Supreme Court Decision Overturns Chevron: Impact on Cannabis Industry

Last month, the United States Supreme Court issued its decision and opinion in Loper Bright Enterprises v. Raimondo, significantly overruling the nearly 40-year-old precedent set by Chevron. The Chevron decision required federal courts to defer to a government agency’s interpretation of an ambiguous statute unless that interpretation was “arbitrary, capricious, or manifestly contrary” to the statute. This meant that if an agency such as the DEA published a bulletin or letter interpreting an ambiguous law, courts were generally bound to follow this interpretation due to the agency’s presumed expertise.

The Shift in Legal Interpretation

Loper Bright Enterprises has fundamentally changed this legal landscape. Now courts, rather than government agencies, are considered the best equipped to interpret ambiguous statutes. This shift means that a government agency’s interpretation of an ambiguous statute is now merely persuasive and not binding on the courts. This can be likened to a Pennsylvania court interpreting a Pennsylvania law and considering, but not being bound by, a Delaware state court’s interpretation of a similar corporate law. Just as Pennsylvania courts can choose to defer to, distinguish from, or disregard Delaware court decisions, federal courts now have the same discretion regarding agency interpretations of ambiguous statutes.

Impact on the Cannabis Industry

This change has significant implications for the cannabis industry. The Drug Enforcement Administration (DEA) enforces federal drug laws and has issued numerous letters and bulletins determining the legality of various cannabis substances. For example, the DEA issued opinions that seemingly argued that Delta-8 THC products and THCA products were not allowed under the 2018 Farm Bill. I have generally disagreed with these interpretations, believing that the DEA incorrectly cited statutes related to hemp at harvest rather than downstream products.

With Loper Bright Enterprises, these DEA letters will lose their authoritative value. Courts are no longer bound to follow DEA interpretations and can more readily consider arguments opposing the DEA’s stance. This development is critical for the cannabis industry, as it opens the door for courts to reinterpret federal drug laws and potentially challenge the DEA’s restrictive interpretations of the 2018 Farm Bill.

The Importance of This Shift

The overruling of Chevron by Loper Bright Enterprises marks a pivotal change in administrative law, particularly impacting the cannabis industry. This shift of interpretive authority from government agencies to the courts means there is now greater potential for legal challenges to restrictive interpretations of cannabis laws. This change enhances the ability of cannabis businesses and advocates to contest adverse decisions and interpretations by the DEA and other agencies, potentially leading to more favorable outcomes for the industry.

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the relator, Adam Hart, a former McKesson employee, filed a petition for certiorari seeking Supreme Court review of a Second Circuit decision that upheld the dismissal of relator’s complaint asserting claims under the civil False Claims Act (FCA) premised on alleged violations of the AKS. U.S. ex rel. Hart v. McKesson Corp., 96 F.4th 145 (2d Cir. 2024). A violation of the AKS requires as the scienter element that the defendant “knowingly and willfully” offered or paid remuneration to induce the recipient of the renumeration to purchase goods or items for which payment may be made under a federal health care program. 42 U.S.C. § 1320a-7b(b)(2). The Second Circuit held that a defendant does not act “willfully” within the meaning of the AKS unless that defendant “act[s] knowing that his conduct is unlawful.” United States ex rel. Hart, 96 F.4th at 154.

The AKS is enforced both as a criminal statute and, as in this case, is frequently used by the government or relators as a predicate violation to support an alleged violation of the civil FCA. Since 2010, Congress has specified that a claim that includes items or services “resulting from” an AKS violation is a false or fraudulent claim under the FCA. 42 U.S.C. § 1320a-7b(g). Though the evidentiary standard in criminal and civil cases differs, the government or relator in civil cases must adequately plead the “knowingly and willfully” scienter element of the AKS.

Hart alleged in his Second Amended Complaint that McKesson offered physician oncology practices two valuable business tools, the Margin Analyzer and the Regimen Profiler, to induce those practices to purchase oncology pharmaceuticals from McKesson. Hart alleged that these business tools were prohibited remuneration, and that McKesson acted “knowingly and willfully” in offering these two tools to its customers in violation of the AKS. Hart’s basis for alleging “willfulness” included: (1) alleged document destruction during the litigation; (2) Hart informed his supervisor during compliance training about the potential AKS violation, yet McKesson continued to provide these tools, worth about $150,000, to medical practices free of charge in exchange for commitments to purchase drugs from McKesson; and (3) Hart’s discussions with other employees that McKesson was inappropriately exploiting the business tools.

After the government declined to intervene, the District Court dismissed the FCA claims in a Second Amended Complaint (after dismissing the prior complaint as well) by ruling that Hart failed to plausibly allege sufficient facts to suggest McKesson acted “willfully”. The Second Circuit upheld the dismissal and agreed that a defendant acts “willfully” under the AKS only if the defendant knows “that its conduct is, in some way, unlawful.”

The Second Circuit rejected the relator’s proposed approach, a looser standard that would meet the “willfully” standard of the scienter element if (a) the company provided something of value in connection with the sale of pharmaceuticals reimbursed by the government, and (b) knew, even through general compliance training, that it is illegal to provide things of value to induce sales. Hart filed a petition for a writ of certiorari, presenting the question: “[t]o act ‘willfully’ within the meaning of the [AKS], must a defendant know that its conduct violates the law?”

There is no dispute, under the law, that a defendant does not need “specific intent” to violate the AKS. 42 U.S.C. § 1320a-7b(h). However, the petition raises questions about how certain sister Circuits interpret “willfully” when addressing violations of the AKS:

  • The Second Circuit held in this case that a defendant does not act “willfully” within the meaning of the AKS unless that defendant “act[s] knowing that his conduct is unlawful, even if the defendant is not aware that his conduct is unlawful under the AKS specifically.” United States ex rel. Hart v. McKesson Corp., 96 F.4th 145,154 (2d Cir. 2024).
  • The Eleventh Circuit, in accord with the Second, has also held that a defendant must know that its conduct is unlawful in order to violate the AKS. United States v. Sosa, 777 F.3d 1279, 1293 (11th Cir. 2015) (“[T]o find that a person acted willfully in violation of § 1320a-7b, the person must have acted voluntarily and purposely, with the specific intent to do something the law forbids, that is with a bad purpose, either to disobey or disregard the law.”) (internal quotations omitted)).
  • The relator argues in the petition that the Fifth and Eighth Circuits are split with the Second Circuit. Relator relies on a Fifth Circuit case holding that “willfully” requires that a “defendant willfully committed an act that violated the . . . Statute” without a requirement that a defendant know its conduct is unlawful. United States v. St. Junius, 739 F.3d 193, 210 & n.19 (5th Cir. 2013). However, a more recent Fifth Circuit case, which was cited by the Second Circuit, defines “willfully” to mean “the act was committed voluntarily or purposely, with the specific intent to do something the law forbids; that is to say, with bad purpose either to disobey or disregard the law.” United States v. Nora, 988 F.3d 823, 830 (5th Cir. 2021) (citation omitted).
  • The relator cites an Eighth Circuit case holding a defendant’s conduct is willful if a defendant “knew that his conduct was wrongful,” but asserts the Eighth Circuit has not “require[d] proof that [the defendant] . . . knew it violated ‘a known legal duty.’” United States v. Jain, 93 F.3d 436, 441 (8th Cir. 1996). However, a more recent Eighth Circuit relied on Jain to uphold a jury instruction stating, “[a] defendant acts willfully if he knew his conduct was wrongful or unlawful.” United States v. Yielding, 657 F.3d 688, 708 (8th Cir. 2011).
  • The Second Circuit did recognize a circuit split, but described its view as in “align[ment] with the approach to the AKS taken by several of our sister courts [including the Third, Fifth, Sixth, Seventh, Eighth, and Eleventh Circuits], which have held or implied that to be liable under the AKS, defendants must know that their particular conduct was wrongful.” United States ex rel. Hart, 96 F.4th at 154-55.

