Viread® and Truvada® are 2 of the first brand name drugs developed by Gilead Sciences for the treatment of HIV. Viread and Truvada both use tenofovir disoproxil fumarate (TDF), a new type of antiviral drug that was one of the first effective treatments for slowing the HIV virus.
When they first came on the market in the early 2000s, Viread and Truvada were touted as major advancements in the fight against AIDS. It soon became obvious, however, that for a certain percentage of patients TDF drugs resulted in permanent health consequences. Specifically, TDF drugs like Viread and Truvada are highly toxic to the kidneys and bones and can cause permanent kidney failure and bone fractures.
Patients who used TDF drugs like Viread and Truvada are now filing product liability lawsuits against Gilead. If you took a Gilead HIV drug and suffered kidney damage or bone problems, you may be entitled to financial compensation.
About TDF Drugs Viread and Truvada
Viread and Truvada are brand names for unique antiviral drug called TDF (tenofovir disoproxil fumarate). TDF was one of the first effective medical treatments for Human Immunodeficiency Virus (HIV). The HIV virus utilizes a special enzyme called the RT enzyme to replicate its own DNA and duplicate virus cells through a process called reverse transcription.
TDF can slow or stop the growth or progression of the HIV virus by blocking the RT enzyme that the virus cells use to duplicate themselves. This doesn’t kill the virus, but it effectively freezes it and prevents further progression. When TDF is combined with other drugs it can actually reduce the HIV viral load in the system.
The biopharmaceutical company Gilead Sciences Inc., developed and patented TDF and the very first TDF drug, Viread, was approved by the FDA in 2001. A second TDF drug, Truvada, was released 3 years later in 2004. Truvada and Viread were viewed as groundbreaking drugs when they first came out and they were the only real treatment option for people living with HIV. Within a few years, millions of patients were taking Viread or Truvada on a daily basis for HIV treatment.
Sadly, TDF drugs had a very significant downside that became apparent soon after Viread and Truvada were released. As beneficial as these new drugs were for HIV patients, they came with an extremely heavy price tag in terms of side effects. TDF is not easily absorbed into the body and requires very high doses to be effective. This made TDF drugs potentially harmful to the bones and kidneys of users.
Although kidney problems and loss of bone density were listed as side effects, it was soon very obvious that these side effects were much more frequent and severe than suggested by Gilead. Various clinical studies have since established that Viread, Truvada, and other TDF drugs cause osteoporosis and bone fractures as well as very serious kidney damage including permanent kidney failure.
Gilead Purposefully Withheld a Safer Alternative Drug
By the time Truvada was approved by the FDA in 2004, the R&D team at Gilead was already working on a new version of TDF that more effective and much safer. This newer, safer version of TDF was called TAF (tenofovir alafenamide fumarate) which functioned in the same way as TDF but was absorbed into HIV more efficiently.
The better absorption of TAF by the HIV cells meant that TAF was not only better at slowing the growth of the HIV virus, but it was also far less toxic. TAF was still toxic to bones kidneys, but its lower dose requirements and other properties made it less harmful than TDF. Gilead could have released TAF as early as 2004 or even 2002, but at that particular time, the company was already generating billions in revenue from Viread and later Truvada. Moreover, Viread and Truvada were under patent protection for another decade.
If Gilead had immediately released the newer, safer TAF it would have killed the marketability of their existing TDF drugs like Viread and Truvada. This would have effectively ended 10-years of patent-protected revenues for these drugs, so Gilead purposefully decided to withhold the release of TAF. Ultimately, Gilead did not release TAF until shortly before the patent on Viread was about to expire. Gilead chose to maximize profits at the direct expense of patient safety.
Viread and Truvada Product Liability Lawsuits
Since 2018, large number of product liability lawsuits have been filed against Gilead users of TDF drugs like Truvada and Viread who suffered bone fractures, kidney failures and other health consequences.
Every Truvada lawsuit accuses Gilead of manufacturing TDF drugs that were unreasonably and unnecessarily toxic to patients’ and posed safety risks to the kidneys and bones. These HIV drug lawsuits also allege something that absolutely awful. The claim is that Gilead intentionally withheld a better, safer version of the drug for years to boost profits at the expense of patient health.
The Viread and Truvada lawsuits also contend that Gilead gave inadequate warnings about the true level of risk associated with the TDF Drugs. The most common tort claims in these lawsuits are: (1) Strict Liability (Design Defect & Failure to Warn), (2) Negligence and Gross Negligence, (3) Fraud by Omission, and (4) violations of various state consumer protection laws.
Any Viread and Truvada lawsuit against Gilead stands alone. There is no federal class-action MDL like many mass tort prescription drug cases. In 2019, a motion was filed with the Judicial Panel on Multidistrict Litigation asking the panel to consolidate the TDF lawsuits into a new MDL. That motion was subsequently withdrawn, however, and an MDL was never formally initiated.
A non-official MDL for the Viread and Truvada lawsuits has formed organically, however, in the Northern District of California (N.D. Cal.). Most of the initial TDF lawsuits were being filed in the Northern District of California, which is where Gilead is headquartered. In April 2019, these cases were consolidated together before Judge Jon S. Tigar for pretrial purposes. Thereafter, new TDF lawsuits filed against Gilead in other federal districts have been regularly transferred to the Northern District of California and then consolidated before Judge Tigar for efficiency.
The end result of these venue transfers has been the emergence of a purely “organic” MDL that has about 40 cases involving just over 2,200 individual plaintiffs. There are still a number of lawsuits in other federal courts that have not been transferred. There are also a large number of TDF lawsuits pending in California state courts, where the California version of a mass-tort MDL has been established.
When Will TDF Lawsuits Against Gilead Settle?
The first test trial is set for July 2022 and we could potentially see a negotiated settlement by the end of the year.
Do you qualiffy for a Truvada lawsuit?
Anyone who took Truvada (or another TDF drug such as Viread) for the treatment of HIV for a period of 6 months of more and subsequently suffered kidney damage or bone fractures may be eligible to file a Truvada lawsuit.
Contact Us About a Viread or Truvada Lawsuit
If you took Gilead TDF drug for HIV and think you may have a Truvada or Viread lawsuit, please contact the product liability lawyers at Miller & Zois for a free consultation. You can reach us by phone at 800-553-8082 or online.