Falsified HIV drugs reached patients, says Gilead lawsuit

Pharma group Gilead Sciences has filed a large and wide-ranging lawsuit against a long list of defendants that produced falsified versions of its HIV drugs, and managed to introduce them into the US supply chain via distributors and pharmacies.

The counterfeits were mixed in with batches of genuine Gilead product with fake pedigrees to make the scam harder to detect, and 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, according to a lawsuit, which has been filed in the US District Court for the Eastern District of New York.

After refilling the bottles, they heat-sealed them with a replica of Gilead’s tamper-evident foil seal. Gilead first warned of the counterfeits last summer.

According to the complaint, a complex and extensive conspirators of defendants sold, marketed, and distributed counterfeits of several Gilead medications which provide life-saving treatments for patients living with HIV as well as pre-exposure protection from the virus for high-risk people.

Among the defendants are '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.

"Gilead has learned that the suppliers and distributors are not the disparate actors they appear to be," says the complaint, which describes it as a "classic hub-and-spoke conspiracy."

"Rather, the counterfeits are being sold through an organized counterfeiting ring: a largescale, transnational conspiracy to sell counterfeit Gilead-branded HIV medications into the US supply chain."

It accuses three individuals of being the ringleaders – Dhruv Ralhan of D&K Healthcare Solutions, Paul Rosell of Med-Connect Enterprises and Venkata Srinivas Mannava; DSP Consulting – among a ling list of associates.

Some of the counterfeits had altered packaging and others were the wrong pills, including an antipsychotic drug with debilitating side effects, which placed unwitting patients at risk of serious injury or death, according to Gilead.

The defendants allegedly falsified the pedigree documents that track the chain of custody of medicines from the manufacturer to the seller, using unauthorised reproductions of Gilead’s trademarks.

The court has granted Gilead's requests to execute seizures of the defendants' warehouses and offices across multiple states, and the company is seeking an injunction and asset freeze.

Gilead has already seized confirmed counterfeits of a wide variety of medications, including HIV drugs Biktarvy, Descovy, Truvada, Genvoya, Atripla and Stribild, as well as hepatitis C drugs Vosevi and Sovaldi and Ranexa, a treatment for chronic angina.

At the moment, the identity of those producing the counterfeit medicines hasn’t been discovered.