Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. 22 (both articles for the proposition that there are “‘many intense side effects’ and ‘significant complications requiring medical attention’” resulting” from FDA’s regulation of mifepristone), at *22 n.37 We were hardly alone.

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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. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. They excluded bogus expert testimony under Fed. Bonta , 85 F.4th Monsanto Co. ,

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Drug & Device Law

DECEMBER 20, 2023

We are even more likely to blog about a case if it follows up on an earlier decision about which we scribbled. We have blogged about this prosecution twice before. When we represented the United States of America, we were often in court, often on our own, and yet often dealing from positions of strength. Yes, of course.

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Drug & Device Law

FEBRUARY 20, 2023

7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives.

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Drug & Device Law

DECEMBER 5, 2022

The Blog examined the excesses of such litigation here , here , and here , among other posts. 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.

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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). emphasis added).

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Drug & Device Law

JUNE 1, 2022

co-DDL blog founder Mark Herrmann offers all sorts of good advice. Our favorite part of the plaintiff’s case was the reliance on unsworn affidavits and prior testimony by a Dr. Kory, who stated that he is “generally considered the foremost expert” on the proposed Covid treatment. None of those concerns were implicated here.

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