Truvada Lawsuit

Our law firm is taking on new Truvada lawsuits and other HIV drug injury lawsuits involving kidney or bone injuries in all 50 states.

HIV drugs containing tenofovir disoproxil fumarate (TDF) are, we believe, putting patients at risk. This has resulted in HIV drug lawsuits from victims alleging kidney disease and failure, bone density loss, bone injuries, and other side effects.

Viread® and Truvada® are two of the first brand-name drugs developed by Gilead Sciences to treat 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 HIV.

When they first came on the market in the early 2000s, Viread and Truvada were touted as significant advancements in the fight against AIDS. And they were.

It soon became apparent, 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. You can get a free online consultation today.

Let’s begin with the latest Truvada lawsuit update. We have a big one in January 2024.

Truvada February 2024 Update

Truvada lawsuits continue to move forward.

The litigation, which includes over 20,000 plaintiffs in a California coordinated proceeding and several thousand in federal court, will focus on Gilead’s alleged conduct in deliberately delaying the development of TAF for financial motives. The case is going back to trial court, and hopefully, we will push forward toward trials in 2024.

Truvada January 2023 Update

Big news came out today.

Gilead Sciences had filed a motion for summary judgment centered on the FDA’s approval of TDF-containing medications and the assertion that federal law preempts the negligence claim, as they did not allege TDF to be defective.

Admittedly, this sounds a little goofy, right.  But it makes sense.  At the core of every Truvada lawsuit is the claim that plaintiffs claim they were harmed by Gilead’s early HIV drugs and argue that the company was negligent in withholding the development of TAF, thus denying them and their physicians access to a safer option.

The case went to an appeals court in California. Today, in a 65-page opinion, the California Court of Appeal found that the plaintiffs’ negligence theory is viable despite not contending the drug they used was inherently flawed. The court is unanimously green-lit the Truvada lawsuits.

The court discussed whether a drug manufacturer has a duty of care regarding commercializing safer drug alternatives. It concluded that a manufacturer’s duty to exercise reasonable care can extend beyond not marketing a defective product. This includes instances where harm results from a failure to exercise reasonable care, even if the product causing harm is not considered “defective.”

Fradulent Concealment Count Rejected

The plaintiffs did suffer one loss. The court reversed the decision regarding fraudulent concealment claims. The plaintiffs’ argument that Gilead fraudulently covered up the relative safety of TAF drugs was dismissed.

Truvada December 2023 Update

We are still waiting for rulings in the Truvada HIV lawsuits in California.  The court ordered supplemental briefing in the dispute over the legal standards for determining when a prescription drug is considered “defective.” During oral arguments, contrasting views were presented on whether the risk-benefit analysis of a drug should be conducted independently of any alternative treatments or if the availability of a safer alternative should be considered.

The briefs address several key points, including the proper test for a defective drug under the precedent set by Brown v. Superior Court – a 1988 ruling from the California Supreme Court – and whether a safer alternative design must work equally well for all patients or solely for the plaintiffs. The court is also seeking clarification on whether a safer alternative is sufficient to establish that a drug is defective, which could imply a negligent design defect claim.

Additionally, the court is interested in whether plaintiffs are maintaining a cause of action for negligent design defect and how this relates to the decision by the manufacturer to market a particular drug design. The briefs must also discuss the knowledge or presumed knowledge by Gilead Sciences, the manufacturer, regarding the safety of Truvada compared to its alternatives.

Lastly, the court questioned whether the Rowland v. Christian framework applies to the plaintiffs’ negligence claim and if an exception to the duty of care should be recognized.

Hopefully, the court will give favorable rulings soon to keep this litigation on track.

Truvada November 2023 Updates

Gilead’s attempt to disengage from the HIV drug lawsuits collapsed last month in a federal court in California. The judge determined that Gilead cannot avoid design defect and warning-related claims in the federal court litigation, which accuses the company of prioritizing profits over the development of safer HIV drugs. Gilead’s goal was to secure a decisive ruling that federal law precludes strict liability claims alleging that the TDF drugs were defectively designed. Additionally, the core of the failure to warn claims, which our legal team considers the focal point of these Gilead lawsuits, has also withstood Gilead’s argument that warning claims should be dismissed as a matter of law.

