Drug Manufacturer Did Not Adequately Warn of Side Effects of Risperdal

A Philadelphia jury recently decided that the drugmaker Johnson & Johnson should pay $2.5 million to a man who developed enlarged breasts after being prescribed Risperdal as a boy, the Philadelphia Inquirer reports.

Thousands of lawsuits are pending against Johnson & Johnson for failing to warn the Food and Drug Administration, doctors and consumers about the risks of using Risperdal. The antipsychotic medication was approved to treat certain mental disorders in adults in 1993, and expanded to adolescents in 2006.

But the court ruled that Johnson & Johnson had evidence that Risperdal could cause gynecomastia – a condition that causes abnormal breast growth in boys – but did not do enough to disclose it. The plaintiff, a now 20-year-old autistic man, developed 46 DD breasts after he began taking the drug at age 8.

Former FDA Commissioner David Kessler testified that Johnson & Johnson’s Janssen unit had evidence from one if its own 2001 studies that nearly 4 percent of boys given Risperdal grew breasts that were either “probably or very likely” caused by the medication, according to Bloomberg. Kessler added that the Risperdal label did not mention breast growth as an adverse side effect until 2006 – the same year it was approved for use in adolescents.

Internal documents from Johnson & Johnson also suggested “an effort to downplay the prevalence of” gynecomastia, Bloomberg reported.

Drug companies cannot market medications for unapproved uses, but doctors can prescribe drugs off- label if they choose. However, the jury ruled that sales reps did not do enough to inform physicians about the risks of using the medication, even after the label was revised.

The plaintiff’s doctor told the jury he would not have prescribed the drug if he had known it carried the risk of gynecomastia.

This is the first jury trial involving Risperdal, but Johnson & Johnson already agreed to pay $2.2 billion in criminal and civil fines in 2013 for illegally marketing the drug. It settled its first case involving gynecomastia and Risperdal in 2012.

The company maintains that it properly warned consumers about the risks of Risperdal and plans to appeal.

Dangerous Drugs and Failure to Warn

Drug makers have a legal duty to the public to perform clinical trials and inform the FDA of any possible adverse outcomes that could result from taking a new drug.

But unfortunately, many dangerous drug lawsuits involve a “failure to warn” people of potential side effects. Risperdal is not the only medication under scrutiny. Thousands of cases are pending involving drugs that have caused serious injuries and deaths, such as:

• Avandia
• Plavix
• Celebrex
• Fosamax
• Fentanyl
• Bextra
• Accutane
• Seroquel
• Yasmin
• Serzone
• Crestor
• Prozac
• Vioxx
• Xarelto
• Hydroxycut
• Meridia
• Ephedra
• Provigil

The attorneys at the Frank Jenkins Law Office know that you have a right to expect that the drugs you are prescribed have been thoroughly vetted for safety and are safe and effective when used as directed. If you suffered serious side effects after taking a medication and believe you have a claim, please contact us for a free and confidential consultation.