Three HIV positive males - all with a history of severe bone loss and sudden fractures - filed a products liability case against drug giant Gilead Sciences claiming Gilead marketed an antiviral drug it knew (but did not disclose) would cause unnatural bone loss and kidney disease in users. The Plaintiffs are represented by Stephanie Sherman, Sherman Law, P.C.
LOS ANGELES, CA (September 29, 2021). Antiviral HIV drugs are used to combat and slow down the devastating effects of the AIDs virus. Patients who are HIV + must take these drugs for life. Gilead Sciences, a California company, makes approximately 3 billion a year of HIV drugs.
Beginning in 2001, Gilead started exclusively focusing on antiviral drugs and achieved its first approval of HIV drugs in 2001. The drug Gilead manufactured and sold an antiviral drug, was tenofovir disoproxil fumarate (TDF) with product names, Viread, Truvada, Atripla, Complera and Stribild. These drugs were all approved to treat and/or reduce the risk of sexually transmitted HIV-1. Viread was the first to hit the market. At around the same time, Gilead developed another antiviral drug called tenofovir alafenamide fumarate (TAF) or TAF. Both TDF and TAF were developed and shown to slow down the progression of HIV with one major difference, the TDF version was toxic to the kidneys and bones. But Gilead made a financial decision not to market the safer TAF version. Instead it planned to maximize its profits on the TDF version first, then market the safer alternative later as an improvement over the original. Gilead's attempt was to parlay its popularity from the first drug to the "new and improved version" to maintain its profit stream, domination in the market, and reputation as a lead in antiviral drugs. The problem with this scheme is people found out Gilead already had ready the safer drug but chose not to bring it to market. The Plaintiffs allege that for over a decade, Gilead withheld the other form of medication that it knew was safer and more effective than the TDF formulations it sold during that period. For ten years HIV + patients were taking a toxic drug when there was another one readily available that was less toxic and as effective, if not more.
Scientists have studied the key component, TDF, and found a strong correlation between the drug and bone loss and kidney failure. Medical studies confirm that TDF triggers systematic bone loss and/or kidney failure in users. This already in addition to the physical vulnerabilities suffered by the HIV patient population. The added bone loss puts HIV patients at an increased risk of bone fractures, including hips, arms, teeth, and legs. Patients with bone toxicity from the drug report suddenly breaking a bone when doing a simple routine activity. Others report that they are told they have the bone density of a drastically older person when they are decades younger. The bones become so fragile that they can break without significant pressure.
Gilead's income in 2020 was 24.69 billion USD. When Gilead first introduced the HIV drugs, it charged less than $10,000 a year for a year's supply of medication. That price is now up to $20,000 a month. Gilead, enjoys a U.S. monopoly on antivirals. It is "big pharma" with little concern for safety over profits as demonstrated by its past.
The three men who filed this lawsuit have unnatural bone loss, fractures, and multiple surgeries. They can no longer work due to their injuries and physical activity is extremely limited due to their injuries. Their awsuit will show that Gilead intentionally withheld results of clinical trials demonstrating TAF's relative safety and efficacy and shelved TAF-based therapies until 2010, when the Food and Drug Administration approved Gilead's application to patent TAF. These men could. have been taking the safer drug and not be suffering today.
Currently there are more than 18,000 plaintiffs who have filed suit in California against Gilead for similar injuries including kidney failure. The cases are being coordinated in State of California Superior Court, San Francisco County and will be transferred to the home court after the pre-trial proceedings. The three men hope to get their case heard before a Los Angeles jury once discovery is completed.