The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

J&J Hit With Lawsuits Over Alleged Pelvic Mesh Injuries

July 22, 2016
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Johnson & Johnson is facing lawsuits in two states that allege the company engaged in deceptive marketing claims for “new and revolutionary” surgical mesh used to treat women with pelvic organ prolapse.

Attorneys general in California and Washington announced the separate suits that hit the company and its Ethicon unit for distributing deceptive informational and marketing materials to consumers and doctors.

These materials included consumer brochures and radio and television ads, Washington State AG Bob Ferguson said during a press conference.

The products in question are the Prolene Mesh/Prolene Soft Mesh, Gynemesh, Gynemesh PS, TVT, TVT- 19 Obturator, TVT-SECUR , TVT Exact, TVT Abbrevo, Prolift, Prolift+M, 20 Prosima, Artisyn and other polypropylene mesh products.

In their lawsuit, filed in the King County Superior Court, Washington officials maintain that the company was aware that the polypropylene threads that make up the mesh — coupled with the process of implanting mesh through the vagina — could lead to “unavoidable complications,” including loss of sexual function and painful intercourse.

“For more than a decade, Johnson & Johnson misrepresented the risks associated with [its] products,” said Washington State AG Bob Ferguson during a press conference. “This is an important consumer protection case because of how harmful these misrepresentations were.”

State Seeks Penalties

He told reporters that the state was alleging tens of thousands of violations. The state is asking the court to prohibit J&J from using the misleading marketing and seeking the maximum penalty of $2,000 for each violation.

The defendants sold roughly 12,000 such devices in Washington between 2005 and 2015, according to the lawsuit.

While there are no hard figures on the number of women who suffered complications from the mesh, Assistant AG Lisa Erwin said there was a complication rate of 30 percent.

She acknowledged that California was considering suit and that other states “are considering their options in terms of litigating.”

Ferguson said J&J was aware that the state had been conducting an investigation and tried to resolve the dispute. However, Ferguson said he wasn’t satisfied with J&J’s offer to resolve the claims.

California AG Kamala D. Harris made a similar allegation against the company, saying it denied women the chance to make a well-informed choice about their health.

That suit has been filed in the Superior Court of the State of California for the County of San Diego. According to California AG Kamala D. Harris, 42,000 were sold in California between 2008 and 2014.

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