An Arkansas judge fined the drug maker and a subsidiary for misleading doctors and the public on the risks involved with taking an anti-psychotic drug, Risperdal, and for marketing the drug for an off-label use to the state's Medicaid system.
The New York Times: J&J Fined $1.2 Billion In Drug Case
A judge in Arkansas ordered Johnson & Johnson and a subsidiary to pay more than $1.2 billion in fines on Wednesday, a day after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug (Thomas, 4/11).
Los Angeles Times: Companies Belittled Risks Of Risperdal, Slapped With Huge Fine
In a verbal ruling from the bench, Circuit Judge Tim Fox held that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. committed nearly 240,000 violations of the state's Medicaid fraud law -- one for each Risperdal prescription issued to state Medicaid patients over a 3 1/2-year period. Each violation carried a $5,000 fine. He also fined the companies $11 million for more than 4,500 violations of the state's deceptive practices laws (Muskal, 4/11).
The Associated Press/Los Angeles Times: Arkansas Judge Fines J&J $1.1 Billion In Risperdal Case
Atty. Gen. Dustin McDaniel said 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." Janssen issued a statement in which it said, "We are disappointed with the judge's decision on penalties. If our motion for a new trial is denied, we will appeal" (4/11).
The Wall Street Journal: Judge Orders J&J To Pay $1.2 Billion
The Arkansas penalty is the largest to date in a series of state legal cases accusing J&J of improperly marketing Risperdal, which was once J&J's top-selling drug before generic copycats hit the market (Loftus, 4/11).
Bloomberg: J&J Ordered To Pay $1.1 Billion Penalty Over Risperdal
Along with contending that J&J and Janssen defrauded the Medicaid program by failing to properly outline the antipsychotic medicine’s risks, Arkansas officials alleged J&J officials deceptively marketed the drug as safer and better than competing medicines. The state also argued the companies marketed the drug for "unapproved uses, including various symptoms in children and the elderly" after being warned by federal authorities to halt such sales (Francis, Feeley and Voreacos, 4/12).
Reuters: J&J Hit With $1.1 Billion Risperdal Penalty In Arkansas
Arkansas sued the diversified health care company, saying it had deceived thousands of doctors in the state by touting the one-time blockbuster medicine as better and safer than rival therapies and marketing it for unapproved uses in children and the elderly. The state alleged the company had caused its Medicaid insurance program for the poor to greatly overpay for Risperdal (4/11).
The Philadelphia Inquirer: J&J Unit Fined $1.1 Billion-Plus In Risperdal Case
The award, if upheld on appeal, could reverberate through the many courts in which J&J is fighting lawsuits about the drug, which was approved only for schizophrenia and bipolar mania but was prescribed for other ailments (Sell, 4/12).
Earlier, related KHN coverage: Off-Label Use Of Risky Antipsychotic Drugs Raises Concerns.