Norabuena v. Medtronic, Inc.
2017 IL App (1st) 162928
Ill. App. Ct.2017Background
- Senayda Norabuena underwent spinal surgery in 2012 using Medtronic’s Infuse device off-label (posterior, multi‑level, without the device’s metal cage); she later developed heterotopic (ectopic) bone formation and continued pain.
- Infuse is a Class III, FDA premarket‑approved device; FDA approval included labeling limiting use to one spinal level and an anterior approach and warning about ectopic bone with posterior/non‑cage use.
- Plaintiffs sued Medtronic for strict liability and negligence (failure to warn) and the husband for loss of consortium, alleging Medtronic promoted off‑label uses, omitted material risk information, and failed to report adverse events to the FDA.
- Medtronic moved to dismiss under 735 ILCS 5/2‑619(a)(9), arguing federal preemption (21 U.S.C. § 360k(a) and § 337(a)); the trial court granted dismissal.
- The appellate court held the plaintiffs’ failure‑to‑warn claims are not preempted to the extent they allege misbranding (omission of material risks in promotional materials) but found the complaint failed to plead proximate causation, so dismissal should have been without prejudice and remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state failure‑to‑warn and misbranding claims are preempted by 21 U.S.C. § 360k(a) and § 337(a) | Norabuena: claims parallel federal duties (reporting adverse events; prohibition on misbranding) and thus are not preempted | Medtronic: state claims would impose requirements different from or additional to federal requirements and thus are preempted | Not preempted insofar as claims parallel federal misbranding/omission duties; otherwise preempted unless a parallel regulation is identified |
| Whether Buckman implied‑preemption bars claims premised solely on FDCA violations | Plaintiffs: claims are common‑law duties parallel to (not solely created by) FDCA duties | Medtronic: claims rest on violations of federal reporting/approval regime and thus are preempted under Buckman | Buckman bars claims that exist solely by virtue of FDCA violations; here misbranding‑parallel common‑law claims survive Buckman analysis |
| Whether plaintiffs pleaded a viable failure‑to‑warn claim under Illinois law (including proximate causation) | Plaintiffs: pleaded widespread promotional omissions and causation in boilerplate language | Medtronic: complaint is conclusory and fails to allege that the treating surgeon relied on or encountered Medtronic’s promotional materials | Complaint failed to plead facts showing the surgeon encountered/relied on Medtronic’s promotions; proximate causation not adequately alleged |
| Remedy for pleading defects—dismissal with or without prejudice | Plaintiffs: if insufficient, should get leave to amend | Medtronic: dismissal proper (trial court dismissed with prejudice) | Dismissal warranted on pleading grounds but should be without prejudice; plaintiffs may amend to allege causation |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (state tort claims are not always preempted; claims that impose duties parallel to federal requirements may proceed)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA process establishes federal "requirements" and § 360k(a) preempts state requirements that are different or additional)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) (FDCA enforcement intended to be by federal government; state claims that exist solely by virtue of FDCA violations are preempted)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (failure‑to‑warn claim premised on violation of FDA reporting requirements not preempted under both express and implied preemption theories)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (state negligence claim for failing to disclose post‑approval risks to FDA was parallel to federal duties and not preempted)
- Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015) (claims broader than federal labeling/advertising rules are preempted; prescription‑device labeling rules limit applicability of certain FDA regulations to preempt state claims)