Drug-Maker Not Liable for ‘Delayed’ Release of ‘Safer’ Option

Tuesday, August 4, 2026

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California Supreme Court:

Drug-Maker Not Liable for ‘Delayed’ Release of ‘Safer’ Option

Opinion Rejects View That Manufacturer May Be Held Liable for Injuries Caused by Non-Defective HIV Medication Over Alleged Decision to Slow-Roll Alternative With Purportedly Less Severe Side-Effects, Drawing Dissent

By a MetNews Staff Writer

A divided California Supreme Court held yesterday that pharmaceutical giant Gilead Sciences does not owe a duty of care to users of a non-defective HIV drug with known serious side effects over the company’s failure to bring to market an allegedly “safer” alternative until the patent on the original medication was set to expire.

Justice Joshua P. Groban authored the majority opinion, joined in by Justices Carol A. Corrigan, Goodwin H. Liu, Leondra R. Kruger, as well as Justice Tara M. Desautels of Div. Two of the First District Court of Appeal, sitting by assignment. He wrote:

“[H]olding that manufacturers owe a broader duty to not unduly delay developing and commercializing an allegedly safer product to replace a concededly nondefective one could conceivably upend current products liability law. Instead of having to prove that a product is defective…plaintiffs would need only to convince a fact finder that the manufacturer acted unreasonably in its development and commercialization decisions.”

The justice added:

“We need not, however, definitively determine whether a drug manufacturer may ever be liable in tort for negligent conduct that results in injuries from taking a nondefective drug. Even if we were to assume arguendo that manufacturers may owe a general duty of reasonable care apart from their duty to market products free from defects, we held [in 1968] in Rowland v. Christian…that foreseeability and policy considerations may justify an exception to [Civil Code §]1714’s default duty in appropriate circumstances.”

Saying that “[s]uch circumstances exist here,” where “the allegedly safer drug has not yet undergone large-scale clinical testing in humans or received [regulatory] approval,” Groban opined that imposing the asserted duty of care on Gilead would “risk distorting research priorities and chilling pharmaceutical innovation in ways that may ultimately undermine, rather than advance, public health and safety.”

Essential Element

Chief Justice Patricia Guerrero penned a concurring opinion, highlighting that case law has long established that “an essential element of a negligence cause of action against a manufacturer” is that the plaintiff was injured by a defective product and asserting:

“Plaintiffs’ failure to allege an injury based on a product defect is therefore fatal to their claim. We need not make any assumptions regarding a broader duty or consider whether any exception might be justified under Rowland….”

Kruger also wrote separately to “to underscore that the majority makes the threshold assumption” about whether manufacturers may owe consumers a general duty of care apart from the marketing of defect-free products “for the sake of argument only” and remarked on “the tension between plaintiffs’ proposed duty of care and established case law” as well as “the significant administrability and public policy concerns” at play.

Justice Kelli Evans dissented, accusing the majority of “provid[ing] pharmaceutical manufacturers with sweeping immunity from negligence liability, no matter how unreasonably they may act or how much serious and avoidable harm they may cause consumers by intentionally delaying the commercialization of safer drugs.”

Regulatory Approval

The question arose after Gilead obtained approval from the Food and Drug Administration to go to market with Viread, a so-called “tenofovir disoproxil fumarate” (“TDF”) drug, in October 2001. At the time, the company had the exclusive right to sell tenofovir-based drugs for the treatment of the disease.

In November 2001, Gilead filed a request to begin human trials on a related “tenofovir alafenamide fumarate” (“TAF”) product and conducted a 14-day preliminary clinical trial with 30 subjects in which 15 of them would receive the new type of medication and the other half would be administered TDF.

According to a group of more than 20,000 plaintiffs, whose cases asserting Viread-induced injuries were consolidated, the testing confirmed that the TAF drugs were safer because they delivered the active ingredients into targeted cells at lower doses, decreasing serious kidney and bone risks associated with TDF versions.

