Generic Drug Preemption

January 2015

Claims against Generic Drug Manufacturer Allowed to Proceed in State Court

In PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the U.S. Supreme Court held that state law failure-to-warn claims against manufacturers of generic prescription drugs are preempted by federal drug regulations. Observers have characterized this ruling as creating significant challenges for consumers who seek damages for injuries caused by inadequate warnings on generic prescription drugs. A recent decision by the Eastern District of the Missouri Court of Appeals, however, indicates that generic drug manufacturers are still subject to state law claims in certain limited situations. Specifically, in Franzman v. Wyeth, Inc., No. ED 100312 (2014), the Court held that a consumer's claim against a generic drug manufacturer was not preempted by federal law and could proceed in state court to the extent that her claim was based on the generic manufacturer's failure to adopt additional warning language that had been approved by the Food and Drug Administration (FDA) and adopted by the brand-name manufacturer.

Franzman involved allegations related to the prescription drug metoclopramide, which is also sold under the brand name Reglan. The drug is used to treat digestive problems. Users of the drug have alleged that its manufacturers failed to adequately warn doctors, pharmacists, and consumers of the risks of developing tardive dyskinesia from prolonged use of the drug. Tardive dyskinesia is an often irreversible disorder characterized by repetitive, involuntary, purposeless movements, such as excessive eye blinking.

The plaintiff was diagnosed with tardive dyskinesia following her prolonged use of the generic form of metoclopramide. She alleged that the manufacturers and sellers of the generic form of the drug she ingested failed to reasonably and adequately warn of the risks and dangers associated with its long-term use. She similarly sought to hold the manufacturers and sellers of the brand-name form of the drug liable for her injuries, even though she had never ingested the brand-name form of the drug. She also sought damages from a company that disseminated information about the drug to pharmacists and doctors.

The trial court dismissed the plaintiff's claims against the generic defendants, concluding that the plaintiff's claims all sounded in the same failure-to-warn claims preempted by Mensing. The appellate court, however, reversed to the extent that the plaintiff alleged that the generic defendants had failed to update the label of the generic drug to conform to a brand-name label revision approved by the FDA in 2004 (the brand-name label revision's included, among other things, language stating, "Therapy should not exceed 12 weeks in duration."). The court explained that although the Supreme Court's holding in Mensing will preclude many state law failure-to-warn claims against manufacturers of generic drugs, Mensing does not offer blanket immunity to the generic drug market. The court cautioned that only those claims related to the failure to include the additional warning language approved in 2004 were being allowed to proceed, and that any claims that the generic drug should have included stronger warning labels other than those approved for use on the brand-name form of the drug were clearly preempted by federal law.

This decision serves as an important reminder that defendants moving for dismissal based on a preemption affirmative defense, as well as trial courts analyzing such motions, must perform a thorough preemption analysis.

The trial court also dismissed the plaintiff's claims against the brand-name defendants because the plaintiff admitted that she ingested only generic metoclopramide and thus she could not prove that the brand-name drug was the legal cause of her injury. The appellate court affirmed that dismissal, but it repeatedly noted that it thought this result was unfair and unjust and that it was reaching this result only because it was required by Kentucky law (where plaintiff lived when she ingested the drug).