Shirley Bell v. Pfizer
2013 U.S. App. LEXIS 12002
| 8th Cir. | 2013Background
- Bell, an Arkansas resident, was prescribed Reglan but the pharmacist substituted generic metoclopramide manufactured by Pliva.
- Bell asserts she never ingested Reglan and took only the generic; she alleges a tardive dyskinesia linked to long-term metoclopramide use.
- FDA required a black box warning in 2009; Bell faulted brand defendants and Pliva for not adequately informing physicians and patients beforehand.
- Bell filed a 2010 federal product liability action asserting negligence, strict liability, warranties, misrepresentation, fraud, and gross negligence against both brand and generic manufacturers.
- The district court granted brand-defendants’ summary judgment due to Bell’s stipulation she did not use their product, and later dismissed Pliva’s claims as failure-to-warn under Mensing preemption; on appeal, the court affirmed in part, reversed in part, and remanded for non-warning claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Brand defendants' liability when Bell did not use their product | Bell relies on brand labeling liability as a proximate cause | No product identification; no duty to user of competitor's product | Claims against brand defendants barred; no proximate link |
| Mensing preemption of Bell's Pliva claims | Some claims survive as non-warning or design-related | All claims premised on failure to warn are preempted | Most failure-to-warn claims preempted; non-warning design defect and implied warranty claims remanded for district court to consider |
| Effect of 2004 Reglan label change and learned intermediary doctrine | Pliva's failure to adopt 2004 changes could sustain claims | Learned intermediary doctrine breaks causal chain; physician warning suffices | No viable claim against Pliva for failure to incorporate the 2004 label change; causation lacking under learned intermediary doctrine |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (Supreme Court 2009) (brand-name duty to warn not imposed on generic label changes)
- Mensing v. Wyeth, Inc., 131 S. Ct. 2567 (Supreme Court 2011) (federal preemption of state failure-to-warn claims for generics)
- Mensing v. Wyeth, Inc. (Wyeth II), 658 F.3d 867 (8th Cir. 2011) (reinstated brand-claims analysis; preemption discussed)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (Supreme Court 2001) (fraud-on-the-FDA implied preemption principle)
- Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012) (preemption analysis questioned post-Mensing in design-defect context)
- Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012) (post-Mensing preemption and failure-to-warn claims; circuit decisions noted)