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. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105

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

Drug & Device Law

JUNE 14, 2023

Of course, on the defense side, we’re usually as happy as clams if we can show that the Food and Drug Administration (FDA) has already decided which warnings are necessary, so let’s call it a day. The doctor prescribed Cipro for the plaintiff after a urological procedure. There is no carve-out for informed consent.

FDA 59

FDA Malpractice Informed Consent Doctors 59

Drug & Device Law

AUGUST 30, 2022

But it involves the interplay between an FDA “Safety Communication” and punitive damages, so we thought it was worth looking at. The FDA data showed that approximately.28% Within days, the hospital convened a “power morcellation group” tasked with drafting an informed consent form that would reflect the FDA’s concerns.

FDA 59

FDA Informed Consent Malpractice Hospitals 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

AUGUST 8, 2022

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

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JUNE 7, 2022

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. But that does not mean that a doctor “abdicates [his] duty to exercise independent judgment.”

Doctors 69

Doctors FDA Informed Consent Malpractice 69

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.” 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. . .

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

MARCH 9, 2022

Speaking of clothing, sometimes plaintiff regulatory experts engage in cosplay, donning a quasi-military uniform from their service in the FDA many decades ago. This masquerade occurs despite the fact that the expert’s prior FDA position had little or nothing to do with the subject of the litigation. Note that we said “almost.”

Informed Consent 64

Informed Consent FDA Doctors Licensing 64