Johnson & Johnson Subsidiary Loses Drug-labeling Suit

The state of Arkansas won the ruling in its suit alleging the antipsychotic Risperdal included insufficient risk information in inserts and labels.

LITTLE ROCK, Arkansas — A Johnson & Johnson subsidiary downplayed and hid risks associated with the antipsychotic drug Risperdal, a jury determined Tuesday in Arkansas' billion-dollar lawsuit against Janssen Pharmaceuticals Inc.

Attorney General Dustin McDaniel's office is seeking fines of at least $1.2 billion for the 250,000 Risperdal prescriptions a state health coverage program paid over more than three years. The penalty will be decided Wednesday.

Janssen and Johnson & Johnson face dozens of similar lawsuits in federal court and in other states.

Risperdal, introduced in 1994, is a "second-generation" antipsychotic drug that earned Johnson & Johnson billions of dollars in sales before generic versions became available. It is used to treat schizophrenia, bipolar disorder and irritability in autism patients. Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, weight gain and diabetes.

"Today, an Arkansas jury confirmed that Johnson & Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people," McDaniel said in a news release after the verdict was announced.

Janssen maintained that it did not break the law, pointing out that the package insert included with the medication was approved the U.S. Food and Drug Administration. The company can appeal, though it didn't immediately indicate whether it would do so.

"It is our position that an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules," the company said in a statement Tuesday.

Fletch Trammell, a lawyer hired by McDaniel's office to handle the suit, said the rural nature of Arkansas makes it more important for drug companies to keep doctors informed. Non-specialists in mental health were prescribing the drug without knowing the full range of side effects.

Other states that have sued over Risperdal include Texas, which reached a $158 million settlement with Janssen in January. In December, a South Carolina judge upheld a $327 million civil penalty against Johnson & Johnson.

Source: Associated Press

 

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