Former FDA Commish Slams J&J Over Risperdal

In the latest setback to Johnson & Johnson and its seemingly futile attempts to defend its Risperdal marketing, the health care giant is attempting to prevent former FDA commish David Kessler from testifying in yet another case involving a teenage boy who claims the antipsychotic caused him to grow breasts. And J&J wants to keep Kessler off the stand because he wrote a scathing report of its conduct.

"In my opinion," Kessler wrote, J&J's Janssen unit "promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act. The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning. The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning.

"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling," he concluded. The 92-page report, which was first reported by The Philadelphia Inquirer, was submitted for a trial set to begin Oct. 9 in in Philadelphia's Court of Common Pleas.

In his report, Kessler reviewed various efforts to promote Risperdal to physicians allegedly without providing sufficient side effect data, such as preparing articles for publication in medical journals and sponsoring symposiums in which lectures were delivered by academics and physicians dating back more than a decade ago in which off-label use was discussed. His report includes excerpts from internal memos (read here, here, here and here.)

Consequently, J&J lawyers want to keep Kessler from testifying. They argued that his testimony would amount to a last-minute surprise, since the attorneys for the 16-year-old boy only recently listed him as a witness. "...their untimely disclosure of his identity violates the discovery rules governing this mass tort and causes the unfair prejudice they are designed to prevent," they wrote in a motion, according to the paper.

UPDATE: This morning, however, this case and four others were settled, although terms were not disclosed, according to Steve Sheller, the attorney for the 16-year-old boy. However, in one of those other trials, J&J attorneys succeeded in keeping J&J ceo Alex Gorsky from testifying, citing travel plans to Asia would prevent him from being available. Gorsky had been deposed last spring, the paper notes (see more about the other trial and Risperdal popcorn here).

Overall, J&J has had little luck deflecting charges of illegal and inappropriate marketing of its antipsychotic. Already, J&J has agreed to pay $181 million to resolve claims by 36 states for promoting the Risperdal and Invega antipsychotics for unapproved uses (read here). And a $2.2 billion settlement is reportedly being negotiated with the US Department of Justice.

The recent deal came after J&J suffered setbacks in several states where off-label marketing charges went to court. In April, an Arkansas judge fined the health care giant $1 billion. Three months earlier, J&J agreed to settle a lawsuit brought by the Texas attorney general after only a few days of blistering courtroom testimony that placed its marketing practices in a harsh and unflattering light (see this).

Although the lawsuit - which was a so-called bellwether case, which means it was seen as a test case for the many other cases to be tried - Sheller notes that many other lawsuits are being pressed against J&J over Risperdal and male breasts. And he intends to call Kessler to testify in many of those trials, he tells us.

This is not the first time, by the way, that Kessler has offered an expert opinion in litigation about inappropriate behavior by a large drugmaker. Last December, he submitted a highly critical report of Bayer for wrongfully withholding safety data from regulators about the controversial Yaz and Yasmin contraceptive pills (back story).