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First Vaginal Mesh Trial Against Johnson & Johnson Underway

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Ethicon manufactures transvaginal mesh.

The first trial of 1,800 state vaginal mesh implant lawsuits against Johnson & Johnson began with jury selection last week in the Superior Court of Atlantic County, N.J. The plaintiff, Linda Gross of South Dakota, blames the implant for causing her severe, constant pain that required her to undergo 18 surgeries.

Bloomberg reported that Gross’ attorneys filed documents that said: “She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try and reduce the level of pain.” In addition, Gross is forced to take several medications to treat the pain. She is also a former nurse who can no longer work because of the pain caused by the failed mesh device.

Gross had J&J’s Gynecare Prolift product implanted on July 13, 2006, to help repair pelvic organ prolapse. Her lawsuit claims that the New Jersey-based pharmaceutical giant was fully aware of the problems and risks related to the Prolift mesh implant before it began selling it in 2005. The suit accuses J&J of failure to warn the public of the risks, deceit, defective design and negligence.

After jury selection, opening statements began on Jan. 10. In his opening statement, Adam Slater – Gross’ attorney – said J&J “knew every single catastrophe before it happened. They knew Linda Gross was going to happen.” The plaintiff’s first witness, Ethicon project leader Scott Ciarrocca, took the stand on Jan. 11. He testified that a prototype of the company’s vaginal mesh device failed in 20 percent of women within six months of implantation and 27 percent failed within a year. These failures occurred in studies of the product before the device reached the market.

J&J Denies Allegations

In response to Gross’ claims, J&J attorney Christy Jones said, “Prolift did exactly what it was supposed to do. It put her organs back in the correct anatomical position.” The defendant company also says that Gross’ claims are unwarranted because Gross and her surgeon were properly warned of the risks.

J&J’s spokesman, Matthew Johnson, told Bloomberg: “The evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of pelvic mesh products to treat debilitating conditions affecting many women.”

Despite defending the product, the company discontinued four of its mesh products in the United States in June 2012 – including the Prolift. According to J&J, the products are safe and effective, and it stopped global sales of the product because of poor commercial performance.

More Mesh Safety Studies Required

In 2010, 75,000 American women received transvaginal mesh implants to strengthen pelvic muscles following prolapse. For Gross’ pelvic procedure and others like it, the mesh is inserted through incisions made in the vagina. Gross’ attorney claims J&J did not conduct clinical tests on Prolift before releasing it on the market.

One of the problems is that the mesh hardens in the tissue, causing scarring and inflammation. Removing problematic mesh is also difficult because it fuses with muscles and tissues. Women with mesh implants may suffer from perforation of organs, erosion of the vaginal tissue, vaginal bleeding, vaginal scarring and severe pain.

J&J’s internal emails show that the company knew of the risks of the mesh, yet failed to develop a safer product before releasing it.

In January 2012, the U.S. Food and Drug Administration (FDA) directed J&J and several other mesh manufacturers to conduct studies on organ damage and complications caused by vaginal mesh implants.

Controversy Over Prolift FDA Clearance

There is controversy over whether the Prolift device went through the proper channels of approval. J&J was able to start selling the device under the FDA’s 510(k) application process. Instead of having to conduct rigorous tests, the company simply compared the Gynecare Prolift to another one of its mesh products already on the market, Gynecare Gynemesh.

However, the FDA rejected the application and required that J&J file a new application in 2007. The FDA approved the Prolift in 2008, but J&J began sales before its official approval.

According to Slater, Gross’ doctor was unaware that Prolift wasn’t cleared by the FDA when he implanted it, and he wouldn’t have used the device if he knew. J&J’s lawyers claim they released the product “under guidance” of the FDA. Because of the problems arising from 510(k) approval of faulty mesh products, a bill was introduced to Congress in February 2012 to allow regulators to block medical devices based on past safety issues.

J&J is only one of several companies being sued for dangerous mesh products. Other major mesh manufacturers include American Medical Systems, Boston Scientific and C.R. Bard, Inc. In August 2012, a California jury awarded Christine Scott $5.5 million in her transvaginal mesh lawsuit against C.R. Bard and its subsidiary, Bard Medical.