Risperdal lawsuits say makers and marketers promoted Risperdal for off-label uses and hid the risk of gynecomastia. Johnson & Johnson is already on the hook for billions of dollars in Risperdal verdicts and settlements, and the company faces thousands more lawsuits over the antipsychotic drug.
If you or your loved one suffered from gynecomastia after taking Risperdal, you may be eligible for compensation.
NUMBER OF LAWSUITS More than 5,500
PLAINTIFF INJURIES Gynecomastia
DEFENDANTS Janssen Pharmaceuticals Inc.; Johnson & Johnson; Patriot Pharmaceuticals Inc.; Janssen Research and Development
LITIGATION STATUS Active
NOTABLE JURY AWARD $77 million
Men, boys and their families are suing Johnson & Johnson and several of its affiliates, alleging Risperdal use caused gynecomastia, or enlargement of male breasts that can require surgery to correct. Litigation is ongoing, with thousands of lawsuits still pending.
Attorneys continue to accept new cases on behalf of boys and young men who took Risperdal and developed gynecomastia.
Most Risperdal lawsuits are pending in the Philadelphia County Court of Common Pleas and its Complex Litigation Center.
Boys and men may be eligible for compensation through a lawsuit if they developed gynecomastia after taking Risperdal, Risperdal Consta, Invega or Patriot Pharmaceuticals Inc.’s risperidone.
Gynecomastia is a condition in which boys or young men develop large breasts. Some Risperdal users had to undergo double mastectomies to correct this condition.
Many of the men suing Risperdal manufacturers were prescribed the drug as young boys, even though the U.S. Food and Drug Administration had not yet approved the drug for use in children.
Risperdal users who experienced gynecomastia are also suing for pain and swelling in the chest, anxiety, embarrassment, social anxiety, difficulty with physical intimacy, difficulty concentrating, impaired thinking, fear, apprehension, despair, suicidality and other emotional problems.
Risperdal and Risperdal Consta are among the brands named in gynecomastia lawsuits.
You may also be eligible for compensation if you took generic risperidone manufactured by Patriot Pharmaceuticals Inc., or if you took Invega, an antipsychotic that essentially has the same physiological effect as Risperdal but is metabolized by the body differently.
These drugs are manufactured by subsidiaries of Johnson & Johnson. Risperdal is approved to treat schizophrenia, bipolar disorder and irritability associated with autism disorder. Doctors also prescribe the drug for off-label uses, including attention deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression.
Risperdal lawsuits accuse Johnson & Johnson and its affiliates of illegally marketing the drug and failing to warn of its link to gynecomastia, among other wrongdoings.
According to lawsuits, Johnson & Johnson knew Risperdal was no more effective and considerably less safe than other antipsychotics but continued to falsely promote the drug as better.
The company is also accused of failing to disclose to doctors, patients and the public that patients taking Risperdal are at a much higher risk for gynecomastia than patients taking similar medications.
Risperdal decisions in the Philadelphia County Court of Common Pleas have been split.
Juries sided with plaintiffs in four out of eight Risperdal cases. The juries ordered Johnson & Johnson and its Janssen unit to pay awards as high as $70 million.
One judge dismissed a lawsuit. Another twice granted summary judgement in favor of Janssen.
A jury in a different case found Johnson & Johnson illegally marketed Risperdal but it did not order the company to pay damages.
In February 2015, Austin Pledger became the first victim to win a Risperdal jury trial. Pledger, who is an Alabama resident, was prescribed Risperdal in 2002. He sued the drug’s maker after he developed size 46 DD breasts, claiming the company did not disclose or properly warn of such side effects before Pledger was prescribed Risperdal. The court found Johnson & Johnson failed to warn the drug could cause breast development and awarded Pledger $2.5 million.
The following month, a jury in a different trial also found Johnson & Johnson illegally marketed the drug. However, the jury could not find proof the drug caused breast growth in the plaintiff, Billy Cirba, so no damages were awarded. Cirba filed a lawsuit against Johnson & Johnson in March 2013 that alleged he grew large breasts following years of Risperdal use. According to the suit, Cirba began taking Risperdal in 2002 at age 6. At the time, the drug was only approved by the FDA for use in adults.