It is important to remember that the AKS is a felony statute subject to criminal fines and up to 10 years of imprisonment. It also criminalizes conduct that, in other industries, is not illegal. Further, due to the breadth of the statute and its complexity, Congress and the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) have developed a complicated set of guidance to help attorneys and compliance professionals understand and provide counsel with respect to AKS compliance, including statutory exceptions, regulatory safe harbors, advisory opinions, and an enormous body of sub-regulatory guidance. The Second Circuit understood this and noted that its “interpretation of the AKS’s willfulness requirement thus protects those (and only those) who innocently and inadvertently engage in prohibited conduct.” Id. at 155-56.

If the Supreme Court takes an interest in this case, it likely will invite the view of the Solicitor General. Any Supreme Court interest in granting this petition will likely attract a wide range of amici participation at the certiorari stage by health care industry groups and associations, pharmaceutical company associations, other business groups, as well as associations of whistleblower counsel and other supporters of the private action qui tam provisions of the FCA. Though the range of holdings by the Courts of Appeal are often nuanced, Supreme Court consideration of the issue would be viewed as very significant, and a decision that creates a rigorous standard for “willfulness,” or alternatively, a lenient one, could considerably impact the Department of Justice (DOJ) and relators’ ability to successfully plead, and prove, an AKS violation as a predicate to an alleged FCA violation.

Ozempic Lawsuit Overview

Makers of Ozempic and other semaglutide drugs are facing hundreds of lawsuits throughout the United States. While intended for diabetes management and weight loss, research has linked the drug to increased risk of gastroparesis, stomach paralysis, pancreatitis and bowel obstruction.

Plaintiffs and their Ozempic lawsuit lawyers are seeking monetary compensation through products liability litigation. Victims are continuing to come forward. As of June 2024, cases are in preliminary stages, with new cases being added to multi-district litigation.

What Is the Ozempic Lawsuit About?

The Ozempic lawsuit is about whether the manufacturers of semaglutide drugs created and sold an unreasonably dangerous drug that hurt people. Plaintiffs say that the drugs created an unreasonable risk of gastrointestinal injury – a risk that the drug manufacturers knew about, and that they hid from the public.

What drugs are involved in the Ozempic weight loss lawsuit?

Ozempic might be the best known of the drugs involved in the weight loss lawsuits, but there are several drugs named in litigation. These drugs include:

● Ozempic
● Wegovy
● Rybelsus
● Trulicity
● Mounjaro

Ozempic, Wegovy and Rybelsus are manufactured by Danish pharmaceutical giant Novo Nordisk. Trulicity and Mounjaro are manufactured by Eli Lilly and Company.

Each individual case names the drug or drugs that the plaintiff took.

What are the issues in the Ozempic lawsuit?

There are three primary issues alleged in the Ozempic lawsuits:

1. Whether the drug companies knew or should have known that their semaglutide drugs could cause gastroparesis and other gastrointestinal issues.

2. Whether the drug companies adequately warned doctors and patients about the dangers of their products.

3. Whether the drug companies made false, misleading, or incomplete statements about safety as they marketed their products.

Overview of the Drug of Ozempic and How It Works

Danish pharmaceutical company Novo Nordisk developed the diabetes drug Ozempic. Its purpose is to treat type 2 diabetes.

How do Ozempic and related weight loss drugs work?

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist. The drug signals the body that it is not hungry and to stop eating. It is meant to act like the GLP-1 hormone.

When we eat, the body releases the GLP-1 hormone in the intestinal tract. The hormone signals the brain that it is full. When the hormone is present, a person may eat less or stop eating. In diabetes patients, the drugs trigger insulin production and reduce a hormone from the pancreas that increases blood sugar. The drug helps keep the person’s blood sugar level lower, managing their diabetes.

Over time, Novo Nordisk made and marketed three different semaglutide GLP-1 receptor agonist drugs:

● Ozempic – Injected with a pen, approved in 2017
● Rybelsus – Taken by pill, approved in 2019
● Wegovy – Targeted for weight loss patients, in a higher concentration than other forms of semaglutides, approved in 2021

With FDA approval, sales of these weight loss drugs soared. Medicare even began to cover the drug Wegovy in 2024, with some restrictions. There was such a demand for the products that there was a shortage in 2023.

Not a miracle drug after all

At first, manufacturers thought that they had created a miracle drug. The New England Journal of Medicine reported that people taking semaglutide drugs lost up to 15% of their body weight. Novo Nordisk aggressively marketed the drugs, including with consumer-direct marketing campaigns. Influencers on social media touted the benefits, and there were stories of celebrities who had found seemingly effortless success.

However, it soon became clear that there may be serious problems with the drugs. Doctors and researchers began learning that the drugs may cause higher rates of gastroparesis and other gastrointestinal issues. Victims say that when these drugs were marketed to them, they were unaware that they were placing themselves in serious danger.

What’s the problem with Ozempic?

Ozempic and other weight loss drugs may cause higher rates of gastroparesis. Gastroparesis is a medical condition of weakened stomach muscles and intestines. The condition can lead to other problems and complications because the person cannot move food through the body in a
timely manner.

What is gastroparesis?

Gastroparesis is delayed gastric emptying of the digestive tract, including the stomach, intestines and bowels. The person has weakened muscles in their stomach and intestines, so they’re not able to digest food at a reasonable pace. The condition can cause several problems
and complications, including:

● Stomach pain
● Vomiting, nausea, diarrhea
● Fatigue
● Vitamin, nutrition deficiencies
● Bloating
● Too many bacteria in the small intestine
● Obstructed intestine or bowel

Gastroparesis can cause discomfort. The condition can be dangerous and life-threatening. Diabetes can mask the symptoms of gastroparesis, making it harder to detect.

Ozempic Lawsuit Case Details

What type of case is the Ozempic lawsuit?

The Ozempic stomach paralysis lawsuit is a tort product liability case, which is not an Ozempic class action lawsuit. The claims have been consolidated into multidistrict litigation. People who were harmed by taking the drug are bringing civil claims, seeking compensation for their monetary damages, physical harm and suffering.

What is the Ozempic lawsuit case number?

The Ozempic gastrointestinal lawsuits are currently joined in Multi-District Litigation In Re: Glucagon-Like Peptide – 1 Receptor Agonists (GLP-1 RAS) Products Liability Litigation, MDL-3094. The cases are joined in the United States District Court for the Eastern District of Pennsylvania. Each individual case that is part of the multi-district litigation proceeds retains its
own individual case number.

Note: Ozempic is also the subject of unrelated multi-district litigation regarding patents (MDL-3038). The cases have been consolidated in a Delaware court. The issues are unrelated to the issues in the defective drug products liability cases.

Who is the judge of the Ozempic multi-district litigation?

District Judge Gene E.K. Pratter was assigned to preside over the Ozempic multidistrict litigation. However, she passed away in May 2024. A new judge will be assigned to the case.

How many cases are a part of the Ozempic lawsuit?

As of June 2024, there are 101 cases pending in the Ozempic lawsuit multi-district litigation. New cases are being added periodically as victims come forward.

Multi-District Litigation – Cases Joined Together for Preliminary Proceedings

The Ozempic lawsuit started as separate lawsuits filed throughout the United States. At first, 18 cases were filed in 11 judicial districts. There were another 37 related cases in 15 districts.

Nine of the original plaintiffs believed that it would make more sense to build their cases together. They thought their cases were similar enough that they should work together for preliminary proceedings. They wanted to work together in discovery, preliminary motions, depositions and evidentiary rulings. On December 1, 2023, they filed a motion to transfer the cases from their respective courts.

On February 5, 2024, the courts agreed and ordered the cases combined for preliminary proceedings in multi-district litigation.

Not everyone wanted the transfer. Some plaintiffs thought that only claims against Novo Nordisk should be combined. The parties opposing MDL didn’t want multiple defendants combined.

However, the court transferred all claims involving similar allegations about GLP-1 RA drugs and whether they cause gastrointestinal issues. The court said that even though the two companies sold drugs with different molecular structures, complete overlap of issues is not required.

Current Status of the Ozempic Weight Loss Litigation

The Ozempic weight loss litigation is in the early stages. As of June 9, 2024, the court has issued four case management orders. These orders direct the parties to do certain things in preliminary proceedings.

