The Arkansas attorney general just filed a brief backed by his peers in 35 other states that seeks to have the Arkansas Supreme Court uphold a $1.2 billion fine that has been levied against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals Inc., over the way in which the antipsychotic drug, Risperdal, was marketed.
Attorney General Dustin McDaniel is asking the justices to reject the companies’ appeal of a Pulaski County jury’s ruling in 2012 in which it found that the drug makers minimized and hid Risperdal-related risks, according to the Associated Press (AP). The two firms have asked the Arkansas Supreme Court to overturn that ruling.
As we’ve explained, in 2012, an Arkansas state judge ordered Johnson & Johnson to pay $1.2 billion after a jury found prior marketing of Risperdal violated state consumer-protection and Medicaid-fraud laws. The drug maker was also mandated to pay large penalties in other lawsuits brought by attorneys general in South Carolina and Louisiana, and last year agreed to pay $158 million to settle a Texas Risperdal lawsuit.
AG McDaniel said the companies were pushing their argument that the ruling against them was in violation of both the U.S. Constitution’s First Amendment and the free speech provision of Arkansas’ state constitution, the AP explained. “Appellants’ argument that they had a constitutional free-speech right to make false and misleading statements about the safety of their drugs has no merit,” McDaniel wrote in the brief. “If accepted, it would effectively immunize false advertising and false labeling of drug products from regulation.” The attorney general also disputed J&J’s and Janssen’s argument that the fine was excessive.
A group of 65 Arkansas legislators and 35 attorneys general; the AARP; Public Citizen; and former U.S. Food and Drug Administration Commissioner, Donald Kennedy all defended the court’s ruling in just-filed briefs arguing that the fine was consistent with state law. If upheld, noted the AP, the fine would go toward the Arkansas Medicaid Trust Fund in compliance with that state’s law.
In 2012, Pulaski County Circuit Judge Tim Fox ordered Janssen and J&J to pay $5,000 per each of the 240,000 Risperdal prescriptions the state Medicaid program paid during a 3½-year period, which makes up most of the penalty. Judge Fox He also fined both companies $2,500 for more than 4,500 letters Jannsen sent to physicians in Arkansas that, according to the state, minimized Risperdal’s side effects. That total came to about $11 million, according to the AP.
Johnson & Johnson was previously accused of marketing Risperdal as a safe and effective treatment for some symptoms of dementia among the elderly. Risperdal is only approved to treat schizophrenia and symptoms of bipolar disorder and actually increases the risk of death in the elderly who suffer from dementia. The drug was being marketed illegally to treat symptoms including irritability and aggression among dementia sufferers and was also illegally marketed to treat symptoms of Alzheimer’s disease, which also increased patient risks of death and serious injuries.
While it is not illegal for a physician to prescribe a drug for an off-label treatment, it is a violation of FDA regulations for the manufacturer of the drug to do so. Any new indications for a prescription drug must first receive FDA approval and requires extensive clinical safety trials to determine that the drug provides a benefit to a new class of patients.