Waltenburg v. St. Jude Medical, Inc.
33 F. Supp. 3d 818
W.D. Ky.2014Background
- Plaintiff Shawn Waltenburg received a St. Jude Riata model 1580 ICD lead in 2004 and later experienced recurrent inappropriate shocks and was told his lead showed inside-out conductor erosion; plaintiffs allege physical and emotional injuries.
- Plaintiffs sued St. Jude and Pacesetter asserting: (1) strict liability — manufacturing defect; (2) negligent manufacture; (3) negligence per se; and (4) negligent failure to warn; plus punitive damages and loss of consortium. Case removed to federal court; Amended Complaint filed.
- Defendants moved to dismiss under Rule 12(b)(6), asserting failure to state plausible claims and that state-law claims are preempted by the Medical Device Amendments (MDA), 21 U.S.C. § 360k(a).
- The Riata lead is a Class III PMA-approved device; PMA No. P950022 and multiple PMA supplements (including S014 etc.) govern its approval and continued reporting duties.
- Court reviewed pleading standards (Twombly/Iqbal) and the MDA preemption framework derived from Lohr, Buckman, and Riegel, and analyzed circuit splits about how much PMA-specific particularity is required at the pleading stage.
- Court found plaintiffs’ amended complaint pleaded sufficient factual allegations about manufacturing deviations (identifying multiple alleged manufacturing failures) and denied dismissal of Counts I, II, and IV on preemption/pleading grounds; granted dismissal of Count III (negligence per se) as Kentucky law does not recognize negligence per se based on federal statutes/regulations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state tort claims are preempted by MDA §360k(a) | Waltenburg alleges defects/ breaches that parallel PMA requirements and federal reporting duties; pleads specifics about manufacturing deviations and failure to report | St. Jude argues plaintiffs failed to plead PMA-specific deviations and state duties would add to or conflict with federal requirements, so claims are preempted | Court: Counts I (strict manufacturing defect) and II (negligent manufacture) survive at pleading stage as parallel claims; may revisit at summary judgment after discovery |
| Required pleading specificity to avoid MDA preemption | Plaintiffs need not identify exact confidential PMA provisions pre-discovery; factual allegations about deviations suffice | Defendants urge Eleventh Circuit–style requirement to plead particular PMA violations | Court: adopts a middle view — plaintiffs pleaded sufficiently specific factual allegations; Bausch reasoning persuasive; dismissal denied |
| Failure-to-warn/ post-approval reporting claim preempted? | Plaintiffs: duty-to-warn includes ongoing duty to monitor/report; parallel to FDA reporting obligations, so not preempted | Defendants: federal reporting to FDA is not the same as state-law duty to warn; claim conflicts or is impliedly preempted (Buckman) | Court: Count IV not expressly or impliedly preempted at this stage; negligence-based failure-to-warn parallel to federal reporting survives pleading stage |
| Negligence per se based on federal regs cognizable under Kentucky law? | Plaintiffs pleaded violations of federal regs as negligence per se standard | Defendants: Kentucky does not recognize negligence per se based on federal statutes/regulations | Court: Granted dismissal of Count III — Kentucky law limits KRS 446.070 to state statutes, not federal law |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (state-law torts that "parallel" federal requirements avoid MDA preemption)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) (fraud-on-the-FDA claims are impliedly preempted as interfering with federal enforcement)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (MDA §360k expressly preempts state requirements that are different from or in addition to federal PMA requirements)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (plaintiff need not plead exact PMA specifics pre-discovery; less demanding pleading at Rule 8 stage)
- Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (requires pleading of specific PMA violations to avoid preemption)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (synthesizes approaches: key is alleging a manufacturing defect caused by violation of federal requirements and connecting it to plaintiff’s injury)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (failure-to-warn claim premised on state law may survive implied preemption; distinguishes Buckman)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc) (negligent failure-to-warn based on state duty that parallels FDA reporting survives preemption challenge)