Now that Johnson & Johnson has agreed to pay more than $2 billion to settle civil and criminal charges of pushing illegal uses of a drug, it will be paying millions to a pair of whistle-blowers represented by a major local law firm.
Johnson & Johnson has a schizophrenia drug called Risperdal. The company starting peddling the drug to doctors and may have paid some under the table to use it for purposes not allowed by Washington.
U.S. Attorney General Eric Holder delivered remarks at the Johnson & Johnson news conference Monday in Washington.
"In the criminal information filed today, we allege that Johnson & Johnson subsidiary Janssen Pharmaceuticals Incorporated violated the Federal Food, Drug, and Cosmetic Act by introducing Risperdal into the market for unapproved uses. In its plea agreement, Janssen admits that it promoted this drug to health care providers for the treatment of psychotic symptoms and associated behaviors exhibited by elderly, non-schizophrenic patients who suffered from dementia – even though the drug was approved only to treat schizophrenia," said Holder.
Doctors can prescribe drugs for "off-label use," but drug manufacturers cannot offer such recommendations.
While the company agreed to pay the money and settle the cases the executives behind the criminal charges weren't named or charged.
The case blew open when some sales executives worried they might be blamed for the off-label use. Two went to Buffalo law firm Hodgson-Russ for advice.
Law Firm Chairman Daniel Oliverio said they wanted legal advice on what they were being told to do.
"Our relators, Judith Doetterl and Camille McGowan, one was a district manager and the other was a sales person for J&J, who were actively involved in the Risperdal sales effort and recognized that J&J was going about it in an illegal manner."
The major federal weapon in this nine-year long case was the False Claims Act because Medicare and Medicaid were paying for the off-label use.
What's different about this law is that whistle-blowers get a cut of what's collected and in this case the five relators will split $168 million.