Johnson & Johnson has revealed that it is under investigation by state and federal government agencies for alleged false claims related to the marketing of its DePuy metal-on-metal hip replacement and Gynecare transvaginal mesh products. Investigations by the Justice Department and the California attorney general’s office are trying to determine whether Johnson & Johnson may have made false claims to federal health care programs or improperly marketed its products.
The Justice Department investigation is looking into claims that Johnson & Johnson may have submitted false claims regarding the DePuy hip replacements to federal programs such as Medicare and Medicaid. DePuy Orthopaedics, a division of Johnson & Johnson, recalled its ASL XL hip replacements in August 2010 over concerns that the products were more likely to fail prematurely than other hip implants. The Justice Department has requested documents from Johnson & Johnson in connection with the investigation.
Johnson & Johnson is currently facing more than 10,000 DePuy lawsuits alleging that the hip replacements were improperly designed and that the company failed to properly warn patients about the risk of side effects from the ASR implants. The controversy surrounding the DePuy recall has also led to concerns about other metal-on-metal hip replacements, which many experts believe are more dangerous than hip implants manufactured from other materials.
The California attorney general’s office is also investigating Johnson & Johnson regarding the marketing of its Gynecare transvaginal surgical mesh products. The investigation is part of a probe by 42 state attorneys general into the marketing of surgical mesh for hernia repair or gynecological surgery for conditions such as pelvic organ prolapse and stress urinary incontinence.
Patients who were injured after using a surgical mesh product for transvaginal repair have filed at least 1,800 lawsuits against Johnson & Johnson over the company’s Gynecare Prolift implants. In August 2012, the company announced that it would stop selling Prolift and three other transvaginal surgical mesh implants, although the company said that this was because the products were no longer profitable, and not because of any health risks associated with their use.