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Preemption Defense for Generic Pharmaceutical Companies


Generic pharmaceutical manufacturers recently received an historic victory from the highest court in the land. In Pliva, Inc. v. Mensing, the United States Supreme Court held that federal law preempts failure-to-warn tort claims against generic pharmaceutical manufacturers. According to the Court, federal law requiring generic manufacturers to use the same labeling as their brand-name counterparts makes it impossible for generic manufacturers to simultaneously comply both with federal law and a state tort law duty to provide a "better" label.

The vast majority of pharmaceutical product liability lawsuits are premised primarily on the claim that the drug's labeling fails to warn, or fails to warn adequately about known or knowable risks. With Mensing in hand, counsel for generic manufacturers should be ferociously preparing motions to dismiss all claims that they failed to warn, no matter what legal theory is pled (strict liability, negligence, breach of warranty, etc.).

The doctrine of preemption originates from the Supremacy Clause of the United States Constitution: the "Constitution, and the laws of the United States … shall be the supreme Law of the Land." Under the supremacy clause, federal law trumps contrary state laws. Congress can expressly provide that a federal statute preempts any conflicting state laws. But even if Congress does not, state law can impliedly conflict with federal law and thus be preempted. That is what happened in Mensing. The applicable statute did not expressly preempt state law claims, but the Supreme Court found such claims impliedly preempted because it would be impossible for a generic drug manufacturer to comply with the federal law requiring its labels to match brand-name labels and at the same time satisfy a jury-imposed state tort duty to use a "better" label.

Generic Drug Approval

Mensing is a 180-degree turnaround from the Court's 2009 ruling in Wyeth v. Levine that federal law does not impliedly preempt failure-to-warn claims against brand-name pharmaceutical manufacturers. The Court's disparate treatment of branded and generic drugs stems from the differences in the regulatory approval schemes applicable to each. A company seeking approval of a branded drug must undertake years of drug development and studies before submitting a new drug application (NDA) showing the drug is safe and effective as labeled. But Congress wanted to provide incentives for the development and approval of cheaper, generic drugs. Thus, the 1984 Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FDCA), allows generic drug manufacturers to submit an "abbreviated new drug application" (ANDA) demonstrating that the generic drug is bioequivalent to a drug that has already been found safe and effective. Critically, the ANDA process requires the generic drug manufacturer to demonstrate that the proposed labeling for the generic drug is "the same as" the approved labeling for the branded drug. This requirement was the cornerstone of the Supreme Court's "impossibility" analysis in Mensing.

The Road to the Supreme Court's Mensing Decision

Mensing involved two consolidated cases in which the plaintiffs alleged that they developed tardive dyskinesia (TD), an often irreversible movement disorder, from taking generic metoclopramide. Metoclopramide is the generic form of Reglan®, a prescription drug used to treat digestive disorders. Plaintiffs brought state law tort claims alleging that the generic drug manufacturers failed to provide an adequate warning that long-term use could cause TD. The generic manufacturers, relying on the regulatory requirement that their labels match those of the brand-name drug, moved to dismiss on implied pre-emption grounds. They also argued that, unlike brand-name drug makers, generic drug makers cannot unilaterally strengthen warnings without prior FDA approval under the "changes-being-effected" (CBE) regulation.

The two trial courts reached opposite results on the manufacturers’ motions to dismiss. On appeal, both the Fifth and Eighth Circuit Courts of Appeals ruled that the claims were not pre-empted. The United States Supreme Court then reversed by a bare majority.

Both the majority and the dissent in Mensing agreed that CBE regulation did not permit generic manufacturers unilaterally to change their labels. They further agreed that a generic manufacturer cannot unilaterally issue "Dear Doctor" letters with new warnings. Where the majority and dissent parted company was over what was termed at oral argument the "take steps" theory - i.e., to prove impossibility, must the generic manufacturer show that the FDA would have said "no" had the manufacturer taken steps to ask for a label change? The majority assumed, without deciding, that federal law imposes a duty on generic manufacturers to ask for label change if they become aware of new safety information that should be in the label. Even so, it held that this duty did not change the conflict preemption analysis. According to the majority, the proper inquiry is whether "a private party could independently do under federal law what state law requires of it." If the mere possibility that the federal government might do something that would allow a party to comply both with state and federal law were enough to defeat conflict preemption, there effectively would be no conflict preemption, as one always can ask for such action.

The dissent charged that by inserting the word "independently" in the test for conflict preemption, the majority had modified the analysis previously employed by the Court without precedential support. According to the dissent, because avenues existed by which the generic manufacturers could have tried to change their labels, even though they required consent and agreement by the brand manufacturers and the FDA, impossibility did not exist. The dissent accused the majority of stripping consumers of their ability to pursue legal redress when injured by a generic version of a drug, while leaving intact that ability for those who use a branded version.

What is the future of generic drug products liability litigation?

With 75% of all prescriptions in this country being filled with generic drugs, this decision will have a huge impact on pharmaceutical drug litigation. Oddly enough, whether a consumer has a state law remedy for failure to warn now turns on whether the pharmacist fills the a prescription with a brand-name or generic drug. The Court acknowledged the counter-intuitive result but placed the problem in the lap of the legislative and executive branches: "Congress and the FDA retain the authority to change the law and regulations if they so desire." Indeed, Public Citizen has already asked the FDA to overturn Mensing via regulation, though it is not clear the FDA has the power to do so. While Mensing may spur Congress to restore plaintiffs' right to sue generic drug makers for failure to warn, such action may be a long time coming, as shown by Congress' lack of progress passing legislation to overturn preemption in the medical device field after the 2008 Riegel decision - proponents of such a change will face an uphill battle.

Nonetheless, Plaintiffs' lawyers are not likely to give up. They will search for ways to circumvent Mensing, including asserting non-product liability claims, such as fraud, misrepresentation, breach of warranty, and violation of state consumer protection statues. These claims, however, are almost always derivative of a "failure to warn" claim, and in most cases should be subject to preemption. Plaintiffs may also assert design defect claims against generic manufacturers (i.e., that the risks of the drug outweigh its benefits regardless of the warnings), especially if a drug is no longer on the market, but those claims are not viable in all states and are difficult to prove.

For now, Mensing is the law of the land; file your motions to dismiss and get your cases dismissed.

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