Supreme Court Holds Warning Claims Against Generic Drug Manufacturers Are Preempted

Product Liability Update

Date: July 01, 2011


On June 23, 2011 the United States Supreme Court held that U.S. Food and Drug Administration (FDA) regulations applicable to generic drug manufacturers preempt failure-to-warn claims under state law based on alleged failures to include warnings that would conflict with FDA labeling requirements under federal law. PLIVA, Inc., et al. v. Mensing, (and consolidated cases Actavis Elizabeth, LLC v. Mensing, Actavis, Inc. v. Demahy), 564 U.S. ___, No. 09-993 (2011), 2011 WL 2472780 (U.S.).

PLIVA draws a clear distinction between generic drugs and the brand-name drugs subject to the Court's decision in Wyeth v. Levine, 555 U.S. 555 (2009), and affects all drug companies and other defendants who may rely on preemption defenses.


In Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) and Demahy v. Actavis, Inc., 593 F.3d 428(5th Cir. 2010), cert. granted sub nom. PLIVA, Inc., et al. v. Mensing, 131 S.Ct. 817 (2010), the plaintiffs sued the manufacturer of the drug Reglan and various other manufacturers of its generic equivalents containing metoclopramide, alleging that long-term use of metoclopramide caused them to develop tardive dyskinesia,1 and that the manufacturers were liable under state law of Minnesota and Louisiana for failure to warn of these risks. In both cases, the plaintiffs were prescribed the brand-name product, Reglan, by their physicians, but subsequently received generic metoclopramide from their pharmacists.

The district courts addressing these claims reached opposite conclusions when the generic manufacturers moved to dismiss the plaintiffs' claims for failure to warn of risks associated with their products on grounds that the claims were preempted by federal law. In Mensing, the court granted the separate motions of generic manufacturers Actavis and PLIVA, Inc. to dismiss, holding that state law claims against manufacturers of generic drugs for failure to warn of the risk of tardive dyskinesia conflicted with and were thus preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) or the FDA regulations, which, pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984,2 require generic drugs' warning labels to be the "same as" that of listed or branded drugs. Mensing v. Wyeth, Inc., et al., 562 F.Supp.2d 1056, 1064 (D. Minn. 2008). The Minnesota court found that generic drug manufacturers could not unilaterally change the generic version of the Reglan label without prior approval of the FDA. Id. at 1064.

In Demahy, however, the Louisiana court denied generic manufacturer Actavis' motion to dismiss the plaintiff's failure-to-warn claims based on federal conflict preemption, finding that federal regulations requiring that generic labels be the same as the name brand at the time of the initial Abbreviated New Drug Application (ANDA) did not prohibit, and, in fact, contemplated FDA approval of post-ANDA unilateral labeling changes by generic drug manufacturers. Demahy v. Wyeth, Inc., et al., 586 F.Supp.2d 642 (E.D. La. 2008).

Referring throughout their opinions to the Supreme Court's decision in Wyeth v. Levine, the United States Courts of Appeals for the Fifth and Eighth Circuits rejected the generic manufacturers' arguments on appeal and held that the plaintiffs' claims were not preempted. See Mensing, 588 F.3d, at 614; Demahy, 593 F.3d, at 449. Although the Eighth Circuit, in Mensing, did not decide whether generic manufacturers could unilaterally enhance label warnings through the Changes Being Effected (CBE) supplement, it found that nothing prohibited the generic drug manufacturers from proposing label changes through a prior approval process based on new safety hazards associated with their products, or from suggesting that the FDA send out warning letters to health care professionals. Mensing, at 608-610, 614. In Demahy, the Fifth Circuit affirmed the district court's finding that the plaintiff's failure-to-warn claims were not preempted, holding that compliance with federal regulations is not impossible, nor are the goals of such regulations obstructed, when a state imposes duties to warn on generic drug manufacturers. Demahy, 593 F.3d, at 449.

The Majority's Analysis

The Supreme Court reversed the judgments of the Fifth and Eighth Circuits, holding that the Hatch-Waxman Amendments to the FDCA preempt conflicting failure-to-warn claims against manufacturers of generic drugs.

Justice Thomas, writing for the majority including Justices Roberts, Scalia, Alito, and Kennedy, held that, although failure-to-warn claims against brand-name drug manufacturers are not preempted under Wyeth v. Levine, the federal requirement that generic labels be identical to corresponding brand-name labels renders it impossible for generic drug manufacturers to comply with both state and federal law. PLIVA, slip op. at 11-12,17-18. Thus, the Court concluded that the claims for failure to warn against generic manufacturers are preempted. In Wyeth v. Levine, the claims were not preempted because it was possible for the brand-name drug manufacturer to comply with both state and federal law, specifically through the CBE regulations, which the Court held allow unilateral strengthening of pioneer drug labels without prior FDA approval and in compliance with the duty imposed by state law. Id. at 18.

The respondents in PLIVA argued that generic manufacturers could have modified their labels after the initial FDA approval, including through the CBE process and "Dear Doctor" letters providing additional warnings to prescribing physicians and other health care professionals. Id. at 7-8. The Court deferred to the FDA's interpretation of its regulations in finding that the CBE process was not open to the generic manufacturers for the sort of change required by state law, because they could only make changes to match an updated brand-name label or to follow the FDA's instructions, and that additional warnings by generic manufacturers in "Dear Doctor" letters would have qualified as "labeling" and thus would not be consistent with the branded drug's approved labeling. Id. at 7-9. The majority focused on the fact that the federal statutes and regulations treat brand-name manufacturers and generic manufacturers differently, leading to different preemption results. Id. at 19. Accordingly, the Court "[would] not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme." Id.

