Healthy Skepticism Library item: 18845

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Johnson & Johnson Tries To Resolve Risperdal Probe
Pharmalot 2010 Nov 11
http://www.pharmalot.com/2010/11/johnson-johnson-tries-to-resolve-risperal-probe/

Full text:

The healthcare giant is talking to the feds about settling charges of illegal marketing of its Risperdal antipsychotic, according to a filing with the US Securities and Exchange Commission (see page 32). The allegations have plagued Johnson & Johnson since 2004, when Office of the Inspector General of the US Office of Personnel Management issued a subpoena for sales and marketing documents, along with payments to docs and clinical trials from 1997 to 2002.
“Discussions are ongoing in an effort to resolve potential criminal and civil litigation arising from these matters,” the SEC filing states. “Whether a resolution can be reached and on what terms is uncertain.” As Dow Jones notes, J&J previously disclosed numerous government probes into Risperdal marketing, but this is the first indication that settlement talks have taken place.
Those other inquiries include a subpoena from the US Attorney in Philadelphia five years and civil investigative that were issued earlier this year seeking additional info about marketing Risperdal and the Invega follow-up med. There were also grand jury subpoenas issued seeking testimony from various witnesses, according to the SEC filing.
Separately, J&J is fighting claims in a whistleblower lawsuit, which was joined by the US government, that charges the healthcare giant with paying kickbacks – in the form of rebates and educational grants – to the Omnicare nursing home pharmacy so its Risperdal antipsychotic would be prescribed more often (look here).
J&J would not be the first drugmaker to settle charges of off-label marketing for an antipsychotic, of course. Pfizer, Eli Lilly and AstraZeneca have all paid huge fines to resolve allegations of improper marketing among complaints that safety risks were hidden. Lilly also pleaded guilty to a criminal charge.