Metz v. Wyeth, LLC
2012 U.S. Dist. LEXIS 42432
M.D. Fla.2012Background
- Plaintiffs allege injuries from metoclopramide (Reglan) against Actavis as the generic manufacturer; Wyeth and Schwarz are later referenced but Actavis is the focus.
- Court adopts Mensing-based preemption of state-law failure-to-warn and related claims against generic manufacturers.
- Plaintiffs’ claims include negligence, strict liability, implied warranties, misrepresentation/fraud, and negligence per se.
- Court confirms most claims are preempted under Mensing; surviving claims hinge on allegedly improper communication of FDA-approved warnings and the learned intermediary doctrine.
- Summary judgment for Actavis is granted; dismissal of preemptioned and barred claims is with prejudice; case closed.
- Record shows key post-2004 labeling changes and the 12-week warning were available to physicians and patients.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mensing preempts all state-law claims against Actavis | Mensing does not bar non-label-communication claims | Mensing preempts all claims based on failure to warn | Mostly preempted; some negligence claims possibly survive under communication nuances |
| Whether certain claims fail due to learned intermediary doctrine | Plaintiffs can overcome via FDA label changes | Learning intermediary breaks causal chain | Claims relying on inadequate communication to physicians barred by learned intermediary doctrine |
| Whether negligence per se survives under Florida law | FDCA violation grounds private action | No private negligence per se action for FDCA violations | Negligence per se claim dismissed |
| Whether implied warranties survive preemption | Actavis knew long-term use implied safe use | Implied warranties preempted by Mensing | Preempted to the extent based on failure to change warnings; potential limited survival for certain implied warranty theories in some contexts |
| Whether misrepresentation/fraud claims survive given preemption | Concealment of 2004 warnings not preempted | Mensing preempts fraud-on-label claims | Dismissed due to preemption and failure to plead with particularity |
Key Cases Cited
- Mensing v. Wyeth, Inc., 131 S. Ct. 2567 (U.S. 2011) (failure-to-warn preemption for generic drug makers under FDCA)
- Fisher v. Pelstring, 817 F. Supp. 2d 791 (D.S.C. 2011) (negligence based on communicating FDA-labeled warnings not preempted)
- Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp. 2d 870 (D.Md. 2011) (design/manufacturing defect claims dismissed on preemption grounds)
- Gross v. Pfizer, Inc., 825 F. Supp. 2d 654 (D. Md. 2011) (fraudful/false information and testing claims preempted)