Timothy Stange of Wisconsin filed the third Risperdal trial to be heard by a jury. The trial, which began Oct. 15, 2015, was the first jury trial in which the plaintiff began taking Risperdal after the FDA expanded its use. The jury awarded Stange $500,000. He took Risperdal from 2006 to 2009.
A jury in the fourth trial awarded Nicholas Murray $1.75 million. Murray developed breasts after taking Risperdal for five years as an adolescent. He continued taking the drug after the FDA expanded the drug’s approval for use in children. The jury concluded Johnson & Johnson failed to adequately warn of the risk.
In July 2016, a Philadelphia jury awarded $70 million to Andrew Yount, a Tennessee teen who blamed Risperdal for causing him to develop female-size breasts. A judge later ordered Johnson & Johnson’s Janssen unit to pay an additional $7 million.
The award is the largest in Philadelphia litigation over allegations that Risperdal causes gynecomastia, according to a Bloomberg report.
Jury Award Fact
The verdict marked the fifth time a Philadelphia jury found Janssen failed to properly warn users and doctors about the risk of gynecomastia.
In fact, the record-setting award is more than 30 times larger than the former highest Risperdal-side-effect verdict award ($2.5 million given to Austin Pledger).
Yount sued Janssen in April 2013. His lawyers told jurors he started taking Risperdal at age 5 to treat a psychiatric disorder. He never received a warning about breast development, they said.
The lawyers further argued Johnson & Johnson hid the results of a study from doctors which showed Risperdal caused abnormal breast development in boys so that the doctors would keep writing prescriptions.
A jury found the company “intentionally falsified, destroyed or concealed records” and failed to adequately warn Yount and his family that Risperdal could cause him to develop breasts. Jurors awarded Yount damages for emotional distress.
David White sued Janssen in April 2013 on behalf of his son, identified in court records as C.W. The lawsuit claimed the boy, who was from Florida, developed gynecomastia as a result of Risperdal use.
In October 2016, Judge Arnold L. New granted a motion for summary judgment in favor of Janssen.
Judge Sean F. Kennedy dismissed the seventh Risperdal lawsuit set for trial in Philadelphia. The ruling came just 11 days before trial proceedings were to begin.
Kennedy dismissed the lawsuit in December 2016 because he concluded the plaintiff expert witness Dr. Mark P. Solomon provided insufficient testimony to argue Risperdal caused the plaintiff’s gynecomastia.
Tommy Moroni, of Nebraska, filed the lawsuit.
A Virginia woman named Barbara Dawson sued Janssen in June 2013 on behalf of her son, identified in court records as P.D. The lawsuit claimed Janssen failed to adequately warn of Risperdal’s risks. Judge Arnold L. New granted a motion for summary judgement in favor Janssen in February 2017.
In October 2017, a jury awarded $1 million to Shaquil Byrd, 24, who filed a Risperdal lawsuit against Johnson & Johnson in U.S. District Court in Albany, New York.
According to news reports, Byrd was first prescribed Risperdal as a 9-year-old in 2002 to treat mood disorders. He developed female-like breasts and began lactating by age 10. Byrd had his breasts surgically removed in 2014.
The lawsuit accused Johnson & Johnson of negligence and failure to warn of Risperdal’s side effects.
“Byrd's attorneys argued some of the company's own studies show at least 1 out of 20 children — or 4.8 percent of adolescents who take Risperdal can develop gynecomastia”
A spokeswoman for Janssen Pharmaceuticals told local media that the $1 million jury verdict “is not justified by the evidence.”
In November 2017, an appellate court in Pennsylvania affirmed a trial court’s decision to grant summary judgement in favor of Janssen, according to a Reuters report.
The decision involved lawsuits brought by 13 men who say Risperdal caused them to develop gynecomastia. The men filed their complaints between 2013 and 2014.
