CA judges rule Gilead can be sued for taking too long to develop an HIV drug

One of the things I spotted in my casual looking around is this statement: "Therefore, as part of the FDA approval process, Gilead was required to develop an alternative form of the chemical — known as a “prodrug”— that could be taken by mouth." [1]

If Gilead agreed to develop an alternative drug that had fewer adverse side effects in exchange for FDA approval of their preferred (more expensive) drug, then I think the lawsuit has a great deal of merit.

[1] https://lawandcrime.com/lawsuit/federal-court-rejects-drugma...

For more context, try this NYTimes article: https://www.nytimes.com/2023/07/22/business/gilead-hiv-drug-...

> In private, though, something else was at play. Gilead had devised a plan to delay the new drug’s release to maximize profits, even though executives had reason to believe it might turn out to be safer for patients, according to a trove of internal documents made public in litigation against the company.

This is a pretty surprising ruling, and I dont think the negative implications are being oversold.

The court is saying that not developing a better product is negligence, even if the existing product provides value and is FDA approved.

I would be interested in understanding what the judges feel the the limiting principle here is. Almost every product can be improved on, if development cost and return on investment is not a valid consideration.

Do we have a link to the opinion? Is this a conclusion of law, or simply a statement of standing?

Can someone please post full text?

From reading the 2 paragraphs that were available without paywall (see below):

>Some 24,000 patients have sued in California state court for failing to introduce an allegedly safer version of an HIV drug. The Food and Drug Administration in 2001 approved a life-saving HIV medication by Gilead. The plaintiffs don’t argue that the drug is defective or lacked adequate warnings.

I think there's something deeper at play here. If it was approved in 2001, and it was a novel drug, sure, than I agree, Gilead should have probably continued the R&D process on the drug to make it even safer. But the devil is always in the details, and from the 2 paragraphs I could read without being paywalled, there's something I'm missing here that would logically provide greater context.