Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Episode 18 | Unpacking the Packing: A Perspective on the Efforts to Expand the Supreme Court
On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction in Purl v. HHS halting enforcement of the U.S. Department of Health and Human Services’ (HHS) April 2024...more
The US District Court for the Northern District of Texas on June 18, 2025 vacated portions of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Rule) related to reproductive healthcare privacy....more
In June 2024, the U.S. Department of Health & Human Services’ Office for Civil Rights (HHS) issued a Final Rule modifying the HIPAA Privacy Rule to enhance reproductive health care privacy affecting all HIPAA covered entities...more
On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an opinion that vacates the 2024 final rule that enhanced privacy protections for protected health information (PHI) related to reproductive...more
The U.S. Environmental Protection Agency (EPA) provided on update on June 18, 2025, on the status of the December 2024 Toxic Substances Control Act (TSCA) risk management rule for trichloroethylene (TCE). According to EPA, it...more
Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more
The CFPB's 2024 final rule on credit card late fees has been vacated as a result of the lawsuit filed by several banking industry trade groups challenging the rule’s validity....more
On April 15, 2025, the U.S. District Court for the Northern District of Texas vacated a Consumer Financial Protection Bureau (CFPB) rule that capped credit card late fees at $8....more
On April 15, Judge Mark T. Pittman of the U.S. District Court for the Northern District of Texas entered an Order and Final Judgement vacating the CFPB’s 2024 credit card late fee rule (previously discussed here) for...more
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
Following the U.S. Securities and Exchange Commission’s action in March 2025 to end its defense of the final climate-related disclosure rules (Climate Rules), the Attorneys General of Massachusetts and other states...more
On April 15, 2025, Judge Mark T. Pittman of the U.S. District Court for the Northern District of Texas entered an order and final judgment vacating the CFPB's credit card penalty fees rule (the Late Fee Rule). Judge Pittman's...more
On April 7, 2025, Judge Matthew Kacsmaryk of the Northern District of Texas vacated two provisions of a major 2024 CMS nurse staffing regulation requiring nursing homes to have an RN on site 24 hours a day, 7 days per week...more
At the request of both sides of the lawsuit, a federal judge has voided the CFPB’s credit card late fee rule....more
The Consumer Financial Protection Bureau (CFPB or Bureau) agreed to vacate its controversial credit card late fee rule in a joint motion for entry of consent judgment filed in Chamber of Commerce of the United States of...more
The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
On April 7, 2025, the United States District Court for the Northern District of Texas vacated staffing requirements published in the Centers for Medicare & Medicaid Services (CMS) May 2024 Minimum Staffing Rule (the “Final...more
The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more
In light of ongoing litigation and the Trump administration’s new policy approach, federal banking agencies intend to rescind the 2023 CRA final rule and revert to pre-2023 standards....more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more
On March 13, 2025, the Federal Official Gazette published the decree amending and repealing various provisions of the Amparo Law (the "Amendment"). Substance and Objectives of the Amendment - This amendment to the Amparo...more
On February 7, 2025, Texas Supreme Court Chief Justice James D. Blacklock asked the Supreme Court Advisory Committee (the “Committee”) to “study and make recommendations on eliminat[ing] [ ] the Court’s current practice of...more