Pharmaceutical giant Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have pleaded guilty and agreed to pay more than $2.2 billion in criminal fines and civil settlements over the way they marketed and sold Risperdal for off-label uses not approved by the Food and Drug Administration.
Now comes the recent news that the companies lawyers have won an appellate court ruling in Arkansas, overturning a $1.2 billion award that plaintiffs won against the drugmaker over its marketing of the antipsychotic drug.
The Arkansas justices reversed the huge award on a technicality, ruling that the damages were awarded under the wrong state law as violations of the state’s Medicade fraud law.
The medication was approved by the Food and Drug Administration specifically for the treatment of schizophrenia and mixed episodes of bipolar disorders.
Since then, mistakes because of a name similarity with another medication and illegal sales and marketing practices involving unapproved off-label uses have forced the companies to defend themselves against Risperdal lawsuits and make warning label changes for consumers and health care professionals.
One type of Risperdal lawsuits involve a condition known as gynecomastia, a benign enlargement of breast tissue in males, which can have devastating physical and emotional effects.
These victims are seeking compensation for medical costs, pain and suffering and other expenses they say have been caused by side effects that they were not warned about.
The Arkansas case had been heard in 2012 by a jury in Little Rock, which returned a verdict in which it found that the companies were in violation of Medicaid fraud and conducted deceptive trade practices in the marketing of Risperdal.
Bloomberg News reported the specifics of the case:
“J&J’s Janssen unit was accused of making misleading claims about Risperdal’s effectiveness and downplaying its diabetes risks on warning labels. The high court said the state incorrectly tried to use a law governing health-care facilities as the basis for levying sanctions.
“The penalty was the largest of the three handed down so far against New Brunswick, New Jersey-based J&J, the second-biggest maker of health products, in state cases alleging the company hid Risperdal’s risks and tricked Medicaid regulators into paying more than they should have for the medicine.”
It was unclear whether Arkansas officials would appeal the reversal of the verdict. The state’s top law enforcement official issued this comment to Bloomberg:
“We pursued this case based on the belief that the General Assembly intended to give the Attorney General’s Office the authority to pursue penalties against those that would enter our state and blatantly deceive the public,” Arkansas Attorney General Dustin McDaniel said in an e-mailed statement today. “I am disappointed that the court viewed the law differently.”