\nFormer FDA chief David Kessler says J&J broke the law in promoting Risperdal<\/font><\/strong><\/u><\/a>
The Philadelphia Inquirer<\/font><\/strong>
by David Sell
October 4, 2012<\/div>\n<\/p>\n
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."<\/p>\n[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."]<\/p>\n
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."<\/p>\n
Kessler served as FDA Commissioner from 2000 through 2007, 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.<\/p>\n
"On August 20, 2012, a<\/strong>lmost 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<\/font><\/u><\/a><\/strong>, here<\/font><\/u><\/a><\/strong>, here<\/font><\/u><\/a><\/strong> and here<\/font><\/u><\/a><\/strong>…<\/sup><\/div>\n<\/blockquote>\n