J&J Lost or Destroyed Vaginal-Mesh Files, Lawyers Contend

Johnson & Johnson officials destroyed or misplaced documents related to its vaginal-mesh implants and should be barred from relying on some defenses in planned trials over the devices, patients’ lawyers said.

Officials of J&J’s Ethicon unit, which made the company’s Gynecare Prolift implant, lost or disposed of potentially hundreds of thousands of documents over a decade even though they were ordered by executives to preserve them, attorneys for women who blame the devices for their injuries said in a court filing in West Virginia Dec. 2.

“Ethicon’s document destruction has severely prejudiced the plaintiffs for the upcoming bellwether trials,” according to the filing. “Defendants should not benefit from the gaps in plaintiffs’ story that defendant created.”

The filing comes as J&J, based in New Brunswick, New Jersey, is gearing up for the first federal trial over its line of vaginal-mesh inserts that is set for February 10 in federal court in Charleston, West Virginia. A state court jury in New Jersey this year ordered the device maker to pay more than $11 million in damages to a woman who said her Prolift insert caused her chronic pain.

Matthew Johnson, an Ethicon spokesman, said the company had “an appropriate process” for retaining documents and has turned over millions of pages of material to plaintiffs’ lawyers.

“We have never intentionally destroyed, withheld or failed to produce relevant documents,” he said in an e-mailed statement. He said the plaintiffs weren’t “prejudiced by any isolated instances where documents may have inadvertently not been maintained.”

Organ Damage

Last year, the U.S. Food and Drug Administration ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant manufacturers to study rates of organ damage and complications linked to implants. Doctors implanted more than 70,000 mesh devices in the U.S. in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.

Thousands of women contend the meshes have eroded and shrunk over time, causing pain and injuries. Patients have filed suits against J&J, Bard, based in Murray Hill, New Jersey; Endo Health Solutions Inc. of Chadds Ford, Pennsylvania; and Natick, Massachusetts-based Boston Scientific Corp.

J&J officials decided last year to stop selling some lines of vaginal-mesh implants after being hit with a wave of suits over the devices. Still, J&J, the world’s biggest maker of medical products, contends in court filings the Prolift devices are safe and effective and that the company gave adequate warning of any risks associated with the implants.

More than 30,000 vaginal-mesh cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pre-trial information exchanges. Goodwin is slated to preside over the bellwether federal cases.

Document Preservation

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, according to the filing.

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 filing.

“Many employees did not understand that they were supposed to preserve documents or how they were supposed to do it,” the plaintiffs’ attorneys said

Because of the company’s mishandling of documents, J&J should be barred from seeking to throw out suits because they were filed beyond legal deadlines or using other defenses at trial, the women’s lawyers said.

“The proverbial slap on the hand is not enough,” the plaintiffs’ attorneys said in the 26-page filing.

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).

Before it's here, it's on the Bloomberg Terminal.