Gilead pays $40M to settle claims over delayed safer HIV meds

Gilead Sciences, a prominent pharmaceutical company, is dealing with ongoing litigation in California over allegations that it delayed the release of safer HIV medications. The company has proposed a $40 million settlement to address the claims of 2,625 patients who argued that Gilead’s older HIV drugs caused unnecessary kidney and bone damage. These patients are part of a larger group involved in multiple lawsuits against the company.

The litigation focuses on Gilead's earlier tenofovir disoproxil fumarate (TDF)-based medications, such as Viread and Truvada, compared to its newer tenofovir alafenamide fumarate (TAF)-based drug, Vemlidy. In a filing from 2023, the plaintiffs accused Gilead of failing to provide adequate warnings about the risks of the TDF-based drugs and of prioritizing profits over patient safety by delaying the release of the safer TAF-based medications.

According to Gilead, the proposed $40 million settlement is aimed at "avoiding the cost and distraction of litigating these cases" and is not an admission of any wrongdoing or liability. The company stated that the settlement is intended to resolve claims from the "overwhelming majority" of the plaintiffs, although some individuals may choose not to participate or may not be included in the agreement. In such cases, Gilead has promised to continue defending itself vigorously.

Gilead emphasized that its commitment to improving the lives of people with HIV has never wavered. In a statement, the company noted that the long-term safety of TAF was not known or predictable back in October 2004 when it decided to prioritize the development of TDF medications. The settlement requires the agreement of 98% of the plaintiffs in order to proceed.

This proposed settlement is separate from the ongoing California state litigation, which is currently under review by the California Supreme Court. Gilead is expected to submit its initial briefing by July 15, following a decision by the court to review a recent appeals court ruling. The appeals court ruling, issued in January, permitted a unique negligence claim by the plaintiffs, who argued that Gilead's early testing of TAF indicated it could be safer than TDF, but the company delayed further development to maximize profits from its TDF-based drugs.

Approximately 24,000 TDF users have joined the legal action, contending that Gilead's actions were negligent and fell outside the scope of reasonable care. They argue that while TDF itself is not defective, Gilead's delay in releasing the safer TAF-based drugs caused unnecessary harm. Gilead, however, maintains that it cannot be held liable for harm caused by a product that is not proven to be defective.

A spokesperson for Gilead previously stated that the appeals court ruling "upended established California law" by holding a manufacturer liable for a non-defective product, which could have widespread negative consequences across various fields of innovation and manufacturing. The company has been facing similar accusations since 2016, when it successfully defended itself against claims that it manipulated TDF prices and delayed TAF to prevent generic competition.

In summary, Gilead Sciences is navigating a complex legal landscape as it attempts to resolve multiple lawsuits related to its HIV medications. The proposed $40 million settlement marks a significant step in addressing the claims of affected patients, while the broader legal battle continues in California's highest courts.