In In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. Apr. 24, 2014), the U.S. District Court for the Southern District of Illinois granted in part and denied in part defendant’s motion for judgment on the pleadings.
Plaintiff alleged that the generic version of the oral contraceptive Yaz caused her to suffer an acute pulmonary embolism. She filed a lawsuit against the branded-manufacturer (which also manufactured the generic drug) and the drug distributor, bringing claims including strict liability, failure to warn, negligence, and fraud. 2014 WL 1632149, at *1. The distributor defendant moved for judgment on the pleadings, arguing that Plaintiff’s state law tort claims are preempted by federal law. The district court first addressed a threshold question—whether the Supreme Court’s decisions in PLIVA, Inc. v. Mensing, --- U.S. ---, 131 S. Ct. 2567 (2011) and Mutual Pharmaceutical Co., Inc. v. Bartlett, --- U.S. ---, 133 S. Ct. 2466 (2013), which held state law warnings-based tort claims against generic manufacturers preempted, applied equally to drug distributors. Id. at *6. The court found that “the principles announced in Mensing and Bartlett are equally applicable to generic distributors” because “[u]nder applicable federal regulations, generic distributors have no more authority than generic manufacturers to alter a drug’s composition, label, or design.” Id.
Having found Mensing and Bartlett applicable, the court next rejected Plaintiff’s attempts to distinguish her design defect claim from the claim preempted in Bartlett. First, the court did not accept Plaintiff’s argument that unlike the state law at issue in Bartlett, Illinois design defect law “imposes no affirmative duty [on manufacturers], and instead serves to spread risk.” Id. at *7. “Just as in New Hampshire, Illinois’ strict liability does not mean that manufacturers have no affirmative duties.” Id. at *8. Second, the court rejected Plaintiff’s contention that Bartlett was distinguishable because New Hampshire applied a risk-utility approach while Illinois uses a consumer-expectations test, finding “this is a distinction without a difference” because the tests are simply “two different ways whereby a plaintiff can prove the same ground of liability.” Id. The court did, however, recognize what it called an “exception” under Bartlett for state law claims that parallel the federal misbranding statute (requiring a manufacturer to pull a drug from the market—even if FDA-approved—if it is “dangerous to health”). Based on a footnote in Bartlett, in which the Court expressly stated it was “not address[ing] state design-defect claims that parallel the federal misbranding statute,” Bartlett 133 S.Ct. 2477 n.4, the district court found that “to the extent the plaintiff’s design defect claim parallels the federal misbranding statute, it is not foreclosed by Bartlett.” Id. at 10. The court accordingly denied the distributor defendant’s motion for judgment on the pleadings with respect to the parallel misbranding claim, but granted the motion as to the failure to warn claim.
The In re Yasmin and Yaz decision extends the Mensing/Bartlett preemption rationale to generic drug distributors and demonstrates one court’s unwillingness to distinguish Bartlett based on state law differences. The decision, however, also seizes upon dicta in Bartlett, which plaintiffs are likely to continue to argue creates an “exception” for state law claims that parallel the federal misbranding statute. The Sixth Circuit is currently addressing this issue in In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig. (Miller v. Eli Lilly), No. 12- 5929, and will likely render its decision later this year.