September 30, 2010 — Novartis Pharmaceuticals Corp.
Novartis Pharmaceuticals Corporation has agreed to pay more than $420 Million to settle qui tam actions filed against it by private relators.
The allegations asserted against Novartis were that the company illegally marketed Trileptal and five other drugs for “off-label” uses.
An “off-label” use of a drug, is a use which has not been approved of as safe or effective by the Food and Drug Administration (FDA).
When a drug is approved by the FDA, its manufacturer may not market or promote it for any use not approved of by the FDA.
In addition to allegations that Novartis had illegally promoted Trileptal for a variety of uses, including psychiatric and pain uses, the case involved additional allegations that Novartis paid kickbacks to health care professionals to induce them to prescribe Trileptal and five other drugs which included Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.
As a reward for having filed their qui tam claims, the private relators will receive over $25 Million from the settlement.
See U.S. Dept of Justice Press Release 09/30/10