J&J Destroyed Countless Vaginal Mesh Files: JudgeJ&J Destroyed Countless Vaginal Mesh Files: Judge

Qmed Staff

February 6, 2014

2 Min Read
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Johnson & Johnson's Ethicon subsidiary negligently destroyed an unspecified number of documents that could have provided evidence in a host of vaginal mesh-related lawsuits pending in federal court, a U.S. magistrate judge in West Virginia has ruled.

In a pretrial order entered Tuesday, the judge, Cheryl Eifert, found that "Ethicon's loss of evidence was negligent, not willful or deliberate" in the destruction of documents dating back to 2007. The documents were related to the development of Ethicon's vaginal mesh, which is the subject of thousands of lawsuits against J&J in U.S. District Court, Southern District of West Virginia.

Eifert further recommended that juries in vaginal mesh litigations related to Ethicon devices should be permitted to hear evidence related to the destruction of the files on a case-by-case basis. Eifert also plans to place an undetermined monetary sanction on J&J for losing the documents.

The plaintiff in the case argued that Ethicon's loss of documents in the case represented "a systematic failure at all levels." Ethicon acknowledged that its document-storage system "failed miserably in certain instances" in safeguarding the relevant files. In all, at least tens of thousands were said to be destroyed, but the count could be as high as hundreds of thousands.

The case was initially filed by plaintiff Carolyn Lewis, who was treated with the Gynecare TVT mesh sling, and her husband in July 2012.

Last year, a New Jersey trial related to Ethicon's Gynecare Prolift mesh required the company to pay $11 million in compensatory and punitive damages.

In March 2012, FDA said that the company had been selling its Prolift device for three years without proper regulatory clearance.

Johnson & Johnson agreed to stop selling vaginal mesh products in 2012.

The devices were supposed to treat urinary incontinence. But the FDA from 2008 through 2010 received reports of thousands of serious complications, including  mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.

Other companies that have faced lawsuits over vaginal mesh products include American Medical Systems, Boston Scientific Corp., C.R. Bard, Cook Medical, Endo Health, and Coloplast.

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