As ever, we will open with the opinion (119 pages of a PDF) itself. It is a sensible one. While there may in the future be certain edge cases — where a wider duty might be found, this is not that case, in my estimation.
AIDS was (back then) a highly lethal diagnosis — and Gilead’s TDF was providing many years of progression free survival in the early 2000s. True, the side effects were often daunting — but it all meant a very good shot at a longer life. AIDS activists — not wrongly — sought to force Gilead to market a more gentle (on the patient) formulation, as soon as a glimmer of it became known in the research literature. Gilead did not immediately do so. Thus, this suit followed.
The court has held that the duty of care does not extend to a duty to immediately (without regard to economics) “innovate” — for new drugs. It was enough that the drug was effective at prolonging life, and that governments were willing to reimburse patients for taking it, held the courts — top to bottom.
That principle has been re-affirmed today. Here’s the latest on it all, from the SF Chronicle’s reporting:
…Rejecting claims by 24,000 AIDS patients, the California Supreme Court ruled Monday that pharmaceutical giant Gilead Sciences acted legally by marketing a drug for years that was effective but had potentially harmful side effects, while withholding another product that was equally effective but less harmful.
“A manufacturer cannot be held liable for injuries caused by a nondefective product,” Justice Joshua Groban said in a 6-1 decision overturning a lower-court ruling that had allowed the patients to sue the Foster City-based company.
The drug, tenofovir disoproxil fumarate, or TDF, was one of the first effective medications against HIV, the virus that causes AIDS. Gilead began developing it in 1991 and obtained U.S. Food and Drug Administration approval to market it in 2001….
Requiring a company to determine whether a less-harmful product is available and, if so, halt its sales of an equally effective, government-approved medication “would place extraordinary burdens on drug manufacturers,” said Groban….
[From the opinion itself, then:] 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 Rowland v. Christian (1968) 69 Cal.2d 108 (Rowland) that foreseeability and policy considerations may justify an exception to section 1714’s default duty in appropriate circumstances. Such circumstances exist here.
Where, as here, the allegedly safer drug has not yet undergone large-scale clinical testing in humans or received approval from the federal Food and Drug Administration (FDA), any harm resulting from a drug manufacturer’s delay in commercializing that drug would arise, if at all, only through a chain of uncertain scientific outcomes and discretionary decisions by actors beyond the manufacturer’s control….
Now you know — out into the warm sunshine for a bike trek — and, in about ten days, another Northern California half-iron trip! Then… on to France! Smile….
नमस्ते
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