someone from suing him. However, performing within the standard of care is likely to stop Dr. Foot from losing a case against him.

Dr. Goldberg is the director of SkinLaser & Surgery Specialists of New York and New Jersey; director of Mohs surgery and laser research, Mount Sinai School of Medicine; and adjunct professor of law, Fordham Law School.