They alleged that Gilead announced in 2004 that it had ceased development of the TAF option and did not market that drug until 2015, just ahead of the 2017 expiration on the company’s patent on TDF. The defendant disputes that it knew that TAF was a safer alternative, highlighting that the trials were only small-sample preliminary assessments and they had not yet completed the larger “phase III” tests needed for FDA approval.

In 2022, then-San Francisco Superior Court Judge Andrew Cheng (now deceased) denied Gilead’s request for summary judgment on the plaintiffs’ negligence and fraudulent concealment claims.

Div. Four of the First District Court of Appeal granted the defendant’s ensuing petition for writ of mandate as to the negligence claims only in 2024, saying that “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.”

Default Duty

Groban acknowledged that §1714 creates a “default duty” of care but said that, “our decisions have generally defined a manufacturer’s duty under section 1714 as the duty to design, manufacture, and market products that are free from defects” and the “[p]laintiffs’ theory risks circumventing these settled principles.”

Rejecting the Court of Appeal’s “attempt[] to narrow the duty by limiting it to situations in which a drug manufacturer has already invented or developed a drug it knows to be safer and equally effective,” he pointed out that the terms “invented” and “developed” lack clarity in the drug manufacturing process, which operates under multi-step clinical procedures. He continued:

“The same uncertainty surrounds the Court of Appeal’s requirement that the manufacturer “know[]” the alternative drug is safer than and as effective as the existing drug…The court accepted as true plaintiffs’ allegations that Gilead possessed such knowledge based on a single…clinical trial comparing TAF to TDF….But that conclusion rests on a flawed premise; namely, that a drug can be sufficiently developed, and its safety and efficacy sufficiently known, before completion of phase III clinical trials and FDA approval.”

However, he commented that “we need not definitively decide whether the defect requirement categorically limits the scope of a manufacturer’s general duty of reasonable care” because, “[e]ven assuming a broader duty could exist…, plaintiffs’ theory—that Gilead owed them a duty to make reasonable development and commercialization decisions regarding TAF—is not cognizable” under the foreseeability and public policy considerations set forth in Rowland.

Rowland Factors

Analyzing the factors enunciated in that decision, the jurist wrote:

“[T]he Rowland factors support a judicial exception to the default duty in this context. Because a drug manufacturer cannot determine a drug’s safety and efficacy during the early stages of clinical testing, it cannot reasonably foresee that any delay in developing and commercializing an alternative drug will harm users of an existing one.”

He added:

“Rowland’s public policy factors also weigh against recognizing a duty: Moral blame is not meaningfully implicated, given the morally neutral and socially valuable reasons that may underlie drug development decisions….[W]hile a duty might prevent some harms, it also risks distorting research priorities, discouraging innovation, and inviting hindsight-based second-guessing of complex scientific judgments.”

As to Evan’s dissent, Groban criticized the opinion as improperly focuses on pharmaceutical company profits and power imbalances between the parties, concerns he described as virtually universal in “every negligence action against a business,” and said:

“The dissent repeatedly characterizes today’s decision as granting pharmaceutical manufacturers ‘sweeping immunity.’…It does not. The FDA rigorously evaluates new drugs before approving them for commercialization. In addition, plaintiffs injured by FDA approved drugs may seek relief under traditional products liability principles.”

Evan’s View

Evans wrote:

“The default duty of care should attach when drug manufacturers make decisions about whether and when to commercialize a drug known to be significantly safer than and as effective as an existing one.”

She argued:

“We have never before held that drug manufacturers are entitled to an exception to the default negligence duty of care. The majority today applies Rowland with undue deference to the pharmaceutical industry to the peril of vulnerable and captive patients. I fear its broad reasoning, while purporting to be cabined by the facts of this case, risks diluting the ‘traditional’ negligence claims it avers are left untouched.”

The justice argued:

“Today’s decision provides sweeping immunity, allowing pharmaceutical companies to develop drugs without accounting for the risk of harm to consumers like plaintiffs here, who are held captive when a drug is both lifesaving and subject to exclusive manufacturing rights.”

The case is Gilead Tenofovir Cases, 2026 S.O.S. 2340.