Ethicon has motioned to nix the plaintiff’s proposed expert in the ongoing transvaginal mesh MDL, telling the court the expert is not fit to testify.

Rebuffing the opinions and testimony of University of Vanderbilt professor Dr. Russell Dunn, who holds a Ph.D. in chemical engineering and consults on chemical and polymer process and product design issues, Ethicon is challenging the professor’s risk assessment opinion for the design of transvaginal mesh.

Dr. Dunn contends that Ethicon failed to account for polypropylene vaginal mesh’s propensity to degrade due to oxidization.

However, Ethicon argues that this opinion is not helpful to the litigation because Dr. Dunn “fails to articulate any effect a different quality control process would have had on the [vaginal mesh] design.”

Specifically, Ethicon contends that Dr. Dunn has no experience in medical devices or biomaterials, nor has he been involved in the process and design issues for any medical device.

“Dr. Dunn concedes he has no expertise to opine whether oxidative degradation of Prolene in the body has the potential to cause any harm,” Ethicon argues. “Dr. Dunn has no expertise relating to biocompatibility. In fact, he does not even know what a biocompatibility risk assessment is.”

Ethicon pointed out that on at least 24 separate occasions, the court overseeing the transvaginal mesh MDL held that Dr. Dunn lacks the expertise to provide expert-level opinions regarding transvaginal mesh devices.

“This court has previously and repeatedly held that Dr. Dunn lacks the requisite qualifications to offer opinions regarding medical devices,” Ethicon wrote. “Nothing has changed regarding Dr. Dunn’s dearth of experience, and the court should yet again exclude Dr. Dunn from opining regarding polypropylene pelvic mesh devices.”

Currently, there are 33,874 lawsuits against Ethicon and its parent company Johnson & Johnson filed within the transvaginal mesh MDL.  These lawsuits all similarly alleges that side effects of transvaginal mesh devices caused serious harm to patients.

Cases in the Ethicon transvaginal mesh MDL also claim that Ethicon failed to properly warn patients and the medical community about the possible dangers and risks associated with the devices which are implanted in a woman’s pelvic region to reinforce the vaginal wall for pelvic organ prolapse (POP) repair and to support the urethra or bladder neck for stress urinary incontinence (SUI) treatment.

Transvaginal Mesh MDL

Transvaginal mesh lawsuits
have been filed in federal courts across the country by women who claim to have suffered injuries after being implanted with transvaginal mesh products for the treatment of pelvic organ prolapse (POP) and / or stress urinary incontinence (SUI).

Seven separate transvaginal mesh MDLs comprising 70,000 lawsuits are pending in West Virginia federal court over allegations the devices are defective.

The FDA recently reclassified transvaginal mesh as high-risk medical devices and are now subject to the agency’s strictest safety regulations and evaluation before FDA approval.

The Ethicon Transvaginal Mesh MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, Case No. 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia.