863 N.W.2d 404
Minn. Ct. App.2015Background
- Medtronic’s Infuse Bone Graft/LT‑CAGE is a Class III medical device approved by the FDA in 2002 as a three‑component system (LT‑Cage, Infuse Protein, carrier) for specified anterior lumbar uses. The FDA warned safety/effectiveness for other uses/components was not established.
- Plaintiffs are multiple spinal‑surgery patients who allege injury when surgeons used the Infuse Protein apart from the LT‑Cage (off‑label use) after Medtronic allegedly promoted such uses.
- Plaintiffs sued asserting negligence, strict liability, breach of express and implied warranty, fraud (actual and constructive), consumer‑protection and advertising claims, unjust enrichment, negligence per se, and loss of consortium. Claims were consolidated and adjudicated primarily in the Lawrences’ action.
- The district court dismissed many non‑fraud claims as expressly or impliedly preempted by the FDCA/MDA and dismissed fraud claims for failure to plead with particularity under Minn. R. Civ. P. 9.02; plaintiffs amended but some fraud claims again were found insufficient.
- On appeal the court evaluated (1) whether § 360k(a) express preemption or § 337(a) implied preemption barred the state claims, and (2) whether fraud pleadings met Rule 9.02 particularity.
- Holding in part: failure‑to‑warn (to physicians/patients) and design‑defect claims based on off‑label use are preempted; claims based on failure to report adverse events to FDA and breach of express warranty survive preemption and were remanded; fraud claims were dismissed for lack of particularity.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state tort claims (negligence, strict liability, design defect, failure‑to‑warn) are preempted by 21 U.S.C. § 360k(a) | Plaintiffs: FDA approved only the three‑component, labeled use; off‑label uses of Infuse Protein alone are not covered by device‑specific federal requirements, so state law should apply | Medtronic: PMA imposes device‑specific federal requirements on the device/components irrespective of off‑label use; state duties that differ/add to FDA requirements are preempted | Court: Design‑defect and failure‑to‑warn to physicians/patients (based on off‑label use) are preempted; federal PMA requirements apply to the device/components even when used off‑label |
| Whether claims premised on failure to report adverse events to the FDA are preempted | Plaintiffs: Medtronic’s alleged failure to report adverse events is a federal violation but can form the basis of parallel state claims (e.g., failure to warn FDA) | Medtronic: Such claims merely enforce federal law and are impliedly preempted by § 337(a) or are substantively barred by § 360k(a) | Court: Not preempted; claims that Medtronic failed to report adverse events to FDA may survive (must be pleaded with facts linking nonreporting to plaintiffs’ injuries) |
| Whether express‑warranty claims based on off‑label promotional statements are preempted | Plaintiffs: Medtronic voluntarily created express warranties/promotional promises about off‑label uses; such voluntary extra‑label assurances are parallel to federal law and actionable under state law | Medtronic: Warranty claims would conflict with FDA’s approval and are preempted | Court: Express‑warranty claims are not preempted — warranties arise from the manufacturer’s representations and can create parallel state obligations |
| Whether fraud claims were pleaded with the particularity required by Minn. R. Civ. P. 9.02 | Plaintiffs: Amended complaints alleged Medtronic authored/edited articles, used KOLs, paid physicians and reps, concealed adverse events, and had reps in ORs — sufficient to infer fraudulent inducement of surgeons | Medtronic: Pleadings lack specific time/place/content/persons; do not identify the false statements relied upon by treating surgeons | Court: Affirmed dismissal — plaintiffs failed to plead who made what false statements, when, and how surgeons relied; Rule 9.02 particularity not met |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (Plausibly establishes that PMA‑approved Class III devices are subject to device‑specific federal requirements and § 360k(a) can preempt conflicting state law)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (Holds that claims that exist solely to enforce federal regulatory violations are impliedly preempted under the FDCA)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (Explains MDA’s purpose and the scope of federal regulation over medical devices; distinguishes preemption limits)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir.) (Holds that a failure‑to‑report adverse events claim can form a parallel state‑law theory and avoid express preemption)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir.) (Discusses preemption/implied preemption issues for device claims; relied on in district court reasoning)
- Peterson v. Bendix Home Sys., Inc., 318 N.W.2d 50 (Minn. 1982) (States elements of breach‑of‑warranty under Minnesota law and causation requirements)