A judge has ruled that Johnson & Johnson and its Janssen Pharmaceutica unit must pay West Virginia $3.95 million for misleading doctors about the risks and benefits of the antipsychotic drug Risperdal. West Virginia Attorney General Darrell McGraw filed suit in 2004 against Johnson & Johnson and the Janssen unit, contending the companies violated the state’s consumer protection act by claiming the drug was safer than similar medications. Risperdal is a member of a class of drugs called atypical antipsychotics that include Eli Lilly & Co.’s Zyprexa and AstraZeneca’s Seroquel. Janssen is a division of Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals unit.
In September 2003 the U.S. Food and Drug Administration required makers of atypicals to warn doctors that such drugs were associated with an increased risk of diabetes. A judge in West Virginia said that in November 2003 Janssen sent out “false and misleading” letters to doctors that downplayed the risks. The judge wrote in his order:
The court finds the Defendant’s wording of its November 2003 Risperdal letter was deliberately constructed to circumvent the FDA’s mandated warning for an increased risk of diabetes, and deliberately constructed to mislead health-care professionals.
The judge found that the FDA had already determined that the November 2003 letter was misleading under federal guidelines. He fined the companies $1.95 million for these letters and an additional $2 million for Risperdal sales calls made in West Virginia from November 2003 to July 2004. The court agreed with West Virginia’s claim that J&J and Janssen misled doctors on the risks and benefits of the Duragesic pain patch and issued a $525,000 fine.
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