485 F.Supp.3d 843
E.D. Mich.2020Background
- Essure is a Class III permanent contraceptive micro-insert subject to FDA premarket approval; the court took judicial notice of the 2009 Patient Information Booklet (PIB).
- Plaintiff April Hill received Essure in December 2011 and alleges device migration, organ perforation, and a variety of systemic and pelvic injuries requiring possible hysterectomy.
- Hill sued Bayer (multiple corporate defendants) asserting five counts: negligent training; negligent risk management; breach of express warranty; negligent misrepresentation; and negligent failure to warn.
- Bayer moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing federal preemption (express and implied) and failure to plead plausible causation/factual detail; the court permitted judicial notice of the 2009 PIB.
- The court granted Bayer’s motion in full, dismissing all claims and granting Bayer’s second request for judicial notice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Negligent training | Hill alleges Bayer failed to ensure physicians completed FDA-approved training and preceptoring, causing placement errors | Bayer: claims are boilerplate, plaintiff fails to identify implanting physician or plead causal link; training-based duties outside FDA labeling are preempted | Court: training claims premised on deviation from FDA training are not per se preempted, but Count I dismissed for failure to plead plausible facts and causation |
| Negligent risk management / failure-to-warn (reporting to FDA) | Hill: Bayer’s alleged failure to report adverse events to FDA supports a state-law failure-to-warn/risk-management claim | Bayer: such claims are preempted (Buckman) because they seek to enforce FDCA duties that only the federal government may enforce; no Michigan analog duty to report to FDA | Court: claims premised solely on failure to report to FDA are impliedly preempted under Buckman (and lack a Michigan parallel); Counts II and V dismissed; alternative pleading failures (causation) also fatal |
| Breach of express warranty & negligent misrepresentation | Hill alleges reliance on Bayer website/ads containing affirmative statements (e.g., "zero pregnancies," "worry free," "non-surgical") | Bayer: the challenged statements track FDA‑approved labeling and therefore any state-law obligation would be different from or in addition to FDCA requirements (express preemption) | Court: statements consistent with FDA-approved labeling are expressly preempted; warranty and misrepresentation claims dismissed |
| Judicial notice of 2009 PIB | N/A (defendant requested notice) | N/A | Court: granted judicial notice of the 2009 Patient Information Booklet as an official, publicly available FDA document |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (addressing express preemption under the FDCA for PMA devices)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (private suits that effectively enforce FDCA obligations are impliedly preempted)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading must state a plausible claim to survive Rule 12(b)(6))
- Ashcroft v. Iqbal, 556 U.S. 662 (plausibility standard for federal complaints)
- Perez v. Nidek Co., 711 F.3d 1109 (describing the narrow gap between Riegel and Buckman)
- Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. view that FDA‑approved warnings preempt state failure‑to‑warn claims)
- Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. decision relevant to fraud-on-the-FDA / preemption analysis)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. en banc holding a failure‑to‑warn theory based on reporting to FDA can survive preemption in some circumstances)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. recognizing a reporting-based failure‑to‑warn claim under certain state-law analogs)
- In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir. holding claims based on failure to report adverse events are preempted)