A group of whistleblowers made waves in pharma by suing numerous drugmakers, claiming the companies used nurse educators and other services as kickbacks to boost prescriptions. But instead of jumping aboard, the government said it didn’t want anything to do with the lawsuits—and then, in an unusual move, asked the courts to dismiss them.

But at least one judge doesn't buy the Justice Department's argument, which highlighted the reasons those whistleblowers would sue in the first place.

In a case against the Belgium-based pharma UCB, the government didn’t only raise concerns about the allegations. The DOJ flagged the whistleblowers' motives and pointed out how much it time, effort and money would be required to pursue the claims.

The UCB whistleblowers are associated with the National Healthcare Analysis Group, which claims to be a healthcare research company with "no particular bias" about the industry, the government says. But in fact, the feds say, NCHA has a vested interest: It wants to make a profit from its lawsuits.

NHCA's strategy, the government argued, included using public sources to track down "potential informants" for its lawsuits. It then contacted healthcare professionals "under the guise of conducting a ‘qualitative research study’ of the pharmaceutical industry" and paid those who participated. 

"With this information that it obtained under false pretenses, NHCA Group brought sweeping allegations of nationwide misconduct against 38 different defendants—allegations that, for Medicare Part D alone, implicate more than 73 million prescriptions written by hundreds of thousands of different physicians for millions of different Medicare beneficiaries," the feds argued. "In each case ... the government expended considerable law enforcement and prosecution resources and time to investigate the allegations."

The government said its own research—a 1,500-hour probe—found the allegations didn't merit further litigation.

The whistleblowers alleged Amgen, Biogen, EMD Serono, Teva, AstraZeneca, AbbVie, Otsuka, UCB, Bayer, Eli Lilly and Gilead Sciences used nurse educators and other support services as kickbacks to entice doctors to prescribe their meds. In the UCB case, whistleblowers said the company offered free nursing and reimbursement support to induce prescribers to recommend the company's anti-inflammatory drug Cimzia.

The judge in the UCB case didn't buy the government's argument. At an evidentiary hearing, it became clear that prosecutors actually didn't investigate the case fully, Judge Staci Yandle wrote.

The feds investigated the cases "collectively," Yandle wrote. Prosecutors didn’t review materials specific to UCB or conduct a cost-benefit analysis of pursuing that particular case. They did go to great lengths to deride the whistleblowers’ "business model and litigation activities," Judge Yandle wrote. That, together with the limited investigation, call the DOJ's own motives into question, she wrote.

"Under the circumstances, one could reasonably conclude that the proffered reasons for the decision to dismiss are pretextual and the Government’s true motivation is animus towards the relator," Judge Yandle wrote. "For the foregoing reasons, this Court finds that the Government’s decision to dismiss this action is arbitrary and capricious, and as such, not rationally related to a valid governmental purpose." 

After Judge Yandle rejected the government’s motion to dismiss the UCB case, the plaintiffs filed notices in other cases about that decision. The Bayer, Biogen, Teva and Eli Lilly cases are pending, according to court documents. Courts have dismissed the Amgen, EMD Serono and Otsuka cases, while the whistleblowers agreed to pull their cases against AbbVie and Gilead, filings show.

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.