Schouest v. Medtronic, Inc.
13 F. Supp. 3d 692
S.D. Tex.2014Background
- The FDA granted PMA (premarket approval) to Medtronic’s INFUSE Bone Graft for a limited anterior lumbar single‑level fusion using the LT‑CAGE and rhBMP‑2; PMA labeling is fixed absent FDA permission to change.
- Medtronic allegedly promoted INFUSE for widespread off‑label spinal uses (including posterior approaches and different cages), paid key opinion leaders, and obtained substantial revenue from off‑label use.
- Plaintiff Susan Schouest underwent an off‑label posterior multilevel fusion using INFUSE and later developed bony overgrowth and related injuries; she sued Medtronic in Texas state court asserting negligence, strict liability, breach of warranty, fraud, and consumer‑protection claims.
- Medtronic moved to dismiss under Fed. R. Civ. P. 12(b)(6) chiefly on grounds of federal preemption (express under the MDA and implied under Buckman), statute of limitations, and Rule 9(b) particularity.
- The district court held that failure‑to‑warn, design defect/strict liability, and implied warranty claims were preempted and dismissed with prejudice; claims alleging affirmative, false off‑label promotion (fraud, negligent misrepresentation, express warranty, and certain consumer‑protection claims) could survive preemption but must satisfy Rule 9(b); plaintiff was granted leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under MDA (Riegel) | Schouest: many claims are parallel to federal law or rest on off‑label promotion misconduct, so they aren't preempted | Medtronic: PMA imposes federal requirements; state duties that add or differ are preempted | Failure‑to‑warn, design defect, strict liability, implied warranty claims are expressly preempted; some express‑warranty/ fraud claims may survive |
| Implied preemption (Buckman) | Schouest: fraud/ misrepresentation claims arise from ordinary state tort duties that exist independent of FDCA | Medtronic: claims seeking to enforce FDCA/regulatory scheme are impliedly preempted; off‑label claims are essentially enforcement of FDCA | Buckman does not bar ordinary common‑law fraud/ misrepresentation claims that would exist absent the FDCA; Buckman only preempts claims that exist solely by virtue of federal regulation |
| Lawfulness/status of off‑label promotion under federal law | Schouest: off‑label promotion can be actionable under state law when misleading or false | Medtronic: off‑label promotion conflicts with FDA regime and is preempted; some argue even truthful promotion is prohibited federally | Court: federal law forbids false or misleading off‑label promotion; truthful promotion's status is unsettled, but only misleading promotion aligns with federal prohibitions and can avoid express preemption |
| Failure‑to‑warn vs affirmative misrepresentation | Schouest: Medtronic should have warned more and/or made truthful representations about risks | Medtronic: requiring additional warnings or different design would conflict with FDA‑approved labeling (Riegel) | Failure‑to‑warn and design/change claims are preempted; affirmative fraud/ misrepresentation claims based on allegedly false off‑label promotion can survive |
| Statute of limitations / discovery rule | Schouest: discovery rule and fraudulent concealment tolled accrual until she discovered injury/causation | Medtronic: claims accrued earlier and are time‑barred | On Rule 12 record, court declined to dismiss on limitations because plaintiff plausibly pled discovery rule; factual record required |
| Rule 9(b) particularity for fraud‑based claims | Schouest: some details are peculiarly within Medtronic’s control; requests leave to replead | Medtronic: fraud claims lack the who/what/when/where/how required by Rule 9(b) | Court: fraud claims are subject to Rule 9(b); plaintiff given leave to amend to meet particularity (or explain why relaxed pleading applies) |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (PMA approvals preempt state requirements that are different from or in addition to federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state-law claims that exist solely by virtue of FDCA disclosure requirements are impliedly preempted)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir.) (post‑approval failure to report adverse events claim may survive Buckman)
- United States v. Caronia, 703 F.3d 149 (2d Cir.) (discusses FDA view that off‑label promotion can be misbranding and addresses First Amendment limits on criminalizing truthful promotion)
- Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal.) (distinguishes failure‑to‑warn/preemption from fraud‑based claims; false off‑label promotion can avoid preemption)
- Ramirez v. Medtronic, Inc., 961 F. Supp. 2d 977 (D. Ariz.) (addressing preemption in INFUSE cases and holding many claims survive where off‑label promotion alleged)