Settlements and Verdicts
In November 2013 J&J agreed to pay over $2.2 billion to resolve allegations involving Risperdal, Invega and Natrecor. The government alleged, among other things, that the companies marketed these drugs for off-label use in patients and paid illegal kickbacks to promote their use. Janssen pled guilty to misbranding Risperdal and paid a criminal fine of $400 million. In particular, the government alleged that J&J marketed Risperdal for elderly patients with dementia despite the fact that it was not approved for this purpose. The company allegedly offered incentives to salespeople who for marketed this product for both approved and non-approved uses. The government alleged in a civil complaint that Janssen promoted Risperdal for use in the most vulnerable populations, including elderly nursing home patients, children and individuals with mental disabilities. It was also alleged that J&J knew that the use of Risperdal could increase the risk of strokes in the elderly, but downplayed these dangers.
Attorney General Eric Holder commented on the issue in a Department of Justice press release dated November 4, 2013. “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” he stated, according the release. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” Director of the FDA’s Office of Criminal Investigations John Roth said in the DOJ press release. “Today’s settlement demonstrates thegovernment’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”