Case management order no. 1 – February 15, 2024

● A statement that cases transferred to the court, and cases subsequently transferred to the court, will be subject to the court’s orders.
● Attorneys are directed to review the court’s policies and procedures.
● The court set the date, time and place for the first in-court case conference. The court set aside two hours of court time for the conference.
● Topics to be discussed included selecting plaintiff’s lead counsel, the responsibilities of lead counsel and allocation of tasks. The court said that pleadings, timing, future status conferences and other issues could be discussed.

Case management order no. 2 – February 16, 2024

● Waiving pro hac vice fees in the case.
● Requiring parties to submit the court’s pro hac vice form, if applicable.

Case management order no. 3 – April 23, 2024

● Appointing Liaison Counsel for Plaintiffs, and a mentor.
● Identifying and appointing counsel to the Plaintiff’s Committee.
● Authorizing Committee members to select additional counsel for the Committee, up to 25 total members.
● Allowing the Committee to create subcommittees.
● Ordering the Committee to propose conference dates.

Case management order no. 4 – April 24, 2024

● Requiring the parties to preserve potentially relevant evidence.
● Parties must keep documents, data and tangible things in their presence that are relevant to the claims and defenses in the case.
● Each party must take reasonable steps to avoid loss of the evidence. Auto-delete features must be disabled.
● Certain sources don’t need to be preserved, searched or produced from.
● Keeping evidence or information is not an agreement or concession that the material is relevant to litigation.

There have been other filings in the case. These filings are procedural, like asking the court for additional time to respond to the motion to transfer the cases to multi-district litigation and required proof of service documents.

The court held a status conference on March 14, 2024. Preliminary proceedings will continue, after which the court may schedule bellwether trials. These early trials inform the parties as to how cases may be decided if they go to trial.

Basis of a Claim

The decisions that people make about their medical care may impact the rest of their lives. The choices that people make about their healthcare should be informed.

A critical basis for the Ozempic lawsuit is the claim that the drug manufacturer failed to warn consumers about the risks of the drugs. Some claims allege that the warning label was too generic, listing minor symptoms but saying too little about gastrointestinal issues, and not
emphasizing the dangers enough.

Many patients saw the direct-to-consumer marketing campaigns, including $180.2 million spent to market the drug in 2022. Marketing efforts for Rybelsus were similarly robust in 2022, at $167.2 million spent. Much of the marketing budget was spent on national television ads.

The marketing worked, and sales climbed high that year. Novo Nordisk credited the marketing effort for its 36% revenue growth in North America in 2022.

Consumers say that with marketing efforts this strong, they had the right to complete information before taking Ozempic or another semaglutide drug.

U.S. products liability law and the Ozempic case

In the United States, drug manufacturers have a legal liability to make products that are reasonably safe. Product liability is the type of case that a victim may bring if they are harmed by a dangerous drug. One of the ways that a drug can be dangerous is if the public doesn’t have the information that they need about the risks and potential harm.

A claim may also be based on misleading statements in advertising. The lawsuits say that the drug manufacturer proclaimed the benefits of the drugs without emphasizing the potential risks. Plaintiffs say that the advertising campaigns were deficient enough that the drug companies
should be liable for damages.

Damages for Ozempic Lawsuit

The purpose of the Ozempic lawsuit is to compensate victims. A person who develops gastroparesis likely has significant losses due to medical expenses. They may have physical suffering.

Damages claimed may include economic and non-economic losses. Valuing damages is an important part of any case.

Proving an Ozempic Legal Claim

While you can file an Ozempic lawsuit, to succeed in an Ozempic lawsuit, a person must prove:

● They took Ozempic or a related drug.
● The drug was defective under legal standards.
● Because of taking the drug, the victim developed medical problems. There is causation between using the drug and the harm that occurred.
● Damages resulted to the victim including medical bills, other financial losses, physical pain, suffering and other damages.

Novo Nordisk is aggressively fighting claims. They have responded to the allegations and will be fighting the claims in the months to come. The parties will continue to discuss medical evidence and pursue their respective positions.

Justice for Ozempic Victims

Ozempic lawsuits are still in the early stages. New plaintiffs are continuing to join, and the cases are moving through preliminary proceedings. The court will schedule future dates as the parties develop their cases, pursue settlement and prepare for trial.

Nine Questions, Nine Answers: The Supreme Court’s Decision Overruling ‘Chevron Deference’

On the second-to-last day of its term, the US Supreme Court issued its decisions in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Dep’t of Commerce. These decisions overruled Chevron USA. v. National Resource Defense Council, the 40-year-old precedent that established the “Chevron” doctrine, which gave federal agencies a certain amount of deference to interpret statutes they administer.

The Chevron doctrine provides that when a statute is ambiguous — that is, when it is unclear whether US Congress has spoken directly to the precise issue at hand — courts must defer to the interpretation of the relevant agency as long as the agency interpretation of the statute is reasonable.

Since 1984, the Chevron doctrine has played a foundational role in administrative law and placed federal agencies as the primary interpreters of the statutes they administered. In recent years, many scholars and policy advocates have questioned whether the Supreme Court should, or would, overrule Chevron and reassert the judiciary’s primary role in interpreting statutes.

The Loper Bright decision is available here. Understanding that for many, this decision has resulted in a deep dive into arcane issues of constitutional law and regulatory policy, below we ask and answer nine questions about the decision, its background, context, and likely impact.

What happened?

CASE BACKGROUND

Both Loper Bright and Relentless involve the Magnuson-Stevens Act, a law that empowers the US Secretary of Commerce and the National Marine Fisheries Service (NMFS) to require certain fishing vessel operators to provide space onboard their vessels for federal observers tasked with ensuring compliance with various federal regulations.

To implement the Magnuson-Stevens Act, NMFS issued a rule requiring the fishing companies, rather than the government, to pay the costs and salary of the observers (roughly $710 per day). The petitioners in Loper Bright, four family-operated herring fishing companies, argued that the Act did not authorize the agency to impose these fees and challenged the rule before the US District Court for the District of Columbia. Relentless involved a challenge to the same regulations by two New England fishing vessels brought in Rhode Island federal court.

The appellate courts reviewing Loper Bright and Relentless, the US Courts of Appeals for the DC Circuit and the First Circuit, respectively, both applied the “Chevron doctrine” and ultimately upheld the NMFS regulation.

The DC Circuit found ambiguity in the statute that justified deferring to the agency’s reasonable interpretation. The First Circuit, in turn, cited back to the DC Circuit’s opinion in Loper Bright and similarly found the NMFS regulation did not exceed “the bounds of the permissible.” The Supreme Court granted certiorari in both cases and, considering them together, addressed whether it should uphold, limit, or overturn Chevron.

THE LOPER BRIGHT DECISION

In a 6-3 decision, the Supreme Court overruled Chevron and held that courts must “exercise their independent judgment” when interpreting federal statutes and may not defer to agency interpretations simply because they determine that a statute is ambiguous.

Tracing the history of “deference” from the Federalist Papers through the New Deal, the Court explained that the judicial branch has always had the exclusive responsibility for interpreting the law. While courts should and did give “respect” to executive branch interpretations, the final decision has historically been for the courts alone.

The judicial branch’s role, explained the Court, was solidified in 1946 with the passage of the Administrative Procedure Act (APA), which provides that the courts will decide “all relevant questions of law” arising during a review of agency actions. The courts may “seek aid” from the agency interpretations, but courts still must “independently interpret the statute and effectuate the will of congress.”

The Court concluded that Chevron deference is inconsistent with this history and the text of the APA, and further noted that federal agencies (as opposed to federal judges) have no special expertise when it comes to interpreting statutes.

Why now? 

Chevron has been in the Court’s crosshairs for the better part of a decade. Justice Neil Gorsuch pointed out in a lengthy concurrence in Loper Bright that the Supreme Court has not applied the Chevron doctrine since 2016. In a separate dissenting opinion last year — discussed here — Justice Gorsuch outlined how the Chevron doctrine has been subjected to so many competing interpretations and carve-outs that it has been rendered practically unworkable and incoherent.

Further, as the majority recognized, if courts defer to agencies under Chevron, that approach is inconsistent with other interpretive doctrines, most notably the “major questions doctrine,” which the Court used to strike down the US Environmental Protection Agency’s (EPA) regulation of greenhouse gases in West Virginia v. EPAin 2022 because the Clean Air Act had not “expressly” granted EPA authority to require decarbonization of the US energy sector. (For more on this case, see here.)

