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.
The drug is prescribed for the treatment of mental illnesses. It is used for schizophrenia, acute manic or mixed episodes associated with bipolar I disorder and irritability associated with autism and related conditions.
Gynecomastia is a side effect in which young boys develop large breasts that can require surgery to correct.
Adults and children experienced humiliation and psychological trauma due to breast growth resulting from the antipsychotic drug. Many children were prescribed the drug even though the U.S. Food and Drug Administration (FDA) had not yet approved the drug for pediatric use.
Lawsuits in the U.S. and Canada
According to J&J’s August 2018 quarterly report, 13.500 lawsuits have been filed primarily in state courts in Pennsylvania, California and Missouri. Other cases are pending in courts around the United States and Canada. Product liability lawsuits continue to be filed, and the company has settled or otherwise resolved many of the U.S. cases.
More than 6,600 Risperdal cases have been filed in the Philadelphia County Court of Common Pleas and its Complex Litigation Center alone, according to court statistics.
- Risperdal Consta
- Janssen Pharmaceuticals Inc.
- Johnson & Johnson
- Patriot Pharmaceuticals Inc.
- Janssen Research and Development
Juries Award Millions
Risperdal decisions in the Philadelphia County Court of Common Pleas have been split.
- Juries sided with plaintiffs in four cases. They ordered J&J and its Janssen unit to pay awards as high as $70 million.
- One judge dismissed a lawsuit. Another twice granted summary judgment in favor of Janssen.
- A jury in a different case found J&J illegally marketed the drug but it did not order the company to pay damages.
- In addition, a federal jury in New York awarded a man $1 million. But that verdict was later set aside by the judge.
$70 Million Risperdal Verdict
In July 2016, a Philadelphia jury awarded $70 million to Andrew Yount, a Tennessee teen who blamed the drug for causing him to develop female-size breasts. The award is the largest in Philadelphia litigation over the drug and gynecomastia, according to a Bloomberg report.
The teen’s lawyers told jurors he started taking the drug at age 5 to treat a psychiatric disorder. He never received a warning about breast development, they said. The lawyers further argued J&J hid from doctors the results from a study showing the drug caused abnormal breast development in boys so that the doctors would keep writing prescriptions.
The jury found the drugmaker failed to adequately warn the teen and his family that the drug could cause him to develop breasts and awarded him damages for emotional distress.
The verdict is under appeal. The judge who presided over the trial, Paula Patrick, issued an opinion in June 2018 urging the appellate court to uphold the verdict.
Patrick called the verdict “not unreasonable.”
The record-setting award is almost 30 times larger than the former highest Risperdal-side-effect verdict award: $2.5 million given to Austin Pledger.
In February 2015, Austin Pledger became the first victim to win a Risperdal jury trial. Pledger, who is an Alabama resident, was prescribed the drug 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 the drug. The court found J&J failed to warn the drug could cause breast development and awarded Pledger $2.5 million. That verdict is under appeal.
A federal jury in New York awarded Shaquil Byrd, 24, of Troy $1 million on his claim that he developed gynecomastia while taking the drug. The September 2017 verdict included $500,000 for past pain and suffering and an equal amount for future pain and suffering.
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 judge in the case overturned the verdict on Sept. 21, 2018, a year after it was handed up by jurors.
Another jury found in March 2015 that J&J 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 J&J in March 2013 that alleged he grew large breasts following years of Risperdal use. Cirba said he started taking the drug in 2002 at age 6. At the time, the drug was only approved for use in adults. Cirba successfully appealed, and a new trial has been ordered.
Timothy Stange of Wisconsin filed the third Risperdal trial 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 to include treatment for bipolar disorder in adults and adolescents and autism spectrum disorders in children and adolescents. The jury awarded Stange $500,000. He took Risperdal from 2006 to 2009.
Court of Common Pleas Judge Arnold New in September 2018 ordered a second trial in the case to determine whether the drugmaker should also have to pay punitive damages to Stange.
