Bills were just recently introduced in the US House of Representatives and the US Senate which would effectively overrule the Supreme Court’s decision 2011 decision in Pliva v. Mensing by “allow[ing] generic drug companies to be held liable under state tort law for failing to update warning labels with known dangers.” In a 5-4 split, the Supreme Court’s decision in Mensing held that generic drug-makers are not liable for label warnings because they are legally required to use the same label as brand-name makers. In the dissent, Supreme Court Justice Sonia Sotomayor noted, “As the majority itself admits, a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. The majority offers no reason to think – apart from its new articulation of the impossibility standard- that Congress would have intended such an arbitrary distinction.”
As expected, the 2011 decision created uproar with concerned and affected consumers as well as with the legal community. Following the ruling, generic drug-makers have been successfully moving to be dismissed from mass torts and class actions across the country, including the Darvocet multidistrict litigation currently centralized in Kentucky. It appears that the new legislation would require generic drug-makers to follow the same guidelines that brand name makers use for updating product safety on their labels. “The Mensing decision creates a troubling inconsistency in the law governing prescription drugs,” said Senator Patrick J. Leahy (VT), who sponsored the bill along with six other Democrats, in a statement on April 18, 2012. Some argue that the likelihood of the bill passing in the House, which is controlled by Republicans, is slim.