A U.S. judge has ordered Novartis to do something it’s been trying for a year to avoid: Hand over documents on 79,236 educational events the company says it held with doctors.
Federal prosecutors claim those events were shams. They call them “kickbacks” instead. The government alleges that Novartis invited the same doctors to speaker events over and over, treating them to lavish dinners at Nobu and Smith & Wollensky—and gatherings at Hooters—in return for prescribing more Novartis meds.
In a legal drama on TV, this is when we would see a montage of photocopying and stacking, and a final shot of hand trucks delivering box upon box of documents. The whistleblower in the case, former Novartis sales rep Oswald Bilotta, might shake hands or high-five with the Justice Department lawyers accepting the delivery.
Lacking Hollywood license, Judge Paul Gardephe offers these comments in his Tuesday order (PDF) compelling Novartis to muster its paperwork.
Novartis must produce backup documentation on its events from a company database. The company also has to turn over records of its payments to doctors speaking at the events, educational PowerPoint presentations and reports on Novartis’ own investigations into complaints about its speaker programs.
Judge Gardephe denied a request that Novartis search electronic records kept by 363 additional sales staffers because the DOJ had agreed to limit those searches to 150 reps.
Novartis had argued that the DOJ also agreed to limit its demands for information to 6,600 events—rather than more than 80,000—and that gathering up documentation for the additional 70,000-plus would be too monumental a task.
The court didn’t buy it. Satisfying the demands for evidence wouldn’t be unduly burdensome, Gardephe wrote. And in any case, the stakes are high enough to warrant some sweat on Novartis’ part, the order states.
The government claims that “sham” events and honoraria, paid from 2002 through at least 2011, were essentially bribes to induce doctors to prescribe Novartis cardiovascular drugs, including the now-off-patent blood pressure med Diovan and the diabetes med Starlix.
According to the feds, the presentations were often cursory at best and sometimes didn't take place at all. The DOJ says they were essentially social occasions disguised as educational programs. Novartis held some events in noisy restaurants without private dining rooms where speakers might have set up slide presentations. Physicians repeatedly attended programs on the same topic, the government said.
To amount to kickbacks, though, these entertainments had to be linked to increased prescription numbers. The lawsuit claims attendees did boost their prescribing of the drugs involved—and doctors knew they wouldn’t be asked back if they didn’t.
According to Gardephe’s order, the prosecutors say Novartis paid “tens of thousands of doctors kickbacks,” and each of those doctors then “wrote many thousands of dollars’ worth of prescriptions” for Novartis drugs that were paid for by federal healthcare programs. That means the case “has the potential for broad public impact”—justifying the time and trouble necessary to produce those records, Gardephe wrote.