Scovil v. Medtronic, Inc.
995 F. Supp. 2d 1082
D. Ariz.2014Background
- Two brothers (Brett, Nevada; Leigh, Arizona) had Medtronic INFUSE Bone Graft implanted in separate spinal surgeries and allege off-label use caused bone overgrowth, pain, and nerve damage.
- INFUSE is a Class III device approved via PMA; FDA labeling approved use in specified spinal procedures and required reporting and approval for changes. Plaintiffs allege extensive off-label promotion by Medtronic to increase sales.
- Plaintiffs asserted ten state-law claims (manufacturing defect, failure to warn, design defect, negligence, fraud, intentional misrepresentation, Arizona unfair competition, breach of warranties, negligence per se, strict liability) tied to alleged off-label promotion and concealment of risks.
- Defendants moved to dismiss under Rule 12(b)(6) as preempted by the MDA/FDA scheme, to sever the two plaintiffs, and to transfer Brett’s case to Nevada. The court first resolved preemption.
- The court found most claims preempted (manufacturing, design, failure to warn, negligence as to manufacture/design/labeling, strict liability, warranties) but allowed state-law claims tied to off-label promotion, fraud, and intentional misrepresentation to proceed; it severed the plaintiffs and transferred Brett’s case to the District of Nevada.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims challenging device safety/design/manufacture are preempted by 21 U.S.C. § 360k when device received PMA | Scovil: state tort duties (manufacturing, design, strict liability) enforce traditional state protections and can proceed | Medtronic: PMA imposes device-specific federal requirements; state claims would add or conflict and are preempted (Riegel) | Dismissed: manufacturing, design, and strict liability claims preempted |
| Whether failure-to-warn and nondisclosure claims based on allegedly insufficient warnings about off-label risks are preempted | Scovil: failure to warn of dangers from off-label use is actionable under state law given off-label promotion | Medtronic: requiring additional warnings imposes requirements beyond FDA labeling and is expressly preempted (Perez) | Dismissed: failure-to-warn nondisclosure claims preempted |
| Whether claims rooted in alleged off-label promotion, fraud, and intentional misrepresentation survive preemption and meet pleading standards | Scovil: Medtronic knowingly promoted off-label uses and concealed safety data, causing physicians to use the device off-label; these are traditional state-law wrongs | Medtronic: such claims either conflict with federal scheme or are not pled with Rule 9(b) particularity | Allowed to proceed: claims based on off-label promotion, fraud, and intentional misrepresentation survive preemption; court finds fraud pled with sufficient particularity |
| Whether the two plaintiffs should be tried together and whether Brett’s case should be transferred to Nevada | Scovil: joinder is proper; Brett prefers Arizona forum | Medtronic: surgeries occurred in different states with different witnesses/laws; Brett is Nevada resident so transfer is proper | Severed the claims (joinder improper); transferred Brett’s severed case to District of Nevada |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA process creates device-specific federal requirements that can preempt state tort claims challenging safety/effectiveness)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law "fraud-on-the-FDA" claims are impliedly preempted because they intrude on federal enforcement scheme)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) clearance does not create device-specific federal requirements; some state-law claims may survive if they parallel federal requirements)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (post-PMA failure-to-report claims to FDA may survive preemption where state law parallels federal reporting duties)
- Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013) (claims seeking additional disclosure about PMA scope are preempted; off-label promotion alone did not save nondisclosure claims)
- Ramirez v. Medtronic, Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013) (district court held many off-label-promotion-based claims not preempted; discussed limits of § 360k where defendant allegedly violated federal law by promoting off-label uses)