Truvada September 2023 Updates

• The first big Truvada lawsuit set for trial will be in California on January 24, 2024. This is a bellwether trial.  So if there is a large jury payout, it will impact future Truvada settlement amounts.
• Gilead is asking a California appellate court to dismiss claims by over 24,000 patients claiming that the biopharmaceutical company should be liable for deliberately delaying a new, safer HIV drug to maximize profits. At oral argument yesterday, lawyers for Gilead claimed that “no court in any state has ever recognized” a legal duty for a pharmaceutical company to release safer drugs promptly. The trial court has already rejected this argument in denying Gilead’s motion to summary judgment. Gilead is now claiming that this “threatens to radically transform mass tort litigation … allowing unprecedented ‘failure-to-innovate’ claims.”

Truvada August 2023 Updates

• Our office has seen a significant uptick in the volume of calls and inquiries about Truvada and Viread lawsuits in the weeks following the publication of the recent article in the New York Times. The article generated more awareness and attention and essentially substantiated the claims made in the Truvada lawsuits that Gilead slow-walked a newer, safer drug to boost profits.

Truvada July 2023 Updates

• There is still no Truvada class action lawsuit, and our lawyers do not expect one anytime soon.  But Truvada lawsuits are still being filed.  Johnson, et al. v. Gilead Sciences Inc. is a new suit filed in the Central District of California involving the HIV drug Truvada. This comprehensive 81-page complaint meticulously outlines the timeline of Truvada’s development alongside other HIV medications by Gilead. The suit alleges that Gilead failed to properly inform physicians and patients of the genuine risks associated with their drugs.

In particular, the plaintiffs contend that inadequate warning labels hindered doctors from taking suitable measures to scrutinize patients for potential bone and kidney complications. The plaintiff’s TDF lawsuit claims he suffered from kidney disease, bone demineralization, and bone fractures.

Meanwhile, Gilead won a huge antitrust trial last month when A jury decided that the drug company didn’t pay to delay competing HIV  drugs from entering the market.

• Our lawyers’ view of this litigation is that more than many other mass tort lawsuits, Gilead’s conduct was exceedingly awful.  We alleged from the beginning that Gilead slow-walked a better HIV drug to maximize profits.  This was dismissed as plaintiffs’ lawyers will say anything to make a buck.  Well, look at this New York Times article, which talks about how reckless Gilead was with patient safety… to make a buck. That tracks.

Truvada May 2023 Updates

5/17/2023: Gilead Sciences Inc. embarked on the first of two summary jury trials yesterday, a significant step in the ongoing litigation involving accusations of hidden side effects of its anti-HIV drug Truvada. These nonbinding trials allow both parties to present their cases in an unrecorded, private setting. The development comes after allegations against Gilead that started in 2018, with more than 3,500 patients joining the legal battle as plaintiffs.

5/15/2023: Patients suing Gilead Sciences Inc. over its anti-HIV drug Truvada have implored a California federal judge to prevent Gilead from dismissing hundreds of plaintiffs, claiming they have fulfilled discovery demands. Gilead had requested the dismissal of these plaintiffs for allegedly not fully completing court-required fact sheets. However, the plaintiffs maintain they have adequately completed these sheets. Gilead, in turn, insists that the legal counsel for the plaintiffs is presenting baseless allegations and seeks to drop around 650 plaintiffs who haven’t supplied the necessary information to support their accusations. The plaintiffs argue that Gilead manufactured its HIV drugs with a harmful substance when a safer alternative could have been made available.

