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Defective Drugs - Risperdal

Risperdal is a prescription medication used to treat schizophrenia and bipolar disorder that is alleged to have caused gynecomastia, (development of female breast tissue) in boys and young men. This condition results from elevated levels of the hormone prolactin, which the plaintiffs allege is from their use of Risperdal.

Breast Growth - Gynecomastia

Scientific research supports claims that Risperdal may cause gynecomastia in boys. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology concluded that risperidone, (a generic of Risperdal) “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”

Some adolescent males who suffer from gynecomastia have had to undergo surgery. Generally, stopping the medication does not make the breast growth go away. The treatment is generally painful and scarring surgical removal of the unwanted breast tissue. Hundreds of lawsuits have been filed against Johnson & Johnson, the pharmaceutical company that manufactures Risperdal. Obviously, most of its victims had no idea that Risperdal could cause breast growth.

In September 2012, Johnson & Johnson settled its first Risperdal gynecomastia lawsuit on the opening day of the trial. The plaintiff was a 21-year-old male who took Risperdal from the ages of 9 to 13. At the time he was taking it, Risperdal had not been approved by the FDA for treatment of children. The amount of the settlement has not been disclosed.

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History of Risperdal

FDA approval was given to Johnson & Johnson for Risperdal in 1993 for the treatment of schizophrenia and bipolar disorder in adults and adolescents. Within three years, more than one million prescriptions had been dispensed.

Since its first approvals, Risperdal has also been prescribed to patients for conditions that the drug was not approved to treat. These are called “off label” uses. Risperdal’s “off label” prescriptions included those for attention deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties, depression, Tourette syndrome, stuttering, and obsessive-compulsive disorders. Although doctors are allowed to prescribe medications for “off-label” uses, the law prohibits drug companies from promoting or marketing their drugs for these uses. Essentially, the use of the drug for anything not approved is supposed to be left solely between the patient and their doctor. Despite these laws, Johnson & Johnson has been sued by the government for illegal promotion of Risperdal.

Johnson & Johnson made billions of dollars from the sale of Risperdal before it lost its patent in 2007 and generic versions of risperidone became available. Once Johnson & Johnson’s best-selling drug, Risperdal generated worldwide sales of $24.2 billion from 2003 to 2010.

The litigation has been ongoing for three years. Thousands of cases have been filed in Philadelphia and Los Angeles and trials have been set. Despite the manufacturer denying liability, three earlier trials have resulted in verdicts in favor of the injured plaintiff for $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that Johnson and Johnson failed to adequately warn of the risks of gynecomastia.

The manufacturer, a subsidiary of Johnson & Johnson, never got approval to market the drug for minors. In fact, Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013.

Former commissioner of the U.S. Food & Drug Administration David Kessler testified in 2015 that the company hid information about the gynecomastia risk as early as 6 years before it changed the label to include the injury. He also told the jury that the manufacturer failed to inform physicians of the gynecomastia risk associated with the drug.

Johnson and Johnson has been settling Risperdal cases. Boys who have undergone a double mastectomy are getting the most compensation. Boys who got a prescription between the years 2000 to 2006 are most likely to settle their case. The attorneys at continue to monitor these cases.

In July of 2010, the first gynecomastia lawsuit was filed. The 21-year-old plaintiff took Risperdal from the ages of 9 to 13 and unfortunately suffered unwanted breast growth. At the time he was taking it, Risperdal had not been approved by the FDA for treatment of children. Johnson & Johnson settled the case for an undisclosed sum.

In 2010, a jury in Louisiana awarded nearly $258 million in damages against Johnson & Johnson based on their defrauding of the state’s Medicaid system by claiming Risperdal was superior to other drugs and minimizing its risks.

In 2011, a South Carolina judge ordered Johnson & Johnson to pay $327 million for untruthful marketing. And in 2012, a Texas case cost Johnson & Johnson $158 million in settlement for “making false or misleading statements about the safety, cost and effectiveness of the expensive anti-psychotic medication Risperdal, and improperly influencing officials and doctors to push the drug.”

In August of 2012, the government settled one such lawsuit for $181 million. They had accused Johnson & Johnson of paying well-known physicians to promote use of the drug to other doctors who would value their opinion. A few months later, Johnson & Johnson settled five more Risperdal gynecomastia cases.

If you or someone you care about is a boy or young man that has been the victim of breast growth while taking Risperdal, you owe it to yourself to call us for a free consultation.

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