Johnson & Johnson settled several Risperdal personal injury lawsuits both before and during trials. However, the company did not admit wrongdoing under the agreements and continues to deny liability for Risperdal injuries. The settlement amounts have not been publicized.
Although Pledger received the first jury verdict, Aron Banks actually had the first Risperdal personal injury lawsuit to go to trial. In September 2012, Johnson & Johnson agreed to settle the case on the first day of trial in a Philadelphia court.
Banks claimed the drug caused him to develop breasts large enough to require surgery to remove them. He was prescribed Risperdal in 2000 when he was 9 years old — before the drug was approved for use by children — and continued taking it until 2004. Banks says he also suffered psychological trauma, rapid weight gain and injury to his endocrine system.
In the month following the Banks settlement, Johnson & Johnson settled five more cases in Philadelphia court. The settlement amounts for each case were kept confidential.
In November 2013, Johnson & Johnson backed out of settlements with 77 plaintiffs before the agreements were finalized. The plaintiffs had argued that the company had created marketing materials and published articles understating the risks of developing breast tissue.
Many Risperdal patients who developed gynecomastia have filed individual lawsuits against Johnson & Johnson rather than joining together for a class action.
If a Risperdal class action lawsuit were to emerge, it would require class action certification to proceed. The process for certifying a class may be different depending on the state.
Johnson & Johnson and its affiliates continued to sell Risperdal and promote it as safe and effective, despite patient reports of adverse events, FDA warnings regarding Risperdal’s dangers, and FDA requests to modify the warning labels, according to lawsuits.
In 1999 and again in 2004, the FDA warned Risperdal companies that they were unlawfully promoting the drug for unapproved uses. The FDA said the companies were publishing false and misleading promotional materials by omitting material information, minimizing potentially fatal risks and claiming the drug is safer than other atypical antipsychotics without adequate proof.
The companies repeatedly disregarded FDA warnings not to market Risperdal beyond its FDA-approved uses and repeatedly promoted Risperdal as superior to other antipsychotics even after the FDA expressly forbid the company to do so and issued notices about the companies’ infractions.
Former U.S. Attorney General Eric Holder accused Johnson & Johnson of putting “some of the most vulnerable members of our society” at risk of serious injury while it pursued greater profits. Specifically, the company used illegal, aggressive marketing to get doctors to prescribe Risperdal to the elderly and children for unapproved uses, according to the U.S. Department of Justice.
In November 2013, Johnson & Johnson agreed to pay more than $2.2 billion to settle a decade-long investigation into illegal promotion of Risperdal between 1999 and 2005. The resolution is one of the largest health-care fraud settlements in U.S. history, the Justice Department said. It includes criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
At the heart of the investigation were claims that Johnson & Johnson used aggressive marketing to get doctors to prescribe Risperdal to children. State and federal attorneys general also claimed the company specifically disregarded FDA warnings not to promote the antipsychotic for childhood use.
In particular, they alleged that Johnson & Johnson promoted Risperdal for pediatric use as early as 1994, despite not receiving FDA-approval for any Risperdal childhood use until 2006. By 2000, more than one-fifth of Risperdal was going to children and adolescents.
At a Risperdal trial in Pennsylvania, a sales manager claimed that Johnson & Johnson trained salespeople to promote Risperdal to children’s doctors as early 2003. In fact, that year the company had a “back to school” marketing campaign for Risperdal, and a manager allegedly discussed including “lollipops and small toys” in sample packages.
In addition, the company is accused of paying doctors to speak favorably of the drug, sponsoring golf outings and offering other incentives encouraging physicians to prescribe Risperdal to children and adolescents.
In 2015, a Philadelphia jury ruled against J&J in a suit filed by the family of an autistic 20-year-old Alabama man who developed breasts after taking Risperdal. The jury, which awarded $2.5 million to the family, heard testimony from former FDA Commissioner David Kessler. He testified that the drugmaker didn’t do enough to warn everyone about the gynecomastia risk. Kessler said the drugmaker knew Risperdal could cause breast development in boys as early as 2001 but information about that wasn’t added to the drug labeling until 2006.
