260 F. Supp. 3d 485
W.D.N.C.2017Background
- Plaintiff received the Essure Class III permanent birth-control device (manufactured/marketed by Bayer) and experienced complications, leading to suit in North Carolina state court in December 2016.
- Plaintiff asserted state-law claims: negligence (failure-to-warn, training, manufacturing), products liability (design/strict liability), breach of express and implied warranty, fraud, unfair/deceptive trade practices (N.C. Gen. Stat. § 75-1.1), and medical malpractice against the implanting physician and clinic.
- Defendants removed to federal court and moved to dismiss; plaintiff filed a motion to reconsider remand denial and for certification to appeal, both denied.
- Essure had FDA premarket approval under the Medical Device Amendments (MDA); 21 U.S.C. § 360k contains an express preemption clause for Class III premarket-approved devices.
- The court analyzed preemption (express and Buckman implied preemption), Rule 12(b)(6) pleading standards (Twombly/Iqbal), and Rule 9(b) for fraud pleading; it found most state-law claims fall into the narrow preemption gap and are preempted.
- The only non-federal claim pleaded was medical malpractice against the physician/clinic; the court declined to exercise supplemental jurisdiction and dismissed that claim without prejudice so it may be reasserted in state court.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted by the MDA/FDCA | Plaintiff contends claims are "parallel" to federal law and therefore not preempted | Bayer argues express preemption under §360k and Buckman implied preemption bars claims based on FDA duties | Claims for negligence (failure-to-warn/training/manufacturing), products liability, breach of warranties, fraud, and UDTP are preempted and dismissed with prejudice |
| Whether failure-to-warn/negligence claims survive pleading and causation standards | Plaintiff alleges Bayer failed to report adverse events and warn physicians/patient, causing implantation/injury | Bayer says reporting/warning duties derive from FDCA (preempted) and plaintiff cannot show causal link because FDA knew of adverse events before implantation | Failure-to-warn/negligence claims are preempted; independent causation allegations are insufficient to state a plausible claim |
| Whether fraud/UDTP claims meet Rule 9(b) and avoid preemption | Plaintiff alleges affirmative misrepresentations and concealment caused reliance | Bayer contends alleged statements mirror FDA-approved labeling (preempted) and fraud pleadings lack particularity | Fraud and UDTP claims are preempted and fail Rule 9(b)/plausibility pleading standards; dismissed |
| Whether the court should retain or decline supplemental jurisdiction over medical malpractice | Plaintiff seeks to keep state malpractice claim in federal court | Defendants note federal claims were dismissed, leaving only state malpractice | Court declined supplemental jurisdiction under 28 U.S.C. §1367(c)(3); malpractice claim dismissed (may be refiled in state court) |
Key Cases Cited
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (established plausibility pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (applied and explained plausibility standard to pleadings)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (recognized §360k express preemption for PMA devices)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (held FDCA-related fraud-on-the-FDA claims are impliedly preempted)
- Gunn v. Minton, 568 U.S. 251 (test for federal-question jurisdiction where federal issue is central to a state-law claim)
- Wyeth v. Levine, 555 U.S. 555 (discussed presumption against preemption in FDA/regulatory context)