14 A.3d 850
Pa. Super. Ct.2011Background
- Appellants Jacqueline and Howard Wright sue vaccine manufacturers for their minor Jared Wright's alleged neurological injuries after thimerosal-containing vaccines.
- Wrights claim design defect and failure-to-warn theories, arguing thimerosal as preservative caused autism/ developmental delays.
- Vaccine Act (42 U.S.C. § 300aa-22) preempts state tort claims; VICP provides a no-fault compensation route and limits further suits.
- Trial court granted summary judgment to vaccine defendants, finding preemption or presumptions bar the Wrights' claims.
- Pennsylvania Superior Court initially reversed; en banc review and briefing followed, with majority adopting case-by-case analysis for unavoidability.
- Court concludes §300aa-22(b)(1) does not automatically preempt all design-defect claims and requires case-by-case inquiry for unavoidability; §300aa-22(b)(2) presumption applies to failure-to-warn claim; §300aa-22(e) not reached on the record.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Scope of §300aa-22(b)(1) preemption | Preemption is not absolute; only unavoidable side effects are shielded. | §300aa-22(b)(1) preempts all design defect claims regardless of unavoidability. | Not outright; requires case-by-case inquiry into unavoidability. |
| Case-by-case inquiry for design defect claims | Court should determine unavoidability per case facts. | Uniform preemption would apply if side effects are unavoidable. | Court must conduct case-by-case inquiry before ruling on preemption for design defect claims. |
| Application of §300aa-22(b)(2) presumption to failure-to-warn | Presumption should not bar failure-to-warn claims; only design defect claims. | Presumption applies to warnings and defeats failure-to-warn unless overcome. | Presumption applies to failure-to-warn; Wrights failed to overcome it. |
| Relation of §300aa-22(e) to state-law barriers | §22(e) preserves state-law claims and may preempt Pennsylvania barriers. | §22(e) does not rescue design-defect or failure-to-warn claims beyond preemption. | Not reached on record; decision reserved as to §22(e). |
Key Cases Cited
- Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3d Cir.2009) (express preemption in §300aa-22(b)(1) discussed)
- Sykes v. Glaxo-SmithKline, 484 F.Supp.2d 289 (E.D. Pa. 2007) (preemption considerations in Vaccine Act context)
- Wyeth v. Levine, 129 S. Ct. 1187 (2009) (preemption and labeling considerations in vaccine context)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (statutory preemption framework and field vs. conflict preemption)
- Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992) (presumption against preemption and statutory interpretation guidance)