Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M

Gilead indicates that it has reached an agreement in principle to pay $40 million to settle 2,625 Truvada lawsuits, Atripla lawsuits, Stribild lawsits, Viread lawsuits and Complera lawsuits pending in the the federal court system, which involve allegations that users suffered kidney problems and bone fractures because the company sat on the development of safer versions of the HIV drugs, as part of a scheme to increase profits.

Although the Gilead settlement is an important first step toward resolving litigation over the sale of drugs containing the compound tenofovir disoproxil fumarate (TDF), the deal does not impact tens of thousands of lawsuits over the HIV drugs pending in California state court, where the vast majority of claims were filed.

Both the state court and federal litigation involves similar allegations, indicating that Gilead intentionally sold more toxic and dangerous versions of it’s TDF-Based drugs, including Truvada, Viread, Atripla, Complera and Stribild.

Although the company promoted the drugs as safe and effective, plaintiffs indicate that the drug maker was aware of a safer alternative design, involving the compound tenofovir alafenamide fumarate (TAF), which reduces the risk of bone problems kidney damage and other side effects. However, Gilead allegedly delayed development of TAF-based HIV drugs until the existing TDF-based drugs neared the end of patent protections, extending the drug maker’s monopoly over the market by avoiding competition from generic competitors.

On June 4, Gilead issued a press release announcing that it has reached a deal to settle lawsuits pending in the U.S. District Court for the Northern District of California, with a payout of $40 million that may resolve about 2,625 claims.

“Gilead expects that the settlement will resolve the claims of the overwhelming majority of plaintiffs in the federal TDF litigation,” the press release states. “However, there may be some plaintiffs in the federal TDF litigation who do not elect to participate in the settlement and there are others who are not part of this agreement. As to those plaintiffs, Gilead will continue to vigorously defend itself.”

For the agreement to be finalized, it must be signed onto by 98% of eligible plaintiffs and approved by a federal judge. Gilead indicates that the settlement is not an admission of guilt.

HIV Drug Lawsuits in California State Court Remain Unresolved

Following the settlement, Gilead will continue to face an estimated 24,000 lawsuits that are currently centralized in the California state court system, where individual cases may soon start to go before juries.

Gilead previously sought to have those lawsuits dismissed, arguing that plaintiffs must prove the drugs were defective to pursue negligence claims, and that the company should not be held liable for delaying development of a newer version. After a lower court rejected Gilead’s arguments, the manufacturer appealed the ruling to the Court of Appeals for the State of California, which cleared the HIV drug lawsuits to move forward in a decision in January 2024.

The appeals court’s decision will allow the California state court judge presiding over the litigation to move forward with a series of “bellwether” trials, which will allow individual representative cases to go before a jury, to help gauge how they may respond to certain evidence and testimony that will be repeated throughout the claims.

While the outcome of these early test trials will not be binding on other plaintiffs, the lawsuit payout awarded may influence the amount Gilead must pay to settle TDF-based HIV drug lawsuits, and avoid the need for each individual claim to go before a jury in California state court.