Caplinger v. Medtronic, Inc.
2013 U.S. Dist. LEXIS 16047
| W.D. Okla. | 2013Background
- Plaintiff underwent a posterior lumbar interbody fusion at L5-S1 in Aug 2010 using the Infuse Device.
- Postoperative symptoms returned with a right drop foot, attributed to exuberant bone growth from Infuse, leading to a revision in Sept 2011 and ongoing progression.
- Infuse is a Class III medical device approved by the FDA via PMA; FDA approvals cover anterior lumbar use, not posterior; PMA process governs labeling and safety standards.
- Plaintiff filed a June 4, 2012 complaint and an amended complaint asserting seven claims including fraud, strict liability, breach of warranty, and negligence.
- Defendants moved to dismiss under Rule 12(b)(6) arguing express and implied preemption under the MDA (29 U.S.C. § 360k) and Buckman, seeking dismissal with prejudice.
- Court analyzes preemption framework, the PMA process, and whether alleged off-label promotion affects preemption, ultimately granting dismissal of all claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted under § 360k(a). | Claims parallel FDA requirements; not preempted because they involve off-label use and independent tort duties. | All claims seek FDA-labeling, design, manufacturing, or off-label promotion duties that are preempted. | Claims preempted under § 360k(a). |
| Whether Buckman implied preemption bars off-label promotion theories. | Buckman does not bar parallel off-label conduct claims; they are traditional tort claims. | Off-label promotion claims rely on FDCA violations and are impliedly preempted or barred by § 337(a). | Buckman implied preemption applies; claims predicated on off-label promotion barred. |
| Whether plaintiff’s fraud, negligence, and warranty claims survive as parallel claims. | Some claims are traditional state torts and warranty claims not preempted by FDA regulations. | Parallel claims are not genuine equivalents and would require different labeling or marketing duties. | Most claims dismissed as preempted; parallel claims not sustained. |
| Whether off-label promotion allegations affect preemption analysis of other claims. | Promotional conduct outside FDA approvals should negate preemption for certain claims. | Preemption analysis focuses on device-wide requirements, not uses or promotions. | Off-label promotion does not defeat preemption; device-wide preemption remains. |
| Whether discovery is necessary to resolve preemption issues. | Need extensive discovery into off-label marketing and warnings. | Preemption is a question of law, suitably decided on dismissal without discovery. | Discovery not necessary; motion to dismiss properly resolves the issue. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMA imposes federal requirements; state duties must be parallel to avoid preemption)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (FDCA enforcement exclusively by federal government; private FDCA claims barred)
- Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (parallel claims require genuinely equivalent federal and state requirements)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (explains express vs. implied preemption interplay for medical devices)
- Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) (narrow Buckman/§360k(a) framework; parallel vs. conflicting theories)