Risperdal Lawsuits, Verdicts & Settlements

In an Oct. 29, 2021 filing with the U.S. Securities and Exchange Commission, Johnson & Johnson said it had settled most lawsuits from men who claimed their drug Risperdal caused excessive breast tissue. They recorded $800 million in expenses for the settlement and which the company said resolved “substantially all” of the 9,000 cases that were still pending.

According to Johnson & Johnson’s 2018 annual report, 13,400 lawsuits had been filed a one time, primarily in Pennsylvania, California and Missouri. Other cases were pending in courts around the United States.

Drugwatch is not aware of any attorneys currently taking Risperdal cases.

Men, boys and their families sued Johnson & Johnson and several of its affiliates, alleging Risperdal use caused gynecomastia, or enlargement of male breasts that can require surgery to correct.

The drug is prescribed for the treatment of various mental illnesses, including schizophrenia, acute manic or mixed episodes associated with bipolar I disorder, and irritability associated with autism and related conditions.

Many children were prescribed the medication even though the U.S. Food and Drug Administration had not yet approved the drug for pediatric use. Adults and children with gynecomastia frequently experienced humiliation and psychological trauma due to embarrassing breast growth.

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.
• The court dismissed one lawsuit and 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.

$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 Bloomberg.

The teen started taking the drug at age 5 to treat a psychiatric disorder but never received a warning about breast development. Yount introduced evidence that 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, Hon. Paula Patrick, issued an opinion in June 2018 urging the appellate court to uphold the verdict.

Yount 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.

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 and later developed gynecomastia as a result. 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.

Shaquil Byrd

Shaquil 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.

A federal jury in New York awarded Byrd $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.

The judge in the case overturned the verdict on Sept. 21, 2018, a year after it was handed up by jurors.

Billy Cirba

Billy 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. In March 2015, a jury found that J&J illegally marketed the drug. However, the jury could not find proof the drug caused Cirba’s breast growth so no damages were awarded. He successfully appealed, and a new trial has since been ordered.

Timothy Stange

Timothy Stange of Wisconsin filed the third Risperdal trial heard by a jury. The trial 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.

In September 2018, the court ordered a second trial in the case to determine whether the drugmaker should also have to pay punitive damages to Stange.

Nicholas Murray

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.

The court subsequently ordered a second trial for Stange to determine whether Murray is entitled to receive punitive damages in addition to the other award. In October 2019, a jury hit Johnson & Johnson with an $8 billion punitive damages verdict.

Tommy Moroni

The court dismissed a Risperdal lawsuit set for trial in Philadelphia in 2016 because it concluded the plaintiff’s expert witness, Dr. Mark P. Solomon, provided insufficient testimony to argue the drug caused Tommy Moroni’s gynecomastia in this case. The ruling came just 11 days before the trial was to begin.

P.D.

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 has not admitted any wrongdoing under the agreements and continues to deny liability for injuries. The settlement amounts have not been made public.

Aron Banks

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.

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.

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.