The California Supreme Court will consider on Wednesday whether manufacturers of drugs that are considered safe can be legally required to continue developing medications that are alleged to be safer for patients. At issue in the appeal is whether patients using an approved HIV medication may sue for negligence because the manufacturer chose not to bring an alternative formulation to market.
The litigation centers on Gilead Sciences and claims by about 24,000 HIV patients who took drugs containing tenofovir disoproxil fumarate, or TDF. Those drugs received approval from the U.S. Food and Drug Administration in 2001, despite documentation of potential side effects including kidney dysfunction and bone problems.
Gilead later tested a related compound, tenofovir alafenamide fumarate, or TAF, which clinical data indicated produced fewer side effects. The company halted development of TAF in 2004, stating that its effectiveness and safety were not sufficiently different from TDF to warrant continued expenditure.
Lower courts allowed the patients to pursue negligence claims, and Gilead has appealed those rulings to the states highest court. The company argues that permitting such lawsuits would chill innovation by exposing manufacturers to liability when they develop but ultimately do not commercialize new products.
In its appeal brief, Gilead warned that "In permitting liability for failing to bring to market an allegedly marginally better product - even when the accused product is not defective - and requiring manufacturers to disclose information to physicians about products still in development, the ruling weaponizes innovation itself." The company said the outcome "would be less product development, not more."
Plaintiffs counter that Gilead recognized TAF would "cannibalize" sales of its TDF-based medicines, and deliberately delayed TAFs release to maximize profits and to time commercialization around the expiration of TDFs patent in 2017. "Gilead made billions in additional profit from tenofovir-containing drugs sold after 2017," the patients said, adding that "A jury must now decide whether this boardroom decision to intentionally delay the commercialization of TAF at the expense of thousands of HIV-infected patients using TDF was unreasonable."
The choice before the California Supreme Court could have broader implications for product liability law if the court's ruling effectively imposes a duty on manufacturers to spend more and accelerate commercialization of alternative products. That legal question - whether a company can be held liable for choosing not to bring a marginally better product to market - is central to the appeal and the plaintiffs' theory of negligence.
Case status: Appeal currently before the California Supreme Court.