A lawsuit against Gilead Sciences, a prominent drug company known for its HIV medications, has been allowed to continue in federal court after the company filed a motion to dismiss the claims. Although the ruling dismissed some claims against the biopharma giant, it allowed all the core causes of action to continue deciding a decisive victory for the plaintiffs. There is still a long way to go but these cases may have legs that could take the plaintiffs to victories at trial and ultimately a global settlement for all the victims.
The legal allegations against Gilead involve the company’s groundbreaking prescription drugs used to treat HIV. In 2001, Gilead developed and released a first of its kind drug, tenofovir disoproxil fumarate (TDF) under the brand name Viread. TDF is a unique antiretroviral medicine that works by blocking an enzyme that HIV virus cells use to replicate and multiply. By preventing the virus cells from replicating, Viread and Gilead’s other TDF drugs stop HIV from growing and progressing into AIDS.
Gilead dominates, arguably with antitrust implications, HIV drugs known as antiretrovirals. In the U.S. today, over 80% of patients on HIV treatment take one or more of Gilead’s products every day.
These drugs are essential to effective HIV therapy. Gilead’s TDF drugs (Viread, Atripla, Complera, Stribild) literally changed the treatment landscape for HIV patients. TDF made living long term with HIV a possibility and was being taken every day by hundreds of thousands of patients across the country. Give Gilead a ton of credit for this. They saved lives and a lot of them. Before we write any folks songs about Gilead, remember the company is well for their efforts. Gilead’s sales of these products in the United States alone bring in more than $11 billion annually.
TDF drugs were not perfect. No one expected them to be perfect. There was one major drawback to TDF was the way it metabolized inside the body. TDF does not get fully absorbed by the virus cells it is designed to combat, so it has to be taken in very high doses. Once in the patient’s system, only a small portion of the TDF gets absorbed by the virus while the rest ends up in the kidneys and the gastrointestinal system where it acts like a poison. Over the long term, this can lead to potentially severe side effects, including renal toxicity and reduced bone density.
Even though TDF was known to be harmful to a patient’s bones and kidneys, the drug was literally saving lives, so these were viewed as acceptable risks. Of course, this was based on the assumption that TDF was the only option and that there was no safer alternative drug to combat HIV. Incredibly, however, Gilead had already developed a safer alternative drug that was even better than TDF. By the time Gilead initially released Viread in 2001, the company had already developed a better version of the drug called TAF. TAF was metabolized differently, so it did not damage the kidneys and bones like TDF. Not only was TAF much safer than TDF, but earlier trials showed that it was actually more effective.
This is where plaintiffs’ lawyers claim Gilead made a fateful business decision that would endanger thousands of patients and ultimately lead to the lawsuits the company is now facing. Gilead was already making billions from Viread and its TDF drugs, which were under patent protection for another 10 years. It is alleged, and this is a strong allegation, that Gilead realized that if they released their newer, better, and safer TAF drug it would immediately kill the market for Viread and the TDF drugs. So instead of immediately getting the safer TAF drug approved, Gilead put TAF on the shelf and deliberately waited for the TDF patent was about to expire before announcing that they had a better, safer drug.
Gilead may have potentially gotten away with this strategy if they hadn’t tried to push the boundaries even further. When Gilead eventually released the new TAF drug, they wanted to get patients taking TDF to switch so the company deliberately hiked up prices. Suddenly, patients were paying much more for their TDF drugs. This raised a lot of eyebrows and eventually led to the discovery that Gilead could have released the safer TAF years earlier. Not surprisingly, many patients were outraged when they concluded that Gilead exposed them to years of harm from the TDF drugs to maximize profits.
Lawsuit Against Gilead
The discovery of Gilead’s alleged actions quickly led a large group of over 50 HIV patients to sue the company in federal court. The lawsuit alleges that Gilead new it had a safer alternative drug, and the company had a duty to release that safer drug immediately. Once the lawsuit was filed, Gilead filed a motion to dismiss arguing that the plaintiffs’ claims were preempted by federal laws. U.S. District Judge Jon S. Tigar was not persuaded by Gilead’s preemption argument. In a ruling issued earlier this Sumer, Judge Tigar noted that there was no federal law that would have prevented Gilead from using the safer TAF drug compared to the potentially more dangerous TDF drug.
Tigar concluded that Gilead complied with both state and federal laws before they sent the TDF drug to the FDA for approval. In his opinion, Gilead did not present enough evidence to prove that the FDA would not have approved the safer drug that the plaintiffs argue would have complied with state law.
Despite letting the case move forward, Tigar narrowed the scope of the case and dismissed some of the other claims plaintiffs brought to court. Specifically, Judge Tigar dismissed all of the failure to warn claims. He also dismissed fraud and consumer protection claims based on alleged misrepresentations.
If the plaintiffs succeed in their lawsuit against Gilead, it could another landmark case against one of the biggest pharmaceutical companies in the United States. Many drug companies have recently been facing heat for the misuse of drug prescriptions, especially for opioids which will, any day, lead to a settlement of many billions of dollars.
Are these cases going to take off? I really have no idea. Ultimately, these are the allegations. Can they be proven? Time will tell.