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
Suppose an administrative agency issues a rule governing private conduct. And suppose no one uses an available judicial review process to challenge that rule before it takes effect. If that rule is then invoked against a...more
The Supreme Court’s decision in NRC v. Texas gives nuclear energy generators and storage facilities, as well as NRC, the latest win in the decades-long struggle over used-fuel storage....more
The Congressional Review Act (“CRA”), enacted in 1996, allows Congress to disapprove federal regulations promulgated by government agencies within 60 legislative working days after the rule is submitted to Congress. In order...more
On May 29, 2025, in Seven County Infrastructure Coalition v. Eagle County, Colorado (2025) 605 U.S. ____, the Supreme Court gave instruction that the National Environmental Policy Act (NEPA) “is a procedural cross-check, not...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
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 March 4, 2025, the Supreme Court issued its opinion in City and County of San Francisco v. Environmental Protection Agency, holding that EPA does not have the authority to issue “end-result” requirements in National...more
For over 65 years, Public Law 86-272 has dictated a state’s ability to assert income tax on an out-of-state business. While the 1959 federal law predated the emergence of e-commerce and digital services and could not have...more
As we previously reported, in April 2024 the Equal Employment Opportunity Commission (EEOC) issued its final regulations implementing the Pregnant Workers Fairness Act (PWFA). Among other things, the rule stated that...more
In a recent decision, a New Jersey court reaffirmed the Judiciary Branch’s exclusive constitutional authority to regulate the practice of law within the state. The case involved a challenge to the “limited attorney exemption”...more
More than 50 years ago, the Federal Clean Water Act (CWA or Act) was enacted by Congress to protect the quality of the Nation’s waters. The scope of that protection has been evolving ever since. Until relatively recently, the...more
Following the US Supreme Court’s decision in Loper Bright announcing the end of Chevron deference, lower federal courts have begun to apply the decision to uphold some federal wage-hour rules while striking down others; state...more
In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more
In a significant ruling, the Supreme Court affirmed the authority of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to regulate weapon parts kits and unfinished frames or receivers as “firearms” under the Gun...more
In a much-anticipated decision, the U.S. Supreme Court significantly narrowed the EPA's authority under the Clean Water Act (CWA) to impose so-called "end-result" requirements in NPDES permits. These "end-result" requirements...more
On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more
On March 31, 2025, Judge Sean D. Jordan of 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...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...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
President Trump issued more than 70 Executive Orders in the first 30 days of his new administration – nearly twice the amount his closest competitor (President Biden) issued in his first 100 days. These Executive Orders have...more
On January 8, the United States District Court for the Southern District of New York dismissed the claims brought by Banco San Juan Internacional, Inc. (BSJI) against the Federal Reserve Bank of New York (FRBNY) and the Board...more
Last term’s opinion in Loper Bright Enterprises v. Raimondo was a landmark in the U.S. Supreme Court’s administrative law jurisprudence, overturning 40 years of Chevron deference with a pen stroke. The Loper Bright/Chevron...more
In a landmark ruling on 28 June 2024, the US Supreme Court expressly overruled the 40-year-old Chevron doctrine with its decision in Loper Bright Enterprises v. Raimondo, eliminating the requirement that courts defer to...more
It is instructive to review the Supreme Court’s record in its most recent term, concentrating on regulatory and administrative law cases, which are usually back-burner issues. But not this term....more
On 28 June 2024, the U.S. Supreme Court issued a landmark decision in the case of Loper Bright Enterprises v. Raimondo, overturning its decision in Chevron USA v. National Resources Defense Council, and with it, 40 years’...more