WLF General Counsel Pens Wall Street Journal Op-ed

On Wednesday, May 6, the California Supreme Court will hear oral arguments in Gilead Tenofovir Cases. WLF has participated as an amicus in the case, filing five separate briefs at both the Court of Appeal and Supreme Court levels since 2022.

Today, the Wall Street Journal published an op-ed on the case authored by WLF’s General Counsel and Vice President of Litigation, Cory L. Andrews.

As Cory writes, the California justices face a stark question:

Can a company be sued for negligence—not because its Food and Drug Administration-approved drug was defective or its warnings insufficient (the complaint claims neither)—but because the company didn’t bring a better version to market sooner?

Gilead released a revolutionary HIV treatment in 2001, Viread, which was re-released and renamed Truvada in 2004. Gilead had been researching an alternative version of this medication but paused further development in 2004. The company restarted research on that alternative in 2010 and FDA approved it in 2015. The new treatment had comparable efficacy to Truvada and improved kidney and bone safety for some patients.

The plaintiffs in the Gilead Tenofovir Cases accuse Gilead of negligently delaying the release of the treatment approved in 2015. As the op-ed explains:

The California Court of Appeal embraced this claim. It held that a manufacturer can breach a duty of reasonable care merely by pausing or delaying a “safer” alternative—even when the existing product met every regulatory and tort-law standard of its era. Traditional product liability demands a defect in the product or its labeling. This ruling discards both requirements. It converts ordinary scientific and business judgments into actionable negligence.

A California Supreme Court decision affirming the lower court will allow lay jurors to decide, years after a drug’s approval, whether a company’s billion-dollar research-and-development decisions were “reasonable.” That outcome, Cory explains, “penaliz[es] the scientific caution that careful safety requires,” resulting in fewer cures for debilitating diseases.

Cory concludes:

The stakes reach far beyond this case. If California blesses liability for the pace of innovation, other states will feel the pull. The result won’t be safer or faster drugs. It will be fewer of both. Medical miracles depend on risk-taking, not on risk-free litigation. California’s patients—and the nation’s—deserve no less.