On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva Pharmaceuticals USA Inc. and other companies failed to warn about dangers associated with its version of the osteoporosis drug Fosamax.
Teva’s appeal raised questions regarding the scope of the Supreme Court’s 2011 decision in Pliva v. Mensing, 131 S.Ct. 2567 (2011). In Mensing, it was held that the U.S. Food and Drug Administration (FDA) federal labeling requirements directly conflict with, and thus preempt, state-law tort claims alleging a failure to provide adequate warning labels. Mensing effectively shielded generic drug makers from lawsuits as long as their warning labels complied with the requirements for the branded versions of their products.
In Teva, Plaintiff alleged a failure-to-warn claim on the assertion that Teva and other generic makers failed to bring their warnings in line with an update to branded Fosamax’s label. Teva argued that Plaintiff’s claims were preempted under Mensing. The trial court sided with Plaintiff and the Court of Appeal affirmed, finding that federal law does not preempt state tort claims predicated on allegations that a generic drug manufacturer violated the Food, Drug and Cosmetic Act by failing to immediately implement or otherwise disseminate notice of labeling changes that the FDA had approved for use on a generic drug product’s brand-name equivalent. The Court of Appeal noted that Plaintiff was not suing the generic drug companies for failing to provide stronger warnings than those for brand-name Fosamax, but rather for failing to update their safety warnings after Fosamax’s label had changed.
The California Supreme Court declined to review the appellate decision, prompting Teva to petition the U.S. Supreme Court. Teva argued in its petition that, if upheld, the California appeals decision would allow plaintiffs to sue generic makers for failing to update labels “every time” the FDA posts a drug labeling change on its website. The U.S. Supreme Court’s refusal to hear the appeal likely paves the way for similar cases against other generic drug makers.
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