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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 2012 WL 3265002, at *5 (N.D. 23 in its current form.

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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

2012), it had to apply the rule. Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” 2012 WL 12848432, at *4 (E.D. 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . Hamilton , 372 S.W.3d

FDA 59
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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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Who Needs a Lawyer in the Eleventh Circuit?

Drug & Device Law

This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. Plaintiffs Legal Committee , 531 U.S. 341 (2001). at 1334.