Smith v. Wyeth, Inc.
657 F.3d 420
6th Cir.2011Background
- Plaintiffs Lala Smith, Alice Wilson, and Dennis Morris alleged tardive dyskinesia from long-term use of generic metoclopramide prescribed for gastroesophageal reflux.
- Prescriptions were filled under Kentucky's generic-substitution statute with generic metoclopramide manufactured by multiple generic defendants.
- District court dismissed the claims against generic defendants as federally preempted by the regulation of generic-label changes, and dismissed name-brand claims for lack of proof of Reglan ingestion and Kentucky loss.
- Plaintiffs asserted Kentucky products-liability theory against the name-brand defendants for misrepresentation and failed warnings on Reglan labeling, arguing vicarious liability via label information.
- Court analyzed whether federal preemption bars state-law failure-to-warn claims against generics after PLIVA v. Mensing and whether Kentucky PLA applies to claims involving generics rather than the name-brand drug.
- Court affirmed the district court’s rulings, holding preemption of state-law warnings against generic-makers and lack of injury from the name-brand drug in the PLIVA context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal preemption bars state-law failure-to-warn claims against generic makers. | Smith/Wilson/Morris argue state claims survive state/federal conflict. | Defendants contend Mensing requires preemption of such state-law claims. | Preemption affirmed; state-law failure-to-warn claims barred. |
| Whether Kentucky PL Act applies to claims against name-brand defendants when plaintiffs consumed generics. | PL Act covers all product-damage actions regardless of theory. | PL Act applies only to injuries from the defendant's product, i.e., Reglan, not generics. | The Act applies, but injury must be tied to the defendant's product; plaintiffs lacked that link for Reglan. |
| Whether plaintiffs can pursue name-brand defendants for misrepresentation when plaintiffs ingested generics. | Label information for Reglan affects users of generics; foreseeability creates duty. | No duty to patients who took only generics manufactured by others. | No duty; plaintiffs failed to show injury from Reglan-specific labeling. |
| Whether the district court correctly dismissed claims against generic and name-brand defendants on the merits. | Claims should proceed under Kentucky law. | Claims preempted or failing threshold causation under KY PL Act. | affirmed; dismissals proper. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (federal preemption of state tort claims based on generic-drug labeling duties)
- Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994) (no duty by name-brand manufacturer to users of generics)
- Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006) (collection of cases on brand vs. generic liability)
- Monsanto Co. v. Reed, 950 S.W.2d 811 (Ky. 1997) (KY PL Act applies to all damage claims arising from product use)