522 F.Supp.3d 492
E.D. Ark.2021Background
- Plaintiff received the Essure permanent contraceptive implant in April 2009 and later suffered severe pain and abnormal bleeding, leading to a hysterectomy in March 2020.
- Essure is a Class III medical device that held Conditional Premarket Approval (CPMA) from the FDA and was regulated under the Medical Device Amendments (MDA)/PMA regime.
- Plaintiff sued Bayer alleging negligent training, negligent risk management (failure to report adverse events), and breach of express warranty; defendants moved to dismiss for federal preemption and failure to state claims.
- The court applied the Riegel/Buckman framework: determine whether federal requirements exist and whether state claims impose different or additional requirements; recognize a narrow ‘‘gap’’ for parallel state-law claims.
- The court dismissed all three claims for either preemption or failure to plead causation/specific facts, denied leave to amend as futile, and denied the motion to stay discovery as moot.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Negligent training — preemption/pleading | Bayer assumed a duty by training implanting physicians and breached FDA-aligned training obligations causing Plaintiff's injury | Preempted unless a parallel state duty; Plaintiff fails to plead how training differed from FDA requirements or how that caused injury | Not expressly preempted if alleging deviation from FDA training, but complaint lacks factual allegations tying inadequate training to injury — claim dismissed for failure to state a claim |
| Risk management (failure to report adverse events) — enforceability | Bayer failed to report adverse events and consumer complaints to FDA, which prevented corrective action and caused Plaintiff's harm | Such claims amount to private enforcement of the FDCA (fraud-on-the-FDA); only government may enforce; also no causation pled | Claim impliedly preempted under Buckman and dismissed; alternative dismissal for failure to plead causation |
| Breach of express warranty — content and preemption | Plaintiff relied on Bayer website/promotional statements as express warranties inducing implantation | Warranty claims are preempted if the statements do not go beyond FDA-approved labeling; Plaintiff fails to plead what statements were made or that they differed from FDA statements | Dismissed for failure to plead specific content or that representations exceeded FDA-approved statements; preemption bars the claim |
| Motion to amend — proposed manufacturing and failure-to-warn claims | Seeks to add negligent manufacture, strict liability, and failure-to-warn claims based on FDA Notices of Violation and alleged defects | Amendment would be futile because claims are preempted or lack factual specificity linking alleged manufacturing irregularities to Plaintiff's device/injury | Denied as futile: manufacturing and failure-to-warn claims are either preempted or insufficiently pleaded |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (establishes that PMA-approved devices trigger express preemption under the MDA when state requirements are different from or in addition to federal ones)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (bars private suits that are essentially attempts to enforce the FDCA or allege fraud-on-the-FDA)
- In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (Eighth Circuit synthesizes Riegel and Buckman, describing the narrow gap where parallel state claims may proceed)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: allegations must state a plausible claim, not mere legal conclusions)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading standard requiring factual allegations raising a plausible claim for relief)
- Wilson v. Rebsamen Ins., Inc., 330 Ark. 687, 957 S.W.2d 678 (1997) (Arkansas Supreme Court recognizing liability under Restatement § 324A for voluntary assumption of duty)
- McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005) (holding state-law duty to provide warnings beyond FDA-approved labeling can be preempted)