Drug & Device Law

FEBRUARY 16, 2024

The Dearinger case in the Western District of Washington provided a lot of defense friendly blog fodder. We blogged about that decision here. Plaintiffs provided testimony from that physician suggesting that he would have changed his prescribing decision if presented with plaintiffs’ proposed warning language.

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Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. FDA litigation that is now before the Supreme Court. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards.

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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

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

NOVEMBER 3, 2022

This post is from the non-Reed Smith side of the blog. Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.” As long as they don’t, the door to this testimony remains closed. .

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