Lawyers Contend Johnson & Johnson Lost or Destroyed Vaginal-Mesh Files
Written by James P. Nevin
Johnson & Johnson officials destroyed or misplaced documents regarding its vaginal-mesh implants and therefore should be barred from relying on some defenses in upcoming trials, according to patients' lawyers.
J&J's Ethicon unit made the company's Gynecare Prolift implant. Ethicon officials lost or disposed of potentially hundreds of thousand documents over a decade even though they were ordered by executives to preserve them, plaintiffs' attorneys' stated in a court filing in West Virginia. The filing says that Ethicon's document destruction has "severely prejudiced the plaintiffs for the upcoming bellwether trials." Thus, the defendant's should not, according to the plaintiffs' attorneys, benefit from the gaps in plaintiffs' story that defendant created."
The filing is part of the first federal trial over J&J's line of vaginal-mesh inserts and is set for February 10 in federal court in Charleston, West Virginia. A state court in New Jersey this year ordered the device maker to pay more than $11 million in damages to a woman who said the Prolift caused her chronic pain.
Matthew Johnson, spokesman for Ethicon, denies the company intentionally destroyed, withheld or failed to produce relevant documents. And so plaintiffs were not prejudiced by any isolated instances where the documents "may have inadvertently not been maintained."
However, Ethicon acknowledges that not all employees complied with the order to retain documents related to the development and regulatory approval of the vaginal mesh inserts that was issued by J&J executives. For example, Ethicon destroyed all documents Renee Selman (former president of Ethicon) had on her computer's hard drive, according to the filing.
The U.S. Food and Drug Administration ordered J&J, C.R. Bard Inc., and 31 other vaginal-implant manufacturers last year to study the rate of organ damage and complications caused by their product. More than 70,000 mesh devices were implanted by doctors in the U.S. in 2010. The devices were threaded through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.
Thousands of women contend the meshes have caused them pain and injury by eroding and shrinking over time. Patients have filed suits against J&J, Bard, Endo Health Solutions Inc., and Boston Scientific Corp. J&J officials ceased selling some lines of vaginal-mesh implants after being hit with a wave of suits over the devices. After all these issues, J&J still claims in court filings that the Prolift devices are safe and effective and that the company gave adequate warning of any risks associated with the devices.
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.
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).