Gilead Biosciences’ HIV drugs have been a giant moneymaker for the company since they were introduced in 1997. This particular class of drugs, which consisted of five separate medications, made billions of dollars in profits for the company before their patent protection ran out and the company replaced these drugs with a new product that also has earned the company massive profits. Now, the company is facing a multitude of lawsuits claiming that the first generation of drugs caused bone and kidney damage. The company is now accused of suppressing the knowledge that it had that these drugs could be dangerous in order to maximize their profits and to keep selling this class of drugs for as long as possible.
The allegations that are at the core of these lawsuits have been levied against Gilead for many years. The basic claims in the lawsuit accuse Gilead or purposefully delaying the release of a safer drug so that they could continue to maximize their profits from a drug that they knew to be dangerous. According to the plaintiffs, Gilead continued to sell this potentially harmful drug for over ten years with the knowledge of the harm that it could cause.
For years, Gilead’s flagship HIV drugs were a series of medicines known as tenofovir disoproxil fumarate (TDF). Eventually, when the patent protections on TDF ran out, Gilead switched to selling tenofovir alafenamide fumarate (TAF). There are differences between these two classes of drugs. Both of these drugs are antiretroviral medications. TDF has a much shorter half life than TAF. As a result, TDF must be given in much higher doses than TAF in order to be effective. The TAF dose is only a fraction of the drug content of TDF since much less is required in order to achieve the same result.
TDF was a class of drugs. There were five different drugs in the class that were sold at one point or another in the last 20 years. Since Gilead is one of the dominant drug manufacturers in the HIV space, hundreds of thousands of people have taken one of these drugs over the years.
The problem with TDF is that there are negative impacts on both renal function as well as bone density. When TDF was first released, Gilead toured it as a “miracle drug.” Not only that, but the company also stressed the drug’s safety. However, Gilead soon ran afoul of the FDA as a result of the claims that it was making. The regulator took action against Gilead for these claims and directed it stop making unfounded marketing claims.
However, at the same time that Gilead was making these claims, they allegedly had information in their hands that contradicted the promises of safety. Gilead allegedly had this information in its hands nearly the entire time that it was selling TDF drugs. In fact, one of the lawsuits alleges that Gilead even put this knowledge into a patent application all the way back in 2000, almost 15 years before it applied for the TAF patent.
The specific danger results from the fact that the dose that must be given to the patient is very high. Since there is an impact on the bones and kidneys as a result of the medication, the high dosage magnifies the side effects of the drugs. Patients also reported suffering damage to their teeth after taking the medication. The side effects impacted both people with HIV as well as people taking the HIV preventative drug Truvada.
The problem for Gilead is that it allegedly attempted to have it both ways with regard to the TDF and TAF medication. On one hand, Gilead touted the increased safety of TAF drugs when it began to sell them in the marketplace. The problem with that approach is it invites a natural comparison with the alternative. Here, the other class of drugs was the TDF drugs that Gilead sold for many years.
However, Gilead had patent protection for TDF drugs and was making billions of dollars on the medications. Gilead is a massive company with sales of over $22 billion in 2018. The lawsuits allege that Gildead avoided replacing TDF drugs with TAF medications so long as it has patent protection on TDF drugs and was profiting handsomely. It was only when the TDF patent expired did Gilead decide that TAF drugs (which carried with them a new patent protection period) were safer and should replace TDF. The lawsuits claim that Gilead knew that TAF was safer all along, and even had the opportunity to replace TDF 15 years ago, but declined to do so out of profit motives.
Gilead has faced a number of allegations relating to its sale of TDF drugs. The company was also alleged to have used anticompetitive practices to sell the drugs, but it defeated those lawsuits. Now, the company is facing lawsuits for the fact that it allegedly sold a dangerous product and failed to warn customers of the potential dangers associated with the use of the drug. The company is accused of designing a selling a defective product due to the impact that the drugs had on patients’ bones and kidneys.
Currently, there are hundreds of lawsuits pending against Gilead with new lawsuits being filed. The cases are generally centered in state and federal court in California, where Gilead is based. The cases have survived judicial scrutiny thus far, as a judge has cleared the case to proceed, allowing nearly all of the grounds to survive a motion for dismissal.
Learn more about Drug Safety News.