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David Ferrera, a partner in the firm’s Litigation Department and chair of the Product Liability Litigation practice group, published “Juries vs. FDA on drug safety” in The Boston Globe on October 31. The op-ed discusses the implications of the court’s decision in the U.S. Supreme Court case Wyeth v. Levine. Several members of Congress and patient advocates have raised false alarms regarding a favorable decision for Wyeth, which they believe will amount to a blanket immunity for drug makers from liability for injuries caused by their products. However, David notes that this distorts what the case is about, because at issue in this case is whether a company should have changed a drug label previously approved by the FDA to protect patients from certain known medical risks.

The case boils down to the question of who should be empowered to make difficult judgments about the safety, effectiveness, and warnings on proper use of a drug. David points out that if the Wyeth verdict stands, the judgment of a jury of laypeople would replace that of FDA experts regarding the appropriate labeling of a drug. 

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