The Court overseeing the consolidation of transvaginal mesh cases recently determined that Johnson & Johnson’s Ethicon unit which manufactured the Gynecare TVT and Prolift products destroyed thousands of documents and files regarding the development of the devices. It was determined that the Defendants failed to preserve documents that were important to Plaintiff’s claims placing them at a disadvantage during trial.
J&J’s behavior prompted one judge to state that the company had “failed miserable in certain instances” regarding attempting to preserve documents associated with the litigation. Ethicon and Johnson & Johnson are facing allegations regarding their vaginal mesh products including pain during intercourse, infection, pelvic pain, recurrent incontinence and removal surgeries.
It is estimated that approximately 300,000 women have the vaginal mesh implanted each year. Johnson & Johnson and Ethicon produced a large portion of these products. Recently, a case regarding Ethicon’s Prolift product went to trial in New Jersey and the Plaintiff was awarded $11 million in compensatory and punitive damages. It is unclear the precise numbers of Ethicon cases but it is believed that there is approximately 13,000 cases in the Ethicon MDL, In re: Ethicon, Pelvic Repair Systems Product Liability Litigation, MDL No. 2327 in the U.S. District Court for the Southern District of West Virginia.
Ethicon is not only facing personal injury lawsuits, the company is also facing claims regarding false and deceptive marketing of its products. This has not been a good year for Ethicon since it was recently revealed that they marketed their Prolift product without FDA approval.
In June 2012, Johnson & Johnson’s Ethicon division announced that it would stop selling four types of mesh implants, GynecareTVTSecur™ System, GynecareProsima™ Pelvic Floor Repair System, GynecareProlift™ Pelvic Floor Repair System, and GynecareProlift+M™ Pelvic Floor Repair System, used to treat stress urinary incontinence. The company claimed that it was removing the products “in light of changing market dynamics, and is not related to safety or efficacy.” However, the timing is very coincidental in light of the FDA’s demand that the manufacturers test these products and monitor adverse event reports.
After reports from manufacturers and analysis by the FDA, it was announced on April 29, 2014 that these mesh products would be reclassified as “high risk products.” The FDA is now requiring manufacturers to provide detailed evidence that the products are safe and effective. However, these actions from the FDA come too late as hundreds of thousands of women have been affected by these products. – See more at: http://pcsblaw.com/lawyer/2014/05/14/Bladder-sling/Johnson–Johnson-Destroys-Crucial-Files-Regarding-Vaginal-Mesh-Implants_bl13019.htm#sthash.UJTIDm0K.dpuf