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Malpractice Consult


Off-label prescribing and the standard of care.


Malpractice Consult

By Lee J. Johnson, JD

Off-label prescribing and the standard of care

Q: Off-label use of prescription drugs is fairly common. Still, can a plaintiff argue in court that I violated the accepted standard of care because I deviated from information in the package insert or the Physicians' Desk Reference?

A: He can argue it, but without expert testimony to back up his claim, he'll probably lose.

A Tennessee appeals court recently held that a pharmaceutical company's package insert or an entry in the PDR, standing alone, doesn't establish the standard of care in a medical malpractice case. A jury may consider the evidence only if it is supported by expert testimony that the defendant acted negligently in prescribing and administering the drug.

The ruling is in line with many other court decisions around the country.

The Tennessee case arose when a physician prescribed terbutaline to a woman experiencing labor pains in her 35th week of pregnancy. The drug had been approved by the FDA for asthma, but is frequently used to stop contractions because of its muscle—relaxing properties, the court noted.

The patient experienced chest pains, and then suffered a myocardial infarction before giving birth to a healthy child. She later underwent open heart surgery to repair a tear in her coronary artery associated with the MI.

The patient alleged that the doctor was negligent in ordering and administering the drug. The physician's attorney attempted to stop the plaintiff from presenting evidence about the package insert and PDR entry, or from making any reference to the fact that the drug hadn't been approved by the FDA to stop premature labor. The insert states the drug shouldn't be used for tocolysis because it could cause severe adverse reactions in women in labor.

A trial court granted the physician's motion to exclude that evidence, and the jury found in favor of the defendant doctor. However, an appeals court ordered a new trial, because it ruled that evidence about the off—label use shouldn't automatically have been excluded. (The new trial hasn't yet taken place.) The court held that the package insert and PDR entry could be relevant in establishing the standard of care—if presented with expert witness testimony.

The court held that off—label prescribing is a common medical practice, and by itself doesn't breach the standard of care. But since the plaintiff also presented expert testimony to bolster her claim, the trial judge should have allowed her to present evidence about the drug's labeling. Labeling information should be admissible to show what a doctor knew or should have known about the drug.

Drug manufacturers don't design PDR entries or package inserts to establish the standard of care. The entries are written to comply with FDA requirements, to provide useful information to physicians, and to limit the manufacturer's liability. A physician's failure to adhere to these warnings doesn't, by itself, constitute negligence, the court ruled.

The author, who can be contacted at 2402 Regent Drive, Mount Kisco, NY 10549, or at, is a health care attorney who specializes in risk management issues. This department answers common professional-liability questions. It isn't intended to provide specific legal advice. If you have a question, please submit it to Malpractice Consult, Medical Economics magazine, 5 Paragon Drive, Montvale, NJ 07645-1742. You may also fax your question to 201-722-2688 or send it via e-mail to


Lee Johnson. Malpractice Consult. Medical Economics 2001;16:97.

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