Johnson & Johnson’s Regulatory Filing Indicates Two Governmental Probes

In separate disclosures, Johnson & Johnson, stated that government investigations are underway concerning two of its medical device products. Johnson & Johnson is the world’s largest health care products manufacturer and the products in question have been making headlines in recent days.

The now-recalled DePuy Orthopaedics ASR hip device and the mesh Johnson & Johnson uses in hernia and transvaginal surgeries are both involved in the government probes, according to Bloomberg Businessweek. The DePuy ASR is being investigated over potential false claims accusations, while the way in which surgical mesh was marketed is being probed. DePuy Orthopaedics is a unit of Johnson & Johnson.

As we’ve long noted, 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.

The U.S. Justice Department requested documents on whether DePuy 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, also indicated that the ASR hip devices were recalled in August 2010 and that a multi-state investigation is underway in California over the marketing of its surgical mesh.

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 over the summer. The request involved the way in which the ASR 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.”

Meanwhile, increasing adverse event report claims of hip device failure and the ultimate recall of 93,000 ASR hip devices prompted mounting lawsuits with more than 10,000 cases pending in the United States over the DePuy ASR. Claims include allegations 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 is now being heard in California state court.

Regarding its mesh devices, the attorney general of California contacted Johnson & Johnson this past October concerning an investigation into how hernia and urogynecological mesh were marketed, said Bloomberg Businessweek. That probe encompasses 42 states, said Johnson & Johnson.

As we’ve explained, 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, Johnson & Johnson now faces some 1,800 lawsuits over its Gynecare Prolift vaginal mesh implant; the case is being heard in state court in Atlantic City, New Jersey and the 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 that the FDA 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, not over any alleged safety or efficacy issues.