On March 4, during the most recent Risperdal trial for the ongoing Risperdal multidistrict litigation, the senior marketing director for Janssen Pharmaceuticals was interrogated over the pharmaceutical company’s promotion of the antipsychotic drug Risperdal.

In the second case to go to trial for the Philadelphia Risperdal mass tort, plaintiff William C.’s legal representative called forth Carmen DeLoria to testify. As a member of Janssen’s global marketing division, DeLoria was questioned regarding the company’s alleged knowledge of Risperdal’s off-label use by child patients and how it has caused some adolescent boys to allegedly develop Risperdal gynecomastia, or male breast growth.

This is not the first Risperdal lawsuit to go to court before a Philadelphia court and jury. On Feb. 25, the first of about 1,250 Risperdal gynecomastia lawsuits consolidated in the Risperdal mass tort resulted in a $2.5 million award for the plaintiff, who alleged Janssen’s antipsychotic drug caused him to develop enlarged male breasts.

The plaintiff, like many young men, was allegedly prescribed Risperdal to treat an oppositional defiant disorder, even though at the time Risperdal had not been U.S. Food and Drug Administration (FDA) approved for use by children.

Risperdal Gynecomastia Lawsuit Allegations

In the second Risperdal gynecomastia lawsuit, the plaintiff’s attorney referred to this last month’s Risperdal win, and stated to DeLoria that Janssen had been aware that a significant amount of the company’s revenue was generated by Risperdal prescriptions to children and adolescents before the 2006 FDA approval for those under the age of 18.

When presented with this assertion during the Risperdal gynecomastia trial, DeLoria answered, “We were aware that a portion of our business was coming from children and adolescents,” but did not categorize this Risperdal demographic and the resulting business as significant.

Additionally, DeLoria stated during the Risperdal lawsuit proceedings that Janssen’s sales representatives did present their antipsychotic drug to child psychiatrists, but DeLoria clarified that most child psychiatrists also treat adults and asserted that there were very few medical practitioners who may have been approached by Janssen regarding Risperdal promotion who were also solely child psychiatrists. DeLoria claims that the Risperdal sales pitches were not focused on getting children to use Risperdal.

The plaintiff’s counsel countered the DeLoria’s assertion, pointing out that until 2009, Janssen’s sales employees were allegedly given bonuses for Risperdal pediatric sales. DeLoria replied to these accusations by stating the bonuses were awarded to employees for general sales and were not tied to the sale of Risperdal drug to pediatric psychiatrists.

However, plaintiff’s counsel demonstrated graphs representing Janssen’s 2002 business plan, which showed Risperdal comprised over 50 percent of the pediatric antipsychotic drug market. Another section of this business plan also detailed the public and medical views on Risperdal and its alleged stimulation of prolactin, a hormone that encourages breast growth and leads to gynecomastia in males.

Additionally, another section of the Janssen 2002 business plan recommended that the company “establish Risperdal as having a favorable risk-benefit relative to other compounds.” The plaintiff’s legal counsel claims this section was added to the drugmaker’s business plan after it was discovered Risperdal increased the prolactin level of its consumers.

Despite the plaintiff’s attorney’s allegations during this Risperdal gynecomastia trial, DeLoria continued to defend Risperdal and Janssen. Additionally, the witness claimed the reason Risperdal was so widely prescribed by psychiatrists was because these medical professionals recognized the antipsychotic drug’s effectiveness in managing patient’s bipolar, schizophrenia, and even autism symptoms.

This Risperdal gynecomastia trial is still in litigation and no decision regarding the plaintiff’s claims has been reached.