Johnson & Johnson and its subsidiaries will pay more than $2.2 billion to resolve charges related to the prescription drugs Risperdal, Invega, and Natrecor, including promotion for uses not approved as safe and effective by the U.S. Food and Drug Administration and payment of kickbacks.
Risperdal and Invega are anti-psychotic medications approved by the FDA to treat schizophrenia and bipolar disorder.
The U.S. Department of Justice contends that from Jan. 1, 1999, through Dec. 31, 2005, J&J and its subsidiary Janssen Pharmaceuticals Inc., marketed Risperdal for off-label uses and made false and misleading statements about the safety and effectiveness of Risperdal. The federal government also charge that the companies paid illegal kickbacks to health care professionals and long-term care pharmacies to induce them to promote or prescribe Risperdal to patients, such as children, adolescents, and the elderly, for which there was no FDA approval.
Consulting pharmacists with Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients, regularly made recommendations to physicians on what drugs should be prescribed to these patients and were viewed as an “extension of [J&J’s] sales force,” federal officials said.
In addition, federal officials said that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.
Johnson & Johnson has agreed to plead guilty to a criminal misdemeanor, acknowledging that it improperly marketed Risperdal to older adults for unapproved uses.
Federal officials also contend that from Jan. 1, 2007, through Dec. 31, 2009, the companies promoted Invega for off-label uses and made false or misleading statements about the safety and effectiveness of the drug.
In addition, the settlement resolves charges that J&J and another of its subsidiaries, Scios Inc., were responsible for false claims to be submitted to federal health care programs for the heart failure drug Natrecor.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said U.S. Attorney General Eric Holder.
As part of the resolution, the companies have also entered into an agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will monitor the company’s future marketing and sales practices.
The settlement, announced Monday, requires the approval of a federal judge. It's the third largest settlement in the United States involving a pharmaceutical company.
“This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud,” Holder said. “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.”