In re Reglan/Metoclopramide Litigation
74 A.3d 221
Pa. Super. Ct.2013Background
- Morton Grove appeals trial court's ruling overruling preliminary objections premised on federal pre-emption under Mensing in mass tort claims involving metoclopramide.
- Issue: whether generic manufacturers' failure-to-warn claims are pre-empted when FDA designates Morton Grove as the Reference Listed Drug (RLD) holder for liquid metoclopramide.
- FDA designated Morton Grove as RLD after the original RLD discontinued marketing and FDA withdrew its approval, creating a successor RLD framework for labeling standards.
- Plaintiffs argue the RLD designation places Morton Grove in the shoes of the brand-name maker with duty to update warnings via CBE; Mensing pre-emption would bar state-law claims.
- Defendant contends it remains a generic manufacturer with no unilateral labeling power; pre-emption applies only to impossibility to meet both federal and state duties.
- Court holds Mensing does not blanket pre-emption and reviews whether Morton Grove, as RLD holder, could unilaterally modify its label; ultimately affirms the order overruling objections.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether RLD designation imposes additional duties on Morton Grove | M Grove argues RLD status creates brand-like duties to update warnings. | M Grove remains a generic holder with no unilateral labeling power. | Not pre-empted; order affirmed. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (manufacturer bears label responsibility; CBE power to change label)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (impossibility preemption for generic failure-to-warn claims)
- Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (U.S. 2013) (preemption of failure-to-warn claims reaffirmed; modern scope)