'Failure to Warn' Claims Against Generic Manufacturers Not Preempted By Federal Law

The district court granted the generic manufacturers' motion to dismiss. (In the same ruling, the district court also granted the brand name manufacturers' motions for summary judgment, a decision later affirmed by the Eighth Circuit. For more information about that aspect of the case, see Mayer Brown's Client Alert, “Eighth Circuit Rejects Innovator Liability Theory in Mensing v. Wyeth, Inc.” (http://www.mayerbrown.com/productliability/article.asp?id=8194&nid=12487)) The generic manufacturers argued that the plaintiff's failure-to-warn claims conflicted with, and, therefore, were impliedly preempted by, federal law because the claims would require generic manufacturers to deviate from the drug label prescribed for name brand Reglan. The district court agreed, and the plaintiff's appeal to the Eighth Circuit followed.

The Ruling

The Eighth Circuit reversed the judgment and held that the plaintiff's claims were not preempted. The court concluded that generic metoclopramide manufacturers could, in fact, simultaneously comply with both federal and state law and, moreover, that enforcement of state tort law in this context would not present an obstacle to the purposes of federal law.

Following the Supreme Court's lead in Wyeth v. Levine, 129 S. Ct. 1187 (2009), the Eighth Circuit began its implied preemption analysis by applying “a presumption against preemption.” In the Eighth Circuit's view, Levine's holding that failure-to-warn claims against name brand manufacturers were not preempted by the FDCA “carrie[d] significant implications” for the generic manufacturers' preemption arguments because Levine clarified that the responsibility for ensuring the adequacy of drug warnings typically rested with manufacturers in the first instance.

According to the court, it was possible for the generic manufacturers to comply with their state law tort duties and with the FDCA's labeling requirements. The generic manufacturers argued that they were prohibited by federal law from modifying their labels to include the additional warnings that the plaintiff asserted should have been added because the FDCA required labels for generic drugs to be substantively identical to the label for the corresponding brand name equivalent. The Eighth Circuit rejected this argument, stating that the generic manufacturers could at least have “proposed a label change” to the brand-name drug label that the FDA could then have imposed uniformly on all manufacturers of metoclopramide, brand name and generic. True, it was not clear what the FDA would have done if such a change had been proposed. But under Wyeth, the Eighth Circuit held, uncertainty about the FDA's response weighed against a finding of preemption. Because the generic manufacturers did not present “clear evidence” that the FDA would have not acted, preemption was inappropriate.

The court also rejected the generic manufacturers' alternative argument that failure-to-warn claims would obstruct the objectives and purposes of federal law. The generic manufacturers asserted that they could not have proposed any label change without first conducting expensive clinical studies ' thereby thwarting the goal of the Hatch-Waxman Amendments to bring generic drugs to market quickly ' because all requests for a label change had to be scientifically substantiated. The Eighth Circuit was not persuaded. The court reasoned that generic manufacturers were already required by federal law to collect and report adverse drug experiences. By presenting this information to the FDA, the generic manufacturers could in principle have substantiated a request to change the label without the need to conduct expensive studies.

In sum, the Eighth Circuit concluded that the plaintiff's state law claims were not impliedly preempted. Federal law did not prevent generic manufacturers of metoclopramide from taking further steps to warn (or at least to seek permission to warn) customers of the risks of developing tardive dyskinesia.

Conclusion

Mensing is the first appellate decision addressing preemption for generic drug manufacturers since the Supreme Court's decision in the Levine case. Other courts will be addressing the issue soon, however. Furthermore,there are a number of pending appellate cases addressing the circumstances in which a name brand drug manufacturer may succeed on a preemption defense after Levine.

David Gossett, a Partner in Mayer Brown's Washington, DC, office, focuses his practice on U.S. Supreme Court and appellate litigation, with particular emphasis on administrative law, ERISA, class actions, federal preemption, and arbitration. Henninger Bullock, a Partner in the New York office, counsels clients in the financial services and the pharmaceutical industry sectors. Daniel Ring, a Partner in the Chicago office, has extensive experience in all phases of litigation involving product liability, mass and toxic torts, and complex commercial disputes.

The U.S. Court of Appeals for the Eighth Circuit recently held that “failure to warn” claims brought against generic manufacturers of Reglan' (a prescription drug used to treat certain gastric disorders) were not preempted by federal law and could, therefore, proceed to discovery. The Eighth Circuit's decision in Mensing v. Wyeth, Inc. (http://druganddevicelaw.net/Opinions%20in%20blog/Mensing.pdf) rejected the generic manufacturers' argument that the Food, Drug and Cosmetic Act (FDCA) impliedly preempted state law tort claims relating to the labeling of the drug.

