Otis-Wisher v. Fletcher Allen Health Care, Inc.
951 F. Supp. 2d 592
D. Vt.2013Background
- Plaintiff Koleen Otis-Wisher underwent posterior C1–2 fusion at Fletcher Allen in 2008 using Medtronic’s Infuse (rhBMP) product; she alleges off‑label posterior/cervical use caused exuberant ectopic bone growth and ongoing injury.
- Infuse is a Class III device that received FDA premarket approval (PMA) for a different (anterior lumbar) indication; Medtronic made multiple supplemental PMAs for changes.
- Otis‑Wisher amended her complaint to add claims against Medtronic (fraud, strict liability, negligence, negligent misrepresentation, consumer fraud) and added lack of informed consent and consumer fraud claims against Fletcher Allen.
- Medtronic moved to dismiss under Rule 12(b)(6), arguing MDA preemption, failure to plead parallel federal violations, and inadequate fraud pleading under Rule 9(b); Fletcher Allen moved to dismiss the informed consent and consumer fraud claims as time‑barred or nonactionable.
- The court accepted complaint allegations as true for the motion and analyzed preemption under the Medical Device Amendments (MDA)/Riegel framework and relation‑back under Rule 15(c).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Medtronic’s common‑law claims are preempted by the MDA (PMA) | Otis‑Wisher alleges off‑label promotion/use and failures that caused injury; claims should survive | Medtronic contends PMA creates specific federal requirements that preempt state common‑law duties absent detailed parallel‑law allegations | Dismissed: most common‑law claims preempted because plaintiff failed to allege device‑specific federal violations or parallel requirements |
| Sufficiency of fraud/misrepresentation pleading against Medtronic (Rule 9(b)) | Plaintiff alleges Medtronic sponsored biased studies, concealed risks, promoted off‑label use | Medtronic argues fraud claims lack particularized facts (statements, who, when, where) | Dismissed: fraud claims also fail Rule 9(b) particularity requirements |
| Consumer Fraud Act (Vermont) claim vs. Medtronic — is plaintiff a "consumer"? | Plaintiff treats herself as consumer injured by device implantation | Medtronic argues Infuse is a prescription device provided by physicians, so plaintiff is not a purchaser/consumer under the statute | Dismissed: plaintiff does not fit statutory consumer definition; CFA claim fails against Medtronic |
| Relation back and timeliness of informed consent and CFA claims vs. Fletcher Allen | Otis‑Wisher says claims were filed within limitations after discovery and/or relate back to original malpractice complaint | Fletcher Allen contends late amendment is time‑barred and CFA claim is not a proper vehicle for malpractice | Informed consent claim re: off‑label use relates back and is timely; informed consent claim based on doctor–Medtronic relationship fails on substance; CFA claim against Fletcher Allen dismissed as impermissible repackaging of malpractice |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (preemption under MDA; PMA creates device‑specific federal requirements)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (plausibility pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (application of plausibility standard and context‑specific inquiry)
- Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (district court analysis dismissing similar Infuse/off‑label claims as preempted)
- United States v. Caronia, 703 F.3d 149 (2d Cir.) (observing FDCA does not expressly criminalize off‑label promotion)
- Eternity Global Master Fund Ltd. v. Morgan Guar. Trust Co. of N.Y., 375 F.3d 168 (fraud pleading particularity under Rule 9(b))