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. That’s why Buckman Co.

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Drug & Device Law

SEPTEMBER 1, 2023

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. So the plaintiffs pivoted. Superior Court , which plaintiffs have to find a way around.

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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. See Enriquez v.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001).

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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.” at 237-38.

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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. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

JANUARY 9, 2023

Bayer Healthcare Pharmaceuticals Inc. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). In examining the law applicable to OTC drugs, ASH-ADHD ignored what the applicable FDA regulations state, in favor of what they don’t state.

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