896 F. Supp. 2d 694
W.D. Tenn.2011Background
- Defendant argues Plaintiffs’ claims are preempted by federal law governing medical devices, guided by Riegel, Buckman, and Medtronic v. Lohr and Sixth Circuit precedents (Howard, Kemp, Cupek).
- The court delineates claims preempted by FDA regulatory requirements (PMA-related) and those not preempted (manufacturing/design deviations and CGMP testing under 21 C.F.R. § 820.30(g)).
- Plaintiffs’ PMA-related theories include failure to submit PMA Supplement for the HiRes90K with AstroSeal feedthru and failure to report the AstroSeal change in annual reports; both are characterized as impliedly preempted, i.e., disguised fraud-on-the-FDA claims.
- Claims premised on adulteration/misbranding under 21 U.S.C. § 351 are also impliedly preempted.
- Plaintiffs’ claims based on alleged deviation from PMA Supplement 30 and CGMP testing under 21 C.F.R. § 820.30(g) may survive as parallel claims, because some CGMPs impose substantive standards beyond PMA.
- Other CGMP allegations (e.g., §§ 820.20, 820.80, 820.100, 820.198) are too generic to support parallel claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| PMA submission and annual-report violations preemption | Plaintiffs rely on PMA and annual-report requirements to support claims. | Violations are impliedly preempted as fraud-on-the-FDA or administrative requirements. | Implied preemption applies. |
| Adulteration/misbranding claims preemption | HiRes90K with AstroSeal feedthru was adulterated/misbranded under 21 U.S.C. § 351. | These are impliedly preempted as fraud-on-the-FDA. | Implied preemption applies. |
| Deviation from PMA 30 and survival as parallel claim | Deviation from PMA Supplement 30 constitutes a parallel claim not preempted. | Modifications require FDA approval and may be preempted unless they do not affect safety/efficacy. | Not preempted; survives as a parallel claim. |
| CGMP testing under 21 C.F.R. § 820.30(g) preemption | Failure to test under actual/simulated use supports a claim under CGMP. | CGMP testing is a design/quality requirement that may be preempted only if it mirrors PMA. | Not preempted; admissible as a parallel claim. |
| Other CGMP regulations as basis for parallel claim | Regulations like §§ 820.20, 820.80, 820.100, 820.198 support parallel claims. | These regulations are too generic to support parallel claims. | Unable to support parallel claims based solely on these CGMPs. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption for PMA-specific requirements; parallel claims possible for FDA-regulatory violations)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (U.S. 2001) (implied preemption for fraud-on-the-FDA under 337(a))
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (FDA approval pathways and device regulation framework)
- Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436 (6th Cir. 2010) (CGMPs may impose additional requirements beyond PMA; some may support parallel claims)
- Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005) (negligence per se and fraud-on-the-FDA considerations; preemption analysis)
- Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000) (design/manufacturing/labeling interplay with FDA approvals; PMA compliance scope)
- In re Medtronic Sprint Fidelis Leads Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009) (CGMPs and manufacturing-defect claims; preemption context)
- In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (adverse event reporting preemption under Buckman framework)