2017 and FDA Compliance - Drug Discovery Digest

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

The court also disagreed with defendants’ argument that plaintiff’s claims should be time barred because she alleges that she began experiencing symptoms soon after her surgery in 2014 and therefore, she should have discovered her injury before the statute of limitations ran in 2017.

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Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic

Drug & Device Law

JULY 26, 2023

Hrymoc has a lot of “one-off” flavor about it, as it was tried under North Carolina law in late 2017. 470 (1996), outside of the (now obsolete) presumption against preemption context in which it occurred − making FDA compliance an all-or-nothing proposition in medical device cases. 3d 503, 523 (N.J. Lohr , 518 U.S.

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Drug Discovery Digest

A Thorny PMA Preemption Decision from Rhode Island

Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic

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