By Kurt R. Karst –
Ever since the U.S. Court of Appeals for the First Circuit issued its opinion in May 2012 in Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012) denying Mutual Pharmaceutical Company’s (“Mutual’s”) appeal of a decision from the U.S. District Court for the District of New Hampshire in which the district court denied Mutual’s Motion for Judgment as a Matter of Law – see Bartlett v. Mutual Pharm. Co., 760 F. Supp. 2d 220 (D.N.H. 2011) – concerning design defect and generic drug preemption, there’s been a lot of speculation that Mutual would petition the U.S. Supreme Court to review the case. That day has come with Mutual’s July 31st Petition for Writ of Certiorari.
The Bartlett case has a long history in federal court beginning with a September 2009 pre-Mensing decision (see our previous post here), and then, after a couple of additional district court decisions, ending (until now) with the First Circuit’s post-Mensing decision. Our Mensing reference, of course, refers to the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), in which 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 (whose drug product is approved under an NDA) preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are unable to comply with both federal and state duties to warn. This is in contrast to the Court’s March 4, 2009 decision in Wyeth v. Levine, 555 U.S. 555 (2009), holding that a state-law tort action against a brand-name drug manufacturer for failure-to-warn is not preempted. Since the Supreme Court issued its Mensing decision, scores of court decisions have dismissed litigation against generic drug manufacturers on Mensing grounds, including some Circuit Court decisions. The Drug and Device Law Blog maintains a Generic Drug Preemption Scorecard of the decisions.
The drug at issue in Bartlett is Sulindac Tablets, a non-steroidal anti-inflammatory drug. Mutual markets the drug under an ANDA FDA approved in 1991 (ANDA No. 072051). (Mutual’s product is an AB-rated version of Merck’s CLINORIL (sulindac) Tablets, which FDA approved in September 1978 under NDA No. 017911.) The Bartletts (Respondents) claim that Mrs. Bartlett suffered serious injuries after taking Mutual’s Sulindac Tablets and raised myriad state-law tort claims. Those claims were ultimately winnowed down to a state-law design defect claim that proceeded to trial. (Specfically, the claim that “sulindac’s risks outweighed its benefits making it unreasonably dangerous to consumers, despite the [FDA] having never withdrawn its statutory ‘safe and effective’ designation that the original manufacturer had secured and on which Mutual was entitled to piggyback,” which goes to the very core of the generic drug system established under the Hatch-Waxman Amendments.) A jury eventually awarded Respondent over $21 million in damages, and the district court denied various post-trial motions filed by Mutual, including Mutual’s renewed preemption defense based on the Supreme Court’s Mensing decision.
Mutual appealed to the First Circuit, which affirmed the district court in a decision that our friends over at the Drug and Device Law Blog characterized as an “essentially absurd result.” In reaching its decision, the First Circuit first turned not to Mensing, but to Wyeth, saying that although Wyeth, which did not involve a design defect claim, “was technically limited to failure-to-warn claims, its logic applies to design defect claims as well.” Moreover, according to the Court, Mensing merely “carved out an exception to Wyeth, finding that the FDCA preempts failure-to-warn claims against generic drug manufacturers . . . [because] the generic maker cannot alter the labeling.” That is, the Supreme Court “adopted a general no-preemption rule in Wyeth. . . .” Based on this thinking, the First Circuit concluded that to avoid state tort law liability a company could simply stop making its generic drug product.
Setting the case up for a request for Supreme Court review, the First Circuit commented that “it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims. . . . Given the widespread use of generic drugs and the developing split in the lower courts . . . , this issue needs a decisive answer from the only court that can supply it.” And maybe that will happen with Mutual’s Petition for Writ of Certiorari, which presents the following question for the Supreme Court:
Whether the First Circuit erred when it created a circuit split and held—in clear conflict with this Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)—that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.