Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. That makes no sense either, because at the time of FDA approval, not to mention before FDA approval, there is, by definition, no “newly acquired information” beyond what the FDA considered in its approval decision.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Sullivan , OAJC, 2023 WL 8859656, at *11.

Compliance 52

Compliance Government FDA Compliance Production 52

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]”).

Testimonials 64

Testimonials Doctors Production Trials 64

Drug & Device Law

DECEMBER 28, 2023

In a paraphrase of the testimony of a difficult opposing epidemiology expert who passed away recently, “you have to say what you will do and then do what you say.” including all neurodevelopmental issues to get an increased risk in a study that was only designed to look at ASD).) at *23-29.

Testimonials 52

Testimonials FDA Science Drugs 52

Drug & Device Law

DECEMBER 20, 2023

Despite the chorus of criticism of recent Congressional testimony by a trio of tone-deaf college presidents, there really is a valid, if sometimes difficult, distinction between speech and conduct.) Could such “notice” have a chilling effect? Yes, of course. We have a lot of sympathy for the defense position on this point.

FDA 52

FDA Trials Production Testimonials 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). While the compensation claims did “not definitively establish” other asbestos exposure, plaintiff “nonetheless made statements. . ., 11-17 (Jan. It got worse. quoting 45 C.F.R. 46.111(a)(7)).

Testimonials 59

Testimonials Regulations Research International 59

Drug & Device Law

JUNE 1, 2022

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. One doctor wrote an ivermectin prescription based solely on statements from the patient’s wife.

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Doctors Hospitals Treatment Testimonials 124

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., How does such testimony meet the relevance requirement of Fed. Evidence 402?

Testimonials 64

Testimonials FDA Doctors Regulations 64

Drug & Device Law

AUGUST 24, 2023

The court exercised its “gatekeeping” function under Rule 702 to assess whether the methodology underlying Plaintiff’s proffered expert testimony was “scientifically valid” and whether it could “be [properly] applied to the facts in issue.” Nor could Plaintiff fill that void by relying on expert testimony from other cases.

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