Following on the heels of the preemption victory in Wyeth v. Levine, in which the Supreme Court decided that consumers can sue a drug company for inadequate prescription drug labeling even if the FDA has approved the label, the US Court of Appeals for the Eighth Circuit has ruled that generic drug manufacturers cannot claim federal preemption to avoid liability for inadequate drug warning labels.
According to the ruling, FDA approval of a generic drug’s label does not preempt claims against the drug makers for failing to sufficiently warn consumers of a drug’s risks.
The case involves Gladys Mensing, who was prescribed metoclopramide to treat her diabetic gastroparesis. The drug caused her to suffer serious and permanent tardive dyskinesia, a neurological disorder that causes facial grimacing, lip twisting, tongue thrusting, gait instability, difficulty swallowing, and difficulty controlling her hands and arms. Ms. Mensing sued several manufacturers of generic metoclopramide, among others, alleging that the manufacturers failed adequately to warn of the drug’s side effects. –Public Justice
The generic drug manufacturers moved for dismissal, on grounds that an FDA regulation requiring generic drug labels to contain the same language as the labels of brand-name versions conflicted with, and thus preempted, failure-to-warn claims. The district court agreed to dismiss the case, but the Eighth Circuit overturned the dismissal, disagreeing with the preemption argument.
The Eight Circuit emphasized that generic manufacturers, like name-brand drug companies, "bear primary responsibility for their drug labeling at all times." Lawsuits like Ms. Mensing’s, the court said, do not "obstruct the purposes and objectives" of federal drug regulation "in any way." Instead, they help achieve the "fundamental" purpose of federal regulation—ensuring that "all marketed drugs remain safe." –Public Justice
This is a great win for the American consumer. It’s gratifying to see all drug companies being held accountable for the harms they cause when they’re not careful enough with their products.