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.”
