41 F. Supp. 3d 170
N.D.N.Y.2014Background
- Plaintiff Rosen alleges injuries from Riata Lead devices manufactured by St. Jude Medical, Inc. and Pacesetter, Inc. due to manufacturing defects and failure to warn.
- Defendants moved to dismiss; Amended Complaint analyzed after initial dismissal motion.
- Riata Leads were approved in 2002 after FDA PMAs and multiple PMA supplements through 2002–2012.
- Plaintiff was implanted with a Riata Lead in 2004 and had it removed in 2012 after discovering fracture and externalization.
- FDA QSIT inspection in 2009 revealed CAPA, MDR, and complaint handling deficiencies; 8,463 complaints vs. 3,689 MDRs reported since 2002.
- Dear Doctor letters (2010, 2011) highlighted insulation defects and later led to a Class I recall designation by FDA in 2011.
- Plaintiff asserts five defects allegedly violating PMAs/CGMPs, resulting in insulation abrasion and lead failure; asserts three New York claims: strict liability manufacturing defect, negligent manufacturing defect, and failure to warn.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether manufacturing defect claims are expressly preempted | Plaintiff alleges violations of PMAs/CGMPs; seeks parallel state-law claims. | Defendants argue claims are preempted under § 360k unless they plead device-specific PMA violations. | Plaintiff's claims survive as parallel, not preempted under § 360k/Riegel. |
| Whether Plaintiff states a parallel manufacturing defect claim | Allegations reference PMAs/CGMPs and FDA actions with causal link to injuries. | Plaintiff must plead device-specific PMA violations to avoid preemption. | Parallel manufacturing defect claim properly pled; survives dismissal. |
| Whether failure-to-warn is preempted | Failure to warn based on continuing FDA reporting obligations; not labeling. | Either express or implied preemption through federal reporting requirements. | Failure-to-warn claim not expressly or impliedly preempted; not barred at pleading stage. |
| Whether causation is adequately pled | Reporting violations could have reached physicians via MAUDE; would have mitigated injuries. | Plaintiff must show direct causal link; not proven at pleading. | Causation sufficiently pled; plausible connection between reporting violations and injuries. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption framework for medical devices; parallel claims allowed)
- Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011) (parallel claims framework for CGMP/PMAs at pleading stage)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (parallel claim approach for device-specific vs general requirements)
- Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) (court’s view on pleading PMA violations and preemption)
- Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582 (E.D.N.Y. 2009) ( CGMPs alone insufficient without factual support; pleading standard)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (parallelism concept for federal safety requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (Buckman clarifies limits on private FDCA-based claims; fraud-on-FDA context)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (parallel failure-to-warn claim under state law via FDA reporting)
- Medtronic, Inc. v. McConologue, 8 F. Supp. 3d 93 () (treats continuing reporting requirements as parallel state claims)