Risperdal Lawsuit Settled on Trial’s Opening Day

In another legal matter involving Risperdal, Johnson & Johnson settled a lawsuit on the first day of trial. The antipsychotic, Risperdal, is marketed by Johnson & Johnson subsidiary, Janssen Pharmaceuticals Inc.

Johnson & Johnson chose to settle a lawsuit involving claims that Risperdal caused a male plaintiff to grow breasts, according to one of his attorneys. The lawsuit was brought by Aron Banks, 21, and was the first to go to trial over Risperdal and claims the drugs caused boys to grow breasts, said Bloomberg.com. Another trial on the same claim is scheduled to begin on September 20.

The lawsuit is just one of some 420 against Johnson & Johnson and its Janssen unit over allegations of personal injuries related to Risperdal, the company indicated in a January 2013 regulatory filing. About 130 of the cases involve allegations that Risperdal caused young males to develop breasts, said Bloomberg,com. In this case, Banks alleged he suffered psychological trauma from breast growth he experienced when taking Risperdal when he was a boy from 2000 to 2004. At that time, Risperdal was not approved for pediatric patients.

Last year, Johnson & Johnson lost an Arkansas Risperdal lawsuit. In that case, Johnson & Johnson was ordered to pay $1.2 billion in fines over Risperdal marketing, said Bloomberg.com. That verdict followed a prior case in which Johnson & Johnson opted to end a trial in Texas over Risperdal sales with a $158 million settlement. That case involved claims that the drug maker marketed Risperdal for children with no FDA approval for that purpose. In June 2011, a South Carolina judge ordered Johnson & Johnson to pay $327 million in penalties over its deceptive Risperdal marketing. Also, said Bloomberg.com, the drug maker lost an August 31 bid to have an appeals court throw out an award of nearly $258 million that a jury ordered it to pay over Risperdal marketing in Louisiana.

As we’ve written, Johnson & Johnson was previously accused of marketing Risperdal as a safe and effective treatment for some symptoms of dementia among the elderly. Risperdal is only approved to treat schizophrenia and symptoms of bipolar disorder and actually increases the risk of death in the elderly who suffer from dementia. The drug was being marketed illegally to treat symptoms including irritability and aggression among dementia sufferers and was also illegally marketed to treat symptoms of Alzheimer’s disease, which also increased patient risks of death and serious injuries.

Even for the conditions for which it is approved to treat, Risperdal is an expensive and dangerous option among other drugs in its class. Previous studies on the drug’s effectiveness found that more patients are likely to suffer stroke while taking Risperdal and are 50 percent more likely to develop diabetes than patients taking another drug in the same class. The drug has also been linked to side effects like an irregular heartbeat, weak muscles and muscle spasms, fever, weight gain and constipation, and headaches. Serious side effects of Risperdal include Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia.

We previously wrote that federal authorities threatened to ban Johnson & Johnson from marketing its products to the Medicare program, a move that could have drastically and adversely affected the company financially. The charges were filed against the drug maker for allegedly offering kickback payments equaling tens of millions of dollars to a company that sold prescription drugs to a large network of nursing homes.

The pharmaceutical giant allegedly hired Omnicare Inc. to distribute Risperdal to its nationwide nursing home network for these treatments. Omnicare previously agreed to a $90 million settlement over charges tied to this investigation in 2009. Its sales of Risperdal tripled to $280 million during a five-year period when it was alleged to have accepted the largess from Johnson & Johnson.

While it is not illegal for a physician to prescribe a drug for an off-label treatment, it is a violation of U.S. Food and Drug Administration (FDA) regulations for the manufacturer of the drug to do so. Any new indications for a prescription drug must first receive FDA approval and requires extensive clinical safety trials to determine that the drug provides a benefit to a new class of patients.