139 N.E.3d 1127
Ind. Ct. App.2019Background
- More than 30 women (the "Women") sued Bayer and related entities alleging injuries from the Essure permanent birth-control device.
- Plaintiffs allege manufacturing defects tied to violations of federal manufacturing/FMDA/MDA requirements for Essure, a Class III device that underwent PMA.
- Complaint pleads plaintiff-by-plaintiff post-implantation symptoms and a range of device defects (e.g., improper adhesion, trace lead in solder, fracturing).
- Bayer moved for judgment on the pleadings under Indiana Trial Rule 12(C), arguing (a) the manufacturing-defect allegations are conclusory/inadequately pleaded and (b) plaintiffs’ claims are preempted by federal law.
- Trial court denied the motion; Bayer brought an interlocutory appeal. The Court of Appeals applied de novo review and Indiana’s liberal notice-pleading standard.
- The court held the manufacturing-defect claim survives: pleading was adequate and the IPLA-based manufacturing claim, premised on violations of federal requirements, is neither expressly nor impliedly preempted at this stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Sufficiency of manufacturing-defect pleading | Plaintiffs pleaded specific device defects and individual post-implant symptoms giving Bayer notice. | Allegations are cursory, conclusory, and describe only possible defects without tying them to injuries. | Pleading sufficient under Indiana Rule 8/Alexandria liberal notice; discovery needed for technical detail. |
| Express preemption under MDA/21 U.S.C. §360k | Plaintiffs base claims on violations of federal manufacturing requirements (parallel duty). | State-law claims conflict with federal PMA regime and are therefore preempted. | Not expressly preempted because the claim is premised on failure to meet federal requirements (a parallel duty). |
| Implied preemption (Buckman conflict re: FDCA enforcement) | Claim is traditional state tort (IPLA manufacturing-defect) and does not depend solely on FDCA enforcement. | Allowing claims would interfere with federal enforcement and create extraneous pull on the FDCA scheme. | Not impliedly preempted at pleading stage: claim enforces an independent state tort duty that mirrors federal standards rather than creating an FDCA-based private cause of action. |
| Viability under Indiana Product Liability Act (IPLA) | Essure is a product; plaintiffs are consumers; IPLA governs manufacturing-defect claims based on defective, unreasonably dangerous products. | Some factual theories may assert conduct compliant with federal law and thus fail, but pleadings need not specify viable theories now. | IPLA governs; a claim that device was adulterated by violating federal manufacturing requirements can support an IPLA manufacturing-defect claim. |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (establishes PMA-related express preemption framework under the MDA)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (limits private causes of action that exist solely by virtue of the FDCA; implied preemption concern)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (recognizes historic role of state tort law over health/safety matters and limits of preemption)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.) (manufacturing-defect claim premised on federal manufacturing violations is not impliedly preempted)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir.) (articulates dual-step test to avoid express and implied preemption)
- KS&E Sports v. Runnels, 72 N.E.3d 892 (Ind.) (standard for Trial Rule 12(C)/12(B)(6) review and liberal pleading standard)
- McGookin v. Guidant Corp., 942 N.E.2d 831 (Ind. Ct. App.) (discusses parallel claims and MDA preemption in Indiana context)
- Stegemoller v. ACandS, Inc., 767 N.E.2d 974 (Ind.) (IPLA governs product liability claims regardless of underlying theory)