Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, received a $1.1 billion fine by an Arkansas judge for allegedly lowering the profile of the risk of certain side effects in off-label uses and hiding risks associated with Risperdal, an antipsychotic drug. The ruling could affect dozens of pending lawsuits concerning the drug. This verdict is one of many brought against the pharmaceutical giants by state governments. Additional lawsuits are pending in other states.
Circuit Judge Tim Fox ruled Janssen Pharmaceuticals Inc. and Johnson & Johnson must pay $5,000 each for 240,000 Risperdal prescriptions paid for by the state Medicaid program during a three and one half year span. He also fined the companies an additional $2,500 for more than 4,500 letters Janssen sent to Arkansas doctors, totaling more than $11 million.
The state sued the companies for allegedly misleading doctors across the state in a letter than minimized Risperdal’s side effects. According to state attorney General Dustin McDaniel, the ruling “sends a clear signal that big drug companies like Johnson & Johnson and Janssen Pharmaceuticals cannot lie to the (U.S. Food and Drug Administration), patients and doctors in order to defraud Arkansas taxpayers of our Medicaid dollars.”
Risperdal is an antipsychotic drug that made billions of dollars in sales for Johnson & Johnson before its generic versions were made available. The FDA forced the company to revise the drugs label in 2004 to describe increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.
J&J fined $1.1 Billion in Risperdal Case
Arkansas isn’t the only state to file lawsuits making claims similar to those of Arkansas. In South Carolina a judge upheld a $327 million civil penalty against Johnson & Johnson and Janssen. In Texas, a $158 million settlement was reached with the companies, though they didn’t admit fault.