Novartis sales reps and doctors plan to testify in a long-running kickbacks case, court filings show, as prosecutors marshal evidence they say will show the company traded fancy dinners and entertainment—and in some cases, jobs for physicians' relatives—to increase prescription numbers.
The doctors and reps are set to open up about "lavish meals, alcohol and other benefits" Novartis provided physicians in exchange for prescriptions, prosecutors say. The government plans to lay out a case that the drugmaker was "essentially buying scripts," according to a new filing.
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Novartis attorneys, however, argue that the government's evidence isn't specific enough to support the allegations and plan to ask the court to toss out at least some of the charges.
Federal prosecutors said Monday their evidence was "wide-ranging and comprehensive." The suit alleges that Novartis used thousands of "sham" events—social gatherings billed as educational programs—to induce doctors to write more scripts. In a previous ruling in the case, Judge Paul Gardephe ordered Novartis to release information on almost 80,000 physician events held between 2002 and 2011.
Doctors will testify that "based upon their interactions with [Novartis] sales representatives, they understood that they had been invited to attend speaker programs and roundtables because [Novartis] wanted to induce them to write more" prescriptions, U.S. attorney Geoffrey Berman wrote in Monday's filing.
At some of the physician "roundtables," only one doctor was present, according to the government's 2013 complaint. In multiple instances, the company hired doctors' family members as reps to keep scripts coming in, the government alleges. In 2008, the company threw a holiday party at a restaurant in Huntington, New York, for sales reps and prescribers. No doctors attended, according to the complaint, although one received an honorarium payment.
A Novartis spokesperson told FiercePharma "each side will provide witness testimony to support our respective cases."
"The fact is that Novartis has identified multiple aspects for which the government lacks specific evidence to support its arguments," he said, adding that the company believes it's entitled to summary judgment.
"Novartis disagrees with the government’s characterization of our conduct and continues to dispute the allegations concerning certain speaker programs from 2002 through 2011," the spokesman said. "We strongly believe in the value of peer-to-peer medical education and transparency around these interactions."
Attorneys for Novartis said in a filing last week that the government lacks "particularized evidence that the programs served as a quid pro quo for prescriptions." The company plans to move for summary judgment based on its assertion the government lacks reliable evidence, among other points.
Further, some of the allegations are covered in a $422.5 million settlement inked in 2010, the drugmaker says. The settlement covered promotional activities on several drugs, including Diovan, Exforge and Tekturna.
Novartis says the government intends to use "markers," such as the number of events a doctor attended, instead of "individualized evidence" to prove doctors received kickbacks. But prosecutors say they have records that contain dates of the events, individual attendance, venues, costs, and more.
Some doctors received payments for some events that never happened, and other meetings contained "no educational content," according to the government. Further, Novartis "deliberately incentivized its sales force to organize promotional events" with its compensation structure, according to the filing, and had a "close to nonexistent" compliance program during the period.
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A status conference in the case is scheduled for April 19, according to Novartis' filing.
As the U.S. case plays out, Novartis is also embroiled in a bribery investigation in Greece, where lawmakers have voted to initiate a probe into 10 officials accused of taking bribes. The situation has grown increasingly political, but the drugmaker said if wrongdoing is found, it intends to “accept responsibility” and act “decisively" to "prevent future misconduct."