Lawsuits Over Truvada, Other TDF-Based HIV Drugs Cleared To Move Forward By Appeals Court

A California appeals court has determined that Gilead can face liability for failing to develop safer versions of its controversial HIV drugs, even if users who suffered kidney damage and bone fractures do not establish that the medications were defective.

Over the past few decades, Gilead has introduced a series of HIV drugs containing the compound tenofovir disoproxil fumarate (TDF), including Truvada, Viread, Atripla, Complera and Stribild, promoting the drugs them as safe and effective HIV treatments. However, thousands of HIV drug lawsuits have been filed by former users of the medications who suffered devastating bone problems, kidney damage and other side effects.

The lawsuits do not allege that the TDF-based drugs are defective, but rather that Gilead intentionally sold more toxic and dangerous versions of the medications for years, even after it was aware that a safer alternative design existed, involving the use of the compound tenofovir alafenamide fumarate (TAF), which could be taken at substantially lower doses and be equally as effective.

Rather than developing and introducing safer TAF-based versions of the drug, plaintiffs indicate that Gilead continued to market and promote the more toxic TDF-based version for years, waiting until patent protections began to expire before working to introduce TAF-based versions of the medications, allowing the drug maker to avoid competition from generic competitors and extend its monopoly of the HIV treatment market.

The manufacturer now faces about 24,000 lawsuits over the HIV drugs in California state court, each raising similar allegations that Gilead placed its desire for profits before consumer safety, by continuing to sell and promote more toxic formulations.

Gilead sought to have the 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 denied Gilead’s motion, the manufacturer appealed the ruling to the Court of Appeals for the State of California.

In an opinion (PDF) issued on January 9, the California intermediate appellate court again rejected Gilead’s argument, confirming that the legal duty of drug manufacturers can, in certain circumstances, extend beyond the duty to not market a defective product.

“Developing and selling a life-saving drug, even one with potentially severe side effects, is morally praiseworthy. But that is not the conduct at issue; Gilead seeks an exception that would allow, in a sense, the opposite conduct: a manufacturer’s decision not to market, or to delay marketing, a drug it invented that would avoid the harm caused by an existing drug that the manufacturer continues to sell,” according the ruling, which concludes that depriving people of a safer drug and leaving them reliant on a more dangerous drug is “morally blameworthy.”

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 after 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.