PENNSYLVANIA RECORD

Attorneys for a Texas teen who is suing Johnson & Johnson and Janssen Pharmaceuticals

over claims he grew breasts as a result of taking the defendants’ drug Risperdal on Sept. 27 called to the witness stand a psychiatrist who believes the antipsychotic medication does indeed cause gynecomastia.

The plaintiff, a 17-year-old identified as “A.B.,” says he was diagnosed with gynecomastia, or development of female-like breast tissue in males, in 2009 when he was 14 years old.

He alleges a decade-long regiment of Risperdal was to blame for his diagnosis.

On Thursday, Bob Hilliard, a Texas attorney working with lawyers from Philadelphia-based Sheller P.C., called to the stand Bill Glazer, a psychiatrist with offices in Massachusetts and Key West, Fla.

Glazer said he was asked to look at whether Risperdal is considered a “causative agent” of gynecomastia.

Before the substantive portion of Glazer’s testimony got under way, however, a lawyer for the defendants cross-examined the doctor as to his assertion that he could be considered an expert witness for the plaintiff.

Laura Smith, an attorney with Arkansas-based Friday, Eldredge & Clark, who is representing the pharmaceutical companies alongside lawyers with Drinker Biddle & Reath, called into question Glazer’s qualifications, saying the doctor may not be the best person to assess the side effects of an antipsychotic medication in children when the man specializes in adult psychiatry.

Smith asked Glazer if his writings on prolactin, the hormone that can stimulate the mammary glands and causes lactation, and gynecomastia itself, that were done for the plaintiff’s attorneys were the first time he had undertaken such written work.

Glazer answered in the affirmative, although he assured Smith and her team that he was qualified to be an expert witness on the subjects of prolactin and gynecomastia because he had worked with drug companies in the past, including Janssen, and was extremely familiar with the topics.

Glazer said he even worked with Janssen in 1993, the year of Risperdal’s launch.

After reviewing the defendants’ own studies, about 18 of them to be exact, Glazer said he came to the conclusion that Risperdal is the only one of a number of so-called “second generation,” or “atypical” antipsychotic medications, that causes gynecomastia.

Smith pointed out that Glazer’s opinion about the matter was slightly different when he gave his deposition last spring, but the witness stood by his current belief while on the witness stand.

“Risperdal can cause gynecomastia,” Glazer said in court.

Glazer explained that antipsychotic drugs, like Risperdal, are designed to block dopamine in the brain, with dopamine believed to be the cause of psychosis.

But when dopamine is blocked, prolactin levels can increase, which ultimately can lead to gynecomastia in men, especially young men.

The case, the first to go to trial out of about 86 in the Risperdal mass tort docket at the Philadelphia Court of Common Pleas, began Sept. 24 before a 12-member jury in Judge Mark Bernstein’s courtroom at Philadelphia City Hall.

The central allegation is that the defendants’ off-label marketing of Risperdal, namely, that it would be safe for use in children and adolescents despite not having had FDA approval for such a population at the time, led to scores of young men developing gynecomastia.

The plaintiff in the current case, A.B., began taking Risperdal in 2000 at age 5.

Doctors prescribed the drug to help with the plaintiff’s Asperger’s Disorder, which is classified as a mood disorder, and not psychosis.

The plaintiff’s attorneys claim that Johnson & Johnson and Janssen Pharmaceuticals illegally marketed the drug to children and adolescents with mood disorders because the adult population with psychotic disorders like schizophrenia was not a large enough customer base to make the drug profitable.

A former sales rep for the defendants earlier at trial testified that company higher-ups desired to have Risperdal turn into a billion dollar drug, and getting to that point meant marketing it to “symptoms” and not just “disorders.”

On Thursday, Glazer, the psychiatrist, said that Risperdal releases prolactin much more than other second-generation antipsychotic meds, such as Ability and Prolixin.

Some other second-generation antipsychotics don’t stimulate prolactin at all, Glazer testified.

Glazer said he formed his opinion that Risperdal causes gynecomastia after viewing certain data provided by the defendants themselves.

The trial is expected to last about three weeks.