Category: Administrative & Regulatory

New Agreement to Accelerate Importation of Health Products Through PAHO

On June 11, 2025, was published in the DOF the “AGREEMENT recognizing as equivalent the requirements established in the Health Regulation and the technical evaluation procedures carried out by the Federal Commission for the Protection against Sanitary Risks for the granting of the marketing authorization of health products, to the requirements, tests and evaluation procedures carried out by the regulatory authorities of reference to allow the sale, distribution and use of health products in their country, and to the evaluations of the World Health Organization’s Prequalification Program, as well as the criteria for the importation of products for the treatment of emerging, unattended diseases or in cases of national emergency“.
The Agreement establishes the criteria for the importation of products for the treatment of emerging and unattended diseases or in situations of national emergency. Among its provisions, it highlights that certain products such as vaccines, medicines and medical devices may be acquired by the Ministry of Health through the Strategic Fund and the Revolving Fund of the Pan American Health Organization (PAHO), without the need to have a marketing authorization in Mexico.
It should be recalled that this is not the first agreement of this nature, the last similar agreement was published in the DOF on December 4, 2024, “AGREEMENT to obtain the import permit for health products destined to guarantee the supply of the public sector”, which allows obtaining more expedited import permits for products that already have a marketing authorization or sanitary registration issued by recognized regulatory authorities. (See our newsletter editions: SEP 19, 2024; FEB 2020; JUN 30, 2021).
In comparison, the new pathway through PAHO could represent an even more expeditious mechanism to try to “secure” the health sector’s supply in priority cases than the one established by the agreement of December 4, 2024. In addition, this new agreement leaves without effect those previously published on March 29, 2019, January 28, 2020, and the June 22, 2021, amendment, although it does not repeal the December 4, 2024, agreement.
This new agreement does not define or specify the terms “emerging or neglected diseases or cases of national emergency”, nor does it clearly establish the timeframe or the conditions for its application, which generates uncertainty regarding the scope and operability of the Agreement. Likewise, there is a possible affectation due to possible conditions of competitive disadvantage, discrimination and inequity to the suppliers of health products, due to the entry of products acquired from PAHO, at their discretion.

HSE Begins Public Consultation on CLP Reform Proposal

The United Kingdom’s (UK) Health & Safety Executive (HSE) has begun a public consultation on a legislative proposal to reform the Great Britain (GB) Classification, Labelling and Packaging (CLP) Regulation. HSE notes that GB CLP Article 37 links mandatory classification and labeling (MCL) in GB to evaluation activity in the European Union’s (EU) harmonized classification and labeling (CLH) system by creating a statutory obligation to consider the European Chemicals Agency’s (ECHA) Committee for Risk Assessment’s (RAC) opinions on harmonized classification proposals made under the EU CLP. This consideration is required “even for those which consider substances or hazard classes not authorised for use in GB.” The requirement to consider RAC opinions that are not relevant to GB adds additional burdens for the regulator and is exacerbated by the recent EU CLP revisions. The European Commission (EC) introduced six new hazard classes into the EU CLP, and these classes are prioritized for consideration under the EU CLH system. HSE states that this revision to the EU CLP “will result in a greater proportion of RAC opinions featuring non-GB CLP hazard classes.” HSE notes that the statutory timelines in Article 37 of the GB CLP are currently triggered when a RAC opinion is published, “requiring evaluations to be sequenced by the RAC opinion publication date determined for the EU.” According to HSE, the current timelines restrict its ability to prioritize its GB MCL evaluation work appropriately and to provide regulatory clarity to a timescale dictated by relevance to the GB market.
HSE states that it believes amending the GB CLP is necessary to provide greater certainty for duty holders and to ensure that future GB MCL evaluation activity can be delivered “predictably and sustainably.” HSE proposes to consolidate GB CLP Articles 37 and 37A into one procedure under which MCL proposals would be evaluated, thereby simplifying the process for substance and mixture classification in GB. HSE notes that the consolidated procedure would include a fast-track evaluation pathway for assessing classification proposals from territories that adopt the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS).and have a transparent classification process. Classification proposals from jurisdictions that do not adopt the UN GHS and do not have a transparent classification process would be evaluated under a full process, similar to that currently described in Article 37A. HSE provides a flowchart showing a possible route to fast-track evaluation for assessing classification proposals from UN GHS adopting territories that have a transparent classification process:

HSE also proposes to omit from the consolidated procedure the legal requirement for it to send a copy of its ministerial recommendation to devolved government (DG) ministers. According to HSE, “[t]his would reduce the administrative burdens arising from this aspect of delivery of the GB MCL system and ensure that resource is used proportionately.” HSE notes that it “remains committed to the evaluation of classification proposals that focus on carcinogenic, mutagenic, reproductive toxic and respiratory sensitising hazards” and states that these proposals would be prioritized for fast-track evaluation where they originate from the EU. Comments are due August 18, 2025.

