In re Reglan/Metoclopramide Litigation
81 A.3d 80
Pa. Super. Ct.2013Background
- Plaintiffs (over 2,000 claimants) sued name-brand and generic manufacturers of metoclopramide (Reglan and generics) for injuries including tardive dyskinesia allegedly tied to long-term use; label warnings were strengthened in 1985, 2004, and 2009.
- Generic defendants (PLIVA, Teva, Hospira) moved to dismiss under federal pre-emption (impossibility) based on PLIVA, Inc. v. Mensing, claiming all claims are essentially failure-to-warn claims pre-empted because federal law requires generic labels to match the reference listed drug (RLD).
- Hospira separately argued that pre-2009 claims based on its failure to adopt an RLD warning are pre-empted because the RLD for injectable Reglan did not adopt the warning until 2009.
- Trial court overruled preliminary objections; Commonwealth Court accepted interlocutory appeal under the collateral order doctrine.
- The court applied the demurrer standard (accepting pleaded facts) and addressed whether Mensing pre-empts all pleaded claims or only a subset, and whether pre-/post-FDAAA (2007) timing matters.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mensing pre-empts all claims against generic manufacturers | Many claims (design-defect, warranty, fraud, misrepresentation, disgorgement, conspiracy, negligence per se) are not failure-to-warn and therefore not pre-empted | All claims are, in substance, failure-to-warn claims indistinguishable from Mensing and therefore pre-empted | Reversed in part/affirmed in part: not all claims are Mensing failure-to-warn claims; blanket pre-emption rejected |
| Whether pre-2007 failure-to-warn claims premised on generic labels identical to the RLD are pre-empted | Pre-Act carve-outs and other claims survive; some negligence per se or misbranding-based claims are viable | Pre-2007 label-based failure-to-warn claims are impossible to satisfy and thus pre-empted | Pre-Act failure-to-warn claims that rely solely on generic labels that conformed to the RLD are pre-empted under Mensing |
| Whether Hospira’s pre-2009 claims (injectable RLD didn’t add warning until 2009) are pre-empted | Hospira could be liable for failing to adopt or communicate warnings where obligations under state law do not conflict with federal law | Pre-2009 claims premised on failing to conform to an RLD update are impossible because RLD had not updated; pre-2009 claims pre-empted | Hospira’s pre-2009 Mensing-carve-out claims are pre-empted because the RLD had not updated its label pre-2009 |
| Whether post-2007 FDAAA claims are pre-empted | FDAAA altered the federal/regulatory landscape (FDA may order/require label changes), so post-Act failure-to-warn claims require careful state-law-specific analysis and should not be summarily pre-empted | Generic defendants argued for blanket pre-emption regardless of Act | Post-2007 failure-to-warn claims not dismissed; Mensing expressly reserved view on FDAAA, so pre-emption requires state-law-specific impossibility analysis |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (generic manufacturers’ duty-to-match requirement can make state-law failure-to-warn claims impossible to satisfy)
- Wyeth v. Levine, 555 U.S. 555 (2009) (impossibility pre-emption is demanding; name-brand manufacturer could unilaterally strengthen warnings so state-law failure-to-warn claim not pre-empted)
- Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013) (design-defect liability that effectively requires relabeling or redesign can be pre-empted for generics)
- Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005) (state design-defect, negligence, and warranty rules do not automatically constitute labeling/packaging requirements pre-empted by federal labeling law)
- Cipollone v. Liggett Group, 505 U.S. 504 (1992) (distinguishing failure-to-warn claims from other tort theories like negligent testing, advertising; not all state duties are pre-empted)
- Merrell Dow Pharm. v. Thompson, 478 U.S. 804 (1986) (federal regulatory violation can inform state negligence per se claims; absence of private federal remedy does not bar state tort claims)
- Altria Group, Inc. v. Good, 555 U.S. 70 (2008) (cautionary presumption against finding federal pre-emption when state regulation occupies traditional police powers)