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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. Such power rests solely with the FDA.”

Doctors 52
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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

They’re experienced at what they do and aren’t intimidated by plaintiffs’ counsel and their threats of malpractice claims if they don’t testify the way plaintiffs want them to. procedure that existed at the time of [plaintiff’s] injury”; malpractice was “intervening cause”) (applying Kansas law); Eck v. 3d 1223, 1233 (11th Cir.

FDA 59
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No DTC Advertising Exception to Learned Intermediary Rule in Washington

Drug & Device Law

Plaintiff argued this conflicted with the learned intermediary rule because the FDA requires warnings to consumers when manufacturers market drugs to consumers. The FDA also requires warnings to physicians. Doctors are charged with discussing the risks and benefits of treatment and obtaining informed consent from their patients.

Doctors 69