Why is everyone talking about “Chevron deference”? 

Loper Bright, when read in conjunction with other decisions like West Virginia v. EPA from two terms ago or SEC v. Jarkesy, decided this term and discussed here, has been interpreted by some as the culmination of a long-term trend in which justices appointed by Republican presidents are reconfiguring US administrative law. Some view Chevron deference as a crucial safeguard to protect administrative agencies and permit them to regulate in highly technical areas based upon sometimes broad mandates from Congress without fear that a judge lacking technical knowledge or expertise would overstep. For those individuals, the end of Chevron deference represents a threat to the administrative state as we know it and raises fear that judges rather than agencies will decide the propriety of complex technical issues.

For others, Chevron deference represents a usurpation of the judiciary’s role in interpreting the law and leads to administrative agencies over-regulating and over-stepping the authority vested in them by Congress. Some groups may view Chevron deference as part and parcel of some unaccountable deep state. For these individuals, the end of Chevron deference represents a long-awaited victory against overactive agencies exerting authority beyond that granted by Congress.

For many, Chevron deference is simply an interpretive mandate that attempted to balance the judiciary’s role in statutory interpretation with some level of deference to the agency’s particular knowledge and expertise.

Any tendency to catastrophize may be exacerbated by this being a presidential election year. While the Loper Bright decision is important, the practical impact of it is debatable and not yet clear. While it is possible that Loper Bright will announce a sea change in administrative practice, it is also possible that Loper Bright’s calls for “administrative respect” but not “deference” will be modest in the near term. Further, the Court went out of its way to note that prior cases that applied Chevron to uphold an agency’s actions were still good law based on the doctrine of stare decisis and that “mere reliance on Chevron cannot constitute” a reason for “overruling such a holding[.]”

What does the decision mean for agency interpretations of their own regulations? 

It does not affect them. Kisor v. Wilkie, a 2019 Supreme Court decision, remains the key precedent governing judicial review of an agency’s interpretation of its own regulations. Significantly, Loper Bright cites Kisor favorably. Under Kisor,agency regulatory interpretations are entitled to deference if they are reasonable when viewed with traditional tools of statutory construction and courts should defer to agency interpretations that:

  • Are official positions of the agency made in some formal context.
  • Are consistent with prior formal interpretations of the agency.
  • Rest on actual agency expertise and not a litigation position.
  • Were issued with fair notice to regulated entities.

Citing the APA, the Court in Kisor stated that where a rule is ambiguous, “when a court defers to a regulatory reading, it acts consistently with [APA] Section 706.” For more on Kisor, see here.

Does the decision bar courts from considering an agency’s expert input?

It does not. The majority notes that

[d]elegating ultimate interpretive authority to agencies is simply not necessary to ensure that the resolution of statutory ambiguities is well informed by subject matter expertise. The better presumption is … that Congress expects courts to do their ordinary job of interpreting statutes, with due respect for the views of the Executive Branch. And to the extent that Congress and the Executive Branch may disagree with how the courts have performed that job in a particular case, they are of course always free to act by revising the statute.

Loper Bright acknowledges that Congress can delegate policymaking authorities and that reviewing courts should consider any such delegation in reviewing related challenges.

It also notes that “Congress expects courts to handle technical statutory questions. Many statutory cases call upon courts to interpret the mass of technical detail that is the ordinary diet of the law and courts did so without issue in agency cases before Chevron.” (Internal citation omitted.) The majority suggests that courts “do not decide such questions blindly” and that “parties” — including agencies — “and amici in such cases are steeped in the subject matter, and reviewing courts have the benefit of their perspective.”

In such circumstances, while “an agency’s interpretation of a statute ‘cannot bind a court,’ it may be especially informative ‘to the extent it rests on factual premises within’ [the agency’s] expertise.’” Accordingly, citing Skidmore v. Swift & Co., Executive Branch interpretations may still have particular “power to persuade, if lacking power to control.”

Will the decision allow regulatory challenges to be decided more quickly by courts?

Probably not. As we discussed above, nothing in Loper Bright portends that agencies now lack the ability to use technical input to justify how they have interpreted statutes they are tasked with executing. Further, the Loper Bright formulation of “respect” to agencies — with courts being empowered to make ultimate decisions about statutory interpretation — may procedurally look very much like pre-Loper Bright “deference” in terms of what sorts of briefs are filed, how technical evidence is submitted, or how courts process challenges.

Many disputes will also involve an additional layer of briefing related to the impact of the decision itself as challenges proceed through courts, particularly when there are questions about whether Congress delegated specific questions to agencies.

Will this decision result in more litigation? 

Yes. Post-Loper Bright, we can expect increase in challenges to regulations across the government, with parties evaluating what pre-Loper Bright regulations they can encourage the Court to revisit, especially in light of the Court’s decision in Corner Post v. Board of Governors, which effectively relaxes APA-related statutes of limitations in some cases. This litigation will occur even though the Loper Bright majority attempted to stem the tide by stating that agency rules which were enforceable before the decision remain good law for now. As we have discussed before, many regulatory challenges are filed in forums perceived to be hostile to regulation. Those cases will then percolate through appellate courts to flesh out what administrative litigation looks like after this decision, particularly on the issue of how courts can appropriately parse out statutory interpretation, which is in the province of the courts from decisions delegated by Congress to agencies.

The regulated community should use the Loper Bright decision as an opportunity to review key regulations that govern their operations and assess whether regulations are newly vulnerable. Our teams are ready to provide assistance in conducting this review.

Does the decision affect state law?

The Loper Bright decision binds only federal courts.

Traditionally, state courts have not uniformly adopted Chevron. Around half the states, including Illinois, New Jersey, New York, and Pennsylvania, allow for Chevron-style deference to state agencies. Others, including California and Virginia, allow some degree of deference depending on the particulars of agency decisions.

Given that Chevron deference has been controversial for some time, state legislatures in Arizona, Georgia, Idaho, Indiana, Nebraska, Ohio, and Tennessee have in recent years passed laws closely cabining deference afforded to state agencies. Florida voters amended the state constitution in 2018 to prohibit courts from deferring to state agencies. States including Arkansas, Colorado, Delaware, Michigan, Mississippi, and Utah have court decisions to the same effect. (See here for a more detailed discussion.)

What should we watch for next? 

In the coming days, many ArentFox Schiff teams will analyze how the Loper Bright decision will affect specific practice areas. Additionally, watch for our end-of-term wrap-up on administrative and environmental law.

Two Blockbuster U.S. Supreme Court Decisions May Spell End of NLRB’s Expansion of Reach of NLRA as Well as How Agency Prosecutes Cases

The U.S. Supreme Court issued two blockbuster decisions this week, both of which likely will curtail the ability of federal agencies, including the NLRB, to prosecute cases and expand the law.

In a 6-3 decision announced Thursday in Securities and Exchange Commission v. Jarkesy et al., U.S., No. 22-859 (Jun. 27, 2024), the Supreme Court ruled that when the SEC seeks civil penalties against a defendant, the defendant is entitled to a trial by jury. As reported here, this decision could affect a future ruling in Space Exploration Technologies Corp., v. NLRB, No. 24-40315 (5th Cir. 2024), a case challenging the authority of National Labor Relations Board (“NLRB”) Administrative Law Judges (“ALJs”) on the same grounds.

Perhaps more significant, a 6-2 decision announced Friday in Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al., No. 22-451 (Jun. 28, 2024), eliminates the deference given to federal agencies to interpret laws by reversing the Chevron decision.

Jarkesy: Viability of Agency Administrative Law Judges Put Into Question

Jarkesy Background
In 2013, the Securities and Exchange Commission (“SEC”) initiated an enforcement action and sought civil penalties for alleged fraud against Defendants. Relying on relatively new authority conferred by the 2010 Dodd-Frank Act, the SEC opted to adjudicate the matter itself before an agency ALJ. In 2014, the SEC ALJ issued a decision levying civil penalties as well as other relief against the Defendants.

