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November 13, 2012 Articles

Design Defect Claims in the Wake of PLIVA, Inc. v. Mensing

Christopher Windover

In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the U.S. Supreme Court held that federal law and regulations preempted state law failure-to-warn claims against generic drug manufacturers. Since the Mensing opinion was issued in June 2011, courts and litigants have grappled with the scope of the Court’s decision. An important issue that remains unresolved in the lower courts is the extent to which other state law tort claims—aside from failure-to-warn claims—fall within Mensing’s preemptive reach. State law design defect claims fall within this gray area, and they have received conflicting treatment from lower courts.

The Mensing Decision

Mensing, which involved two consolidated cases originating in the Fifth and Eighth Circuit Courts of Appeals, included claims under state tort law against generic manufacturers for failing to provide adequate warning labels. Mensing, 131 S. Ct. at 2573. In both cases, the generic manufacturers argued that federal statutes and Food and Drug Administration (FDA) regulations preempted the state law tort claims because the federal statutes and FDA regulations required them to maintain identical safety and efficacy labeling as their brand-name counterparts.  Accordingly, the generic manufacturers contended that it was impossible to comply simultaneously with both federal law and any state tort law duties that would have required them to use a different label from that of their brand-name counterparts. The Fifth and Eighth Circuits rejected the generic manufacturers’ arguments and found that the plaintiffs’ claims were not preempted.

On appeal, the Supreme Court reversed, finding that federal statutes and FDA regulations preempted the failure-to-warn claims against the generic manufacturers. The Court analyzed the unique federal drug labeling requirements applicable to generic manufacturers. Id. at 2574–75. The Court noted that “generic drug manufacturers have an ongoing federal duty of ‘sameness,’” which requires their label to be identical to that of their brand-name counterpart. Id. Moreover, under FDA regulations, generic manufacturers could not unilaterally change their label unless they did so “to match an updated brand-name label or to follow the FDA’s instructions.” Id. at 2575.

The Court held “that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the judgment by a federal agency, that party cannot independently satisfy those duties for pre-emption purposes.” Id. at 2581. Therefore, the plaintiffs’ state-law-based failure-to-warn claims were preempted because “it was 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.” Id. at 2579.

Claims That Do Not Involve a Failure to Warn

Because Mensing specifically addressed only failure-to-warn claims, it is unclear whether the Court’s decision preempts non-warning-based claims as well. Sally Aiello, “PLIVA Update: Design Defect Claims Involving Generics May Survive Preemption,” 2012 Emerging Issues LEXIS 6503, at 4 (June 24, 2012). The majority of federal and state courts have broadly interpreted Mensing to mean that a wide range of non-warning-based, common-law claims are preempted. Id. at 4–5; see, e.g., Gross v. Pfizer, Inc., 825 F. Supp. 2d 654, 659 (D. Md. 2011) (negligence); Cooper v. Wyeth, Inc., 2012 U.S. Dist. LEXIS 29209, at *14–17 (M.D. La. Mar. 6, 2012) (failure to monitor); Bartoli v. APP Pharms., Inc. (In re Pamidronate Prods. Liab. Litig.), 2012 U.S. Dist. LEXIS 10901, at *13 (E.D.N.Y. Jan. 30, 2012) (breach of express warranty); Grinage v. Mylan Pharms., Inc., 2011 U.S. Dist. LEXIS 149667, at *9–18 (D. Md. Dec. 30, 2011) (fraud-based claims).

Some courts, however, have adopted a narrow interpretation of Mensing and have allowed other tort claims to proceed. Aiello, supra, at 5–6; see, e.g., Fisher v. Pelstring, 817 F. Supp. 2d 791, 835 (D.S.C. 2012) (breach of implied warranty, fraud by concealment, violation of state unfair trade practices acts, and infliction of emotional distress); Couick v. Wyeth, 2012 U.S. Dist. LEXIS 3699, at *9–10 (W.D.N.C. Jan. 11, 2012) (breach of implied warranty). But see Bartoli, 2012 U.S. Dist. LEXIS 10901, at *13. A common thread in both lines of cases is an inclination by courts to dismiss causes of action that are substantively rooted in a failure-to-warn theory of liability.

Design Defect Claims Since Bartlett v. Mutual Pharmaceutical Co., Inc.

A particular cause of action that has received conflicting treatment in federal and state courts is the design defect cause of action. Siding with other courts addressing non-warning-based claims, the majority of courts to address the viability of design defect claims have found them preempted by Mensing. These courts have found preemption on the basis that the federal duty of “sameness” also requires generic drugs to be of the same design as their brand-name counterparts. See, e.g., In re Pamidronate Prods. Liab. Litig., 842 F. Supp. 2d 479, 484 (E.D.N.Y. 2012) (holding that the duty of “sameness” also preempts design defect claims); In re Accutane Prods. Liab., 2012 WL 3194952, at *2–3 (M.D. Fla. Aug. 7, 2012) (dismissing design defect claim based on the federal duty of “sameness”); Aucoin v. Amneal Pharms., LLC, 2012 WL 2990697, at *9 (E.D. La. July 20, 2012) (same); Lashley v. Pfizer, Inc., 2012 WL 2459148, at *11 (S.D. Miss. June 27, 2012) (“Because [the generic manufacturer] could not have altered their package inserts without FDA approval, Plaintiffs’ claim based upon defective design is preempted by federal law.”); Johnson v. Teva Pharms. USA, Inc., 2012 WL 1866839, at *4 (W.D. La. May 21, 2012) (dismissing design defect claim under Mensing); Eckhardt v. Qualitest Pharms. Inc., 2012 WL 1511817, at *6–7 (S.D. Tex. Apr. 30, 2012) (holding that design defect claim is preempted, because “[g]enerics were required to produce a drug that was equivalent to the brand-name drug”); Metz v. Wyeth LLC, 2012 WL 1058870, at *4 (M.D. Fla. Mar. 28, 2012) (“A claim that Actavis should have redesigned metoclopramide to alleviate the risks associated with its long-term use would be preempted under Mensing.”); Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012) (holding that design defect claims “are preempted as well by Mensing’s logic”); In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), 2011 WL 5903623, at *6 (D.N.J. Nov. 21, 2011) (holding that design defect claims are preempted, “because FDA requires generic Fosamax to have the same active ingredient as Fosamax”); Stevens v. PLIVA, Inc., 2011 WL 6224569, at *2 (W.D. La. Nov. 15, 2011) (holding that “federal law pre-empts state law imposing the duty to change a drug’s design”).

