Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. This novel duty has implications far beyond FDA-regulated products.

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Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

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Drug & Device Law

OCTOBER 26, 2023

341 (2001) (a Bone Screw case). Plaintiffs constantly seek to create FDCA violations that do not exist, often through bizarre interpretations of FDA regulations that the FDA has never followed. That’s exactly how we attacked – and usually beat – FDCA-based negligence per se claims before we won the preemption ruling in Buckman Co.

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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. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 727 F.

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Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. The Doctors therefore sustain a concrete injury when they are forced to divert time and resources away from their regular patients. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 727 F.

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Drug & Device Law

AUGUST 11, 2023

We’re not doctors, we just play them on TV.) Hydrogen peroxide is an FDA-regulated over-the-counter (OTC) drug, so Novotney addressed whether plaintiff’s claims were barred by federal preemption. At least that was our take-away. Note: Don’t take medical advice from lawyers. Which brings us around to Novotney v. Walgreen Co. , — F.

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Drug & Device Law

AUGUST 22, 2022

She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. 341 (2001). What the offending “component” or “material” was isn’t stated, nor how anything was “inconsistent” with some unidentified “regulation” or “requirement.” Plaintiffs Legal Committee , 531 U.S. 2019 WL 6766574, at *3.

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Drug & Device Law

FEBRUARY 1, 2022

341 (2001) as impermissible attempts at private enforcement of the FDCA. The same was true of plaintiff’s claims based on failing to report adverse events to the FDA and on failing to comply with federal regulations for medical devices generally. Defendant argued that these claims are impliedly preempted under Buckman Co.

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