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Regen Biologics, Inc. v. Sebelius
Citation: Not availableDocket: Civil Action No. 2011-1006
Court: District Court, District of Columbia; October 24, 2012; Federal District Court
Original Court Document: View Document
Ivy Sports Medicine, LLC has filed a motion with the U.S. District Court for the District of Columbia, seeking to compel the U.S. Food and Drug Administration (FDA) to supplement the administrative record with materials it claims are missing. The Court's ruling on this motion is partially granted and partially denied. The memorandum, which is not intended for publication, serves to clarify the rationale for the decision and may assist in future legal analyses regarding res judicata and the law of the case. The Court emphasizes that when reviewing agency actions under the Administrative Procedure Act (APA), it must consider the entire administrative record as it existed when the FDA made its decision, rather than a limited subset of materials. The APA mandates a comprehensive review, ensuring the Court has access to the same information the agency relied upon. The standard for supplementing the administrative record is stringent; there exists a strong presumption that the agency has correctly compiled the record, and supplementation is considered an exception. Courts should avoid the temptation to second-guess agency decisions unless there is clear evidence that the record was improperly designated. A motion to supplement the administrative record requires proof that the documents were reviewed by the actual decision-makers involved in the determination, rather than mere implication. In the case presented, the plaintiff seeks to include interview notes from FDA employees related to a 2009 review intended to assess potential changes to FDA policies. However, these notes were not part of the decision-making process regarding the rescission of a Substantial Equivalence Order in 2011 and thus do not need to be included in the record. Additionally, the notes are protected under the deliberative process privilege, as they were part of an internal deliberation intended to influence policy decisions. Regarding the request for seven 510(k) submissions, the FDA acknowledges consulting these documents when considering the rescission of Ivy's device clearance. The court finds that Ivy's request for these specific submissions is justified, as they are not merely duplicative of already provided summaries. The FDA's claims of undue burden do not hold, as they do not sufficiently address the need for the actual submissions. The court grants Ivy's motion in part, allowing the inclusion of the 510(k) submissions while denying the inclusion of the interview notes, with an accompanying order to be issued.