81 F. Supp. 3d 619
W.D. Mich.2015Background
- Defendants designed Infuse, a bioengineered bone graft device used with an LT-CAGE fusion device; FDA PMA approval in 2002 covered anterior lumbar uses with labeling that restricts usage.
- Plaintiff underwent an off-label posterior lumbar surgery in March 2010 using Infuse and allegedly developed ectopic bone growth causing spinal cord compression and pain.
- Plaintiff alleges Defendants misled about off-label risks and actively promoted off-label use, including sponsorship of inaccurate articles.
- Plaintiff filed a three-count Amended Complaint: Failure to Warn (Count I), Negligence/Gross Negligence (Count II), and Breach of Warranty (Count III).
- Defendants moved to dismiss under Rule 12(b)(6) arguing preemption under the Medical Device Amendments (MDA) and other grounds; Michigan law governs, and the court granted the motion to dismiss.
- The court addressed express preemption, implied preemption, and independent grounds, concluding all claims are preempted or insufficiently pled and thus dismissed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under 21 U.S.C. §360k(a) applies to Count I | Plaintiff argues FDA approval does not immunize liability for off-label misrepresentations | Defendants contend claims seek state requirements different from FDA mandates | Count I express-preempted |
| Implied preemption under Buckman for off-label promotion | Plaintiff relies on Buckman to allow state claims arising from off-label conduct | Defendants assert off-label promotion is governed by FDCA and preempts state claims | Counts I (and related mispromotion aspects) impliedly preempted |
| Independent federal/state grounds viability | Plaintiff argues state-law claims survive parallel federal regulation | Claims fail because preemption bars them and no parallel duties remain | Counts I–III dismissed on preemption grounds; no independent grounds salvage claims |
| Breach of Warranty viability given labeling disclaimer | Express warranty plausibly alleged beyond FDA labeling | FDA label disclaims warranties and there is no privity; claims lack specificity | Count III dismissed for lack of specific warranties; not saved by express warranty theory |
| Failure to warn/negligence off-label promotion linked to preemption | Warnings should cover off-label risks notwithstanding FDA labeling | Claims would impermissibly impose duties beyond FDA-approved labeling | Counts I and II dismissed as preempted; Count II also dismissed as impliedly preempted |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (express preemption framework for MDA §360k(a))
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (no private right of action; implied preemption via Buckman)
- Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013) (off-label promotion; preemption analysis expressions in Buckman framework)