Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

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Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

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Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. 4, 353 (2001).

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Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S.

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Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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Drug & Device Law

JANUARY 23, 2024

Today’s case is a counterpart to our post a few months ago about a case applying Buckman preemption to a contract dispute where adjudicating the alleged breach would have forced the court to decide FDA regulatory issues. 4, 353 (2001). In that case ( Thogus Products Co. Bleep, LLC , 2023 WL 5607458 (N.D. Buckman Co. 341, 349 n.4,

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