Risperdal and Diabetes — Another Tale of Marketing Over Disclosure

Johnson & Johnson has been ordered by a South Carolina court to pay $327 million for minimizing the links between its antipsychotic drug, Risperdal, and diabetes.

The case centers on allegations that Johnson & Johnson marketed Risperdal in a way that was misleading in product labels, “Dear Doctor letters” and in personal sales calls to physicians.

In 2004, the Food & Drug Administration sent Janssen Pharmaceuticals (the division of Johnson & Johnson responsible for Risperdal) a warning letter. The FDA had received post-marketing reports of diabetes mellitus developing in patients who were prescribed Risperdal. The FDA had previously demanded that Jannsen send a warning letter to physicians and it its 2004 correspondence sets forth that Johnson & Johnson minimized the “…risks associated with Risperdal and claims that Risperdal is safer than other atypical antipsychotics, when this has not been demonstrated by substantial evidence or substantial clinical experience”.

In the South Carolina case, the state sued Johnson & Johnson and alleged that deceptive information was disseminated about the dangers of Risperdal and, in particular, that the company downplayed the significant dangers of diabetes secondary to taking the drug. In the ruling, the judge, Judge Roger Couch, wrote a 17 page decision that the drug maker’s executives had “allowed the profit-at-all-costs mentality to cloud” good judgment that would have resulted in a clear warning about Risperdal.

Risperdal was a very big seller for Johnson & Johnson until it lost its patent on the drug. Sales in 2007 were $4.5.8 billion and declined to $527 million last year. The drug maker still made over $8 billion in the years 2007 to 2010 in sales of the drug.

Judge Couch found that Johnson & Johnson had marketed the drug using labels with deceptive information, marketing letters to physicians and sales calls to doctors’ offices. He fined the drug manufacturer in hundereds of thousands of individual instances for violation of South Carolina’s state consumer protection laws.

Similar cases have been heard in Pennsylvania, Louisiana, and West Virginia.

Johnson & Johnson has indicated they will appeal Judge Couch’s decision.