On September 5, 2014, after a two-week trial in federal court in West Virginia, a jury awarded $3.27 million to the plaintiff for her alleged injuries resulting from the transvaginal mesh that had been implanted in her to treat her urinary incontinence. The plaintiff alleged that she had to undergo multiple corrective surgeries and suffers from chronic pelvic pain due to the defective device. This was the second federal jury verdict in favor of the plaintiff in transvaginal mesh cases.
The verdict in this case was against Ethicon, which is a unit of Johnson & Johnson. The defendant was found liable for selling a defective product (the transvaginal mesh) and for failing to warn patients and their doctors regarding the risks associated with its mesh product. Johnson & Johnson is facing more than 30,000 lawsuits claiming that Ethicon sold improperly designed vaginal inserts (the plaintiff’s device was Ethicon’s Gynecare TVT Obturator that is often referred to as TVT-O pelvic mesh). More than 21,000 of the defective device cases have been filed against Ethicon in the federal U.S. District Court for the Southern District of West Virginia.
At the state level, Ethicon has been found liable in two transvaginal mesh cases that have gone to trial: a New Jersey plaintiff was awarded more than $11 million in compensatory and punitive damages by a jury in March 2013, and a 64-year-old Texas woman was awarded $1.2 million in April 2014 for the injuries she suffered as a result of the TVT-O sling. The TVT-O sling remains on the market.
The plaintiff’s attorney stated after last week’s verdict in favor of his client, “We are pleased the jury understood innocent people should not be suffering because of Ethicon’s negligence.”
A spokesperson for Ethicon stated after the verdict, “The verdict is disappointing and we believe we have strong grounds for appeal. Ethicon’s TVT-O sling was properly designed, and Ethicon acted appropriately and responsibly in the research, development and marketing of the product.”
Huskey v. Ethicon, U.S. District Court for the Southern District of West Virginia, Case No. 12-5201.
On April 29, 2014, the FDA issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and would reclassify urogynecologic surgical mesh instrumentation from class I to class II, based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for the device. The FDA also proposes to require manufacturers to submit a premarket approval (PMA) application for the FDA to evaluate safety and effectiveness.
If you or a loved one suffered injuries or other harms due to transvaginal mesh or another surgical mesh product, you should promptly seek the legal advice of a mesh claim attorney in your U.S. state who may investigate your mesh claim for you and represent you in a case against its manufacturer, if appropriate.
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