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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” June 29, 2017) (no causation where “[t]he prescribing doctors would not have changed their prescriptions based on what they now know about [the drug]”); Lord v. Schering Corp. , 2d 1140, 1148 (N.J.

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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.” Best Pharmacal , 577 P.2d Robins Co. ,

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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. 801.109(c). Bard, Inc. , 3d at 1286.