Johnson and Johnson will pay out billions of dollars in what is being touted as one of the largest health care fraud settlements in the history of America. A statement released Monday by the United States Department of Justice outlines allegations relating to three prescription drugs Risperdal, Invega and Natrecor produced by Johnson & Johnson (J&J) subsidiaries, Janssen Pharmaceuticals and Scios Inc.
The allegations point to a pervasive problem in the medical industry which includes promoting drugs for uses not approved as safe and effective by the Food and Drug Administration (FDA) and paying kickbacks to physicians to prescribe drugs like the schizophrenia drug, Risperdal, often for unapproved uses, to those most vulnerable, the elderly, children and the disabled.
In the case of Risperdal, pharmaceutical representatives of Janssen promoted the drug to doctors who treated elderly dementia patients by urging them to use Risperdal to ease symptoms like anxiety, agitation, depression, hostility and confusion even though they were aware that Risperdal actually posed serious health risks for the elderly, including an increased risk of stroke.
From 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force”, trained to target nursing homes and doctors of the elderly. The sales force promoted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in the elderly.
According to the allegations, written sales aids used by the ElderCare sales force emphasized treatment of symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia. The government further alleges that the “FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.”
The FDA cautioned Janssen that behavioral disturbances observed in elderly dementia patients were not always manifestations of psychotic disorders and could possibly even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”
Janssen did not just target the elderly with Risperdal, the DOJ allegations note that even though J&J and Janssen knew that Risperdal posed health risks to children, including the risk of breast development and milk production. Boys with boobs didn’t concern the pharmaceutical company, in fact, one of Janssen’s Key Base Business Goals was to grow the drug’s market share with youth patients.
This time, the sales representatives were trained to call on child psychiatrists, and mental health facilities that treated children. Once again, despite known risks, the drug was marketed as safe and effective for symptoms of various conditions, like ADHD, obsessive-compulsive disorder and autism. Risperdal was not approved for use in children for any purpose, until late in 2006, and the FDA alleges that they repeatedly warned Janssen against promoting its use in children.
The FDA maintains that, while “physicians may, within the practice of medicine, use a drug to treat patients for symptoms or diseases even when the drug is not FDA-approved for such uses. However, if a pharmaceutical manufacturer intends its drug to be used for a new use, not approved by the FDA, and introduces the drug into interstate commerce for that use, the drug is misbranded, and introduction of that misbranded drug into interstate commerce is a violation of the law.”
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “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.”