Off-label use ruling might help sued docs — Decision could affect med/mal suits

Pharmaceutical companies could become more forthcoming with information provided to physicians on off-label usage of medications as a result of a recent decision from the U.S. Court of Appeals for the Second Circuit. The ruling vacated the criminal conviction of a pharmaceutical sales representative who was found guilty of conspiracy to introduce a misbranded drug under the Food, Drug & Cosmetic Act, because he spoke about off-label uses of a particular drug.1

The decision could diminish the Food & Drug Administration (FDA)’s ability to rein in dissemination of truthful information on off-label uses, says Joseph P. McMenamin, MD, JD, FCLM, a Richmond, VA-based healthcare attorney and former practicing emergency physician.

“It wasn’t as though there was a complete embargo against it, but the doctor and the company had to jump through a bunch of hoops for the information to be provided to the physician,” he explains.

Drug reps are not allowed to initiate or even to prompt discussion of off-label uses. If asked directly by a physician about off-label uses, the rep can do no more than to refer the doctor to someone at the company with additional training, often called a medical science liaison, and usually someone with a clinical background, such as a nurse, a pharmacist, or even a physician.

In the recent Caronia case, the drug rep broke these rules. He promoted the drug for off-label uses to a physician who was a government informant. The Caronia court noted that, if information on off-label uses is withheld from physicians, the public could be harmed. FDA elected not to appeal the case.

“In the wake of Caronia, companies will probably proceed cautiously. FDA law remains substantially intact,” says McMenamin. “Caronia is good law only in the Second Circuit: New York, Connecticut, and Vermont.”

FDA rules stand

Even there, untruthful or misleading information is not protected, and FDA’s rules on labeling, misbranding, and adulteration still stand. Nevertheless, the decision eventually could help physicians who prescribe medications off-label because, at least in the Second Circuit, drug companies might believe they face a lower risk of prosecution for making information on off-label uses more readily available.

“That information that could help physicians make better judgments about therapy,” says McMenamin.

While the decision involves communication between regulated industry and the medical profession, it also has some potential implications for malpractice litigation, says McMenamin.

“I can imagine some confusion in the minds of jurors, if they hear about the seemingly inconsistent rule that although the doctor is at liberty to write for the product for whatever reason he thinks appropriate, the company is not allowed to promote it except for government-approved indications,” he says.

The ruling could make it easier for physician defendants to convince jurors that that off-label use isn’t necessarily a breach of the standard of care, says McMenamin. “Doctors write off label all the time, and in fact, in certain situations doing so may be required by the standard of care,” he says.

If a drug’s off-label use is admissible, the plaintiff’s attorney likely would emphasize the demonstration of safety and efficacy that the FDA insists on before it allows a drug to be marketed in the United States, says McMenamin. “The expert would say, ‘The indication is not on the label for a reason. No one has ever satisfied FDA that it is any good for Condition X, yet this maverick doctor over there wrote this script, and my client came to harm,’” he says.

The defense then would need to explain that many times, off-label use is not only appropriate but required, and that the FDA approval process is slow and cumbersome, says McMenamin. The defense also could point out to jurors that Medicare pays for off-label uses of medications, he says.

“So it’s not only accepted by the profession as the standard of care, it’s accepted by a third party payer — even though another branch of the U.S. government is telling pharmaceutical houses that they are not allowed to advertise this information,” says McMenamin.


1. United States v. Caronia, 703 F.3d 149 (2d Cir. December 3, 2012


Joseph P. McMenamin, MD, JD, FCLM, Richmond, VA. Phone: (804) 828-5460. Email: