Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. United States Department of Health and Human Services , 58 F.4th 4th 696 (3d.

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Testimonials Drugs FDA Vaccine 105

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., Pharmacy v. 21 U.S.C. §

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Compounding Pharmacies Pharmacy FDA Approval FDA 59

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. It seems quite logical that Plaintiffs would have paid for a different drug to treat patients’ diabetes. . . .

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Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MAY 26, 2023

In that case, the Fourth Circuit knocked out a Maryland law designed to prevent price gouging on drugs because of its extraterritorial reach. Since Bartlett (and in some cases before it), stop selling claims as to NDA and ANDA drugs have been widely preempted. 2011), aff’d , 741 F.3d Prescription drugs are not.

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Regulations Production FDA FDA Approval 59

Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN. In GenBioPro, Inc.

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FDA Approval Pharmacy FDA Production 111

Drug & Device Law

MARCH 31, 2023

Criticizing attempts to sue publishers of scientific content, here in 2011, and again, here in 2013. Thus it should not be surprising that the area of scientific free speech is one of the few instances in which we are willing to disagree with the litigation position of a drug or device company. 2023 WL 2621131, at *1.

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Drug & Device Law

MARCH 30, 2023

As we have said so many times before, ivermectin is a veterinary drug that is not indicated for the treatment of any condition in humans and hydroxychloroquine is indicated to prevent or treat malaria in humans and to treat lupus and rheumatoid arthritis in humans. IMS Health, Inc. , Reagan Nat’l Adver. of Austin , 142 S.

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Vaccine Pharmacy FDA Treatment 75

Drug & Device Law

FEBRUARY 20, 2023

223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design: [T]he [design] decision is surely not an easy one. Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. In Bruesewitz v.

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FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 27, 2022

Earlier this week a district court dismissed claims brought against the manufacturer and the distributor of a generic drug, holding that all of the claims were preempted by federal law and the several also failed under Florida law. The plaintiff’s claims against the dispensing pharmacy fared no better. The decision, Hernandez v.

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