Pharmaceutical

Third Risperdal side effects lawsuit goes to trial

risperdal Third Risperdal side effects lawsuit goes to trialAttorneys for the plaintiff in the third Risperdal side effects lawsuit to go to trial blasted Johnson & Johnson’s unit Janssen Pharmaceuticals over illegally promoting the antipsychotic as a treatment for children with behavioral conditions.

Risperdal, known generically as risperidone, is approved to treat symptoms of schizophrenia, bipolar disorder and irritability with autism. It wasn’t approved for pediatric patients until 2006. However, even before the drug was approved for children and adolescents with those conditions, Janssen pushed its sales force to market the drug to doctors for off-label uses.

Doctors have the discretion to prescribe drugs for conditions or patients for which they are not approved, but it is illegal for drug companies to market the drugs for unapproved uses. Johnson & Johnson and Janssen have since paid billions to settle lawsuits related to off-label marketing of some of its drugs, including Risperdal.

At issue are Risperdal side effects that specifically affect children. The drug increases levels of prolactin in the blood, which is the hormone responsible for making pregnant women lactate. Increased prolactin levels in adolescent boys, however, can cause them to grow breasts that can become large and painful, a condition known as gynecomastia. Treatment often involves surgeries including liposuction and mastectomy.

The third Risperdal gynecomastia lawsuit to go to trial involves the case of Timothy Strange who in 2006 at age 11 was prescribed Risperdal by his pediatric neurologist to treat symptoms of Tourette syndrome. His doctor had been persuaded to prescribe the drug based on conversations with Janssen sales staff, but he was never told of gynecomastia risks when the drug is prescribed to pediatric patients.

Strange gained weight after taking the drug – a known side effect of Risperdal – and his breasts enlarged as well. But after losing the weight, the breasts remained. He later underwent surgery to have the breasts removed but only after suffering years of emotional distress after being teased about his condition. His lawsuit claims Johnson & Johnson and Janssen intentionally concealed data showing gynecomastia risks in adolescent males.

In February, a Philadelphia jury slapped Johnson & Johnson and Janssen with a $2.5 million verdict after finding the company did not adequately warn that using Risperdal could cause gynecomastia in boys and young men. The second case to go to trial resulted in no damages against the company.

Source: Law 360