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Disruptive Decisions

November 23, 2023

December 2023

A flurry of court decisions threatens to undermine expert health decisions.

Thomas R. Collins

Thomas R. Collins is a medical journalist based in West Palm Beach, Florida.

COVID-19, the worst contagious disease in a hundred years, has swept across the globe, taking millions of lives, leaving millions more with lingering illness, and keeping the most vulnerable groups on edge as the virus persists.

At the same time, this pandemic has brought U.S. courts – and politics – front and center in determining how the COVID-19 virus should be managed, leading to bitter litigation over masking, vaccination requirements, and public gatherings.

This, too, legal experts say, has been contagious.

As the courts, including federal judges and the conservative Supreme Court majority, have shown themselves to be more open to the idea that public health decisions made by expert agencies might not pass legal muster, litigation over health and medical policy — including abortion-pill access and care for transgender patients — has made its way through the courts, with potentially far-reaching consequences for health care in the U.S.

“The courts are increasingly playing a very prominent role in health policy,” said Wendy Parmet, JD, a law professor at Northeastern University in Boston who specializes in public health law. “This has been a long time coming, but the willingness of certain courts, particularly the federal courts, in recent years to intervene in health policy – and more broadly what I’ve referred to in other places as the erosion of deference – invites increased litigation.”

Instances of Intrusion versus Public Health

In November 2020, a month after the confirmation of Justice Amy Coney Barrett, who replaced Justice Ruth Bader Ginsburg, the U.S. Supreme Court’s majority opinion prohibited New York from enforcing an executive order’s limits of 10 and 25 people in churches and synagogues, saying houses of worship had been “singled out” for harsh treatment and that less restrictive means could be used to limit the spread of COVID. The minority, however, said that experts had shown the measure was epidemiologically justified.

In August 2021, the court blocked the Centers for Disease Control and Prevention’s (CDC) moratorium on evictions of tenants living in counties with high levels of COVID spread who attested that they were in financial need. The court ruled the CDC didn’t have the power to issue the moratorium and that Congress would have to authorize such a power through legislation. The dissenting justices said the moratorium was within the CDC’s purview and second-guessing the CDC ran counter to public interest.

In January 2022, the Supreme Court blocked the Occupational Safety and Health Administration’s (OSHA) mandate that employers with at least 100 employees require employees to get vaccinated or submit to weekly testing, saying the measure was a “significant encroachment into the lives” of a vast number of people and OSHA was not empowered to regulate general public health, only workplace hazards.1 The minority ruled that OSHA was simply overseeing health in the workplace, as directed by Congress.

Then came the Dobbs v. Jackson decision in June 2022 and its overturning of Roe v. Wade, which had guaranteed the right to abortion nationwide. The ruling returned the issue to states, with a majority of the court concluding that the Constitution does not provide such protection. The minority argued that, in Roe, it had been decided that the Constitution does provide such protection and criticized the majority for setting off an “upheaval in law and society.”2

In April 2023, a judge appointed by former Presi­dent Donald Trump in the Northern District of Texas issued a preliminary ruling invalidating the U.S. Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone, an approval that was granted 23 years earlier. A federal appeals court allowed the drug to stay on the market but with significant restrictions, such as not allowing it to be prescribed by telehealth. The issue is now in the hands of the Supreme Court, which has said mifepristone would continue to be available as the case moves forward.

In another flurry of litigation, judges blocked bans on health care for transgender minors in several states before Republican-appointed judges in federal appeals courts issued rulings allowing states to enforce such bans. The issue is now likely to be decided by the Supreme Court.

Detrimental Restrictions

Experts say the ability of public health experts to make lasting decisions on public health and medical care has been eroded, affecting the quality of care people receive and can access. Hematology is not unaffected. Because abortion access is now a matter left to the states, access to medications such as methotrexate, an abortifacient that is also used to treat acute lymphoblastic leukemia, has been complicated in states where abortion is illegal. Physicians have been cautioned to be explicit when writing prescriptions.

“There’s so much uncertainty if an agency takes an action — what is going to stay and what is going to go,” said Andrew Twinamatsiko, JD, director of the Health Policy and the Law Initiative at the O’Neill Institute at Georgetown University in Washington, DC.

The American Society of Hematology (ASH) has not issued statements on recent judicial and political decisions on expert-guided health policy, but after the Dobbs decision, it made clear the organization considers access to abortion a maternal health rights matter.

