Arkansas Attorney General Dustin McDaniel says he will ask the state Supreme Court to reconsider tossing out a $1.2 billion judgment against Johnson & Johnson over questionable marketing practices involving its antipsychotic drug Risperdal.
McDaniel argues that the state misapplied the Medicaid fraud law and has requested an analysis comparing the 1993 law as it was passed to the way it was written into state code. The report, which he was granted a copy of, may be helpful in asking for a new hearing, he said.
The lawsuit alleged Johnson & Johnson and its subsidiary Janssen Pharmaceuticals did not adequately communicate Risperdal side effects to patients and promoted the drug for unapproved uses.
Risperdal, known generically as risperidone, is approved to treat adults and children five years of age and older with schizophrenia, bipolar disorder and irritability with autism. The drug is sometimes prescribed by doctors for off-label uses such as attention deficient hyperactivity disorder (ADHD), attention deficit disorder (ADD), and other behavior problems.
Risperdal side effects include hyperglycemia, type 2 diabetes, a movement disorder known as tardive dyskinesia, and the life threatening neurological disorder neuroleptic malignant syndrome. It has also been associated with gynecomastia, a condition in which boys grow breast tissue.
Gynecomastia is an uncomfortable and embarrassing condition for boys, causing symptoms such as breast tenderness and nipple discharge. It also puts boys at risk for breast cancer and reproductive problems. Treatment is invasive, involving medications such as the breast cancer drug tamoxifen, or surgeries such as liposuction and mastectomies.
In recent years, Johnson & Johnson and Janssen have faced mounting lawsuits from boys who claim the drug companies withheld information about Risperdal side effects and did not adequately warn of the gynecomastia risk.