When pharmaceutical companies create their drugs, they have a duty to the consumer to market those drugs only as far as the U.S. Food and Drug Administration has approved. If a drug was approved for use in a certain way, then the pharmaceutical company is prohibited by law from presenting it for treatment of any other conditions. However, a consumer rights attorney Nevada knows that many companies fail to abide by this law.
This was the case with a drug known as Risperdal, which was produced by Janssen Pharmaceuticals, a Johnson & Johnson company. Psych Central reports that the drug was approved for treatment of schizophrenia in 2002 and then for acute mania associated with Bipolar 1 Disorder in 2003. However, by 2002, Janssen began to market the drug as a treatment for agitation in dementia patients. Additionally, Janssen marketed the drug as safe for use in children and adolescents.
Legal action
The U.S. Department of Justice recently announced that it had added a $400 million criminal fine to the $1.25 billion civil settlement against Janssen for introducing a misbranded drug. A consumer rights attorney in Nevada understands that this crime occurs when a pharmaceutical manufacturer wants its drug to be used in a new way that is not approved by the FDA, and introduces the drugs to interstate commerce, such as doctors and other caregivers, for that unapproved use.
Previous knowledge of potential effects
The fine and civil settlement are also in place because of the DOJ’s assertion that that Johnson & Johnson and Janssen knew that the drug caused severe health risks for the elderly, including an increased risk of injury by stroke. It was also known to cause gynecomastia, a conditions where those affected grow breasts, even when male.
The government further alleges that to downplay the risks associated with use of the drug in all ages, the company combined the negative results of one study with other studies. This allowed them to continue to market the drugs as safe and without deleterious side effects.
A family’s nightmare
According to Philly.com, one family has been particularly affected by the illegal marketing of Risperdal. A young boy in Philadelphia grew breasts after years of treatment with the drug. The boy, who is severely autistic, was eight years old when he first started taking Risperdal and ceased the medication when he was 12. The boy’s doctor, a pediatric neurologist, claims that well before the time that the drug was approved for use in children in 2006, sales representatives from Janssen repeatedly came to his office to give samples of the drugs and encourage their use in children. The trial in the matter is currently underway.