A judge has held that Johnson & Johnson improperly destroyed files related to its embattled vaginal-mesh implants, raising the possibility that the destruction will be brought before the jury currently weighing the class action suit that now enters its second year of litigation, court officials said on Thursday.
U.S. magistrate judge Cheryl Eifert, presiding over the Charleston, W. Va., court where the suits have been consolidated, said that J&J’s Ethicon unit acted negligently in destroying or losing thousands of documents and files relating to the development of its vaginal-mesh implants, with gaps in data reaching as far back as 2007. Devices like Gynecare Prolift and TVT Retropubic sling, which are designed to reinforce a weakened pelvic wall, have been subject to numerous lawsuits and attracted countless consumer injury lawyers over the past decade. So far, consumers have collected settlements and awards amounting to millions for a variety of complications.
Judge Eifert’s finding at the pre-trial hearing was not disputed by counsel for Ethicon, whose officials promptly admitted that their protocols for document-retention had “failed miserably in certain instances.” While acknowledging that the files may have been destroyed in good faith, Eifert nonetheless ceded the matter to U.S. District Judge Joseph Goodwin, who will now decide whether the jury will hear about the lost documentation. It is not clear whether this would sway the jurors’ verdict on the more than 12,000 federal claims the class action suit includes.
Speaking to Bloomberg, Matthew Johnson, a spokesperson for Ethicon, characterized the destruction as an unfortunate error in procedure, citing the volume of documentation as a source of possible confusion. “While Ethicon produced millions of pages of documents in the MDL, it did inadvertently fail to preserve some documents, many of which were available elsewhere” he said. Eifert’s report appeared to confirm this, linking the bulk of the destruction to routines regarding employees leaving the company.
The current vaginal-mesh lawsuit is the latest in a long line of claims against J&J implants linked to severe complications for patients. According to Adam Slater, a New Jersey lawyer who successfully argued a million-dollar claim for Prolift victims in 2012, some of these devices have been approved through the FDA’s 501(k) clause — an abbreviated clearance process that allows products to enter the market with significantly less testing.
"The whole concept of the 510(k) process should be scrapped," he told ABC News in 2011. “The doctor who created the product has even said that they need more studies to determine if this mesh has long-term safety and effectiveness. If you didn't have the 510(k) process, J & J would have had to do those studies before they could sell it on the market.”