Pharmaceutical company Johnson & Johnson has agreed to pay the state of Massachusetts $62.5 million to settle three cases that alleged it improperly marketed antipsychotic drugs for people who had dementia or Alzheimer’s disease and offered kickbacks to a pharmacy company to increase prescribing of the company’s products.
The bulk of the money is part of a $1.25 billion settlement with the US Department of Justice and Food and Drug Administration over misbranding of the drug Risperdal, which was approved a decade ago for treatment of schizophrenia, acute mania, and bipolar disorder.
When given to the elderly, antipsychotic medications can pose serious risks, including stroke or death. Kay Lazar and Matt Carroll of the Globe staff last year wrote a two-part series showing how many nursing homes were routinely using antipsychotics to control patients, despite the health risks.
Lazar and Carroll found that in more than one in five nursing homes in the country the drugs were administered to a significant portion of residents, though they did not have a severe mental illness that would have warranted use of the drugs. The numbers were even higher in Massachusetts.
Federal officials alleged that J&J knew about problems posed by Risperdal, but issued data that deliberately played down the risks of the drug. The case also involved Invega, another antipsychotic allegedly marketed for uses not approved by the FDA.
Johnson & Johnson, in a statement posted on its website, said the settlement “is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.”
Its subsidiary Janssen Pharmaceuticals, Inc. also agreed to pay a $400 million criminal fine for misbranding Risperdal.
In a separate five-state settlement, Massachusetts’s Medicaid program will receive $8 million. That case alleged that J&J paid kickbacks to pharmaceutical services company Omnicare for switching nursing homes to the drug company’s products, including the antipsychotics, for off-label use. And, in an agreement filed in Suffolk Superior Court, Janssen will pay the state $15.1 million to settle a consumer protection case that alleged the company promoted Risperdal to treat dementia and for use with children and adolescents, without federal approval.
“Illegal marketing puts patient safety at serious risk and diverts scarce health care dollars from the care and treatment of our most vulnerable citizens,” Attorney General Martha Coakley said in a press release.
Of the $15.1 million state settlement, $2 million will be distributed by the Department of Public Health grants for programs aimed at reducing the inappropriate use of antipsychotic medications in nursing homes, and $3.5 million will go to the state general fund. The remainder will be used by Coakley’s office to fund health care programs.