77 F. Supp. 3d 809
E.D. Wis.2015Background
- Medtronic’s Infuse device is a Class III, FDA-premarket-approved combination device (spinal cage + bone graft component) approved for anterior lumbar fusion at L4–S1; FDA labeling forbids use of the bone graft component alone or at other spinal locations/approaches.
- In 2008 plaintiff underwent posterior L1–L2 surgery in which the surgeon implanted only the bone graft component (an off-label use); she later developed excess bone growth and alleges injury from that use.
- Plaintiff alleges Medtronic promoted off-label posterior and single-component uses, paid opinion leaders to downplay risks, discouraged/failed to report adverse events, and thus violated federal law and various state tort duties (fraud, negligent misrepresentation, negligence, strict products liability—failure to warn and design defect, and breach of warranties).
- Medtronic moved to dismiss primarily on preemption grounds (express and implied), statute of limitations, failure-to-warn doctrines, Rule 9(b) pleading, and other pleading-defect arguments; it also sought dismissal of warranty claims.
- The court took judicial notice of the FDA-approved labeling but declined to take notice of other proffered documents; it denied most of Medtronic’s dismissal arguments and dismissed only the express and implied warranty claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state tort claims are expressly preempted by 21 U.S.C. §360k(a) | Garross argues claims rely on Medtronic’s violation of FDA requirements and seek state remedies, not additional device requirements | Medtronic contends PMA creates federal requirements that preempt state-law claims related to safety/effectiveness | Not preempted: court finds state claims do not impose different or additional requirements and may rely on alleged FDCA violations as evidence under state law |
| Whether state claims are impliedly preempted under Buckman (i.e., are claims solely for FDCA violations) | Garross says claims rest on independent state-law duties (fraud, negligence, failure to warn) even if they invoke federal violations as evidence | Medtronic argues claims merely rest on violations of federal law and are therefore impliedly preempted | Not impliedly preempted: court finds claims arise from independent, well-recognized state duties and are not solely federal-law claims |
| Statute of limitations (Wis. 3‑year rule) | Garross pleads she did not and could not reasonably discover injury until Sept. 11, 2012 | Medtronic says claims accrued earlier and are time-barred | Denied on motion to dismiss: accrual is fact-specific; complaint’s allegation of delayed discovery suffices to survive Rule 12(b)(6) |
| Pleading sufficiency (failure to warn, negligence, fraud, Rule 9(b), warranties) | Garross alleges promotion, misrepresentation, failure to report, and causal link; pleads who/what/when/where/how for fraud | Medtronic says allegations lack detail, learned intermediary/sophisticated user bars, and warranties deficient | Most claims survive: court finds pleadings adequate under Twombly/Iqbal and Rule 9(b); learned intermediary/sophisticated user arguments raise factual issues; warranty claims dismissed for failure to defend those arguments |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA device requirements can preempt state law that imposes different/additional requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (state-law claims that are essentially enforcement of federal requirements are impliedly preempted)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (claims based on alleged FDCA violations may survive preemption where they invoke independent state-law duties)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (§360k preempts different/added requirements but does not bar state remedies for federal-law violations)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (complaint must state a plausible claim to survive dismissal)