940 F.3d 582
11th Cir.2019Background
- Plaintiff Teresa Taylor received a Mentor-manufactured ObTape polypropylene transobturator sling in 2004 and later complained of chronic bladder inflammation (cystitis) and thinning of urethral tissue.
- Taylor alleged ObTape was defectively designed (small pore size preventing tissue ingrowth; propensity to degrade and shed polypropylene particles), and that Mentor failed to warn physicians pre- and post-implant; she sought compensatory and punitive damages.
- At trial experts testified for Taylor: Dr. Hyman on porosity/erosion, Dr. El‑Ghannam on ObTape degradation and particle shedding, and Dr. Porter for specific causation; defense experts offered alternative causes (e.g., Durasphere, atrophic changes).
- Dr. Porter’s trial testimony included opinions not fully disclosed in his Rule 26 report/deposition (he accepted the degradation theory and offered a new opinion about urethral thinning); Mentor moved to strike under Rule 37 but was instead granted an overnight continuance to prepare cross-examination.
- A jury found Mentor liable for design defect, failure to warn (pre/post), and negligence; awarded $400,000 compensatory and $4 million punitive; the district court denied JMOL/new trial but reduced punitive damages to $2 million under Florida law for lack of specific intent to harm.
- On appeal Mentor challenged evidentiary rulings (Rule 26/37, Daubert/dose-response, foreign-regulatory and other evidence rulings) and punitive damages scope; Taylor cross-appealed the punitive reduction. The Eleventh Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Dr. Porter’s trial testimony (new/"evolved" opinions) should have been excluded under Rule 26/37 | Taylor: testimony consistent with report or harmless; any new aspects were proper responses to a hypothetical and were cured by cross-exam | Mentor: late, undisclosed opinion was ambush; exclusion required under Rule 37(c)(1) | Court: affirmed district court’s discretionary refusal to strike; overnight continuance and effective cross cured prejudice; no JMOL owed on that ground |
| Whether an incorrect causation standard was applied to failure-to-warn claims | Taylor: causation evidence (experts) supported jury findings | Mentor: district court applied wrong standard for failure-to-warn causation | Court: because expert testimony supporting design/negligence was admissible, Mentor not entitled to JMOL; court did not resolve alternate causation-standard challenge |
| Admissibility of Dr. El‑Ghannam’s degradation theory (Daubert/dose-response) | Taylor: degradation theory is reliable; no toxicological dose-response requirement for a device that invariably degrades and provokes immune response | Mentor: analogy to toxic-tort cases (McClain) requires proof of dose-response and exposure level | Court: affirmed admission; dose-response not implicated for this device/physiologic-response theory; district court did not abuse discretion |
| Sufficiency and cap of punitive damages (specific intent; unreasonable financial gain) | Taylor: evidence supported specific intent to harm and knowledge such that jury’s uncapped $4M award stands | Mentor: insufficient proof of specific intent or actual knowledge by policy‑makers; punitive should be remitted or eliminated | Court: punitive damages allowed for gross negligence and motivated-by-financial-gain findings; affirmed liability for punitive awards but upheld district court’s reduction to $2M because record lacked proof of specific intent to harm |
Key Cases Cited
- Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017) (standard of review for JMOL and evidentiary rulings)
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (federal gatekeeping standard for expert testimony)
- McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005) (dose‑response requirement in certain toxic‑tort causation opinions)
- Knight through Kerr v. Miami‑Dade Cty., 856 F.3d 795 (11th Cir. 2017) (Rule 37 burden and harmlessness considerations)
- State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408 (2003) (constitutional limits and review principles for punitive damages)
- Philip Morris USA v. Williams, 549 U.S. 346 (2007) (punitive damages may not punish defendant for injury to nonparties)