Transvaginal & Pelvic Mesh

    What is a “Failure to Warn” Claim in Vaginal Mesh Mass Tort?

    failure to warn

    Plaintiffs’ “failure to warn” claims are common in mass tort litigation, especially for transvaginal mesh cases. The claim that manufacturers didn’t properly convey potential product dangers is a common theme in TVM lawsuits.

    What Does ‘Failure to Warn’ Mean?

    According to the New York Law Journal, “failure to warn” indicates that defendants knew information that wasn’t disclosed to consumers. This means the public used their products without fully understanding devices’ potential risks. The U.S. District Court of the Southern District of New York recently said “failure to warn” claims are difficult to address. This is because the level of proof needed to file or dismiss a claim depends on its specification.

    The law journal reported on a case in which one defendant asked to dismiss the plaintiff’s “failure to warn” claim. The judge approved it because the plaintiff did “not identify the allegedly defective warnings, nor [did] she allege facts in support of her claim that these warnings were, in fact, defective.”

    Failure to Warn Claims Rising in TVM Cases

    With ongoing transvaginal mesh litigation over allegedly unsafe implants, plaintiffs often cite the “failure to warn” claim. In fact, a “failure to warn” claim was used by a South Dakota woman during one famous vaginal mesh case, Bloomberg reported. According to Bloomberg, J&J’s lawyer said if it was true the company knew about defective devices harming consumers, the plaintiff’s concerns were warranted. In fact, the plaintiff’s physician said he wouldn’t have implanted the mesh if he’d known it wasn’t FDA-approved or threatened her health.

    According to Fox News, the jury sided with the plaintiff in the vaginal mesh case, ruling that Johnson & Johnson had to pay the plaintiff $3.35 million for failing to warn the physician and the public about the risks associated with its device.

    An Ethicon lawsuit alleges the company knew its Prolift-M, Prosima and TVT-Oturator (TVT-O) devices were potentially defective. However, Ethicon didn’t warn consumers, according to the filed lawsuit. The Ohio plaintiff says that she didn’t know about vaginal mesh implant risks before her surgery. (She was surgically implanted with TVM to treat her stress urinary incontinence symtoms.) Afterwards, the plaintiff needed additional surgeries to correct damage caused by her pelvic mesh.

    Understanding how a “failure to warn” claim works can be helpful in filing your own TVM lawsuit. “Failure to warn” is a common claim among settled vaginal mesh cases as well as those currently pending.

    What You Can Do

    If you or a loved one experienced complications following transvaginal mesh surgery, you may be entitled to compensation. Over 50,000 transvaginal mesh injury claims have been filed. if you were injured, get a free case evaluation today before the statute of limitations runs out.

    Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as, Yahoo!, MSN, AOL, Xfinity,, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.

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