Last year the United States Supreme Court held in Pliva, Inc. v. Mensing, No. 09-993 (June 23, 2011) that the Hatch-Waxman Amendments to the federal Food, Drug and Cosmetic Act (FDCA) preempted state law, failure to warn claims against manufacturers of generic drugs. The decision should result in the dismissal of similar claims pending in California. If federal law preempts state court claims based on failure to warn against generic manufacturers, then such claims should all be dismissed in California. One California court, however, has so far declined to do so.
In Mensing, the plaintiffs claimed they developed neurological conditions after long term use of metoclopramide, a generic version of the drug Reglan, to treat acid reflux and other ailments. They sued generic drug manufacturers claiming that the generic drug’s warnings were inadequate under state law. The plaintiffs argued that the generic drug manufacturers should be liable because the manufacturers 1) failed to warn about the risks associated with long-term use of the drug; 2) failed to request a labeling change revision with the United States Food and Drug Administration (FDA) as provided under the FDCA’s “Changes Being Effected” provisions; and 3) failed to report safety information to the medical community.
The generic drug manufacturing defendants responded that the plaintiffs’ claims were preempted. The defendants argued that it was impossible to add the warnings that plaintiffs required without violating federal law because the FDA prohibited generic companies from unilaterally changing any warnings that differed from the brand name labeling. In addition, the defendants asserted that the plaintiffs’ claims created an impermissible conflict with congressional objectives which applied to generic drug manufacturers under the FDCA.
Writing for a 5-4 majority, Associate Justice Clarence Thomas reasoned that federal law prohibited generic drug manufacturers from unilaterally changing warnings in a product’s labeling, thereby making it impossible for generic manufacturers to comply with both their state law duty to change the label and their federal law duty to keep the label the same. Generic drug manufacturers therefore could not be held liable for failing to request a label change on their products when they obtained information on new risks.
Despite the United States Supreme Court’s holding in Mensing, on April 17, 2012 the San Francisco Superior Court overruled a general demurrer brought by defendants to dismiss all pending metoclopromide cases in San Francisco. The defendants argued that, as a result of Mensing, there no longer were any legal bases under state law to continue the lawsuits. The judge disagreed: “Mensing does not hold that any claim relating to labeling is precluded by federal law. It only states that a state cannot require a drug manufacturer to label its product, where to do so would violate federal law. So I don’t find that any of the causes of action are preempted by Mensing.”
Although it appears that the metoclopramide cases will continue to proceed in San Francisco, on July 23, 2012 the defendants filed a petition for writ of mandate in the First District Court of Appeal. If the petition is granted, then the superior court could be ordered to find that Mensing did apply to the claims in the pending metoclopramide cases. Consequently, such cases would be dismissed.
So did Mensing sound the death knell for metoclopramide cases in California? We will just need to wait and listen.