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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52
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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal.

FDA 59