Ramirez v. Medtronic Inc.
961 F. Supp. 2d 977
D. Ariz.2013Background
- Plaintiff Cristina Ramirez underwent a posterior lumbar fusion in 2009 in which her surgeon used only the rhBMP-2 component of Medtronic’s Infuse device; she later developed uncontrolled bone growth and nerve-impinging pain allegedly from that use.
- Infuse is a Class III medical device approved by the FDA via PMA for a specific single-level anterior lumbar interbody fusion using all device components; the FDA did not approve the posterior/off-label use at issue.
- Ramirez alleges Medtronic aggressively promoted off-label uses (including via paid consultants and sponsored studies), hid adverse-event information, and failed to report events to the FDA, causing physicians (including her surgeon) to use Infuse off-label.
- Ramirez sued in state court (diversity jurisdiction) asserting six Arizona-law tort claims: fraud/fraud in inducement, failure to warn, defective design, misrepresentation, negligence, and breach of express warranty; Medtronic moved to dismiss and to strike certain judicial-notice materials.
- The core legal question was whether Ramirez’s state-law claims are preempted by the Medical Device Amendments (MDA)/FDCA (21 U.S.C. § 360k) given Infuse’s PMA approval, and whether claims based on manufacturer-promoted off-label use survive preemption and pleading rules.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims premised on injuries from off-label use promoted by manufacturer are preempted under § 360k | Ramirez: claims arise from Medtronic’s unlawful off-label promotion (a new, unreviewed use) so § 360k does not preempt state-law remedies | Medtronic: broad preemption applies because Infuse is PMA-approved; claims would impose requirements different from federal law | Court: majority of claims based on Medtronic’s off-label promotion are not preempted; preemption avoids manufacturers escaping liability when they violate federal law by creating an unreviewed use |
| Whether claims that rest solely on physician’s off-label use (without manufacturer promotion) are preempted | Ramirez: some allegations may overlap but core is manufacturer promotion | Medtronic: such claims attack FDA approval and are preempted | Held: claims premised only on physician off-label use (without promotion) are preempted and dismissed with prejudice (except reporting-to-FDA theory) |
| Whether plaintiff’s fraud/failure-to-warn/misrepresentation/design-defect/negligence claims survive heightened pleading and implied-preemption (Buckman) analysis | Ramirez: claims have independent state-law origins and satisfy Rule 9(b) where fraud alleged; not purely FDCA enforcement | Medtronic: claims are essentially attempts to enforce FDCA/MDA (implied preemption) and are insufficiently particular | Held: Fraud and off-label-promotion-based failure-to-warn, misrepresentation, and design-defect claims survive preemption; fraud pleadings meet Rule 9(b) as to consultant recipients; negligence claim premised solely on federal violations (negligence per se) is impliedly preempted and dismissed with prejudice |
| Whether breach of express warranty claim is sufficiently pleaded and preempted | Ramirez: warranties arose from Medtronic’s promotional statements | Medtronic: even if not preempted, plaintiff cannot show seller-to-buyer affirmation to plaintiff | Held: Warranty claim not preempted as to promotional statements, but dismissed without prejudice for failure to plead that Medtronic’s affirmative statements were made to Ramirez (seller-buyer nexus missing) |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (§ 360k preempts state-law claims that would impose requirements different from or in addition to federal PMA-based requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law claims that rest solely on FDCA violations are impliedly preempted because enforcement is exclusively federal)
- United States v. Lohr, 518 U.S. 470 (1996) (presumption against preemption in device regulation and discussion of parallel/state-law duties)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. en banc 2013) (claims for failure to report adverse events to FDA can survive preemption as parallel claims)
- Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) (claims premised solely on nondisclosure of FDA status and without injury can be preempted; distinguishes manufacturer-promotion contexts)