Skip to content
Drugmakers dealing with the complex process of developing medicines must be allowed to decide against trying to bring a drug to market, the Biotechnology Innovation Organization (BIO) argues in an amicus filed with the California Supreme Court on Nov. 4.
The brief urges the court to grant summary dismissal of a suit against Gilead.
The plaintiffs in the suit make the unusual argument that—even though drugs using tenofovir disoproxil fumarate (TDF) are safe and effective—because the antiviral tenofovir alafenamide fumarate (TAF) has fewer side effects, Gilead should be held liable for not getting TAF to market sooner.
Gilead sought summary dismissal of the case, and when it wasn’t granted by the trial court, the company appealed to the California Supreme Court. BIO supported Gilead’s request for state Supreme Court review with a March 12 amicus brief.
The California Supreme Court agreed to review the case, and BIO submitted its latest amicus brief for the appeal, which is ongoing.
BiO’s new brief explains the drug development process and tells why Gilead had no way of knowing which of two very similar drugs might have a better safety profile. BIO’s brief also explains how allowing patients to sue over a drug that is approved by the Food and Drug Administration (FDA) and has no defects would intimidate investors, preventing the development of new lifesaving drugs.
“The liability regime Plaintiffs advocate would disincentivize advances in medicines that are critical to promoting patient wellbeing,” says the brief. “Imposing liability on a company for selling an FDA-approved, admittedly non-defective medicine because of some subsequent medical advance creates an untenable and ultimately unworkable liability regime.”
The history of the Gilead case
More than 20 years ago, drugmaker Gilead was investigating a drug called tenofovir to create an antiretroviral for people with HIV/AIDS. Initial research included development of two types of treatment involving tenofovir, TDF and TAF. The first medicine, developed with TDF, was approved by the FDA in 2001. TDF-based medications, of which there were several, went on to change the HIV landscape and become the standard of care. These medicines remain approved by the FDA today, and there is no dispute they have treated and prevented HIV in millions of people.
In 2004, with one TDF medicine approved and another poised to enter the market, Gilead made the decision to discontinue development of the second treatment, TAF. The company explains that the data at that time did not show TAF was sufficiently different from TDF in terms of effectiveness, safety, and tolerability.
In 2010, Gilead restarted TAF research, and the newer drug was approved by 2015. A class of plaintiffs treated with TDF subsequently argued that they could have avoided bone and kidney damage (risks that were and are disclosed on the FDA-approved label) if TAF had been made available to them sooner. Despite the potential side effects, plaintiffs acknowledge that TDF is deemed safe by the FDA, remains on the market, and is helping many patients.
Gilead argued in response that there can be no liability for negligence when a product is non-defective. Gilead’s request for a summary dismissal is now with the California Supreme Court, and BIO’s latest amicus brief supports that request.
