Generic Industry Faces Uphill Battle In Preemption Case Before Supreme Court
Generic companies appear to be the underdogs as they head to the Supreme Court to argue they should not be held liable for inadequate label warnings.
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In Pliva v. Mensing, the high court said it was impossible for generic manufacturers to comply with both state tort laws and FDA regulations requiring them to have the same labels as those for brand name counterparts.
Generic Liability: Supreme Court Appears Divided On Whether ANDA Sponsors Must Seek Label Change When New Risks Emerge
In oral arguments in Pliva v. Mensing, justices suggest generic companies have an obligation to ask FDA to revise labeling; Chief Justice John Roberts Jr. says that could lead to boilerplate letters to FDA.
The court agreed to review three cases in which generic manufacturers of Reglan (metoclopramide) were held responsible for warning about the risk of tardive dyskinesia.