The pharmaceutical giant Johnson & Johnson has agreed to pay $2.2 billion to resolve criminal and civil cases over its marketing of the anti psychotic drug Risperdal and other medications.
The Risperdal case goes back years. The drug was approved for treating schizophrenia, but the New Jersey-based company has now agreed to plead guilty to a criminal charge that it promoted the drug tor treat elderly patients with dementia in 2002 and 2003.
US Attorney Zane David Memeger said those prescriptions “put those patients at risk of harm, and over the course of time, clinical studies had shown that there was an increased of stroke, heart attack with regard to elderly patients, and increased risk of diabetes.”
In a prepared statement, Johnson & Johnson said it “accepts accountability” for its actions in that criminal plea, for which It will pay about $485 million in fines and forfeiture.
But Johnson & Johnson is also agreeing to pay more than $1.7 billion to settle civil claims by federal authorities and 45 states, and the company’s statement statement says the settlement “is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.
Those allegations include improperly marketing Risperdal to children for the treatment of attention deficit hyperactivity disorder, obsessive-compulsive disorder and autism despite known health risks, including production of a hormone that triggers breast development.
Some of the conduct involved in the settlement dates back more than 10 years. Asked why it took so long, Memeger said prosecutors often get such cases months or years after someone has filed a civil suit, and prosecutors have to re-construct the conduct at issue.
“In a lot of these type of cases industry participants may have moved on to another company,” Memeger said. “Electronic information, depending on the length of time may be more difficult to get access to.”
The plea agreement is subject to approval by a federal judge.