Novartis dodges Gilenya kickback claims—again—after whistleblower lawsuit dismissed

For the second time in as many years, Novartis has dodged claims it paid doctors kickbacks at “sham” speaker programs to boost prescriptions of its multiple sclerosis blockbuster Gilenya.

U.S. District Judge Kimba Wood dismissed the whistleblower lawsuit this week, arguing former Novartis sales representative Steven Camburn—who first sued Novartis under the False Claims Act in 2013—did not “adequately plead the existence of a kickback scheme with sufficient particularity,” according to court documents filed Tuesday.

Camburn’s lawyer says he and his client plan to appeal the decision, adding that they’re confident the ruling will be reversed, Reuters reports.  

The dismissal revolves around speaker programs Novartis organized to promote Gilenya, which ranked as Novartis’ third-best selling drug in 2021 behind Cosentyx and Entresto. Last year, Gilenya brought home (PDF) total sales of about $2.79 billion.

In an amended complaint filed in November 2021, whistleblower Camburn claims these Gilenya speaker programs were “shams” that provided “little, if any educational value” for the doctors in attendance.

In addition to the alleged poor educational value of the events, Camburn claims Novartis conducted an excessive number of speaker programs. Further, these programs were poorly attended or had no “legitimate attendees,” according to the suit.

At high-end restaurants, Novartis “wined and dined” speakers in a bid to build relationships and influence prescription-writing, Camburn argued.

Wood dismissed an earlier version of Camburn’s lawsuit for lack of detail, giving the whistleblower a chance to amend the case, Reuters points out.

Camburn did so in May 2020 and again in November 2021, but now his latest effort fell flat.

Novartis is no stranger to kickback litigation. Back in 2020, the Swiss drug juggernaut agreed to pay $729 million to settle allegations it offered kickbacks to doctors and illegal copayment support to Medicare patients to boost its drugs’ sales.

That settlement covered two separate cases: In the first, federal prosecutors said Novartis used “tens of thousands of” speaker programs and events to obfuscate doctor bribes, with the goal, according to prosecutors, to induce prescription of Novartis meds such as Lotrel, Valturna, Starlix, Tekturna, Tekamlo, Diovan and Exforge.

In the second case, Novartis shelled out $51.25 million to resolve charges that it funneled money through charities to cover copayments of Medicare patients so that they would use multiple sclerosis med Gilenya or cancer drug Afinitor.

Just a week before that settlement, Novartis in June 2020 inked a $347 million deal with U.S. authorities to settle allegations of Greek doctor bribes around wet age-related macular degeneration drug Lucentis.

Novartis’ latest whistleblower litigation win comes after a bittersweet few months for Gilenya on the patent front.

After handing Novartis a win in January, a U.S. appeals court changed tack in late June, ruling a certain Gilenya patent invalid and reviving the bid of Chinese drugmaker HEC Pharm to advance a generic of Novartis’ drug.

Following the Gilenya patent loss, Novartis vowed to file a petition seeking further review of the court’s decision. The company plans to “vigorously defend” the validity of Gilenya’s patent, leaving “all available options” on the table, Novartis said at the time.