616 F. App'x 433
2d Cir.2015Background
- Plaintiff Koleen Otis-Wisher underwent spinal surgery in which her surgeon used Medtronic’s Infuse (an FDA-approved bone fusion device); she later suffered excess bone growth and related symptoms.
- She sued Medtronic asserting eight state-law claims: fraudulent misrepresentation, constructive fraud, consumer fraud (Vermont Consumer Protection Act), negligence, negligent misrepresentation, strict liability (design defect, manufacturing defect, failure to warn).
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6); the District Court granted the motion and entered judgment for defendants.
- On appeal, the Second Circuit reviewed dismissal de novo under Twombly/Iqbal pleading standards.
- The court focused on federal preemption under the Medical Device Amendments (21 U.S.C. § 360k) for safety/labeling claims and on Rule 9(b) particularity for fraud-based claims.
- The court affirmed: safety/labeling claims were preempted; manufacturing-defect allegation was conclusory; fraud claims failed Rule 9(b); the Vermont consumer-protection claim failed because plaintiff was not a statutory "consumer."
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law design/failure-to-warn claims are preempted by the FDCA/Medical Device Amendments | Otis-Wisher argued state common-law duties can support her safety/labeling claims | Medtronic argued § 360k preempts state-law requirements that are different from or in addition to FDA requirements | Held: design and failure-to-warn claims are expressly preempted under § 360k (Riegel controlling) |
| Whether strict-liability manufacturing-defect claim survives | Plaintiff alleged a manufacturing defect caused her injuries | Medtronic contended claim was conclusory and insufficiently pleaded | Held: manufacturing-defect claim is conclusory and dismissed for failure to plead plausible factual support |
| Whether fraud/off-label promotion claims survive preemption and pleading standards | Plaintiff alleged misleading off-label promotion caused injury | Medtronic argued such claims are preempted or inadequately pleaded | Held: court did not decide preemption for fraud claims but dismissed them for failure to meet Rule 9(b) particularity requirements |
| Whether plaintiff qualifies as a "consumer" under the Vermont Consumer Protection Act | Otis-Wisher claimed consumer-protection remedy for misleading conduct | Medtronic argued she did not "purchase" or "agree to pay" for Infuse and thus is not a consumer | Held: plaintiff is not a statutory "consumer" (Infuse was prescribed, not purchased by plaintiff); claim dismissed |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (federal preemption of state requirements for FDA-approved medical devices)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (state-law claims survive preemption only if identical to federal requirements)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (application of plausibility standard to pleadings)
- Carpenters Pension Trust Fund v. Barclays PLC, 750 F.3d 227 (de novo review standard for Rule 12(b)(6) dismissal)
- Fin. Guar. Ins. Co. v. Putnam Advisory Co., 783 F.3d 395 (Rule 9(b) particularity requirements)
- Doninger v. Niehoff, 527 F.3d 41 (appellate court may affirm on any ground in the record)
- United States v. Caronia, 703 F.3d 149 (FDCA does not itself prohibit off-label promotion)
- Caplinger v. Medtronic, Inc., 784 F.3d 1335 (questioning viability of state off-label promotion claims under § 360k)