Risperdal Safety Data for Kids Was Manipulated by Drug Maker, Former FDA Director Testifies

A former head of the FDA indicates that Johnson & Johnson’s Janssen subsidiary manipulated data involving the potential safety of Risperdal for kids, in testimony stemming from lawsuits over unnatural breast growth among young boys using the antipsychotic medication. 

Dr. David Kessler, commissioner of the FDA from 1990 to 1997, recently filed a report in the litigation that claims Janssen controlled and influenced the findings of a 2003 study that looked at the potential side effects of Risperdal on children, concluding that there is no direct correlation between prolactin elevation caused by Risperdal and breast development among boys, which is known as gynecomastia.

Kessler and some others involved with the study indicate that those conclusions were misleading or outright lies. In truth, they say that the data showed a significant increase in the risk of gynecomastia with Risperdal use among young boys, but that information was left out when the study was edited by Janssen employees.

The revelations came as a result of the continuing Risperdal litigation brought against Johnson & Johnson by families and young males who have been diagnosed with gynecomastia after using the medication. About 1,300 claims are currently pending in Pennsylvania state court, alleging that the drug company failed to adequately warn users or the medical community about the risks associated with using the drug by males when they are children.

The study at issue was published in the Journal of Clinical Psychiatry in 2003. It was co-authored by Janssen employees and the top pediatrician at Canada’s SickKids hospital, Dr. Dennis Daneman.

According to Kessler, who is also a pediatrician, the company manipulated more than 40 manuscripts, and Daneman has testified as well, saying that the study understated Risperdal side effects. However, he notes that the manipulation of the data occurred outside of his own involvement.

Last yearm a class action lawsuit was filed against the Johnson & Johnson unit over its alleged clinical trial data manipulation, which accuses the company of downplaying Risperdal risks and ghostwriting medical articles in support of the drug without revealing the connections to the company.

Daneman and another author involved in the study, Robert Findling, are having the data reanalyzed by an independent biostatistician, indicating that they will decide whether to issue a full retraction or corrections based on those findings.

Johnson & Johnson has been quietly dealing with breast growth lawsuits over Risperdal for years, but the number of cases has continued to grow as more families and young adults learn that there may be a link between problems suffered following a diagnosis of gynecomastia and Risperdal use as a child.

In February 2015, the first Risperdal bellwether trial in Pennsylvania ended in a $2.5 million jury award, with a second case the following month ending with a defense verdict. While that second jury found that the plaintiff failed to establish that his abnormal breast growth was caused by the medication, the same jury determined that Johnson & Johnson failed to adequately warn the boys and their parents about the gynecomastia risks. A third bellwether case was settled out of court in May.

While the outcomes of the cases are not binding on other claims, they are being closely watched by lawyers involved in the litigation, as they may influence negotiations to reach Risperdal gynecomastia settlements that would avoid the need for hundreds of individual trials to be scheduled.