The antipsychotic schizophrenia drug, Risperdal, has come under scrutiny recently, with allegations that the drug has been causing male breast development (gynecomastia) in several users. Now, plaintiffs who have filed Risperdal lawsuits against its manufacturer, Janssen, a subsidiary of Johnson and Johnson, are requesting files retained by the company that contain data from clinical studies conducted on the drug as well as risks associated with Risperdal.
Last month, Janssen filed a motion to maintain a 2011 order that protected the files in question from the public eye, arguing that the Risperdal documents were not to be disclosed as they were not public records and had not been filed with the court.
The plaintiffs’ request filed last week blasted the previous Janssen motion, stating that “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,” reported Public Health Watchdog.
“Unfortunately, pharmaceutical companies sometimes fail to own up to risks associated with their product, and will go at great lengths to keep these risks from being disclosed to the public,” commented Megan McBride, a product liability lawyer with the Levin, Papantonio law firm.
Nonetheless, it seems troubles may be mounting for Janssen and it’s parent-company, Johnson and Johnson. Last month, Johnson and Johnson agreed to pay out $2.2 billion to settle claimsfiled under the False Claims Act, after the company allegedly marketed Risperdal and two of its other drugs for off-label use. It is illegal for drug-makers to market a product for non-approved uses.
Risperdal lawsuits have already been filed against Janssen with several set for trial in early June 2014.