The majority declined to resolve a disagreement between the FDA and the generic manufacturers regarding whether the generic manufacturers had a duty to request a stronger warning label as soon as they had reasonable evidence of a serious hazard associated with the drug, determining that, even if such a duty existed, a request for FDA assistance would not satisfy the state law duty to provide adequate labeling. Id. at 9-12. The majority rejected the respondents' argument that generic manufacturers could have effected label changes by seeking FDA permission, holding "that when a party cannot satisfy its state duties without the Federal Government's special permissions and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes." Id. at 17.

Justice Kennedy declined, however, to join Part III(B)(2) of Justice Thomas's opinion, in which Justice Thomas construed the phrase "any Thing in the Constitution or Laws of any State notwithstanding" in the Supremacy Clause as a non obstante provision intended to mean "that federal law should be understood to impliedly repeal conflicting state law," and "that courts should not strain to find ways to reconcile federal law with seemingly conflicting state law." Id. at 15. Only four justices joined in this portion of the opinion, with Justice Kennedy neither joining the plurality or dissent nor writing separately to state his own opinion on the topic.

The Dissent

In a strongly worded dissent joined by Justices Ginsburg, Breyer, and Kagan, Justice Sotomayor accused the majority of eroding the high standard required for preemption based on impossibility. "Until today, the mere possibility of impossibility had not been enough to establish pre-emption." PLIVA, dissent at 1-2. Finding that the petitioners had shown only that they might have been unable to comply with both federal and state law, the dissent argued that the generic manufacturers failed to meet their heavy burden of proving impossibility. As in Wyeth v. Levine, the dissent would have required generic manufacturers to show that the FDA would not have approved a proposed label change. Id. at 9-12.

The dissent placed great weight on two principles that "guide all preemption analysis": preemption rests on what Congress intended and if Congress legislates in an area historically regulated by the states, such as matters of health and safety, the Court starts with a presumption against preemption in the absence of a showing of a "clear and manifest purpose" of Congress to preempt state law. Id. at 8. Justice Sotomayor found no such congressional intent, noting that there is no express preemption of state tort law actions against drug manufacturers, that the 1962 amendments to the FDCA showed an intent to preserve state law, and that the 1984 Hatch-Waxman Amendments included no preemption provisions even though Congress had enacted an express preemption provision for medical devices in 1976. Id. at 9. Furthermore, by allowing both brand-name and generic drug manufacturers to approach the FDA and request a label change, Congress had affirmatively provided a mechanism for the petitioners to comply with state law duties to warn of dangers associated with their products. Id. at 12. Justice Sotomayor warned that the potential consequences of the Court's decision were at odds with the goal of the Hatch-Waxman Amendments to increase the availability and use of generic drugs. Id. at 21.

The dissent attacked the plurality's adoption of what it termed a "novel theory" that the framers of the Constitution intended the Supremacy Clause to act as a non obstante provision directing courts not to apply the general presumption against implied repeals. Id. at 16-18. According to Justice Sotomayor, this theory, which was not advocated by any party or amici, "is a direct assault" on and "just the opposite of" more than 50 years of court precedents that consistently presume against preemption of state law. Id. at 17.

A Broad Defense for Generics, a Potential Challenge for Pioneers, and a Result that "Makes Little Sense" for Plaintiffs

PLIVA establishes a broad preemption defense for manufacturers of generic drugs against failure-to-warn claims under state law when the challenged labeling complies with FDA requirements for the approved labeling for the reference NDA drug. Its implications for brand-name manufacturers are much less clear. Lurking in the background for them is the potential for renewed interest of the plaintiffs' bar in holding them liable for allegedly inadequate warnings by generic manufacturers. This theory has gained little currency since its acceptance in Conte v. Wyeth, Inc., et al., 85 Cal.Rptr.3d 299 (Cal. Ct. App. 2008), review denied, Case No. S169116, Sup. Ct. Cal. (Jan. 21, 2009), and it is not addressed in PLIVA, but it is predictable that plaintiffs will now argue that, since generic manufacturers cannot be held liable for their own products and warnings, brand-name manufacturers should be. Preparing for and confronting these arguments is likely to be the next challenge for brand-name manufacturers.

While the different results in Levine and PLIVA are based on the different regulatory schemes applicable to branded and generic drugs, both the majority and dissent in PLIVA acknowledged that the outcome of this case from a plaintiff's perspective - whether or not a state failure-to-warn claim can succeed rests on whether a pharmacist fills a prescription with the brand name or a generic - "makes little sense." PLIVA, slip op. at 18, dissent at 2. Justice Sotomayor went even further in stating that the decision "leads to so many absurd consequences that [the dissent] cannot fathom that Congress would have intended to pre-empt state law in these cases." PLIVA, dissent at 18. Justice Thomas rejected that characterization as extreme and as overstating the extent to which the dissent's approach would resolve the claimed absurd consequences. PLIVA, slip op. at 19 n. 9. He further observed that "[a]s always, Congress and the FDA retain the authority to change the law and regulations if they so desire," demonstrating once more his adherence to strict construction of statutory language in analyzing federal preemption of state laws. PLIVA, slip op. at 19-20.


1Tardive dyskinesia is a neurological syndrome characterized by repetitive, involuntary, purposeless movements.

2The Drug Price Competition and Patent Term Restoration Act of 1984 is more commonly known as the Hatch-Waxman Amendments to the FDCA.