Shortly after his clients reached an out-of-court settlement over claims that the antipsychotic drug Risperdal caused increased breast-tissue growth in several boys an attorney voiced his dismay about the side effects caused by the medication:
“I’ll never be truly satisfied because of what happened here with these kids,” he said. “It’s a sad commentary on what goes on with prescription drugs and their use in children.”
The medical definition of the devastating side effect these boys suffered is called gynecomastia, which is male breast growth, most prominently occurring in adolescent males.
What makes Risperdal breast-growth lawsuits even more tragic is that fact that by being treated with a medication targeting mental issues, the development of breasts in males led to even more serious psychological problems, according to the allegations.
The Food and Drug Administration originally approved Risperdal in 1993 for the treatment of schizophrenia, although that approval later was expanded to also address bi-polar disorder.
However, according to these Risperdal lawsuits, the manufacturer’s parent company, Johnson & Johnson, was aware of this dangerous side effect and failed to reveal it to consumers, health care professionals and government regulators.
In fact, a lawyer for one boy suing over breast growth told a jury, Risperdal sales personnel were trained to downplay the fact that the medication could raise hormone levels and have this effect.
At the time Johnson & Johnson was reaping in huge profits from the sales of Risperdal, which peaked at $4.5 billion in 2007.
Bloomberg News reported that federal officials began investigating Risperdal sales practices in 2004, including allegations the company marketed the drug for unapproved uses.
The company eventually reached an agreement with the U.S. Justice Department to pay as much as $2.2 billion to resolve probes of its sales of drugs, including Risperdal.
The fallout from these allegations and fines has been that there has been a steady increase in the number of Risperdal breast-growth lawsuits filed in state and federal courts across the country.
In addition to claims that Risperdal officials were aware of these side effects and failed to warn patients and health care professions, these lawsuits allege that the drug was marketed for use in treating children without specific FDA approval.