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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” See also Rodriguez v.

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FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

357 (2002); United States v. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. E.g. , Sorrell v. IMS Health Inc. , 552 (2011); Thompson v. Western States Medical Center , 535 U.S. Caronia , 703 F.3d FDA , 119 F.

FDA 64
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The Medical Device Labeling Exception for “Commonly Known” Hazards

Drug & Device Law

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Bard, Inc. , 3d 1272 (11th Cir.