Supreme Court Rules in Bartlett Generic Drug Preemption Case; Says State-Law Design-Defect Claims That Turn on a Drug Warning’s Adequacy are Preempted

By Kurt R. Karst –      

Shortly after 10:00 AM this morning, the generic drug industry let out a collective sigh of relief.  It was at that time the U.S. Supreme Court issued its highly anticipated ruling in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142).  In a big win for the generic drug industry, the Court, in a 5-4 decision penned by Justice Alito (and joined in by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas), held that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by the FDC Act and under the Court’s 2011 decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011).  Jutice Breyer filed a dissenting opinion joined in by Justice Kagan.  Justice Sotomayor filed a separate dissenting opinion joined in by Justice Ginsburg.  The composition of Justices in the 5-4 Bartlett decision mirrors that of the 5-4 decision in PLIVA.

As we previously reported (here, here, and here), the question presented to the Court was whether the U.S. Court of Appeals for the First Circuit erred when it ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic drug manufacturer stops selling its products.  Interestingly, the First Circuit characterized Wyeth v. Levine, 555 U.S. 555 (2009) as a general no-preemption rule and PLIVA as an exception to that rule.  By way of background, in PLIVA, the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because it is impossible for generic drug manufacturers to comply with both federal and state duties to warn.  In contrast, in Wyeth, the Court held that a state-law tort action against a brand-name drug manufacturer for failure-to-warn is not preempted.

The opening paragraphs of Justice Alito’s majority opinion nicely summarize the Court’s holding:

We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID).  New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings.  Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of actioneffectively required Mutual to change sulindac’s labeling to provide stronger warnings.  But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs’ labels.  Accordingly, state law imposed a duty on Mutual not to comply with federal law.  Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.”  Maryland v. Louisiana, 451 U. S. 725, 746 (1981).

The Court of Appeals’ solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution.  Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.

Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are preempted by federal law under PLIVA.  We thus reverse the decision of the Court of Appeals below.

In two different dissenting opinions, Jutices Breyer and Sotomayor take issue with the majority’s decision.  For his part, Justice Breyer does not believe that it is literally impossible for a generic drug manufacturer to comply with conflicting state and federal law.  “Without giving [FDA’s] views special weight, Iwould conclude that it is not impossible for petitioner to comply with both state and federal regulatory schemes and that the federal regulatory scheme does not pre-emptstate common law (read as potentially requiring petitioner to pay damages or leave the market),” writes Justice Breyer in his 4-page dissent. 

For her part, Justice Sotomayor sees the majority decision as expanding the scope of impossibility preemption, leaving injured consumers without any remedy.  “Today, the Court unnecessarily and unwisely extends its holding in Mensing to pre-empt New Hampshire’s law governing design-defects with respect to generic drugs. . . .  If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett’s recovery,” writes Justice Sotomayor in her 26-page dissent.

And so, with the Supreme Court’s decision, yet another attempt to chip away at the PLIVA decision has failed.  But the generic drug industry is likely in for more controversy – and not just in product liability litigation.  As we previously discussed, the United States’ amicus brief in Bartlett signals that changes are afoot at FDA.  According to footnote 2 of the brief, “FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.  If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.”  Now that the Supreme Court has decided Bartlett, might FDA unveil its plan in the coming months? 

Additional Reading:

• Public Citizen – Inability of Generic Drug Manufacturers to Warn of Newly Discovered Hazards Puts Patients at Risk; Serious Safety Hazards Often Take Years to Emerge (see also Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing)
• GPhA – Statement from Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association on the Mutual v. Bartlett Supreme Court Ruling