Gilead accuses Floridian clinics of HIV drug fraud
Gilead Sciences has claimed that a group of Florida-based healthcare clinics, pharmacies, and lab testing facilities have “wrongfully captured tens of millions of dollars” through a fraudulent programme.
According to the suit, filed yesterday November 3 at the US District Court for the Southern District of Florida, the “interconnected” groups have repackaged HIV pre-exposure prophylaxis (PrEP) medication in a trademark-infringing manner as part of their “dangerous and fraudulent” schemes.
The suit names a number of clinics, pharmacies, and laboratories associated with Doctors United and Positive Health, alongside the individuals who own and operate the networks and certain doctors, nurse practitioners, and physician assistants whom they employ.
Gilead claimed that these “criminal networks” have stolen millions from its Advancing Access medication assistance programme, a charitable endeavour that provides eligible uninsured persons with free medication to help protect them from becoming infected with HIV.
“Defendants’ schemes are not just a colossal financial fraud; they also actively endanger the health and safety of Floridians, placing the public at risk of serious illness or death,” said the suit.
The defendants allegedly recruit individuals who earn low incomes or are homeless and prescribe them PrEP medication under Gilead’s programme.
Then, the defendants allegedly seek reimbursement from Gilead, repackage the PrEP medication in an “unlawful, trademark-infringing, and potentially dangerous manner for dispensation to the recruited ‘patients’” and repurchase those medications back for “pennies on the dollar” to resell them on the black market.
The suit added: “In addition to defrauding Gilead out of tens of millions of dollars and jeopardising Gilead’s hard-earned goodwill, defendants’ schemes have placed at risk the health—and even the lives—of Floridians who are economically challenged.”
Gilead said it first had concern over the conduct when it noticed that certain prescriber defendants and other prescribers associated with the clinics were prescribing “enormous volumes of PrEP medication to a suspiciously large number of individuals”.
“But it was only after receiving credible and consistent reports of fraud from multiple whistleblowers, including some of the clinic defendants’ own current and former employees, that Gilead learned the true nature and scope of defendants’ fraudulent schemes,” said the claim.
As part of its trademark and trade dress infringement claims, Gilead asserted that the defendants are taking the medication out of its Food and Drug Administration (FDA)-required packaging and repackaging it.
“As a result, defendants are dispensing PrEP medication that, in numerous respects, does not comply with critical FDA regulations and causes confusion among consumers, who, based on Gilead’s sterling reputation and product quality, expect the medication to be safe and reliable because it bears certain Gilead marks,” said Gilead.
The pharmaceutical company is seeking an injunction to “immediately halt defendants’ dangerous and fraudulent schemes”, an order forcing the defendants to return the medication to Gilead, and damages.
Late yesterday, the Floridian court granted Gilead's request for a temporary restraining order and ordered the defendants to make arrangements to turn over PrEP medication to Gilead.
A telephone hearing is scheduled for November 16, where defendants will need to show cause as to why a preliminary injunction shouldn’t be granted.
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