In the Gilead Tenofovir Cases, the Supreme Court yesterday held a pharmaceutical company cannot be sued for not more quickly making available a drug that is safer than another HIV-treatment drug that is not defective but nonetheless causes harm. The court concluded that “[i]mposing such liability would create substantial burdens and would risk adverse consequences for pharmaceutical innovation, public health, and patient safety.”
There are four opinions. The court’s opinion is by Justice Groban, with Justices Corrigan, Liu, and Kruger, and pro tem Justice Desautels concurring. Chief Justice Guerrero filed a separate concurrence. Besides signing the court’s opinion, Justice Kruger, with Justices Corrigan and Desautels, also wrote a concurring opinion. Justice Evans dissented.
The court didn’t “definitively determine whether a drug manufacturer may ever be liable in tort for negligent conduct that results in injuries from taking a nondefective drug,” but said, “we have substantial doubt that California law recognizes a general negligence duty requiring drug manufacturers to act reasonably in making drug development and commercialization decisions apart from their established duty to design, manufacture, and market products free from defects.” It also noted that “accepting plaintiffs’ theory of liability could have far-reaching consequences across a broad range of industries.”
The Chief Justice’s concurrence is more straightforward, finding dispositive the lack of a defect in the injury-producing drug. “A manufacturer that sells a reasonably safe and nondefective product does not owe its existing customers and users a duty to develop a reasonable alternative product,” she wrote.
Justice Kruger’s three-justice concurring opinion “share[s] the Chief Justice’s skepticism that Civil Code section 1714[’s general due care principles] override[ ] th[e] [product] defect requirement” for liability, but is “nonetheless willing to assume with the majority that there might be some conceivable theory of negligence, not yet identified in our cases, based on the sale of a nondefective product.”
In dissent, Justice Evans criticized the majority for “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.” She urged the Legislature to consider whether the immunity the majority grants is proper.
The court reversed the First District, Division Four, Court of Appeal published opinion.
