Plaintiff sued defendants when a Gynecare TVT Device, implanted into the defendant allegedly caused significant injury. The plaintiffs hired a urology expert witness to provide testimony. The defendants filed a motion to exclude, which the court partially allowed.
Facts: This case (Wiltgen et al v. Ethicon, Inc. d/b/a Ethicon Women’s Health and Urology – United States District Court – Northern District of Illinois – October 6th, 2017) involves product liability. The Plaintiffs filed suit against the Defendants after a Gynecare TVT Device, implanted in Plaintiff to treat her stress urinary incontinence, allegedly caused significant injury. The claims currently alive in this case include negligence, strict liability, failure to warn, and four others. The Plaintiffs hired Dr. Daniel Elliot, M.D. (urology expert witness) to assist in her case. The Defendants have filed a motion to exclude Dr. Elliot’s expert witness testimony.
Discussion: The Defendants motion seeks to exclude four parts of Dr. Elliot’s opinion: 1) that non-synthetic mesh procedures and other synthetic mesh devices are safer alternatives to the TVT; 2) the sufficiency of Ethicon’s research and testing; 3) risks and complications of the TVT; and 4) the adequacy of
Ethicon’s product warnings.
First, the Defendants argue that Dr. Elliot’s testimony regarding non-synthetic mesh procedures being a safer alternative for the treatment of SUI should be excluded because these alternatives are not medical devices. The court opined that while they agree that evidence regarding a different surgical procedure not involving mesh is irrelevant to an existing safe alternative design, they also agree with the Plaintiff that this evidence is relevant to determine if a product is unreasonably dangerous. Thus, this part of the motion was denied with regard to safe alternatives, but allowed for risk utility analysis.
Second, the Defendants argue that Dr. Elliott has testified that he believes all transvaginal mesh is unsafe and thus should not be allowed to testify that other mesh devices are safer than TVT. The court disagreed, stating that Dr. Elliott will be allowed to testify regarding other synthetic mesh devices.
Third, the Defendants allege that Dr. Elliot should be excluded from opining Ethicon’s research and testing as it goes beyond Dr. Elliott’s expertise. They state that nothing in Dr. Elliott’s experience or background makes him qualified to speak to the standard of care of a manufacturer. The Plaintiffs argue that Dr. Elliott’s opinions on Ethicon’s testing and research relate to his experience and knowledge. The court partially granted this piece of the motion. Dr. Elliott will not be allowed to provide testimony on regulatory or legal adequacy or comment on the absence of studies. He will be allowed to testify on how the studies impacted his opinion.
Last, the Defendants seek to exclude Dr. Elliott’s testimony on the TVT’s instruction for use. The court denied this part of the motion, stating that Dr. Elliott will be allowed only to testify on the TVT’s instructions for use based on his knowledge and clinical experience with the risks of SUI products.
Conclusion: The motion to exclude the expert witness testimony of Dr. Daniel Elliot, M.D. is denied in part and granted in part.