I don't think there's even the remotest chance that the FDA will be sued for negligence. They keep approving stronger opioids and nothing like that happens.
The FDA has the right to ban whatever, that's a lot different than them being required to ban whatever. They're not breaking any laws, why wouldn't people sue tobacco companies instead? They're the ones actually killing people.
Your scenario is like a driver running down a pedestrian in a crosswalk and then the victim's family suing the Dept of Transportation because the speed limit isn't low enough at that intersection. You sue the driver not the regulator.
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