In Re Fosamax (Alendronate Sodium) Products Liability Litigation
751 F.3d 150
| 3rd Cir. | 2014Background
- FDCA regulates prescription drugs; FDA approval requires NDA, safety/efficacy, and labeling; labeling must be kept in line with federal requirements (sameness for generics).
- Hatch-Waxman Act allows generics to obtain approval via ANDA showing bioequivalence to brand-name drug; generics cannot unilaterally change labeling or design without FDA action.
- Fosamax (brand) approved by FDA in 1995; Teva and others later obtained FDA approval for generic alendronate sodium; generics follow same active ingredient, administration, dosage, and labeling.
- MDL consolidation in MDL No. 2243; district court granted judgment on the pleadings for generic Defendants, finding state-law design-defect claims pre-empted by federal law.
- Appellants (Patri ck Welch et al.) appealed the judgment on the pleadings; the district court’s finality was certified under Rule 54(b), giving appellate jurisdiction over the pre-emption ruling.
- Appellants’ theory centered on strict-liability design-defect claims; district court read these as conflicting with FDA-mandated sameness and thus pre-empted under Mensing/Bartlett framework.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether strict-liability design-defect claims against generic drug manufacturers are pre-empted | Mensing/Bartlett do not extend to strict-liability design claims | Mensing/Bartlett show impossibility pre-emption; generics cannot redesign or change labeling | Pre-emption affirmed; design-defect claims pre-empted. |
| Scope of claims on appeal and waiver of negligence-based claims | Negligence-based design-defect claims preserved and viable | Negligence-based theories waived; only risk-utility design-defect claims considered | Negligence-based design-defect arguments waived; only strict-liability design-defect, Count IX, considered. |
| Application of Mensing and Bartlett to generic drug labeling/design | Bartlett limits pre-emption; design claims not strictly labeling-based | Bartlett, like Mensing, prohibits unilateral changes; impossibility pre-emption applies | Mensing and Bartlett require pre-emption; no viable non-label-change path for generics. |
| Stop-selling theory as pre-emption premise | Stop-selling could avoid liability | Bartlett rejects stop-selling as a valid route | Stop-selling theory rejected; Bartlett forecloses. |
| State-by-state variation in design-defect regimes | Design-defect claims vary; require state-by-state pre-emption analysis | No need for state-by-state; Bartlett/Mensing control | waived to the extent not raised in opening brief; not addressed. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (impossibility pre-emption for generic-drug labeling; sameness duty prohibits unilateral changes)
- Bartlett v. Mutual Pharmaceutical Co., 133 S. Ct. 2466 (2013) (design-defect pre-emption; inability of generics to redesign; stop-selling rejected)
- Wyeth v. Levine, 555 U.S. 555 (2009) (brand-name labeling duties; pre-emption context for labeling changes)