On Wednesday, May 6, the California Supreme Court will hear a case that could upend the economics of medical innovation.
Roughly 24,000 plaintiffs are suing pharmaceutical company Gilead over one of its HIV drugs. They do not claim that the drug failed to work, nor that it was defectively manufactured, nor that they were insufficiently warned of its side effects.
Their argument is far more radical. They claim Gilead should be punished because it didn’t develop a better version quickly enough.
If that theory prevails, it will create a new legal standard — one that’s not just misguided but dangerous.
The drug at the center of the case is tenofovir disoproxil fumarate, or TDF, which Gilead introduced in 2001. It became a cornerstone of HIV treatment and prevention, helping transform what was once a fatal diagnosis into a manageable chronic condition.
Like many medicines, TDF can have side effects. Some patients say that the drug caused bone, kidney, and tooth injuries. Those risks were documented and reflected in the drug’s labeling — and weighed against its substantial clinical benefits.
Around the time TDF was approved, Gilead’s scientists began testing another potential treatment for HIV, tenofovir alafenamide, or TAF. But in 2004, the company paused that work to focus on developing a once-daily pill containing TDF to replace the multi-pill cocktails HIV patients had to take.
Gilead reasoned that TDF had proven safe and effective, while TAF had not yet demonstrated clear advantages. A daily pill would also make a treatment regimen much easier to follow.
The company revisited TAF in 2010, launching additional research and clinical trials. In 2015, the U.S. Food and Drug Administration approved TAF.
Which brings us to the present. The plaintiffs allege that TAF may cause fewer side effects for some patients than TDF. Looking back at the development timeline for the two drugs, they claim that Gilead should’ve brought TAF to market sooner — and that the delay amounts to negligence.
That theory ignores the realities of drug development.
Ushering a new medicine through the regulatory process is long, uncertain, and extraordinarily expensive. On average, it costs $2.6 billion to develop a single drug. Only about 1 in 10 candidates that enter clinical trials ever win FDA approval.
Researchers cannot know in advance which compounds will prove safer or more effective, how long trials will take, or whether regulators will ultimately sign off. Scientific progress rarely follows a straight or predictable path.
Allowing courts to second-guess those decisions years later with the benefit of hindsight would distort the incentives that drive innovation.
Some companies may scale back work on incremental improvements to existing therapies, especially in complex fields where progress is slow and uncertain. Others may delay bringing new drugs to market, waiting until they’ve explored every conceivable variation — just in case a future plaintiff argues they should have done more.
A ruling for the plaintiffs could open the floodgates to litigation. Every time a newer, better drug reaches the market, trial lawyers could argue that patients who took the earlier version deserve compensation — not because the original drug was unsafe but because something better came along later.
It would also blur a critical legal distinction. Liability has traditionally been tied to defective or unreasonably dangerous products. This case asks the court to extend it to cover hypothetical alternatives — drugs that might have existed sooner under ideal circumstances.
That’s not a workable standard.
Patients are best served by a system that encourages companies to take risks, invest in research, and bring new therapies to market as quickly as possible — not one that penalizes them for failing to meet arbitrary, or even impossible, product-development timelines.
If the California Supreme Court gets this wrong, the consequences won’t be limited to one company or one class of drugs. It will send a chilling signal across the entire life sciences industry, much of which is based in California.
And it won’t be drugmakers who pay the highest price. It will be patients — those waiting for the next breakthrough, one that may never arrive if courts start punishing the process that makes longer, healthier lives possible.
Sally C. Pipes is President, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is “The World’s Medicine Chest: How America Achieved Pharmaceutical Supremacy — and How to Keep It.” Follow her on X @sallypipes.
This article originally appeared on Ventura County Star: A lawsuit that may kill tomorrow’s cures | Your Turn
Reporting by Sally C. Pipes, Your Turn / Ventura County Star
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