Kaiser v. Johnson & Johnson

Record contained sufficient evidence to support jury’s verdict in favor of plaintiff in products liability action under Indiana law alleging that transvaginal mesh device manufactured by defendants was defectively designed, where plaintiff experienced severe pelvic pain, bladder spasms and pain during intercourse after said device was implanted, and where defendant failed to adequately warn about its complications, one of which precluded plaintiff’s surgeon from removing all of said device and made permanent plaintiff’s pain symptoms. Plaintiff was not required under Indiana law to provide evidence of reasonable alternative design for instant device. Moreover, jury could properly consider evidence of frequency and severity of device’s complications when determining that device created risks beyond expectations of ordinary pelvic-floor surgeon. Also, defendants’ brief list of complications constituted inadequate warnings about danger of instant device, especially where there was no warning about device’s potential for permanent pelvic pain and sexual dysfunction, and jury could otherwise credit testimony of plaintiff’s surgeon, who indicated that additional warnings about complications of device would have led him to choose different treatment plan. Too, Ct. rejected defendants’ argument that plaintiff’s action was preempted by federal law, which, according to defendants, precluded them from redesigning instant devise to satisfy Indiana products liability law absent FDA clearance to do so.