Defendants petitioned for judicial review at the Fifth Circuit, which held in 2022 that the agency’s decision to have an ALJ adjudicate the case violated the Defendants’ Seventh Amendment right to a jury trial. The Fifth Circuit also identified two further constitutional problems: (1) Congress violated the nondelegation doctrine by authorizing the SEC to choose whether to litigate this action in court or adjudicate the matter itself; and (2) the insulation of SEC ALJs from executive supervision, with two layers of for-cause removal protections, violated the separation of powers doctrine.

On March 8, 2023, the SEC appealed the Fifth Circuit’s decision to the Supreme Court. Oral argument was heard on November 29, 2023.

Jarkesy Supreme Court Decision
The Supreme Court held that the Seventh Amendment of the United States Constitution entitled Defendants to a jury trial where the SEC sought civil penalties for securities fraud. Writing for the majority, Chief Justice John Roberts reasoned that the SEC’s antifraud provisions “replicate common law fraud” claims, which must be heard by a jury. As a result, where a claim brought by an agency (1) resembles common law causes of action; and (2) seeks a remedy traditionally obtained in a court of law, a Seventh Amendment jury right attaches to the claim.

The Court recognized an exception to this general rule under a “public rights” doctrine, which permits non-Article III courts to adjudicate matters that “historically could have been determined exclusively by [the executive and legislative] branches.” However, causes of action that are “quintessentially suits at common law” and not “closely intertwined” with a public right—like the anti-fraud provisions at issue here—are unable to utilize this exception and must be heard in Article III courts.

Because the jury trial issue resolved the case, the Court declined to reach the nondelegation or removal issues. As a result, the Fifth Circuit’s decision in Jarkesy on these issues remains good law.

Sotomayor Dissent in Jarkesy
In dissent, Justice Sonia Sotomayor argued that Congress has latitude—via the Constitution as well as prior Supreme Court decisions—to assign the enforcement of civil penalties “outside the regular courts of law.” This would be the case “even if the Seventh Amendment would have required a jury where the adjudication of those rights is assigned to a federal court of law instead of an administrative agency.”

Justice Sotomayor also raised issue with the majority’s interpretation of a public rights doctrine. Notably, the dissent challenges the majority’s claim that most causes of actions that should be protected under the doctrine involve areas of the law where political branches “traditionally held exclusive power…and had exercised it.” To this end, Justice Sotomayor argues that the majority cannot distinguish between Congress’ enacting of statutes such as the National Labor Relations Act (“NLRA”) and its enacting of the Dodd-Frank Act. The dissent implies that neither labor relations nor securities were traditionally governed by political branches, thus (purportedly) refuting the majority’s reliance upon this principle.

NLRB Implications
Similar to the SEC, the NLRB utilizes ALJs to adjudicate violations of the NLRA. Contrary to the SEC, however, the NLRB ALJ scheme has been in place for decades. These judges hear and decide unfair labor practice cases in quasi-judicial hearings that affect the rights of parties to the cases. Moreover, unlike potential violations of the NLRA, the SEC is not always the exclusive forum for vindication of securities issues. The Department of Justice often prosecutes securities laws issues and private plaintiffs can bring lawsuits to vindicate civil claims. Contrast this with the NLRB, which is the exclusive forum for the vast majority of issues arising under the NLRA.

In the wake of the Fifth Circuit’s 2022 decision in Jarkesy, on January 4, 2024, Space Exploration Technologies Corp. (“SpaceX”) filed a complaint in the Southern District of Texas challenging the constitutionality of NLRB ALJs. SpaceX specifically argued that: (1) the NLRB’s structure is unconstitutional in that it limits the removal of NLRB ALJs and Board Members and permits Board Members to exercise executive, legislative, and judicial power in the same administrative proceeding; and (2) the Board’s expanded remedies constitute consequential damages, and therefore violate employers’ Seventh Amendment right to a trial-by-jury.

Because the Supreme Court in Jarkesy declined to reach the nondelegation or removal issues, the Fifth Circuit’s decision on these issues remains good law. This makes the current forum battle even more significant, as the Jarkesy Fifth Circuit opinion could provide dispositive precedent for SpaceX’s removal and nondelegation arguments. In addition, the Supreme Court’s ruling on the Seventh Amendment issue might support SpaceX’s argument that the Board’s expanded consequential damages remedies should be adjudicated in a trial by jury, depending on how the court interprets the current state of NLRB remedies.

As reported here, in Thryv, Inc., 372 NLRB No. 22 (2022), the NLRB expanded remedies under the NLRA to include “all direct or foreseeable pecuniary harms suffered as a result of the respondent’s unfair labor practice.” The Board has been committed to expanding remedies since 2021, when General Counsel Jennifer Abruzzo issued a memorandum on this subject. NLRB Regional Offices have also been aggressive in seeking these expanded remedies, which arguably are punitive rather than remedial in nature. In its Complaint, SpaceX used the Board’s position on remedies, coupled with the Jarkesy Fifth Circuit ruling, to argue that the Board has sanctioned compensatory relief that can only be issued through a trial by jury.

However, this position could be impacted by the Fifth Circuit’s ruling in Thryv, Inc. v. NLRB, No. 23-60132 (5th Cir. May 24, 2024). In this decision, the Court vacated the Board’s ruling in Thryv, Inc., 372 NLRB No. 22 (2022) on the merits, and thus did not reach the consequential damages issue. The Court did however label this remedy as “draconian” and “a novel, consequential-damages-like labor law remedy.” The Board therefore will require a new case to codify the issuing of consequential damages. It remains to be seen how this ruling would impact SpaceX’s Seventh Amendment argument concerning consequential damages, which could be a key element of its potential reliance on the Supreme Court’s ruling in Jarkesy.

Court Deference to Agency Positions Dead: Chevron Reversal
In a massive blow to agency power, the U.S. Supreme Court on Friday reversed Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), in a case involving a fishing industry rule. Under Chevron, on review of agency action, where the relevant statute was silent or ambiguous regarding a specific issue, courts were directed to defer to agencies and were not to “impose [their] own construction on the statute.” Thus, where an agency offered “a permissible construction of the statute,” courts were to defer to the agency even if the court would have reached a different conclusion. In the years since Chevron was issued, reviewing courts often remarked that they were bound to uphold an agency determination even if they disagreed with the interpretation. Justice Roberts, writing for the majority, held that Chevron could not be reconciled with the Administrative Procedures Act (“APA”), which commands “the reviewing court” to decide “all relevant questions of law” arising on review of agency action, which of course includes interpretation of the federal statute at issue. As a result, the majority determined that there should be no deference to agencies in answering legal questions, although deference is mandated for judicial review of agency policy-making and fact-finding. The majority concluded that, in deciding Chevron, the Supreme Court had required judges to “disregard their statutory duties,” which required this Court to “leave Chevron behind.”

Takeaways
These two Supreme Court decisions could substantially curtail the NLRB’s ability to bring and prosecute actions against parties (not just employers, but unions as well). While the Jarkesy Supreme Court decision is narrow, it could end the ability of the NLRB to bring certain claims in front of agency ALJs (all of whom are employed directly at the Board and who are not subject to removal). The pending SpaceX decision likely will further the development of the law, as it is a direct challenge to the NLRB adjudicatory scheme, and will also give a Circuit Court—and eventually maybe the Supreme Court—a chance to rule on additional constitutional challenges to federal agencies.

In addition, the reversal of Chevron likely will have a substantial effect on the review of NLRB cases. At time of unprecedented expansion of the reach of the NLRA—including finding non-compete agreements and confidentiality clauses unlawful—the end of Chevron deference allows a reviewing court the ability to disregard NLRB actions as not rooted in the NLRA or beyond the scope of the agency’s mandate. There is no doubt many challenges of NLRB actions will be brought as the probability of prevailing in a reviewing court has increased substantially with the end of deference.

As always, we will monitor decisions and agency actions to see how these important developments play out.

What Does the End of Chevron Deference Mean for Federal Health Care Programs?

On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo.[1] In a 6-3 decision, the Court held that Chevron’s rule that courts must defer to federal agencies’ interpretation of ambiguous statutes gave the executive branch interpretive authority that properly belonged with the courts. Moreover, the Court concluded that Chevron deference was inconsistent with the Administrative Procedure Act (APA), holding that the APA requires courts to exercise independent judgment when deciding legal issues in the review of agency action.

