The Suits Keep Rolling In
Risperdal lawsuits are piling up. Risperdal, a common antipsychotic drug, has been found to cause teenage boys to grow “man boobs,” with one case even reporting a teenage boy who had grown DDs!
Johnson & Johnson (J&J) and its subsidiary, Ortho-McNewil Janssen Pharmaceuticals, the manufacturers of Risperdal, are on the wrong end of some 2,300 Risperdal lawsuits in Pennsylvania alone, not to mention over 18,500 Risperdal lawsuits in the rest of the country filed by men and their families who’ve been wrestling with man-boobs side-effects. Risperdal (risperidone) is a powerful antipsychotic medicine that works by changing the way chemicals affect the brain. It is most commonly used to treat schizophrenia and symptoms of bipolar disorder, and has also been used to treat symptoms of irritability in children with autism.
According to drugs.com Risperdal is a globally prescribed drug, and was, at one time, J&J’s biggest selling drug worldwide; from 2003 to 2010, global sales of Risperdal amounted to $24.2 billion (peaking at $4.5 billion in 2007). However, Risperdal manufacturers faced federal criminal charges over their marketing methods and paid $2.2 billion to settle the case, in addition to settling numerous individual Risperdal lawsuits outside of court.
There has been a slew of Risperdal lawsuits filed over the past few years in relation to unethical and unapproved marketing of the product, and unwanted and downplayed side-effects of the drug – but what exactly is all the fuss about?
Risperdal Lawsuits: Allegations Galore
Many of the cases allege that use of Risperdal led to gynecomastia (a benign growth of male breast tissue), that the risks of developing such a condition were downplayed, or even ignored, and that the drug company hid their knowledge of this adverse effect from both the public and the medical community at large.
There have also been claims that Risperdal was illegally marketed to children before U.S. regulators approved the drug for use on children, and that the drug was marketed to both children and the elderly for off label use – meaning it was being prescribed for illnesses other than what it was designed and approved to treat. Patients who have taken the drug often have emotional reactions to taking Risperdal.
“[Taking] the drug was the most painful experience I’ve ever had both physically and mentally, especially when I stopped it cold turkey. It made me feel ‘stuck’ in a doomed feeling while feeling severely tense,” said an adolescent user of the drug, who wishes to remain anonymous. “Fortunately I was on it for I think three weeks. Others are on it for months or even years.”
They also allegedly marketed Risperdal to children by pushing promotional material to doctors in 2003, at which point the drug had not been Food and Drug Administration (FDA)-approved for children. This is not an isolated incident of off label prescriptions – Consumer Reports published a survey of 457 physicians and psychiatrists in which 20 percent had prescribed Seroquel, another antipsychotic drug, to seniors, despite the fact that it was not approved and increases the risk of death in elderly patients.
HoneyColony spoke to DrugWatch, who are currently compiling Risperdal lawsuits against Johnson & Johnson on behalf of numerous families and individuals.
Off Label Prescriptions
In 2013, a 17 year-old New York boy filed charges for developing “female-like breasts” after almost a decade of taking Risperdal. When he was first prescribed the drug, it had not been approved for use by children, and the labeling listed gynecomastia as a rare complication that only affected around 0.1 percent of patients – this was eventually updated to state a more realistic figure: there’s a 2.3 percent chance of adolescents developing gynecomastia when taking this drug.
In Ontario, there has been widespread cases of off-label use, with a study by the Institute for Clinical Evaluative Sciences indicating that almost 12 percent of ADHD patients up to age 24 were prescribed antipsychotics like Risperdal. Of those prescribed antipsychotic drugs, a full quarter had no record of mental health problems, such as schizophrenia or bipolar disorder — conditions that the drug was designed to treat.
Dr. Paul Kurdyak, a clinician scientist with the Institute for Mental Health Policy Research and medical director of Performance Improvement at CAMH (Centre for Addiction and Mental Health), was horrified at the results of this study – citing other inherent risks of antipsychotic medication such as weight gain, diabetes, and the potential effects on mental health (especially for those with no history of mental health problems).
When speaking to The Star he was quoted saying:
We don’t know why these children and youth with ADHD are on antipsychotics, but there is a risk associated with early antipsychotic exposure, so we need to know more about why they are being used so that the benefits can be weighed against the risks.
What’s The Verdict?
To this date, the majority of cases involving Risperdal and gynecomastia have been settled in favor of the patients. In 2013 the company paid $2.2 billion in fines and penalties to the U.S. Department of Justice to avoid prosecution over the misbranding of Risperdal, whilst a recent case in July 2016 resulted in a $70 million settlement. There have been such an excessive number of Risperdal cases in Pennsylvania that the drug has been blamed for; a record number of pharmaceutical lawsuits being filed across the state, with some 2,000 cases being centralized in one massive Risperdal lawsuit, that is scheduled to go to court later this year.
However, for now J&J seem confident in their drug — despite the record number of cases. J&J have signaled their intent to continue to try and defend cases. They have made no plans to remove Risperdal from the market and continued to reference the drug as safe and effective. They claim that the benefits outweigh the risks for patients who have been correctly prescribed Risperdal. The FDA have been unsuccessfully petitioned to re-examine their rulings on the safety of the drug for a number of years now, so perhaps the Risperdal lawsuits still awaiting trials and settlements could overturn these decisions by the FDA.
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