38 F. Supp. 3d 1061
W.D. Mo.2014Background
- Infuse is a two-component spinal fusion device (Infuse Bone Graft and LT-Cage) approved by the FDA in 2002 for single-level anterior lumbar fusions within L4-S1, with off-label use prohibited by labeling.
- Plaintiff underwent a 2006 TLIF at L4-L5 using Infuse via a posterior approach without LT-Cage, an off-label use promoted by Defendants’ representatives.
- Plaintiff sues for eleven claims, including manufacturing/design defects, failure to warn, negligence, strict liability, breach of express warranty, multiple fraud theories, misrepresentation, negligence per se, and MMPA violations.
- Defendants move to dismiss under Rule 12(b)(6), arguing express and implied preemption under the MDA/FDCA and other independent grounds.
- The court engages in the Riegel two-step express preemption analysis and evaluates implied preemption and parallel/federal-law claims, denying some claims and granting others.
- Count Eleven (MMPA) survives in part; most other claims are preempted or dismissed for failure to plead with particularity as required under Rule 9(b).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are Counts One–Three expressly preempted by the MDA/Riegel analysis? | Plaintiff asserts manufacturing, design, and warning claims defy federal requirements and are not parallel. | Defendants contend the claims seek requirements beyond FDA-approved specifications and are thus expressly preempted. | Counts One–Three expressly preempted. |
| Do any negligence theories survive preemption, including off-label promotion? | Plaintiff argues Defendants’ promotion and related duties violate state law and parallel federal requirements. | Defendants maintain these theories conflict with federal requirements or are impliedly preempted. | First negligence theory (off-label promotion) survives implied preemption but is barred; other theories expressly/impliedly preempted. |
| Is Count Six (express warranty) preempted or adequately pleaded? | Defendants’ warranties regarding off-label use are alleged to have induced purchase. | Preemption and pleading standards bar recovery due to lack of fact-specific warranties. | Count Six escapes preemption but lacks sufficient facts; dismissed for failure to plead binding warranties. |
| Do fraud-based claims (Counts Seven–Nine) survive preemption and are they pleaded with particularity? | Fraud claims are parallel to federal requirements and not preempted; they allege misrepresentations/omissions. | Must be pleaded with specificity and tied to particular misrepresentations; may be preempted if solely federal requirements drive the claim. | Fraud claims survive preemption but are dismissed for lack of Rule 9(b) particularity. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (two-step express preemption test for medical device claims)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (implied preemption where claims exist solely by virtue of federal requirements)
- United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (FDA regulation interpretation and related activities)