Novartis Pharmaceuticals Corporation has agreed to plea guilty to charges of off-label marketing and bribing doctors to prescribe the anti-epileptic drug Trileptal, as well as other drugs, and has agreed to pay nearly half a billion dollars to settle a whistleblower lawsuit and federal charges.
The Department of Justice (DOJ) announced the Trileptal settlement (pdf) on September 30. The DOJ claimed that Novartis created marketing materials that promoted Trileptal for the treatment of neuropathic pain and bipolar disease; neither of which is an approved use by FDA. While doctors can prescribe drugs to treat any ailment they feel is appropriate, it is illegal for drug companies to promote drugs for uses not federally approved.
In addition to the marketing charges, the DOJ claims that the drug maker violated the False Claims Act by paying illegal kickbacks to health care professionals to induce them to prescribe Trileptal, Zelnorm, Sandostatin, Exforge and Tekturna for off-label uses. The DOJ claims that Novartis used speaker programs, advisory boards, entertainment, travel and meals as bribes. Novartis earned hundreds of millions of dollars from the illegal activities, according to the DOJ.
As part of the settlement, Novartis agreed to pay a forfeiture of funds and a criminal fine totaling $185 million. It also agreed to settle four civil whistleblower lawsuits for $237.5 million. The whistleblower suits were brought by former employees, including Jim Austin, Daryl Copeland, Steve McKee and Jeremy Garrity, who will receive $25.6 million of the civil lawsuit settlement.
Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the case. The DOJ intervened in all four cases.
Trileptal (Oxcarbazepine) is an anticonvulsant drug approved by FDA to treat seizures, but it is frequently used to treat bipolar disorder and neuropathic pain as well. In April 2005 the label was updated to add warnings that the drug had been linked to rare and sometimes fatal skin disorders known as Stevens-Johnson Syndrome (SJS), which is referred to as Toxic Epidermal Necrolysis Syndrome (TENS) in severe cases.
SJS is known to occur as a side effect of several medications, causing the skin to burn, producing blisters, severe rashes and the skin may begin to separate from the body. It can also cause eye damage that could lead to blindness. When the skin lesions affect more than 30% of the body, the condition is referred to as TENS. Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.
In 2008, the FDA added suicide warnings to Trileptal and 10 other anti-epileptic drugs after findings from clinical trials suggested that patients taking the drugs were nearly twice as likely to experience suicidal behavior or thoughts when compared to those taking a placebo.