Loper will have significant and immediate implications for the U.S. Department of Health and Human Services (HHS), the federal agency charged with the administration of the federal health care programs, including Medicare and Medicaid. As detailed below, the Court’s decision sets a more exacting standard for courts to apply when reviewing HHS’s regulations and legal positions.

What Was Chevron Deference?

The doctrine of Chevron deference was established in 1984 by the Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.[2] In that case, the Court held when a “statute is silent or ambiguous with respect to the specific issue” raised regarding a statute that the agency administers, “the question for the court is whether the agency’s answer is based on a permissible construction of the statute.”[3]

Although scholars have debated Chevron’s rationale at length, it generally was read to require deference based upon agencies’ presumed subject matter expertise and an assumption that Congress delegated authority to agencies—rather than courts—to fill in gaps in statutory schemes. Notably, the Supreme Court had not itself invoked Chevron deference since 2016, although lower courts have continued to rely on it regularly.[4]

What Did Loper Decide?

Loper involved two New England fishing companies appealing the D.C. Circuit’s ruling that applied Chevron deference to uphold the National Marine Fisheries Service’s interpretation of the Federal Magnuson-Stevens Act (the “Act”) as requiring fishermen to pay for the use of compliance monitors on certain fishing boats, even though the federal law is silent on who must pay. Petitioners used the case as a vehicle to present a broader challenge to Chevron,arguing that the doctrine has led to excessive deference to federal agencies, resulting in overregulation, the abdication of judicial responsibility to interpret statutes, and the unwarranted imposition of regulatory enforcement costs.

The Loper majority firmly rejected Chevron and held that the APA requires courts to exercise their independent judgment in deciding legal questions that arise in reviewing agency action. As the majority held, “courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”[5]

Importantly, however, Loper noted that deference may still be afforded agencies in certain instances. First, the Court observed that the APA expressly mandates a deferential standard of review for agency policy-making and fact-finding.[6] Second, Loper explained that some statutes are best read to “delegate[] discretionary authority to an agency,” in which case a court’s role is to merely ensure the agency “engaged in ‘reasoned decisionmaking’” within that authority.[7] Lastly, Loper reaffirmed that an agency’s “expertise” remains “one of the factors” that may make an agency’s interpretation persuasive.[8]

How Will Loper Impact Federal Health Care Programs?

Loper’s directive that courts should construe statutes independently and not defer to agencies’ positions has enormous implications for providers and suppliers that participate in federal health care programs. Much of today’s health care landscape is governed by HHS’ regulations, impacting many Americans and much of the federal budget. For example, Medicare currently covers more than 67 million beneficiaries, and Medicare spending comprised 12% of the federal budget in 2022 and 21% of national health care spending in 2021.[9]

Federal health care programs like Medicare and Medicaid are established by statutes that set forth myriad requirements regarding the coverage of items and services, and how, when, and by whom those items and services may be furnished.[10] HHS’s various components—most notably the Centers for Medicare and Medicaid Services (CMS)—have issued numerous, detailed regulations to implement these statutes. HHS’s components also include FDA, CDC, HRSA, AHRQ, OCR, NIH, and many others that intersect with health care providers and suppliers regularly.

Going forward under Loper, future challenges to agency regulations will take place upon a much different playing field. This has several important implications:

  • More Legal Challenges: We expect to see more legal challenges brought against HHS’s regulations as they are issued. Loper expressly stated that it “does not call into question prior cases that relied on the Chevron framework,” so prior decisions affirming regulations should be stable.[11] But going forward, Loper means that courts have no “thumb on the scale” in favor of HHS’s legal positions, and so litigants may view Loper as increasing their odds of success. At the same time, this may create more uncertainty for providers and suppliers who must determine how to comply with new regulations under challenge.
  • Less Ability for HHS to Create New Programs or Impose New Requirements: Especially where HHS imposes new substantive requirements that are not clearly authorized by statute, HHS’s regulations may be vulnerable. For example, the challengers to CMS’s minimum-staffing requirements for nursing homes are sure to cite Loper.[12] Likewise, when HHS creates new programs or initiatives by regulation based on broad statutory language (e.g., HHS’s recent creation of rural emergency hospital regulations[13]), the regulations may be more vulnerable to challenges. As another example, legal challenges to FDA’s new rule on Laboratory Developed Tests are pending and will likely invoke Loper.[14]
  • More Incentive to Challenge Reimbursement Rules: Legal challenges are frequently brought to CMS’s rules governing reimbursement, which often have complicated statutory formulas subject to differing interpretations. Whereas in the past, courts often deferred to CMS’s interpretations,[15] Loper now creates more potential for providers and suppliers to seek more favorable legal interpretations to enhance reimbursement.
  • Slower and More Cautious Rulemaking: As HHS promulgates new regulations, it will now have to consider the enhanced litigation risk that Loper creates. This may lead to agencies slowing and proceeding more cautiously in rulemaking as agencies seek to craft defensible regulations.
  • Inconsistent Decisions by Courts: Because Loper directs courts to exercise independent judgment rather than defer to HHS’s interpretations, we expect that courts in different areas of the country may reach differing conclusions regarding HHS regulations. This may make certain geographic locations more advantageous for provider and supplier operations or expansions.

Conclusion

Going forward, courts will be more amenable than ever to siding with challenges to HHS regulations. This creates both challenges and opportunities for providers and suppliers who should carefully assess the legal basis for all new regulations.

The authors acknowledge the contributions of Callie Ericksen, a student at the University of California Davis Law School and 2024 summer associate at Foley & Lardner LLP.


[1] Loper Bright Enterprises v. Raimondo, No. 22-451 (June 28, 2024), together with Relentless, Inc. v. Department of Commerce, No. 22-1219, available here.

[2] 467 U.S. 837 (1984).

[3] Id. at 843 (emphasis added).

[4] See Am. Hosp. Ass’n (“AHA”) v. Becerra, 142 S. Ct. 1896, 1904 (2022) (determining that HHS’s preclusion of judicial review “lacks any textual basis,” remaining silent with respect to Chevron); Becerra v. Empire Health Found., 142 S. Ct. 2354, 2362 (2022) (illustrating that HHS’s reading aligns with the statute’s “text, context, and structure” in calculating the Medicare fraction for purposes of Medicare Part A benefits, without any mention of Chevron); Vanda Pharms., Inc. v. Ctrs. for Medicare & Medicaid Servs.,98 F.4th 483 (2024) (holding that CMS’s definitions of “line-extension” and “new formulation” did not conflict with the Medicaid statute).

[5] Loper Bright Enterprises v. Raimondo, No. 22-451, slip op. 35 (June 28, 2024).

[6] Id. at slip. op. 14 (citing 5 U.S.C. §§ 706(2)(A), (E)).

[7] Id. at slip op. 18.

[8] Id. at slip op. 25 (citing Skidmore v. Swift & Co., 323 U.S. 134 (1944).

[9] See KFF, Medicare 101 (published May 28, 2024), available here.

[10] See 42 U.S.C. §§ 1395–1395lll.

[11] Loper Bright Enterprises v. Raimondo, No. 22-451, slip op. 34 (June 28, 2024).

[12] See Am. Health Care Ass’n v. Becerra, No. 24-cv-114 (N.D. Tex) (challenging the rule issued at 89 Fed. Reg. 40876 (May 10, 2024).

[13] Conditions of Participation, 42 C.F.R. §§ 485.500-485.546 (Subpart E), and Payments, §§ 419.90-419.95 (Subpart J), 87 Fed. Reg. 71748, 72292-93 (Nov. 23, 2022),

[14] 21 C.F.R. § 809, 89 Fed. Reg. 37286 (May 6, 2024).

[15] See, e.g.Baptist Mem’l Hosp. – Golden Triangle, Inc. v. Azar, 956 F.3d 689 (5th Cir. 2020) (deferring to CMS’s rule addressing “costs incurred” for calculating Medicaid Disproportionate Share Hospital payments).

Supreme Court Issues Landmark Decision Upending Deference to Federal Agencies

On June 28, 2024, the Supreme Court of the United States upended the 40-year-old doctrine whereby federal courts gave deference to administrative agencies’ reasonable interpretations of federal statutes. The ruling stands to have significant implications for federal agencies’ rulemaking and enforcement of federal labor and employment laws.

