SCOTUS ‘Major Question’ Decision Cited In Litigation, Comments

In June 2022, the US Supreme Court issued its ruling in West Virginia v. Environmental Protection Agency (EPA), a significant decision that capped off an already blockbuster term. Much has been written about the implications of the Court’s blockbuster decisions on abortion rights, gun control, and the 340B program, among others. But there has been less attention to the fallout from West Virginia and the “major questions” doctrine embraced by the Court.

We and other experts predicted that plaintiffs and lower courts would cite West Virginia to invalidate federal health policies. There was some basis for this prediction: Even before West Virginia, there was a documented surge in the number of federal court filings that mentioned the major questions doctrine. We raised concerns that this shift, coupled with increased judicial skepticism of the administrative state, could limit the executive branch’s ability to implement federal law.

Although only a handful of courts (to date) have relied solely on West Virginia to invalidate federal policy, the major questions doctrine is being cited regularly to challenge agency action. It is also being cited in comments on proposed federal rules by industry and opponents, previewing legal arguments to come once policies are finalized. This article highlights just some of the ways that the major questions doctrine is being used in both judicial and rulemaking processes, with an emphasis on health policy-related issues.

Overview Of West Virginia V. EPA

West Virginia involved the Clean Power Plan (CPP), an Obama-era rule that addressed greenhouse gas emissions from power plants. The CPP was adopted under the Clean Air Act (CAA), a law that authorizes the EPA to limit power plant pollution using the “best system of emission reduction.” In the CPP, the EPA determined that the best system for emission reduction from existing power plants was generation shifting—that is, for those plants to shift gradually from fossil fuel sources (such as coal and gas) to renewable energy sources (such as solar and wind). Under the CPP, electricity generation from coal was projected to decrease from 38 percent of total electricity generation in 2014 to 27 percent by 2030.

Republican attorneys general and other interest groups challenged the rule, arguing that the CAA did not authorize the EPA to adopt generation shifting. After many years of litigation (and repeal of the CPP by the Trump administration), the US Supreme Court held in West Virginia that Congress did not clearly authorize the EPA to adopt the CPP. Chief Justice John Roberts wrote the decision on behalf of a 6 to 3 majority.

Characterizing the CPP as “an extraordinary case,” Chief Justice Roberts explained that agencies that assert broad, highly consequential power—as the EPA did with the CPP—must point to clear congressional authorization. He did not, however, give clear guidelines as to the meaning of “extraordinary case” or “clear congressional authorization.” According to Chief Justice Roberts, an extraordinary case is determined by looking at “history and the breadth of the authority that the agency has asserted, and the economic and political significance of that assertion.” In this instance, the CPP qualified as a major question without clear congressional authorization. Congress’ use of the word “system,” although broad, was insufficient to give the EPA the authority to adopt the CPP.

West Virginia significantly constrains the EPA’s ability to meaningfully address climate change, undermines deference to federal agencies, and could limit how Congress may delegate authority. As Justice Elena Kagan pointed out in dissent, the amorphous major questions standard may be challenging to satisfy. The decision, she noted, will “prevent agencies from doing important work, even though that is what Congress directed.”

Major Questions Doctrine In Litigation Post-West Virginia

Litigants and courts are already citing West Virginia in disputes over federal policies—from COVID-19 protections to guidance on emergency medical care to student loan debt relief. Health policy’s prominent representation among these cases is unsurprising. As explained here and here, health care featured prominently in litigation involving agency delegation issues such as the major questions doctrine even before West Virginia. Older cases involved the Food and Drug Administration’s (FDA’s) attempt to regulate tobacco products as drugs or devices and the Internal Revenue Service’s conclusion that Marketplace premium tax credits are available in all states under the Affordable Care Act. More recently, the US Supreme Court struck down Occupational Safety and Health Administration’s vaccine-or-test mandate for workers and the Centers for Disease Control and Prevention’s (CDC’s) eviction moratorium. In these cases, however, the Court did not precisely articulate the doctrine it was applying. In West Virginia, the Court finally “announce[d] the arrival of the major questions doctrine,” characterizing those cases as falling under that doctrine. West Virginia crystalized the major questions doctrine as statutory interpretation canon in US law.

Now, West Virginia is being cited to challenge attempts to address some of the most pressing issues facing the nation.

COVID-19 Policies

Given this history, it is unsurprising that the major questions doctrine continues to figure prominently in disputes over federal COVID-19 policies. In recent months, district and appellate courts have applied the major questions doctrine to invalidate vaccination and masking policies for Head Start staff and vaccination requirements for federal contractors. At least one appellate court rejected these arguments with respect to the Head Start program, explaining that the Department of Health and Human Services (HHS) likely has the authority to adopt the policies. Appeals over the vaccine mandate for federal contractors remain pending before several appellate courts.

Similar challenges have been brought to masking policies on public transportation adopted by the CDC and the Transportation Security Administration. In early 2022, a federal district court in Florida invalidated the CDC’s masking requirement on major questions grounds. The decision is on appeal to the Eleventh Circuit, and the challengers have doubled down on their major questions arguments. Related challenges are pending before at least the District of Columbia Court of Appeals and a federal district court in Colorado.

Abortion As Emergency Care

The major questions doctrine is being cited to challenge federal health policies beyond the COVID-19 context. The attorney general of Texas recently invoked West Virginia to challenge HHS guidance on health care providers’ obligations under the Emergency Medical Treatment and Labor Act (EMTALA). EMTALA requires certain federally funded hospitals to provide “stabilizing treatment” to patients with an “emergency medical condition.”

