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.