According to Bloomberg news, Johnson & Johnson (J&J) officials destroyed or lost documents related to its vaginal-mesh implants. J&J’s Ethicon unit, manufacturers the company’s Gynecare Prolift implant, lost or disposed of hundreds of thousands of documents over a decade even though they were ordered to preserve them.
The first federal trial over J&J’s Ethicon unit line of vaginal-mesh inserts is set for February 10 in federal court in Charleston, West Virginia. A New Jersey state court jury earlier this year ordered J&J to pay more than $11 million in damages to a woman who said her Ethicon Prolift insert caused her chronic pain.
FDA Warnings: Vaginal Mesh Injuries
In 2012, the U.S. Food and Drug Administration ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant manufacturers to investigate complication rates of organ damage. Doctors implanted more than 70,000 mesh devices in the U.S. in 2010, pelvic organ prolapse and urinary incontinence.
Vaginal Mesh Lawsuits
Judge Goodwin is presiding over more than 36,000 federal vaginal mesh lawsuits, which have been centralized in the Southern District of West Virginia as part of six different MDLs, or Multi-District Litigations. These coordinated proceedings have been established against different manufacturers of the mesh products used to repair pelvic organ prolapse or female stress urinary incontinence.
According to the latest case list released by the U.S. Judicial Panel on Multidistrict Litigation on November 18, there are currently 5,275 Bard Avaulta mesh lawsuits, 11,369 American Medical System (AMS) mesh lawsuits, 7,131 Boston Scientific mesh lawsuits, 11,376 Ethicon Gynecare mesh lawsuits, 1,101 Coloplast bladder sling lawsuits and about 133 Cook Medical biologic mesh lawsuits.
According to thousands of women, the meshes have eroded and shrunk over time, causing pain and injuries. J&J officials decided last year to stop selling some lines of vaginal-mesh implants after thousands of lawsuits over the devices. J&J, claims that the Prolift devices are safe and effective and that the company gave adequate warning of any risks associated with the implants.
While J&J executives said they warned Ethicon officials to retain documents related to the development and regulatory approval of the vaginal-mesh inserts, Ethicon acknowledged that not all employees complied with that order. Ethicon “admitted that it destroyed all documents” that Renee Selman, the J&J unit’s former president, had on her computer’s hard drive, according to the report.
The case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston).
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.