Blankenship v. Medtronic, Inc.
6 F. Supp. 3d 979
E.D. Mo.2014Background
- Medtronic manufactures Infuse Bone Graft/LT-CAGE device for spinal fusion; Infuse received FDA PMA in 2002 and a 2003 supplemental approval for use with INTERFIX Cage.
- Plaintiff underwent cervical diskectomy and fusion in 2007 using an Infuse graft with a cage not LT/INTERFIX; she alleges post-surgical pain and disability.
- Plaintiff claims Medtronic promoted off-label use of Infuse, contrary to FDA indications, through pricing and sales tactics.
- Plaintiff asserts nine claims, including manufacturing/design defects, negligence, strict liability, fraud, negligent misrepresentation, and California UCL; Missouri plaintiff asserts claims are preempted under MDA (21 U.S.C. §§ 360k(a), 337(a)).
- Court analyzes express and implied preemption under Riegel and Buckman, focusing on whether a specific federal violation is pled and whether state claims are truly parallel to FDA requirements.
- Court may consider Exhibits 1-6 (FDA approvals) for judicial notice; off-label use is defined as use contrary to FDA-approved indications.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the claims are expressly or impliedly preempted. | Plaintiff argues some state claims parallel FDA requirements. | Medtronic argues a broad preemption regime bars state claims. | Yes; most claims preempted; fraud claims potentially parallel but require Rule 9(b) specificity. |
| Whether plaintiff pled a specific federal violation to support preemption analysis. | Plaintiff cites off-label promotion and misbranding theories. | Defendant contends off-label promotion is not a federal violation. | Second amended complaint alleges a specific federal misbranding violation; sufficient pleaded facts for preemption analysis. |
| Whether Counts One, Three, Five are preempted as manufacturing/design defects. | Alleges nonconformance with FDA PMA specifications. | Such claims would impose state duties beyond federal requirements. | Preempted under § 360k(a) as they seek design/manufacturing fault beyond FDA-approved parameters. |
| Whether Counts Two, Four, Seven are preempted as failure to warn, negligence, negligence per se. | Claims based on deeper state duties to warn or be negligent. | Off-label promotion falls under FDCA; state duties would diverge from federal requirements. | Counts Four and Seven impliedly preempted; Count Two preempted; fraud-based negligence claims dismissed or limited. |
| Whether Counts Six, Eight (fraud/intentional misrepresentation) survive under Rule 9(b) pleading. | Plaintiff alleges multiple misrepresentations by Medtronic. | Claims lack particularity under Rule 9(b). | Dismissed for lack of Rule 9(b) specificity; without prejudice, give leave to amend. |
| Whether Count Nine (California UCL) survives given plaintiff’s domicile/aspect. | UCL cannot be maintained by non-Californian plaintiff. | Dismissed with prejudice. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption framework for medical devices; FDA PMA as federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (no private right to enforce federal FDCA; preemption by Buckman)
- In re Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) (parallel claims must be genuinely equivalent; avoid off-label-only theories)
- Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) (fraud-based and off-label claims; preemption analysis for state claims)
- Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp. 2d 592 (D. Vt. 2013) (distinguishes CGMP from PMA-specific violations; design/marketing claims)
- Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (parallels to federal requirements; need factual basis for violation)
- Caronia v. United States, 703 F.3d 149 (2d Cir. 2012) (FDA misbranding/promotional considerations; context of criminal case)
- Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013) (preemption; off-label promotion as impliedly preempted)
- Gomez v. St. Jude Medical Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006) (negligence claims tied to FDCA are preempted unless parallel)