Drug manufacturers have a responsibility to thoroughly test new drugs before putting them on the open market, where patients who use them can be placed in danger. Side effects must be determined and disclosed, so that doctors and patients are aware of them and can make intelligent decisions regarding the patient’s health. Too often, drug companies fail in this duty, creating long-term problems for those who are prescribed the drug.
Expanding the intended use of a drug creates problems
Risperdal is the brand name for the generic drug risperidone. It is an antipsychotic drug manufactured and distributed by Johnson & Johnson. Originally approved by the FDA in 1994, it was intended to be used only by adults to treat schizophrenia. Risperdal works by decreasing levels of dopamine in the brain.
However, pharmaceutical giant Johnson & Johnson eventually began marketing the drug for use in children, which is where the serious problems began. Most recently, the company settled a lawsuit involving approximately 9,000 people who suffered side effects from taking the drug – side effects of which they were not properly warned. In boys as young as 4 years of age, Risperdal can cause gynecomastia, a growth of breast tissue. In young boys, this growth change can be permanent.
For more than a decade, Johnson & Johnson has been forced to pay huge sums of money in both civil and criminal penalties for improperly marketing Risperdal for use in children. In 2013, the company paid more than $2 billion, in a settlement with the Department of Justice, as a result of its marketing tactics.
Thousands of civil lawsuits have been brought throughout the United States, most as a result of gynecomastia. These victims will continue to suffer from Johnson & Johnson’s efforts to expand the sale of the drug beyond its intended and approved use.