For the past few years, Johnson & Johnson’s Ethicon has been involved in litigation over its transvaginal mesh products. These devices, which are used to treat urinary incontinence and pelvic organ prolapse, are allegedly defective and cause a number of severe, sometimes permanent complications in women. Numerous transvaginal mesh lawsuits have been filed into the multidistrict litigation, consolidated in the U.S. District Court for Southern West Virginia before Judge Joseph Goodwin.
Now, the company is facing sanction in the litigation over destroyed or missing documents that “should have been preserved in anticipation of this litigation,” stated Magistrate Judge Cheryl Eifert. Mass Device reports that last year, plaintiffs in the litigation asked the court to impose “severe sanctions” for allegedly mishandling and destroying related evidence.
Eifert now writes that “…plaintiffs are entitled to monetary sanctions to compensate them for the additional time spent by their counsel piecing together missing custodial files and preparing for depositions of key employees for whom scant information was provided by Ethicon.” She also recommended that the plaintiffs be allowed to introduce evidence of spoliation on a case-by-case basis, which gives plaintiffs’ parties more of a chance to demonstrate that Ethicon intentionally hid or destroyed the documents.
Johnson & Johnson, C.R. Bard, Boston Scientific, Endo Health Solutions, Cook Medical and Coloplast are all facing litigation over their transvaginal mesh products. Judge Goodwin is overseeing all of these multidistrict litigations. Recently, the C.R. Bard litigation moved forward when a federal judge ordered 200 lawsuits to be slated for discovery.
Transvaginal mesh implants were approved with little to no clinical testing, a point emphasized by the plaintiffs. Because of a regulatory loophole known as 510(k) manufacturers were able to sell and implant these devices in thousands of women without much clinical evidence that they are safe or effective. The 510(k) process foregoes the need for clinical testing so long as the device is shown to be similar enough to an older device; the approval route has now been severely criticized and is being called into question.