Lashley v. Pfizer, Inc.
2012 U.S. Dist. LEXIS 88843
S.D. Miss.2012Background
- Plaintiffs allege injuries from long-term Reglan/metoclopramide use by Walter Lashley.
- Pfizer, Wyeth, and Schwarz Pharma manufactured brand Reglan and warned in labeling; Watson entities sold generic metoclopramide.
- Plaintiff asserts negligence, strict liability, breach of warranty, misrepresentation, suppression of evidence, fraud, and punitive damages.
- Supreme Court Mensing decision later held federal law preempts certain state-law failure-to-warn claims against generic manufacturers.
- Court granted summary judgment for Pfizer Defendants and preempted Watson Defendants’ claims; stay and subsequent motions addressed related issues.
- Record shows Lashley ingested Reglan or generic metoclopramide; warnings existed but adequacy contested; learned intermediary doctrine applied; brand-name vs. generic liability debated.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of claims against Pfizer based on Mensing | Plaintiffs argue state-law claims survive; warnings and design issues independent of generic labeling. | Mensing preempts state-law failure-to-warn, misrepresentation, and warranty claims for generic/metoclopramide; FDA labeling constraints. | Preemption applies; claims barred. |
| Adequacy of warnings under MPLA and learned intermediary doctrine | Warnings were inadequate; design and warning failures supported claims. | Prescriber warning suffices under learned intermediary doctrine; generic/brand labeling compliance with FDA rules forecloses liability. | Warnings deemed adequate; claims against Pfizer for failure-to-warn, negligence, strict liability, misrepresentation fail. |
| Breach of implied warranties related to merchantability and fitness for particular purpose | Pfizer brand/metoclopramide product unmerchantable and not fit for intended use. | Pfizer not the manufacturer/seller of the ingested drug; warranties cannot be imposed under MPLA for brand-only claims. | Preempted and/or not sufficiently pled; claims dismissed. |
| Defective design and danger-claims as preempted | Design defect theories remain viable despite Mensing. | Federal labeling requirements preclude design-defect claims when warnings cannot be altered without FDA approval. | Preempted; design claims dismissed. |
| Claims against Watson Defendants due to preemption | Watson claims should proceed despite Mensing. | Mensing preempts failure-to-warn and related claims against generic manufacturers; warranty claims merge with warnings. | Mensing preempts; Watson motions granted. |
Key Cases Cited
- Swayze v. McNeil Laboratories, 807 F.2d 464 (5th Cir. 1987) (warnings and learned intermediary analysis under §402A)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (federal regulations preempt state-law failure-to-warn claims against generic manufacturers)
- Metris v. Wyeth LLC, 872 F.Supp.2d 1335 (M.D. Fla. 2012) (preemption extends to implied warranty claims under Mensing)
- Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (brand vs. generic liability post-Mensing; preemption applied)
- Windham v. Wyeth Laboratories, Inc., 786 F. Supp. 607 (S.D. Miss. 1992) (learned intermediary doctrine governs warnings for prescription drugs)