The U.S. Food and Drug Administration (FDA) has issued warnings that boys and young men who have taken antipsychotic drug Risperdal have been linked to increasing levels of the hormone Prolactin stimulating breast growth and milk production. There have been more than 420 lawsuits alleging personal injuries filed against Johnson & Johnson. The drug manufacturer has already paid billions of dollars to settle federal and state government allegations of illegally marketing Risperdal.
Johnson & Johnson is trying to keep some significant documents from public view. The company told a Pennsylvania state judge that lawyers for Plaintiffs in a number of product liability suits involving Risperdal claims are seeking to publicly release a series of clinical studies that were kept under seal by a 2011 court order. The company and its subsidiary, Janssen Pharmaceuticals Inc., argued in a recent court filing that the documents in question were neither filed with the court nor deemed public records. As a result, Johnson & Johnson claims they are exempt from public access. The company made this argument:
These materials are generated for scientists, researchers and regulatory authorities – not the general public. Simply stated, no legitimate purpose would be served by declassifying the documents identified by plaintiffs.
But lawyers for Plaintiffs in the product liability lawsuits against Janssen Pharmaceuticals told the court that documents detailing the medication’s risks were too vital to the public interest to remain under seal as part of court proceedings. These lawyers represent Plaintiffs in 275 product liability suits against Janssen that are pending in the Philadelphia County Court of Common Pleas. The Plaintiffs argued that the material consisted of observations about the effectiveness and risks of the drug and that it could not be considered proprietary. The Plaintiffs said in their brief filed with the court:
The tremendous public interest in this case and the data and materials being hidden by Janssen outweighs defendants’ claims to secrecy. They cannot be proprietary, as claimed by Janssen. Rather, they are safety documents that require disclosure for the well-being of the public, full and unfettered review by regulatory authorities and the education of healthcare providers who are prescribing this powerful drug.
Janssen’s track record of misrepresenting the risks and benefits associated with its drugs warranted the material being released to the public. The Plaintiffs’ brief said on this point:
Plaintiffs have uncovered evidence that Defendants have repeatedly misrepresented the safety of Risperdal to regulatory authorities, healthcare providers and the public. Plaintiffs now possess evidence that Janssen systematically under-reported or misrepresented clinically important study results relating to the occurrence of gynecomastia … in the child and adolescent market. However, the discovery that Plaintiffs have uncovered is protected behind the shield of the protective order entered in this case.
Johnson & Johnson agreed in November to pay $2.2 billion to resolve civil and criminal claims from whistleblowers under the False Claims Act that it showered doctors with kickbacks and illegally promoted off-label uses of three drugs, including Risperdal. While the Plaintiffs in the Philadelphia cases alleged that the company also marketed the drug off-label to children, the settlement announced in November dealt exclusively with allegations that it promoted Risperdal for use in the elderly. Only part of the expanding docket of Risperdal cases in Philadelphia has been disposed of thus far.
A hearing was held on this matter Dec. 16, but at press time no decision had been made by the Court. Thus far, only a few of the Risperdal cases in Philadelphia have been disposed of. An initial set of six cases was slated to go to trial starting in September 2012. Janssen settled the first of the set the morning the trial was scheduled to get underway for an undisclosed sum. Although the trial started in a second case later that month, Janssen agreed to settle with the Plaintiff after a week of testimony before a jury. The same day, the company announced it had reached agreements to settle claims in the four other cases pending in the first set. Meanwhile, a second set of Risperdal cases is expected to go to trial in Philadelphia starting in early June.
The Plaintiffs in the case mentioned above are represented by Stephen Sheller and Brian McCormick, lawyers with the Philadelphia firm of Sheller PC. If you need additional information about the Risperdal litigation generally, contact Frank Woodson, a lawyer in our Mass Torts Section, at 800-898-0234 or by email at Frank.Woodson@beasleyallen.com.
Sources: Law 360 and Forbes
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