FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty.
The U.S. Food and Drug Administration (FDA) recently announced it will not finalize a rule to allow generic drug manufacturers to independently update their warning labels this summer as planned. The rule would have negated Pliva v. Mensing, 131 S.Ct. 2567, 2571 (2011), a 2011 United States Supreme Court case that struck a blow to the plaintiffs’ bar by dramatically limiting products liability lawsuits for consumers who took generic versions of prescription drugs. Specifically, as a result of the decision, plaintiffs cannot sue for injuries caused by a generic manufacturer’s failure to adequately warn of the drug’s side effects and risks — by far the most common theory for products liability claims brought against pharmaceutical companies. In the aftermath of Mensing, the FDA proposed rule changes for generic manufacturers while plaintiffs’ lawyers searched — with varied success — for ways around the decision’s prohibitions. With the FDA’s recent announcement, though, experts question the proposed rule’s future, resulting in a renewed focus on generic drug manufacturer liability and increased incentive on the plaintiffs’ side to continue creative lawyering and lobbying efforts to change the relevant laws. This changing landscape will generate consequences not just for generic manufacturers, but also for branded drug makers. The entire industry therefore has reason stay on top of the latest trends and past developments.
Please see full publication below for more information.
