Fri, Apr 13, 2012 - Page 10 News List

Johnson & Johnson fined US$1.1bn for concealing drug risk

AP, Little Rock, Arkansas

An Arkansas judge on Wednesday fined Johnson & Johnson and a subsidiary more than US$1.1 billion for downplaying and concealing risks associated with the antipsychotic drug Risperdal, a ruling that could affect dozens of pending lawsuits over the drug.

Circuit Judge Tim Fox ruled that Janssen Pharmaceuticals Inc and its parent company must pay US$5,000 for each of 240,000 Risperdal prescriptions the state health coverage program paid for during a three-and-a-half-year period, accounting for the bulk of the penalty.

A jury on Tuesday found the companies liable.

MISLEADING

Arkansas sued the companies alleging they misled doctors about Risperdal’s side effects. Arkansas State Attorney General Dustin McDaniel said in an e-mailed statement that the ruling “sends a clear signal that big drug companies like Johnson & Johnson and Janssen Pharmaceuticals cannot lie to the [US Food and Drug Administration], patients and doctors.”

Janssen said in an e-mailed statement that evidence showed it acted responsibly, and it pledged to appeal to the Arkansas Supreme Court if Fox denies a motion for a new trial.

Risperdal, introduced in 1994, is a “second-generation” antipsychotic drug that earned Johnson & Johnson billions of US dollars in sales before generic versions became available several years ago.

LABELING

The US Food and Drug Administration in 2004 forced the company to revise the drug’s labeling to reflect increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.

Dozens of states have since filed lawsuits making claims similar to those in Arkansas. A South Carolina judge upheld a US$327 million civil penalty against Johnson & Johnson and Janssen in December. Texas reached a US$158 million settlement with the companies in January.

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