The South Carolina Supreme Court has ordered Johnson & Johnson subsidiary Janssen Pharmacetuicals to pay $136 million to the state for deceptively marketing its antipsychotic drug Risperdal. The decision upholds penalties against the company but reduces the damages, which were originally set at $327 million by a trial court in 2011.
Justices said the penalty had to be reduced because of South Carolina’s three-year statute of limitations.
Risperdal, known generically as risperidone, is used to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. The drug has also been prescribed off label to treat attention deficit hyperactivity disorder (ADHD) and other behavioral problems in both pediatric and geriatric populations.
Doctors have the authority to prescribe drugs for conditions for which they are not approved, but drug companies are forbidden from marketing medications for unapproved uses. Drug companies are also required to provide information about side effects associated with the drugs they promote.
In 2013, Janssen agreed to pay $181 million to settle similar claims brought by 36 states and the District of Columbia. South Carolina was not part of that arrangement. Similar decisions in Arkansas and Louisiana were overturned. But the company agreed to pay $5.9 million to Montana.
Illegal marketing practices and failure to warn about side effects were also front-and-center in a recent jury decision that awarded an Alabama man with autism $2.5 million as a result of his claim that he grew large breasts after taking Risperdal. Austin Pledger, now 20, took the drug for five years beginning at age 8, before the medication was approved to treat pediatric patients.
A former Food and Drug Administration (FDA) chief testified that Janssen manipulated data involving Risperdal side effects, including information that the antipsychotic could cause boys and young men to develop breasts, a condition known as gynecomastia.