Instead, Risperdal has been connected to serious side effects like diabetes, massive weight gain and a condition called gynecomastia - the aberrant growth of breasts in males, especially young males.
Veteran attorney Stephen Sheller calls Risperdal “by far the most dangerous drug on the market.” His firm has filed more than 235 cases on behalf of Risperdal users who developed enlarged breasts after being prescribed Risperdal for psychiatric problems as children or adolescents.
Several studies have shown that Risperdal, chemical name risperdone, causes elevated levels of the hormone prolactin that causes breasts to become enlarged.
“Taking kids who are already at risk and screwing them up even more with this drug is just really wrong,” says Sheller from his office in Philadelphia, Pennsylvania. “It makes me angry to tell you the truth.”
A very lucrative drug
Soon after coming to market in the early 90’s, Risperdal quickly became a top earner for Johnson and Johnson (J&J) and its subsidiary Janssen. Despite the fact that Risperdal was not approved for use by children, J&J went on an aggressive marketing campaign to get doctors to prescribe Risperdal to children with psychiatric problems and for other off-label conditions.
Between 1994 and 2010, Risperdal sales went through the roof. With a 97 percent profit margin, the company earned somewhere between $30 and $40 billion over that period, and Risperdal continues to earn J&J billions in sales every year.
However, fraudulent marketing tactics and personal injury liability claims are also costing the company billions.
The Attorneys General in a number of states, including the state of Texas, have successfully litigated against J&J and received compensation for Medicaid fraud alleging that the drugmaker’s Risperdal marketing plan was an unfair and deceptive trade practice that cost taxpayers millions of dollars.
In 2012, a court ruling found that the company overstated the safety of the drug, as well as its applications, and underplayed the risks. It urged physicians to prescribe Risperdal to adolescents, Alzheimer’s patients, people with anxiety disorders and depression, even though the drug was not FDA approved for any of those conditions.
At the same time, J&J was hiding data that showed a link between Risperdal and Type 2 diabetes.
And in a massive whistleblower case in 2013, speared-headed in part by attorney Stephen Sheller and other members of his firm, J&J was ordered to pay millions more for making false claims about Risperdal.
The focus of the Risperdal story in 2014 now turns from a drug company’s ruthless pursuit of sales to the bizarre growth of breasts in young men who were part of the sales churn at J&J.
Around 2004, at the same time as Risperdal users with diabetes were coming forward, investigators began to hear about unusually large numbers of gynecomastia cases, particularly in young men who had been prescribed Risperdal as teenagers or sometimes as children.
“As we got deeper into the litigation we believed that Johnson and Johnson knew more about the high percentage of males that would develop gynecomastia than they were explaining in the label or reporting to the FDA. That’s when I began to file, research and investigate these kinds of cases,” says attorney Brian McCormick from the Sheller firm.
Of the 230 cases of young men with gynecomastia the firm is handling, Sheller has settled 70 out of court. This summer, McCormick has three trial dates booked in Philadelphia on behalf of young men who had their lives changed by Risperdal.
“Besides the fact that it is sometimes physically painful, it is psychologically devastating,” says McCormick.
“We have interviewed and met with many, many clients. It means never going to a swimming pool or taking off your shirt in public. Sometimes they are harassed by peers. These are not just cases where there was obesity; some of these kids are as thin as a rail, which makes it even more obvious. These boys have suffered. It’s terrible.”
This isn’t McCormick’s first rodeo when it comes to dealing with Risperdal and J&J. He says the case is ready and expert witnesses are standing by.
“We have endocrinologists and some nationally known people that are going testify. I don’t think there is any question that Risperdal leads to elevated levels of prolactin, which then leads to gynecomastia.”
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Stephen Sheller is known as an aggressive and principled litigator who has recovered billions in damages for his clients. He is known for representing whistleblowers in qui tam cases, product liability, defective drugs, personal injury and class-action cases. Brian McCormick is an attorney with the Sheller firm. His practice includes pharmaceutical injury, consumer protection, product liability and mass tort litigation. His main focus is on representing whistleblowers and has litigated the largest qui tam case in history, recovering $6.2 billion for the US government.