J&J Discloses Government Investigations of Hips, Mesh
Johnson & Johnson (JNJ), the world’s largest seller of health-care products, disclosed separate government investigations into possible false claims related to its hip devices and the marketing of its surgical mesh.
The U.S. Justice Department requested documents relating to whether J&J’s DePuy unit may have submitted false claims to federal health-care programs over its ASR XL hip devices, which were recalled in August 2010, the company said today in a regulatory filing. California is leading a multistate investigation into the marketing of surgical mesh, J&J said.
J&J, based in New Brunswick, New Jersey, said it’s “fully cooperating” with the Justice Department’s civil division and the U.S. Attorney’s Office in Massachusetts after getting an informal request in August about the marketing and use of the hips.
“The government is investigating whether any person or entity submitted or caused to be submitted false claims or false statements affecting federal health-care programs in connection with the marketing and use of the ASR XL hip device,” according to the filing. “The government has since made additional informal requests for the production of documents.”
More than 10,000 lawsuits are pending in the U.S. over the ASR hips, which claim J&J defectively designed the device and failed to warn of possible problems. J&J recalled 93,000 worldwide after saying 12 percent failed in the U.K. The first lawsuit to go to trial is under way in state court in Los Angeles.
California’s attorney general contacted J&J in October regarding a probe of the marketing of mesh products for hernia and urogynecological purposes, J&J said. That probe involves 42 states, the company said.
J&J faces at least 1,800 lawsuits over its Gynecare Prolift vaginal mesh implant used to shore up pelvic muscles. The first of those cases has gone to trial in state court in Atlantic City, New Jersey, where a jury will enter its fourth day of deliberations today.
In August, J&J stopped selling four mesh devices in the U.S., including Prolift. The company said in June that it would end sales worldwide because of the products’ lack of commercial viability, and not based on their safety and effectiveness.
The cases are Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles); and Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).
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