A recent New York State Supreme Court ruling holds that the manufacturer of a name-brand drug cannot be held liable for labeling defects of the generic form of the drug. The case involved a plaintiff that had taken Sertraline, the generic form of Pfizer’s SSRI antidepressant drug Zoloft. The plaintiff claimed that the generic Sertraline’s label failed to warn of potential birth defects risks linked to the medication.
The lawsuit against Pfizer alleged that the warning label on generic Sertraline is inadequate because it must be identical to Pfizer’s indequate warninglabel on name-brand Zoloft. The plaintiff argued that Pfizer should be held liable for the generic Sertraline’s warning label because it was foreseable that the generic warning label would be identical to the Pfizer’s name-brand Zoloft warning label.
The Court held that Pfizer had a labeling duty to warn only with regard to its own drug, name-brand Zoloft. The Court opined that those duties “should not extend to products and labeling over which it had no control, even if those products and labels mirror its own, because it had nothing to do with putting them in the hands of consumers.”
The ruling is significant as it declines to follow a 2008 decision from California. In Conte vs. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal Ct. App. 2008), a California court held “the common law duty to use care owed by name-brand prescription drug manufacturer when providing product warning extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturer’s product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug.”