Drug & Device Law

JANUARY 24, 2022

Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Valsartan Testimony ¶3. PPI ¶11 (participants must “comply with any government law, regulation or guidance regarding public health and safety during the COVID-19 pandemic”). All depositions. . . H/C ¶1(A); accord Zantac ¶22. Generic Pharmaceuticals Pricing ¶14.

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Drug & Device Law

DECEMBER 5, 2022

The linchpin of J&J’s Due Process arguments is the concept of “fair notice.” “A fundamental principle in our legal system is that laws which regulate persons or entities must give fair notice of conduct that is forbidden or required.” FCC v. at 27 (testimony that “large” amount of material had to be “recycl[ed]”).

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Testimonials Doctors Production Trials 64

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 11, 2024

Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. 9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22

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Drug & Device Law

FEBRUARY 21, 2022

The defendant sought Pence’s exclusion because “she is not qualified due to her lack of education, experience, or specified knowledge about the regulation of medical devices, specifically the defendants’ mesh.” Plaintiff’s] argument that [her] testimony has been admitted in other cases is not persuasive. Coloplast Corp.

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Testimonials Clinical Trials Production Trials 59

Drug & Device Law

MARCH 9, 2022

The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. When we consider the damage a regulatory expert can do, misinterpreting both company documents and FDA regulations to make the company look like Murder, Inc., So much for judicial gate-keeping, Inadequate Warnings to Doctors.

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Testimonials FDA Doctors Regulations 64

Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” That testimony was contrary, not only to the common-law cases discussed in our prior posts , but also flatly contradicted §801.109(c). 801.109(c). Bard, Inc. ,

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Drug & Device Law

JUNE 1, 2022

We’ve been writing for a while about cases rejecting someone’s insistence that a doctor prescribe ivermectin for Covid-19, even when that doctor (or hospital) thinks such use of ivermectin is not appropriate medical care – is, in fact, horsebleep. ?. You will, of course, say this very respectfully.).

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Doctors Hospitals Treatment Testimonials 124

Drug & Device Law

FEBRUARY 16, 2024

Plaintiffs included in their motion for reconsideration a lengthy affidavit contending that the court’s decision dismissing their failure to warn claim was based on the wrong physician’s testimony. If accepted, the testimony may have altered the court’s analysis in the second motion for summary judgment. Allied Mut.

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Testimonials FDA Approval FDA Doctors 52