Wagner v. Teva Pharmaceuticals USA, Inc.
2016 U.S. App. LEXIS 18671
7th Cir.2016Background
- Pro se plaintiff Kathleen Wagner, a former user of both brand-name and generic hormone therapy, developed breast cancer and sued multiple drug companies under Wisconsin tort law for selling dangerous products and failing to warn.
- Appellees Teva, Barr Pharmaceuticals, and Barr Laboratories were the manufacturers of the generic versions of the drugs Wagner took; they moved for judgment on the pleadings under Federal Rule of Civil Procedure 12(c).
- District court granted judgment for defendants, holding federal law (the FDCA) preempted Wagner’s state-law claims based on the Supreme Court’s "duty of sameness" decisions for generics.
- Wagner argued on appeal that the FDA Amendments Act of 2007 (FDAAA) changed the preemption analysis and, alternatively, that defendants were liable for failing to update generic labels to match later-updated brand labels.
- The Seventh Circuit affirmed: it rejected Wagner’s FDAAA argument and declined to accept her failure-to-update theory because she never pleaded it (and her factual allegations were insufficient to establish causation).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDCA preempts Wagner’s state-law tort claims | Wagner: FDAAA undermines Mensing/Bartlett; claims are not preempted | Defendants: Mensing/Bartlett impose a duty of sameness that preempts state-law duties on generics | Held: Preemption applies; FDAAA does not eliminate the duty of sameness |
| Whether failure-to-update claim (generic labels lagging behind brand updates) survives preemption or pleading rules | Wagner: Claims based on defendants’ failure to update generic labels to match brand label are viable | Defendants: Such claims are preempted or were not pleaded; plaintiffs cannot amend in late briefing | Held: Claim waived and inadequately pleaded; court need not resolve open circuit split on preemption of failure-to-update claims |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic manufacturers must keep labels the same as brand-name labels; state-law duties requiring different labeling are preempted)
- Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013) (extended Mensing principles to design-defect claims; generics cannot change formula or label without violating federal law)
- Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) (per curiam) (failure-to-update claims are preempted)
- Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (failure-to-update claims may be viable)
- Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014) (discussed circuit split and addressed failure-to-update theory on the merits)