Gilead sues alleged counterfeit ring over US-wide fake HIV meds plot

Gilead Sciences has sued an array of pharmaceutical suppliers and distributors accusing them of forming a counterfeiting network and allegedly selling fake versions of its HIV medications.

The US District Court for the Eastern District of New York published unsealed documents related to the anti-counterfeiting lawsuit this week, which had been initially filed by Gilead on October 14 last year.

According to the complaint and memorandum of law, the defendants allegedly sold, marketed, and distributed counterfeits of Gilead’s medications, Biktarvy (emtricitabine, tenofovir alafenamide and bictegravir sodium), and Descovy (emtricitabine and tenofovir alafenamide).

These treatments are used by patients living with HIV and also provide pre-exposure protection from the virus for high-risk patients.

A criminal network

Gilead said that its investigation had revealed that most, if not all, of the counterfeit Gilead-branded medications sold in the US originate from an organised counterfeiting ring.

Gilead contends that this counterfeiting ring is led by a broker and salesman for Med-Connect, the owner of D&K Healthcare Solutions and a registered agent of DSP Consulting.

The suit alleges that the trio coordinated a shifting series of “fly-by-night corporate entities” to supply counterfeits to “established grey-market pharmaceutical distributors” who then distributed them to pharmacies throughout the US.

Gilead holds that its evidence showed that the distributor defendants sold 85,247 bottles of purported Gilead drug products to pharmacies over the past two years using counterfeit supply chain documentation to conceal their illicit origin.

“Patient safety is our first priority, and our actions were instrumental in removing counterfeit HIV medications from the US supply chain and protecting individuals who rely on our medications,” said Lori Mayall, head of anti-counterfeiting and brand protection, Gilead Sciences in a statement issued on January 19.

“Gilead will continue to pursue necessary measures, including working closely with the Food and Drug Administration and law enforcement, to protect public health and safety by thwarting the illegal distribution of medication that is fraudulently misrepresented as a Gilead product. Based on our actions, we believe that we have successfully stopped these defendants from distributing additional counterfeit versions of Gilead medication to patients.”

Altered packaging, wrong pills

Some of the counterfeits seizures during its investigation had altered packaging and others featured 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's complaint.

The counterfeiters used authentic Gilead bottles that at one point contained authentic Gilead HIV or other medications, it added.

“The tamper-evident seals of these authentic bottles had been broken and their contents emptied. The counterfeiters inserted the foreign tablets into these empty bottles, and then re-sealed the bottles. The counterfeits were thus engineered to resemble a new, unopened, and authentic bottle of authentic Gilead medication.”

The pharmaceutical company went on to emphasise that the dangers posed by these counterfeits was “dire”.

“Those who receive and ingest these counterfeits unwittingly miss their HIV treatment or falsely believe themselves to be protected against HIV infection,” warned Gilead.

“The foreign drugs in the counterfeit bottles were never prescribed by those individuals’ doctors and could cause serious harm or death, through contraindicated drug-drug interactions or the onset of unanticipated side effects such as loss of consciousness while operating heavy machinery or driving,” the complaint said.

The suit also accused the defendants of allegedly faking the pedigree documents that tracked the sale of the drugs from the manufacturer to the seller.

The court has granted Gilead's requests to execute seizures of the defendants' warehouses and offices across multiple states.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.