Barbara Kaiser v. Johnson & Johnson
947 F.3d 996
7th Cir.2020Background
- Barbara Kaiser (age 60 at surgery) received Ethicon’s Prolift transvaginal mesh in 2009 for anterior pelvic-organ prolapse; she later developed severe pelvic pain, bladder spasms, and sexual dysfunction related to mesh contraction.
- Revision surgery in 2013 removed only part of the mesh; surgeon testified some mesh could not be fully removed and complications were likely permanent.
- Kaiser sued Ethicon under the Indiana Products Liability Act (IPLA) for design defect and failure to warn; after trial a jury awarded $10 million compensatory and $25 million punitive damages (judge reduced punitive to $10 million via remittitur).
- Ethicon argued federal preemption (FDA §510(k) clearance), that Indiana law required proof of a reasonable alternative design, that warnings were adequate, and raised evidentiary/instructional errors and excess-damages claims on appeal.
- The Seventh Circuit affirmed: rejected implied-preemption and other challenges, applied the Indiana Supreme Court’s TRW decision (holding IPLA does not require proof of an alternative design), upheld failure-to-warn and damages rulings, and found no reversible evidentiary or instruction error.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Federal preemption (§510(k)) of design-defect claim | State-law duties should govern; §510(k) clearance does not preclude state tort claims | §510(k) clearance prevents independent state-law design duties because FDA clearance controls design changes and makes compliance with both impossible | No implied preemption; §510(k) did not make it impossible to comply with IPLA; Wyeth and Lohr analogies support allowing state claims |
| Alternative-design requirement under IPLA | Kaiser argued TRW controls: IPLA does not impose an alternative-design element | Ethicon argued Seventh Circuit precedent requires proof of a feasible, cost-effective alternative design | Followed TRW: Indiana Supreme Court controls; IPLA does not require proof of a reasonable alternative design, though such evidence may be admissible |
| Failure-to-warn (learned intermediary) | Warnings were inadequate as to frequency, severity, and permanence of complications; surgeon testimony supported causation | Warnings in Instructions for Use and limited-distribution monograph were adequate; causation not proven (surgeon would still have used Prolift) | Jury reasonably found warnings inadequate and causation disputed but for the jury; verdict sustained |
| Admissibility of §510(k) clearance and jury instructions (state-of-the-art/regulatory presumptions) | Kaiser sought exclusion of §510(k) evidence; no state-of-the-art presumption applies | Ethicon sought to admit §510(k) clearance and requested state-of-the-art and regulatory-compliance instructions | District court did not abuse discretion: §510(k) probative value minimal and confusing; no adequate evidence to support state-of-the-art or regulatory presumptions |
Key Cases Cited
- TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d 201 (Ind. 2010) (Indiana Supreme Court holds IPLA does not require proof of alternative design)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (§510(k) substantial-equivalence clearance is not the same as FDA premarket approval for express-preemption analysis)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (brand-name drug manufacturer may unilaterally strengthen warnings; supports no impossibility preemption absent clear FDA denial)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (U.S. 2011) (generic-drug framework and duty of sameness informs preemption analysis)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (U.S. 2013) (limits on "stop-selling" escape and preemption principles for generics)
- McMahon v. Bunn-O-Matic Corp., 150 F.3d 651 (7th Cir. 1998) (Seventh Circuit precedent applying alternative-design/cost-effectiveness theory under Indiana law)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (distinguishes premarket approval preemption from §510(k) clearance)
- Gasperini v. Center for Humanities, Inc., 518 U.S. 415 (U.S. 1996) (state standards govern review of state-law damages awards)