After the US Supreme Court decided Dobbs v. Jackson Women’s Health Organization, HHS issued guidance affirming EMTALA’s requirements, regardless of state restrictions. If a physician concludes that a pregnant patient is experiencing an emergency medical condition under EMTALA—and that abortion is the stabilizing treatment necessary to resolve that condition—the hospital and physician have an obligation to provide that treatment. Examples of emergency medical conditions might include ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features.

In July 2022, Texas sued over the guidance. The attorney general, joined by two provider organizations, argued that HHS did not have the authority to clarify EMTALA, that federal officials failed to follow procedural requirements before issuing the guidance, and that HHS failed to justify its guidance. The complaint also invoked the major questions doctrine, asserting that abortion is an “issue of vast political significance;” because EMTALA does not specifically mention abortion, HHS lacks the authority to affirm that abortion may qualify as a stabilizing treatment. The district court set aside the guidance on other grounds, but the arguments show how the major questions doctrine can be cited to dispute agency interpretations of broad federal health care statutes.

340B Program

AstraZeneca, a pharmaceutical company, recently cited the major questions doctrine in its appeal over whether federal law requires drug manufacturers to provide discounts to contract pharmacies under the 340B program. The dispute stems from limits that AstraZeneca and other drug companies placed on the sale of drugs at 340B-discounted rates. In December 2020, HHS issued an advisory opinion affirming that drug manufacturers must provide the discounts when a contract pharmacy provides services on behalf of a 340B entity. HHS then wrote to several pharmaceutical companies, including AstraZeneca, instructing them to end contract pharmacy restrictions. Litigation over the advisory opinion and the letters followed, leading HHS to later withdraw the advisory opinion.

In its appeal to the Third Circuit, AstraZeneca argued that the 340B statute does not clearly require HHS’s interpretation with respect to contract pharmacy sales. HHS, the company argues, claimed “to establish and administer a complex system for the distribution of drugs” to the tune of billions of dollars, and the agency’s claim to regulate contract pharmacy arrangements is based on “newly discovered” authority. The government argued that AstraZeneca’s dispute is over the 340B statute itself (not HHS’s interpretation) and that, in any event, the company did not make this argument at the district court level. The Washington Legal Foundation, a legal advocacy organization focused on limiting executive branch authority, filed an amicus brief in support of AstraZeneca on why the major questions doctrine should be applied.

It remains to be seen how the Third Circuit will decide this dispute and whether the panel will address AstraZeneca’s arguments about the major questions doctrine. Major questions arguments could become more prominent in 340B disputes across the country.

Beyond Health Litigation

Arguments about a “major question” are not limited to health care. For example, the doctrine has been invoked in lawsuits challenging student loan debt relief—a measure adopted by the Biden administration under the Higher Education Relief Opportunities for Students Act (HEROES) Act. Challengers argued that this “blanket cancellation” of student loans has never been adopted under the HEROES Act and is a matter of great political significance because it is “one of today’s hotly debated issues.” The relief, they argue, was not clearly authorized by Congress, which failed repeatedly to enact legislation on student loan debt relief.

Other examples include legal challenges over a minimum wage increase for federal contractors from the Department of Labor; an executive order on the social cost of greenhouse gas emissions; visa requirements from the Department of Homeland Security; and the definition of “firearm” from the Bureau of Alcohol, Tobacco, Firearms and Explosives. These are just some recent examples.

The Major Questions Doctrine In The Rulemaking Process

In a preview of court challenges to come, the major questions doctrine is being raised in comments on a wide array of proposed federal rules. Agencies will have to respond to these arguments when finalizing their proposals, and stakeholders are expected to make these arguments in litigation over the rules (once finalized). This article highlights several examples, but comments that have invoked the major questions doctrine following West Virginia are legion.

In April 2022, the FDA issued long-awaited proposed rules banning menthol and all flavors in cigarettes and cigars. The FDA did so under the Tobacco Control Act in which Congress authorized the adoption of tobacco product standards to protect public health. In comments on the proposed rules, the tobacco industry asserted that prohibiting the use of flavors in tobacco has great political and economic significance that requires clear congressional authorization. Like the word “system” in the CAA, the industry argues, the term “product standard” is ambiguous and does not satisfy the clear congressional authorization requirement.

Commenters have also cited the major questions doctrine in comments on the Department of Education’s proposed rule on nondiscrimination protections under Title IX. Some commenters asserted that defining sex-based discrimination to include LGBTQ people alters the meaning of sex under Title IX that, under West Virginia v. EPA, is unlawful absent clear congressional authorization. (The US Supreme Court rejected a related argument in Bostock v. Clayton County when interpreting nondiscrimination protections under Title VII of the Civil Rights Act.)

These are far from the only instances in which commenters have cited the major questions doctrine in comments on federal rules. Other examples include a Securities and Exchange Commission proposed rule to require climate-related disclosures by publicly traded companies; a request for comments in response to a citizen’s petition urging the EPA to address greenhouse gas and fossil fuel emissions; a Department of Energy proposed rule on energy conservation standards for commercial water heaters; a Department of the Interior request for information to improve hard rock mining regulations; and an Agricultural Marketing Service proposed rule on transparency in poultry production contracting. Many of these rules focus on environmental protection or labor and workforce issues.

Conclusion

These citations are likely just the tip of the iceberg when it comes to how the major questions doctrine will evolve. At a minimum, however, the examples underscore how commenters, litigants, and courts are likely to use the major questions doctrine and the US Supreme Court’s decision in West Virginia to challenge a dizzying array of federal administrative policies. This activity is likely exacerbated by the amorphous standard adopted by Chief Justice Roberts in West Virginia. A full embrace of the major questions doctrine—except in what is truly the most “extraordinary case”—will constrain federal agencies in using the broad authority given by Congress to respond to emerging health issues.