Subsidiaries of Johnson & Johnson have agreed to pay $5.9 million to settle a lawsuit with Montana over how an anti-psychotic drug was marketed, state Attorney General Tim Fox said Thursday.
The settlement with Janssen Ortho LLC and Janssen Pharmaceuticals closes the latest in a string of lawsuits across the nation over the drug Risperdal, including a $2.2 billion settlement in November with the U.S. Department of Justice.
The companies knew the drug had the potential to cause weight gain, diabetes and complications to the brain’s blood vessels in the elderly, attorneys for the state claimed.
But the pharmaceutical companies hid those risks from physicians, patients and others in the medical community about those risks, attorney William Rossbach said in the state’s 2008 lawsuit.
The drug was approved for use by the Food and Drug Administration for adult schizophrenia and short-term treatment of bipolar disorder. But the companies also promoted Riserpdal for other uses, including various conditions in children, dementia in the elderly and anxiety, depression and other metal problems in both minors and adults, the lawsuit said.
Doctors may prescribe a drug for any use, but drugmakers may not promote them in ways not approved by the FDA.
The companies admit no wrongdoing in the Montana settlement, which was signed Feb. 16.
“Janssen is committed to ethical business practices, and has policies in place to ensure its products are only promoted for their FDA-approved indications,” spokeswoman Pam Van Houten said in a statement.
Risperdal is still being prescribed for schizophrenia and bipolar mania, she said.
Of the proceeds in the settlement, $1.5 million will be used to hire a public education specialist and create a program to educate students, expand prescription drug drop-box locations in the state and create a public-awareness campaign on the dangers of prescription-drug addiction, Fox said.
The program, which is expected to begin sometime after June, is a reflection of the need to do more to combat the epidemic of prescription-drug abuse, Fox said.
“It’s going to take the efforts of a lot of different people and agencies,” he said.
Another $1.5 million will go to the Montana Mental Health Trust for mental health services and programs. Plus, $675,000 will be for consumer protection education and $825,275 will reimburse the state Department of Public Health and Human Services for the Medicaid money it spent buying Risperdal.
The bulk of the remainder will go toward legal fees, which totaled more than $1 million, Fox said.
November’s $2.2 billion settlement with the Department of Justice and several states was the third-largest in the U.S. involving a drugmaker. Janssen Pharmaceuticals admitted that it promoted Risperdal to control the behavior in seniors with dementia, a use barred on warning labels because of the risk of stroke and death in elderly patients.
Montana and a handful of other states filed separate litigation instead of joining the Justice Department litigation. Appeals of judgments against the companies are pending before the Arkansas and South Carolina supreme courts, while the Louisiana Supreme Court in January overturned a $330 million verdict against the companies.
Cases also are pending in Kentucky and Mississippi, Van Houten said.