Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Plaintiff knew about it, too, since he signed an informed consent document mentioning it.

FDA 105

FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

AUGUST 22, 2022

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. 2011 WL 8879258 (Mag. 9, 2011); Williams v.

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

JUNE 6, 2022

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” 2011) (no causation where “at the time of her deposition ? the very same illness for which she treated Plaintiff”); In re Trasylol Products Liability Litigation , 2011 WL 2117257, at *5 (S.D.

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

MAY 30, 2022

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.” 31, 2011), aff’d , 483 Fed.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59