Products Liability
Our lawyers handle HIV drug injury cases involving a kidney injury or other injuries connected to HIV drugs in all 50 states.
HIV medications containing tenofovir disoproxil fumarate (TDF) have led to lawsuits from victims alleging kidney disease and kidney failure, bone density loss, bone fractures, and other side effects.
Which HIV drugs are implicated?
- Truvada
- Viread
- Atripla
- Stribild
- Complera
Tenofovir disoproxil fumarate (TDF) is an antiretroviral drug initially developed by Gilead Sciences and sold under the brand name Viread. Other TDF drug brand names include Atripla, Complera, Stribild, and Truvada. Since first coming on the market back in 2001, TDF drugs have become widely used for the long-term treatment of HIV and AIDS. Hundreds of thousands of people with HIV take these drugs every day, and they have generated billions in revenue for Gilead and other drug companies.
Gilead and other TDF makers are now facing a growing number of HIV drug toxicity lawsuits alleging that the company failed to adequately warn about severe adverse health effects caused by TDF drugs. Even more concerning are allegations that Gilead developed an alternative type of drug that was much safer but intentionally delayed its release for years to maximize profits before the patent ran out on the TDF drugs.
2024 Truvada Lawsuit Update
Gilead Sciences sought to dismiss negligence claims through a motion for summary judgment, arguing that the FDA’s approval of TDF-containing drugs and federal law shielded them from liability, as their claim did not label TDF as inherently defective. This approach might seem somewhat unconventional, right? The negligence is not that the drug is terrible but that the defendants sandbagged patients by holding back a better drug because, for convoluted reasons, it would give them more in profits.
But that is the case. Central to the debate in every Truvada lawsuit is the allegation that the company negligently delayed the development of TAF and thus deprived them and their doctors of a safer treatment alternative. So the question is, does this claim fly? If the answer is no, everyone goes home.
The California Court of Appeal now answers this question in a 65-page ruling. The court determined that the plaintiffs’ negligence claim is tenable, even without asserting the drug they used was intrinsically defective, allowing the Truvada lawsuits to proceed.
The court evaluated whether a drug manufacturer owes a duty of care in making safer drug alternatives available. It affirmed that a manufacturer’s responsibility to practice reasonable care transcends merely avoiding the sale of defective products, covering situations where harm arises from not exercising reasonable care, regardless of whether the product is labeled “defective.” So it is game on. for plaintiffs seeking justice.
Viread and TDF Drugs
Viread is the brand name for a prescription medication known as TDF (tenofovir disoproxil fumarate). TDF is a member of a very unique group of pharmaceutical drugs known as NRTIs (nucleoside reverse transcriptase inhibitors). Inside the body, NRTI drugs like TDF work by blocking a specific enzyme called reverse transcriptase (RT). The RT enzyme helps specific cells copy their DNA and replicate themselves through reverse transcription.
Retroviruses such as HIV (human immunodeficiency virus) utilize the RT enzyme to duplicate and fuel the progression and expansion of the virus inside the body. TDF doesn’t kill the virus, so it cannot cure HIV/AIDS. However, by blocking the RT enzyme, Viread and other TDF drugs effectively prevent the HIV cells from multiplying. When used in combination with other drugs, TDF can not only stop HIV from growing but reduce the amount of HIV in the system.
TDF was developed and patented by Gilead Sciences Inc., a biopharmaceutical company based in Foster City, California. In 2001, the Food and Drug Administration approved TDF for use in the treatment of HIV infection, and Gilead released the drug under the brand name Viread. Viread was a groundbreaking drug, and soon after its release in the U.S., hundreds of thousands of people living with HIV-1 were using it to manage their condition. If left untreated, HIV (which eventually develops into AIDS) can destroy the body’s immune system and be fatal. Viread drastically changed the outlook and prognosis of countless HIV patients.
Unfortunately, the fantastic benefits of Viread came with a fairly heavy price tag. TDF is not easily absorbed into the body. As a result, users must take very high doses of the drug for it to have any effect. This meant that Viread had a long list of potential side effects, including problems with the kidneys and loss of bone density.
