Sept 30 – US: J and J Owes Louisiana for Risperdal Claims

From: SF Gate

Johnson and Johnson  should pay $351 million to Louisiana for defrauding the state’s Medicaid system with false claims about the safety of its antipsychotic drug Risperdal, a lawyer for the state told jurors.

The state’s case centers on drug safety claims that J and J and its Ortho-McNeil-Janssen Pharmaceutical unit made in November 2003 correspondence to 700,000 doctors. The U.S. Food and Drug Administration responded with a warning letter saying J and J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to competitors.

An FDA warning letter sent in April 2004 said the J and J missive failed to disclose new data on diabetes in the warning label; “minimizes the risk of hyperglycemia-related adverse events” that can lead to coma or death; fails to recommend glucose control monitoring for patients; and “misleadingly claims that Risperdal is safer than other atypical antipsychotics.”

J and J said research “suggests” that Risperdal “is not associated with an increased risk of diabetes” compared with an earlier class of antipsychotics. It also said evidence “suggests” Risperdal is “associated with a lower risk of diabetes than some other studied atypical antipsychotics.”

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