Background

After four years of ingesting generic metoclopramide, the plaintiff in Mensing allegedly developed a neurological condition known as tardive dyskinesia. The plaintiff's suit asserted various tort claims against both the manufacturers of the generic metoclopramide she had ingested, and the manufacturers of brand-name Reglan. At their core, all of the plaintiff's claims were premised on a failure-to-warn theory. The plaintiff contended that patients who took metoclopramide were at greater risk of developing tardive dyskinesia than was indicated by the language on the drug's labeling.

The district court granted the generic manufacturers' motion to dismiss. (In the same ruling, the district court also granted the brand name manufacturers' motions for summary judgment, a decision later affirmed by the Eighth Circuit. For more information about that aspect of the case, see Mayer Brown's Client Alert, “Eighth Circuit Rejects Innovator Liability Theory in Mensing v. Wyeth, Inc.” (http://www.mayerbrown.com/productliability/article.asp?id=8194&nid=12487)) The generic manufacturers argued that the plaintiff's failure-to-warn claims conflicted with, and, therefore, were impliedly preempted by, federal law because the claims would require generic manufacturers to deviate from the drug label prescribed for name brand Reglan. The district court agreed, and the plaintiff's appeal to the Eighth Circuit followed.

The Ruling

The Eighth Circuit reversed the judgment and held that the plaintiff's claims were not preempted. The court concluded that generic metoclopramide manufacturers could, in fact, simultaneously comply with both federal and state law and, moreover, that enforcement of state tort law in this context would not present an obstacle to the purposes of federal law.

Following the Supreme Court's lead in Wyeth v. Levine , 129 S. Ct. 1187 (2009), the Eighth Circuit began its implied preemption analysis by applying “a presumption against preemption.” In the Eighth Circuit's view, Levine's holding that failure-to-warn claims against name brand manufacturers were not preempted by the FDCA “carrie[d] significant implications” for the generic manufacturers' preemption arguments because Levine clarified that the responsibility for ensuring the adequacy of drug warnings typically rested with manufacturers in the first instance.

According to the court, it was possible for the generic manufacturers to comply with their state law tort duties and with the FDCA's labeling requirements. The generic manufacturers argued that they were prohibited by federal law from modifying their labels to include the additional warnings that the plaintiff asserted should have been added because the FDCA required labels for generic drugs to be substantively identical to the label for the corresponding brand name equivalent. The Eighth Circuit rejected this argument, stating that the generic manufacturers could at least have “proposed a label change” to the brand-name drug label that the FDA could then have imposed uniformly on all manufacturers of metoclopramide, brand name and generic. True, it was not clear what the FDA would have done if such a change had been proposed. But under Wyeth, the Eighth Circuit held, uncertainty about the FDA's response weighed against a finding of preemption. Because the generic manufacturers did not present “clear evidence” that the FDA would have not acted, preemption was inappropriate.

The court also rejected the generic manufacturers' alternative argument that failure-to-warn claims would obstruct the objectives and purposes of federal law. The generic manufacturers asserted that they could not have proposed any label change without first conducting expensive clinical studies ' thereby thwarting the goal of the Hatch-Waxman Amendments to bring generic drugs to market quickly ' because all requests for a label change had to be scientifically substantiated. The Eighth Circuit was not persuaded. The court reasoned that generic manufacturers were already required by federal law to collect and report adverse drug experiences. By presenting this information to the FDA, the generic manufacturers could in principle have substantiated a request to change the label without the need to conduct expensive studies.

In sum, the Eighth Circuit concluded that the plaintiff's state law claims were not impliedly preempted. Federal law did not prevent generic manufacturers of metoclopramide from taking further steps to warn (or at least to seek permission to warn) customers of the risks of developing tardive dyskinesia.

Conclusion

Mensing is the first appellate decision addressing preemption for generic drug manufacturers since the Supreme Court's decision in the Levine case. Other courts will be addressing the issue soon, however. Furthermore,there are a number of pending appellate cases addressing the circumstances in which a name brand drug manufacturer may succeed on a preemption defense after Levine.

David Gossett, a Partner in Mayer Brown's Washington, DC, office, focuses his practice on U.S. Supreme Court and appellate litigation, with particular emphasis on administrative law, ERISA, class actions, federal preemption, and arbitration. Henninger Bullock, a Partner in the New York office, counsels clients in the financial services and the pharmaceutical industry sectors. Daniel Ring, a Partner in the Chicago office, has extensive experience in all phases of litigation involving product liability, mass and toxic torts, and complex commercial disputes.