Numerous transvaginal mesh cases are pending or in progress in courts across the country. One case, taking place in West Virginia, recently experienced an update as U.S. District Judge Joseph R. Goodwin, who is overseeing more than 37,000 multi-district litigation transvaginal mesh cases, ruled Johnson & Johnson company Ethicon cannot use one of its arguments.
According to The State Journal, a business newspaper for West Virginia, Ethicon wanted to include information that one of the materials used in its devices went through the U.S. Food and Drug Administration’s pre-market approval process as evidence in the case. However, in Goodwin’s 21-page ruling he said using such information would only deceive the jury and complicate the issue, as the material is actually a different product used in a different manner from what the FDA approved.
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Issues with the material in Ethicon’s transvaginal mesh device
The State Journal reported there are numerous problems with Ethicon’s argument. First, Johnson & Johnson avoided the FDA’s full pre-market review process, citing that the FDA already approved the sutures in the company’s Gynecare TVT device. The company used an abbreviated process instead, which actually limits FDA’s scrutiny of the materials, the news source reported. In addition, Goodwin argued that since the FDA did not approve polypropylene, the material used in the company’s Prolene suture, for use in medical devices, Ethicon cannot say the company was in the right.
In addition, the FDA issued a public health web notification in 2003 about Ethicon alerting the public to counterfeit polypropylene material, according to the administration’s website. The FDA announcement did not include the Prolene suture products, but a counterfeit product that posed dangers. The administration said it even conducted tests on the counterfeit product.
“Although FDA testing indicates that the counterfeit device has chemical and mechanical properties similar to other polypropylene mesh products currently on the market, the counterfeit products were manufactured in facilities that were not inspected by FDA,” the administration said in the notification. “Therefore there is no assurance that these products were designed and manufactured according to FDA requirements.”
According to Goodwin, Ethicon’s argument for the use of the material seems to have merit, but, upon closer inspection, the judge ruled the argument does not have a place in the transvaginal mesh case.
“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,” Goodwin wrote, according to The State Journal. “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.”
Goodwin’s ruling is a win for plaintiffs who have suffered from transvaginal mesh complications. Vaginal mesh side effects have had much media attention in recent years, and more women are coming forward to seek compensation for their injuries, making it increasingly important for vaginal mesh makers to be able to provide evidence supporting their product safety claims. Attorneys practiced in transvaginal mesh cases can help to bring such bogus safety claims to light and get you the compensation you deserve.