Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic
Drug & Device Law
JULY 26, 2023
At trial, plaintiffs not only attacked the defendant’s due care generally, they specifically assailed “the reasonableness of [the defendant’s] conduct in not performing clinical trials or studies.” and was approved or licensed. . . This aspect of Hrymoc ignored altogether one of the express statutory terms – “licensed.”
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