Ex FDA Chief Says J&J Broke The Law In Promoting Risperdal
By David Sell, Thursday, October 4, 2012
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.
"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.
"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 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 don'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.
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.
Continue reading Mr Sell's report at Philly.com here.
Thank you Philly.com and Mr Sell
Published 4:00 a.m., Saturday, December 15, 2007
In light of the San Francisco Conspiracy with its non-existent Risperdal pushing Hospitals and Staffs, its Illuminati chaired UCSF Psychiatry Dept, and its SFGH being the Only 24hr/16hr PES in town, and its C&C MHB going deaf dumb and blind at City Hall just 6 months earlier, ..... you have to wonder, .....
SFGATE.com has coverage of Dr. Kessler leaving UCSF: