Alerts

A putative class action against Whoop, the wearable technology company, uses the US Food and Drug Administration’s (FDA) July 2025 warning letter regarding its new blood pressure product feature as a litigation springboard. The case shows how misalignment with regulators’ expectations can quickly cascade from agency scrutiny to consumer litigation.

The New Mexico Environment Department (NMED) recently proposed broadly applicable labeling requirements for all products (including consumer products) that contain intentionally added per- or polyfluoroalkyl substances (PFAS) — the first such requirements in the nation.

On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System (HOPPS).

On December 1, the US Supreme Court will hear oral arguments in a case that could reshape secondary copyright liability for internet service providers (ISPs) and other network operators.

Generally, the Employee Retirement Income Security Act of 1974 (ERISA) prohibits discrimination based on a plan participant’s health status-related factor, such as a medical condition, medical history, or genetic information.

After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the submission of reasonable assumptions related to their average sales price (ASP) calculations. CMS also mandates that manufacturers submit Bona Fide Service Fee (BFSF) certification or warranty letters for new or renewal contracts dated January 1, 2026, or later that contain BFSFs with quarterly ASP.

Montway LLC is an Illinois-based leading automotive-transport broker that assists customers with transporting their vehicles across the country to alleviate them of the burden of driving those vehicles themselves.

US bankruptcy law is designed to promote and reconcile two core policy objectives: providing relief to financially distressed debtors and ensuring the equitable treatment of creditors vis-à-vis the debtor and other creditors.

Headlines that Matter for Companies and Executives in Regulated Industries

On October 30, the Illinois General Assembly passed the Clean and Reliable Grid Affordability Act (CRGA). CRGA makes significant updates to Illinois’ current statewide siting and zoning framework for renewable energy projects and creates a statewide standard for energy storage projects.

The US Supreme Court has fast-tracked challenges to President Trump’s unprecedented use of the International Emergency Economic Powers Act (IEEPA) to impose wide‑ranging tariffs, and based on recent oral argument, it is unclear how the Court will decide the case.

At the end of October, the Illinois legislature passed the Clean and Reliable Grid Affordability Act (CRGA), an omnibus energy bill creating various incentives for renewable energy and storage projects, modifying the project siting process, and creating a new siting process for energy storage systems.

A high‑stakes test of presidential tariff power took center stage on November 5 when the US Supreme Court (SCOTUS) heard consolidated arguments in Learning Resources Inc. v. Trump and V.O.S. Selections, Inc. v. Trump over sweeping, worldwide tariffs imposed under the International Emergency Economic Powers Act (IEEPA) to address “reciprocal” trade‑deficit measures and fentanyl trafficking.

US Congress tucked a big change into the latest government spending bill: a federal crackdown on intoxicating hemp-derived products.

In the environmental space, there is perhaps no more closely watched issue than how the US Environmental Protection Agency (EPA) defines the Clean Water Act term, “waters of the United States.”

Now in its 13th year, the Patent Trial and Appeal Board (PTAB) remains a central forum for resolving patent validity disputes.

Headlines that Matter for Companies and Executives in Regulated Industries

Welcome to the November 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

The US Patent and Trademark Office (USPTO) recently launched the Streamlined Claim Set Pilot Program — a new initiative designed to expedite patent examination for eligible patent application by advancing them out of turn until the issuance of a first Office Action.

On October 30, the Illinois General Assembly passed the Clean and Reliable Grid Affordability Act (CRGA), an omnibus energy bill creating incentives for energy storage projects.

The plaintiff, BDO USA, P.C. is an accounting and professional services advisory firm. The defendants are Ankura Consulting Group, LLC, Ankura’s CEO Kevin Lavin, and Phuoc Vin Phan.

On June 12, 2023, Deckers Outdoor Corporation, owner of the UGG brand, sued Quince, an affordable fashion e-commerce company, alleging that Quince’s shearling lined boots infringed Deckers’ unregistered trade dress and one design patent (US Patent D927,161) (the “’161 Patent”) covering one of its most popular boots, the Classic Ultra Mini Boot.

On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026.

The last legislative session in California brought with it a wave of changes to California employment law.

The US Food and Drug Administration (FDA) regulates the products hospitals and health systems use, make, or study. As health system innovations increasingly leap quickly across service lines, regulatory obligations can shift in real time.