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Johnson & Johnson, (J&J) the world’s largest pharmaceutical and medical device maker is under withering fire over its antipsychotic blockbuster drug, Risperdal.

Earlier in February, the drug manufacturer lost the first trial in state court in Philadelphia over allegations that Risperdal causes gynecomastia or abnormal breast growth in boys and young men exposed to the popular antipsychotic drug.

The jury hammered Johnson & Johnson to pay $2.5 million in compensatory damages to a young Alabama man blamed the company for promoting the “off label” use of Risperdal, which in turn resulted in gynecomastia.

According to riveting court testimony, J&J, knew as early as 2001 that the medication caused boys to grow breasts. This key testimony was provided by David Kessler, the former head of the U.S. Food and Drug Administration, in the first case over the antipsychotic medication to be decided by a jury .

South Carolina Wins its Lawsuit Against J&J Risperdal

Adding salt to J&J legal Risperdal wounds, South Carolina’s Supreme Court ordered J&J this week to pay a penalty of $136 million, upholding a jury’s finding that the drugmaker’s Janssen unit had improperly marketed its anti-psychotic drug Risperdal and concealed its risks.

A trial court had earlier ordered J&J to pay $327 million, but the Supreme Court more than halved that penalty, citing a provision in South Carolina law that no action can be taken in such cases after three years of the discovery of unlawful conduct. South Carolina filed its complaint in April 2007.

According the Supreme Court Chief Justice, “Janssen’s desire for market share and increased sales knew no bounds, leading to its egregious violation of South Carolina law.”

“Red Flag” Study

According to Kessler, J&J’s Janssen unit funded a medical study in 2001, that demonstrated 3.8 percent of boys given Risperdal during the clinical trial developed breasts that were either “probably or very likely” caused by the drug.

Kessler told jurors in the trial that the study “certainly was a red flag to me.” The lawsuit brought by Austin Pledger, a 20-year-old Alabama man, claims that the drug caused his 100-pound weight gain and the development of female breasts, which will require surgical removal because of their size.

Over 1,250 Risperdal Male Breast Lawsuits

J&J, is exposed more than 1,250 lawsuits over the Risperdal breast growth side effect in state court in Philadelphia, centralized in the Philadelphia Court of Common Pleas as a mass tort. There are several thousand Risperdal Gynecomastia lawsuits pending in California state court.

In 2012, J&J settled the first case to go to trial over the allegations that the drug caused gynecomastia, or abnormal breast development, in boys.

J&J Paid $2.2 Billion in Criminal Fines

In 2013, J&J agreed to pay $2.2 billion to settle criminal and civil investigations that the company illegally marketed the drug to children and the elderly. That settlement, which also includes marketing claims about two other J&J drugs, was one of the largest U.S. health-fraud penalties in history.

Risperdal Gynecomastia Side Effects

Gynecomastia is defined as the growth of breast tissue among males. In the Risperdal cases, the plaintiffs blame the breast development caused by Risperdal for the surgical treatment to remove the breasts, which causes scarring, physical injury, and severe psychological damage from Risperdal breast growth.

Risperdal has been also linked to excessive weight gain and diabetes. The drug, once J&J’s biggest seller, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007.

J&J Quietly Settling Risperdal Gynecomastia Claims

Johnson & Johnson has been quietly been settling the breast growth litigation over Risperdal for the past several years, but the number of claims has continued to increase as more families and young adults learn that there may be a link between gynecomastia and Risperdal use as a child.

The case is PP v. Ortho-McNeil Janssen Pharmaceuticals, 120401997, Court of Common Pleas Philadelphia County (Philadelphia)

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