How much liability do generics makers bear? That's one question the U.S. Supreme Court says it will answer next year. At issue is whether patients can sue generics makers in state court: Does FDA approval shield the companies from labeling-related liability? Or not?
If the question sounds familiar, that's because it is. Last year, the Supreme Court weighed the idea of FDA approval-as-shield, in the much-publicized case of Wyeth v. Levine; the company (now part of Pfizer) had argued that it wasn't liable for patient Diana Levine's injury, because the label on the drug--the anti-nausea treatment Phenergan--was FDA-approved. In that case, the Supremes came down on the side of the patient, saying that FDA approval did not preempt the patient's right to sue.
Now, the high court will hear two cases involving generic knock-offs of the gastrointestinal drug Reglan. In these cases, the patient-plaintiffs say the copycat drugmakers failed to adequately warn them about their risks of the drug. In one case, against Actavis, the plaintiff says the company should have flagged the neurological risks of metoclopromide (Reglan) and should have changed the label to highlight them. In another, the plaintiff sued Actavis, Teva Pharmaceutical Industries, and Mylan's UDL Laboratories after she developed a neurological movement disorder after using generic Reglan.
Lower courts sided with the patients, and now the Supreme Court has agreed to hear the companies' appeals. They argue that the Court's previous failure-to-warn ruling doesn't apply to them, because federal law requires generics to include the same packaging inserts as the branded versions do. Arguments are expected in March or April, with a ruling to come by June.