The government investigations revealed that Johnson & Johnson used a variety of tactics to get doctors to prescribe Risperdal.
Offering sales representatives incentives to promote unapproved uses to doctors
Paying kickbacks to the largest nursing home pharmacy in the U.S.
Offering doctors trips and “lucrative consulting agreements” to prescribe Risperdal to more patients
Johnson & Johnson cut a deal with Omnicare, a company that provided pharmaceutical services in nursing homes. Johnson & Johnson agreed to share profits with Omnicare if Omnicare doctors would prescribe Risperdal.
Despite knowing the FDA had not approved Risperdal for the elderly, Johnson & Johnson created a sales force of 136 people to market it to that demographic. The company called its team ElderCare. The FDA objected and pointed to “an excess number of deaths” among the seniors who took the drug.
In 2005, the FDA issued a black box warning, the agency’s strongest warning, alerting the public that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The box also warns the drug is not approved for use in patients with dementia-related psychosis.
Allegations of illegal marketing activities between 1993 and 2004 eventually landed Johnson & Johnson and Janssen in hot water with consumer protection regulators in 36 states and the District of Columbia. The company and its pharmaceutical unit reached a $181 million consumer fraud settlement with those states in August 2012.
The company did not admit to wrongdoing in any multistate investigations. In fact, Johnson & Johnson continues to deny wrongdoing.
In May 2012, the Kentucky attorney general announced a lawsuit alleging Johnson & Johnson concealed dangerous side effects of Risperdal, including diabetes, substantial weight gain, stroke and gynecomastia. According to researchers, the link of Risperdal to adolescent gynecomastia is higher than other antipsychotic drugs.
The complaint filed by the Kentucky attorney general alleged that “despite knowledge to the contrary,” Johnson & Johnson represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug.
The company even directed salespeople to say that “Risperdal had a zero percent rate of diabetes in trials, contrary to its own study result,” according to the complaint. These types of misrepresentations allegedly resulted in a wide range of injuries affecting populations from young boys to elderly dementia patients. Johnson & Johnson settled the suit in 2015 for $15.5 million.
In 2008, the attorney general’s office in Montana filed a lawsuit against Janssen Ortho LLC and Janssen Pharmaceuticals Inc. over its illegal, unfair and deceptive marketing of Risperdal. Janssen agreed to settle the lawsuit for $5.9 million in 2014. “Janssen actively deceived Montana physicians and consumers when it promoted Risperdal as safe and effective for a variety of conditions, when in fact, Janssen was aware of dangers associated with its drug that it hid from the public,” the office said in a press release.
South Carolina filed a complaint against Johnson & Johnson in April 2007 over false marketing claims related to Risperdal. A trial court found the drugmaker’s Janssen unit had improperly marketed Risperdal and concealed its risks. The court ordered the company to pay $327 million. South Carolina’s Supreme Court later dropped the penalty to $136 million.
The attorney general of Texas brought a lawsuit against Johnson & Johnson accusing the company of improperly marketing Risperdal to state residents on the Medicaid health program for the poor, including children. Johnson & Johnson offered to settle with the attorney general on the sixth day of the trial. The company agreed to pay $158 million
Risperdal was also the subject of several lawsuits over diabetes risks, prompting New Jersey to centralize Risperdal diabetes cases under mass tort procedures.
Drugwatch’s legal partners are not currently accepting Risperdal diabetes cases but that could change in the future. Other law firms may be accepting these cases now.
Please seek the advice of a medical professional before making health care decisions.
Emily Miller is an award-winning writer who has held editorial positions with reputable print and online publications around the U.S. As the editor of Drugwatch.com, Emily draws on her background as both a patient and a journalist to ensure her team of writers provides consumers with the latest and most accurate information on drugs, medical devices, procedures and related lawsuits. Emily holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science, the Society of Professional Journalists and the Society for Technical Communication.
Did you or a loved one suffer from gynecomastia (breast growth) after taking Risperdal?