What Did the Former FDA Chief Say About Risperdal?

What Did the Former FDA Chief Say About Risperdal?

Posted By The Maher Law Firm || 20-Feb-2015

Johnson & Johnson's Janssen unit knew as far back as 2001 that Risperdal could cause breast growth in boys, the former head of the U.S. Food and Drug Administration (FDA) recently testified in the first case to go to trial against the manufacturer of the antipsychotic medication.

Dr. David Kessler, a pediatrician who served as the FDA's commissioner between 1990-1997, testified that Janssen funded a study in 2001 "that showed 3.8 percent of boys given Risperdal developed breasts that were either 'probably or very likely' caused by the drug," Bloomberg reports.

The study "certainly was a red flag to me," Kessler said, according to Bloomberg.

Additionally, Philly.com reports that company emails and manuscript drafts presented in court "indicate an effort to downplay the prevalence" of the breast growth condition, which is called gynecomastia.

Case Involves Autistic Man Who Developed Gynecomastia After Taking Risperdal

As Philly.com reports, the trial is currently underway in the Philadelphia Court of Common Pleas. More than 1,000 similar Risperdal lawsuits are pending in the same court, Bloomberg reports.

Risperdal is an atypical antipsychotic medication that the FDA approved for the treatment of certain psychotic disorders in adults in 1993 and for treatment of adolescents in 2006.

As Philly.com reports, the plaintiffs in this case are the parents of a now 20-year-old severely autistic Alabama man who was prescribed Risperdal in 2002 when he was eight years old. He used the drug until 2007. The lawsuit claims that the man gained more than 100 pounds and developed gynecomastia due to taking Risperdal, according to Bloomberg.

Kessler was testifying as an expert witness for the plaintiffs.

According to Bloomberg, Kessler testified that the Risperdal labeling did not include a warning about breast growth until 2006, or the year it was approved by the FDA for treatment of adolescents.

However, prior to that approval, the manufacturers "pushed" doctors to prescribe Risperdal for off-label uses, including giving doctors Lego-like blocks for children with the Risperdal label, Bloomberg quotes Kessler as stating in a report.

According to Philly.com, the pediatric neurologist for the plaintiffs' son testified that a sales rep from Janssen visited his office "20 times between 2002 and 2004," with Risperdal samples.

The doctor testified that he would have liked to have known about the 2001 study, Philly.com reports.

In a statement to Philly.com, a Janssen spokesperson said the company had followed all rules regarding the reporting of clinical trial data and believes that it has provided "appropriate" Risperdal prescribing information at all times.

It should be noted that Johnson & Johnson paid $2.2 billion in civil and criminal fines in 2013 to resolve allegations that it had improperly promoted Risperdal for "off-label" uses such as treatment of dementia in children and the elderly, according to the New York Times.

The Maher Law Firm currently is reviewing cases of those who believe they developed gynecomastia after taking the Risperdal antipsychotic medication. To learn more and receive a free consultation about a possible Risperdal lawsuit, call or contact our firmonline today.

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