After years of contentious litigation, attorneys Mark W. Tanner
and Peter M. Newman
reached a confidential settlement for a woman who suffered years of painful and embarrassing complications following surgical implantation of a bladder sling to treat her urinary incontinence. With support from a team of renowned experts, Plaintiffs alleged that the sling manufacturer was motivated by financial gain to rush the sling to market without conducting clinical trials and to disseminate misleading data regarding the efficacy of its untested product. The defendant blamed the implanting surgeon for the post-operative complications, arguing that the Plaintiff was not a good candidate for the sling procedure due to her diabetes and that the surgeon did not follow proper surgical technique.
Plaintiff’s retained an Ivy League Professor of Bioengineering, who was prepared to testify that the product manufacturer failed to follow well-established procedures for testing its new device, including in vitro evaluation under functional conditions, in vivo evaluation in appropriate animal models, and clinical trials. Plaintiff’s Ph.D. immunologist was a specialist in the development of collagen coatings for implanted synthetic materials, like the bladder sling in question. He had examined dozens of explanted bladder slings and prepared a report explaining why the Plaintiff’s complications were caused by the manufacturer’s choice of sling material, which did not promote tissue ingrowth as designed, which did not resist infection as the manufacturer claimed, and which caused erosion of adjacent vaginal and urethral tissues. Plaintiff’s regulatory affairs expert, the former Chief Medical Officer in the FDA’s Office of Device Evaluation, testified at deposition that FDA approval of the device did not relieve the manufacturer of its duty to conduct clinical testing to ensure that its device was safe, effective and adequately labeled.
Tanner and Newman deposed the implanting surgeon who revealed that the defendant’s sales representatives were present in the operating room when he implanted Plaintiff’s sling, and that he followed their guidelines precisely. Plaintiffs also retained a Professor of Urogynecology who specializes in the treatment of female urinary incontinence, and a Board-certified Urologist, who had each treated hundreds of patients with urinary incontinence. Each testified at deposition that the implanting surgeon followed proper surgical technique and that the device manufacturer had misled the surgeon to believe the sling had a long track record of effectiveness when, in fact, the Plaintiff was one of the first to receive the device.