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Michigan’s Product Liability Act works to bar claims by young men who allege Risperdal caused them to grow female breast tissue even though they were using the drug for an off-label purpose, ruled a Pennsylvania court.
According to the ruling, claims based on FDA approved drugs being prescribed for off-label uses are barred by the “plain language” of the Michigan law.
The court said that the Michigan law intended to protect drug makers from claims over FDA approved drugs, also applies to whether or not the drugs were being used for an off-label purpose.
The Risperdal lawsuits allege that young boys were prescribed the drug for mental issues, like autism or behavioral problems.
The drug was approved by the Food and Drug Administration for use in children for irritability associated with autism in 2006, but was being prescribed for off-label use prior to that date.
The Risperdal lawsuits allege that the drug makers, Johnson & Johnson and Janssen, failed to adequately assess and warn doctors, patients and their parents, about the risks associated with the drug.
One of those risks was a condition called gynecomastia which refers to the development of breasts in young boys. Drug makers were hit with thousands of lawsuits alleging Risperdal caused gynecomastia and further research has discovered increased risk of that condition and others linked to the drug.
A mass torts procedure is working its way through the Pennsylvania court system to address the Risperdal lawsuits.
The drug makers argued that the plaintiffs from Michigan were barred by that state’s Product Liability Law.
The plaintiffs said that the law should not apply because the drug makers fraudulently obtained FDA approval of the drug for use in children.
The Pennsylvania court of appeals rejected the plaintiffs’ argument, pointing out that although there is evidence showing that Janssen and Johnson & Johnson fraudulently obtained approval from the FDA for use of the drug in children, there is no evidence showing that they fraudulently obtained approval initially for the drug.
“A review of the record reveals appellants’ allegations of facts and presentation of data to support their assertion that appellees fraudulently obtained FDA approval for Risperdal in relation to its approvals for adolescents and children in 2006 and 2007,” noted the opinion. “There is, however, an absence in the record of any facts, or even argument, that appellees fraudulently obtained FDA approval for the first time.”
The Risperdal Lawsuits are In Re: Risperdal Litigation, Case No. 577 EDA 2015, 578 EDA 2015, 579 EDA 2015, 580 EDA 2015, 581 EDA 2015, 582 EDA 2015, 583 EDA 2015, 584 EDA 2015, 585 EDA 2015, 586 EDA 2015, 587 EDA 2015, 588 EDA 2015, and 589 EDA 2015, all in the Pennsylvania Superior Court.
If you or a loved one experienced abnormal breast growth or any other side effects after taking Risperdal, time may be running out on your claim. The attorneys at McDonald Worley are currently investigating Risperdal claims.