172 F. Supp. 3d 804
E.D. Pa.2016Background
- Five consolidated suits by women alleging injuries (device migration, organ perforation, surgeries, birth defects, systemic symptoms) after implantation of Essure, a Class III FDA-approved (PMA) permanent birth-control device now manufactured by Bayer.
- Essure received PMA in 2002 with conditions (restricted use, required training, postapproval studies and adverse-event reporting); Bayer acquired Conceptus in 2013 and continued training, marketing, and reporting activities.
- Plaintiffs assert twelve claims (negligent training, negligent entrustment, pharmacovigilance/negligent distribution/advertising/reporting, negligent risk management, breach of express warranty, UTPCPL, fraudulent concealment, fraudulent and negligent misrepresentation, strict liability, negligent manufacture, negligent failure to warn, etc.).
- Bayer moved for judgment on the pleadings under Fed. R. Civ. P. 12(c), arguing express and implied federal preemption (MDA/FDCA), failure to state plausible claims (Twombly/Iqbal), and failure to plead fraud with particularity (Rule 9(b)).
- The court granted the motion in part and denied it in part: it dismissed several claims as preempted or for pleading defects, permitted amendment for certain counts, and held some claims survived (negligent misrepresentation and negligent failure to warn).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under MDA §360k for PMA device claims | Plaintiffs: many claims are parallel to federal requirements or arise from contractual/express warranties and state tort law, not federal duties; the PMA may be invalid for post-approval violations | Bayer: Essure’s PMA creates device-specific federal requirements; state claims that add/differ are expressly preempted under Riegel | Court: Where plaintiffs assert parallel claims tied to federal requirements or contractual promises (express warranties) they may survive; several state-law safety-based claims that would add to PMA requirements are expressly preempted (e.g., negligent entrustment) |
| Implied preemption (fraud-on-the-FDA / Buckman) for concealment/reporting claims | Plaintiffs: fraudulent concealment / failure-to-warn can be based on state duties (including reporting to FDA that reaches physicians) and are not purely enforcement of FDCA | Bayer: Claims grounded solely on alleged violations of federal disclosure/reporting duties are impliedly preempted as fraud-on-the-FDA | Court: Fraudulent concealment claim (Count VII) that exists solely by virtue of FDCA reporting duties is impliedly preempted and dismissed; failure-to-warn claims premised on reporting to FDA may survive if grounded in parallel state duties (Count XII survives) |
| Pleading sufficiency (Rule 12(b)(6) and 9(b)) for warranty/misrepresentation/risk-management/manufacturing claims | Plaintiffs: complaints sufficiently allege misrepresentations, warranty reliance, manufacturing and risk-management failures; seek leave to amend if needed | Bayer: many counts are conclusory, fail to allege particularity (Rule 9(b)) or causation and factual nexus to plaintiffs’ specific injuries | Court: Dismissed several counts for pleading defects (negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation under Rule 9(b), negligent manufacturing) but granted leave to amend most (except where preemption or futility found) |
| Viability of strict liability for medical devices under Pennsylvania law | Plaintiffs: assert strict liability manufacturing/failure-to-warn claims | Bayer: Pennsylvania law (Comment k and precedent) bars strict liability for prescription drugs/devices | Court: Applied Comment k rationale to medical devices and dismissed strict liability claims as not cognizable under Pennsylvania law |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (P.M.A. approvals create device-specific federal requirements and can expressly preempt conflicting state-law claims)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law claims that exist solely by virtue of FDCA disclosure requirements are impliedly preempted as fraud-on-the-FDA)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must be plausible, not merely possible)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (legal conclusions not accepted as true for plausibility analysis)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (fraud-on-the-FDA / preemption analysis applied to post-approval reporting allegations)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc) (held that state failure-to-warn claim based on failure to report adverse events to FDA could survive preemption where state law imposes a duty to warn via a third party)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (failure-to-warn claims based on failure to report device malfunctions/serious injuries to FDA are not necessarily preempted if they parallel state law duties)