Gardley-Starks v. Pfizer, Inc.
2013 U.S. Dist. LEXIS 3966
N.D. Miss.2013Background
- Metoclopramide labeled warnings about tardive dyskinesia; FDA labeling changes in 1985, 2003, 2004, and a 2009 boxed warning.
- Plaintiff ingested generic metoclopramide (ESI Lederle, Northstar, PLIVA, Purepac) between 2002–2008; never ingested brand Reglan.
- Mississippi law MPLA governs products-liability claims, requiring proof of defect and causation.
- Mensing (federal preemption) held generic-label warnings are preempted by federal law; plaintiffs’ claims framed as failure to warn are typically preempted.
- This suit asserts multiple Mississippi-law claims (negligence, strict liability, warranties, misrepresentation, gross negligence) arising from use of generics rather than brand-name Reglan.
- Court granted Brand Defendants’ summary/partial dismissal and Generic Defendants’ dismissal based on preemption and lack of causation evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Brand Defendants can be liable where Plaintiff did not ingest brand Reglan | Gardley-Starks may recover for negligence/misrepresentation regardless of brand | Plaintiffs’ claims bar because MPLA covers only injuries from brand or generic product actually used; no duty to users of competitors’ product | Granted: Brand Defendants entitled to summary judgment |
| Whether generic manufacturers are preempted under Mensing for failure-to-warn claims | Mensing should be read narrowly; liability for misbranding and information suppression remains | Mensing preempts state-law failure-to-warn claims against generics; labeling is governed by federal sameness rule | Granted: Generic Defendants’ claims preempted |
| Whether other theories against generic defendants (withdrawal, Dear Doctor communications, post-market surveillance, updating label) survive | Claims not purely failure-to-warn could survive; pursuit of non-warning theories | All such theories are preempted or fail to state causation; learned intermediary doctrine applied | Granted: all remaining theories preempted or inadequately pleaded |
| Whether Plaintiff’s failure-to-update label claim against PLIVA remains viable | PLIVA could have updated label to reflect changes; state-law duty to warn applies | Label updates governed by federal regulation; no private action to enforce FDA labeling; causation not shown | Dismissed: preemption or lack of causation; no viable state-law claim |
Key Cases Cited
- Mensing v. Wyeth, Inc., 131 S. Ct. 2567 (U.S. 2011) (holding generic labeling must match brand; state claims preempted)
- Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012) (broad preemption reach; failure-to-warn claims still preempted)
- Lashley v. Pfizer, Inc., 877 F. Supp. 2d 466 (S.D. Miss. 2012) (MPLA precludes non-brand-injury claims; product caveat)
- In re Darvocet, Darvon & Propoxyphene Prod. Liab. Litig., 856 F. Supp. 2d 904 (E.D. Ky. 2012) (preemption principle across multiple states including Mississippi)
- Lawson v. Honeywell Int’l, Inc., 75 So. 3d 1024 (Miss. 2011) (lawson distinguishes designer vs. manufacturer; MPLA scope limits claims)