STORY FROM: Drugs & Medical Devices

Pedicle Screw Plaintiff Not Entitled to 510(k) Submissions for Unrelated Components, Judge Rules

ABERDEEN, Miss. — The plaintiff in a pedicle screw case is not entitled to production of the defendant’s 510(k) submissions for components used in a device not at issue in this case, a Mississippi federal judge affirmed, explaining that they are not relevant to the plaintiff’s claim that the device he received is defective.

On December 11, Judge Sharion Aycock of the U.S. District Court for the Northern District of Mississippi upheld a magistrate judge’s ruling that the plaintiff is not entitled to the submissions. Nor is the plaintiff entitled to customer complaint records, which the magistrate judge deemed “irrelevant,” ...

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Baker Donelson Bearman Caldwell & Berkowitz
Duncan Lott

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