Johnson & Johnson Facing Two Governmental Probes Concerning Medical Devices

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In separate disclosures, health care products giant, Johnson & Johnson, stated that government investigations are underway concerning two of its medical device products.

Both its hip devices and its surgical mesh are involved in government probes, Bloomberg Businessweek, reports. Hip devices are being investigated over potential false claims accusations and the marketing of surgical mesh is also being probed.

The U.S. Justice Department requested documents concerning if Johnson & Johnson’s DePuy Orthopaedics unit might have provided false claims to federal health care programs over its ASR XL hip devices, Johnson & Johnson stated in a regulatory filing. The filing, noted Bloomberg Businessweek, indicated that the ASR hip devices were recalled in August 2010. Johnson & Johnson also stated that a multi-state investigation is underway in California over the marketing of surgical mesh, according to Bloomberg Businessweek.

Johnson & Johnson stated that it is “fully cooperating” with both the Justice Department’s civil division and the U.S. Attorney’s Office in Massachusetts after it received an informal request this summer over how its hip devices were marketed and used, said Bloomberg Businessweek. “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,” said Johnson & Johnson in the filing. “The government has since made additional informal requests for the production of documents,” the statement continued.

Increasing adverse event report claims of device failure and the ultimate recall of 93,000 ASR hip devices prompted mounting lawsuits. Now, more than 10,000 lawsuits are pending in the United States over the DePuy ASR hip, including that the device maker not only defectively designed the device, but also neglected to warn of its potential risks. At the time of the recall, noted Bloomberg Businessweek, Johnson & Johnson acknowledged that 12 percent of the devices failed in the United Kingdom. Since, reports of much higher failure rates have been reported. The first trial of the 10,000 cases is being heard in California state court.

Meanwhile, the attorney general of California contacted the device maker this past October concerning an investigation into how its mesh products for hernia and urogynecological purposes was marketed, said Bloomberg Businessweek. That probe encompasses 42 states, said Johnson & Johnson.

Transvaginal mesh is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety, with Johnson & Johnson facing some 1,800 lawsuits over its Gynecare Prolift vaginal mesh implant. The case is being heard in state court in Atlantic City, New Jersey; jury is in the midst of deliberations, said Bloomberg Businessweek.

Last July, the U.S. Food & Drug Administration said that the mesh has no clear advantage over non-mesh methods for treating POP and may actually present additional risks. The FDA went on to say that most POP cases can be successfully treated without the use of transvaginal mesh. In June, Johnson & Johnson told a judge that it will no longer sell four types of transvaginal mesh implants, including the Prolift, Prolift + M, TVT Secur, and Prosima. The company also asked the FDA to postpone post-market safety studies of the devices. Bloomberg Businessweek noted that Johnson & Johnson stated that it was ending worldwide sales of the device because of the products’ lack of commercial viability, and not over any alleged safety or efficacy issues.

Both devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, the process has drawn increasing criticism.