First Ethicon Transvaginal Mesh Jury Verdict Awarded
A jury recently awarded Plaintiff, Linda Gross, damages in her Ethicon transvaginal mesh lawsuit. Despite the TVM jury verdict, Johnson & Johnson subsidiary, Ethicon, requested that the transvaginal mesh jury verdict be overturned. On Tuesday, July 15th, a federal judge denied the pharmaceutical company’s request.
The first bellwether transvaginal mesh jury awarded plaintiff Linda Gross, $11.1 million for the company’s neglect that led to her ongoing personal injury due to her transvaginal mesh implant. On Tuesday, Atlantic County Superior Court Judge Carol Higbee denied Ethicon’s request.
The award was divided into $3.35 million for compensatory damages, likely to go to the plaintiff’s ongoing medical expenses as her Ethicon transvaginal mesh continues to injure her, and $7.76 million in punitive damages.
At trial, “there was strong evidence presented and multiple sources of evidence that in fact there were many problems with this product,” Higbee said in court, according to a preliminary transcript.
However, Ethicon spokesman Matthew Johnson said that the pharmaceutical company would not give up. The motion to overturn the original verdict “only marks the beginning of the appeals process,” he said.
“We will be filing an appeal in this case as we believe the jury’s verdict and damage awards were not supported by the evidence presented at trial,” he said.
Higbee’s preliminary transcript said that there was sufficient evidence that Ethicon knew about the dangers of their Prolift transvaginal mesh device. That testimony “could have been believed, and apparently was believed by the jury…that the defendant knew about this problem, that they were told about this problem, that their own doctors were warning them about this problem, that their own studies were showing this problem…and therefore, that the defendant had a duty to warn about the problem,” Higbee was quoted as saying in the transcript.
FDA Rejects Request from Watchdog Group to Ban Transvaginal Mesh Devices
In April of this year, the FDA announced that, due to studies showing the dangers of transvaginal mesh devices, the regulatory agency would change its rules involving the devices and would require in-depth clinical testing before the devices could be sold. However, the agency also responded to Public Citizen, a drug and medical device watchdog group that demanded the FDA ban transvaginal mesh devices completely, stating that they would not ban the devices, but instead limit their use and continue investigating the injuries they cause.
Public Citizen submitted its request to ban transvaginal mesh devices in 2011.
The FDA stated, in its denial of the demand, that the new, more stringent regulations would actually help keep some useful devices on the market, while also preventing harmful transvaginal mesh devices from being used in patients. Many transvaginal mesh devices snuck onto the market through the 510(k) approval process, which allows devices that are substantially similar to previously-approved devices to pass without in-depth clinical study. The FDA will now refuse to allow transvaginal mesh devices to take that route, and they believe that the companies’ inability to produce satisfactory in-depth safety tests will limit the number of dangerous transvaginal mesh devices available for doctors.
“As a result of these [surveillance] orders, many manufacturers have elected to cease marketing devices indicated for transvaginal [pelvic organ prolapse] repair,” the FDA wrote.
“Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it had taken so long,” Michael Carome, director of Public Citizen’s Health Research Group and the petition’s author, 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. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal 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