If The Shoe Doesn’t Fit: Supreme Court Rejects “Minimum Contacts” For Personal Jurisdiction Under FSIA

The Supreme Court recently confirmed in a unanimous decision the requirements for personal jurisdiction over foreign states when parties seek to confirm international arbitration awards, but important questions remain.
In CC/Devas (Mauritius) Ltd. v. Antrix Corp. Ltd., after nearly fifteen years of litigation, the Supreme Court held that personal jurisdiction exists over a foreign state under the Foreign Sovereign Immunities Act of 1976 (“FSIA”) when at least one of FSIA’s sovereign immunity exceptions applies and service is proper. In reaching that conclusion, the Court reversed the Ninth Circuit’s earlier determination that, based on International Shoe Co. v. Washington, 326 U.S. 310 (1945), personal jurisdiction cannot exist under FSIA absent “minimum contacts” with the United States.
This case, like many others, “began with two companies and a contract.” Antrix Corporation Ltd. (“Antrix”)—a company owned by the Republic of India—and Devas Multimedia Private Ltd. (“Devas”) entered into a satellite-leasing agreement. Under the agreement, Antrix agreed to build a satellite network and lease a portion of it to Devas. After several years, and right before the satellites were scheduled to launch, Antrix terminated the agreement, at the government’s request, invoking the contract’s force majeure clause. 
Devas initiated arbitration, and the arbitral panel unanimously concluded Antrix breached the contract and awarded Devas $562.5 million in damages, plus interest. After successfully confirming the arbitration award in France and the United Kingdom, Devas sought to do the same in the Western District of Washington, resulting in a $1.29 billion judgment. On appeal, however, the Ninth Circuit, relying on circuit precedent, concluded the district court lacked personal jurisdiction over Antrix because it did not have sufficient “minimum contacts” with the United States under International Shoe.
The Supreme Court reversed. Starting with FSIA’s plain text, the Supreme Court explained that personal jurisdiction “shall exist” if (1) one of the Act’s enumerated exceptions applies and (2) service was proper. By importing the requirements of International Shoe, the Ninth Circuit created a third requirement divorced from the plain text and not otherwise supported by the FSIA’s structure or history.
While the Court’s holding confirms that the FSIA does not itself require minimum contacts, it left open whether such a nexus remains necessary to comport with the requirements of the Due Process Clause of the Fifth Amendment. The Court also declined to decide whether the FSIA’s arbitration exception to foreign sovereign immunity applies only to arbitration agreements that concern commerce within or with the United States; and whether this case, which involves parties located in a foreign country (India) engaged in commerce in a foreign country under the laws of that country, should be dismissed under forum non conveniens. These questions will likely need to be sorted on remand to the District Court.

Meta’s AI Copyright Victory: What It Means for the Future of AI Training

On the heels of our post on Anthropic’s mixed ruling in its copyright case, we have witnessed another plot twist in the AI copyrighted-data-usage saga, this time with Meta scoring a significant victory of its own in federal court. 
The Battle Lines: Authors vs. Meta’s Llama
Several prominent public figures, including comedian Sarah Silverman and Pulitzer Prize winners Andrew Sean Greer and Junot Díaz, have challenged Meta’s extensive AI plans, arguing that Meta’s Llama AI (whose branding is an amalgam of “Large Language Model”) was trained on their works without authorization. 
In discovery, Meta essentially conceded that point. Nonetheless, US District Judge Vince Chhabria just delivered a major victory for Meta, granting summary judgment in its favor. But this decision is different from the Anthropic outcome, with far-reaching implications for both content creators and AI developers.
Why Meta Won (And What the Authors Got Wrong)
A key inquiry in the fair-use analysis is whether the secondary work (here, Llama) is likely to substitute for the original work (the authors’ books) in the marketplace and thereby undermine the incentive to create. The judge’s reasoning centered on a key oversight by the authors: they failed to establish a vital point in this inquiry—market harm. Consider this: if someone takes your work and creates something entirely different, does it impact your book sales? That’s the critical question the authors didn’t address. Judge Chhabria pointed out, Look, you might have a case about AI saturating the market, but you never really made that argument in court.
Meta’s defense? Their AI isn’t trying to be a book. It’s not meant to be read like a novel. Instead, it’s a “quintessentially transformative” product that learns from books to do something entirely different. It’s like saying a chef who learns techniques from cookbooks isn’t competing with those cookbooks—they’re creating meals, not recipes. 
A recent study on Llama indicates this isn’t entirely accurate. That study revealed that Llama 3.1 “memorizes certain books, such as Harry Potter and 1984, almost completely.” In the Harry Potter example, the study found that Llama 3.1 memorized 42 percent of the first Harry Potter book (HP and the Philosopher’s Stone) so thoroughly that it can reproduce verbatim excerpts at least half the time. 
The Piracy Problem Nobody’s Talking (Enough) About 
Here’s the surprising part: evidence suggests that Meta may have knowingly downloaded millions of books from shady “shadow libraries” such as Books3, Library Genesis, and Z-Library. These are piracy networks, and internal emails reportedly revealed that Meta brass approved of using “likely pirated” material.
You might think that Llama has run out of grazing space, right? Surprisingly, the judge didn’t dwell on this revelation as much as you’d expect. This judicial divergence raises broader questions about how courts should weigh the methods by which AI systems acquire their capabilities against their ultimate functions. When AI systems increasingly serve as intermediaries between humans and information, the legitimacy of their training processes may matter beyond traditional copyright analysis, affecting public trust in AI-mediated knowledge and decision-making. 
A Tale of Two Rulings: Meta vs. Anthropic
Our earlier discussion of the Anthropic case is highly relevant to this context. While Meta emerged victorious, Anthropic faced a more complex result. Judge Alsup concluded that training AI using copyrighted books is acceptable (describing it as “exceedingly transformative”), but downloading those books from pirated sites is clearly prohibited. Anthropic remains at risk of a damages trial over its methods of collecting training data. As Judge Alsup put it, “You can’t just bless yourself by saying I have a research purpose.” 
The comparison is notable: two federal judges, two AI companies, similar copyright claims, yet different emphasis and rulings. Judge Chhabria even questioned some of Judge Alsup’s reasoning, highlighting ongoing debates on how to address AI and copyright issues. These differing approaches suggest courts are still developing frameworks for evaluating AI systems that will increasingly shape how people access and understand information. The question isn’t just whether AI training constitutes fair use, but how the integrity of AI development processes affects their role as knowledge intermediaries.
What This Means for You
If You’re in AI:
The good news? Training AI models with copyrighted material appears to have legal support as “transformative use.” However, you must ensure you’re obtaining that data legally. The era of “download first, ask questions later” is seemingly coming to an end.
If You’re a Creator:
Stay hopeful. The Anthropic ruling protects your work from piracy by proxy from LLMs. This ruling offers a clear guide for upcoming cases. The main focus is on demonstrating market harm. Show how AI-generated content might flood your market and impact your sales negatively. Keep records of everything. Get involved with creator advocacy organizations. And display “NO AI TRAINING” notices on your work. 
The Bottom Line
These rulings arrive as AI systems transition from experimental technologies to essential infrastructure for information processing and decision-making. We are witnessing the emergence of new legal frameworks for the AI era. Meta’s victory doesn’t mean AI companies have free rein to use any content they want. It means they need to be smarter about how they acquire data and how they utilize it.
The message is becoming clearer: AI can learn from the world’s creative works, but it must adhere to the rules and establish its authority through legitimate means. Think of it like this — AI needs a library card rather than a pirate’s map. As these systems become more powerful mediators of human knowledge and creativity, the integrity of their development processes becomes as important as their capabilities. 
As these technologies transform how we create and consume content, one thing’s certain: the legal battles are far from over. But at least now we’re beginning to see where the boundaries might be.
Stay tuned for more updates on AI copyright law as this fascinating legal landscape continues to develop.
“Llama is not capable of generating enough text from the plaintiffs’ books to matter, and the plaintiffs are not entitled to the market for licensing their works as AI training data.” U.S. District Judge Vince Chhabria

Federal Court Nullifies HHS Rule Granting Extra Protections to Reproductive Health Information

On June 18, 2025, a federal district court struck down a regulation from the U.S. Department of Health and Human Services (HHS) that restricted disclosure of reproductive health information in connection with investigations and prosecutions of patients who receive, or people who help them receive, reproductive health care.

Quick Hits

The U.S. District Court for the Northern District of Texas recently invalidated an HHS rule that imposed additional limits and conditions on disclosure of a person’s reproductive health information for the purpose of criminal and civil investigations and prosecutions.
The court ruled that health plans and healthcare providers can disclose a person’s reproductive health information to comply with state reporting mandates.
The court left intact part of the regulations that implemented notice of privacy practices requirements for Part 2 substance abuse disorder protections.

On June 18, 2025, the U.S. District Court for the Northern District of Texas struck down a 2024 HHS rule that bestowed extra privacy protections on reproductive health information that is personally identifiable. The ruling applies nationwide.
As a result, the modifications to the privacy rule under the federal Health Insurance Portability and Accountability Act (HIPAA) that further limited situations in which health plans and healthcare providers could disclose reproductive health information in the context of criminal or civil prosecutions is no longer in effect.
In Purl v. U.S. Department of Health and Human Services, the court reasoned that the HHS rule is “contrary to law” because it “unlawfully limits” state public health laws. In particular, the court found the HHS rule “impermissibly redefines ‘person’ and ‘public health’ in contravention of federal law and in excess of statutory authority.” Furthermore, the court stated, “HHS regulations cannot preempt a contrary state law with more stringent health-information protection requirements.”
HIPAA states that federal law does not “invalidate or limit the authority, power, or procedures established under any law providing for the reporting of disease or injury, child abuse, birth, or death, public health surveillance, or public health investigation or intervention.”
In this case, a healthcare clinic owner in Texas sued, claiming the HHS rule impaired her ability to fulfill a state-mandated obligation to report child abuse to authorities. Many states mandate that certain professions, such as teachers, social workers, and healthcare providers, report to the police when they have reasonable cause to suspect child abuse or child neglect.
Background on the Rule
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy took effect on June 25, 2024, and covered entities were required to comply by December 23, 2024.
That regulation was published after the Supreme Court of the United States decided in 2022, in Dobbs v. Jackson Women’s Health Organization, that states could ban abortions. A few states passed laws to permit criminal charges against women for getting an abortion, or against individuals who helped women travel to obtain an abortion. In response, the Biden administration issued an executive order requiring HHS to find methods to protect and expand access to reproductive healthcare services. HHS issued regulations to restrict the disclosure of reproductive health information for certain purposes.
The final rule specifically added “reproductive health care” to the types of medical information protected by HIPAA, if the medical care was lawful where and when it was provided. This term includes abortion, contraception, emergency contraception, pregnancy-related conditions, miscarriage management, and infertility diagnosis and treatment.
The final rule restricted HIPAA-regulated entities when disclosing reproductive health information for the following purposes:

to conduct a criminal, civil, or administrative investigation;
to impose criminal, civil, or administrative liability on a person for seeking, obtaining, providing, or facilitating reproductive health care; or
to identify any person for the purpose of conducting such an investigation or imposing such a liability.

At least sixteen states challenged the final rule in court. They argued the Biden-era rule exceeded HHS’s statutory authority and unlawfully restricted state-mandated reporting obligations, particularly those related to child abuse. The Trump administration revoked the previous executive order but has issued no further guidance. As of the date of publication, HHS has flagged the court’s vacatur of most of the regulations and the retention of the Part 2 provisions related to the notice of privacy practices, and it has stated that it “will determine next steps after a thorough review of the court’s decision.”
Next Steps
HIPAA-regulated entities may wish to review their policies and practices related to disclosing information about reproductive health care, including abortion. Pursuant to Purl v. U.S. Department of Health and Human Services, they will not be held liable for revealing a person’s reproductive health information to cooperate with a criminal or civil investigation.
The court decision upheld one part of the 2024 final rule that required HIPAA-regulated entities to communicate Part 2 requirements, when applicable, to obtain written consent before disclosing any information that identifies an individual as having a substance use disorder. Thus, health plans and healthcare providers are still required to amend their notice of privacy practices by February 16, 2026, to comply with the regulation related to Part 2’s substance use disorder information requirements.

Supreme Court Rules Federal District Courts Likely Lack Authority for Universal Injunctions

On June 27, 2025, the Supreme Court of the United States held that federal district courts likely lack the authority to issue universal injunctions blocking presidential actions nationwide, a ruling that is likely to allow the Trump administration to continue enforcing executive orders (EO) or other policies despite legal challenges to their constitutionality.

Quick Hits

The Supreme Court ruled that federal district courts likely lack the authority to issue universal injunctions blocking presidential actions nationwide.
The Court found that the Judiciary Act of 1789 does not provide for universal injunctions, emphasizing that equitable relief must be tailored to the specific plaintiffs involved in a case.
The decision will potentially allow the Trump administration to continue enforcing its executive orders despite ongoing legal challenges, while not commenting on the constitutionality of the specific executive order regarding birthright citizenship.

In the 6–3 decision in Trump v. CASA, Inc., the Supreme Court found that the Trump administration was likely to prove that the U.S. Congress did not provide district courts with equitable authority to issue universal injunctions in the Judiciary Act of 1789. The decision comes in cases alleging President Donald Trump’s EO limiting birthright citizenship is unconstitutional.
Three district courts have issued universal injunctions blocking the enforcement of the EO. Universal injunctions, often referred to as nationwide injunctions, are court orders that apply to a broader group of affected individuals or entities across the country.
“These injunctions … likely exceed the equitable authority that Congress has granted to federal courts,” the Court said.
The Supreme Court granted the administration’s applications to stay the injunctions “to the extent that the injunctions are broader than necessary” and ordered the lower courts to “move expeditiously to ensure that, with respect to each plaintiff, the injunctions comport” with the ruling and the principles of equity.
The ruling has significant implications for the powers of the federal courts and their authority to enjoin government actions beyond how they affect parties in a case. However, the Court expressly did not address whether the EO limiting birthright citizenship is unconstitutional.
Background
The decision stems from three cases brought by a group of individuals, organizations, and states alleging that challenging President Trump’s EO 14160, which asserted that citizenship may only be conferred to children with one or more parents who hold U.S. citizenship or lawful permanent resident (LPR) status (i.e., a “green card”). The plaintiffs alleged the EO violates the Fourteenth Amendment to the U.S. Constitution’s Citizenship Clause and Section 201 of the Nationality Act of 1940.
Federal district courts in each case ruled the EO is likely unconstitutional, and each court entered a universal injunction barring the enforcement of EO 14160 against anyone, not just the plaintiffs. The Trump administration sought stays of those universal injunctions but was denied by the First, Fourth, and Ninth Circuit Courts of Appeals. The Trump administration then filed emergency applications to the Supreme Court seeking partial stays limiting those injunctions.
Equitable Authority
The Supreme Court reasoned that the Judiciary Act of 1789, which authorizes federal courts to issue equitable remedies, does not extend to universal injunctions, as such remedies were not traditionally available in the High Court of Chancery in England at the time of the founding. The Court said the only “analogous” form of relief is the type of relief modern U.S. courts are only authorized to provide in class actions under Rule 23 of the Federal Rules of Civil Procedure. 
The Court further emphasized that injunctions should provide “complete relief” to the plaintiffs, but should not extend beyond what is necessary to achieve that relief. The Court said “‘[c]omplete relief’ is not synonymous with ‘universal relief,’” which it said is a “narrower concept” that addresses providing relief between the parties.
“Here, prohibiting enforcement of the Executive Order against the child of an individual pregnant plaintiff will give that plaintiff complete relief: Her child will not be denied citizenship,” the Court said. “Extending the injunction to cover all other similarly situated individuals would not render her relief any more complete.”
The plaintiff had argued that universal injunctions allow courts to protect groups from unlawful government actions. In contrast, the Trump administration had argued that blocking government action forces the government to seek stays and thereby requires federal courts to resolve difficult legal questions on an expedited basis without full briefing. However, the Court declined to address such policy arguments, holding that “well-established precedent” establishes the limits of equitable relief that district courts may provide.
“Nothing like a universal injunction was available at the founding, or for that matter, for more than a century thereafter,” the Court said. “Thus, under the Judiciary Act, federal courts lack authority to issue them.”
Rule of Law Questions
Justice Sonia Sotomayor issued a dissent, which was joined by Justices Elena Kagan and Ketanji Brown Jackson, arguing that the Court’s holding allows the government to continue to enforce an unconstitutional order against parties unless they file their own suit.
“The majority holds that, absent cumbersome class-action litigation, courts cannot completely enjoin even such plainly unlawful policies unless doing so is necessary to afford the formal parties complete relief,” Justice Sotomayor wrote. “That holding renders constitutional guarantees meaningful in name only for any individuals who are not parties to a lawsuit.”
Separately, Justice Jackson argued that the holding is an “existential threat to the rule of law” and that “courts must have the power to order everyone (including the Executive) to follow the law—full stop.”
Next Steps
The decision in Trump v. CASA, Inc., provides the Trump administration with a key judicial victory that will allow it to continue to enforce part of its EO on birthright citizenship against individuals who do not file suit, and could open the door for similar enforcement of other executive orders or policies that are facing constitutional challenges.

In TCPA Case, SCOTUS Rules District Courts Are Not Bound by Final FCC Orders

Key Takeaways:

The U.S. Supreme Court has ruled that the Hobbs Act does not require district courts in civil enforcement proceedings to follow federal administrative agencies’ legal interpretations of federal statutes.
This ruling is a logical extension of Loper Bright, which, in overturning Chevron deference, expanded the judiciary’s power to review and reject agency interpretations of federal statutes.
Justice Kavanaugh, writing for the 6-3 majority, determined it would be unfair to preclude judicial review by district courts and announced a “default rule” that applies where the statute neither expressly allows nor prohibits judicial review in the context of enforcement proceedings.
Justice Kagan, joined by Justices Jackson and Sotomayor, vigorously dissented, asserting that the ruling effectively rewards parties that “intentionally or negligently forgo [ ]Hobbs Act review.”

In June 2024, the U.S. Supreme Court decided Loper Bright Enterprises v. Raimondo, which, in overturning Chevron deference, expanded the judiciary’s power to review and reject interpretations of statutes adopted by federal administrative agencies. Last week, the Court’s majority articulated a logical extension of Loper Bright, holding, over a vigorous dissent, that the Administrative Orders Review Act — usually referred to as the Hobbs Act, 64 Stat. 1129 — does not require district courts in civil enforcement proceedings to follow an agency’s legal interpretation of a federal statute. Instead, this ruling in McLaughlin Chiropractic Associates, Inc. v. McKesson Corp., et al. held that district courts “must determine the meaning of the law under ordinary principles of statutory interpretation, affording appropriate respect to the agency’s interpretation.” 1
McLaughlin involved a Federal Communications Commission (FCC) order interpreting the Telephone Consumer Protection Act (TCPA) 47 U.S.C.A. § 227, specifically the TCPA’s prohibition on unsolicited advertisements sent by fax to a “telephone facsimile machine.” McLaughlin claimed, on behalf of a class, that McKesson had violated the TCPA by faxing unsolicited advertisements that did not contain an opt-in notice required by the statute. Most class members received those faxes via online fax services; only a few received them via traditional fax machines. The district court did not differentiate and certified a class of all fax recipients.
The Amerifactors Order
But, while the McLaughlin litigation was pending, a third party, wholly uninvolved in the litigation, petitioned the FCC for a declaratory ruling as to whether the TCPA applied to faxes received through online fax services. The FCC answered “no” in In re Amerifactors Financial Group, LLC, interpreting the term “telephone facsimile machine” to exclude online fax services.2 The McLaughlin district court found the FCC’s Amerifactors Order to be binding, in that the court had no authority to “question the validity of FCC final orders,” which are, under the Hobbs Act, “subject to the exclusive review of the court of appeals in pre-enforcement suits.” McLaughlin, 2025 WL 1716136 at *3 (internal quotations omitted). The district court, therefore, granted summary judgment in favor of McKesson on claims involving online faxes and, because there were only twelve people left, decertified the class. Id.
The Ninth Circuit agreed that the district court was “bound by” the Amerifactors order and affirmed. The Supreme Court, however, granted certiorari to “decide whether the Hobbs Act required the District Court to follow the FCC’s legal interpretation of the TCPA.” Id. at 4. Justice Brett M. Kavanaugh, writing for a 6-3 majority, held that the answer is “no.”
A “Default Rule” Allowing Judicial Review When Not Expressly Prohibited
The Hobbs Act provides for pre-enforcement judicial review of FCC orders (and orders from other listed agencies). A party that disagrees with an agency order may file a petition in a federal court of appeals within 60 days of the order. The Hobbs Act provides that “[t]he court of appeals…has exclusive jurisdiction to enjoin, set aside, or suspend (in whole or in part), or to determine the validity of … all final orders of the [FCC].” 28 U.S.C. § 2342(1). The problem, the Supreme Court wrote, is what happens if nobody does this and the 60 days passed? Are all federal courts then required to accept the agency’s interpretation, even if they find it incorrect or even irrational? Unsurprisingly, in the wake of Loper Bright, the Court answered in the negative.
The Court found it unfair that judicial review should be precluded and announced a “default rule” that applies where the statute neither expressly allows nor expressly prohibits judicial review in the context of enforcement proceedings: “In an enforcement proceeding, the district court must independently determine for itself whether an agency’s interpretation of a statute is correct,” including reviewing “whether the rule or order was arbitrary and capricious under the APA or otherwise was unlawful.” Id.,2025 WL 1716136 at *6, n.2. The Court remanded McLaughlin back to the District Court for its independent determination as to whether the FCC’s decision excluding online faxes from the TPCA is correct.
A Cautionary Dissent
But Justice Kagan’s dissent — with Justices Jackson and Sotomayor joining — asked, what about the Hobbs Act’s language to the effect that the courts of appeals have “exclusive jurisdiction” to “determine the validity of” FCC or other agency orders? Id., 2025 WL 1716136 at *17. Doesn’t the plain language of the statute require that aggrieved parties seek review in a court of appeals within 60 days or forever hold their peace? Isn’t the “default rule” just made up? Why should we reward parties that “intentionally or negligently forgo [ ]Hobbs Act review?” Id., 2025 WL 1716136 at *14, n.1. Do we really want, for example, plutonium shippers to scoff at Atomic Energy Commission regulations until (or unless) an enforcement action is brought, and only then challenge the regulation? Justice Kavanaugh spent at least ten pages rebutting arguments made by McKesson, the Government and the dissent. The bottom line is that the majority found that none of these arguments outweighed the unfairness of precluding a party, who may well have been unaware of the agency’s ruling, from challenging its validity when that ruling is actually being applied to it.
After Loper Bright, the result in McLaughlin should have come as no surprise. Parties should consider the doors for challenging many administrative rules and regulations to be wide open.
[1] McLaughlin Chiropractic Associates, Inc. v. McKesson Corp., et al., No. 23-1226, 2025 WL 1716136 at *6 (June 20, 2025); https://www.supremecourt.gov/opinions/24pdf/23-1226_1a72.pdf
[2] In re Amerifactors Financial Group, LLC, 34 FCC Rcd. 11950 (2019); https://docs.fcc.gov/public/attachments/DA-19-1247A1_Rcd.pdf

