Companies belittled risks of Risperdal, slapped with huge fine

Johnson & Johnson and a subsidiary have been fined about $1.2 billion by an Arkansas judge after a jury found that the companies had downplayed risks associated with Risperdal, an antipsychotic drug.

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.

The decision is expected to be appealed, Janssen said in an emailed statement. The company has filed a motion for a new trial as well.

“This is a big win for Arkansas,” state Atty. Gen. Dustin McDaniel said in a statement emailed to reporters. “Today’s imposition of more than $1.2 billion in penalties sends a clear signal that big drug companies like Johnson & Johnson and Janssen Pharmaceuticals cannot lie to the FDA, patients and doctors in order to defraud Arkansas taxpayers of our Medicaid dollars.

“These two companies put profits before people, and they are rightfully being held responsible for their actions,” McDaniel stated.

A jury deliberated for three hours on Tuesday before deciding in favor of the state.

Risperdal, introduced in 1994, is an antipsychotic drug that earned Johnson & Johnson billions of dollars in sales before generic versions became available several years ago. It’s used to treat schizophrenia, bipolar disorder and irritability in autism patients.

But Risperdal and similar drugs have been linked to increased risk of strokes, seizures and death in elderly patients.

The generic version, risperidone, has also been used off-label for the treatment of some anxiety disorders, such as obsessive-compulsive disorder and eating disorders.

The Arkansas action follows other state rulings. A South Caroline judge upheld a $327 million civil penalty against Johnson & Johnson and Janssen in December. Meanwhile, Texas reached a $158 million settlement with the companies in January in which the company didn’t admit fault.

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