California businesses could now face legal action for failing to develop an improvement on an existing product, after a Jan. 9 ruling by an appeals court affirmed a California-based pharmaceutical company delayed introducing a safer version of an HIV drug, which petitioners in a lawsuit alleged was due to maximizing profits.
Gilead Sciences, a global biopharmaceutical company based in Foster City, in the San Francisco Bay Area’s southeast region, received approval from the Food and Drug Administration (FDA) in 2001 for a life-saving HIV medication, which helps reverse and prevent damage to the immune system for those with AIDS-related illnesses.
Some 24,000 patients claimed the company should have launched the safer version of the medication that produces fewer side effects to the bones and kidneys sooner.
The drug company discovered—during the development of the medication—a similar, alternative option that produced fewer negative effects, but it didn’t receive FDA approval until 2015, according to court filings.
Plaintiffs say the drug company was negligent for not releasing a safer version when they were able, deferring the development to “maximize its profits,” and that such was a breach of reasonable care to users.
A California Superior Court Judge in 2022 ruled Gilead could be negligent for doing so, which was upheld in the recent ruling by a three-judge appeals panel, which said the company’s continued selling of their other medication was flawed, knowing a better alternative was available.
“We conclude that the legal duty of a manufacturer to exercise reasonable care can, in appropriate circumstances, extend beyond the duty not to market a defective product,” wrote Associate Justice Jeremy Goldman in the recent ruling.
The ruling doesn’t mean that manufacturers who obtain FDA approval to sell a prescription drug are legally obligated to invent a “safer alternative,” according to Judge Goldman, but in such circumstances where a known safer and equally effective formula is available, they have “a duty of responsible care to users of the current drug when making decisions about the commercialization of an alternative drug,” he wrote.
Attorneys for Gilead argued that such duty “would massively expand manufacturers’ existing exposure to liability,” which would also increase the cost of insurance, according to court documents.
But Judge Goldman said he, and the other two judges, weren’t convinced.
A spokesperson for the company, in an emailed response to media outlets, said “the court’s decision will have widespread, negative consequences across all fields of innovation and manufacturing.”
A spokesperson for Gilead did not return a request for comment on deadline.
