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Former FDA chief David Kessler says J&J broke the law in promoting Risperdal

Former FDA Commissioner David Kessler, a pediatrician by training, said that Johnson & Johnson and its Janssen subsidiary broke the law in marketing its antipsychotic drug Risperdal for use in children and adolescents.

Former U.S. Food and Drug Administration Commissioner David Kessler, a pediatrician by training, said that Johnson & Johnson and its Janssen subsidiary broke the law in marketing its antipsychotic drug Risperdal for use in children and adolescents.

"In my opinion," Kessler wrote in a report submitted for a trial set to begin Oct. 9 in in Philadelphia's Court of Common Pleas, "Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act."

(UPDATE: J&J settled four so-called bellweather cases Thursday morning for undisclosed amounts. Asked if the prospect of Kessler testifying against the company prompted it to offer enough to settle, plaintiffs' attorney Stephen Sheller said, "Yes.")

In his report, Kessler wrote that there were levels of concern in these matter and actions of J&J and Janssen rose fairly high.

"The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning," Kessler wrote.

"The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning.

"The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning.

"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."

Kessler served as FDA Commissioner from 1990 through 1997, under Presidents George H.W. Bush and Bill Clinton.

It probably won't shock anyone to know that J&J's attorneys in the lawsuit didn't want Kessler saying anything on the witness stand in the suit, in which a Missouri mother sued on behalf of her 16-year old son who grew breasts after being prescribed Risperdal.

But the J&J attorneys in their motion to prevent Kessler from testifying focused on the relatively last-minute nature of the plaintiff's attorneys request to add Kessler to the witness list and the submission of Kessler's 92-page report, without letting them depose Kessler ahead of time.

"On August 20, 2012, almost four months after fact discovery closed and three months after the deadline to produce generic expert reports passed in this bellwether case, counsel identified David A. Kessler, M.D. as a trial witness in this mass tort for the first time," the motion read in part. "Almost one month later, on September 18, counsel produced Dr. Kessler's ninety-two-page expert report in another bellwether case. Finally, on September 27, Plaintiffs S.B. and Donna Barney informed Janssen that they intend to call Dr. Kessler as 'a failure-to-warn expert[.]' Plaintiffs should be precluded from calling Dr. Kessler at trial, as their untimely disclosure of his identity violates the discovery rules governing this mass tort and causes the unfair prejudice they are designed to prevent."

Kessler's report was posted to the Court of Common Pleas electronic docket system late Wednesday in four pieces, as part of the J&J motion to preclude him from testifying. The pieces are all PDFs and links are here, here, here and here.

In most lawsuits and trials, judges set a schedule for attorneys to submit requests for rulings on disputed points of law, lists of witnesses, depositions of witnesses and evidence. But that doesn't preclude attorneys from arguing for whatever they want, including relatively last-minute requests.

The Barney case is the third "bellweather" Rispderal cases brought by a Philadelphia law firm led by Stephen Sheller and Brian McCormick.

The first two cases serve as examples of changes that do occur at the last minute.

In the first one, with a jury waiting, J&J agreed to pay the plaintiff enough to settle the case, rather than risk having the judge handling that case rule that chief executive officer Alex Gorsky would have to testify.

The second trial is set to resume Thursday morning in front of a jury, with judge Mark Bernstein presiding. The cases involves a 17-year-old from Sherman, Tex., who was prescribed Risperdal when he was five and started growing breasts when he was 12.

Days before Bernstein started the case, judge Arnold New ruled that Gorsky would not have to testify. But that ruling followed a motion - also relatively late - by J&J attorneys who said Gorsky was unavailable to testify because he was going to be in Asia. Plaintiffs attorneys complained that Gorsky, who was deposed in May, had not revealed his travel plans until just before the trial. But New sided with J&J and granted the motion, saving Gorsky from taking the stand, without explaining why.

Kessler got his medical degree at Harvard and his legal degree at the University of Chicago.

Kessler said his fellow doctors are naive and unduly swayed by pharmaceutical company promotional messages, including those spread through supposedly neutral continuing educational events and written material generated by the company.

"Drug promotion strongly influences prescribing behavior, but doctors underestimate this influence," Kessler wrote. "Company funding of doctors, of educational events and of research are important elements in this influence."

Knowing the limits to the FDA reach, Kessler wrote that drug companies are responsible for doing the right thing, including divulging all information gleaned from clinical trials and notifying regulators, doctors and patients of problems with drugs.

"A drug company," Kessler wrote, "has a responsibility, independent of what FDA directs it to do, to alert physicians and patients to the risks that were unknown to or poorly understood by the FDA, but were known to the company."