Last month, the US government intervened, or joined, a whistleblower lawsuit filed against Johnson & Johnson and its Janssen unit over allegations the health care giant paid kickbacks - in the form of rebates and educational grants - to the Omnicare nursing home pharmacy so its Risperdal antipsychotic would be prescribed more often. The lawsuit also alleged J&J hid the payments from Medicaid to avoid reporting a ‘best price’ that would have triggered paying rebates to Medicaid (The US Department of Justice recently reached a settlement with Omnicare).

One exhibited contained in the lawsuit appears to raise the issue of off-label promotion. A report prepared about Omnicare by J&J long-term care business managers includes this passage: “In June of 1999, Omnicare was willing to provide a prescriber list to the J&J Group and Janssen Elder Care Sales Force. These names were provided to the sales force in an effort to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient. As of July 1999, over 350 names have been acquired and the representatives have begun their targeting on these prescribers.” (see page 21).

However, Risperdal was not approved for use in patients with dementia-related psychosis, according to the label, which now includes a warning that such patients are at an increased risk of death. You may recall that, last year, Eli Lilly paid a $1.3 billion fine to settle civil and criminal charges for off-label promotion of Zyprexa, specifically for promoting the antipsychotic for dementia in elderly people (look here). So could the report on Omnicare and Risperdal be a smoking gun?