Risperdal is an antipsychotic medication used by children and adults in order to treat schizophrenia, bipolar disorder and irritability associated with autism and other mental health conditions. The drug is technically known as risperidone but is sold under the trade name Risperdal as well as several others. It was first produced by Johnson/Janssen Pharmaceuticals and has been approved by the FDA for use by children and adolescents since 2006. Unfortunately, the drug has several unwanted side effects, including the formation of female breasts in young boys.
What made matters worse, was that Johnson and Johnson did not warn of possible gynecomastia on its labels, despite repeated pressure from doctors. There is a substantial body of evidence that suggests J&J may have known about the risk of gynecomastia but chose to withheld this information from the FDA. Thus, many young boys have gone on to develop this distressing and life-changing condition. In 2013, J&J faced a $2.2 billion fine for illegally marketing Risperdal by the US Justice Department.
Since then, many people have filed lawsuits against J&J in order to seek compensation for damages caused by gynecomastia and the drug that caused it. Several of these high profile cases have been settled resulting in the claimants being awarded millions of dollars. In one case, plaintiff Andrew Yount received $70 million.
Gynecomastia is the formation of breasts in males. This can be caused by a hormonal imbalance and specifically an increase in estrogen or prolactin. Use of anabolic steroids for example is known to cause gynecomastia, seeing as testosterone will be converted to estrogen in the body. It is thought that Risperdal can similarly cause gynecomastia in young males by increasing levels of the hormone prolactin. The ‘lact’ in prolactin shares its roots with the word ‘lactate’ and as you might have guessed, stimulates the development and lactation of female breasts.
One study published in 2006 by a psychiatrist in Duke, found a strong link between Risperdal and gynecomastia in young children and adolescents. This study demonstrated that where risperidone is administered to adolescents for psychotic issues, it can increase prolactin with gynecomastia as one possible outcome.
This was followed by another study in the same year that concluded that risperidone should only be administered to young patients under extreme caution.
Studies have continued to be conducted with one of the most recent having been published in the Journal of Child and Adolescent Psychopharmacology. This once again found a strong association between risperidone and the development of gynecomastia in young male patients. Children and teenagers using the medication were found to be at five times greater risk of developing the condition compared with those not using the drug. The study was also keen to highlight the ‘high psychological burden’ associated with the condition.
Of course it is normal for a medication to carry risks and side effects however. What is important though, is that the patient is given all the necessary information upfront that they need in order to make a reasoned decision. So the question is: was J&J at fault?
The controversy here is surrounding J&J’s potential foreknowledge of the gynecomastia effects and failure to properly inform patients.
According to one investigative report that was carried out by The Huffington Post, Janssen had held a meeting in 2002 in order to discuss the data that demonstrated the causal relationship between Risperdal and gynecomastia. It is alleged that the company went on to carry out their own ‘re-analysis’ of the data with the objective of skewing the numbers in their favor. Their changes managed to reinterpret the statistically significant 4.5% correlation as an insignificant 0.8%. To accomplish this, the company simply removed the portion of the data pertaining to children below the age of 10 – the reasoning being that they were likely to be going through puberty.
Essentially, J&J used data manipulation in order to challenge claims about the link between Risperdal and gynecomastia.
A similar investigative piece carried out by Bloomberg, former head of the FDA (David Kessler) testified that Janssen knew as early as 2001 that their product was ‘probably or very likely’ to cause gynecomastia. This was during a Risperdal lawsuit and Kessler described the finding as a ‘red flag’.
During a separate lawsuit, a J&J biochemist that had been working closely with Risperdal, similarly testified that J&J had withheld data (from the 2002 study) from the FDA.
Do you think that Janssen should be held accountable for its actions? Then get in touch and make your case!
What is perhaps even worse, is that Janssen is also believed to have aggressively marketed its drug for off-label use despite its knowledge of the potential risks. The Justice department revealed that between 1999 and 2005, Janssen had been promoting Risperdal for use among children for a range of other mental health disabilities. This was despite recognizing that the drug ‘posed certain health risks to children, including risk of elevated levels of prolactin, a hormone that can stimulate breast development.’
Janssen sales reps are known to have made calls to child psychiatrists and mental health care providers during this time, promoting Risperdal for ‘safe and effective’ treatment against a large range of different disorders. These included but were not limited to: ADHD, OCD, autism and oppositional defiance disorder. This is despite many other more effective treatments existing for those problems.
Janssen even went as far as to offer toys and candies along with sample Risperdal packages. This heavy promotion led to 1 in 5 Risperdal users being children or adolescents by 2000. According to the Wall Street Journal, J&J also backed an academic institute with the aim of encouraging Risperdal use among the youth.
This was all before Risperdal had been approved for use in children by the FDA (which happened in 2006). J&J nevertheless continued to heavily push their product to children in spite of repeat warnings from the FDA to stop.
In January 2016, J&J were refused an appeal by the Supreme Court in South Carolina and was required to pay a penalty of $124 million for its unlawful marketing.
In April 2016, the company paid another $15.5 million settlement for failure to warn of the risk of gynecomastia and for its off-label marketing practices.
What is important to remember here though, is that these are only small sums for such a large and wealthy organization. The company has managed to earn far more by promoting its product to children than it has lost; in fact, the company was believed to have made $18 billion in domestic Risperdal profits by 2015 and an additional $10 billion from overseas sales.
And despite all this damning evidence and all these high profile cases, Risperdal has still not been pulled from the market. In 2007, the J&J patent for Risperdal expired but generic versions have been approved since 2008. Thus, many generic risperidone medications are still available, as is Risperdal’s successor Invega.
As of right now, there is simply no incentive for companies to stop selling this medication – despite bad press and large payouts.
In November of 2015, 1,500 Risperdal cases were consolidated as part of a mass tort at the Philadelphia Court of Common Please. All these cases had in common that young men and boys had suffered from gynecomastia and that they had not been warned about this possible side effect by Janssen.
Many of these victims have already been awarded huge payouts or are in line too.
In April 2015 for instance, a jury awarded one victim who developed size 44D breasts with $2.5 million in compensation. The jury found that he had not been given proper warning about the potential side effect.
Likewise, in November of the same year, a jury also awarded $1.75 million to a patient using Risperdal for schizophrenia. Another jury awarded $500,000 to a plaintiff in December.
Janssen now faces roughly 5,400 Risperdal cases around the world, with more new victims coming forward all the time. The company has set up a large reserve of funds reportedly to settle these suits.
Gynecomastia is a hugely traumatic condition for any man and especially for young children who may face teasing, issues with their body image and damaged self-esteem. J&J should be held accountable for knowingly marketing their medication regardless of this known risk. If you are suffering from gynecomastia and you believe it may be the result of Risperdal use, then get in touch to find out if you may be entitled to compensation.
Compensation can be used to cover economic damage. For instance, if a patient had to undergo a mastectomy or if they had to take time out of work. Likewise, it can be used to cover damages such as physical pain, disfigurement, emotional anguish etc.
If you or a loved one have used Risperdal and developed symptoms as a result, then you should strongly considered speaking with an attorney. Not only could you be entitled to a payout but you may also be able to help others avoid the same fates.
Some cases of Risperdal lawsuits have been dismissed in court, either because the plaintiff violated the statute of limitations (filing too late) or because they should have been aware of the link between the conditions. If you are unsure, then allow a qualified attorney to help you decide if you may be eligible.
Get in touch today for a free, no-obligation consultation.