Parallel Misbranding Exception To PLIVA/Bartlett Is No Substitute For A New Rule From FDA

In PLIVA v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court ruled that state law based failure-to-warn and design defect claims against generic drug manufacturers were barred on federal preemption grounds.  Earlier this Summer, in In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al. (6th Cir. June 27, 2014), the Sixth Circuit rejected the plaintiff’s bar’s latest attempt to circumvent PLIVA/Bartlett while sidestepping the question of whether the Supreme Court left room for a design defect “parallel misbranding” exception.     


As Pharmarisc readers will recall from previous posts, ever since the Supreme Court ruled in PLIVA that state law based failure-to-warn claims were preempted under the Hatch-Waxman Act on the grounds that generic manufacturers were under a “duty of sameness” in labeling (i.e., meaning they could not unilaterally alter their drug labeling), the plaintiffs’ bar has been searching for alternative theories upon which to hold generic drug companies — which make about 80% of all drugs consumed in this country — liable for personal injuries caused by their products.  After the Court’s decision in Bartlett overturned a verdict based on a state law design defect claim, the plaintiff’s bar and their supporters were apoplectic.  Consequently, under political pressure from the plaintiffs’ bar, various consumer groups, 40 state attorneys general and numerous federal and state lawmakers, the FDA issued a proposed rule last Fall that, if enacted, would require a generic drug maker in possession of “newly acquired information”– information that constitutes “sufficient evidence of a causal association” between an unlabeled warning and the approved product — to submit a “Changes Being Effected-O (“CBE-O”) supplement to their ANDA and immediately implement the changed labeling.  However, as we explained in FDA Proposed Rule Would “Preempt” Supreme Court Rulings in Pliva and Bartlett, the FDA’s proposed rule is not without its problems.  More importantly, the rule has yet to be enacted, suggesting that the political and regulatory momentum in the months after Bartlett may have dissipated entirely, putting the plaintiff’s bar back at square one.

Parallel Misbranding Exception

Enter the “parallel misbranding” exception and the Sixth Circuit’s decision in Darvocet.  As discussed in a Client Alert prepared by products liability expert Beth Rose of Sills Cummis & Gross in Newark, N.J., the parallel misbranding theory arose out of an amicus brief that the FDA filed in Bartlett, in which the agency argued that “pure design defect claims were distinguishable [from failure-to-warn claims] and [that] they would not be preempted if they ‘parallel’ the FDCA’s drug ‘misbranding’ prohibition.”  Then, when Bartlett was decided, the Supreme Court stated in footnote 4 that its decision did not address “state design defect claims that parallel the federal misbranding statute,” which requires a manufacturer to pull even an FDA-approved drug from the market when use of the drug is “dangerous to health,” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended or suggested in the labeling thereof”.  Bartlett, 133 S. Ct. 2466, 2477 n. 4.  Although footnote 4 was all the plaintiffs’ bar needed to press forward in Darvocet, the Sixth Circuit concluded that, while it wasn’t clear whether Bartlett left room for a parallel misbranding exception, if such an exception existed, it was not sufficiently pled by the Darvocet plaintiffs.  According to the court, the bar for pleading parallel misbranding with sufficient particularity is quite high and includes (1) identifying “specific wrongful marketing claims [under state law] . . . that parallel, i.e., have elements identical to, a federal misbranding claim”; (2) identifying “new information” not previously before the FDA; and (3)  showing that such new information, if it had been known by the FDA, would have changed the agency’s mind.


Since Darvocet did not rule that there was no parallel misbranding exception to Bartlett, plaintiff’s lawyers and their allies can take some solace in knowing that they can live to fight again some other day.  However, if other courts were to adopt the Darvocet framework for establishing a parallel misbranding exception, it is highly unlikely the results will be any different.  Indeed, in the absence of access to clinical data solely in the hands of a branded manufacturer, it is difficult (if not impossible) to see how plaintiffs’ and their lawyers can learn of the existence of “new information” not previously before the FDA, much less show that if the agency had known of such information, it would have acted differently.  In short, Darvocet proves, yet again, that without FDA or Congressional intervention, the chances of putting generic drug manufacturers on the same footing as their branded drug counterparts remain slim at best.


About José P Sierra

José Sierra is a partner at Laredo & Smith, LLP, in Boston, which provides respected advice and creative representation in business litigation, white collar criminal defense, government investigations, corporate compliance, and business and employment law. Prior to joining the Firm, Mr. Sierra was a principal at Fish & Richardson. Previously, Mr. Sierra was senior vice president, chief compliance and ethics officer for Sepracor Inc., and Kos Pharmaceuticals, and was legal director at Schering-Plough Corporation, and an assistant U.S. attorney in the Newark, NJ U.S. Attorney's Office.

Mr. Sierra's practice focuses on white collar criminal defense, government investigations and corporate compliance. Contact him at 617-443-1100 or via .

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