Hafer v. Medtronic, Inc.
99 F. Supp. 3d 844
W.D. Tenn.2015Background
- This is an order granting defendants’ motion to dismiss the Master Complaint with leave to amend certain deficiencies.
- Plaintiffs allege off-label promotion of Infuse Bone Graft/LT-Cage device components caused injuries.
- Infuse is a Class III device approved via PMA; its components include BMP, a sponge-like carrier, and LT-Cage.
- Plaintiffs contend the Cage components (Class II) were used off-label and promoted in a way not covered by PMA.
- Court addresses express and implied preemption under 21 U.S.C. § 360k(a) and § 337(a) and analysis of device-specific PMA requirements.
- Court ultimately dismisses several claims as preempted while allowing amendment for some claims to address pleading deficiencies.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether fraud claims are preempted by the MDA | Plaintiff Hafer argues some fraud claims are parallel to federal law and not preempted | Defendants contend fraud claims tied to FDA labeling are preempted | Partially not preempted for off-label promotion; labeling-based fraud preempted. |
| Whether failure-to-warn claims are preempted | Plaintiffs claim Defendants failed to warn about off-label risks | Warnings were approved by FDA and not subject to state-law variation | Express preemption; claim dismissed. |
| Whether design-defect claims are preempted | Plaintiffs allege BMP/Sponge design was defective | Design defect claims would contradict FDA PMA requirements | Express preemption; design defect claim dismissed. |
| Whether negligent misrepresentation claims survive preemption | Misrepresentations in off-label promotion may survive | Off-label context implicated by preemption; misrepresentation may be preempted | Not preempted; requires particularity; leave to amend., |
| Whether negligence and warranty claims survive preemption | Plaintiffs may recover for negligence and warranties not tied to FDA labeling | Many theories would be impliedly preempted; some warranties may be voluntary | Negligence claim largely preempted; express/implied warranty claims tied to FDA label preempted; limited to standalone warranties with proper pleading; leave to amend. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMA vs 510(k) regime; preemption framework for devices)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (FDCA premarket review and device regulation)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (Implied preemption; enforcement by federal government only)
- Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013) (Express preemption and parallel claims analysis)
- Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (Implied preemption and Buckman framework)
- Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692 (S.D. Tex. 2014) (Preemption applied to design/marketing claims in device cases)