May 30, 2024

Device Recall Notice Turned into Plaintiff Lawyer Advertising?

Drug & Device Law
Eric L. Alexander

Litigation attorney Eric Alexander authored a blog post for Drug & Device Law breaking down a case that implicated Federal Rule of Civil Procedure 23(d)(1)(B), which concerns notice for proposed class action members. F.G. v. CooperSurgical, Inc., from the U.S. District Court for the Northern District of California, arose because of a recall notice for a Class II medical device. The plaintiffs brought a proposed class action and filed a motion for protective order related to communications about the recall, saying the recall notice was misleading because it did not mention the existence of the proposed class action. The court agreed with the plaintiffs. Mr. Alexander explains why this decision is troubling; not only did the court cite other district court decisions with notably distinct fact patterns, but it also made a judgment on communications relayed to patients by the clinics that treated them in accordance with U.S. Food and Drug Administration (FDA) guidance. He argues the court should have notified the FDA first before issuing its ruling, adding that the agency could have, for example, shared concerns about privacy rights of patients whose names were given to plaintiff lawyers without their consent.

READ: Device Recall Notice Turned into Plaintiff Lawyer Advertising?

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