J&J files US lawsuit against counterfeit HIV drug network

Pharma group Johnson & Johnson has filed a lawsuit against distributors and pharmacies that it accuses of selling counterfeit versions of its HV drugs, shortly after a similar action was revealed by Gilead Sciences.

The defendants in the case include many of the same organisations cited in Gilead's lawsuit, including 'grey market' distributors Safe Chain Solutions and ProPharma Distribution, along with Scripts Wholesale, I Care Pharmacy and individuals reported to be associated with the companies.

Manhattan-based I Care Pharmacy – reported to be one of the largest sellers of Janssen HIV medication in New York City by the time it was discovered selling counterfeits in late December 2021 – is not mentioned in the Gilead lawsuit.

The case revolves around falsified versions of J&J's Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide), sold by its Janssen pharma division, a single-pill antiretroviral therapy for HIV.

The complaint notes that Janssen has received a series of complaints from patients "distressed to find that their prescribed bottles of Symtuza…contained the wrong pills inside the bottles."

An investigation revealed that the bottles were counterfeits, with fake labels, falsified instructions for use, and fraudulent supply-chain pedigrees.

Moreover, the pills found inside the counterfeit bottles "were different drugs that do not adequately control…patients' viral loads and thus place them at serious risk of disease progression," according to court documents.

One of the patients who reported the counterfeiting to Janssen could not be located for follow-up monitoring, and seems to have fallen out of care – perhaps due to loss of trust after the incident.

J&J notes that I Care Pharmcy's business has since been taken over by another organisation, raising concerns that it is connected to a criminal network "that continues to actively dispense dangerous counterfeit HIV medication in New York City."

Also named in the lawsuit are SafeChain co-owners Patrick and Charles Boy, ProPharma founder Levi Ellis, Scripts Wholesale principal Steven Diamantstein, and I Care Pharmacy principal Edward Gendin.