According to recent reports, the FDA is considering new labeling requirements for the manufacturers of generic drugs, which could lead to a change in a company’s responsibility to consumers. Currently, generic manufacturers are required by federal law to have the same labels as the branded version. As a result of this federal law, the United States Supreme Court held in Pliva v. Mensing that generic manufacturers could not be held liable in state court for failure to warn claims. According to a 2011 petition by Public Citizen, a national consumer organization, approximately 90% of all prescriptions issued in 2010 were for generic drugs. The proposed revision would allow the generic manufacturer to change the label warnings without FDA approval, thereby eliminating the legal loophole currently available to generic manufacturers.
The Court’s decision in Mensing has had devastating effects on thousands of plaintiffs nationwide who have had their claims dismissed, in cases such as the Darvocet litigation, because they had ingested the generic version of the drug rather than the branded version. As it stands, these plaintiffs are essentially left without any legal recourse for injuries allegedly sustained as a result of these generic drugs.