153 N.E.3d 1168
Ind. Ct. App.2020Background
- More than 30 women sued Bayer (maker of Essure) alleging physical injuries from the Essure permanent birth-control device; claims included IPLA product-liability counts, UCC express-warranty, and Consumer Sales Act allegations.
- Bayer moved for judgment on the pleadings under Trial Rule 12(C), arguing federal preemption (express and implied) and pleading defects; the trial court denied the motion and Bayer appealed.
- The Court of Appeals treated Essure as a PMA-approved Class III device and applied MDA/FDCA preemption principles (express preemption under 21 U.S.C. § 360k and Buckman conflict-preemption analysis).
- The court held the IPLA governs the product-liability claims and limited viable defect theories to the three types the IPLA recognizes (design, manufacturing, inadequate warning/instruction).
- The court: (a) affirmed survival of manufacturing-defect claims premised on violations of federal requirements (not impliedly preempted), (b) reversed as to claims premised on failing to proactively strengthen FDA-approved labeling (expressly preempted), and (c) held failure-to-warn claims based solely on allegedly inadequate FDA-approved labeling are expressly preempted, while failure-to-instruct/training claims can survive.
- The court also held express-warranty (UCC) claims are not preempted and denied Bayer judgment on pleading sufficiency for those claims; Bayer waived its Rule 9(B) challenge to the Consumer Sales Act claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does the IPLA govern these claims? | Leach: IPLA applies to all product-liability theories for physical harm. | Bayer: (did not dispute IPLA applicability) | Held: IPLA applies; only IPLA defect categories are viable. |
| Are manufacturing-defect claims premised on federal violations preempted? | Leach: Violations of FDCA/MDA/manufacturer duties can show manufacturing defect (adulterated/misbranded device). | Bayer: Such claims conflict with federal scheme or depend solely on FDCA, so preempted. | Held: Not impliedly preempted; manufacturing-defect claims premised on federal violations may proceed. |
| Are claims based on failure to proactively strengthen FDA-approved warnings preempted? | Leach: Bayer should have proactively strengthened warnings based on new information. | Bayer: Federal law permits but does not require proactive label changes; state law cannot impose additional requirements. | Held: Expressly preempted; judgment for Bayer on those claims. |
| Are failure-to-warn (IPLA) claims based on alleged reporting omissions viable? | Leach: Omissions in FDA reporting rendered labeling inadequate. | Bayer: Warnings/labeling were FDA-approved; state cannot require different labeling. | Held: Expressly preempted when claim seeks a different/stronger FDA-approved label; reporting omissions may still support a manufacturing-defect theory. |
| Are failure-to-instruct / training claims preempted? | Leach: Bayer failed to meet FDA training duties and/or negligently performed voluntary training. | Bayer: Training obligations arise from FDA approval; state law cannot impose different requirements. | Held: Claims that Bayer negligently performed FDA-imposed training or negligently performed voluntarily assumed training survive (not preempted). |
| Are other tort claims (fraud, concealment, negligent testing) and UCC express-warranty claims viable? | Leach: These are variants of product-defect claims under IPLA; express warranties were made and relied upon. | Bayer: Many tort theories collapse into IPLA and/or are preempted; warranty claims lack privity. | Held: Common-law tort variants (fraud, concealment, negligent testing) that do not fit IPLA defect categories are dismissed; express-warranty claims under UCC survive and vertical privity not required where warranties were made to plaintiffs. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA approval and express preemption under the MDA)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (state claims that exist solely by virtue of FDCA create conflict-preemption concerns)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (manufacturing/adulteration-based state claims premised on federal violations are not impliedly preempted)
- McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005) (state law cannot impose mandatory conduct when federal law permits but does not require it)
- McGookin v. Guidant Corp., 942 N.E.2d 831 (Ind. Ct. App. 2011) (state attempts to require proactive label changes are preempted)
- KS&E Sports v. Runnels, 72 N.E.3d 892 (Ind. 2017) (TT-R 12(C) standard and Indiana notice-pleading principles)
- Stegemoller v. ACandS, Inc., 767 N.E.2d 974 (Ind. 2002) (IPLA governs all product-liability actions)
- Prairie Prod., Inc. v. Agchem Div.-Pennwalt Corp., 514 N.E.2d 1299 (Ind. 1987) (express-warranty privity exception for warranties made to remote purchasers)
- Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997) (express-warranty claims are not necessarily preempted by MDA)