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Years before the U.S. Food and Drug Administration’s 2006 approval of the anti-psychotic medication Risperdal for use in children, pharmaceutical giants Johnson & Johnson and Janssen Pharmaceuticals promoted its use, resulting in thousands of young boys developing gynecomastia, a condition in which males them develop female breast tissue.
The same year the FDA approved the use of the drug by children, the drug companies updated the label to include a warning of the nexus between Risperdal and male breast growth.
The label warning indicated that approximately 2.3 percent of male adolescents treated with Risperdal developed gynecomastia. Previously, Risperdal’s label characterized the risk gynecomastia as a rare occurrence affecting fewer than one in 1,000 patients.
Risperdal, first approved by the FDA in 1993, is approved to treat children and adolescents with severe emotional and behavioral disorders, including schizophrenia, bipolar disorder and irritability in children with autism.
The blockbuster drug accounted for 97 percent — or $28.9 billion — of Johnson & Johnson’s sales between 1994-2010, according to The Daily Beast.
Tens of thousands of lawsuits alleging a connection between Risperdal and male breast growth have been filed nationwide. Plaintiffs claim that Johnson & Johnson and Janssen knew about the risk of gynecomastia but failed to warn doctors and patients.
As of January 2017, some 16,000 Risperdal gynecomastia lawsuits were consolidated in California Superior Court in Los Angeles.
Often called man boobs, gynecomastia (a condition that causes male breast growth) may require surgery to correct.
In July 2016, a Philadelphia jury awarded a whopping $70 million to a Tennessee boy, who in 2003, at age five, began taking Risperdal to treat attention-deficit hyperactivity disorder — commonly known as ADHD — and oppositional defiant disorder.
In 2003, Risperdal had not been FDA-approved for use in treating behavior disorders in children. The child developed female breasts within a year of taking the drug.
In 2015, a then 20-year-old Alabama man with severe autism was awarded $2.5 million in damages for Risperdal gynecomastia. The man was prescribed the drug in 2002, when he was eight, to deal with outbursts and irritability associated with autism.
By the time he was a teenager, the man had developed size 46DD breasts.
Also in 2015, a jury awarded a then 21-year-old Maryland man $1.75 million for disfigurement and mental anguish as the result of Risperdal gynecomastia. The man was prescribed the drug at age nine to treat attention-deficit hyperactivity disorder.
Jurors found that Johnson & Johnson and Janssen failed to warn healthcare providers and patients of the risk associated with Risperdal and male breast growth.
Risperdal lawsuits have resulted in Philadelphia’s largest mass tort program, according to Law.com, with some 5,500 pending cases as of June 2017.
“Litigation over the anti-psychotic drug Risperdal jumped from being 31.4 percent … as of Jan. 1 to 55.8 percent as of June 14,” the site reports, noting that the figure represented a 185 percent increase from January 2017 to June 2017.
If you or a loved one suffered from Risperdal side effects, contact the Risperdal attorneys at McDonald Worley today for a free case evaluation.