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Gross v. Pfizer, Inc.
2012 U.S. Dist. LEXIS 11154
D. Maryland
2012
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Background

  • 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)
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Case Details

Case Name: Gross v. Pfizer, Inc.
Court Name: District Court, D. Maryland
Date Published: Jan 27, 2012
Citation: 2012 U.S. Dist. LEXIS 11154
Docket Number: 8:10-mj-00110
Court Abbreviation: D. Maryland