Over the past 20 years Gilead Sciences has developed an essential monopoly over certain HIV “cocktail” drugs, with the introduction of a series of medications involving the antiretroviral tenofovir. These treatments are critical for individuals living with HIV and hepatitis, as well as those considered to be in a ‘high risk’ population of exposure to the disease (PrEP). However, it appears that the company held back important information about serious kidney and bone related side effects, placing profits over patients.

In 2001, Viread was introduced as the first HIV treatment featuring tenofovir disoproxil fumarate (TDF), which allowed the compound to be taken orally, via a ‘pro-drug’ (pill), removing the need for an injection. Viread was followed by the introduction of other compounds in the TDF suite of drugs. Truvada was approved in 2004, Atripla in 2006, Complera in 2011, and Stribild in 2012, each involving different combination treatments with TDF. As a result, the drugmaker was able to maintain control of their patents, and the subsequent blockbuster sales for their newer medications, delaying competition from generic options for the HIV drugs.

Over the last several years, Gilead has generated more than $11 billion in annual sales, marketing HIV and PrEP drugs with known toxic side effects on the kidneys and the bones. All the while Gilead Sciences CEO, Dan O’Day, contended that TDF was a “Miracle Drug”.

Safer TAF Drugs

Research into the Company’s actions raised allegations arising from Gilead HIV drug lawsuits, that the drugmaker placed its desire for profits before consumer safety by delaying the development of a known safer alternative design, known as tenofovir alafenamide (TAF), which is effective at a much lower and less toxic dose (25mg of tenofovir in TAF as opposed to 300mg average in TDF).

Gilead did not introduce the safer TAF drugs, such as Genvoya, Odefsey, and Descovy, until the end of patent protection for TDF drugs approached in 2018. While this profiteering allowed the drugmaker to generate billions in profits and avoid generic competition until 2032, thousands of consumers throughout the United States medicated by TDF drugs have been left with severe kidney damage and bone problems that knowingly could have been avoided with adequate safety warnings. Even the US government is getting involved. In November 2019, the government filed suit against Gilead stating that the drugs were developed using taxpayer funding and that the company is illegally profiting from that research.

Current Status Of Litigation

In October of 2019 plaintiffs were granted consolidated proceedings in California state court (JCCP #5043). Claims were transferred to the Super Court for the County of San Francisco to be overseen by Judge Andrew Chang. As Gilead Sciences is headquartered in San Francisco there is no issue of diversity for claims arising outside of the state of California. As the population of the San Francisco Bay Area was one of the most adversely affected by the AIDS epidemic that began in the 1980s, it is likely the best venue for the trials to take place. There are currently more than 24,000 cases pending in California state court.

Update

On January 9, 2024 the, California Intermediate Appellate court rejected yet another attempt by Gilead Sciences attempt to have the lawsuits dismissed paving the way for the bellwether trials to move forward. In June 2024 Gilead announced a $40 million settlement offer to resolve roughly 2,000 cases.

Links:

1. https://www.cnbc.com/2019/05/14/lawsuit-alleges-gilead-propped-up-cost-of-hiv-drug.html
2. https://www.c-span.org/video/?c4800770/user-clip-sarbanes-challenges-gilead-ceo-taf
3. https://www.washingtonpost.com/business/economy/trump-administration-sues-drugmaker-gilead-sciences-over-patent-on-truvada-for-hiv-prevention/2019/11/06/68b1cc52-010c-11ea-8501-2a7123a38c58_story.html
4. https://www.fiercepharma.com/pharma/gilead-offers-40m-settle-federal-claims-wide-web-litigation-over-allegedly-delayed-launch