How Deep Are the Risperdal Maker’s Pockets?

July 14, 2016, 5:30PM. By Jane Mundy

Philadelphia, PAThe Risperdal maker, Johnson & Johnson, was ordered July 1 to pay $70 million to a teenager who developed gynecomastia, which is the abnormal development of breasts in males. This latest lawsuit is surely a blow to the drug giant, especially because it is still facing more than 1,200 lawsuits nationwide, but mainly in Philadelphia.

Last February, in another Risperdal trial and subsequent award of $2.5 million, J&J was accused by Stephen Sheller, the attorney for Austin Pledger, of “grave mistreatment of children.” The lawsuit claimed that it hid data from the FDA, prescribing doctors and parents. And documents brought forward in court showed J&J knew there was a much higher percentage of children getting gynecomastia than they claimed. Janssen’s mathematical sleight-of-hand made it seem like only 0.8% of boys on Risperdal grew breasts, when the actual number was closer to 4.5%.

How the giant pharmaceutical company thought it could get away with off-label marketing and promotion of this drug to children is incomprehensible. Or maybe its profits more than pay Risperdal settlements.

This fifth and latest verdict (Case No. No. 130402094) is the highest awarded to date. It’s the fifth time the jury found that J&J failed to warn of Rispderal gynecomastia and the fourth time a plaintiff has been awarded a large amount of financial damages. The 16-year-old plaintiff, Andrew Yount, was first prescribed Risperdal to treat a psychiatric problem (according to his attorneys) when he was just five years old - when Risperdal was not approved for anyone under the age of 12. Risperdal was only approved for adults with schizophrenia until 2006.

Risperdal settlements

2012: J&J agreed to pay $158 million to settle Texas officials’ claims that it fraudulently marketed its Risperdal antipsychotic drug, ending a trial over the allegations. Settlement will resolve claims it defrauded the state’s Medicaid program by promoting Risperdal for uses not approved by US regulators, including for children with psychiatric disorders.

2013: Janssen Pharmaceuticals - a J&J subsidiary - paid $2.2 billion that ended a Justice Department investigation into illegally marketing Risperdal, along with Invega and Natrecor, “off-label” in children, elderly adults and disabled people from 1999-2005.

Risperdal trials

1st: In February 2015, the jury awarded an autistic Alabama boy $2.5 million (Case No. A-196444). The lawsuit was brought by the family of the boy who took the drug from 2002 through 2006 and developed size 46 DD breasts. Austin Pledger was seven years old when he was prescribed Risperdal.

2nd: A jury found that gynecomastia warnings provided by J&J to patients and doctors were inadequate. But they declined to award the plaintiff any damages after determining that there was not enough evidence to conclude that the drug had caused his condition. William Cirba started taking Risperdal when he was only six years old (Case No. 130301803).

3rd: The plaintiff was awarded $1.75 million, although the Court later reduced the verdict to $680,000 (Case No. 130401990). Nicholas Murray was nine years old when he was prescribed Risperdal to treat schizophrenia, but the antipsychotic drug had only been approved by the FDA for adults.

4th: The plaintiff was awarded $500,000 (Case No. 130401984). The Wisconsin man developed breasts when he was 12 years old while taking the medication.

According to court documents, more than 1,750 Risperdal lawsuits have been filed in the Pennsylvania mass tort program on behalf of plaintiffs who claim they were harmed by the drug.