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Justice Department Considers Criminal Probe into J&J


Posted in Regulatory and Compliance by Jamie Hartford on April 24, 2014

An advocacy group says the company's destruction of documents related to women who have been injured by pelvic mesh implants may have violated a deferred prosecution agreement with the U.S. Department of Justice.


By Jim Dickinson

The Justice Department says it is considering a March 26 request by the Corporate Action Network (CAN) that it open a criminal probe into Johnson & Johnson (J&J) for destroying thousands of documents relating to women who have been injured by pelvic mesh implants.

Learn how to overcome regulatory pitfalls of medical device development with early clinical involvement at MD&M Texas, May 7–8, 2014, in Fort Worth, TX.

The group says the destruction of evidence may also have violated a deferred prosecution agreement with the department.

A West Virginia federal judge concluded in March that J&J destroyed thousands of documents relating to the development of its pelvic mesh implants and said there was no proof that it was done intentionally. The documents reportedly included reports on patient testing of the mesh implants and could have shown whether participants suffered severe complications.

“Hundreds of thousands of women continue to suffer ongoing, severe harm,” CAN spokesperson Levana Layendecker told the news media. “I hope Johnson & Johnson is held accountable for their failure to warn.”

A spokesperson for J&J's Ethicon, which makes the implants, said it “acted appropriately and responsibly in the research, development, and marketing of our pelvic mesh products. Ethicon has engaged in extensive efforts to preserve and produce evidence in the pelvic mesh (federal litigation) which has led to the production of millions of pages of documents to date. In the context of Ethicon’s substantial document production, the inadvertent loss of certain, limited documents has not prejudiced plaintiffs in their ability to pursue their claims.”

Learn how to overcome regulatory pitfalls of medical device development with early clinical involvement at MD&M Texas, May 7–8, 2014, in Fort Worth, TX.

Jim Dickinson is MD+DI's contributing editor. 

[image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET]


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