MPCA Will Postpone January 1, 2026, Reporting Deadline On Products Containing Intentionally Added PFAS

This week the Minnesota Pollution Control Agency (MPCA) posted Parts One and Two of its response to pre-hearing and hearing comments. Part One states that 67 commenters submitted written comments on the April 2025 proposed rule. During the May 22, 2025, hearing on the proposed rule, 11 stakeholders presented verbal testimony. According to the document, MPCA has reviewed the comments and “has identified some parts of the proposed rule that require clarification, or that the agency would consider minor, non-substantive changes to.” MPCA “does not believe that these potential changes will result in rules that are ‘substantially different.’” Part Two of the response to comments notes that the Commissioner of the Pollution Control Agency “has clear authority to extend the deadline if more time is needed for manufacturers to comply.” According to the document, MPCA “has decided outside of the rulemaking process to issue an extension to the initial due date to ensure program success.” MPCA will provide more information on the extension of the January 1, 2026, reporting deadline “in the near future.” MPCA will respond to comments received during the post-hearing comment period in a future rebuttal document. More information on the proposed rule and May 2025 hearing is available in our memoranda.

UK Data Use and Access Bill Becomes Law

The UK’s major post-Brexit reform of the UK General Data Protection Regulation (UK GDPR), the Data Use and Access Act (DUAA), was became law on 19 June 2025.
The DUAA had a long gestation in the form of two previous draft laws, the Data Protection and Digital Information Bills No. 1 and 2, the second of which failed when the UK general election 2024 was called. The new government resurrected most elements of the previous proposals as the DUAA.
The UK Information Commissioner’s Office has published guidance on the effects of the DUAA for businesses, but some of the more eye-catching changes include:

Of particular interest to businesses considering AI solutions – the removal of restrictions on use of personal data for automated decision-making, as long as there are some safeguards in place.
Consent no longer required to set statistical and functionality cookies.

The wider impact of the DUAA on UK–EU data transfers remains to be seen, with the EU due to review its UK adequacy decision by the end of 2025. However, as the EU has announced its own intention to reform the GDPR, more change could be on the way.

E-Verify Begins Notifying U.S. Employers of Terminations Under the CHNV Parole Program

The U.S. Department of Homeland Security (DHS) may exercise its authority to terminate parole or other humanitarian programs and revoke Employment Authorization Documents (EADs) at any time. 
Revoked EADs may still appear facially valid.
E-Verify will no longer issue Case Alerts to notify employers of revoked EADs.
E-Verify employers must use Form I-9, Supplement B to reverify affected employees and complete the reverification process within a reasonable period of time.

