A recent Reuters article discussed a label issue that went all the way to the Supreme Court. Merck & Co has received multiple lawsuits claiming the company failed to properly warn patients of the risk of femoral fractures while taking its osteoporosis drug Fosamax. In 2008, Merck submitted data to the FDA that suggested Fosamax could be linked to certain bone fractures, but the FDA denied the warning label proposal. Two years later, the FDA ordered manufacturers to revise labels to include the warning, which Merck did.
In order to alleviate the drug company of any liability, the Supreme Court said it must show that it “fully informed” the FDA of the need for a warning label. Last Monday, the Supreme Court unanimously directed the Circuit Court of Appeals to reconsider its decision to let lawsuits against Merck move forward. The ruling clarifies that product liability claims brought under state law are preempted by the actions of a federal agency since federal law trumps state law under the U.S. Constitution. In other words, Merck cannot be penalized for failing to issue a warning that the FDA blocked.