Generic Injury Lawsuits Upheld by Federal Appeals Court

Patients may sue generic drug makers under their state laws for failing to adequately warn users about potential side effects, a federal appeals court has ruled.

The important ruling from the U.S. Fifth Circuit Court of Appeals upheld a lower court’s ruling in a case against drug maker Actavis Inc. and its heartburn drug Reglan. The drug has been linked in some cases to tardive dyskinesia, a neurological condition that causes involuntary movements of the lower face and extremities.

Reglan is available in generic form called metoclopramide from Actavis and other companies. About 70 percent of all prescriptions in the U.S. are written for generic drugs, which are less expensive than brand-name drugs.

Louisiana Case at Issue in Ruling

Patient Julie Demahy sued Actavis under Louisiana law claiming she developed tardive dyskinesia after the company failed to adequately warn her about the risks of using metoclopramide. The suit also claims the company failed to change the drug’s label to caution users of the potential side effects.

In a January 8 ruling, the appeals court upheld Demahy’s right to sue, citing a recent U.S. Supreme Court case (Wyeth v. Levine) involving Wyeth’s antinausea drug Phenergan. The appeals court’s opinion said there is not enough evidence to show Congress clearly wanted to preempt state law or let the federal Food and Drug Administration do so, according to a Reuters news report.

“To hold otherwise would leave us with the bizarre conclusion that Congress intended to implicitly deprive a plaintiff whose doctor prescribes a generic drug of any remedy, while under Levine, that same plaintiff would have a state-law claim had she only demanded a name brand drug instead,” the judge wrote.

No related posts.