February 6, 2014 | By Mark Hollmer
Johnson & Johnson’s Ethicon arm lost an early fight ahead of trials alleging that it sold faulty vaginal mesh implants that harmed women. Patients’ attorneys had accused the company of inappropriately destroying or losing hundreds of thousands of product documents relating to the issue, and a judge has concluded the allegation is true. The company’s first trial is slated to begin Feb. 10.
As Bloomberg reported, a U.S. magistrate judge in Charleston, West Virginia ruled that the company lost or destroyed thousands of documents and computer files dating back to 2007. They related to development of its Gynecare Prolift and TVT Retropublic meshes, and the magistrate judge recommended that juries get to hear evidence concerning the destruction, assuming plaintiffs can show that the loss of evidence harms their case. At the same time, the judge determined that Ethicon execs didn’t intentionally destroy the file. Rather, she said the actions appear to stem from negligence, according to the story.
U.S. District Court Judge Joseph Goodwin is overseeing a consolidated group of vaginal mesh cases at the U.S. District Court, Southern District of West Virginia. He’ll review whether juries should be allowed to hear about the evidence destruction, plus other recommendations from the magistrate judge, before they’re finalized, Bloomberg reported.
An Ethicon spokesman noted to Bloomberg that Ethicon had produced millions of pages of documents during the legal-ramp up, but acknowledged that “it did inadvertently fail to preserve some documents.” The spokesman said that some of the information was available in other files that had been subsequently turned over to plaintiffs. Previously, Ethicon has acknowledged that some employees didn’t comply with an executive order to preserve documents relating to vaginal-mesh inserts and their development and regulatory approval over the last 10 years. The company asserted that the problem stemmed from a misunderstanding over the request itself or how to preserve the documents.
Johnson & Johnson/Ethicon continues to assert the safety of its vaginal mesh products, which are meant to help strengthen weak pelvic muscles and treat conditions such as urinary incontinence. The company said patients were properly warned about implant risks, though it stopped selling four vaginal mesh products in 2012 as lawsuits began to swell. There’s also an issue concerning the FDA, which claimed in 2012 that Ethicon sold Gynecare Prolift for three years even though it lacked proper regulatory approvals.
Other vaginal mesh manufacturers face their own lawsuits, including C.R. Bard ($BCR), Endo Health Solutions ($ENDP) and Boston Scientific ($BSX), though rumors have swirled about that Bard, Endo and more may be seeking a settlement. (Johnson & Johnson was not part of those rumors.)
The FDA is also sifting through safety data from 31 vaginal mesh-implant manufacturers and may reclassify them as Class III–or riskier–devices moving ahead.
J&J’s first trial in the case begins Feb 10 in West Virginia, Bloomberg noted, revolving around claims that the TVT Retropublic device, which helps support a woman’s internal organs, injured patients after eroding and shrinking.
About Mark Hollmer
Mark Hollmer is a veteran life sciences journalist. Before joining FierceMarkets, he was a staff writer for “The Gray Sheet,” an Elsevier Business Intelligence publication, where he wrote about medical device and diagnostics startups, and regulatory milestones for large companies in both sectors, among other topics. Previously, he spent several years as a life sciences and health care reporter at the Boston Business Journal, where he followed the biotechnology, medical devices, hospital and health insurance industries. While there, he spoke regularly about top life sciences stories during appearances on New England Cable News, and commented on the growth of the Bay State’s life sciences industry as part of a special that aired on the WGBH Boston public television station. Separately, he served a stint at Brown University, promoting innovations generated by the school’s life sciences researchers and medical school. Mark lives with his partner in Washington, D.C. where he enjoys the region’s multiple museums, great restaurants and excellent cultural scene