In a related/not related development, Gilead has emerged victorious from its 4-year battle with the federal government over the rights to sell the drugs Truvada and Descovy as pre-exposure treatments to prevent HIV. According to the government, the CDC invested taxpayer money in researching and developing the use of a Truvada and Descovy regimen to prevent HIV and obtained a patent for this regime. In 2019, the U.S. government filed a lawsuit against Gilead, claiming that the company violated its patent rights by selling the Truvada Descovy combination as an HIV preventative. Following a jury trial in Delaware, however, a jury rejected the government’s case and issued a defense verdict in favor of Gilead.

Truvada Lawsuit January 2023 Update

Truvada lawsuits continue to be filed around the country.  Days before the new year, a new Truvada lawsuit was filed in federal court in the Northern District of California. The case, Sharp v. Gilead Sciences, involves over 20 plaintiffs suing Gilead for “unreasonably dangerous” TDF drug claims, including Viread, Truvada, Atripla, and/or Stribild.  The TFF lawsuit alleges:

• Gilead knew before Viread was approved that TDF posed a significant safety risk
• Gilead’s knowledge of  the consequences of TDF toxicity grew as patients’ kidneys and bones were damaged by the TDF drugs
• Before Gilead developed Stribild, it knew that renal adverse events were more likely when patients took TDF as part of a boosted regimen
• Before Gilead developed each of the TDF drugs, it knew that renal adverse events were more likely when patients took TDF as part of a boosted regimen
• Gilead withheld its safer TAF design to protect its TDF sales and extend profits on its HIV franchise (juries will go ballistic if they accept this allegation)
• Gilead knowingly designed its TDF drugs to be unreasonably dangerous and unsafe to patients’ kidneys and bones
• Gilead failed to warn patients’ doctors about the risks of TDF adequately

The most awful allegation is the claim that Gilead withheld a safer design:

Before it obtained approval to market Viread and Gilead’s subsequent TDF Drugs, Gilead also knew that it had discovered a safer tenofovir prodrug, tenofovir alafenamide fumarate (“TAF”). TAF is absorbed into the cells HIV targets much more efficiently than TDF.

As a result, TAF can be administered at a dramatically reduced dose compared to TDF but still achieve the same or higher concentrations of active tenofovir in the target cells. Because TAF can be administered at a much lower dose than TDF, its use is associated with less toxicity and fewer side effects. A 25 mg dose of TAF achieves the same therapeutic effect as a 300 mg dose of TDF, with a better safety profile.

Despite knowing that TAF could be given at a much lower, safer dose, Gilead designed Viread, Truvada, Atripla, Complera, and Stribild to contain TDF rather than safer TAF. Falsely claiming that TAF was not different enough from TDF, Gilead abruptly shelved its TAF design in 2004.

However, as John Milligan, Gilead’s President and Chief Executive Officer, later admitted to investment analysts, the real reason Gilead abandoned the TAF design was that TAF was too different from TDF. Once Gilead’s first TDF product, Viread, was on the market, Gilead did not want to hurt TDF sales by admitting that its TDF-based products were unreasonably and unnecessarily unsafe.

Truvada Lawsuit December 2022 Update

You have seen an increase in lawyer advertising for Viread, Truvada, and other TDF injuries in recent weeks.  Why?  There is renewed hope in some quarters of HIV drug settlements in 2023 or 2024.  We will see.

Truvada Lawsuit October 2022 Update

Over 20 individual plaintiffs recently filed a new Truvada product liability lawsuit against Gilead Sciences. The case (Harlan et al. v. Gilead Sciences, Inc., 4:22-cv-03156-JST) was initially filed in the Middle District of Florida and transferred to the Northern District of California after Gilead filed a change of venue motion.

The Complaint alleges that before Gilead released Truvada on the market, it was already aware that the active compound in the drug (TDF) posed a safety risk to patients’ kidneys and bones and that long-term use would cause serious health problems. The Complaint further alleges that Gilead had developed a safer alternative to Truvada but intentionally shelved that safer drug for over ten years to maximize profits under the Truvada patent.

