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
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
President Donald Trump recently signed a proclamation reinstating and expanding the United States travel ban. The travel ban takes effect Monday, June 9, 2025, and as such, those affected by the ban should ensure they enter...more
On June 5, 2025, the Supreme Court in Ames v. Ohio Department of Youth Services unanimously struck down the Sixth Circuit’s “background circumstances” rule, which had required majority-group plaintiffs to meet a heightened...more
In a landmark decision, the U.S. Court of International Trade (CIT) has ruled against President Trump’s imposition of tariffs under the International Emergency Economic Powers Act (IEEPA). In its decision (involving two...more
On June 5, 2025, the United States Supreme Court issued a unanimous opinion in Ames v. Ohio Department of Youth Services, rejecting a longstanding rule applied by the Sixth Circuit and other circuit courts that imposed a...more
On June 5, 2025, the US Supreme Court dismissed as improvidently granted a closely watched case that could have clarified whether federal courts may certify damages class actions under Rule 23 when the class includes both...more
On June 5, 2025, the Supreme Court lowered the bar for majority-group plaintiffs – ruling they are not required to meet a higher standard to bring reverse discrimination claims. The Supreme Court unanimously ruled in Ames v....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
On May 29, 2025, the U.S. Supreme Court issued an 8-0 opinion that clarifies the scope of environmental effects analysis under the National Environmental Policy Act (NEPA) and requires substantial judicial deference to...more
The US Court of International Trade and the US District Court for the District of Columbia have invalidated President Donald Trump’s actions imposing tariffs pursuant to the International Emergency Economic Powers Act of...more
Orders the Counsel to the President, in consultation with the Attorney General and the head of any other relevant executive department or agency to investigate whether certain individuals conspired to deceive the public about...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
Last week, two federal courts struck down sweeping tariffs that the Trump Administration had recently imposed under the International Emergency Economic Powers Act (IEEPA). ...more
On May 22, 2025, the U.S. Court of Appeals for the Fifth Circuit (“Fifth Circuit”) addressed a dispute between ANR Pipeline Company (“ANR”) and FERC. The case centered on the interpretation of ANR’s tariff and whether it...more
On June 2, 2025, the U.S. Supreme Court rejected the appeal of a Fifth Circuit Court of Appeals decision interpreting the limitations period for filing lawsuits under Section 1981 of the Civil Rights Act of 1866. ...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
On June 5th the U.S. Supreme Court held that majority-group plaintiffs do not have to show special “background circumstances” to support a Title VII discrimination claim. ...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
After coming into office, President Donald Trump has invoked the International Emergency Economic Powers Act (“IEEPA”) to impose a series of tariffs on imports from worldwide trading partners. The President’s numerous...more
The Second Panel of the Brazilian Superior Court of Justice (STJ) recently issued a significant decision regarding the time limit for the offset of tax credits recognized in final and unappealable judicial decisions. The...more
Last week, two different district courts found that President Donald Trump did not have the authority under the International Emergency Economic Powers Act (“IEEPA”) to impose sweeping tariffs....more
Updated: Jun 4, 2025 -If you’ve ever watched Succession, you know that the show is a fierce exploration of power, influence, and legacy, with each member of the Roy family vying to be the voice and changemaker of their...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
The US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s final determination that challenged patent claims were not unpatentable, finding that the Board’s decision relied on an erroneous...more
Under Fed. R. Evid 502(d), a federal court can assure that an inadvertent disclosure of privileged documents in the case before it will not allow litigants in subsequent cases to argue that such disclosure triggered a...more