Pharmaceutical

First transvaginal mesh trial against Johnson & Johnson underway in NJ

mesh1 First transvaginal mesh trial against Johnson & Johnson underway in NJThe first of 1,800 lawsuits against Johnson & Johnson for injuries allegedly caused by its transvaginal mesh products is underway in Superior Court of Atlantic County, New Jersey, in Atlantic City.

On July 13, 2006, Plaintiff Linda Gross, 47, had a Gynecare Prolift mesh device implanted to correct pelvic organ prolapse (POP), a condition in which the organs in the pelvis drop due to pelvic muscles weakened by childbirth, age or obesity. Ms. Gross and her surgeon believed the Gynecare mesh was the perfect solution at the time because it was less intrusive than conventional pelvic muscle surgeries, quick, and supposedly very effective in correcting the condition.

However, as Ms. Gross’ lawyers explained to the jury, instead of correcting her case of POP as it was intended to do, the transvaginal mesh device turned Ms. Gross’ life into a nightmare full of intense pain, debilitating injuries, and a seemingly endless series of corrective surgeries aimed at restoring her health and quality of life but which have failed thus far.

Ms. Gross’ attorneys argued that Johnson & Johnson and its Ethicon unit, which produced the mesh, knew about the Prolift device’s risks before it went to market in March 2005, but withheld that information from patients and their doctors. Gross’ lawsuit accuses the companies of failing to warn about the product’s risks, defective design, deceit, and negligence.

“They knew every single catastrophe before it happened,” Ms. Gross’ lawyer said in his opening statement. “They knew Linda Gross was going to happen.”

Ms. Gross, a South Dakota resident, had to quit her nursing job as the transvaginal mesh tore into her vaginal wall. Sitting is unbearable for more than 20 minutes at a time, yet being active for more than a few minutes at a time is also impossible. Sexual intercourse with her husband is a thing of the past as it’s too painful for her and the risk of injury is too high for him. Eighteen operations to remove the mesh have failed to fix the problem, leaving Ms. Gross to face an uncertain future potentially filled with constant pain.

“It’s horrible. There are unknown amounts of the mesh still in me,” Ms. Gross told ABC News.

“They never ever studied how can you get this stuff out, what’s the best way to do it,” Ms. Gross’ attorney said, explaining to the jury how Johnson & Johnson sold the Gynecare Prolift mesh without first conducting adequate safety studies and without obtaining U.S. Food and Drug Administration approval.

According to Bloomberg, Ms. Gross’ lawyer explained how the porous polypropylene mesh hardens and contracts as tissue grows around it, creating scar tissue and chronic inflammation. Trying to remove the mesh, he said, was like trying to pull rebar rods out of cement.

Faced with mounting personal-injury complaints, Johnson & Johnson announced in June that it would no longer manufacture transvaginal mesh products.

Sources:

Bloomberg
Reuters
ABC News