Injured By Risperdal?
Our Attorneys Can Help
If you or your children unexpectedly grew a male breast after taking the antipsychotic drug Risperdal, you may qualify for financial compensation by filing a lawsuit.
Risperdal is an antipsychotic drug whose dangerous side effects include male gynecomastia, leading many plaintiffs to file a lawsuit and seek compensation. Many boys affected by schizophrenia grew a female breast after taking this medicine and suffered severe emotional trauma since they had to undergo a complicated surgery (mastectomy) to have it removed. The manufacturer Janssen Pharmaceuticals failed to warn the public about the risks and even paid kickbacks to doctors to prescribe it “off-label” to children and the elderly.
Our Risperdal attorneys can help you file a litigation against the pharmaceutical companies and bring your case to a federal court. We argue that this drug forced many vulnerable youths to endure from life-altering complications such as gynecomastia or other serious injuries. The pharmaceutical companies that marketed risperidone as a safe medication without warning the public about its dangers must be held responsible for their negligence.
What is Risperdal?
Risperdal (risperidone) is a second-generation, atypical antipsychotic agent used to treat schizophrenia, autism, and bipolar disorder. It is also sometimes used with other drugs such as the antidepressants to treat obsessive–compulsive disorder, depression, and personality disorders. Risperidone acts by binding to the dopaminergic receptors of the D1 and D2 families, antagonizing their effect in the mesolimbic and prefrontal cortex limbic pathways. In simpler terms, it blocks the transmission of impulses in several brain regions whose hyperactivity is associated with many conditions such as anxiety and schizophrenia. However, by antagonizing the activity of various neurons (brain cells), this drug also causes multiple side effects including weight gain, restlessness, tremors, increased salivation, diarrhea as well as severe withdrawal symptoms. In particular, since it blocks the D2 receptors of the pituitary gland, Risperdal may increase the levels of prolactin in the blood (hyperprolactinemia) causing an abnormal growth of the breast even in male individuals (gynecomastia). This may eventually lead to other adverse reactions such as galactorrhea (spontaneous production of milk from the breasts) and increased risk of fractures due to demineralization and loss of bone strength.
The U.S. Food and Drug Administration (FDA) granted approval to Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) to market this drug in 1993. Its original indication was the therapy of schizophrenia in adults. Later in 2006 and 2007, its label was updated to include the treatment several other psychiatric disorders including bipolar disorder and autism in children. Risperdal and its generics are available as oral tablets and solution and as long-acting injectable form.
The companies that manufacture the drug downplayed the risks associated with its use in several instances. Salespersons were instructed to present risperidone to physicians as a new antipsychotic medication whose safety profile was unmatched by any other drug in its category. On the contrary, it is linked to many very serious health threats such as the development or worsening of diabetes, heart failure, stroke, and pneumonia especially in the elderly. They even claimed it caused less extrapyramidal symptoms than the older alternatives, but although this is true in adult patients, it may induce many movement disorders such as tremors, akathisia, tardive dyskinesia, and akinesia in children. In 2006 the FDA requested the drugmakers to add the infamous black box to the medication’s label, to warn practitioners of its significant danger. Later, Since then, many lots of the antipsychotic have been recalled because of chemical contamination.
Risperdals Illegal Marketing Investigations?
Between 1999 and 2005 Johnson & Johnson and its subsidiaries started illegally marketing risperidone to vulnerable individuals such as children and seniors, lacking any approval from the FDA for these uses. The companies were brought to court by the U.S. Department of Justice, who held them accountable for several criminal and civil liabilities, including off-label marketing and payments of kickbacks to pharmacists and doctors.
According to the information provided during the trial, the Big Pharma promoted Risperdal to healthcare providers as a new treatment for depression, hostility, anxiety and agitation in elderly patients affected by dementia and in children with developmental disorders. J&J paid kickbacks to physicians to sponsor their medicine, including offering them incentives such as golf trips and expensive dinners, and wrote sale aids that minimized the risks and the fact that the FDA never approved the drug for anything except schizophrenia.
On November 2013, J&J agreed to pay a $2.2 billion fine to settle down the case and resolve all the allegations on the opening day of trial. This is just small money compared to the over $40 billion in sales that the antipsychotic medication earned for the company over its lifetime.
Verdicts and Settlements
Since several clinical studies found a correlation between treatment with risperidone and markedly raised levels of prolactin (hyperprolactinemia), many lawyers brought their plaintiff’s cases to court to stop J&J’s misbehaviors. To date, a total of 1777 Risperdal litigations are pending in the Philadelphia Court of Common Pleas and three bellwether trials have been held. The company tried to keep the scandal under control by paying huge out-of-court settlements avoiding trial verdicts which may disclose further information on their wrongdoings.
Aaron Banks and the Philadelphia litigations
The first lawsuit was filed on September 2012 by the 21-year-old Aaron Banks, a boy who claimed the medication caused him to grow breasts after he received an off-label prescription in pediatric age. The drugmaker agreed to settle the case on the first day of trial for an undisclosed amount of money. In the upcoming months, Johnson & Johnson settled five more cases to avoid accusations of improper conduct in a Pennsylvania court.
Pledger v. Janssen Pharmaceuticals
In February 2015, the first bellwether case was heard. The court awarded $2.5 million in damages to Austin Pledger, an autistic man from Alabama. The 20-year-old plaintiff grew a 46DD breast as a side effect of the drug he took when he was eight. The jury determined that Pledger “was not adequately warned” about the risk of gynecomastia, a condition that had a tremendous impact on the victim’s self-confidence during adolescence. Janssen Pharmaceuticals appealed the decision to the Philadelphia County Court of Common Pleas, but on May 2016 Judge Ramy I. Djerassi rejected the company’s argument and confirmed the verdict.
Nicholas Murray’s gynecomastia and the latest $70 million verdict
Two other verdicts confirmed that J&J and its subsidiaries failed to warn patients about Risperdal’s side effects. In October 2015, the jury awarded $1.75 million to Nicholas Murray to repay him of the damages he suffered from mental anguish and disfigurement. The pharmaceutical companies kept refusing to take responsibility for the harm they’ve done, claiming they properly warned the public about the dangers. However, according to the information included in the drug’s label, the risk of gynecomastia was just 0.8 percent, a fraction of the 4.5 percent actually found by the same scientists who worked for Janssen. On July 1, 2016, a Tennessee teenager won an outstanding $70 million verdict after the jury determined that the manufacturers of the medication had destroyed, falsified or concealed, material evidence to manipulate data from their own studies.
Written by: Dr. Claudio Butticè, Pharm.D.
Visuals and Design by: Luke Kist