Johnson & Johnson's ($JNJ) executives have had little time to breathe these days. Weeks after submitting a massive offer to settle thousands of metal hip lawsuits, they must prepare for upcoming trials alleging the company's Ethicon division sold faulty vaginal mesh that harmed legions of women. But even before those trials start, there is already a bombshell accusation: patients' attorneys accuse employees of destroying or losing hundreds of thousands of vital product documents.
Bloomberg reports on the allegation, made by patients' attorneys in a court filing at the U.S. District Court, Southern District of West Virginia, which is handling a consolidated group of vaginal-mesh cases. They assert that executives ordered Ethicon employees to preserve documents relating to vaginal-mesh inserts and their development/regulatory approval over a decade, but that employees either lost or destroyed the documents outright. As a result, the attorneys allege that the missing documents put plaintiffs at a disadvantage as they present their stories and want J&J/Ethicon to be barred from benefiting from gaps in their cases that might tie to missing documents.
According to the filing cited by Bloomberg, Ethicon admitted that some employees didn't comply with the order, likely because they didn't understand the request or how to preserve the documents in the first place.
Johnson & Johnson/Ethicon's Gynecare Prolift vaginal mesh implants are at issue here, though the company has long asserted that the products are safe, and that patients received proper warnings of the risks. Still, the company decided in 2012 to stop selling four vaginal mesh products in the face of the mushrooming lawsuits. J&J had already faced pushback from the FDA, which asserted in 2012 that the company sold Gynecare Prolift for three years even though it didn't have the right regulatory approval to do so.
Johnson & Johnson is not the only company facing lawsuits alleging the sale of faulty vaginal mesh, which is meant to help strengthen weak pelvic muscles to better support internal organs and treat conditions such as urinary incontinence. Thousands of cases are pending against J&J and rivals including C.R. Bard ($BCR), Endo Health Solutions and Boston Scientific ($BSX). Bard, Endo and others (excluding J&J) are rumored to be negotiating a legal settlement, however.
When all the dust is settled, there could be wide-ranging industry fallout. The FDA is still sifting through safety data from 31 vaginal mesh-implant manufacturers in order to assess the rate and types of complications caused by the implants. Regulators may also reclassify vaginal mesh implants as Class III devices--a more serious designation than what is currently required for the products under the 510(k) approval process. Regulators warned in 2011 that vaginal meshes had been linked to a variety of safety problems.
- read the full Bloomberg story