Risperdal (risperidone) is an antipsychotic approved for the treatment of schizophrenia in adults and children, bipolar disorder in adults and children and behavioral disorders caused by autism in children. Shortly after its 1993 approval, reports of serious issues with Risperdal side effects and the inappropriate marketing of Risperdal began to surface.
Since that time, Janssen Pharmaceuticals and parent company, Johnson & Johnson have paid $billions in criminal penalties, fines and lawsuit settlements for illegal marketing. They are still facing more than 13,000 lawsuits for medical injuries such as gynecomastia or breast tissue development in boys, along with other serious side effects.
Breast Development in Boys
Risperdal has been associated with gynecomastia or breast tissue growth in males, some as young as age four. Gynecomastia is generally a permanent change that will require surgical breast reduction and will often result in serious emotional trauma for boys and adolescents. Gynecomastia associated with Risperdal may be caused by stimulation of the hormone prolactin, responsible for production of milk and the drug has also been associated with lactation in pre-pubescent girls.
Other serious side effects linked to Risperdal use include movement disorders such as tardive dyskinesia which may be permanent, increased risk of development or worsening of diabetes, and increased risk of death in the elderly.
Risperdal Legal Actions
Illegal marketing of Risperdal for unapproved uses such as ADHD and chemical restraint were reported as early as 1994 and by 1999, significant concerns had been raised about serious injuries and complications related to Risperdal use. Concerns about gynecomastia have been ongoing and experts have stated that up to 70% of gynecomastia childhood events may have been caused by Risperdal use between 1999 and 2008.
In 2002, Janssen Pharmaceuticals warned Canadian doctors about increased risk of death in elderly patients but did not warn U.S. practitioners until one year later and an FDA warning was not issued until 2005 when a black box statement was added to labeling.
Janssen and Johnson & Johnson have faced hundreds of lawsuits filed by governmental agencies and individuals who were harmed or whose children were harmed. The company has paid well over $5 billion in fines and settlements to date for fraud, illegal marketing, drug violations and serious events which have resulted in permanent harm or even, death. An estimated 13,000 lawsuits against Risperdal’s manufacturer are still pending.
Risperdal (risperidone) is an antipsychotic approved by the Food and Drug Administration in 1993 for the treatment of schizophrenia in adults. In 2006 and 2007, the FDA approved additional uses for Risperdal including schizophrenia in children, bipolar disorder in adults and children and behavioral disorders caused by autism in children.
Since shortly after its approval, reports of serious issues with Risperdal effects and the inappropriate marketing of Risperdal began to surface. To date, the manufacturers of Risperdal have paid $billions in criminal penalties, fines and lawsuit settlements for a variety of reasons including injury to patients. The company is also facing more than 13,000 medical injury lawsuits for serious side effects caused by Risperdal including breast growth in males and death in elderly.
Breast Development in Boys
Risperdal may increase the risk of gynecomastia or development of breast tissue in males, particularly children or adolescent males. Gynecomastia has been attributed to Risperdal’s stimulation of prolactin, a hormone common in women who are pregnant or nursing. The development of gynecomastia is usually a permanent change that will require surgical removal by a reconstructive surgeon. Adolescents or boys who develop breast tissue suffer not only physical changes but also severe emotional trauma.
Risperdal has also been associated with other side effects which may be serious, permanent or life-threatening including:
- Lactation in girls, non-nursing women and males
- Movement Disorders including tardive dyskinesia and extrapyramidal symptoms
- Increased death risk in elderly dementia
- Development or worsening of diabetes
Risperdal events and FDA actions
Risperdal has one of the longest and largest histories of difficulties and disputes of any medication on the market and at its peak, it was the most common antipsychotic used in the US.
Marketing abnormalities for Risperdal including inappropriate marketing for unapproved uses in children and adults and for other indications such as ADHD, chemical restraint and schizoaffective disorder have been reported as far back as 1994 and by 1999, reports began to surface regarding problems with Risperdal use in children. In 2001, the Miami Herald reported cases of Risperdal side effects including gynecomastia development in juvenile males in the Florida foster care system who had been given the medication as a pharmaceutical “restraint”, a problem which had been suspected for at least two years.
The Wall Street Journal reported that Risperdal had been shown to increase prolactin levels (leading to breast development and lactation) and experts stated that up to 70 percent of gynecomastia childhood events were found to be caused by Risperdal use. Serious adverse event reports of Risperdal use in children numbered over 1200, including 31 deaths between 1999 and 2008.
In 2002, Janssen Pharmaceuticals issued a warning letter to Canadian practitioners regarding risks in the elderly dementia population but did not warn US practitioners until the following year. Risperdal is responsible for at least 37 cases of stroke type events including 16 deaths. A black box warning (the most severe warning a medication can have) was required in 2005 by the FDA to be included on labeling of Risperdal and other antipsychotics warning practitioners of the dangers of Risperdal in elderly patients with dementia.
Risperdal Fines, Settlements and Other Actions
The first lawsuit regarding harm caused by Risperdal use was filed in 2010 by a 21-year-old man who had taken Risperdal for off-label use between 1999 and 2004 and suffered physical and emotional trauma due to gynecomastia or the development of male breasts. In 2012, the case was settled by Johnson & Johnson on the first day of trial for an undisclosed amount, prior to the plaintiff’s attorney calling a former company CEO as a witness.
The same year, Johnson & Johnson was accused of improper marketing practices and was fined $1.2 billion in an Arkansas federal court due to claims that they downplayed risks and that over 240,000 cases of Medicaid fraud and 4,500 deceptive practices had been caused by the manufacturers marketing activity.
Also, in 2012 the company settled lawsuits with 36 states and the District of Columbia regarding improper marketing techniques, specifically for the treatment of children. The cases were settled by the payment of $181 million. Other state cases had also been settled including $327 million in South Carolina, $258 million in Louisiana and $158 million in Texas.
During 2012, Bloomberg News reported of over 420 additional lawsuits including over 100 which were related to gynecomastia and the company’s failure to adequately warn of the risk. Six gynecomastia suits were settled for undisclosed amounts before the FDA Commissioner could be called as a witness.
The company paid $2.2 billion in fines and penalties to the US Department of Justice in 2013 to avoid prosecution related to misbranding of Risperdal, which is the largest settlement of its type. Several medical injury trials have been conducted and resulted in multi-million dollar judgement awards to plaintiffs who were injured by Risperdal use, including a 2019 award for $8 billion in punitive damages to a Philadelphia man which has been appealed and a $70 million verdict which has been upheld.
Johnson & Johnson and its subsidiary, Janssen are still facing over 13,000 Risperdal lawsuits filed by Risperdal users or parents of children given Risperdal who developed serious side effects. Most of these lawsuits have been filed due to gynecomastia associated with Risperdal use. Costs of settling these cases may near $1 billion.
Attorneys for the victims have claimed that Johnson & Johnson and its subsidiary, Janssen used illegal marketing to promote Risperdal for unapproved uses even after they were aware of the threats of gynecomastia, movement disorders and the risk of death and that they minimized and did not adequately warn of those risks.