CALIFORNIA SUPREME COURT TO DECIDE WHETHER DRUG MAKERS CAN BE SUED FOR “INNOVATING TOO LATE”

Gilead Tenofovir Cases, No. S283862

The Supreme Court of California will soon decide whether a manufacturer that sells an FDA-approved, non-defective product can be held liable simply for bringing a safer follow-up product to market too slowly. The lawsuit targets Gilead’s HIV treatment tenofovir disoproxil fumarate (TDF). Plaintiffs do not claim TDF was flawed when they took it. Instead, they say Gilead should have launched a later iteration, tenofovir alafenamide (TAF), years earlier.

What is at stake

If the Court affirms the lower decision, negligence suits could move beyond defects in the product actually used and focus instead on a company’s research calendars and business judgments. For example, decisions about when to update a truck’s braking system, release a new consumer device, or upgrade safety software, could all become fodder for hindsight litigation. Companies would face discovery into board minutes and budget spreadsheets, with juries asked to parse why one project moved faster than another.

How the case reached the Court

TDF has been on pharmacy shelves since 2001. In 2024 the Court of Appeal held that a manufacturer owes “ordinary care” not only in making and warning about its existing product but also in deciding when to release an equally effective option that presents fewer risks. Gilead petitioned for review, arguing that the decision abolishes the long-standing rule that a plaintiff must show a defect in the product that caused injury. Merits briefing is complete, more than seventy amici have weighed in, and oral argument is expected late this year.

Parties’ main themes

Gilead contends that extending duty beyond the product in use invites unlimited liability and discourages genuine breakthroughs, because any delay, real or perceived, could spawn lawsuits. Plaintiffs answer that Civil Code section 1714 imposes a broad duty of reasonable care and that delaying a safer alternative is no different from failing to fix a known hazard.

Industry groups, patient advocates, and trade associations have largely lined up with Gilead, warning that the new theory will raise costs and slow research by forcing companies to launch half-finished ideas just to avoid later accusations of delay. Public-interest organizations and professors supporting Plaintiffs reply that liability is needed to prevent manufacturers from milking older products after learning how to make them safer.

Practical concerns for manufacturers

Regardless of outcome, the litigation highlights the wisdom of keeping clear contemporaneous records explaining why projects advance at particular speeds, whether due to safety data, regulatory hurdles, supply-chain limits, or funding priorities. Companies should also confirm that document-retention schedules strike the right balance between preserving essential evidence and shedding material no longer required by law.

Likely direction of the Court

In recent years the California Supreme Court has been cautious about expanding tort duties without clear policy justification. It may reverse outright or, alternatively, craft a narrow rule that any duty to introduce an alternative arises only once its safety and effectiveness are well established. Even a limited duty, however, would reshape discovery and settlement dynamics in product liability cases.

A decision is expected in early 2026. Companies whose business depends on steady product updates should watch closely, as the ruling will influence how innovation timelines are judged in California courts for years to come.