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Risperdal Lawsuit 2015: Jury Awards $2.5 Million in Damages For Failure To Warn Of Gynecomastia Risk

Written by on February 25, 2015
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A Philadelphia jury awarded $2.5 million in damages yesterday, February 24, 2015. Johnson & Johnson was accused of failing to warn that Risperdal causes gynecomastia, or male breast growth, in adolescents. This first Risperdal lawsuit in 2015 marks the beginning of a series of trials intended to determine if J&J knew about the risks associated with Risperdal. Expert witness David Kessler testified that the pharmaceutical company knew about the risk and failed to disclose the data showing the extent of that risk.

The Risperdal lawsuit was filed on behalf of a man named Austin Pledger. Now 20 years old, Pledger began using Risperdal as early as 2002 as a young boy. He continued treatment for 5 years, during which time he developed size 46 DD breasts. His lawsuit alleges Janssen knew or should have known about the risk, and failed to sufficiently warn the public.

Former FDA Chief Claims J&J Knew About The Gynecomastia Risk

In 2006, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, updated the safety labeling on its antipsychotic Risperdal. The purpose was to mention the drug might cause young boys to develop breasts. But testimony in the Risperdal lawsuit alleges Janssen and J&J knew about the Risperdal gynecomastia risk several years beforehand. The testimony comes from David Kessler, a former commissioner of the FDA.

Kessler’s testimony is startling because it suggests Janssen deliberately concealed information about the link between Risperdal and gynecomastia. There’s no way to know how many adolescent boys took the drug and suffered abnormal breast growth as a result of Janssen’s silence.

Gynecomastia can have a significant psychological impact on its sufferers, particularly at a young age. If you or your son developed the condition after taking Risperdal, call 1-888-210-9968 for a free case review. You may be able to pursue a Risperdal settlement.

Was Johnson & Johnson Aware Of The Risperdal Gynecomastia Risk?

Drug companies facing accusations that their medications cause undisclosed side effects usually insist their drugs are safe. That ship has sailed for Janssen and Johnson & Johnson. Studies have long shown that use of Risperdal might elevate prolactin levels, which, in turn, can cause gynecomastia.

The controversy is not over whether the drug can trigger the condition. Rather, it involves when Johnson & Johnson became aware of the breast growth risk, and why it waited so long to notify consumers and doctors.

Former FDA chief Kessler highlighted a 2001 clinical trial showing that nearly 4% of adolescent boys taking risperidone (generic for Risperdal) developed breasts. He noted the incidence rate was “certainly was a red flag to me,” suggesting that Janssen executives should have taken note. They surely knew about the study; the company had funded it.

Manufacturer Aggressively Promoted Risperdal For Off-Label Use

Kessler also mentioned that Johnson & Johnson had illegally marketed Risperdal for off-label uses among children. A formal investigation by the U.S. Department of Justice resulted in criminal fines approaching $500 million and a massive $1.72 billion settlement to resolve federal and state civil complaints.

Neither J&J nor Janssen Pharmaceuticals are strangers to controversy over their prescription medications. Nor is either company afraid to stoke the FDA’s ire.

In 1999, the agency sent a stern letter to Janssen executives, expressing concerns over the marketing materials used to promote Risperdal.1 The materials were found to be “false, misleading, and/or lacking in fair balance.

In 2004, it sent an even sterner warning to Janssen regarding a “Dear Healthcare Provider” letter the company had distributed to nearly 700,000 physicians.2 The FDA accused Janssen of downplaying the risks of using its antipsychotic and making misleading claims regarding its benefits.

Given the above, Kessler’s testimony that J&J and Janssen knew Risperdal might stimulate breast growth in young boys, but chose to remain silent, is unsurprising. Both companies have a track record of failing to meet a reasonable standard of care with regard to manufacturing and promoting their prescription medications.

Number Of Risperdal Breast Growth Lawsuits Continues To Surge

Several lawsuits that have targeted Johnson & Johnson and Janssen over Risperdal gynecomastia side effects have ended in settlements. The litigation currently under way in Philadelphia may eventually compel both drug makers to negotiate a mass Risperdal settlement with plaintiffs.

In the meantime, the number of claims being filed on behalf of injured boys and young men who developed breasts after taking Risperdal continues to grow.

If you or a loved one used Risperdal and later experienced abnormal breast growth, you’re not alone. Call 1-888-210-9968 to discuss your case with our Risperdal gynecomastia lawyers. You may be eligible to join the existing litigation and recover compensation for you and your family.

The legal consultation is free. There is no obligation to hire our firm if you decide to file a lawsuit. If you choose to do so, there are never any legal fees unless we win your case and obtain a recovery for you.

There is limited time to file a Risperdal gynecomastia claim based on your state’s statute of limitations. Contact our offices today to find out the filing deadline and take the first step toward recovering the compensation you deserve.

1. FDA Notice of Violation for Risperdal
2. FDA Warning Letter for Risperdal

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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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