May 6 (Reuters) – The California Supreme Court will on Wednesday consider whether manufacturers of drugs that are considered safe are legally obligated to continue developing drugs that are allegedly safer.
Gilead Sciences is appealing lower court rulings that said patients using its HIV drug can pursue negligence claims over its decision to stop developing an alternative drug that had fewer side effects.
A decision could change product liability law if it effectively required drugmakers to spend more to develop and quickly commercialize alternative products, sometimes called a “duty to innovate.”
The case was brought by about 24,000 HIV patients who took Gilead drugs made with tenofovir disoproxil fumarate, or TDF.
Those drugs won U.S. Food and Drug Administration approval in 2001 despite possible side effects including kidney dysfunction and bone problems.
Gilead soon began testing the similar tenofovir alafenamide fumarate, or TAF, which had fewer side effects.
It discontinued TAF development in 2004, saying its effectiveness and safety was not different enough from TDF to justify continued spending.
Gilead argued in its appeal that letting patients sue would stifle innovation, by subjecting drugmakers to liability for developing but failing to commercialize new drugs.
“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,” Gilead said. “The result would be less product development, not more.”
Patients countered that Gilead realized TAF would “cannibalize” sales of TDF, and delayed the release of TAF to maximize profit and coincide with the expiration of TDF’s patent in 2017.
“Gilead made billions in additional profit from tenofovir-containing drugs sold after 2017,” the patients said. “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.”
(Reporting by Jonathan Stempel in New York; Editing by Himani Sarkar)
