Hundreds of parents and their sons are speaking out about the physically and emotionally crippling side effect of Risperdal that has generated litigation against drugmaker Johnson & Johnson. Risperdal (also known by its generic name Risperidone) is an atypical antipsychotic that has been linked to excessive breast growth in males: a condition known as gynecomastia.
Thousands have now filed Risperdal lawsuits, claiming the drug maker failed to adequately warn about this harmful side effect. According to allegations leveled by the U.S. Department of Justice in 2012, J&J illegally marketed Risperidone to pediatric physicians before the drug was FDA approved to treat mood disorders in children. Along with its Janssen unit, J&J stands accused of concealing gynecomastia risks posed to children taking Risperdal; the companies have recently faced major setbacks in court.
What is Risperdal used for?
Risperidone is prescribed to manage symptoms of schizophrenia and bipolar disorder in adults and teenagers age 13 and older. In 2006, the FDA approved Risperdal for the symptomatic treatment of irritability (such as self-injury and aggression) in autistic children and adolescents. One year later, health regulators approved the drug for the short-term treatment of manic episodes (marked by an excited or frenzied mood) and bipolar disorder in children and adolescents aged 10-17.
Besides these FDA-approved conditions, Risperdal has also been prescribed for “off-label” purposes – uses that were not studied for safety and efficacy. One of the most publicized off-label Risperdal uses was to treat aggression and outbursts in elderly dementia patients. After reports of sudden death, cardiovascular injury and stroke were reported in connection to the medication, the FDA required Janssen to add a black box warning about increased mortality risks in senior patients with dementia.
Serious Risperdal side effects
Risperdal helps various mood disorders by changing the effects of chemicals in the brain. According to pediatric and adult trials and post-market reports, some of the most serious Risperdal side effects noted include:
- Gynecomastia (breast growth in males)
- Hormonal imbalance
- High blood sugar/ diabetes
- Neuroleptic Malignant Syndrome
- Cardiovascular events
- Difficulty breathing
- Irregular heartbeat
- Uncontrolled muscle movements
Additional risperidone side effects
- Dry mouth
- Increased appetite
- Weight gain
- Vision problems
- Stomach pain
- Dry skin
- Vomiting and nausea
- Decreased sexual ability
Risperdal is known to boost levels of prolactin, a hormone responsible for breast tissue enlargement. In women, prolactin spikes can cause galactorrhea, a spontaneous production of breast milk. In male patients, increases in prolactin can lead to unusual breast growth. Research dating back to 1999 has shown a causal relationship between Risperidone and gynecomastia, with at least one study suggesting a 5-fold increased risk in young male patients. These disturbing findings have prompted a second look by some medical professionals who might normally prescribe the drug to adolescents or children with autism, ADHD or other behavioral disorders.
Symptoms of gynecomastia include tender and swollen breast tissue, pain and nipple discharge. Unfortunately, the only solution for young men who develop C or D cup breasts after taking Risperdal is surgical excision. Beyond the physical challenges of gynecomastia, many Risperdal patients struggle with low self-esteem, social anxiety and feelings of depression and isolation.
Risperdal lawsuit information
At present, more than 1,500 plaintiffs have filed a Risperdal lawsuit, in the hopes of holding J&J accountable for purposefully concealing breast growth side effects. The majority of cases have been centralized in the Philadelphia Court of Common Pleas for more efficient proceedings. Early on, the New Jersey-based J&J settled a handful of gynecomastia cases for confidential sums, and has recently been hit with a number of courtroom losses.
In 2015, a Philadelphia jury found that J&J failed to warn the family of an autistic boy about gynecomastia risks. Austin Pledger developed 46DD breasts after taking Risperidone for four years and was awarded $2.5 million in damages. This substantial verdict was dwarfed in 2016, when a separate jury hit J&J with a $70 million verdict. At the age of 5, plaintiff Andrew Yount developed female-sized breasts while taking Risperdal. Yount’s award included damages for medical expenses, physical suffering and emotional distress.
The landmark judgment, which Johnson & Johnson plans to challenge, offers hope to other claimants as they await their day in court. There is also speculation that Risperdal settlements may soon be on the table, which may prove less costly for J&J given recent court room losses.
Average Risperdal lawsuit settlement amount
Negotiations to settle remaining Risperdal lawsuits would likely consider case-specific factors in order to determine settlement amounts. The potential value of a Risperdal claim, or that of any dangerous drug side effect, is dependent on:
- The severity and duration of the injury suffered
- The level of emotional distress suffered because of breast growth
- The amount of pain and mental anguish incurred in the past and anticipated for the future
- Loss of quality of life
- Past and future medical costs including surgery
- Whether punitive damages are awarded for reckless and wanton behavior
On June 17, 2011, Janssen voluntary recalled one lot of 3mg Risperdal tablets and one lot of 2mg tablets based on reports of a musty, unpleasant odor. The smell was thought to be caused by TBA – a non-toxic chemical preservative. While no serious injuries were reported, some patients experienced gastrointestinal problems as a result of the contaminated pills.
A second recall was issued in September of 2013, after routine testing found evidence of mold on one lot (around 70,000 units) of injectable Risperdal Consta. The recall was issued for lot No. 309316 over concerns that the mold could cause infections around the injection site.
FDA Risperdal warning?
Based on adverse event reports and placebo-controlled trials, the FDA issued a Risperdal alert on April 11, 2005, cautioning of an increasing mortality in elderly patients with dementia-related psychosis. The black box warning was included on Risperidone products after trial data showed a 4.5 percent rate of death in patients given Risperdal and other antipsychotic medications, compared with a 2.6 percent risk for the placebo group. The agency warned that atypical antipsychotics like Risperdal could increase the risk of death in patients suffering from dementia.
Why hire a Risperdal attorney?
An experienced Risperdal lawyer leverages the resources and knowledge to help plaintiffs navigate the legal process. An attorney who specializes in product liability law and litigating claims against Big Pharma can build a strong case, raising the chances of securing a sizeable settlement or jury award.
Monetary damages for hospital bills, pain and suffering, emotional trauma, lost enjoyment of life, and future loss of earnings can be recovered with the aid of a skilled legal advocate.
Risperdal and gynecomastia: resources
- Bloomberg, J&J Hit With $70 Million Risperdal Verdict Over Male Breasts http://www.bloomberg.com/news/articles/2016-07-01/j-j-faces-record-70-million-verdict-over-male-breasts
- Medscape, Use of Risperidone in Children With Autism, Bipolar Disease, or Schizophrenia http://www.medscape.com/viewarticle/571416_6
- The Philadelphia Courts, First Judicial District of Pennsylvania, “In re Risperdal Litigation: Expert Report of David A. Kessler, M.D.” http://freepdfhosting.com/e617b66c6d.pdf
- MedicineNet.com, Risperidone, Risperdal, http://www.medicinenet.com/risperidone/article.htm
- Mayo Clinic, gynecomastia (enlarged breasts in men) http://www.mayoclinic.org/diseases-conditions/gynecomastia/basics/definition/con-20028710