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. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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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

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”).

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Drug & Device Law

DECEMBER 27, 2022

Filing a citizen’s petition, Valisure shocked the FDA into an ill-advised recall by reporting that “tests found NDMA in ranitidine in excess of 3,000,000 ng [nanograms] per pill” – far above FDA’s 96 ng/day “daily limit.” The FDA recognized these results as bogus, “conclud[ing] that. . . 2022 WL 17480906, at *1.

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Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). I-Flow Corp. , 2d 1092, 1119-25 (D. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co. 1998 WL 1297690, at *4, 7-8 (W.D. 31, 1998), aff’d , 243 F.3d 3d 244 (6th Cir. Whitehall Laboratories, Inc. ,

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Drug & Device Law

MARCH 31, 2022

The Court accurately perceived the issue as “not.simply a question of creating a new liability in the nature of a tort,” but rather one of “fiscal policy” and what branch of government properly sets such policy. Thus, the Standard Oil court rejected the government’s “tort law analogy” as a basis for “establishing. . . 2d 481, 489 (Md.

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Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman. Medtronic, Inc. ,

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