Kaiser Health News

NOVEMBER 27, 2023

“We’re not going to be like California and have massive numbers of people on government programs without work requirements,” DeSantis said at a presidential primary debate in Southern California earlier this year. California bans short-term health plans.

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Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Such power rests solely with the FDA.” 23 in its current form. at 183 (quoting Meyers v.

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Doctors Fraud Licensing Compliance 52

Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). Jaqueline Moline, and her increasingly questionable paper “Mesothelioma Associated with the Use of Cosmetic Talc,” 62 J. 11-17 (Jan. may well be factually applicable to Dr.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Instead, Zofran turned mainly on animal studies – three Japanese studies that were not “newly acquired information” that could avoid preemption.

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

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. Second, the FDCA (21 U.S.C. CHDI , 2024 WL 637353, at *5. Cuomo , 592 U.S. 14, 18 (2020)).

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COVID-19 COVID-19 Vaccine Informed Consent FDA 52

Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption?

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COVID-19 Informed Consent FDA Governance 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.

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FDA Informed Consent Malpractice Hospitals 59