The interesting fact pattern that gives rise to the problem in this case is what are the duties of a generic drug manufacturer if, after a drug’s initial federal approval (and approval (and then mandated use) of a specific warning label), new information comes to light about potentially harmful side effects? Can a claim be brought against the manufacturer under state law for failure to warn?
Gloria Mensing took a medicine, MCP, a generic equivalent of a Wyeth medicine brand-named Reglan, for her gastrointestinal disorder (diabetic gastroparesis) and she alleges she developed tardive dyskinesia, a neurological disorder, as a result. Such a claim, on its face, might seem straight-forward (drugs are not supposed to make one sicker, after all (though causation, of course, must be proven)). Due to the complex interrelationship between the federal regulatory regime (FDA regulation) and Minnesota’s regulatory system (a.k.a. state tort law remedies), however, the clarification of Mensing’s rights (or their absence) is anything but simple.
Mensing brought suit for the generic manufacturer’s failure to warn of this risk from long-term use of MCP but U.S. District Court Judge Donovan W. Frank (D. Minn.) dismissed her claim, holding that her claims against the generic manufacture were preempted by federal law. (The generic manufacturers had argued that they were in a Catch-22 where federal law required warning labels that Mensing alleged violated state law.) The U.S. Court of Appeals for the Eight Circuit reversed Judge Frank, suggesting that federal law could not be read to “permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it.”
The U.S. Supreme Court is now considering whether to weigh in on the case and has sought input from the Solicitor General as to whether this case should be reviewed by the Supreme Court. The Solicitor General has asked the Supreme Court to let the Eighth Circuit decision stand. If you’ve read this far and are still interested, try reading more here.