Drug & Device Law

JUNE 6, 2022

2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . July 8, 2009) (applying California law); Nix v.

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

FEBRUARY 26, 2024

As much as we like preemption, no basis for preemption exists based with respect to the informed consent requirement of the statute’s provision governing emergency use authorized (“EUA”) products, such as (at the time) COVID-19 vaccines. 555, 573 (2009), and these antivaxxers didn’t come close. Second, the FDCA (21 U.S.C.

COVID-19 52

COVID-19 COVID-19 Vaccine Informed Consent FDA 52