Shirley Brinkley v. Pliva, Inc.
2014 U.S. App. LEXIS 22742
8th Cir.2014Background
- In 2002 Brinkley was prescribed Reglan; Missouri law allowed substitution with Pliva’s generic metoclopramide, which she took through April 2007 and alleges caused tardive dyskinesia.
- FDA requires generics to match brand drugs in design and labeling; generic manufacturers may not change labels or send supplemental warnings to physicians.
- In 2004 the brand Reglan label was updated to warn that use should not exceed 12 weeks; Pliva did not adopt that change for its generic product.
- Brinkley sued brand manufacturers and Pliva (failure-to-warn, design defect, implied warranty, MMPA claims). The district court granted judgment on the pleadings for Pliva after Mensing and Bartlett decisions and dismissed claims.
- On appeal, Brinkley limited some claims to Pliva’s failure to adopt the 2004 label change and challenged dismissal of non-warning design-defect and implied-warranty claims.
- The Eighth Circuit affirmed: (1) claims tied to the 2004 label update fail under Missouri’s learned-intermediary and causation requirements, and (2) non-warning design-defect and implied-warranty claims are preempted as impossible to comply with under federal law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure to adopt 2004 Reglan label warning (12-week limitation) | Brinkley: Pliva was liable for not incorporating the 2004 brand warning; physician was unaware of the 2004 warning, so Pliva’s omission caused injury | Pliva: Mensing preempts such state-law failure-to-warn claims; physician relied on brand labeling, breaking causation | Dismissed: Learned-intermediary doctrine + lack of causation; claim fails even assuming physician unaware of generic warning |
| Non-warning design defect | Brinkley: Design made metoclopramide unreasonably dangerous under Missouri law; Missouri’s open-ended jury standard differs from Bartlett | Pliva: Bartlett/Mensing preempt design claims that would require redesign or relabeling (impossibility) | Dismissed: Preempted—no action (redesign, relabel, or exit) would satisfy state duty without violating federal law |
| Breach of implied warranty (merchantability/fitness) | Brinkley: Implied warranties made drug fit/safe; breach caused harm | Pliva: Claim attacks design/labeling and thus is preempted under the same impossibility rationale | Dismissed: Preempted as it would impose duties inconsistent with FDCA sameness requirement |
| Whether Mensing/Bartlett preemption leaves any remandable issue | Brinkley: Courts should remand like prior Eighth Circuit cases for district court factfinding | Pliva: Mensing/Bartlett dispose of claims as a matter of law | Affirmed without remand: Bartlett’s analysis forecloses the remaining claims under Missouri law as pleaded |
Key Cases Cited
- Bell v. Pfizer, 716 F.3d 1087 (8th Cir. 2013) (learned-intermediary analysis and failure-to-adopt-2004-label claim rejected)
- Fullington v. Pfizer, 720 F.3d 739 (8th Cir. 2013) (similar hold to Bell on learned-intermediary causation)
- Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (discussing non-preemption of narrow 2004-label failure-to-warn theory)
- Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) (applying Bartlett/Mensing to preempt design/label-based claims)
- In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), 751 F.3d 150 (3d Cir. 2014) (preemption of state-law claims attacking generic drug safety)
- Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605 (5th Cir. 2014) (preemption of failure-to-warn/design claims post-Mensing/Bartlett)
- Schrock v. Wyeth, Inc., 727 F.3d 1273 (10th Cir. 2013) (implied-warranty and design claims preempted for generics)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (federal-law preemption principles regarding FDA-related claims)