Finally, the Complaint asserts that in addition to wrongfully withholding the safer alternative drug, Gilead failed to adequately warn doctors and patients about the true risks of Truvada. Specifically, the plaintiffs claim that the warnings for Truvada were too weak and failed to disclose the risk of bone and kidney damage, thereby preventing doctors from detecting early signs of Truvada toxicity. According to the Complaint, Gilead had numerous opportunities to strengthen the warning labels for Truvada and failed to do so.

Each of the individual plaintiffs in Truvada lawsuits against Gilead in the MDL have alleged strict liability, negligent failure to warn, and fraudulent concealment. Each plaintiff asserts specific physical injuries incurred because of taking Truvada. These injuries include chronic kidney disease, total kidney failure, bone demineralization, osteoporosis, and bone fractures.

Since being transferred to the Northern District of California, this case has been consolidated for pretrial purposes with several other cases involving Truvada product liability claims against Gilead.

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 particular enzyme called the RT enzyme to replicate its DNA and duplicate virus cells through reverse transcription.

TDF can slow or stop the growth or progression of HIV by blocking the RT enzyme that the virus cells use to duplicate themselves. This doesn’t kill the virus but effectively freezes it and prevents further progression. When TDF is combined with other drugs, it can reduce the HIV viral load in the system.

Truvada is also approved for use as a preventive measure against HIV infection in at-risk adults and adolescents who are HIV-negative. When taken consistently every day, PrEP can significantly lower the risk of contracting HIV through sex.

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 three 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 daily for HIV treatment.

Sadly, TDF drugs had a 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 a hefty 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 self-evident 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, bone fractures, and severe 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 was more effective and much safer. This newer, safer version of TDF was called TAF (tenofovir alafenamide fumarate), which functioned like TDF but was absorbed into HIV more efficiently.

The better absorption of TAF by the HIV cells meant TAF was not only better at slowing the growth of the HIV, but it was also far less toxic. TAF was still toxic to bones and 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 ten years of patent-protected revenues for these drugs, so Gilead purposefully withheld 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.  Our prediction? This will impact Truvada lawsuit settlement amounts when all is said and done.

Admittedly, it is a novel claim.  The lawsuit is not about a product defect.  No one is arguing there should have been a Truvada recall or even that the product was negligently designed.  The claim is you had a better drug – you knew it was a better drug – and you choose to keep a worse product on the market to try to make more money.  It may be novel but it is grounded in very basic tort law and it looks like these claims will be allow to move forward in California with the new ruling in 2024.

Viread and Truvada Product Liability Lawsuits

Since 2018, many 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.

Truvada lawsuits have accused 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 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. Common tort claims in these MDL class action lawsuit 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.   (Gilead’s counsel has pointed out to us that “plaintiffs in the JCCP, which comprise more than 90% of all plaintiffs in this litigation as a whole, no longer contend that the TDF medications were defectively designed.”)

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. However, that motion was subsequently withdrawn, 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 initial TDF lawsuits were being filed in the Northern District of California, where Gilead is headquartered. In  April 2019, these cases were consolidated before Judge Jon S. Tigar for pretrial purposes. After that, 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.

These venue transfers resulted in the emergence of a purely “organic” MDL, with about 40 cases involving just over 2,200 individual plaintiffs. Some lawsuits in other federal courts still have not been transferred. Many TDF lawsuits are also pending in California state courts, where the California version of a mass-tort MDL has been established.

The hope for plaintiffs in this or any MDL is to win some big bellwether trial and hope to force Gilead into making reasonable Truvada lawsuit settlement offers.  Because the best way to increase settlement about in the HIV drug cases is huge verdict that cost the defendants money and prestige.

FAQs

When Will TDF Lawsuit Be Settled?

The first test trial is set for January 2024 in California and we could potentially see a negotiated settlement by the end of the year. That is probably more of a hope than a real prediction but it is hard to imagine Gilead letting one of these case go to trial because the publicity continues to highlight their conduct in the case.

Do you qualify for a Truvada lawsuit?

Anyone who took Truvada (or another TDF drug such as Viread) for the treatment of HIV for six months or 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 the 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.