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Ex-FDA Chief Tesitimony: J&J Knew About Risperdal Link to Male Breast Growth in Adolescents

Written by on February 5, 2015
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Former FDA Chief David Kessler testified in Philadelphia state court for the plaintiff over the allegations that Risperdal causes male breast growth. According to Bloomberg Business News, Kessler told the jury that officials of J&J’s Janssen unit funded a 2001 study that showed 3.8 percent of boys given Risperdal during the clinical trial developed breasts that were either ‘probably or very likely’ caused by the drug.1

Kessler also testified that J&J knew as early as 2001 that the drug could potentially cause Gynecomastia. However, the Risperdal warning didn’t include breast growth as a possible side effect until 2006, when J&J received FDA approval for use in children.

First Risperdal Breast Growth Lawsuit in 2015 Underway

According to a Risperdal gynecomastia lawsuit currently underway in Philadelphia, Austin Pledger was 8 years old when he started taking Risperdal. He subsequently experienced abnormal breast growth, a condition known as gynecomastia. Now 20, Pledger claims the manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) deliberately withheld information about the risk.

Pledger began using Risperdal in 2002. At the time, Janssen apparently illegally promoted the drug for off-label use in children exhibiting various behavioral disorders. The company eventually negotiated a $2.2 billion Risperdal lawsuit settlement to clear civil and criminal charges brought by the U.S. Department of Justice.

Johnson & Johnson and Janssen’s legal troubles involving their antipsychotic medication are far from over. The companies are currently facing more than 1,200 lawsuits filed on behalf of boys and young men who experienced Risperdal gynecomastia side effects. Pledger’s case is one of the first to go to trial in recent years.

Abnormal breast growth is more than just embarrassing for adolescent boys. It can also cause lasting psychological problems. Moreover, the condition may warrant a mastectomy. If you or your son experienced unnatural breast development after taking Janssen’s antipsychotic drug, call 1-888-210-9968. You may be eligible to file a claim for compensation.

Manufacturer Accused of Failing To Warn About Risperdal Gynecomastia Risk

One of the allegations made in Pledger’s case is that both Johnson & Johnson and Janssen failed to provide adequate warning that Risperdal might cause gynecomastia. Instead, the companies claimed the drug was safe.

Lawyers for the defendants argued that neither J&J nor Janssen were liable for Pledger’s condition. They said the drug’s label mentioned the possibility that Risperdal might cause a rise in prolactin levels (known as hyperprolactinemia). Because studies have shown that elevated prolactin levels were linked to breast development, they asserted the label didn’t need to list gynecomastia as a potential side effect.

Pledger’s doctor at the time, Jan Mathisen, testified he would have thought twice about prescribing Risperdal to Pledger had he been aware that it might cause breast growth. Had he known about the risk, he claimed he would have warned Pledger’s family.

Johnson & Johnson Quickly Settles Risperdal Lawsuit Claims

The lawsuit filed on behalf of Pledger isn’t the first to reach a jury. In 2012, a case brought by a man named Aaron Banks went to trial. Like Pledger, Banks had taken Risperdal as a child and subsequently developed breasts. Johnson & Johnson settled the Risperdal breast growth lawsuit on the first day of trial for an undisclosed amount. Other lawsuits targeting J&J and Janssen have been scheduled for trial, but those Risperdal lawsuits were also settled.

Johnson & Johnson has reaped billions of dollars in revenue from sales of Risperdal since it obtained FDA approval to market it in 1994. But the pharmaceutical giant’s legal troubles over of the drug have been costly. When the dust finally settles, it will have paid billions in fines, penalties, and potential settlements with claimants.

Pledger’s case in Philadelphia is being closely watched to learn how jurors will respond to evidence and testimony presented by both sides. The 1,200+ cases pending against J&J and Janssen have been organized into a mass tort. A jury verdict in favor of Pledger may compel both companies to settle outstanding cases.

Illegal Marketing Leads To A Massive Risperdal Settlement

Johnson & Johnson brazenly marketed Risperdal for use in adolescents years before the U.S. Food and Drug Administration approved it for such. The company was warned by the FDA on multiple occasions to stop doing so. Rather than complying, J&J seems to have dismissed the warnings and continued to promote Risperdal for a host of psychiatric conditions in children.

Dozens of states filed lawsuits against Johnson & Johnson, claiming it ignored the FDA’s warnings and engaged in fraudulent marketing. Those cases, along with an investigation conducted by the U.S. DOJ, resulted in the aforementioned $2.2 billion Risperdal lawsuit settlement.

Are You Eligible To Join The Expanding Risperdal Litigation?

Financial compensation may be due to boys and families that have suffered from abnormal breast development after taking Risperdal. If you or someone in your family was diagnosed with gynecomastia after using Johnson & Johnson’s antipsychotic drug, call us toll-free at 1-888-210-9968 for a free case review.

Our Risperdal settlement lawyers are here to listen and answer any questions you have about filing a Risperdal lawsuit for compensation. If you decide to do so, there are never any legal fees unless we obtain a recovery for you.

There is limited time to file a Risperdal settlement claim. Contact our offices to find out if you’re eligible to join the growing Risperdal litigation. Receive the legal help you need to hold the manufacturers accountable and recover the compensation you and your family deserve.

1. Ex-FDA Chief Says J&J Knew Drug Linked to Male Breast Growth

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Attorney Stephen Fields believes that all people harmed by dangerous drugs and devices should be fairly compensated for their injuries. With this goal in mind he founded the Fields Law Firm, where he strives to achieve the best possible outcomes for his clients. Connect with Stephen via .
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