Courts have also dismissed design defect claims where the gravamen of such claims is a failure-to-warn theory of liability. See, e.g., Jacobsen v. Wyeth, LLC, 2012 U.S. Dist. LEXIS 116887, at *34; Lyman v. Pfizer, Inc., 2012 U.S. Dist. LEXIS 101152, at *38–39 (D. Vt. July 20, 2012); Grinage, 2011 U.S. Dist. LEXIS 149667, at *9–18.

An exception to these approaches, however, was adopted by the first federal appellate court to review Mensing. In Bartlett v. Mutual Pharmaceutical Co., Inc., 678 F.3d 30 (1st Cir. May 2, 2012), the First Circuit Court of Appeals found that design defect claims against generic manufacturers were not preempted by federal law and FDA regulations. In that case, the plaintiff sued Mutual Pharmaceutical Co., a generic manufacturer of the anti-inflammatory drug sulindac, alleging that a design defect in the drug caused her to suffer a near-fatal skin condition. Id. at 34. The design defect claim was tried before the district court, and a jury awarded the plaintiff over $20 million in compensatory damages. Id. at 35.

Mutual appealed the district court’s decision to allow the design defect claim to proceed, arguing, inter alia, that such claims were impliedly preempted because federal law and FDA regulations prohibited Mutual from altering sulindac’s warning label or composition. The First Circuit acknowledged Mutual’s inability to alter its label but ultimately rejected Mutual’s preemption argument by finding that the company could have decided not to place the drug on the market. Id. at 37–38. The “failure-to-withdraw” theory espoused by Bartlett is highly controversial and has been rejected by numerous courts. See, e.g., Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011), cert. denied, 132 S. Ct. 2103 (2012) (rejecting “failure-to-withdraw” argument); Mensing v. Wyeth, Inc., 658 F. 3d 867 (8th Cir. 2011) (vacating portion of earlier opinion that embraced the “failure-to-withdraw” theory and denying plaintiff’s motion to file a supplemental brief on that issue); Strayhorn v. Wyeth Pharms., Inc., 2012 WL 3261377, at *16 (W.D. Tenn. Aug. 8, 2012) (finding claims raising allegations that the generic manufacturers failed to remove metoclopramide from the market to be invalid); In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., 2012 U.S. Dist. LEXIS 89994, at *37–40 (E.D. Ky. June 22, 2012) (finding Bartlett unpersuasive and rejecting “failure-to-withdraw” theory); Johnson v. Teva Pharms. USA, Inc., 2012 WL 1866839, at *5 (W.D. La. May 21, 2012) (rejecting “failure-to-withdraw” theory); Fulgenzi v. PLIVA, Inc., 2012 WL 1110009, at *7 n.5 (N.D. Ohio Mar. 31, 2012) (noting invalidity of “failure-to-withdraw” theory); Bowman v. Wyeth, LLC, 2012 WL 684116, at *6 (D. Minn. Mar. 2, 2012) (rejecting “failure-to-withdraw” theory); Moretti v. PLIVA, Inc., 2012 WL 628502, at *5–6 (D. Nev. Feb. 27, 2012) (same); Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 n.5 (D. Vt. Feb. 3, 2012) (same).

The Bartlett court concluded its analysis by stating that “it is up to the Supreme Court to decide whether [Mensing] . . . is to be enlarged to include design defect claims. . . . Given the widespread use of generic drugs and the developing split in the lower courts . . . this issue needs a decisive answer from the only court that can supply it.” 678 F.3d at 38. On July 31, 2012, Mutual filed a writ of certiorari with the United States Supreme Court, arguing that the “sameness” rationale of Mensing applies with equal force to generic drug design as it does to labeling. Neil Merkl & Clifford Katz, “Litigation: Mutual Pharmaceutical Co. Petitions Supreme Court to Reverse Design-Defect Decision,” Inside Counsel, Sept. 6, 2012.


With its appeal pending before the Supreme Court, Bartlett has the opportunity to provide significant guidance as to Mensing’s preemptive effect on design defect claims against generic manufacturers. Although less likely, it is possible that Bartlett may provide insight into the viability of other non-warning-based claims as well.

As Bartlett illustrates, the scope of Mensing’s preemptive reach is unclear, and at least until Bartlett is considered by the Supreme Court, it is unlikely that the controversy surrounding the Court’s decision will subside any time soon. It is therefore imperative for attorneys to stay abreast of recent developments so that they may put forth their most cogent and persuasive arguments if they are required to argue Mensing’s preemption issues before a federal or state court.

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