“Having the right to choose to terminate a pregnancy is critical for the patients our members serve. Blood disorders, including sickle cell disease and blood cancers like leukemia and lymphoma, can pose a profound risk to maternal health. In some cases, denying women their right to terminate a pregnancy puts them at risk of serious illness or death,” read the statement, issued in June 2022. “ASH supports the right to maternal health care that addresses hematologic disorders and advocates for access to reproductive health services for all people.”3

Authority of Federal Agencies Stymied

Some of the core legal concepts that have undergirded judicial decisions have recently been used as tools to decide against federal agencies on questions that have profound effects on public health policy, Mr. Twinamatsiko said. In the Supreme Court’s decisions in the OSHA vaccination case and the CDC eviction moratorium case, justices used the major questions doctrine to strike down COVID mitigation measures. Under this doctrine, the court says that Congress must speak very clearly if a federal agency is going to take an action of great political and economic significance.

This doctrine, Mr. Twinamatsiko said, is “huge in terms of how the government does its business.” Employing this doctrine in a way that runs counter to the expertise of government agencies is troubling, he said.

The major questions doctrine played a significant role in West Virginia v. EPA in June 2022, in which the court ruled that the Environmental Protection Agency (EPA) had overstepped its authority with the Clean Power Plan rule by calling for the U.S. to gradually move away from coal-sourced power in favor of renewable energy. The EPA, the court ruled, could only require already regulated sources to function more cleanly, not require the adoption of new energy sources unless Congress expressly authorized it. In dissents, liberal justices argued that the Clean Air Act directs the EPA to regulate stationary sources of public-​health-​endangering air pollution and that this is enough to authorize its Clean Power Plan rule.

“Clarity seems to lie in the eye of the beholder, and the beholder is the court. So how can Congress do its job? How clearly can Congress speak?” Mr. Twinamatsiko said. “You have a problem because you are both tying the hands of the agency and putting all these roadblocks in how Congress can achieve its goals when it seeks the help of federal agencies.”

In Loper Bright Enterprises v. Raimondo, the Supreme Court will consider another critical principle, the Chevron doctrine, a decision that could have ripple effects in health care. Under this doctrine, if an agency is interpreting a statute that is ambiguous, then deference is given to an agency’s reasonable interpretation of that statute unless the interpretation is unreasonable, Mr. Twinamatsiko said.

“The justification of the Chevron doctrine is birthed in the idea that Congress seldom has the expertise — they’re not experts, they’re not scientists, they’re not environmentalists,” Mr. Twinamatsiko said. “They’re legislators who don’t know the nuances of different policies or anticipate what’s going to arise within a certain framework of legislation, so what they do is direct agencies to implement their laws…. Chevron actually enables agencies to do their work.”

The doctrines involved in these crucial decisions have wiggle room, and the trend is to use this wiggle room to pull away from the deference to expert agencies, he said.

“The doctrines that the courts are using are amorphous enough for them to kind of justify their reasons in the law, but there aren’t definitive contours to hold the judges’ feet to the fire and say, ‘Hey, this case is just like the other one. How come you aren’t ruling in the same way?’” he said.

Ms. Parmet said the mifepristone case will be important to watch. She said the Supreme Court’s decision earlier this year to keep mifepristone available until the case is heard by the court might be a sign that the court is “not altogether comfortable with going too far out ahead of the politics.” That was a sign, she said, that “they know it was a big deal and it was going to be exceptionally disruptive.”

“The Supreme Court might signal, ‘You’ve gone too far, Fifth Circuit (U.S. Fifth Circuit Court of Appeals).’ I think there are reasons the Supreme Court might say that. But the cases are continuing to come, so I think we’re going to see more erosion, at least somewhat more erosion, even if at a decelerated rate.”

As for the long-term trend of the erosion of expert agency authority, Ms. Parmet said, it is not possible to know. Much of it will depend on the next presidential election and any other “unknown unknowns” that might arise, she said.

In a paper published earlier this year in the American Journal of Public Health, Ms. Parmet and coauthor Faith Khalik, JD, noted that in three-​quarters of the decisions regarding COVID-​related public health, the plaintiffs seeking to override the decisions were not awarded the relief they sought.4 Still, they wrote, “some courts, including the U.S. Supreme Court, have granted health officials less deference than they have traditionally received.”

In a detailed analysis of the mifepristone case, Peter Grossi, JD, a former litigator for various industries, such as pharmaceuticals, and now a lecturer at Harvard Law School, wrote that the review of the case law shows “that the court’s conservative members — especially Chief Justice [John] Roberts and Justices [Samuel] Alito and [Brett] Kavanaugh — have consistently argued and voted in favor of ‘reasoned deference’ to the FDA’s judgments,” in cases involving drugs for migraine, sore shoulders, and osteoporosis.5

He also recounted 25 years of FDA review on mifepristone’s efficacy and safety that led to the current approval of its use.