A jury in the fourth trial awarded Nicholas Murray $1.75 million. Murray developed breasts after taking the drug 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 J&J failed to adequately warn of the risks for breast growth.
At the same time Judge New ordered a second trial for Stange, he ordered another trial for Murray as well. The second trial will be to determine whether Murray is entitled to receive punitive damages in addition to the other award.
Judge Sean F. Kennedy dismissed a Risperdal lawsuit set for trial in Philadelphia in 2016. The ruling came just 11 days before trial proceedings were to begin.
Kennedy dismissed the lawsuit in because he concluded the plaintiff’s expert witness, Dr. Mark P. Solomon, provided insufficient testimony to argue the drug caused gynecomastia in this case. Nebraska resident Tommy Moroni 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 the drug’s risks. Judge Arnold L. New granted a motion for summary judgment in favor Janssen in February 2017.
J&J has settled several personal injury lawsuits both before and during trials. However, the company did not admit wrongdoing under the agreements and continues to deny liability for injuries. The settlement amounts have not been made public.
A lawsuit filed by Aron Banks was the first Risperdal personal injury suit to go to trial. J&J agreed to settle the case on the first day of trial in a Philadelphia court in September 2012.
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 — 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.
Other Confidential Settlements
In the month following the settlement with Banks, J&J settled five more cases in Philadelphia court. The settlement amounts for each case were kept confidential.
In November 2013, J&J 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.
J&J Pays Billions to Settle Marketing Scandal
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, J&J 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 included criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
Illegally Marketing Drug to Children
At the heart of the investigation were claims that J&J used aggressive marketing to get doctors to prescribe Risperdal to children. State and federal attorneys general also claimed the company disregarded FDA warnings not to promote the antipsychotic for childhood use.
In particular, they alleged that J&J 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.
Pediatricians Targeted in Campaign
At a Risperdal trial in Pennsylvania, a sales manager claimed that J&J 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, and a manager allegedly discussed including “lollipops and small toys” in sample packages.
In addition, the company was 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 ad adolescents. In 2015, the Philadelphia jury that awarded Austin Pledger $2.5 million 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 its product could cause breast development in boys as early as 2001 but information about that wasn’t added to the drug labeling until 2006.
Team Pushed Drug on Dementia Patients
The government investigations revealed that J&J used a variety of tactics to get doctors to prescribe the drug.
- 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 the drug to more patients
In one tack, J&J cut a deal with Omnicare, a company that provided pharmaceutical services in nursing homes. J&J agreed to share profits with Omnicare if Omnicare doctors would prescribe the drug.
Despite knowing the FDA had not approved the drug for the elderly, J&J 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 antipsychotics 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 J&J 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 with those states in August 2012.
The company did not admit to wrongdoing in any multistate investigations. In fact, J&J continues to deny wrongdoing.
- A Louisiana jury ordered it to pay $257.7 million to the state for defrauding the state Medicaid program and misleading regulators and the public about the drug’s health risks.
- Arkansas fined the company $1.2 billion for improper marketing. That judgment was later overturned by the state Supreme Court, which said the state had wrongly applied the law.
In May 2013, the Kentucky attorney general announced a lawsuit alleging J&J concealed dangerous side effects of the drug, including diabetes, substantial weight gain, stroke and gynecomastia. According to researchers, the drug’s link to adolescent gynecomastia is higher than other antipsychotic.
“The complaint alleged that 'J&J represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug, including low weight gain,'”
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. J&J 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 the drug. 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,”
South Carolina filed a complaint against J&J in April 2007 over false marketing claims related to the drug. A trial court found the drugmaker’s Janssen unit had improperly marketed the drug 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 J&J accusing the company of improperly marketing the drug to state residents on the Medicaid health program for the poor, including children. J&J offered to settle with the attorney general on the sixth day of the trial. The company agreed to pay $158 million.
Please seek the advice of a medical professional before making health care decisions.