- A recent court ruling is forcing Novartis to provide federal officials with documents related to thousands of speaking events the U.S. Department of Justice claims were a front to bribe physicians.
- The verdict from Judge Paul Gardephe of the U.S. District Court for the Southern District of New York means Novartis has to fork over PowerPoint presentations, payment information, internal investigative reports and backup documents from the Advance Health Media database, a financial system used by healthcare companies, related to 79,236 speaking events.
- The civil lawsuit claims that between January 2002 and November 2011, Novartis orchestrated "sham" educational events, which gifted doctors with honoraria, expensive dinners and entertainment in an effort to get them to prescribe the company's products. The Swiss drugmaker held more than one million speaking events during that time frame.
Gardephe's ruling is another hit for Novartis, which already doesn't have the best reputation when it comes to kickbacks.
In 2015, the company paid $390 million to settle another lawsuit filed by the U.S. government that held the drugmaker used illegal tactics to boost sales for a handful of medications, including Gleevec (imatinib) and Myfortic (mycophenolic acid). Five years earlier, Novartis shelled out $422.5 million in criminal and civil fines related to claims it illegally promoted off-label use of the seizure treatment Trileptal (oxcarbazepine) and illegally marketed a handful of other products.
Like that 2010 case, the current lawsuit aimed at Novartis is a qui tam, or whistlerblower, proceeding accusing the company of violating the False Claims Act by making fraudulent claims about their products. What's more, the case, U.S. v. Novartis Pharmaceutical Corporation, alleges the drugmaker unlawfully promoted the off-label use of blood pressure medication Valturna (aliskiren/valsartan).
In court, Novartis argued the Justice Department's documentation requests were not only unreasonably burdensome, but also invalid. The big pharma's rationale was that federal officials had already requested back-up documents from 6,600 speaking events and eschewed rights to any additional records during discovery negotiations.
"This Court finds that the Government never agreed to forego production of backup documentation for the 79,236 speaker events, and further finds that these events and the underlying documents are central to the Government's claims," Gardephe wrote in court papers filed March 28.
While the Department of Justice will receive most of the Novartis documents it requested, there was one exception. Officials had electronically stored information (ESI), mostly in the form of email exchanges, from 150 sales representatives, but wanted access to a total of 363. Gardephe denied this demand, citing an agreement between the two parties to limit the scope of ESI to 150.
Novartis is pleased with the court's decision to cap the amount of information given to the government, a company spokesperson said via email.
"[Novartis] disagrees with the way the Government has characterized its conduct in these matters that concern the time period from 2002 through 2011," the spokesperson wrote."We believe it is essential that physicians and patients have the information they need to make informed healthcare decisions."