Should Healthcare Be Entrusted to People in White Coats or Black Robes?

The American public's trust in the U.S. Supreme Court (SCOTUS) has significantly waned in recent years. The most recent Gallup Poll (2023), found that approval was at a two-decade low (41%), while disapproval was at a high point (58%). This decline can be partly attributed to a growing perception that the Court is dismissive of scientific expertise and evidence-based decision-making, especially in healthcare cases. Instead, the Court is concocting rationales to support its ideological leanings.

Consider, for example, Loper Bright Enterprises v. Raimondo (2024). The case (together with its companion, Relentless, Inc. v. Department of Commerce), eviscerated the Chevron doctrine, which had empowered federal agencies to interpret ambiguous statutes and was especially important in agencies with special substantive expertise. 

This dismantling of deference now facilitates legal challenges to established governmental healthcare consumer protections. Many of these entities exist under the aegis of the Department of Health and Human Services, HHS, (which includes 13 agencies, such as the FDA and CDC), but there are additional relevant agencies such as EPA, NOAA and OSHA, each operating under different Cabinet departments. 

Case-by-case determination of regulatory authority would undoubtedly sow confusion, creating uncertainty for businesses, healthcare providers, and consumers, and potentially undermining established standards of healthcare and environmental protections. Such expected inconsistency will generate a patchwork of decisions as different courts separately examine federal agencies’ determinations. The result will also disrupt insurance decisions, introducing uncertainty (the curse of the underwriter) as each matter is handled individually without any need to follow rulings from another judicial circuit. The case-by-case decision-making renders predictability of results highly elusive, as does the lack of respect for the expert personnel and scientific resources of science-based agencies. As one commentator stated:

Chief Justice John Roberts wrote [in overruling Chevron] that the real experts on deciding if a toxin dumped in the water supply constitutes a dangerous threat or “new and improved taste!” are law school graduates. (Emphasis in original)

Further eroding trust in SCOTUS is the Court's recent handling of the FDA’s drug approval process in abortion-related cases. In FDA v. Alliance for Hippocratic Medicine (2024), the Court dismissed a challenge to the abortion drug mifepristone (Mifeprex) on a procedural technicality – finding that because the doctor-plaintiffs suffered no harm, they did not have legal standing to sue. Thereby, they avoided a substantive ruling on the drug’s safety, the propriety for mail-order administration, and the FDA drug approval process itself. Justice Kavanaugh's concurring opinion even hinted at the possibility of future challenges, leaving healthcare providers apprehensive about the legal status of that drug – and others. 

Similarly, in Moyle v. United States (2024), Idaho's defiance of the Emergency Medical Treatment and Labor Act (EMTALA), which mandates that hospitals must perform emergency abortions to preserve a woman's health, was incompletely addressed. The Court dismissed the case as “improvidently granted” without addressing the merits – namely, EMTALA’s preemption of state abortion bans, again raising concerns about the Court's willingness to uphold federal healthcare regulations that conflict with state-level abortion restrictions.

This lack of respect for scientific authority, evidenced by the Chevron override, along with the Court’s ostrich-like failure to wrestle with scientific/medical determinations, such as in the EMTALA and abortion-drug cases, became apparent in the last decades of the 20th Century. The judiciary’s science phobia of the time led to the failures of various corporations that furnished socially useful products. 

In 1993 (and the years thereafter), a science-sensitive court inaugurated the gatekeeper standard, imposing a higher bar for decision-making based on scientific evidence. It required relevant and reliable science to determine these decisions and saddled the judge with “gatekeeping” to vet appropriate scientific evidence before it could be presented to the jury. The seminal case was Daubert v. Merrell Dow Pharmaceuticals, Inc., which involved a baby born with birth defects caused by the mother's use of an allegedly (but ultimately unprovable) defective anti-nausea drug. 

Much has been written explaining Daubert, including our pieces for ACSH. Here is  an essay from the Cornell University website which furnishes their take on the case: 

The “Daubert Standard” provides a systematic framework for a trial court judge to assess the reliability and relevance of expert witness testimony before it is presented to a jury. Established in the 1993 U.S. Supreme Court case Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993), this standard transformed the landscape of expert testimony by placing the responsibility on trial judges to act as “gatekeepers” of scientific evidence. 

