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Shezad Malik MD JD
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J&J Hit by Texas Transvaginal Mesh Incontinence Sling Verdict

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It’s more bad news for Johnson and Johnson’s (J&J) Ethicon division in its ongoing vaginal mesh debacle. The company will have to pay out again, in these many cases to go to court over its allegedly defective transvaginal mesh products and urinary incontinence slings.

Johnson & Johnson, the world’s biggest maker of medical products, was ordered by a Texas jury to pay $1.2 million to a woman who alleged that vaginal-mesh implants to treat incontinence was defectively designed. This was the first verdict against the company over those devices.

Texas State Court Verdict

Jurors in state court in Dallas, Texas found that the design of the TVT-O mesh sling implanted in Linda Batiste was defective and that she deserved $1.2 million in compensatory damages, for her injuries. Batiste, aged 64, suffered severe and debilitating pelvic pain when the J&J device eroded inside her. The Dallas jury did not award punitive damages.

This verdict represents the first time a state court jury found that Ethicon’s sling products are defective.

Johnson & Johnson Vaginal Mesh Lawsuits

J&J, is exposed to more than 12,000 lawsuits, which allege that its Ethicon unit improperly designed vaginal inserts, such as the slings, that damaged women’s internal organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.

FDA Investigations

The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. (BCR) and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants devices.

Vaginal Mesh: Huge Medical Industry

Doctors inserted more than 70,000 transvaginal mesh devices in the U.S. in 2010, to strengthen weakened pelvic floor muscles that do not support internal pelvic organs or to treat stress urinary incontinence.

Other Vaginal Mesh Verdicts

In 2013, a New Jersey jury found that J&J was liable and awarded $11.1 million in damages to a woman who claimed that she was injured by a Prolift device. This case was the first case over any of the company’s Vaginal Mesh implants to go to trial.

The jurors found that Johnson & Johnson/Ethicon knew about complications related to its Gynecare Prolift transvaginal mesh (TVM) device, but did not adequately warn the plaintiff and continued to market the product.

The jury awarded 47-year-old Linda Gross and her husband $3.35 million in February 2013, and then an additional $7.8 million in punitive damages. Johnson & Johnson/Ethicon still face thousands of cases over transvaginal mesh implants, which are used to treat bladder incontinence and pelvic prolapse. Plaintiffs claim the devices eroded and shrunk, causing debilitating side effects.

J&J lawyers for  argued that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.

In February, 2014, Judge Goodwin who is overseeing the federal transvaginal consolidated litigation in West Virginia, rejected a woman’s claims that another line of the company’s sling inserts was defective.

The Texas case is Batiste v. McNabb, No. 12-14350, District Court for the 95th Judicial District, Dallas County Texas (Dallas). The West Virginia case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston).