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Shezad Malik MD JD
Shezad Malik MD JD
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Bard Vaginal Mesh New Jersey Lawsuit Scheduled for September Trial

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Judge Carol E. Higbee, who is overseeing the New Jersey Mass Tort Vaginal Mesh docket, has scheduled the first trial date for a Bard vaginal mesh lawsuit. The bellwether trial is to begin in September, in the New Jersey state court litigation, where thousands of similar lawsuits are pending.

This case for Bard vaginal mesh, involve a woman who received the mesh transvaginally for repair of pelvic organ prolapse (POP).

Judge Higbee is is in charge of the centralized New Jersey state court litigation involving more than 550 lawsuits over Bard vaginal mesh and more than 3,000 lawsuits over Ethicon’s Gynecare pelvic mesh.

Vaginal Mesh Claims

All of the cases involve allegations of pain and debilitating side effects and injuries from vaginal mesh implanted to treat pelvic organ prolapse or female stress urinary incontinence.

The plaintiffs allege that the surgical mesh products manufactured by C.R. Bard and Ethicon were defectively designed and increase the risk of erosion through the vagina, causing infections and other catastrophic injuries.

New Jersey Verdict

Earlier this year, a positive jury verdict resulted in an award of $11.1 million in damages to a woman injured by Ethicon’s Gynecare Prolift mesh, including $7.76 million in punitive damages designed to punish the manufacturer for failing to warn about the risks associated with their mesh.

Federal Vaginal Mesh Litigation Update

More than 12,500 vaginal mesh lawsuits are pending, where the cases have been centralized as part of 6 different MDLs or multidistrict litigations, involving products manufactured by C.R. Bard, Ethicon, American Medical Systems (AMS), Boston Scientific, Coloplast and Cook Medical.

According to the U.S. Judicial Panel on Multidistrict Litigation, there are at least 2,938 Bard Avaulta mesh lawsuits, 6,028 AMS vaginal mesh lawsuits, 3,557 Boston Scientific pelvic mesh lawsuits, 5,763 Ethicon Gynecare mesh lawsuits and 320 Coloplast bladder slings lawsuits, pending the the Southern District of West Virgina.

The first Bard Avaulta lawsuits are set for trial to begin on July 8, with a series of four cases to go before a jury. Later this year or early next year, additional trials are expected in the federal court system involving products manufactured by AMS, Ethicon and Boston Scientific.

FDA Investigation and Report

The FDA found that there was no evidence that transvaginal mesh provides any additional benefits when compared to traditional surgery, but the device poses an increased risk of serious complications.

Concerns from medical experts about the safety of surgical mesh for treatment of pelvic organ prolapse and female stress urinary incontinence gained attention in July 2011, when the FDA stated that there were nearly 3,000 reports of problems with vaginal mesh were received by the agency between January 2008 and December 2010, including cases where the mesh eroded through the vagina, caused infections and other severe injuries.

In 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, looking for additional information to establish whether they pose an unreasonable risk of injury for women.