Gross v. Pfizer, Inc.
2012 U.S. Dist. LEXIS 11154
D. Maryland2012Background
- Plaintiff ingested a generic metoclopramide manufactured by PLIVA and alleges injuries.
- Plaintiff did not ingest Pfizer/Wyeth/Schwarz brand metoclopramide.
- Claims against brand-name manufacturers were dismissed under Maryland law.
- Supreme Court's Mensing decision held generic warnings are preempted by federal law.
- Court lifted stay to brief Mensing impact, then granted PLIVA's Rule 12 motion for judgment on the pleadings.
- Court concludes state-law claims against PLIVA are preempted and dismisses them.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Post-Mensing viability of PLIVA claims | Gross argues some claims survive Mensing. | Mensing preempts all state-law failure-to-warn claims against generics. | All PLIVA claims preempted; dismissal affirmed. |
| Continuing to sell metoclopramide(inadequate warnings) | Plaintiff can plead negligence for continued sale with inadequate labeling. | Mensing precludes such claims against generics. | Preempted; no surviving negligence claims. |
| Concealment of safety information | Concealment claims may survive if not tied to labeling changes. | Claims preempted when based on labeling or FDA-related concealment. | Preempted under Mensing. |
| Testing/inspecting and 2004/2009 label-change arguments | Claims relate to 2004 label deviation not requiring new warnings. | Mensing preempts such claims; amendment rejected. | Claims related to 2004 labeling changes dismissed; amendment denied. |
Key Cases Cited
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (federal duties and preemption principles in labeling context)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (federal labeling duties and preemption of certain warnings)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (federal preemption of state-law failure-to-warn claims for generics)
