Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.

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Drug & Device Law

JUNE 6, 2022

March 4, 2021) (no causation where implanting surgeon “did not testify that he would have shared warnings about increased risks with Plaintiff, or that the warnings would have altered his decision to implant the [device]”); Paseka v. Abbott Laboratories , 2014 WL 4197494, at *7 (C.D. Ethicon, Inc. 2021 WL 824411, at *3 (D. California.

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Drug & Device Law

JANUARY 28, 2022

How often can you say that about a safer reasonable alternative design decision ( one of this blog’s frequently revisited genres ), particularly if you practice in the problematic world of surgical mesh? It forced the majority to respond with more depth and detail in an already favorable opinion about reasonable alternative design.

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Drug & Device Law

MAY 30, 2022

The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. 2d 349 (2d Cir.

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Drug & Device Law

APRIL 22, 2022

But what about cases where the plaintiff says, sure a stronger warning would not have influenced my doctor, but what about me? If my doctor had informed me, I would not have consented to the treatment. 2014) (applying California law)). would have known about any stronger warnings issued by [the defendant].”

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Drug & Device Law

AUGUST 22, 2022

This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. Mentor Worldwide LLC , 2014 WL 6390307 (D.S.C. 23, 2014); Malonzo v. Mentor Worldwide, LLC , 2014 WL 2212235 (N.D. May 28, 2014); Couvillier v.

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Drug & Device Law

FEBRUARY 29, 2024

How about “immunity”? The plaintiffs alleged that the decedent had been hospitalized for COVID-19 and treated with the defendants’ antivirals without adequate informed consent, and passed away after three weeks. What could be better than preemption? Or is it that the same thing by a different name? Gilead Sciences, Inc.,

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