Supreme Court Rejects Design Defect End-Around Of Pliva v Mensing Ruling

In the last week of the its 2012-13 term, the Supreme Court spurned the First Circuit’s attempt to circumvent the Court’s 2011 decision in PLIVA, Inc. v. Mensing, which immunized generic manufacturers from liability based on state “failure to warn” claims on federal preemption grounds.  In Mutual Pharmaceutical Co., Inc., v. Bartlett, the Court re-affirmed Mensing and ruled that design defect claims were also preempted, leaving consumers injured by generic drug products with no legal recourse . . . except for a possible “misbranding” claim against generic manufacturers or even a possible direct claim against the original pioneer manufacturer in some state courts.

Case Background 

As Pharmarisc readers will recall from our March 26 post titled “Pay For Delay and Drug Design Defect Cases Take Center Stage at Supreme Court,” in Mensing, the Court found that because FDA regulations require that the labeling on a generic drug be identical to its brand drug counterpart, federal law preempts state court failure to warn claims.  Since the Supreme Court’s Mensing decision, the federal courts have rejected all attempts by plaintiffs to distinguish their suits from Mensing or to otherwise circumvent Mensing’s seemingly hard and fast preemption ruling — that is, until Bartlett.  In Bartlett, the plaintiff had taken Mutual’s generic sulindac for shoulder pain and later developed Steven-Johnson syndrome and toxic epidermal necrolysis, leaving her nearly permanently blind and disabled.  Rather than sue Mutual on a typical failure to warn theory, Bartlett’s husband filed suit in New Hampshire on a design defect theory, claiming that the FDA never should have approved the drug and that the medication was unreasonably dangerous and defective. The First Circuit affirmed the jury’s $21 million verdict and in March of this year the Supreme Court heard Mutual’s arguments that the First Circuit’s ruling distinguishing Bartlett from Mensing was nothing more than an “end-around” circumvention of Mensing’s import: specifically, that a drug’s design, much like its labeling, is within the exclusive purview of the FDA and that the FDA’s regulations (no matter how illogical or unfair it might be to plaintiffs like Mrs. Bartlett) preempt any state-based claim.

On Monday, Justic Alito, writing for the 5-4 majority, concluded that because 1) New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe — as determined by the drug’s chemical properties and the adequacy of its warnings — and 2) 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 action effectively required Mutual to change sulindac’s labeling to provide stronger warnings.  Accordingly, the majority held that since the effect of New Hampshire’s design defect law was to require Mutual to strengthen the warnings on its sulindac drug’s labeling, the New Hampshire law was preempted by federal law under Mensing.  The majority rejected the First Circuit’s and dissents’ conclusion that even if Mensing prohibited Mutual from strengthening its label, Mutual could still comply with both federal and New Hampshire law by ceasing to market the drug altogether:  “We reject this ‘stop-selling’ rationale as incompatible with our pre-emption jurisprudence.  Our pre-emption 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 pre-emption would be ‘all but meaningless’.” (citing Mensing).

For their part, the two dissenting opinions (J. Breyer and J. Sotomayor) relied on the absence of an explicit preemption provision and the historic roles of the FDCA and state common law liability in promoting consumer safety in arguing that federal law did not preempt New Hampshire’s design defect law under Mensing.  Justice Sotomayor’s criticism of the majority’s holding was particularly harsh:  “The Court laments her ‘tragic’ situation . . . but responsibility for the fact that [petitioner] Karen Bartlett has been deprived of a remedy for her injuries rests with this Court.  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.”


The outcome for Mrs. Bartlett was never really in much doubt, despite the obvious sympathy she generated for the Justices (both in the majority and dissent), consumer advocate groups and lawmakers.  Indeed, sympathy for Mrs. Bartlett and similarly situated consumers in the future may have influenced Justice Alito to state in footnote 5 of the majority opinion that the Court’s ruling does not address (and, therefore, does not preclude) a claim that a drug may become so “dangerous to health” even if used in accordance with its labeled instructions as to violate the misbranding statute under 21 U.S.C. Section 352(j).   While the misbranding footnote in Bartlett is intriguing and will no doubt be studied by plaintiffs’ lawyers far and wide, it remains a footnote and will not mollify the products liability plaintiffs’ bar and their allies.

Indeed, under mounting pressure from Democratic lawmakers in Congress, 40 state attorneys general and various consumer groups, the FDA acknowledged earlier this year that it was considering allowing generic drug manufacturers to change their labels, particularly since most branded drug sales cease once the branded drug goes generic, and the pressure is only likely to increase.  (According to a Public Citizen amicus brief filed with the Court, there are 434 generic drugs for which no brand-name drugs are being marketed).  And while courts in Vermont, California and Alabama have been inclined to let injured consumers sue the branded manufacturer for harms by caused by generic versions of their non-existent products, the only real recourse for consumers like Mrs. Bartlett will be for the FDA to promulgate a rule that 1) permits a generic manufacturer to seek FDA approval to strengthen the warnings on its products’ labels; and 2) if approved, requires all other generic manufacturers of the same drug to follow suit.  By taking the preemption defense away from generic manufacturers like Mutual, the FDA will encourage the generic drug industry to assume the same degree of vigilance currently required of branded manufacturers.



About José Sierra

José Sierra+ is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

Speak Your Mind