If you don't succeed in court, try the FDA. That's the approach of a Philadelphia lawyer who wants to make some Risperdal data public, but is barred from doing so by a federal judge's order.
As the Philadelphia Inquirer reports, attorney Stephen Sheller, who's representing patients suing Johnson & Johnson ($JNJ) over Risperdal side effects, obtained some information from J&J as he worked on the litigation. But J&J's lawyers persuaded a judge to put the documents under seal. So, Sheller last year petitioned the FDA to obtain the data itself. And now, he's writing the FDA to urge the agency to action.
"The FDA has the authority to demand safety-related documents in order to review them," Sheller wrote to Janet Woodcock, the director fo the Center for Drug Evaluation and Research (as quoted by the Inquirer). "The J&J information is already available to the FDA--all you have to do is ask them for the documents."
Sheller's request comes as J&J continues its Risperdal battles. The company has suffered a series of Risperdal-related fines in state court, including a $1.2 billion penalty in Arkansas (which is under appeal). It settled its fight with Texas in a $158 million deal and agreed to pay another $181 million to 36 states and the District of Coumbia. And it's still negotiating a settlement with the Justice Department to wrap up a longstanding probe of its Risperdal marketing practices.
Meanwhile, it's been fighting a slew of patient lawsuits, including a group consolidated in Philadelphia. The company and plaintiffs' lawyers have wrangled over witnesses, including one attempt to get J&J CEO Alex Gorsky onto the stand.
The FDA may actually have asked J&J for the documents Sheller wants, the newspaper says. Company spokeswoman Teresa Mueller said the agency requested "all available data" about Risperdal's use in kids, "as required by the applicable federal regulations," after Sheller filed his petition. And so J&J's Janssen unit "provided all of the available data requested" about Risperdal products, Mueller said.
Mueller also emphasized that the company says Risperdal products are safe and effective. The agency tells the Inquirer that it's reviewing Sheller's petition.
- get the story from the Inquirer
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