Gilead wins latest rounds in fake medicines lawsuit

Gilead Sciences has won two key judgments in its ongoing legal battle against a network of individuals and companies it accuses of running a nationwide scheme to distribute counterfeit versions of its HIV medicines.

The  falsified versions of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Descovy (emtricitabine/tenofovir alafenamide) were mixed in with batches of genuine Gilead product with fake pedigrees to make the scam harder to detect, according to the complaint.

In some cases the knockoff bottles were dispensed to patients, placing them at risk of treatment failure and/or toxic effects.

The fraudsters used authentic Gilead bottles that were filled with completely different drugs that were not made by the company, says the suit, which estimates that hundreds of millions of dollars' worth of fake HIV drugs were distributed by the conspirators. After refilling the bottles, they heat-sealed them with a replica of Gilead’s tamper-evident foil seal, it continues.

Last week, a New York federal judge froze the assets of several individuals, shell companies, pharmacies, distributors, and 'collectors' – people who pay cash on the street for the used bottles – with court documents identifying some newly named defendants including some alleged to be kingpins in the network as well as mid-level leaders.

New individually named defendants include alleged kingpins Lazaro Roberto Hernandez and Armando Herrera.

"Gilead's ongoing investigation revealed that these two kingpins directed the initial sale of the counterfeits through suppliers created solely to sell counterfeit medications," the company said in a statement. It identified the two men by matching approximate locations of their disposable burner cell phones with flight records.

Along with the two ringleaders, the suit names new defendants John Levitan, David Dunn, Stephen Smith, Frank Betancourt, Jose Hernandez, Nicole Alston and Boris Abramov, and companies including My Meds, ITC Group, Abacus Distributors and Laconia Avenue Pharmacy Corp.

Previously identified companies include 'grey market' distributors Safe Chain Solutions and ProPharma Distribution, which are accused of receiving counterfeit Gilead medicines from at least seven fly-by-night suppliers, including Boulevard, Gentek, Omom, Invicta, and Pharma Pac.

Shortly after agreeing to the asset freeze, the judge denied the defendants’ motion to dismiss the case for lack of personal jurisdiction and improper venue, and has allowed the case to proceed in the Eastern District of New York.