The antipsychotic drug Risperdal was originally placed on the market in 1993; as of 2006, it was the only known treatment to help with schizophrenia in adolescents from the ages of 13 and 17. It was also used to treated adolescents suffering with bipolar disorder as well. However, many researchers have discovered it can have devastating effects on males who are treating the above conditions. It was found that this particular drug causes a growth hormone specifically in males that enlarge their breast tissues, as well as exposing them to greater risks of testicular cancers and other complications. As a result of this, the parent company Johnson & Johnson has been seeking to reach a settlement with the Justice Department, agreeing to pay up to $2.2 billion in order to protect their company.
According to recent news reports, however, J&J has just put this settlement on hold as they are trying to find the most effective way to protect their company and not have to admit that they illegally promoted the drug Risperdal, among other drugs. J&J is trying to be cautious in their wording of the settlement to prevent vulnerabilities in future private lawsuits with victims of drug defects. The company is concerned with the effect this settlement might have also on cases which are currently pending regarding Risperdal and young boys. At this point, J&J has already made a number of personal injury settlements.
Sources explain one of the primary causes for the hold up on the Justice Department settlement is due to the data that J&J submitted to the government regulators regarding the side effects information. This data submission was their request to market the Risperdal drug specifically to adolescents suffering with varying conditions of psychosis including delusions, vaccinations, schizophrenia, or bipolar disorder. Allegedly, the data they originally presented shows that there was a concern about hormone stimulations in males, and that a possible side effect would essentially give males milk production and breast development similar to a female.
Prosecutors fighting J&J are trying to have them admit their fault in downplaying the potential risks for users of their product; yet J&J is attempting to put a stop to that accusation entirely. Still, a number of lawsuits that are in place at this time claim J&J failed to properly warn potential Risperdal users of of the dangers for boys and female growth hormones, primarily prolactin; J&J argues the exact opposite. The company spokesperson reasons that they were FDA approved and they did adequately warn the public about potential risks of the prolactin hormone for young boys.
This drug was first approved by the FDA in the early 90's to be used by adults to treat schizophrenia; then in 2007, the FDA gave the okay for children to receive the drug for the same health concerns. However, under federal law drug makers are only legally given the ability to promote an approved use of the drug, although physicians have the freedom to prescribe the medications for other uses they deem appropriate. The Justice Department investigators are claiming that J&J marketed the product for children well before it was legally approved to do so in 2007. Federal investigators are concerned about their false advertisement, as well as the side effect data submitted with their original application for adolescent usage.
If your child was made ill after using this dangerous drug, or has suffered from the negative effects of the hormones, contact a Risperdal lawyer at Arnold & Itkin LLP today to discuss your case!