Montana Rules J&J Subsidiaries to Pay Millions for Risperdal Marketing
A subsidiary of Johnson & Johnson has agreed to pay $5.9 million after a Montana court ruled that Risperdal was marketed off-label.
The settlement claims that Janssen Pharmaceuticals, Risperdal’s manufacturers, marketed Risperdal for inappropriate uses in children and the elderly. The drug was approved by the FDA for use in adults suffering psychosis.
The Montana settlement is the latest in a string of lawsuits alleging that Risperdal was marketed inappropriately and that caused severe side effects in those that took it.
The latest lawsuit alleged that Janssen knew that Risperdal could cause weight gain, diabetes, and problems with blood vessels in the brains of the elderly. However, Janssen and J&J hid those risks from physicians, patients, and the medical community.
Montana settled the lawsuit in February, and Janssen signed it on February 16th. As part of the multimillion dollar settlement, Janssen will admit no wrongdoing regarding Risperdal’s marketing.
“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.
The settlement money will be divided between several Montana health agencies. Of the settlement money,, $1.5 million will go to the Montana Mental Health Trust for mental services and programs, which spent money on Risperdal prescriptions; $1.5 million will be used to hire a specialist to create a public education programs and prescription drop box locations; and the remainder will go to attorney’s fees.
The Justice Department recently settled an off-label Risperdal lawsuit with J&J for $2.2 billion, which resolved all criminal and civil allegations that the company promoted the powerful antipsychotic for inappropriate use, included in elderly dementia patients and young children. According to the original lawsuit, Johnson & Johnson and their subsidiary Janssen promoted Risperdal for off-label and unapproved uses between 1999 and 2005, such as controlling aggression in elderly dementia patients, as well as behavioral disturbances in children. Risperdal was approved in 1993, launched in 1994, and lost patent protection in 2008; the FDA did not approve pediatric use of the drug until 2006.
After the settlement with the DOJ, J&J has begun the process of overturning verdicts at the state level. The company has managed to overturn Risperdal verdicts in Louisiana, and is pursuing verdicts in Arkansas.
Meanwhile, J&J faces more than 200 personal injury lawsuits involving Risperdal, pending in a consolidated litigation in Philadelphia Common Pleas Court.
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