Healthcare Law Blog

MAY 11, 2023

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain preventative screening tests (the “Arrangement”).

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Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

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Nursing Homes US Department of Health and Human Services Nurses COVID-19 40

Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. 28, 2023) (“ CPAP I ”), addresses primarily medical monitoring. 2023 WL 7019667, at *3 (internal citations and quotation marks omitted). 2023 WL 7019667, at *11-13. Words fail us.

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

OCTOBER 13, 2023

We blogged on similar cases here , here , and here. 18-cv-06972, 2023 WL 6390598, at *3 (N.D. It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is just a claim that the defendant should have proposed to the FDA a different warning than what the FDA approved. 3d 281 (6th Cir.

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Drug & Device Law

JANUARY 23, 2023

2023 WL 239395 (D.N.J. Jan 18, 2023), the plaintiff was implanted with the defendant’s textured breast implant after undergoing a mastectomy. D’Addario , 2023 WL 239395 at *4 (internal punctuation and citation to Riegel omitted). In D’Addario v. Johnson & Johnson , et al., In other words, “where a.

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Drug & Device Law

AUGUST 11, 2023

3d –, 2023 WL 46998149 (N.D. July 20, 2023) involving, yes, hydrogen peroxide. Hydrogen peroxide is an FDA-regulated over-the-counter (OTC) drug, so Novotney addressed whether plaintiff’s claims were barred by federal preemption. Moreover, the FDA established federal labeling for 3% hydrogen peroxide.

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Drug & Device Law

MARCH 8, 2023

March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit. The plaintiffs brought claims for breach of warranties, unjust enrichment, common law fraud, and violations of various state consumer protection statutes. The plaintiffs in Acosta-Aguayo v. Walgreen Co. LEXIS 34836 (N.D. The label was not misleading.

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Drug & Device Law

JUNE 5, 2023

2023 WL 2565853 (N.D. March 17, 2023), reconsideration denied , 2023 WL 3032063 (N.D. Kelley was actually decided a couple of months ago, but due to Reed Smith’s involvement in the case, we could not blog about it until the matter recently settled. 2023 WL 3032063, at *2 (N.D. at *2 (citations omitted).

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Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. FDA litigation that is now before the Supreme Court. 3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). FDA , 78 F.4th 2023) (“ AHM II ”). quoting FDA appellate brief ). See Alliance for Hippocratic Medicine v.

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