Ethicon/J&J Transvaginal Mesh Bellwether Case Thrown Out for Lack of Evidence
The first bellwether case in the transvaginal mesh injury multidistrict litigation (MDL) against Johnson & Johnson subsidiary Ethicon has been thrown out, leaving the device manufacturer to claim victory.
Like many transvaginal mesh victims, Carolyn Lewis had a device – in this case, the TVT Retropubic Sling – implanted to treat incontinence. However, she began suffering side effects like pain, infection, bleeding, and continued incontinence, and her lawsuit claims that the mesh devices are improperly designed. Last year, Lewis had to undergo surgery to remove the transvaginal mesh device because it shrank and frayed, causing damage to her internal organs. She sought to have the jury rule on whether or not the transvaginal mesh device caused painful deformities to her vagina because of the device’s incompatibility with the human body.
However, after Johnson & Johnson filed a motion to have the lawsuit dismissed, Judge Joseph R. Goodwin – who presides over other transvaginal mesh MDLs as well – agreed to dismiss the case, stating that Lewis’s attorneys “failed to present sufficient evidence to support her claim that a defect in the device caused her injury.”
Johnson & Johnson faces 12,000 lawsuits in the transvaginal mesh MDL. The company had its first sling device approved by the FDA in 1998, and despite rising concerns over injuries related to the transvaginal mesh devices, continued to sell them until just last year. The medical manufacturer finally pulled some, but not all, if its transvaginal mesh models off the market for further study.
After looking into hundreds of thousands of complaints, the FDA announced last year that it would not approve any more transvaginal mesh devices until medical manufacturers like Johnson & Johnson, CR Bard, American Medical Systems, and numerous others study the impact of their devices more thoroughly.
Transvaginal mesh manufacturers have been accused of not performing rigorous enough studies on the side effects of the device. In an earlier ruling in the Ethicon case, Judge Goodwin ruled that details regarding the 501(k) process, which can “fast-track” device approval, be excluded because it would confuse the jury.
“Ethicon would like the court to determine that because the FDA found polypropylene is safe to use as a suture, it is automatically safe to use in transvaginal mesh,” he wrote. “Although purportedly constructed of the same material, it is a different product, used in a different manner, for a different purpose … Essentially, Ethicon argues that because the FDA confirmed the safety and effectiveness of the Prolene suture, and the TVT is composed of the same material as the Prolene suture, the plaintiffs should be barred from arguing that the Prolene material is defective…At first glance, this argument appears to have some merit — after all, the FDA gave the Prolene suture its stamp of approval and confirmed its safety and efficacy.”
Goodwin said that Ethicon’s argument ignores the fact that Prolene sutures are not used for the same procedures as transvaginal mesh devices.
“Although Ethicon represents that the products are primarily composed of the same material, it does not automatically follow that the material is safe in both devices,” he said.
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. However, the mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800