193 F. Supp. 3d 218
W.D.N.Y.2016Background
- Teixeira sued St. Jude in New York state court claiming the Durata ICD lead prematurely failed (externalization/abrasion) after implantation in Sept. 2011; St. Jude removed to federal court.
- Plaintiff amended to assert manufacturing-defect strict liability and negligence, failure-to-warn, negligent misrepresentation, and breach of warranty theories; he did not allege examination results of the explanted lead.
- Defendants moved to dismiss; Magistrate Judge Scott recommended allowing the manufacturing-defect and negligent-manufacturing claims to proceed but dismissing failure-to-warn and negligent misrepresentation claims and limiting warranty claims.
- Defendants objected on several grounds (express-warranty pleading, reliance on a 2013 FDA Warning Letter, lack of device-specific factual allegations, and improper “information and belief” allegations).
- The district court reviewed objections de novo where appropriate, dismissed the entire amended complaint for failure to state a claim, adopted portions of the Report, and denied sanctions with prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Sufficiency of manufacturing-defect/negligent-manufacturing claims | Teixeira asserts Durata lead externally abraded causing malfunction; relies on FDA Warning Letter and related materials | St. Jude: no device-specific facts, no examination of explanted lead, and Warning Letter postdates implant and does not tie to alleged defect | Claims insufficient; dismissal for failure to plead causation or a plausible link to FDA violations |
| Breach of express warranty (preemption and pleading) | Plaintiff alleges personal representations and generic warranty statements about safety and longevity | St. Jude: warranty claims based on FDA-approved labeling are preempted; no specific personal representations pled | Express-warranty claim dismissed for failure to plead specific, plausible personal representations |
| Relevance of FDA 2013 Warning Letter and evidence from Riata leads | Plaintiff relies on the FDA Warning Letter and reports about Riata/Durata similarities to show defects and federal violations | St. Jude: Warning Letter arose after implant, cites CGMPs that do not explain externalization, and Riata differs from Durata; reliance on other models is irrelevant | Court finds no factual causal link between the Warning Letter (or Riata evidence) and Teixeira’s device; such reliance does not make claims plausible |
| Use of allegations stated "on information and belief" / copying from other complaints | Teixeira uses information-and-belief assertions and much text similar to other Riata complaints to plead facts beyond his access | St. Jude: these allegations are unsupported, improperly copied, and not reasonably likely to be proved in discovery | Court finds many information-and-belief allegations speculative and insufficient; denies sanctions but dismisses complaint and rejects allowing discovery to cure conclusory assertions |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for federal pleading; courts need not accept legal conclusions)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plaintiff must plead facts crossing line from conceivable to plausible)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (MDA preemption; state claims that add to or differ from federal PMA requirements are preempted)
- Arista Records, LLC v. Doe 3, 604 F.3d 110 (2d Cir. 2010) (permitting information-and-belief allegations when facts are peculiarly within defendant’s control)
- Zuchowicz v. United States, 140 F.3d 381 (2d Cir. 1998) (necessity of showing causal link between defendant’s conduct and plaintiff’s loss)
- Palsgraf v. Long Island R. Co., 248 N.Y. 339 (1928) (famous statement on proximate cause; cited for principle that unsupported proof will not suffice)
- Broder v. Cablevision Sys. Corp., 418 F.3d 187 (2d Cir. 2005) (courts may consider documents integral to complaint even if not incorporated by reference)