Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability

The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not.

In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage. In the years that followed, the company invested in research leading to additional TDF-based regimens critical to the fight against HIV. It had also done preliminary work on a similar but different drug — tenofovir alafenamide fumarate (TAF) — for which it had early, although not definitive, evidence for safety and efficacy.

Ultimately, this medicine was shown to have a better side effect profile than TDF. Starting in 2018, plaintiffs began suing Gilead for negligently failing to develop TAF earlier, on the theory that it wanted to protect the profits from TDF. Now, the California court has agreed to let the suit proceed.

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