2001, FDA and Governance - Health Care Compliance Brief

Contract Claim Based on Alleged FDCA Violation Held Not Impliedly Preempted

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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FDA Compliance Governance

At Least One Aspect of the Camp Lejeune Litigation Isn’t Going FUBAR

Drug & Device Law

JANUARY 11, 2024

Anybody who might attempt to obtain similar discovery from the FDA in a prescription medical product case, take note. 1, 8-9 (2001)) (internal quotations omitted). Peer review in this instance requires “multiple reviews” and approval from not one, but two, government agencies. Klamath Water Users Protective Assn. ,

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FDA Governance

PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 341 (2001), which put an end to any doubt about this proposition. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , at 356 (emphasis added).

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Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted

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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FDA Governance Compliance

Thinking About the FDA’s Alternative Summary Reporting Program

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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FDA Fraud Governance Compliance

Another Update on Medical Abortion Litigation

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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Another Update on Medical Abortion Litigation

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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The FDA and Feasible Alternative Designs

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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Logical Contradiction Doctrine: Buckman for Textualists

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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FDA Fraud Governance Medicare

A Painful Preemption Decision

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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FDA Governance Nurses

Zantac Chronicles – Concluding Chapters in the MDL

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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Stupid Expert Tricks Redux

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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Split Decision

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.

Governance

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Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

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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Health Care Compliance Brief

Contract Claim Based on Alleged FDCA Violation Held Not Impliedly Preempted

At Least One Aspect of the Camp Lejeune Litigation Isn’t Going FUBAR

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PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

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Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted

Thinking About the FDA’s Alternative Summary Reporting Program

Another Update on Medical Abortion Litigation

Another Update on Medical Abortion Litigation

The FDA and Feasible Alternative Designs

Logical Contradiction Doctrine: Buckman for Textualists

A Painful Preemption Decision

Zantac Chronicles – Concluding Chapters in the MDL

Stupid Expert Tricks Redux

Split Decision

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

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