Novartis Ordered to Hand Over 80,000 Records of `Sham’ Events for Doctors

Novartis Ordered to Hand Over 80,000 Records of `Sham’ Events for Doctors

Mark Terry, BioSpace.com / www.corporatecrimereporter.com/ 29. May 2017

 

Former US Attorney Preet Bharara from New York, claimed Novartis is a repeat offender.

 

As part of a federal whistleblower lawsuit , the U.S. federal government has asked 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 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 current case is alleging;

  • that Novartis, “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 events were often little or nothing more than social occasions for the doctors. The payments and lavish dinners given to the doctors were, in reality, kickbacks to the speakers and attendees to induce them to write prescriptions for Novartis drugs.
  • Many speaker programs were also held in circumstances in which it would have been virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast. No slides were shown on the boat.
  • Other Novartis events were held at Hooters restaurants.
  • In connection with these programs, Novartis also frequently treated the doctors to expensive dinners that they hosted at high-end restaurants. For example, a dinner for three, including the speaker, at a Washington, D.C. restaurant cost $2,016, or $672 per person. Novartis also paid a $1,000 honorarium to the speaker for this program. One of the two attendees had attended the same program a short time earlier. At another program held on Valentine’s Day in 2006, Novartis paid $3,127, for a meal for three people at a West Des Moines, Iowa restaurant, or $1,042 per person.
  • Novartis’s internal analyses show that speaker programs had a high return on investment in terms of the additional prescriptions for its drugs written by the doctors who participated in the programs, both as speakers and attendees, with the highest return arising from payments to doctors as “honoraria” for speaking. In short, doctors increased the number of prescriptions they wrote when they were being paid by Novartis to speak about a drug.