In July last this year Johnson & Johnson and it subsidiary Janssen Pharmaceuticals the manufacturers of Risperdal loss a verdict of $70 Million, after this verdict the company are likely struggling to find a new strategy for the thousands of additional pending Risperdal lawsuits in the court. The strongest evidence which will be presented in the Risperdal trials against the manufacturer is a video deposition of former FDA Commissioner David Kessler testifying that Janssen and J&J manipulated clinical trial data presented to the FDA to lessen the risk of gynecomastia. Gynecomastia is a condition in which swelling of the breast tissue in boys or men occurs, due to the imbalance of the hormones estrogen and testosterone. According to Dr. David Kessler, Johnson & Johnson knew about the drug’s ability to raise levels of the hormone that causes male breast growth but the company conspired to hide the risk related to Risperdal.
Risperdal (risperidone) is an antipsychotic medicine belonging to the chemical class of benzisoxazole derivatives. It works by changing the effects of chemicals in the brain. Risperdal is used for the treatment of schizophrenia and symptoms of bipolar disorder (manic depression). Risperdal is also used in autistic children to treat symptoms of irritability. It is also used to treat attention deficit hyperactivity disorder (ADHD), anxiety, insomnia and depression. Risperdal is an FDA-approved prescription medication but it is never been approved for the treatment of patients with dementia-related psychosis. The drug is associated with some serious Risperdal side effects such as:
- Movement disorders
- Pituitary tumors
- Heart problems
Hundreds of boys and young men filed gynecomastia personal injury lawsuits against Johnson & Johnson and its Janssen unit alleging that the drug maker failed to adequately warn patients about the risks and complications associated with the drug. According to a research published in the journal Pharmacotherapy analyzed the FDA’s adverse effect database and found that Risperdal accounted for 70 percent of all pituitary tumors. The U.S. Food and Drug Administration issued a black box warning about antipsychotics increasing the risk of death in elderly with dementia. Black-box warnings are the strictest warning that put in the labeling of prescription drugs by the Food and Drug Administration. The agency determined that use of the drug can lead to serious side effects or death.
From 2003 Janssen Pharmaceuticals is accused of hiding evidence. A team of researchers from Janssen looked at data from 700 children who took Risperdal. As per the research prolactin levels was high in the children over the first 2 months of treatment but then returned to normal by 5 months. The researchers disclosed the tendency called SHAP (side effects hypothetically attributable to prolactin). The side effects included gynecomastia, but the study revealed that there was no direct connection between high prolactin level and SHAP. In the most recent lawsuit the researchers data was introduced which directly contradicts this finding. A Janssen biochemist testified that the data were never provided to the FDA, according to New Brunswick Today.
Already Johnson and Johnson paid millions to the government and U.S. Department of Justice to settle criminal and civil charges that the company for illegally marketing Risperdal and misrepresented the risks associated with the drug, and now it faces thousands of lawsuits filed by patients suffering from the adverse effects associated by the drug. If you, or someone you love, have suffered in any way as a result of using Risperdal antipsychotic medication, Contact Drugsclaim.com for free case review. We have an experience attorneys group who evaluate your case free of cost unless we win the case for you.