DHS recently terminated humanitarian parole and work authorization for nationals of Cuba, Haiti, Nicaragua and Venezuela (CHNV). As a result, affected individuals have received direct correspondence from DHS informing them of the termination of their parole and revocation of their EADs. Importantly, some revoked EADs may still appear facially valid for a period of time following revocation. 
As of June 20, 2025, E-Verify has issued updated guidance intended to put employers on notice of their obligations to immediately identify any current employees whose work authorization may have been revoked, and complete reverification of those employees’ work authorization within a reasonable time.
Previously, E-Verify issued “Case Alerts” to notify employers of EADs that had been revoked by DHS. Under the new guidance, Case Alerts will no longer be used. Instead, E-Verify employers are now responsible for regularly generating Status Change Reports to identify cases involving revoked EADs. Data concerning employees whose work authorization was revoked between April 9 and June 13, 2025, became available in the E-Verify system on June 20. 
What E-Verify Employers Need to Know

E-Verify employers must immediately use Form I-9, Supplement B to reverify employees identified in the Status Change Report as having a revoked EAD within a reasonable amount of time.
Employers must follow up on all entries in the Status Change Report and reverify affected employees using Form I-9, even if the EAD appears active.
Employees may still be authorized to work based on an alternative status and may provide other acceptable Form I-9 documentation to demonstrate employment authorization.

Form I-9 Reverification for E-Verify Employers

Affected employees must provide unexpired documentation from List A or List C of the Lists of Acceptable Documents. 
Employers should not reverify List B identity documents. 
Employers may not accept revoked EADs based on the Status Change Report, even if that EAD appears to be unexpired. 
Employers must allow employees to choose which acceptable documentation to present for reverification.
Employers should not create a new E-Verify case when completing the reverification process for affected employees.

Compliance Reminder
E-Verify employers should be aware that a failure to reverify potentially affected employees within a reasonable period of time may lead to liability. For more information, please contact the Barnes & Thornburg attorney with whom you work.

Workplace Wrap – July 2025

As we find ourselves in the new financial year, a number of the key financial thresholds relating to employees have changed. Click here to view our summary of the key thresholds for the 2025/2026 financial year. 
From 1 July 2025, the national minimum wage has increased by 3.5% to AU$24.94 per hour. 
Award minimum wages have also risen by 3.5%. 
In reaching its conclusion as to the national minimum wage, the Fair Work Commission has cited its principal consideration as a reduction in the real value of wages for employees. 
The Fair Work Commission notes this reduction has been driven by the spike in inflation beginning in 2021 and peaking in late 2022. The result, in the eyes of the Fair Work Commission, has been that the lower paid have experienced greater difficulties in meeting their everyday needs.
Therefore, the Fair Work Commission has sought to temper real wage decline without contributing to higher inflation. 
The Fair Work Commission notes its wage decision this year has been moderated by the upcoming increase in the Superannuation Guarantee contribution rate, and the uncertainties caused by the influence of the United States trade policies. However, the Fair Work Commission considered the wage increase determined is sustainable in a labour market that remains strong overall. 
The Fair Work Commission also observed that workforces that are reliant on modern awards for their wage rates are disproportionately female, with more than half being casual employees and more than a third being low-paid employees. The Fair Work Commission also noted that it intends to continue with its targeted review of particular award classifications to eliminate gender-based undervaluation of work and ensure that female workers receive equal remuneration for work of equal or comparable value. 
From 1 July 2025, the Superannuation Guarantee rate will increase to 12%.
The maximum contribution base per quarter has been reduced from AU$65,070 for the 2025 income year, to AU$62,500 for the 2026 income year so as to accommodate the increased contribution rate but noting that the annual concessional cap remains at AU$30,000.
This means that once an employee’s ordinary time earnings exceed AU$62,500 per quarter, employers are not required to make further superannuation contributions under the Superannuation guarantee legislation. If separate contractual obligations to pay superannuation apply, these obligations are unaffected.
The changes will apply from the first full pay period starting on or after 1 July 2025.
We note that whilst the Australian Taxation Office will begin making superannuation contributions on government-funded Parental Leave Pay, parental leave paid by an employer will continue to not fall within the definition of ordinary time earnings such that employers are not required to pay superannuation on these amounts.
The Fair Work Act’s high income threshold will also be indexed and from 1 July 2025, has increased to AU$183,100. Non-award and non-enterprise agreement covered employees who earn in excess of AU$183,100 will be unable to bring an unfair dismissal claim.
There has been no change in the value of penalty units applicable to the Fair Work Act which remain at AU$330 per unit. 
What You Should Be Doing From 1 July?
Employers should:

Review annualised salary arrangements to ensure that the annualised wage rate is sufficient to meet or exceed the employees’ minimum award or minimum wage entitlements taking into account the 3.5% increase.
Update payroll systems and processes to ensure the increased wages and superannuation contribution are paid from the first full pay period starting on or after 1 July 2025 and note the change to the maximum contribution base.
Review enterprise agreement pay rates (where applicable) and ensure the pay rates do not fall below the applicable modern award base rate or the national minimum wage (as applicable).
Ensure all employees who are eligible are being paid the appropriate super guarantee. 
Be mindful of the new high income threshold of AU$183,100.