Generic Drug Preemption Expanded by Supreme Court's Bartlett Decision


Not surprisingly, the Supreme Court reaffirmed the broad preemptive scope of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and further extended the reach of impossibility preemption to design defect claims, in issuing its eagerly anticipated ruling in Mutual Pharmaceutical. Co. v. Bartlett, No. 12-142, slip op. at 2 (U.S. June 24, 2013). 


In a 5-4 decision authored by Justice Samuel Alito, and mirroring that of the 5-4 decision in Mensing, the Supreme Court held that state law design defect claims against generic drug manufacturers that turn on the adequacy of a drug’s warnings are preempted by federal law under the Court’s 2011 Mensing decision.  In Mensing, the Court had found that federal law preempts state law failure-to-warn claims against generic drug manufacturers because generic drugs are required to have the same warning labels as their brand-name counterparts. 


The Supreme Court ruling reversed the First Circuit Court of Appeals in Bartlett v. Mutual Pharmaceuticals Co., 678 F.3d 30 (1st Cir. 2012), which had upheld a multimillion-dollar jury award arising from design defect claims brought against the generic drug manufacturer of the generic anti-inflammatory drug sulindac by plaintiff Bartlett, who had an undeniably terrible reaction to the drug.  The First Circuit had ruled that Bartlett’s design defect claims were not preempted because Mutual could have stopped selling the drug, even if it could not have changed the drug’s labeling or design.  The high court unequivocally disagreed, rejecting the First Circuit’s “stop-selling” rationale as incompatible with the Court’s prior preemption rulings, which presume that an actor seeking to satisfy both federal and state obligations is not required to cease acting altogether to avoid liability.  “Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility preemption would be ‘all but meaningless.’”   


The Court concluded that compliance with New Hampshire design defect law would require redesign of a drug, which is impossible in the case of generic drugs because of the FDCA’s “sameness” requirement that mandates that generic drugs have the same active ingredients, route of administration, dosage form, strength and labeling as its brand-name equivalent.  21 CFR § 314.70(b)(2)(i). Given the impossibility of redesigning sulindac, the only other avenue for Mutual to improve the drug’s risk-profile under New Hampshire law would be to strengthen the warnings in contravention of federal law that prohibits generic manufacturers from changing their labels, thereby placing the case squarely within the preemptive bounds of Mensing. Because Mutual was prohibited by federal law from taking the remedial action necessary to avoid liability under New Hampshire state law by unilaterally changing the drug composition or labeling, Bartlett’s state law design defect claims were held preempted.


The Supreme Court ruling is another nail in the coffin for plaintiffs taking generic drugs, who have been desperately looking for ways to carve out exceptions to Mensing since the landmark decision.  Those  creative attempts have been largely unsuccessful.  Following another decisive blow in Bartlett, pummeling the last dim glimmer of hope for design defect claims, generic drug plaintiffs are left with very little to hang their hats on. 


Although the Bartlett majority dropped a footnote  specifying that it was not addressing “state design-defect claims that parallel the federal misbranding statute,” which bars the sale of previously approved drugs if new and scientifically significant information comes to light demonstrating that the drug is dangerous to health that is not presented to FDA, the form of such a parallel claim is not readily apparent and such a difficult claim would nevertheless be unavailable in all but a few factually specific scenarios. 


Bartlett also does not address the viability of a claim based on a generic manufacturer’s failure to update its labeling to adopt changes made by the brand-name drug, which is an area where plaintiffs have experienced some intermittent and limited success.  And with the majority of courts having rejected innovator liability theories that attempt to hold a brand manufacturer liable for an injury caused by a generic version of its drug, it seems the only truly promising recourse left for plaintiffs would be for Congress and the FDA to accept the Court’s invitation to change the law and regulation.  For now, the generic drug industry is essentially out of reach in product liability suits.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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