Quick Hits

  • The Supreme Court held that courts must exercise their independent judgment in deciding whether an agency acted within its statutory authority and may not defer to an agency’s interpretation when a law is ambiguous.
  • The decision overruled the four-decades-old doctrine known as Chevron deference, in which courts had deferred to agencies’ reasonable interpretations of ambiguous statutes.
  • The ruling will have a major impact on federal agencies’ rulemaking authority.

The Supreme Court decision in Loper Bright Enterprises v. Raimondo held that courts must exercise independent judgment in deciding whether an agency acted within its statutory authority and may not simply defer to the agency’s interpretation of ambiguities in the law.

The decision overrules the longstanding doctrine known as Chevron deference, under which courts would defer to a federal agency’s reasonable interpretation of an ambiguous law that the agency administers. The deference had provided the rules of such administrative agencies with the force of law, but that authority will, at a minimum, be weakened, along with the corresponding power of the agencies.

In the opinion of the Court, Chief Justice John Roberts wrote that Chevron deference “defies the command of the” Administrative Procedure Act (APA) that courts “not the agency whose action it reviews … ‘decide all relevant questions of law’ and interpret … statutory provisions.” Chevron deference “requires a court to ignore, not follow, ‘the reading the court would have reached’ had it exercised its independent judgment as required by the APA,” (Emphasis in original).

The Court, in its majority, rejected the presumption that ambiguities in federal statutes are implicit delegations of authority to agencies, stating the “presumption is misguided because agencies have no special competence in resolving statutory ambiguities.”

The ruling will have significant implications for the multiple federal agencies that regulate employers, including the U.S. Department of Labor (DOL), the U.S. Equal Employment Opportunity Community Commission (EEOC), the Federal Trade Commission (FTC), the National Labor Relations Board (NLRB), Occupational Safety and Health Administration (OSHA), and the Office of Federal Contract Compliance Programs (OFCCP), among others.

Chevron Deference

Under the two-step Chevron deference framework, the court would first determine whether a statute in question was clear and unambiguous regarding an issue. If the statute was clear, then the court would give effect to it. If, however, the court found the statute was ambiguous or silent on the issue, then the court would proceed to step two. At that step, the court would determine whether the agency’s interpretation was a permissible or reasonable construction of the statute. If so, the court would uphold the agency’s interpretation.

The deference had allowed federal agencies leeway to act, allowing them interpret ambiguities and fill gaps in the laws they enforce. However, the doctrine has been criticized in recent years as unconstitutionally allowing the Executive Branch’s policy positions to be advanced by federal agencies outside the democratic process and for taking power away from federal courts to interpret laws.

Background

The issue over Chevron deference came before the Supreme Court in two cases challenging a National Marine Fisheries Service (NMFS) rule that required fishing vessels to pay the salaries of federal observers that vessels are required to “carry” under the Magnus-Stevenson Act (MSA). The MSA is silent as to whether the fishing industry is responsible for paying the costs for the observers. Given concerns about funding, the NMFS rule required the vessels carrying the observers to pay the costs despite objections from the fishing industry over its negative economic impact on the livelihoods of commercial fishermen.

In Loper Bright Enterprises, four family-owned and –operated fishing companies, argued that the NMFS cannot force vessels to pay for the observers because the MSA did not clearly give the agency power to do so. However, the D.C. Circuit Court of Appeals ruled in favor of the agency, finding that the law’s silence on the issue created an ambiguity that required deference to the agency.

Supreme Court Justice Ketanji Brown Jackson recused herself from the Loper Bright case as she had sat on the D.C. Circuit panel that had ruled in the case. The Court then added Relentless, Inc. v. Department of Commerce, in which the owner of fishing vessels raised a similar challenge to the NMFS rule. The challengers argued that since the MSA provides for observers to be paid in at least three other contexts, the NMFS did not have the authority to require fishing vessels to pay for them. But the First Circuit Court of Appeals affirmed a district court finding that “the rule is a permissible exercise of the agency’s authority and is otherwise lawful.”

At the Supreme Court, the challengers in Loper Bright Enterprises argued that the Court should “either abandon Chevron for good or at least substantially cabin its scope” because it has “proved unworkable” and has “seriously distorted how the political branches operate.” They argued that stare decisis does not bar the court from abandoning the framework since the Court would not have to change the outcome of the case in which the deference was established but merely alter the interpretative methodologies used. Similarly, the challengers in Relentless argued that the deference is unconstitutional because it “compromise[es] judges’ independence when interpreting the law,” which is a power vested in the federal courts under Article III of the U.S. Constitution.

Decision

In deciding Loper Bright, the Supreme Court stated that courts simply “do not throw up their hands because ‘Congress’s instructions have’ supposedly ‘run out.’” “Courts instead understand that such statutes, no matter how impenetrable, do—in fact, must—have a single, best meaning. … So instead of declaring a particular party’s reading ‘permissible’ in such a case, courts use every tool at their disposal to determine the best reading of the statute and resolve the ambiguity,” the Court stated.

The Supreme Court further stated that agencies do not have any special ability to interpret ambiguities, “even when an ambiguity happens to implicate a technical matter” as “Congress expects courts to handle technical statutory questions.” However, the Court stated that courts do not decide cases “blindly” and instead, rely on arguments from the parties and amici, noting that an agency’s interpretation “may be especially informative.”

“The better presumption is therefore that Congress expects courts to do their ordinary job of interpreting statutes, with due respect for the views of the Executive Branch,” the court stated. “And to the extent that Congress and the Executive Branch may disagree with how the courts have performed that job in a particular case, they are of course always free to act by revising the statute.”

However, the Court noted that the decision does “not call into question prior cases that relied on the Chevron framework,” as cases upholding specific agency actions “are still subject to statutory stare decisis despite our change in interpretative methodologies.

Justice Elena Kagan and Justice Sonia Sotomayor dissented and were joined by Justice Jackson to the extent it applied to the Relentless case. In the dissenting opinion authored by Justice Kagan, the justices argued that Chevron deference “has formed the backdrop against which Congress, courts, and agencies—as well as regulated parties and the public—all have operated for decades” and “has been applied in thousands of judicial decisions.”

They argued that Chevron deference is “right” and the “obvious choice” to resolve ambiguities because “[a]gencies have expertise” that “courts do not.” Further, agencies report to the president, “who in turn answers to the public for his policy calls; courts have no such accountability and no proper basis for making policy.” Moreover, “Congress has conferred on that expert, experienced, and politically accountable agency the authority to administer—to make rules about and otherwise implement—the statute giving rise to the ambiguity or gap,” Justice Kagan wrote.

Next Steps

The Supreme Court’s latest decision is likely to shift power dynamics by weakening agency authority to interpret ambiguous statutes and increasing judicial scrutiny. At a minimum, agencies may need to provide stronger justifications on the merits for their interpretations, and overall, they may be less likely to issue rulemaking in areas where statutory authority is not clear.

The decision is also likely to increase litigation and legal uncertainty, as it potentially opens the floodgates to a wave of legal challenges to overturn all sorts of existing agency rules that have been upheld citing Chevron deference and legal challenges to new agency rules moving forward. For example, this decision likely will have significant impact on the litigation challenging the Federal Trade Commission’s (FTC) rule purporting to ban noncompetes nationally.

SCOTUS Freezes States’ Efforts to Resolve Water Conflict

What Happened?

On June 21, 2024, the Supreme Court narrowly held that three states could not enter a consent decree to settle their interstate water dispute without the support of the intervening federal government. The ruling halts the agreement between Texas, New Mexico, and Colorado to settle Texas’s claims and reconfigure water allocation under the Rio Grande Compact going forward. The decision frustrates multi-year efforts by the states to fairly apportion shrinking water supplies and continues uncertainty for water users dependent on flows from the Rio Grande. More generally, the decision highlights the federal government’s power in cases arising under interstate compacts where federal interests are “inextricably intertwined” with the outcome.

