The U.S. Supreme Court is asking the Obama administration for its views on whether generic drug companies can be sued over allegations that they inadequately labeled their products.
A number of generic drugmakers, including Teva Pharmaceuticals USA, Actavis Elizabeth and UDL Laboratories, are seeking to preempt a product liability lawsuit by a woman who allegedly developed tardive dyskinesia after taking copycat versions of Wyeth's heartburn drug Reglan. In March 2001, plaintiff Gladys Mensing was prescribed Reglan to treat her diabetic gastroparesis, and her pharmacist filled her prescription with its generic bioequivalent. After four years of ingesting the product, she developed the severe neurological disorder, according to court documents. She brought suit against Wyeth and the generic companies in the U.S. District Court for the District of Minnesota, alleging the drug posed more serious risks than drugmakers indicated on their labels.
A trial judge ruled against her, but Mensing appealed to the Eighth Circuit Court of Appeals. The Appeals Court affirmed the judgment in favor of Wyeth and Schwarz Pharma (which manufactured the drug), but reversed the favorable decision for the generic drugmakers. "[W]e conclude that Mensing has stated a viable claim against the generic metoclopramide manufacturers," the appeals court said in its opinion. "Far from prohibiting them from taking steps to warn their customers of new safety hazards, federal law requires such action." The court cited the Supreme Court's 2009 decision in Wyeth v. Levine, which stated that FDA drug regulations don't protect a company from being sued under state law over drug labeling, as Dow Jones notes.
However, the generic companies say the lawsuit should be preempted by federal law because it would require them to write labels that deviate from the brand-name drug's label. In a short written order, the Supreme Court asked the Solicitor General's office to express the administration's views on whether the court should consider the drugmakers' appeal.