494 F.Supp.3d 461
S.D. Ohio2020Background
- Plaintiff Seravea Mories had a Boston Scientific SCS 1132 spinal cord stimulator implanted in Nov. 2017; it functioned ~6 months, then caused sporadic painful shocks and was removed.
- Mories sued in Ohio state court alleging design/manufacture defect, failure to warn, negligent handling, breach of express/implied warranties, negligent/fraudulent misrepresentation, and failure to report; case removed to federal court.
- The SCS 1132 is a Class III device that received FDA PMA (original PMA in 2004; model supplement in 2012).
- Boston Scientific moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing MDA express preemption (§ 360k) and insufficient pleading.
- The court took judicial notice of FDA materials and applied the Riegel two‑part preemption framework and Twombly/Iqbal pleading standards.
- Ruling: dismissal granted in part and denied in part — Counts 3 (negligent handling), 5 (negligent/fraudulent misrepresentation), and 6 (failure to report) dismissed; Counts 1 (design/manufacture), 2 (failure to warn), and 4 (express and implied warranties) survive the motion to dismiss.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether MDA (§ 360k) preempts state tort claims | Mories alleges parallel claims grounded on violations of FDA requirements and regulations | Boston Scientific contends PMA establishes federal requirements and most state claims are preempted unless truly parallel | Court applied Riegel; some claims plausibly plead as parallel and survive; others preempted/dismissed |
| Design & manufacturing defect (Count 1) | Device deviated from PMA specs and FDA requirements, causing shocks | Claim would second‑guess FDA PMA unless tied to failure to follow PMA/specs | Survives at pleading stage as a possible parallel claim tied to non‑compliance with PMA/specs |
| Failure to warn (Count 2) | Company failed to warn physicians/patient of known post‑approval risks | If claim targets FDA‑approved labeling it is preempted; post‑approval failure‑to‑warn based on new info is not | Survives; court allowed theory premised on post‑approval failure to warn, but pre‑approval labeling challenges would be preempted |
| Negligent handling/distribution (Count 3) | Alleged inadequate distribution/handling procedures violating 21 C.F.R. Part 820 | No parallel Ohio private cause of action and MDA does not create a private right to enforce FDA regs | Dismissed — no cognizable parallel state claim and no private cause of action under MDA/FDA regs |
| Express & implied warranties (Count 4) | Warranties and marketing representations promise device safety/effectiveness | PMA approval forecloses contradicting federal safety/effectiveness findings | Express warranty claims survive to extent they rest on independent, non‑PMA representations; implied warranty survives past pleading but may be vulnerable later |
| Fraudulent/negligent misrepresentation (Count 5) | Reliance on defendant’s safety/effectiveness statements caused harm | Misrepresentation/fraud must be pled with particularity; many statements are FDA‑approved and preempted | Dismissed for failure to plead fraud with Rule 9(b) particularity and preemption concerns |
| Failure to report (Count 6) | Company failed to report device malfunctions/adverse events to FDA | No parallel Ohio reporting cause of action; Buckman precludes ‘fraud‑on‑the‑FDA’ claims | Dismissed — no state parallel reporting duty identified and preemption/implied preemption problems |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA‑approved device requirements preempt state-law requirements that are different or additional)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (MDA does not preempt most general common‑law duties; distinction between PMA and non‑PMA devices)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law fraud‑on‑the‑FDA claims are impliedly preempted)
- Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000) (distinguishes inadequate pre‑approval labeling claims from post‑approval failure‑to‑warn based on new information)
- Hawkins v. Medtronic, Inc., 909 F. Supp. 2d 901 (S.D. Ohio 2012) (permissive pleading approach for parallel‑claim allegations at motion‑to‑dismiss stage)
- Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016) (stricter pleading approach for MDA preemption at dismissal stage)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (to plead a parallel PMA claim plaintiff must point to specific PMA requirements allegedly violated)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (deviation from FDA‑approved procedures can support a non‑preempted parallel claim)
- Martin v. Telectronics Pacing Sys., 105 F.3d 1090 (6th Cir. 1997) (state claims that would impose different labeling requirements are preempted)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (6th Cir. 2011) (discusses reporting duties and related preemption considerations)