The Daubert case introduced a more comprehensive approach requiring judges to scrutinize the expert’s methodology and the underlying scientific principles. This shift aimed to curtail the admission of pseudoscientific or unreliable expert testimony. Judges are required to assess the methodology and reasoning behind an expert’s opinions rather than simply relying on the expert’s credentials or reputation.

Under the Daubert Standard, the trial court may consider the following (non-exclusive and non-mandatory) factors to determine whether the expert’s testimony is reliable: 

1. Whether the technique or theory in question can be, and has been tested; 
2. Whether it has been subjected to publication and peer review; 
3. Its known or potential error rate; 
4. The existence and maintenance of standards controlling its operation;
5. Whether it has attracted widespread acceptance within a relevant scientific community.

Daubert was later expanded by Joiner v. General Electric, which required expert testimony to be tethered to reliable data and methodology, and the Kumho Tire Case, which broadened the expertise required of experts generally, not just medical ones. 

Daubert is critically important but not bulletproof. First, it does not recognize that the scientific concept of validity is distinct from scientific reliability (except in a footnote, usually disregarded by the courts). And, as one of us (Dr. Billauer) explained in a recent analysis, not all judges “get it” – for example, when a Delaware judge “abdicated or misunderstood her responsibility, dumping all the scientific evidence into the hands of the jury to decide its value” in a multi-plaintiff drug case against the manufacturers of the GI drug Zantac. In fact, other judges did recognize the unreliability of virtually the same “evidence” and threw out similar cases. The mifepristone case is another example of head-ducking on the merits by invoking a technicality to avoid the careful scientific assessment required by Daubert.

The Dobbs v. Jackson Women's Health Organization (2022) case, which upended Roe v. Wade, illustrates an analogous reverence for religion over regard for dispassionate science. This decision has enabled states to interdict lifesaving healthcare even when abortions are medically indicated, and it has had a ripple effect on healthcare access: A 2023 survey showed a significant fraction of graduating OB-GYN residents were reconsidering their practice locations due to abortion restrictions.

Favoring religion (which is supposed to be separate from the government) at the expense of science is also exemplified by the case of Roman Catholic Diocese v. Cuomo, where the Court refused to countenance the New York Health Department’s order disallowing congregations of more than ten persons at the height of the COVID pandemic because it would prevent religious prayer-meetings. Desiring to protect freedom of religion at the expense of public health and the safety of society, the Court rejected the arguments of various medical associations in favor of briefs by religious organizations – even as the epidemic raged and vaccines were not yet available.

Legal scholar Wendy E. Parmet aptly describes the Court's approach as "dismissive of science and the real-world impact of their decisions," suggesting a widespread perception of an imbalance in favor of ideology over respect for scientific expertise in healthcare cases. [1]

Some of the Supreme Court's recent decisions have taken the prudence out of jurisprudence and created a climate of uncertainty and distrust regarding healthcare policy.  The SCOTUS has thus created a quandary: Daubert requires the courts to pay careful attention to science, but by eviscerating Chevron, SCOTUS has signaled that deference to sound science (produced by impartial scientists employed by the government) [1] is insignificant – at least compared to business or political interests. 

Restoring public trust will require the Court to demonstrate a greater willingness to engage with and defer to scientific expertise and prioritize the well-being of patients in healthcare and public health rulings. We are not optimistic that they will successfully thread that needle. 

[1] While the plaintiffs in the Loper Bright cases argued that Chevron favors the defendant (i.e., the government) at the expense of business (i.e., the plaintiffs), that argument, even if true does not apply to scientific issues. Testimony and evidence related to pure science come from an arsenal of scientific resources the Court is disregarding at first instance – as a matter of law.

Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was he founding director of the FDA’s Office of Biotechnology.

Barbara Pfeffer Billauer, JD MA (Occ. Health) Ph.D. is Professor of Law and Bioethics in the International Program in Bioethics of the University of Porto and Research Professor of Scientific Statecraft at the Institute of World Politics in Washington DC