Popular antipsychotic drug Risperdal is still under fire. More cases are coming forward in courts showcasing the drug damaging, lasting effects; at least two have won recent Risperdal settlement awards. While each case is unique, the majority were filed against Johnson & Johnson (and its subsidiary, Janssen Pharmaceuticals). The company marketed Risperdal as a treatment for mental disorders before it was approved by the Food and Drug Administration.
The FDA initially prohibited Johnson & Johnson salespeople from marketing Risperdal to children. This is because they feared the possible side effects it could cause, including hormonal disorders. As it turns out, the manufacturer had every reason to be concerned. In fact, the recent Risperdal settlement awards were won by young men who developed gynecomastia after being prescribed Risperdal as children.
Linked to gynecomastia (breast growth) in young boys, Risperdal has repeatedly caused lasting damage against not only children, but also the elderly. Older patients are a subcategory that Johnson & Johnson aggressively targeted in Risperdal’s marketing plans. Evidence against Johnson & Johnson’s marketing tactics, which include cleverly pitched promotional materials and salespeople who pushed the drug before its FDA approval, is now court evidence. Thankfully, many victims are finally seeing the justice they deserve.
Recent Risperdal Settlement Awards: Austin Pledger, April 2015
“I have never seen a worse case of corporate misconduct than I have seen here,” says Thomas R. Kline, an attorney who has been trying drug cases for 37 years. Kline represented 20-year-old Austin Pledger. The plaintiff, who has autism, first took Johnson & Johnson’s Risperdal as a teen and eventually grew size 44DD breasts. Initially prescribed Risperdal in 2002 when he was just eight years old, Pledger stopped taking it in 2006 after the FDA released a warning. By then, however, the damage had already been done.
During the case, (which deliberated for a day-and-a-half), the jury found Janssen (a subsidiary of Johnson & Johnson), guilty for failing to properly warn the plaintiff’s doctor and Pledger’s family that the drug could cause gynecomastia and for promoting it for use for children with autism and other psychotic behaviors. Although the drug was legal at the time Pledger was prescribed it, Risperdal was not intended for children. Instead, the FDA recommended it be used only for the management of symptoms related to psychotic disorders in adults.
But after more than 20 visits to Pledger’s pediatric neurologist by a Janssen pharmaceutical sales rep encouraging him to prescribe it off-label to patients, Pledger’s doctor felt it was worth a try. The jury awarded Pledger $2.5 million in damages. “This trial is important publicly because it provided for the first time a window into the real risks of the drug,” said Kline.
Recent Risperdal Settlement Awards: Andrew Yount, July 2016
Andrew Yount began taking Risperdal when he was just five, to treat a psychiatric disorder. Similar to Pledger, lawyers led with an explanation about Janssen Pharmaceuticals’ failure to warn patients about the possibility of gynecomastia and other side effects while promoting it off-label.
They then took it one step further, accusing Janssen of concealing records and committing major legal misconduct. After a Pennsylvania state court trial, Yount won $70 million in compensatory damages. (That’s 28 times more than Pledger’s financial settlement.) “This verdict will help thousands of children, boys, and their families be made aware of the dangers of Risperdal,” said Steve Sheller, one of Yount’s attorneys. “To put it mildly, it’s about time that someone put J&J to task.”
But a Johnson & Johnson spokeswoman disagrees. She released a statement that says the company sympathizes with the 17-year-old, she also believes that the verdict is not justified by the evidence, “and that the award is clearly excessive and far out of line with any factual assessment of actual damages.” She also said that the product labeling warned of the risk, and denied that the drug actually caused the gynecomastia.
Recent Risperdal Settlement Awards: Where Johnson & Johnson Went Wrong
Although the company denies any wrongdoing, evidence suggests that Johnson & Johnson intentionally targeted children, despite the FDA’s refusal to approve Risperdal. In fact, according to emails, sales training manuals and business plans brought forward in the Pledger and Yount case, the company organized a sales unit specifically to promote the drug’s off-label use in children and the elderly.
Off-label sales skirts around the issue of prohibiting public drug promotion (i.e. commercials, advertisements, etc.). Exactly how does a company promote prescription drugs off-label? Essentially, it means their salespeople meet with physicians and encourage them to promote prescription drug use in prohibited patient populations.
In Pledger’s case, a salesman confessed to giving thousands of samples to Pledger’s doctor in Birmingham, AL. He states that he did not know this doctor was a “pediatric neurologist” and he had “no way of knowing that the doctor wasn’t treating adults.” By allowing and even encouraging sales representatives to target pediatric doctors, Janssen Pharmaceuticals illegally promoted Risperdal “off-label.” As a result, thousands of young boys have suffered from unnecessary, devastating side effects. This evidence has been used against the drug giant not only in cases representing young boys, but also elderly patients.
Other Side Effects from Risperdal
Although gynecomastia is the most common Risperdal side effect, other adverse reactions initially concerned the FDA. Twitches, somnolence, diabetes, and significant weight gain were all cited. Vomiting, headaches, and bloating were also contenders. Because of these more common side effects, the FDA withheld Risperdal’s approval until 2006.
Were You Injured?
If you or a loved one took Risperdal and later diagnosed with gynecomastia, you may be eligible for financial compensation. Similar to Pledger and Yount, Risperdal has damaged thousands of individuals’ lives, causing irreparable harm and emotional suffering.
With strong evidence already gathered against Janssen Pharmaceuticals, now is the time to file your case and seek justice. Complete your free Risperdal claims review today to see if you may qualify for compensation.