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
The U.S. Supreme Court, in a 6-3 decision, ruled that the Medicaid Act’s any-qualified-provider provision does not confer individual rights enforceable under 42 U.S.C. §1983. This decision reverses the Fourth Circuit’s...more
On June 20, 2025, the Supreme Court of the United States issued six decisions: Diamond Alternative Energy, LLC v. Environmental Protection Agency, No. 24-7: This case addresses fuel producers’ Article III standing to...more
As noted in our prior blog post, on March 25, 2025, significant amendments to the General Corporation Law of the State of Delaware (the DGCL), were adopted by the Delaware General Assembly and signed into law by Governor Matt...more
In Opsis Airport Services Inc. v. Quebec (Attorney General), 2025 SCC 17 (Opsis), the Supreme Court of Canada (SCC) held that a statute can be declared constitutionally inapplicable to an enterprise carrying on activities...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 NRC is undergoing a period of transition, including the unexpected departure of Commissioner Christopher Hanson. Commissioner Christopher Hanson Dismissed On June 14, 2025, Commissioner Christopher Hanson was relieved...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 June 5, 2025, a unanimous Supreme Court eliminated the requirement for a higher evidentiary standard for majority plaintiffs (white, male, heterosexual, etc.) who claim discrimination under Title VII (also known as reverse...more
The Delaware Supreme Court has accepted both questions certified by the Delaware Court of Chancery concerning constitutional challenges to the safe harbor provisions implemented by Senate Bill 21 (“SB21”), which became law on...more
On Friday, Judge Matthew J. Maddox of the U.S. District Court for the District of Maryland ruled that the removal of Democratic Commissioners from the Consumer Product Safety Commission (“CPSC”) without cause was unlawful....more
On May 28, the U.S. Court of International Trade ruled that the tariffs imposed by President Trump under the International Emergency Economic Powers Act (IEEPA) were unlawful. In the case of V.O.S. v. United States, the court...more
A case pending before the Supreme Court could jeopardize the Affordable Care Act’s (ACA) mandate that certain preventive services be provided on a first dollar coverage basis to plan members. Kennedy v. Braidwood Management...more
The Delaware Supreme Court has agreed to accept questions certified to the court relating to the constitutionality of Senate Bill 21 (SB 21), which was signed into law back in March 2025. ...more
Markets plunged earlier this year upon President Trump’s announcement of steep tariffs on imports to the U.S. from its trading partners, at rates varying from 10% to 125% depending on the country of the imported goods’...more
“Equal is not fair, and fair is not equal. Equal is obtainable but fair is not.” The Montgomery County Circuit Court overseeing the launch of Alabama’s medical cannabis program has an interesting dilemma on its hands. It...more
In 24 hours, two federal courts injected significant uncertainty into the viability of tariffs implemented by President Trump under the authority of the International Emergency Economic Powers Act (IEEPA)....more
Several lawsuits challenging the legal validity of the tariff actions taken by President Trump since he took office on January 20, 2025, are in process of moving through the federal courts. They raise a variety of important...more
On May 28, 2025, the U.S. Court of International Trade (CIT) ruled that President Trump lacks authority under the International Emergency Economic Powers Act (IEEPA) to impose his most sweeping tariffs against U.S. trading...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
At a critical stage of the Trump Administration’s aggressive global trade reset, a federal court has struck down a major statutory pylon of the White House trade strategy, potentially depriving President Trump of the most...more
President Trump continues to expand his trade policy by announcing proposed increased tariffs, while trading partners attempt to effectuate trade deals with the US, and as President Trump’s authority to impose his initial...more
On February 18, 2025, President Trump issued Executive Order 14215 “Ensuring Accountability for All Agencies,” Section 7 of which provides that: “[t]he President and the Attorney General’s opinions on questions of law are...more
Two courts this week invalidated the tariffs issued by the President under the International Emergency Economic Powers Act (IEEPA). First, late Wednesday night (May 28), the US Court of International Trade (CIT) in V.O.S. v....more
The Supreme Court of the United States granted certiorari in four cases today: Bost v. Illinois State Board of Elections, No. 24-568: This case involves an Illinois law that required mail-in ballots to be counted as long...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