Seeking Justice When Corporations Put Profits Over People
The History and Uses of TDF Drugs
Tenofovir disoproxil fumarate (TDF) is an oral medication developed and manufactured by Gilead Sciences, Inc. and is used in conjunction with other compounds to treat and prevent the transmission of HIV. TDF drugs manufactured by Gilead Sciences, Inc. include Viread, Truvada, Atripla, Complera, and Stribild.
TDF is metabolized in the body into the antiretroviral compound tenofovir which was first discovered by scientists in Europe in the 1980s. Soon after, Gilead Sciences, Inc., which was at that time a small biotech firm, bought the rights to sell it. TDF drugs were first approved by the U.S. Food and Drug Administration (FDA) in 2001 as a way to treat and reduce the spread of HIV. In 2004, Health Canada also granted approval to market the first TDF drug, Viread, in Canada. In the years following, Health Canada continued to grant approval for Gilead’s other TDF formulations including Truvada, Atripla, Complera, and Stribild.
The Side Effects of TDF Drugs
Since TDF drugs were introduced to the market, they have been linked to serious side effects including permanent and debilitating kidney and bone damage. Specifically, it is alleged that people experience:
- Kidney damage and kidney failure, including:
- Renal insufficiency/impairment
- Decreased kidney function
- Chronic kidney disease
- Tubular dysfunction
- Fanconi syndrome
- Renal failure
- End-stage renal disease
- Bone density loss, including:
- Reduced bone density
- Bone malformation
- Bone breaks/fractures
- Tooth loss
The Manufacturer of TDF Drugs
Gilead Sciences, Inc. is a biopharmaceutical company based in Foster City, CA. Founded in 1987, they focus on researching and developing antiviral drugs (used in the treatment of HIV, hepatitis B, hepatitis C, and influenza) and drugs used to treat liver, cardiovascular, and respiratory diseases and conditions. They have over 14,000 employees and had total revenues in 2021 of over $27 billion.
In recent years, they have come under serious scrutiny amidst accusations including downplaying the serious side effects of their medications, misrepresenting the efficacy of their medications, delaying the release of safer alternatives in the interest of maximizing profits, and failing to warn doctors and patients about risks of their medications.
Klein Lawyers Files a Class Action in Canada Against Gilead
On April 19, 2021, Klein Lawyers filed a class action lawsuit in Canada against Gilead following similar lawsuits launched in the United States. The lawsuit includes individuals who took TDF drugs including Viread, Truvada, Atripla, Complera, and/or Stribild and experienced an injury related to their kidneys or bones. The plaintiffs are seeking compensation for the injuries they sustained, the pain and suffering they endured, and the medical expenses, lost wages, and other financial losses they’ve suffered.
The plaintiffs allege that Gilead knew there was a safer alternative to TDF but intentionally delayed the required research and development, thus maximizing their profit from the sale of TDF drugs. This resulted in Canadians suffering harm and injury needlessly because they were forced to consume drugs that were more toxic than known alternatives.
Were Safer Alternatives Ignored?
The plaintiffs allege that Gilead was aware of the serious side effects of TDF drugs and was researching safer alternatives very early in the process. The claim is that by 2001, Gilead determined that tenofovir alafenamide fumarate (TAF) was a safer prodrug form of tenofovir that could be administered orally to convert the same amount of active tenofovir in the body at a much lower dose than TDF. As a result, TAF produced significantly lower concentrations of active tenofovir in the kidneys, which in turn decreased the risk of renal injuries, as well as bone and tooth loss, when compared to TDF.
In 2004, Gilead announced that it was ending all research on TAF drugs and instead, continued marketing and selling the profitable TDF drugs which produced billions of dollars in annual revenue. However, Gilead continued to apply for patents relating to TAF and, four years before the TDF patents were set to expire, Gilead resumed testing and development of TAF based medications. The first TAF drug, Genvoya, was approved for use in Canada in 2016. Several other TAF drugs have since been approved including Odefsey and Descovy.
The Role of Patent Protections
The lawsuits accuse Gilead of using patent protections to increase profit at the expense of patient health. Many drug companies that manufacture brand-name drugs utilize a variety of strategies designed to extend patent protections. This practice is commonly referred to as “life-cycle management” and aims to prevent competitors from producing generic versions of the medication. That competition typically results in decreased profits for the name-brand manufacturer and eliminates their monopoly on the drug. The plaintiffs allege that Gilead improperly used the patent system to increase their profits resulting in serious harm to patients who were forced to continue using the more dangerous TDF drugs.
Targeting a Vulnerable Community
Making Gilead’s alleged actions all the more egregious is the fact that the drugs they were manufacturing were made to treat men and women with HIV. The HIV and AIDs epidemic in the 1980s was devastating, particularly to marginalized communities. The harm alleged by the plaintiffs in these claims affects individuals who already have suffered significantly and rely on companies like Gilead to make decisions that will not harm them needlessly in the name of profits. Further, HIV medications have provided the benefits of reducing anxiety, increasing security, and providing more independence. This power is undermined, however, when those treatments harm individuals unnecessarily.
Klein Lawyers Can Help
Klein Lawyers is recognized as one of the most experienced class action law firms in Canada, including complex pharmaceutical litigation. David Klein, founder and partner of Klein Lawyers, has been recognized as one of Canada’s top class action lawyers by Lexpert (Canada’s Leading Source of Legal News & Information) and by Best Lawyers in Canada. David and his team have successfully recovered hundreds of millions of dollars for thousands of victims in a wide range of landmark class action lawsuits.
We are a widely respected Canadian law firm that employs over 50 staff members with offices in Vancouver and Toronto, Canada. Our team of dedicated lawyers and legal support staff focus specifically on class action litigation and that has allowed us to become one of the most preeminent class action firms in the country. Our experience and passion help victims gain the justice they deserve.
Class action cases are critical in the quest for justice against huge corporations like pharmaceutical companies. When these companies put profits before the safety and well-being of the patients their medications are supposed to treat, they must be held accountable. Class action lawsuits provide a means by which to level the playing field, allowing ordinary people to stand up to multi-billion dollar corporations. In this case, the plaintiffs allege that Gilead’s actions harmed many Canadians. Our aim is to fight for justice on behalf of these individuals.
If you or a loved one takes or took Truvada, Viread, Atripla, Complera, and/or Stribild and experienced serious side effects, Klein Lawyers can help. Please contact us via our confidential form or call (604) 874-7171 for assistance.