481 F.Supp.3d 1111
D. Mont.2020Background
- Essure is a Class III FDA–premarket‑approved permanent contraceptive manufactured by Bayer; it received PMA and is subject to detailed FDA regulation.
- Amanda Noel received Essure in Nov. 2012, later suffered pelvic pain and abnormal bleeding, and underwent removal surgery in Apr. 2017.
- Noel filed an 11‑count complaint against Bayer alleging design and manufacturing defects, failure to warn, misrepresentation/warranty, negligent training/entrustment (including for hysteroscopic equipment), negligent distribution/risk management, and unfair trade practices.
- Bayer moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing federal preemption (MDA/FDCA) and pleading defects.
- The court held many claims are preempted under Riegel/Buckman; some non‑preempted theories failed for lack of factual allegations tying Bayer’s conduct to Noel’s injuries.
- Court granted dismissal: several counts dismissed with prejudice for preemption; others dismissed without prejudice for failure to state a claim; Noel was given leave to amend limited claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Design and manufacturing defects (Counts X, XI) | Essure was defectively designed and/or manufactured (nonconforming materials, adulteration, unlicensed manufacture). | Design‑defect claims are preempted by PMA approval; manufacturing claims that attack FDA‑approved design are likewise preempted. | Design‑defect claims expressly preempted and dismissed with prejudice. Manufacturing‑defect theory may escape preemption only if tied to a device‑specific manufacturing defect that caused injury; Noel failed to plead causation — dismissed without prejudice. |
| Failure to warn / reporting (Counts VII, parts of X) | Bayer failed to disclose consumer complaints and failed to warn the FDA, health‑care providers, and Noel. | FDA regulation governs reporting/warnings; state duties imposing additional or different obligations are preempted; FDCA provides FDA enforcement authority (Buckman). | Claims requiring duties beyond FDA obligations (including failure to warn providers/consumers) are expressly preempted and dismissed with prejudice; claims premised on reporting to FDA are impliedly preempted and dismissed with prejudice. |
| Misrepresentation / express warranty / fraud (Counts V–IX) | Bayer made affirmative misrepresentations and warranties (safer/more effective, quick/non‑surgical, physician sign‑off required, etc.). | Alleged marketing and labeling track FDA‑approved materials; imposing liability would conflict with PMA and thus is preempted. | Court found the challenged statements were functionally equivalent to FDA‑approved language; misrepresentation, warranty, and related fraud claims are preempted and dismissed with prejudice. |
| Negligent training and negligent entrustment (Counts I–II) — including hysteroscopic equipment | Bayer undertook to train physicians and supplied hysteroscopic equipment but failed to train/supervise and entrusted equipment to incompetent physicians, causing Noel’s harm. | Bayer contends preemption and that Montana law does not recognize the alleged duties; also that Noel failed to plead factual causation or how training deviated from FDA requirements. | Court held a negligent‑training/undertaking claim can be cognizable under Montana law (Restatement §324A as adopted), and hysteroscopic‑equipment claims are not covered by Essure PMA; however, Noel failed to plead factual causation or how training deviated from FDA standards — these claims dismissed without prejudice; supervisory‑type duties beyond FDA training that would add requirements are preempted. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (preemption of state tort law for PMA devices)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (FDCA/FDCA enforcement displaces state fraud‑on‑FDA claims; implied preemption)
- De La Paz v. Bayer HealthCare Ltd. Liab. Co., 159 F. Supp. 3d 1085 (N.D. Cal. 2016) (similar Essure claims; design claims preempted; manufacturing claims require causation)
- McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016) (analysis of negligent training and when state claims may run parallel to FDA requirements)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (framework for parallel‑law survival vs. preemption)
- Perez v. Nidek Co., 711 F.3d 1109 (9th Cir.) (addresses MDA preemption principles)
- Gomez v. St. Jude Med., 442 F.3d 919 (5th Cir.) (marketing/labeling claims that track FDA‑approved language are preempted)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standard: plausibility requirement)