Hassett v. Dafoe
74 A.3d 202
Pa. Super. Ct.2013Background
- Plaintiffs (including Paul Hassett) sued name‑brand Reglan and many generic manufacturers of metoclopramide for injuries (tardive dyskinesia) allegedly caused by long‑term use; the master complaint was amended after PLIVA v. Mensing.
- Generic manufacturers argue federal law (Hatch‑Waxman/FDCA regime) forbids them from unilaterally changing generic labels, so state failure‑to‑warn and related tort claims are impossibility‑preempted under Mensing.
- The trial court overruled generic defendants’ preliminary objections; defendants appealed under the collateral‑order doctrine. The Superior Court accepted interlocutory jurisdiction.
- The core legal question: which of the plaintiffs’ causes of action (design defect, negligence, negligence per se, breach of warranty, fraud, disgorgement, conspiracy, etc.) are preempted by federal law under Mensing and related precedent?
- Court applies presumption against preemption and distinguishes (1) pre‑2007 failure‑to‑warn claims premised solely on generic labels that conformed to the brand label, (2) design‑defect/strict‑liability claims, (3) fraud/false‑promotion/warranty claims, and (4) claims arising after the 2007 FDA Amendments Act (FDAAA).
- Holding: only pre‑FDAAA failure‑to‑warn claims based solely on generic labels that conformed to the RLD label are preempted; all other claims survive the demurrer and proceed for further state‑law analysis.
Issues
| Issue | Hassett (Plaintiff) Argument | Generic Defendants Argument | Held |
|---|---|---|---|
| Whether federal impossibility preemption (Mensing) bars all claims against generic manufacturers | Many counts are not pure failure‑to‑warn claims (e.g., strict liability design defect, fraud, warranty, negligent testing/marketing) and thus are not preempted; negligence per se can rely on FDCA misbranding | All claims are functionally failure‑to‑warn and therefore preempted under Mensing/Bartlett because generics cannot unilaterally strengthen labels | Reversed in part/affirmed in part: only pre‑2007 failure‑to‑warn claims based solely on labels conforming to the RLD are preempted; other claims remain. |
| Preemption effect of post‑2007 FDAAA changes | FDAAA changed the landscape (FDA can order labeling changes, generics can propose changes), so post‑Act failure‑to‑warn claims should not be dismissed without careful analysis | Generics did not press FDAAA impacts in briefing; they urged broad Mensing application | Court declines to find post‑Act claims preempted without a state‑by‑state, claim‑by‑claim analysis; dismissal premature. |
| Whether strict products‑liability/design defect claims are preempted | §402A style strict liability does not require showing the manufacturer could have redesigned or relabeled; thus it can survive Mensing | Such design claims effectively require label change or redesign and therefore are preempted under Bartlett/Mensing | Court: preemption of design claims may be possible under Bartlett but is state‑law specific; blanket preemption is premature. |
| Whether fraud, false promotion, breach of warranty, disgorgement, conspiracy claims are preempted | These claims target advertising, promotion, and warranties (not just label content) and therefore are not Mensing failure‑to‑warn claims | Defendants characterize these as disguised label claims and seek broad preemption | Court: these claims are not Mensing failure‑to‑warn claims and survive demurrer; require further state‑law analysis. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (held state failure‑to‑warn claims against generic manufacturers preempted by federal duty of sameness)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (applied Mensing to bar state law that effectively required a generic to redesign or relabel, reinforcing impossibility preemption)
- Wyeth v. Levine, 555 U.S. 555 (2009) (held name‑brand manufacturer’s failure‑to‑warn claim was not preempted because brand could unilaterally strengthen its label)
- Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (state design, negligence, and warranty claims are not per se preempted by a federal labeling statute unless they impose labeling/packaging requirements different from federal law)
- Cipollone v. Liggett Group, 505 U.S. 504 (1992) (distinguished labeling‑based preemption from other state‑law duties like fraud/misrepresentation)
- Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804 (1986) (addressed use of federal statute violations as elements of state negligence claims; emphasized limits of federal preemption analysis)
- Altria Group, Inc. v. Good, 555 U.S. 70 (2008) (presumption against preemption; state duties not displaced unless clear congressional intent)