Case Activity (12)

1. Order | Filed: March 31, 2025 | Entered: March 31, 2025 American Clinical Laboratory Association et al v. U.S. Food and Drug Administration et al

   Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision | Texas Eastern

   Judgment

   FINAL JUDGMENT. For the reasons set forth in the Court's Memorandum Opinion and Order on this date, (Dkt. # 93 ), it is CONSIDERED, ORDERED, and ADJUDGED that Plaintiffs' Motions for Summary Judgment, (Dkt. # 20 , # 27 ), are GRANTED. Defendants' Cross-Motion for Summary Judgment, (Dkt. # 54 ), is DENIED. The Court thus enters Final Judgment in favor of Plaintiffs the American Clinical Laboratory Association, HealthTrackRX Indiana, Inc., and HealthTrackRX, Inc., the Association for Molecular Pathology and Michael Laposata, M.D., and against Defendants, United States Department of Health and Human Services, the Food and Drug Administration, Robert F. Kennedy, Jr., and Sara Brenner, M.D. in their official capacities. It is further ORDERED, ADJUDGED, and DECREED that: The Court VACATES and SETS ASIDE, in its entirety, the FDA's Final Rule titled Medical Devices; Laboratory Developed Tests, 89 Fed. Reg. 37,286 (May 6, 2024) (to be codified at 21 C.F.R. § 809). The Court remands this matter to the Secretary of Health and Human Services for further consideration. The Clerk is directed to close these consolidated actions. Signed by District Judge Sean D. Jordan on 3/31/2025. (rpc)

2. Order | Filed: March 31, 2025 | Entered: March 31, 2025 American Clinical Laboratory Association et al v. U.S. Food and Drug Administration et al

   Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision | Texas Eastern

   Memorandum & Opinion Order

   MEMORANDUM OPINION AND ORDER. It is ORDERED that the Laboratory Plaintiffs' Motions for Summary Judgment, (Dkt. # 20 , # 27 ), are GRANTED. The final rule is hereby SET ASIDE and VACATED. It is further ORDERED that Defendants' Cross-Motion for Summary Judgment, (Dkt. # 54 ), is DENIED. Signed by District Judge Sean D. Jordan on 3/31/2025. (rpc)

3. 10 additional result(s)