Arvizu v. Medtronic Inc.
41 F. Supp. 3d 783
D. Ariz.2014Background
- Defendants Medtronic and Medtronic Sofamor Danek market the Infuse Device, a PMA-approved Class III spinal fusion system comprising an LT‑Cage, rhBMP‑2 bone protein, and an absorbable collagen sponge. The PMA approved the system for a specific procedure in 2002.
- Plaintiffs John and Josephine Arvizu allege the device was promoted for off‑label uses (including use of bone protein without the LT‑Cage), and that Medtronic sales reps and paid consultants actively promoted and assisted in off‑label procedures.
- Mr. Arvizu allegedly underwent a transforaminal lumbar interbody fusion at L5–S1 using the bone protein without the LT‑Cage after surgeon reliance on Defendants’ promotion.
- Plaintiffs asserted claims including fraud/fraud in the inducement, failure to warn, design defect, negligence, breach of express warranty, consumer fraud, loss of consortium, and punitive damages.
- Defendants moved to dismiss under Rule 12(b)(6), arguing express preemption under 21 U.S.C. § 360k (Riegel) and implied preemption for fraud‑on‑the‑FDA (Buckman). The Court granted in part and denied in part, with leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state common‑law claims are expressly preempted by § 360k (Riegel test) | Arvizu: Off‑label use was not covered by federal requirements, so § 360k does not preempt state claims | Medtronic: Federal requirements apply to the device and its components, so § 360k preempts state claims imposing different/additional requirements | Court: § 360k applies to device components (including bone protein); many state claims are preempted, but fraud claims about off‑label promotion survive as parallel claims |
| Whether fraud‑on‑the‑FDA or claims that depend solely on FDCA duties are impliedly preempted (Buckman) | Arvizu: Claims allege traditional state torts (fraud, misrepresentation) and parallel duties, not private enforcement of the FDCA | Medtronic: Some claims (e.g., negligence based on off‑label promotion) seek to enforce federal requirements and are impliedly preempted | Court: Fraud/misrepresentation claims pleaded with particularity are not impliedly preempted; negligence claims that exist solely by virtue of FDCA are impliedly preempted |
| Whether failure‑to‑warn claims survive preemption | Arvizu: Duty to report adverse events and parallel duty to warn the FDA supports nonpreemption | Medtronic: Failure‑to‑warn doctors would impose state requirements beyond the PMA‑approved labeling and is preempted | Court: Failure‑to‑warn claims against doctors are preempted, but a failure‑to‑report‑to‑FDA claim (adverse events) survives at this stage |
| Whether express warranty, design‑defect, consumer fraud, and statute‑of‑limitations issues bar claims | Arvizu: Warranty and other claims are available; discovery rule delays accrual | Medtronic: Design defect and failure‑to‑warn are preempted; warranty fails because no seller‑buyer affirmations to plaintiffs; some claims time‑barred | Court: Breach of express warranty dismissed (no direct seller‑buyer affirmations to plaintiffs); design defect preempted; Consumer Fraud Act claim dismissed as time‑barred; other claims partially survive with leave to amend |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (state tort claims preempted when they impose requirements different from or additional to federal PMA requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (fraud‑on‑the‑FDA claims impliedly preempted because they would supplant federal enforcement)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (state damages remedies may survive when state duties ‘parallel’ federal requirements)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (Ninth Circuit: claims to enforce reporting to FDA can survive; state failure‑to‑warn‑doctors theories are often preempted)
- Perez v. Nidek Co., 711 F.3d 1109 (Ninth Circuit discussion of narrow path for parallel claims under § 360k)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading must state a plausible claim)
- Ashcroft v. Iqbal, 556 U.S. 662 (courts disregard legal conclusions in pleadings)
- United States v. Caronia, 703 F.3d 149 (2d Cir. criminal‑law context about truthful off‑label promotion; distinguished here)