J&J aims to block ex-FDA chief's testimony in Risperdal case

Lawyers are pulling no punches in that Risperdal litigation playing out in Philadelphia court. After trying to force Johnson & Johnson CEO Alex Gorsky onto the stand to talk about the company's Risperdal marketing practices, plaintiff's attorneys want ex-FDA chief David Kessler to testify--and Kessler is on record saying that J&J's Janssen unit broke the law by marketing Risperdal off-label.

In a court filing yesterday, J&J ($JNJ) asked the court to block Kessler's testimony, saying that the plaintiff's attorneys waited too long to add him to the witness list and submit his 92-page report, the Philadelphia Inquirer reports. J&J says it should also have had the opportunity to depose Kessler first.

This series of lawsuits allege that J&J's antipsychotic drug caused boys to grow breasts, and that the company not only failed to warn about the risk, but marketed the drug for use in children when that wasn't approved by FDA. In his report, Kessler said that he believed J&J's Janssen unit not only violated the Food, Drug, and Cosmetic Act by promoting Risperdal off-label, but that its marketing to children was "most concerning."

"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling," wrote Kessler, who served as FDA Commissioner from 2000 to 2007. You can read the rest of his report through the Inquirer's links to court documents.

It's the latest wave of litigation stemming from Risperdal, an atypical antipsychotic that's also the subject of a Justice Department investigation. J&J won the first trial airing Risperdal's links to diabetes earlier this year, but it has either lost or settled lawsuits filed by various U.S. states over Risperdal's marketing and side effects.

J&J settled the first suit linking Risperdal with boys' breast growth, on the first day of the trial, after lawyers asked for Gorsky to testify. This latest suit--filed by a Missouri woman on behalf of her son--is the third bellwether case to come to trial, the Inquirer reports. (The second was scheduled to resume today in court.)

- read the Inquirer piece