Gilead Intentionally Delayed Release of a Safer, Alternative Drug to Maximize Profit
Gilead is not being sued simply because Viread can cause kidney failure and bone damage. After all, Viread was saving lives, so unless these would be acceptable risks, assuming there was no alternative drug that didn’t damage the kidneys or bones. Gilead is now being sued because there was a safer alternative drug.
By the time Viread was initially released on the market in 2001, researchers at Gilead were already aware that the drug was flawed and could destroy the kidneys and bones. Just as Viread was being marketed as a new “wonder drug,” the research & development team at Gilead was working on a new drug called tenofovir alafenamide fumarate (TAF).
The main advantage of TAF was how it was metabolized inside the body. The inherent problem with Viread and TDF was that only some of the drug was metabolized by the HIV cells, while the remainder ended up as a toxin in the gastrointestinal tract. By contrast, TAF is only metabolized by the HIV cells, so no toxic leftovers end up in the G.I. tract. This made TAF a much safer, much more effective alternative to TDF.
As early as 2001 or 2002, Gilead was fully aware that its new TAF drug was much safer than TAF. TAF was not only safer, but Gilead’s clinical studies suggested that it was also better at suppressing HIV than TDF. The problem was that this discovery presented a business dilemma for Gilead.
The company was already making billions on Viread. Plus, Viread was under patent protection for 11 years (meaning no other companies could make generic versions of Viread). If Gilead announced in 2002 that the new TAF drug was not only better but much safer than Viread, it would immediately kill the market for Viread. Gilead would have lost a decade of patent-protected sales of Viread worth billions in revenue.
Rather than cut off the Viread profits prematurely, Gilead made a deliberate business decision to delay the release of the safer TAF drug until the patent protection on Viread was almost over. Gilead probably could have released the safer TAF drug as early as 2004. Instead, Gilead suppressed study results indicating TAF was safer and waited until 2015 (just before the expiration of the Viread patent) to release this much safer HIV drug.
Gilead Intentionally Hiked Viread Prices to Boost Sales of its New TAF Drugs
Gilead not only deliberately delayed the release of its safer drug to maximize profits, but it also manipulated prices to prompt Viread patients to switch to the new TAF drugs. When Gilead finally released its newer, safer TAF drugs on the market in 2015, there were already hundreds of thousands of HIV patients on Viread prescriptions. The patent on Viread was expiring, so Gilead wanted doctors and patients to stop taking Viread and start taking the new TAF drugs instead (which would be patent-protected for another decade).
To “motivate” patients and doctors to switch from Viread to the newly released TAF drugs, Gilead very deliberately jacked up the prices on Viread soon after the release of its new drugs. The older TDF drugs like Viread suddenly became much more expensive than Gilead’s newly released TAF drugs.
Gilead Put Profits Over Safety, Putting Patients at Risk
In April 2019, a product liability lawsuit was filed against Gilead in California, alleging that over 50 individual plaintiffs were exposed to significant safety risks from using Viread and Gilead’s other TDF drugs. The lawsuit alleges that Gilead had a legal duty to immediately release the TAF drugs once it became aware that they were safer alternatives to the existing TDF drugs. Gilead had a choice between maximizing profits or maximizing patient health and safety. They chose to prioritize profits.
By intentionally delaying the release of the safer alternative TAF drugs, Gilead exposed patients to 10 additional years of toxins known to damage the bones and kidneys.
Do You Have an HIV Drug Lawsuit Against Gilead?
The lawsuits filed against Gilead in April are just the first of what are likely to be thousands of additional cases around the country. Our firm is currently seeking clients who may have claims against Gilead involving its HIV drugs. Potential plaintiffs against Gilead would include anyone taking a prescription TDF drug from 2001 to 2015. Brand names for Gilead’s TDF drugs include:
Anyone who took one of these drugs for the treatment of HIV or hepatitis and has experienced health problems involving their kidneys or bones may be entitled to financial compensation.
Miller & Zois Is Currently Accepting New HIV Drug Cases
Our HIV drug lawyers handle HIV lawsuits on a contingency fee basis. This means you only pay something if you win a settlement or jury payout, and there are no out-of-pocket costs to hire our law firm.
If you took any of the HIV drugs mentioned above and think you may have a lawsuit against Gilead, please contact the product liability lawyers at Miller & Zois for a free consultation. You can reach us by phone at 800-553-8082 or contact us online.