Feb. 5 (Bloomberg) -- Johnson & Johnson improperly destroyed files about some vaginal-mesh implants and may have to let juries weighing lawsuits over the devices hear evidence about the destruction, a court official said.
J&J’s Ethicon unit, which made Gynecare Prolift and TVT Retropubic meshes, lost or destroyed thousands of documents and computer files about the development of the devices from as far back as 2007, Cheryl Eifert, a U.S. magistrate judge in Charleston, West Virginia, concluded yesterday. Suits over the devices are consolidated there for pre-trial hearings.
The finding comes as J&J prepares to face its first trial Feb. 10 in West Virginia over claims the TVT Retropubic sling, used to support women’s internal organs, eroded and shrank over time, causing pain and injuries. J&J, based in New Brunswick, New Jersey, is facing more than 12,000 federal-court claims over the TVT Retropubic and its other vaginal-mesh inserts.
Ethicon officials acknowledged their document-retention system “failed miserably in certain instances” to properly preserve vaginal-mesh files, Eifert said. She recommended that U.S. District Judge Joseph Goodwin, who is overseeing the consolidated cases, allow women suing J&J to tell jurors about the loss of documents if they can show the destruction put them at a disadvantage.
Ethicon officials “did inadvertently fail to preserve some documents,” Matthew Johnson, an Ethicon spokesman, said today in an e-mailed statement. Still, the company turned over millions of pages to women suing over the devices and some of the allegedly missing files were among those records, Johnson added.
In her report, Eifert said there was no evidence Ethicon officials deliberately sought to keep vaginal-mesh files out of court. The documents were destroyed after employees left the company as part of Ethicon’s file-management system, she said.
Eifert found Ethicon officials were negligent in their mishandling of the files and should be punished by allowing some juries to hear about the document destruction. The magistrate’s recommendations must be reviewed by Goodwin before they become final.
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 they’ve been injured by meshes that have eroded. 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. J&J, the world’s biggest maker of medical products, contends in court filings the Prolift and TVT Retropubic devices are safe and effective and that the company gave adequate warning of any risks associated with the implants.
Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed J&J’s Prolift vaginal-mesh device for her injuries in the first case over any of the company’s implants to go to trial.
Lawyers for Carolyn Lewis, a 59-year-old Texas woman who had a TVT Retropubic sling implanted in 2009 to treat incontinence, will argue in next week’s trial the device was defectively designed and caused painful deformities to Lewis’s vagina.
Ethicon’s Johnson said today that the company will defend itself against Lewis’s claims.
“We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing” of its TVT Retropubic sling, Johnson said.
Attorneys for other women suing over the slings contend they don’t have access to files of executives such as Renee Selman, Ethicon’s former president, because the company wrongfully allowed computer hard drives and paper records to be erased or destroyed.
Eifert found Ethicon officials properly ordered employees to retain vaginal-mesh files, but didn’t follow through in collecting the documents or insuring backup files existed. She noted “relevant records” from nine current and former employees, including Selman and Ramy Mahmoud, Ethicon’s former chief medical officer, were missing.
As part of Ethicon’s punishment, the company also should pay a fine, Eifert recommended. The magistrate said the amount of the penalty will be determined later this year.
The consolidated case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston). The case set for trial Feb. 10 is Lewis v. Johnson & Johnson, 12-cv-04301, U.S. District Court, Southern District of West Virginia (Charleston).
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