In re Reglan Litigation
72 A.3d 696
| Pa. Super. Ct. | 2013Background
- Wyeth appeals an order overruling its demurrer to the Third Amended Master Long Form Complaint in mass tort Reglan/metoclopramide cases.
- Plaintiffs allege injuries from ingestion of Reglan or its generic metoclopramide.
- Wyeth transferred the Reglan NDA to Schwarz Pharma in December 2001 and retained some control over labeling for a transitional period.
- Mensing v. Wyeth preempts state-law failure-to-warn claims against generic manufacturers, because generics cannot unilaterally change labeling; the 2007 Act did not alter Mensing’s preemption analysis at the relevant times.
- Plaintiffs contend Wyeth retained labeling responsibilities post-2001 and may be liable under state law despite transfer; Wyeth contends Mensing bars such liability after the transfer.
- The trial court refused Wyeth’s preemption-based objections; Wyeth sought interlocutory review under the collateral-order doctrine, which the panel ultimately quashed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the order is appealable under collateral-order doctrine | Plaintiffs contend the preemption ruling is separable and irreparably reviewable | Wyeth argues the order is appealable because it involves a controlling question of law | Not appealable; order quashed |
| Whether Wyeth's post-2001 claims are preempted under Mensing | Mensing does not apply to Wyeth as NDA holder post-2001; Wyeth could retain state-law duties | Mensing preempts state-law labeling claims against generic manufacturers, implying post-2001 claims are preempted | Not reached on the merits; issue treated as non-reviewable due to lack of collateral-order jurisdiction |
Key Cases Cited
- Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) (preemption of state-law warning claims against generics under federal labeling rules)
- Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (preemption analysis in generic labeling context)
- Pridgen v. Parker Hannifin Corp., 588 Pa. 405 (Pa. 2006) (collateral review allowed for federal preemption and cost considerations under collateral-order doctrine)
- Johnson v. Jones, 515 U.S. 304 (U.S. 1995) (collateral order analysis for summary-judgment-like decisions in qualified-immunity context)
- Rae v. Pennsylvania Funeral Directors Ass’n, 602 Pa. 65 (Pa. 2009) (collateral-order jurisdiction follows three-prong test; finality not required)
- Weiley v. Albert Einstein Med. Ctr., 51 A.3d 202 (Pa. Super. 2012) (de novo review for preemption questions; evidence standard for demurrer)