Posted by: Lawyer Sanders | December 1, 2009

Kentucky environmental attorney Sanders says generic drug manufacturers do not enjoy federal preemption from liability in U.S. 8th Circuit.

The U.S. Court of Appeals for the Eighth Circuit held in Mensing v. Wyeth, Inc., that generic drug manufacturers cannot use federal preemption to avoid liability for failing to warn of dangers from their drugs. The court ruled that the approval of a generic drug’s label by the U.S. Food and Drug Administration (FDA) does not preempt claims against the drug makers for failing to warn consumers of known risks.

Earlier this year, the U.S. Supreme Court held in Wyeth v. Levine that the FDA’s approval of a drug’s label does not preempt – i.e., wipe out – injured consumers’ claims against name-brand drug manufacturers for failing to warn of the drugs’ dangers.  Despite the Wyeth case, generic drug manufacturers continue to argue that the FDA’s approval of their labels preempts failure to warn claims against them.

The generic drug manufacturers’ position seems a bit disingenuous to me in light of the Supreme Court’s ruling in Wyeth.  In any event, the Mensing case is the first federal appellate decision since Wyeth holding that federal preemption does not immunize generic drug manufacturers from liability. 

This distinction between generic and name brand drugs is important as the Eighth Circuit noted in its opinion, seven in ten U.S. prescriptions are now filled with generic drugs.  That percentage is certainly going to rise if health care coverage becomes mandatory in the future.

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.

 The generic drug manufacturers moved to dismiss the case, arguing that the failure-to-warn claims conflicted with – and thus were preempted by – an FDA regulation that requires the labels of general prescription drugs to contain the same language as the FDA-approved label for the brand-name version of that drug. The district court agreed with this legal argument. 

To no surprise after the Wyeth decision, on November 27, 2009, the Eighth Circuit overturned the district court’s dismissal and flatly rejected the generic drug companies’ preemption arguments. 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.” To read the Eighth Circuit’s decision rejecting FDA preemption in Mensing, go to:


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