468 F.Supp.3d 573
W.D.N.Y.2020Background
- Three plaintiffs (implanted with the Essure device between 2009–2011) sued Bayer entities alleging device migration and a range of physical and psychological injuries.
- Essure is a Class III medical device approved via the FDA premarket approval (PMA) process; plaintiffs challenged training, warnings, advertising, and adverse-event reporting.
- Causes of action asserted: negligent training, negligent misrepresentation, breach of express warranty, negligent risk management (failure to report to FDA), and negligent failure to warn.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6) principally on MDA/FDCA preemption grounds; they also moved for sanctions under Rule 41(d) against one plaintiff who had previously dismissed a state-court action.
- The court dismissed the complaint with prejudice as preempted (expressly and/or impliedly), denied leave to amend as futile, and denied sanctions under Rule 41(d) based on the plaintiff’s demonstrated indigence (but warned against further duplicative suits).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| MDA/FDCA preemption of state-law claims | Plaintiffs contend their claims either parallel FDA duties or allege deviations from FDA requirements and thus are not preempted | Essure is a PMA-regulated Class III device; state-law claims imposing requirements different from or adding to FDA PMA requirements are preempted (Riegel/Buckman) | Claims dismissed as preempted (express and/or implied); plaintiffs failed to plead viable parallel state-law duties |
| Negligent training of physicians | Bayer failed to properly train/supervise implanting physicians and monitor patients | Training duties derive from FDA-approved requirements; imposing additional duties would conflict with PMA; no New York parallel cause of action for non-employer negligent training liability | Dismissed as preempted and not supported by New York law |
| Failure to report adverse events / negligent risk management | Failure to report to FDA and to manage risks supports a standalone tort claim | Claims that require additional reporting/warnings beyond FDA requirements are preempted; New York does not recognize a duty to report to the FDA as a private cause of action | Dismissed: preempted if framed as failure to warn; otherwise not cognizable under New York law |
| Misrepresentation & breach of express warranty | Statements/advertising by Bayer allegedly went beyond or differed from FDA labeling and were misleading | Statements that fall within the scope of FDA-approved labeling are functionally equivalent and preempted | Dismissed: plaintiffs did not identify statements that substantively deviated from FDA-approved labeling |
| Motion to amend & Rule 41(d) sanctions | Plaintiffs sought to add fraudulent-misrepresentation claims; Scott argued prior dismissal was for forum choice and is indigent | Defendants argued amendment is futile and proposed amended complaint included copied material; sought costs for previously dismissed state action under Rule 41(d) | Amendment denied as futile and procedurally defective; sanctions denied because Scott proved indigence, with a warning about further duplicative suits |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (PMA-regulated device claims preempted to extent state law imposes different or additional requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state-law claims premised solely on FDCA violations are impliedly preempted)
- In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (narrow gap for parallel state-law claims to survive MDA preemption)
- Williams v. Bayer Corp., 541 S.W.3d 594 (affirming dismissal of Essure-related claims on preemption grounds)
- Faber v. Metropolitan Life Ins. Co., 648 F.3d 98 (pleading standard: accept well-pleaded allegations and test for plausibility)
- Horowitz v. 148 South Emerson Assocs. LLC, 888 F.3d 13 (Rule 41(d): different theories not dispositive; Rule 41(d) deters forum shopping)
- Teixeria v. St. Jude Med. S.C., Inc., 193 F. Supp. 3d 218 (claims based on statements within FDA-approved labeling are preempted)
- Barone v. Bausch & Lomb, 372 F. Supp. 3d 141 (discussion of MDA preemption contours)