March 31, 2017
By Mark Terry, BioSpace.com Breaking News Staff
As part of a federal whistleblower lawsuit, the U.S. federal government has asked Switzerland-based Novartis AG to supply records on about 80,000 promotional programs. The lawsuit is related to kickbacks to healthcare providers.
The court case is U.S. v. Novartis Pharmaceutical Corp. , 11-CV-0071, U.S. District Court, Southern District of New York (Manhattan). This particular filing is in response to a request by Novartis on March 22, arguing that the U.S. had “exploded” the case size.
Novartis claimed that in its initial scope of discovery talks, the Justice Department only sought information about 6,600 events and that the expansion to almost 80,000 was outside the scope of the case and unduly demanding of the company. They also argue that of the 80,000 events, 50,000 are roundtables, which don’t involve a healthcare provider speaker. Arguing the request was “excessive and burdensome,” they said that tens of thousands of the events in question happened more than a decade ago and would require going through the files of 5,400 sales representatives.
U.S. District Judge Paul Gardephe, this week, rejected the company’s argument.
In the filing, the government wrote, “The requested documents go to the core issues in this case: whether educational materials were provided at these events; which doctors actually attended the events; how much money was spent on meals and honoraria; and indeed, most fundamentally, whether the underlying documentation shows that a particular event actually took place.”
In 2016, Novartis paid $390 million to settle a lawsuit with the U.S. government over accusations the company paid kickbacks to pharmacies in order to increase sales of certain prescription drugs.
The current case is alleging that Novartis, according to Bloomberg, “provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed.”
The qui tam, or whistle-blower, provision of the False Claims Act was made by a former Novartis sales representative. Allegedly, Medicare and Medicaid paid millions of dollars in reimbursements based on fraudulent insurance claims that were submitted for various Novartis drugs. The period in question is from 2002 to 2011.
The suit was filed by Oswald Bilotta, a former Novartis sales representative. Per the filing, “The Initial Complaint alleged that during the time period from 2002 through 2011, NPC violated the Anti-Kickback Statute … by paying doctors ‘kickbacks’ through purportedly sham speaker programs in order to induce them to prescribe NPC cardiovascular pharmaceutical products. The Initial Complaint further alleged that NPC’s purported AKS violations ‘caused the submission of thousands of false claims for payment to federal health care programs’ in violation of the FCA.”
The initial complaint was filed on January 5, 2011. The U.S. government subpoenaed Novartis on November 18, 2011, requesting documents related to speaker programs sponsored by Novartis’s CV Division. Novartis turned over 90,000 documents made up of more than 2.5 million pages. The government also interviewed a number of Novartis employees, as well as physicians who prescribed the company’s cardiovascular and metabolic drugs.
In an amended complaint filed on March 21, 2013 and on July 9, 2013, it further noted the prescriptions were for Lotrel, Valturna, Starlix and “other CV division drugs” that were eventually reimbursed by federal health care programs. The amended complaint identified only 15 doctors.
