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, the U.S. Supreme Court issued two decisions that clarify a deceptively simple question under the Clean Air Act: Where should lawsuits challenging EPA actions be filed? The rulings – EPA v. Calumet Shreveport...more
The U.S. Supreme Court issued a pair of decisions in EPA v. Calumet Shreveport Refining and Oklahoma v. EPA on June 18, 2025, resolving two related circuit splits regarding proper venue for challenging certain U.S....more
On May 29, 2025, the U.S. Supreme Court (SCOTUS) issued an opinion in Seven County Infrastructure Coalition et al. v. Eagle County, Colorado et al., which narrowed the requirements of environmental review under the National...more
As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more
Like a gift to land use lawyers that never stops giving, the strange and wondrous interrelationship between CEQA and the Permit Streamlining Act (“PSA”; Gov. Code, § 65920 et seq) continues to inspire litigation and require...more
The State of New York Supreme Court/County of Albany (“Court”) addressed in a May 6th Order whether the New York State Department of Health (“DOH”) has the authority to issue Watershed Rules and Regulations (“Rules”) to...more
On May 29, the Supreme Court issued a unanimous opinion in Seven County Infrastructure Coalition v. Eagle County, Colorado that dramatically changes the way courts scrutinize federal agencies’ environmental reviews under the...more
In Att’y Gen. v. Town Milton, the court ruled that the Massachusetts Bay Transportation Authority (“MBTA”) Communities Act, G. L. c. 40A, § 3A (“Section 3A”), is constitutional, and that the Attorney General has the authority...more
On April 17, 2025, the U.S. Fish and Wildlife Service (“USFWS”) and the National Marine Fisheries Service (“NMFS”) (collectively the “Services”) published a notice in the Federal Register of a proposed rulemaking that would...more
On April 17, 2025, the US Fish and Wildlife Service and the National Oceanic and Atmospheric Administration published a notice of proposed rulemaking to rescind the definition of “harm” under the Endangered Species Act...more
On March 29, 2025, the U.S. District Court for the Western District of Texas (District Court) vacated the Endangered Species Act (ESA) special 4(d) rule for the northern distinct population segment (DPS) of the lesser...more
Holtzman Vogel attorneys wrote on the Supreme Court's landmark Loper Bright decision earlier this month. The Court overruled its 1984 decision in Chevron v. NRDC that introduced the so-called "Chevron deference" principle...more