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. As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Bonta , 85 F.4th

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Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 3d , 2022 WL 6225596 (S.D. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony.

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Drug & Device Law

NOVEMBER 1, 2022

16, 2022) (“ Mixson I ”), and Mixson v. 2022 WL 7581737 (N.D. 23, 2022) (“ Mixson II ”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results. 2022 WL 4364153, at *2. 2022 WL 4364153, at *2. Mixson I , 2022 WL 4364153, at *5. Bard, Inc. ,

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Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 2022 WL 970681 (N.D. 3d at 1286.

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Drug & Device Law

JUNE 1, 2022

Aurora Healthcare , 2022 WL 1657559 (Wisc. May 25, 2022), the Wisconsin Court of Appeals reversed a lower court’s granting of an injunction compelling treatment with ivermectin. The case was brought by a Covid-19 patient’s nephew, who was acting as the patient’s health care representative. None of those arguments passed muster.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. Somatics, LLC , 2022 WL 989469 (9th Cir. April 1, 2022) (the companion case to this ). The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. These propositions were employed recently in Himes v.

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Drug & Device Law

MARCH 9, 2022

Texas March 2, 2022)— is a veritable mixed bag. The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. But the defendant pointed to 21 CFR section 801.109(c), which says that labels may omit information “commonly known” to licensed medical practitioners. Ethicon, Inc. LEXIS 36441 (S.D.

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Testimonials FDA Doctors Regulations 64

Drug & Device Law

FEBRUARY 9, 2022

Mayo Clinic , 2022 Fla. 27, 2022), and its reasoning is crystalline and straightforward. Against the authority of the Mayo Clinic and other reputable sources, the plaintiffs relied on the testimony of a single doctor. The doctor testifying for the plaintiffs was licensed in Florida, but with no board certifications.

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