Background

In 2013, Texas sued New Mexico and Colorado, claiming that New Mexico’s increased groundwater pumping was diminishing flows from the Rio Grande, unfairly shorting water allocated to the Lonestar state. This claim arose under the Rio Grande Compact, a 1938 allocation agreement between the three states that depend on the Rio Grande’s waters. The Supreme Court allowed the federal government, although not a party to the Compact, to intervene in the dispute in 2014, based on the federal interests in delivering water to Mexico under a 1906 treaty, in operating a Bureau of Reclamation reservoir and irrigation project closely connected to Compact compliance, and in fulfilling potential federal obligations to Indian tribes. The Supreme Court held that the federal government’s interests were “inextricably intertwined” with the case.

Since that decision, the states sought a compromise, recognizing that the 1938 Compact failed to predict severe droughts and dwindling water supplies, new circumstances that require adaptation. Despite this negotiated solution, the federal government refused to sign the agreement. The federal government claimed that the settlement undermines the Compact’s plain language, which cannot be modified without congressional approval, and that the negotiated agreement would impose new obligations on the federal reservoir and irrigation project. Based on its intervenor status, the federal government asked the Supreme Court to reject the deal in the absence of its consent.

Writing for the 5-4 majority, Justice Jackson explained that the Court’s 2018 decision to allow federal claims in the case to proceed “leads inexorably” to the federal government’s approval being necessary before a valid resolution. Justice Gorsuch, writing for the dissent, cautioned that this deference to the intervenor risks federalizing interstate water disputes and limiting the necessary discretion for states to independently manage their waters. Despite previously authoring a unanimous 2018 decision that green-lighted the federal claims, his dissent pointed back to “a century’s worth” of precedent, holding that the Reclamation Act requires the federal government to comply with state control of water resources and not to assert incompatible federal interests. The majority reasoned, by contrast, that the federal government’s interest was particular to the Compact, where compliance depends on federal action.

Analysis

The Court’s acknowledgment of the federal interest in the three states aligning Rio Grande Compact compliance with contemporary water realities is expressly tailored to the unique federal role in this situation. The problem the Court focused on was the proposed resolution’s failure to include the federal government, given its intervenor status and its integral role in managing a reservoir and irrigation project essential to the Compact. This does not authorize federal interference in all interstate water compacts, as the dissent fears, but others may be “inextricably intertwined” with federal interests. Still, the pointed dissent may signal that a significant court minority stands ready to guard state control of water resources when the federal government overreaches. The decision’s immediate impact will perpetuate uncertainty for water users in all three states as the parties are forced back to trial or the negotiating table.

A Lawyer’s Guide to Understanding AI Hallucinations in a Closed System

Understanding Artificial Intelligence (AI) and the possibility of hallucinations in a closed system is necessary for the use of any such technology by a lawyer. AI has made significant strides in recent years, demonstrating remarkable capabilities in various fields, from natural language processing to large language models to generative AI. Despite these advancements, AI systems can sometimes produce outputs that are unexpectedly inaccurate or even nonsensical – a phenomenon often referred to as “hallucinations.” Understanding why these hallucinations occur, especially in a closed systems, is crucial for improving AI reliability in the practice of law.

What are AI Hallucinations
AI hallucinations are instances where AI systems generate information that seems plausible but is incorrect or entirely fabricated. These hallucinations can manifest in various forms, such as incorrect responses to prompt, fabricated case details, false medical analysis or even imagined elements in an image.

The Nature of Closed Systems
A closed system in AI refers to a context where the AI operates with a fixed dataset and pre-defined parameters, without real-time interaction or external updates. In the area of legal practice this can include environments or legal AI tools which rely upon a selected universe of information from which to access such information as a case file database, saved case specific medical records, discovery responses, deposition transcripts and pleadings.

Causes of AI Hallucinations in Closed Systems
Closed systems, as opposed to open facing AI which can access the internet, rely entirely on the data they were trained on. If the data is incomplete, biased, or not representative of the real world the AI may fill gaps in its knowledge with incorrect information. This is particularly problematic when the AI encounters scenarios not-well presented in its training data. Similarly, if an AI tool is used incorrectly by way of misused data prompts, a closed system could result in incorrect or nonsensical outputs.

Overfitting
Overfitting occurs when the AI model learns the noise and peculiarities in the training data rather than the underlying patterns. In a closed system, where the training data can be limited and static, the model might generate outputs based on these peculiarities, leading to hallucinations when faced with new or slightly different inputs.

Extrapolation Error
AI models can generalize from their training data to handle new inputs. In a closed system, the lack of continuous learning and updated data may cause the model to make inaccurate extrapolations. For example, a language model might generate plausible sounding but factually incorrect information based upon incomplete context.

Implication of Hallucination for lawyers
For lawyers, AI hallucinations can have serious implications. Relying on AI- generated content without verification could possibly lead to the dissemination or reliance upon false information, which can grievously effect both a client and the lawyer. Lawyers have a duty to provide accurate and reliable advise, information and court filings. Using AI tools that can possibly produce hallucinations without proper checks could very well breach a lawyer’s ethical duty to her client and such errors could damage a lawyer’s reputation or standing. A lawyer must stay vigilant in her practice to safe guard against hallucinations. A lawyer should always verify any AI generated information against reliable sources and treat AI as an assistant, not a replacement. Attorney oversight of outputs especially in critical areas such as legal research, document drafting and case analysis is an ethical requirement.

Notably, the lawyer’s chose of AI tool is critical. A well vetted closed system allows for the tracing of the origin of output and a lawyer to maintain control over the source materials. In the instance of prompt-based data searches, with multiple task prompts, a comprehensive understanding of how the prompts were designed to be used and the proper use of same is also essential to avoid hallucinations in a closed system. Improper use of the AI tool, even in a closed system designed for legal use, can lead to illogical outputs or hallucinations. A lawyer who wishes to utilize AI tools should stay informed about AI developments and understand the limitations and capabilities of the tools used. Regular training and updates can provide a more effective use of AI tools and help to safeguard against hallucinations.

Take Away
AI hallucinations present a unique challenge for the legal profession, but with careful tool vetting, management and training a lawyer can safeguard against false outputs. By understanding the nature of hallucinations and their origins, implementing robust verification processes and maintaining human oversight, lawyers can harness the power of AI while upholding their commitment to accuracy and ethical practice.

Supreme Court Rules Against Taxpayers in IRC Section 965 Case

On June 20, 2024, the Supreme Court of the United States issued a 7-2 opinion in Moore v. United States, 602 U.S. __ (2024), ruling in favor of the Internal Revenue Service (IRS).

Moore concerned whether US Congress and the IRS could tax US shareholders of controlled foreign corporations (CFCs) on those corporations’ earnings even though the earnings were not distributed to the shareholders. The case specifically focused on the so-called “mandatory repatriation tax” under Internal Revenue Code (IRC) Section 965, a one-time tax on certain undistributed income of a CFC that is payable not by the CFC but by its US shareholders. Some viewed the case as hinging upon whether Congress has the power to tax economic gains that have not been “realized.” (i.e., In the case of a house whose value has appreciated from $500,000 to $600,000, the increased value is “realized” only when the house is sold and the additional $100,000 reaches the taxpayer’s coffers.)

However, Justice Brett Kavanaugh, joined by Chief Justice John Roberts and Justices Sonia Sotomayor, Elena Kagan and Ketanji Brown Jackson, rejected that position on the ground that the mandatory repatriation tax “does tax realized income,” albeit income realized by a CFC. On this basis, they reasoned that the question at issue was whether Congress has the power to attribute realized income of a CFC to (and tax) US shareholders on their respective shares of the undistributed income. This group of justices ultimately decided Congress does have the power.

The majority went out of its way to avoid expressing any opinion as to whether Congress can tax unrealized appreciation, with Justice Amy Coney Barrett’s concurrence and Justice Clarence Thomas’s dissent asserting that it cannot. Perhaps the Court was signaling a distaste for the Billionaire Minimum Income Tax proposed by US President Joe Biden, which would impose a minimum 20% tax on the total income of the wealthiest American households, including both realized and unrealized amounts, among other Democratic proposals.

Practice Point: We previously noted that certain taxpayers should consider filing protective refund claims contingent on the possibility that Moore would be decided in favor of the taxpayers. In light of the case’s outcome, however, those protective claims are now moot.