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Preemption of State Law Drug Warnings Claims After Mutual Pharmaceutical, Co., Inc. v. Bartlett

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In a recent case, the Supreme Court reaffirmed that a manufacturer's purported ability to comply with state law by paying state law tort damages or by leaving the market are not viable options to avoid impossibility preemption.

The Supremacy Clause provides that the laws and treaties of the United States “shall be the supreme law of the land.”1 Thus, state laws
that conflict with federal laws are “without effect.”2 Federal preemption may be express or implied. One type of implied preemption, commonly referred to as “impossibility preemption,” exists when it is “impossible for a private party to comply with both state and
federal requirements.”3  Although the concept of federal preemption
appears simple in theory, the Supreme Court faced the issue in the pharmaceutical context for the second time in as many years in the
recent case of Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. _____ , 133 S.Ct. 2466 (June 24, 2013).

Mutual Pharmaceutical was a state law product liability claim brought under New Hampshire state law. The plaintiff, Bartlett, developed
severe toxic epidermal necroloysis after taking a generic form of Sulindac, manufactured by Mutual Pharmaceutical, for shoulder pain.4 Sulindac is a non-steroidal anti-inflammatory drug (NSAID) originally
marketed under the brand name Clinoril.5 At the time Bartlett had been prescribed Sulindac, the drug’s label did not specifically refer to the risk of toxic epidermal necrolysis, but did warn of possible “severe skin
reactions” and “[f]atalities.”6 The package insert, however, listed toxic epidermal necrolysis as a potential adverse reaction.7 

1 U.S. Const., Art.. VI, cl. 2.
2 Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114 (1981). 
3 Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. _____ , 133 S.Ct. 2466 (June 24, 2013) (quoting English v. General Elec. Co., 496 U.S. 72, 79, 110 S.Ct. 2270 (1990)).
4 Id., 133 S.Ct. at 2472.
5 Id. at 2471.
6 Id. at 2472.
7 Id.

The FDA subsequently required the labeling of Sulindac and all other NSAIDs to more explicitly warn against the risk of toxic epidermal necrolysis.8

New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe; a drug's safety is evaluated based on both its chemical properties and the adequacy of its warnings.9  Because Mutual Pharmaceutical was unable to change Sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect cause of action
effectively required Mutual Pharmaceutical to change Sulindac’s labeling to provide stronger warnings.10

Bartlett pursued a design defect strict liability claim against Mutual Pharmaceutical, which resulted in a $21 million verdict.11 Both the
district court and the First Circuit held that Bartlett’s design defect claim was not preempted by the Food, Drug, and Cosmetic Act (“FDCA”).12

In a 5-4 opinion, the Supreme Court reversed, reaffirming its prior holding in PLIVA v. Mensing,13 by holding that New Hampshire’s
“warning-based design defect cause of action is preempted with respect to FDA-approved drugs sold in interstate commerce.”14 The
Court reasoned that federal law prohibits manufacturers from changing a drug’s chemical composition or changing their labels. Thus, state law claims requiring manufacturers to strengthen their warnings so as to render the drug not “unreasonably dangerous” made it impossible to comply with both state and federal law, and thus were “without effect.”15

8 Id.
9 Id. at 2470.
10 Id.
11 The district court dismissed Bartlett’s failure to warn claims based on the prescribing physician’s testimony that he never read the label.
12 Id. See also, e.g., 21 U.S.C. § 335(a) (requiring manufacturers to obtain Food and Drug Administration approval before marketing any brand name or generic drug in interstate commerce).
13 PLIVA v. Mensing, 564 U.S. _____ , 131 S.Ct. 2567 (2011).
14 Mutual Pharmaceutical, 133 S.Ct. at 2476-77.


The Court flatly rejected as incompatible with its preemption jurisprudence the Court of Appeals’ and the dissents’ reasoning that
manufacturers could comply with both state and federal law by choosing not to make Sulindac at all or by paying state law tort
damages.16  The Court emphasized that its prior preemption cases have presumed that an actor seeking to satisfy both federal and state
law is not required to cease acting altogether.17 Similarly, PLIVA also forecloses any argument that manufacturers could “comply” with both federal and state law by actually violating their state law obligations
and then paying state tort law damages.18  To hold otherwise, would render “impossibility preemption” meaningless.19

As mentioned, Justice Breyer’s dissent argued that manufacturers could comply with both state and federal law by either paying state tort law damages or by leaving the market.20 Although Justice Breyer normally would defer to the opinion of the relevant agency, the Food and Drug Administration (“FDA”) in this case, as to whether preemption exists,
he would not do so here as the FDA has argued conflicting views in its previous litigation on this issue and has not set forth any regulations, conducted any hearings, or issued any other agency work product on the issue. Thus, Justice Breyer would find no preemption, because in his view paying state tort damages would not seriously undercut the
federal statutory scheme.21

15 Id. (quoting Maryland, 451 U.S. at 476, 101 S.Ct. at 2014).
16 Id. at 2477 n.3 (“Our [preemption] cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability.  Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility [preemption] would be ‘all but meaningless.’”) (citations omitted).
17 Id. at 2477-78 n.3.
18 Id. (citing PLIVA, 564 U.S. at ___ , 131 S.Ct. at 2578).
19 Id. (citing PLIVA, 564 U.S. at ___ , 131 S.Ct. at 2579).
20 Id. at 2480-82 (Breyer, J., dissenting).

Justice Sotomayor’s vehement dissent argued that the Court’s rulings in PLIVA and in this case expanded impossibility preemption to
completely “immunize” generic drug manufacturers from state-law failure-to-warn claims and now from state law design defect
claims.22  Because state law plays an important “complementary” role to federal drug regulation, because Congress has not enacted express preemption for prescription drugs, and because there is a presumption
against federal preemption absent “a direct and positive conflict,” Justice Sotomayor would allow tort suits to “fill the gaps in federal regulation” – even when doing so would require the manufacturer to pay tort damages or leave the market in order to comply with both state and federal law.23 In Justice Sotomayor’s opinion, a verdict for
state law tort damages “that merely motivates an optional decision” (to leave the market or to “want” to change its label or design, in
violation of federal law), does not rise to the level of impossibility preemption.24

Although the dissenting Justices may be laudable in their attempts to preserve injured consumers’ right to compensation, their approach effectively would obliterate the defense of impossibility preemption.
Moreover, as even Justice Sotomayor pointed out in her dissent, injured consumers may still have a remedy under the FDCA’s
“misbranding” statute if new information comes to light demonstrating that an approved drug is “dangerous to health” and is thus
“misbranded.”25 Indeed, the “misbranding” issue may present the next frontier in preemption jurisprudence. In the meantime, manufacturers of generic26 prescription drug products can and should continue to take shelter in the preemption holdings of PLIVA and Mutual Pharmaceutical when plaintiffs attempt to bring state law failure to warn claims that would require manufacturers to strengthen their warnings.

21 Id. 22 Id. at 2482 (Sotomayor, J., dissenting).
23 See id. at 2485 (citing Bates v. Dow Agrosciences LLC, 544 U.S. 431, 125 S.Ct. 1788 (2005)).  24 Id. at 2489.

International Association of Defense Counsel (IADC)


August 01, 2013