“If not reversed by the Supreme Court, the Fifth Circuit’s rejection of those established standards for reviewing clinical data will thus constitute a waiting snare for other drugs,” Mr. Grossi wrote.

The Power of Persuasion

Camille Puronen, MD, MPH, the 2022-2023 ASH Congressional fellow who worked for a year in Washington, DC, in the office of U.S. Rep. Brian Higgins (D-NY) and is a hematologist at Kaiser Permanente in Seattle, said she has witnessed the tension between politics and science in her work to help draft memoranda and bills related to health care and science.

“Congress is under a constant barrage of people and groups coming in to voice their positions, and that includes people who have a lot of science to back up their positions and people who have less,” she said.

Her fellowship has shown the need for those who work in health care and science to be willing to dive into the political process.

“We sometimes assume that because we know the evidence and we believe in science and we believe this is all very cut and dry and clear, that maybe we don’t need to make noise,” she said. “But as we saw with COVID and the Dobbs decision, a very vocal minority can definitely move policy.”

Putting data out into the world isn’t enough, she said.

“We know now more than ever that persuading people is a different art than just publishing data,” she said.

In their paper, Ms. Parmet and Ms. Khalik wrote that “health officials should remember that persuasion is among their most potent powers.”4 Although, they have not always pulled this off well, Ms. Parmet noted. For example, she said that in most states, the outreach to communities of color led to fairly good COVID vaccination rates. Conversely, she said, officials’ “messaging around masking was abysmal” – at first, masks weren’t necessary, and then they were, but governors and presidents still made public appearances without them.

But health officials have an uphill battle, she acknowledged.

“Health officials are working in an incredibly difficult political environment and an environment that is overrun with misinformation, disinformation, and a world in which the enemy of my enemy is my friend,” Ms. Parmet said. “Health is interrelated to the functionality of our political system, and we are at a moment where our political system is being tested.”

Given this inescapable link with politics, public opinion and messaging is vital to help turn the tide of erosion of expert authority, she said, but that is not just a matter of the words that public health officials use.

“It’s more complicated,” Ms. Parmet said. “It’s really, how do you frame it? How do you act, and what are the actions that you take that are consistent with moving a population and moving a community into embracing it?” For instance, vaccine mandates might seem to make sense if persuasion is regarded as hopeless, but what if the mandate “actually undercuts the persuasion?” she said.

Mr. Twinamatsiko said that as these “esoteric issues” are decided in the courts, matters of life and death hang in the balance.

“There are lives on the line,” he said. “If you are tying the hands of these agencies that are supposed to be protecting health, then there’s going to be a lot of people getting sick and dying. These are decisions that affect everyday life… Courts continuing on this path to rein in agencies and deregulate these human activities that are main drivers of disease and death – the so-called social determinants of health – will perpetuate and even exacerbate death and disease, especially for the most vulnerable people in our communities.”

Dr. Puronen, for all the recent questioning of health expert authority, said her time in DC has made her more hopeful, not less.

“I feel less cynical about it all than before I went there,” she said. “There are so many people working so hard and who care so much. The stereotype we have of politicians – and probably some of it is deserved – is that they are kind of checked out and they’re just up there to toot their horn. Certainly that’s true for many, but a lot of them are working hard all the time, and they really do want what’s best.”

She encouraged her fellow physicians and scientists to also take action, though, even if that means just asking questions “if you’re seeing something that doesn’t make sense to you in your practice.”

“Maybe if I press this lever, if I turn this knob, this could change,” she said. “It’s hard to carve out time, but once you start doing it, you realize how impactful it can really be.”


References

  1. National Federation of Independent Business v. Department of Labor, Occupational Safety & Health Administration, Nos. 21A244 and 21A247, 595 U. S. (2022).
  2. Dobbs v. Jackson Women’s Health Organization, No. 19-1392, 597 U.S. (2022).
  3. American Society of Hematology. ASH advocates for the right to maternal health care. June 24, 2022. Accessed October 26, 2023. https://www.hematology.org/newsroom/press-releases/2022/ash-advocates-for-the-right-to-maternal-health-care.
  4. Parmet WE, Khalik F. Judicial review of public health powers since the start of the COVID-19 pandemic: trends and implications. Am J Public Health. 2023;113(3):280-287.
  5. Grossi P. The conservative court on the unacceptable perils in second-​guessing FDA safety decisions and its coming review of alliance for Hippocratic medicine v. FDA (the ‘abortion pill’ case) [published online ahead of print, 2023 Sep 3]. Virginia Journal of Social Policy and the Law. doi: 10.2139/ssrn.4560486.

 

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