J&J Settles Risperdal Suit With Montana For $5.9 Million

Johnson & Johnson’s subsidiaries have agreed to settle a lawsuit with Montana for $5.9 million. The lawsuit concerns over how the company marketed the anti-psychotic drug Risperdal (risperidone).

Attorneys for the state claimed that the companies Janssen Ortho LLC and Janssen Pharmaceuticals knew their drug Risperdal carried risks but still commercialized it in illegal ways. These ranged from causing weight gain to diabetes to brain blood vessels complications in the aged. The companies have previously faced a series of lawsuits including a $2.2 billion settlement in November with the U.S. Department of Justice regarding Risperdal. It was the third largest in the U.S. involving a pharmaceutical company, where Janssen Pharmaceuticals admitted that it wrongly promoted the drug to control behavior in aged patients with dementia. The indication was barred on warming labels due to the risk of stroke and death in the elderly.

Risperdal is an atypical antipsychotic containing combined concentrations of risperidone and its major metabolite 9-hydroxyrisperidone. The drug’s therapeutic activity in schizophrenia is not well understood but is thought to be due to the combination of dopamine Type 2 and serotonin Type 2 receptor antagonism. The FDA approved Risperdal for the treatment of adult schizophrenia and short-term treatment of bipolar disorder.

But the lawsuit claimed the two companies also promoted the drug for treatment of other disorders such as dementia in the elderly and various conditions in children. The drug was also allegedly promoted for the treatment of anxiety and depression along with other mental problems in both minors and adults patients.

Janssen Ortho LLC and Janssen Pharmaceuticals said they admit no wrongdoing in the Montana settlement, which was closed February 16. Company spokeswoman Pam Van Houten said in a statement, “Janssen is committed to ethical business practices, and has policies in place to ensure its products are only promoted for their FDA-approved indications.”

The drug is still approved for prescription in the treatment of schizophrenia and bipolar mania, the companies said.