Could a drug maker be liable for off-label uses of its product?

Expecting mothers often go to great lengths to protect the health of their developing child. Such proactive measures may include dietary restrictions; prenatal care visits and other health best practices. Imagine, then, the heartbreak that the parents in a recent product liability lawsuit must have felt after discovering that the medication they took during their pregnancy may have resulted in birth defects.

The plaintiffs, an Alabama family, have brought suit against drug maker GlaxoSmithKline (“GSK”) over its prescription medication Zofran. The plaintiffs claim that GSK failed to include adequate warnings of the risk of birth defects. 

The U.S. Food and Drug Administration approved Zofran for reliving nausea and vomiting. However, that approval was for a specific group of patients: individuals undergoing radiation or chemotherapy. Notably, the FDA did not approve the drug for the purpose of treating morning sickness.

The plaintiffs’ doctor presumably prescribed the drug for the mother’s pregnancy-related nausea. A medication used for non-FDA approved reasons is known as an off-label use. Although a drug maker cannot market a medication for non-FDA uses, a doctor has the authority to prescribe drugs for off-label uses.

This raises an interesting question of liability. Is it negligent for a doctor to prescribe for off-label purposes? Does a drug maker have to anticipate such applications? Should Zofran’s packaging have included a warning about potential pregnancy complications and/or birth defects? There might not be easy answers to these questions, but a law firm with experience in medical malpractice and product liability claims, like ours, can work to protect a victim’s rights. 

Source: Injury Lawyer News, “Parents Blame Child’s Heart Defect on Zofran,” Jacky Gale, Dec. 7, 2015

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