In In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, --- F.3d ---, No. 12-5368, 2014 WL 2959271, at *1 (6th Cir. June 27, 2014), the United States Court of Appeals for the Sixth Circuit issued a significant opinion affirming the dismissal of 67 of 68 Plaintiffs' claims against both generic and brand-name pharmaceutical manufacturers.
First, the Sixth Circuit affirmed the dismissal of claims against the generic companies. The district court, which supervised a multidistrict litigation involving claims relating to propoxyphene (branded as Darvocet or Darvon), had dismissed Plaintiffs' wrongful marketing, failure to warn and other related claims against generic manufacturers on both preemption and pleading grounds. Id. at *5. But on appeal, Plaintiffs' argued that their wrongful marketing claims were not preempted in light of Footnote 4 of the Supreme Court's decision in Mutual Pharm. Co., Inc. v. Bartlett, ––– U.S. ––––, 133 S. Ct. 2466 (2013). Id. at *6. In that Footnote, the Court commented that its preemption ruling does "not address state design-defect claims that parallel the federal misbranding statute." Bartlett, 133 S. Ct. 2477, n.4. Plaintiffs asserted that their wrongful marketing claims fell within that exception. Id. Under the federal misbranding statute, plaintiffs argued, a manufacturer must pull even an FDA-approved drug from the market when it is dangerous to health even if used in accordance with its labeling. Id. ( citing 21 U.S.C. § 352(j)).
The Sixth Circuit acknowledged the uncertainty over whether Footnote 4 created an exception to preemption, and if so, what the scope of that exception should be. But it reasoned that, at a minimum, a plaintiff seeking to invoke a "parallel misbranding" theory must: (1) allege a cause of action for misbranding under state law, (2) identify new and scientifically significant information not already before the FDA, and (3) demonstrate that the FDA would have found the drug to be misbranded in light of the new information. Id. Here, the court held that "Plaintiffs cannot state such a claim because they do not point to 'new and scientifically significant information' that the Generic Manufacturers possessed that was not before the FDA." Id. at *9. Thus, the court dismissed the claims on pleading grounds without reaching the "thorny issues" concerning the existence and scope of any "parallel misbranding" theory. And, the Court of Appeals affirmed the dismissal of the remaining claims against the generic manufacturers on pleading and preemption grounds as well, adopting the reasoning of the lower court. Id. at *10-15.
Second, the Sixth Circuit also affirmed the dismissal of 67 of 68 misrepresentation claims against the brandname Defendants, rejecting the innovator liability theory advanced by Plaintiffs under the laws of 22 states. Id. at *18. Plaintiffs argued that physicians had "reasonably and foreseeably" relied on representations of branded manufacturers when prescribing generic propoxyphene because physicians understood that generics are bioequivalent to and have the same labeling as branded drugs. Id. at *16. Yet, the court concluded that the misrepresentation claims failed under the 22 state laws at issue either because (1) they were, in fact, product liability claims subject to the "product identification requirement" rule ( i.e. a plaintiff must assert that the defendant's product caused the plaintiff's injury) or (2) even if the misrepresentation claims were not product liability actions, branded manufacturers do not have a legal duty to plaintiffs. Id. at *17. The court reversed dismissal of a lone claim where the Plaintiff had actually taken a branded drug and adequately pleaded a product liability claim. Id. at *20.
Darvocet is an important decision for defendants on both innovator liability and preemption. Although Darvocet did not directly rule on whether Footnote 4 creates an exception to preemption for state parallel misbranding claims, the court erected a pleadings bar and expressed skepticism that such an exception even exists. And, the Sixth Circuit's sweeping holding that 22 states would reject innovator liability solidifies the overwhelming weight of authority rejecting innovator liability. Notably, in analyzing Illinois law, the court also disagreed with a recent ruling by the Northern District of Illinois endorsing innovator liability. See Dolin v. SmithKline Beecham Corp., 12–C–6403, 2014 WL 804458, at *9 (N.D. Ill. Feb. 28, 2014).