Skip to main content
Mass Tort Settlements

Tenofovir Disoproxil Fumarate (TDF) Litigation: An Update

By December 23, 2024January 28th, 2025No Comments

The ongoing litigation against Gilead Sciences over its HIV drugs containing tenofovir disoproxil fumarate (TDF) has reached a significant milestone. This complex legal battle, which began in 2018, has seen thousands of plaintiffs seeking justice for alleged injuries caused by TDF-containing medications. Let’s delve into the key developments and current status of this high-profile litigation.

Background of the TDF Litigation

TDF is a compound used in several HIV medications manufactured by Gilead Sciences, including Truvada, Viread, Atripla, Complera, and Stribild. These drugs have been widely prescribed for HIV treatment and prevention. However, plaintiffs allege that Gilead knew about the potential toxic effects of TDF on patients’ kidneys and bones before the drugs went to market.

The core of the plaintiffs’ argument is twofold:

  1. Gilead allegedly failed to adequately warn patients and healthcare providers about the risks associated with TDF.
  2. The company is accused of intentionally delaying the development and release of a safer alternative, tenofovir alafenamide (TAF), to maximize profits from TDF-containing drugs.

Key Developments in the Litigation

Consolidation of Cases

Since May 2018, thousands of TDF drug users have filed lawsuits over injuries they experienced. These cases have been consolidated into two main groups:

  1. Federal cases in the U.S. District Court for the Northern District of California
  2. State cases in California Superior Court

Recent Settlement Agreement

On June 4, 2024, Gilead Sciences announced a significant development in the federal TDF litigation. The company reached an agreement in principle to settle approximately 2,625 claims in the federal litigation for up to $40 million. This settlement is subject to at least 98% of eligible plaintiffs participating.

Key points of the settlement:

  • It’s a one-time payment to resolve claims in the federal litigation.
  • Gilead emphasizes that this settlement is not an admission of liability or wrongdoing.
  • The company states it entered the agreement to avoid the cost and distraction of continued litigation.

Ongoing State Litigation

While the federal settlement marks progress, it’s important to note that it does not affect the California state TDF litigation. This separate set of cases is currently pending review by the California Supreme Court. In February 2024, Gilead petitioned the California Supreme Court to challenge a lower court’s decision that allowed a negligence claim based on alleged delay in developing a new product.

Legal Claims and Allegations

The lawsuits against Gilead include several key allegations:

  1. Strict Liability (Design Defect & Failure to Warn)
  2. Negligence and Gross Negligence
  3. Fraud by Omission
  4. Violations of various state consumer protection laws

Plaintiffs claim that Gilead:

  • Knew about TDF’s toxicity risks before market approval
  • Failed to adequately warn about kidney and bone damage risks
  • Intentionally withheld the safer TAF design to protect TDF sales and extend profits

Health Risks and Injuries

Plaintiffs in the TDF litigation report various health issues allegedly caused by the medications, including:

  1. Kidney problems (chronic kidney disease, kidney failure)
  2. Bone density loss (osteoporosis, increased fracture risk)
  3. Lactic acidosis
  4. Liver damage

Scientific Evidence

Recent studies have further solidified the link between TDF exposure and health risks. For instance, research has shown an increased risk of kidney and bone-related issues in patients using TDF-containing medications compared to those on newer formulations.

Challenges in the Litigation

The TDF litigation faces several challenges:

  1. Proving direct causation between TDF use and specific health issues
  2. Balancing the benefits of TDF in HIV treatment against its potential risks
  3. Addressing Gilead’s defense that the long-term safety of TAF was unknown when TDF development continued

Looking Ahead

As the litigation progresses, several key events are on the horizon:

  1. Implementation of the federal settlement agreement
  2. California Supreme Court review of the state litigation
  3. Potential additional settlements or trials for non-settling plaintiffs
  4. Ongoing scientific research into the long-term effects of TDF exposure

Implications for Patients and Healthcare Providers

This litigation highlights the importance of informed consent and thorough risk assessment in medical treatment. It also underscores the need for pharmaceutical companies to prioritize patient safety and transparency in drug development and marketing.

TDF Litigation

The TDF litigation against Gilead Sciences represents a complex intersection of pharmaceutical innovation, corporate responsibility, and patient rights. While the recent federal settlement marks a significant step, many cases remain unresolved, particularly in the California state courts. As the legal proceedings continue, it remains crucial for affected individuals to stay informed about their rights and potential compensation.

How LitPRO Can Help with TDF Litigation

At LitPRO, we understand the complexities of mass tort litigation, especially in cases involving pharmaceutical products like TDF drugs. Our team of experienced professionals specializes in lien resolution and can help law firms navigate the challenges of managing multiple claimants in complex litigation.

If your firm is handling TDF cases or other mass tort litigation, don’t let lien resolution complexities slow down your settlements. Contact LitPRO today to learn how our expertise can streamline your processes, ensure compliance, and maximize recoveries for your clients. Let us be your partner in achieving optimal outcomes in these high-stakes cases.

With our deep understanding of healthcare lien laws and regulations, insider knowledge of government processes, and advanced data management capabilities, LitPRO is uniquely positioned to support your firm in efficiently resolving liens and moving your TDF cases forward. Don’t navigate these complex waters alone – reach out to LitPRO and let us help you secure the best possible outcomes for your clients affected by TDF medications.