[author: Aaron Kase]
The manufacturer of the antipsychotic drug Risperdal owes hundreds of millions of dollars to various states for improperly marketing the drug and encouraging doctors to prescribe it for ailments it was not approved for. The drug is also the subject of personal injury lawsuits for, among other side effects, causing adolescent boys to grow breasts.
Risperdal, manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc., came on the market in 1994. It was designed and approved to treat people with schizophrenia. In later years, it was approved to treat bipolar disorder, and irritability in children with autism. In 2007, its approval was extended to treat schizophrenia and bipolar disorder in adolescents.
However, the drug had been regularly promoted for and used to treat children for years before its approval for that purpose, and was also used off-label for illnesses such as dementia, depression and anxiety.
On Sept. 14 the company announced a settlement for $181 million with 36 states and the District of Columbia for consumer fraud. While Janssen did not admit wrongdoing, it did agree to not make false and misleading claims about the drug.
The settlement seems like a good deal for Janssen, since they are getting dinged for far larger sums by individual states. Earlier this month, a Louisiana appeals court affirmed a $330.6 million penalty against the company, while in April an Arkansas judge fined them $1.2 billion, on top of $327 million they were hit with in South Carolina last year. The Arkansas and South Carolina fines are currently under appeal.
The drug is also the subject of a federal investigation which, it is rumored, could cost the manufacturer as much as $1.5 billion.
Brian J. McCormick Jr.
While states across the country are seeking to recoup the money they spent on Risperdal, individuals who were injured seek recourse as well.
“The company is being hit from a number of different directions on this drug,” says Brian J. McCormick Jr., an attorney in Philadelphia whose firm is prosecuting personal injury lawsuits for consumers harmed by Risperdal. “We have a number of cases lined up.
“Johnson & Johnson was out promoting Risperdal for children and adolescents even though the FDA hadn’t approved it yet,” McCormick says. “Children and adolescent males were especially susceptible to the injuries that could be caused by Risperdal.”
The drug can unleash cornucopia of side effects, from intestinal issues to sexual problems to mood effects like anxiety and aggression. Some are even more serious.
“The two major side effects that we have seen and filed lawsuits on are diabetes and gynecomastia, a condition where young boys and young adult males actually develop female breasts from ingesting Risperdal,” McCormick says. “Not just small breasts, but large B or C cup breasts in some cases. We have had clients who have had mastectomies.”
The overall effect of the various lawsuits is a massive comeuppance for a company that seemingly didn’t want to play by the rules.
“For the consuming public, the effect of these state cases is it makes the pharmaceutical companies think twice about marketing the drug off-label,” says the attorney. “More importantly it affects the consuming public’s health. They can be more confident that a drug is being prescribed only for something the FDA believes it is safe for, not for something a doctor heard at a conference.
“The marketing of a drug off-label, especially for children and adolescents, is particularly delicate,” McCormick says. “You don’t know how these kids are going to react if there’s been no clinical trials. It’s scary.”