Houston v. Medtronic, Inc.
957 F. Supp. 2d 1166
D. Cal.2013Background
- Plaintiff Jennifer Houston sues Medtronic for injuries from Infuse Device used off-label in lumbar fusion.
- Infuse Device is a Class III device with LT-Cage and InFUSE Bone Graft; FDA labeling restricts use to anterior lumbar spine with LT-Cage.
- FDA PMA approved on July 2, 2002; labeling and PMA regulate device use, making off-label use nonconforming to the label.
- Plaintiff underwent posterior L4-L5-S1 fusion in 2008 using Infuse off-label (posterior approach, no LT-Cage).
- Plaintiff alleges Defendants misrepresented risks, promoted off-label use, and failed to warn; sues for six causes of action; court grants dismissal with leave to amend.
- Court analyzes MDA preemption framework, concluding some claims are expressly impliedly preempted and others require pleading deficiencies.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the claims are expressly preempted under §360k(a) | Plaintiff asserts state duties parallel FDA requirements. | Defendants contend state claims add to federal requirements. | Express preemption applies to several claims (warnings, design) under §360k(a). |
| Whether strict liability failure-to-warn is preempted | Failure to warn claims rely on state law beyond FDA labeling. | FDA labeling governs warnings; state duty cannot add. | Expressly preempted. |
| Whether design-defect and related negligence claims are preempted | Design defect/NEGLIGENCE based on state duties. | These claims would require different or additional FDA-mandated requirements. | Expressly preempted for design defect; negligence on off-label promotion largely preempted Buckman grounds. |
| Whether fraud-based claims are preempted or require Rule 9(b) pleading | Claims allege misrepresentation/mispromotion related to off-label use. | Some claims parallel federal law; others may be impliedly preempted. | Fraud-based claims not preempted on parallel theory but dismissed for failure to plead with Rule 9(b) particularity. |
| Whether breach of express warranty claim is preempted or sufficiently pled | Defendants allegedly made off-label warranties. | Warranties could be at issue under state law without adding to federal requirements. | Not preempted; dismissed for lack of facts showing notice and specific warranties to Plaintiff. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption for FDA-approved device requirements; PMA imposes device-specific federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (implied preemption for fraud-on-FDA claims; federal scheme supremacy)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (parallel claims require true equivalence to avoid preemption; en banc discussion on adverse-event reporting)
- Perez v. Nidek Co., Ltd., 711 F.3d 1109 (9th Cir. 2013) (parallel claims analysis; off-label-use context and FDA regulations)
- Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009) (negligence claims may survive if grounded in traditional state duties; distinguish preemption)