Drug & Device Law

AUGUST 28, 2023

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F. 1, 6 (D.D.C.

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Drug & Device Law

JULY 24, 2023

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co.

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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. ASH-ADHD is illustrative of the big difference that the “product liability” exception to express preemption for OTC drugs makes.

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 727 F.

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Drug & Device Law

MARCH 31, 2022

The underlying liability allegations are little different than what has been asserted in the Zantac MDL, which we described here: Zantac is a drug that has been around, in branded or generic form, since 1983. In other words, the generic manufacturers are not allowed to change the FDA-approved label. 2022 WL 53700, at *3.

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Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. 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.

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Drug & Device Law

SEPTEMBER 1, 2023

a panel of the California Court of Appeal is considering whether a prescription drug manufacturer can be liable in tort not for a product defect, but for negligence in failing to develop a different, allegedly safer product sooner than it actually did. First Dist.), No court has allowed this. See, e.g., here and here. Keep that in mind.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). Health & Safety C.

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Drug & Device Law

SEPTEMBER 18, 2023

Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. 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.” 341 (2001).

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Drug & Device Law

SEPTEMBER 29, 2022

Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” Once approved, a biologics label generally may not be changed without prior FDA approval. 341 (2001). Albrecht , 139 S.

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Drug & Device Law

FEBRUARY 11, 2024

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. See Alliance for Hippocratic Medicine v. 3d , 2023 WL 2825871 (N.D. See AHM I , 2023 WL 2825871, at *4 n.9

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Drug & Device Law

MARCH 10, 2022

341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. As we noted at the time, although the case arose in the food context, its analysis is directly applicable to drug and device cases. Today we report on another food case relevant to device, if not drug, cases, Nacarino v.

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Drug & Device Law

FEBRUARY 15, 2024

Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis , and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. Lynch & Co. Flex Techs., 2d 180, 182 (Mich.

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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.”

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Drug & Device Law

SEPTEMBER 22, 2023

Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not invents—new legal issues and ideas, then proselytizes about them until they become part of the fabric of our legal lives. Compliant drugs are GRASE—generally recognized as safe and effective.

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Drug & Device Law

OCTOBER 10, 2023

Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Doing so comes with obligations to comply with FDA’s labeling requirements for such OTC drugs, which Plaintiff alleges they do. The Food, Drug, and Cosmetic Act (“FDCA”) does not contain a private right of action. 341 (2001).

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Drug & Device Law

JANUARY 12, 2024

At issue was whether a product manufacturer could be liable to patients taking one drug for failing to bring a different, but allegedly safer drug to market sooner than it actually did. The drugs at issue are life-saving antiretroviral drugs used to treat patients with HIV. But how did we get here? This is a major issue.

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Drug & Device Law

NOVEMBER 2, 2023

A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted by a drug manufacturer against a compounding pharmacy. Despite generally rooting for drug manufacturers, we are okay with the decision, Zyla Life Scis., 21 U.S.C. § Mukasey , 536 F.3d Whole Foods, Inc.,

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Drug & Device Law

OCTOBER 6, 2023

He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute. 341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. 472 (2013), and (3) express OTC drug preemption under 21 U.S.C. 109 (2023).

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