Walter Lashley v. Pfizer, Incorporated
750 F.3d 470
5th Cir.2014Background
- Two consolidated appeals from injuries alleged after plaintiffs took generic metoclopramide (Reglan): Lashley (Mississippi) and Del Valle (Texas). Plaintiffs developed tardive dyskinesia and akathisia and sued both generic manufacturers and brand manufacturers.
- Generic-defendant claims challenged below as failure-to-warn (and related theories); district courts dismissed those claims as preempted under federal law.
- Brand-defendant claims were resolved on summary judgment for the brands because plaintiffs never ingested the brand product and state products-liability law limits liability to manufacturers of the product that caused the injury.
- Plaintiffs urged narrow readings of Mensing, argued some non-warning theories survived, and urged brands could be liable despite lack of ingestion.
- The Fifth Circuit affirmed dismissal of all claims against generic manufacturers (preemption under Mensing/Bartlett/Morris) and affirmed summary judgment for brand manufacturers under Mississippi and Texas law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims against generic manufacturers are preempted by federal law | Plaintiffs: Mensing should be read narrowly; generics could have warned or taken actions consistent with brand labeling, or be liable under non-failure-to-warn theories | Generics: Federal duty-of-sameness and Mensing/Bartlett make state-law duties to change or add warnings impossible; such claims are preempted | Affirmed: Claims against generics preempted under Mensing and Bartlett; Morris controls |
| Whether non-failure-to-warn theories (strict liability, breach of warranty, design defect) evade preemption | Plaintiffs: These theories hold generics accountable for unsafe product/distribution even if they could not change label | Generics: Any useful remedy would implicate warnings; these are attempts to circumvent Mensing and thus preempted | Affirmed: Non-failure-to-warn theories preempted (Morris, Bartlett) |
| Whether brand manufacturers are liable to plaintiffs who never ingested the brand product | Plaintiffs: Brands promoted product or made misrepresentations to medical community and should be liable | Brands: State product-liability law requires causation by defendant’s product; no duty to users of other manufacturers' products | Affirmed: Brands not liable where plaintiff did not ingest brand product under Mississippi and Texas law |
| Whether FDA approval or alleged fraud on FDA removes presumption against brand liability (Texas) | Del Valle: Alleged fraud might overcome statutory presumption of non-liability for brands | Brands: No FDA finding of fraud; statutory presumption stands absent FDA determination | Affirmed: Presumption not overcome; summary judgment for brands upheld |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (federal duty-of-sameness preempts state-law failure-to-warn claims against generics)
- Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (state-law design-defect and related claims preempted when they conflict with federal generic labeling regime)
- Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) (failure-to-warn and related theories against generics preempted; attempts to circumvent Mensing rejected)
- Demahy v. Schwarz Pharm., Inc., 702 F.3d 177 (5th Cir. 2012) (applying Mensing preemption principles to Reglan claims)
- Wyeth v. Levine, 555 U.S. 555 (2009) (brands — not generics — can face state-law failure-to-warn claims when not preempted; establishes contrast between brand and generic preemption regimes)