Omicron, Best Laid Plans, and the Supreme Court

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Even as the Supreme Court authorized the Department of Health and Human Services (HHS) to mandate vaccination of all Medicaid and Medicare employees–including those not employed by the federal government, a Texas court [1] just blocked the federal government from mandating vaccination over its own employees. That case surely will eventually reach the Supreme Court. All the while, we will grapple with the delay in vaccination – the effect of which, for the moment, is not entirely known. Perhaps, this is all about “decision-making under uncertainty?”

Alas, not. This is about decision-making when views conflict regarding whether personal liberty outweighs public rights, health, and safety.  This is about judicial ego - and who gets to fill the vacant shoes left by Justice Scalia. And this is about who makes legal decisions regarding science - when the science is in doubt.

"…this is just insane…. The federal government lacks the power to require its [own] employees to be vaccinated?"

Steve Vladeck, law professor at the University of Texas

According to Judge Jeffrey Brown: the Texas case is about:

"…whether the President can, with the stroke of a pen and without the input of Congress, require millions of federal employees to undergo a medical procedure as a condition of their employment.”

Judge Brown’s question is bizarre. Merely a few days before his decision, the Supreme Court ruled, unequivocally, that the Secretary of HHS can order “millions of [non] federal employees to undergo a medical procedure as a condition of their employment.” Brown’s decision is a delaying tactic, one tethered to preserving jobs. Delay will serve no public good.

For sure, the evidence will be in flux when the courts are eventually called to decide; there is rarely certainty in emergencies. But someone must make hard decisions during public health emergencies. The question is who? And then, we need to discuss preventing impediments (legal or otherwise) to immediate implementation, taking note of the cost or damage such delay might cause.

The uncertainty of the “science.”

Some may claim the damage from delay in vaccinating when Omicron is the primary variant is minimal or non-existent  - since one initial report indicated the vaccine is ineffective against preventing Omicron transmission. The buzz this single, small, preliminary, non-peer-reviewed report generated in the non-medical and non-legal community was astounding. Yet, what that study measured is not clear - antibody response, viral load, or actual transmission. I’ve read different reports saying different things. The “official” results, described with astounding scientific precision, were reported in the venerable scientific journal, USA Today, on January 17:

“We see many infected with Omicron who received the fourth dose. Granted, a bit less than in the control group, but still a lot of infections.” Gili Regev-Yochay, MD, director of infection prevention and control, Sheba Medical Center.

Four subsequent studies released a few days later got far less attention. Interestingly, these showed that “Covid vaccines offer… significant protection against omicron.” One study was conducted in the same Sheba Medical Center as the one claiming the vaccine doesn’t work. This one was done in collaboration with the Weizmann Institute and Hebrew University and reported that vaccination halved omicron transmission in children 5 to 11 and resulted in a fourfold decrease in transmission in 12 to 15 year-olds, the age groups which are, in Israel, the predominant spreaders of disease.

And then there are the three studies released Friday, January 21; two by CDC and one published by JAMA, attesting to the benefits of three vaccines in stemming severe omicron cases. And yes, I agree, the CDC doesn’t have the greatest reputation for truth and veracity. Let’s suppose the vaccine does prevent severe cases but doesn’t reduce transmission. In that case, this benefit will surely throw the court into disarray as the issue surrounding health care worker vaccination is to prevent transmission to patients - not to prevent severe cases in the health care workers.

The shape-shifting of scientific reports demonstrates with absolute certainty that we really don’t know the impact of vaccination against Omicron – and probably won’t for some time. Nor will we know whether preventing severe disease is in some way related to reducing overall transmission. Regarding Delta, the predominant variant, at least in Israel, the verdict is in far less doubt in severe cases. Even the author of the preliminary “little-effect study,” Regev-Yochay, said, “The vaccine still works well against the Alpha and Delta variants….” 

If Delta is still circulating, that fact should be determinative. But what if it isn’t; what if the only virus circulating is one for which the vaccine only prevents severe disease but doesn’t stem transmission? Or perhaps the two issues are interrelated?  Or what if, as Pfizer CEO, Bourda is saying, there is a new vaccine available, but not yet FDA authorized, proven effective in stemming transmission of Omicron, or whatever the prevailing variant circulating is?

Enter the Courts

At least for legal purposes, the critical issue is not whether reports sustain mandated vaccination when Omicron is the main variant. The legal issue is not what happens if the science is in doubt. The issue is who makes the determination regarding public health emergencies.

The HHS case mandating vaccination for healthcare workers will again be heard by the 5th and 8th circuits. Likely, their decisions will be based on any reports supporting the lack of efficacy against the omicron variant to enable them to strike down the mandate. We can then expect the matter to surely return to the Supreme Court - down the road.

We cannot estimate the damage that will occur during the interim:

  • delta will continue to be transmitted
  • elderly people will continue to die
  • youngsters will continue to spread the omicron variant, infecting health care workers, who will, in turn, pass the disease on to their wards in healthcare facilities.

How does the Supreme Court decide when the science is uncertain?

Nowhere is there more of a conflict between law and society, perhaps, than in the interface between law and science. This is not new. The fact is that law indeed lags behind science. There is an inherent conflict in the two systems, compounded by a preponderance of scientifically illiterate and disinterested judges and lawyers. The Daubert decision (1993) creating a standard of scientific testimony – written in the wake of the junk science of the 1980s and 1990s, which brought down companies and embarrassed the law, was ensconced to remedy the latter issue. Thousands of pages have been written arguing the Daubert decision favors one side or the other. After personally speaking with then Chief Justice Rehnquist and doing significant research, I’ve concluded it does neither. It forces judges to pay attention to what is offered as scientific evidence and not be swayed by sympathetic plaintiffs or expensive experts. Until recently, it worked pretty well to keep both sides “honest.”

But there is an inherent problem between science and law that cannot be remedied: Science is ever-changing; scientists are encouraged to renew, review, re-investigate their findings. Law seeks finality and closure [2]. Nowhere does this frisson manifest better than the recent supreme court cases regarding vaccination.

The lesson to be learned here is that the first reports off the lay-press are not always correct, any more than the CDC’s opinions or advice. The Daubert decision sets standards for evaluating science even when such science is subject to change. One is peer-reviewed literature. Hot-off-the-press reports don’t count.  Another is that the evidence needs to be scientifically reliable. That means one study – even a good one- doesn’t cut it. The Frye decision, which is still the law in seven states, requires decisions based on the consensus of the medical and scientific communities. – and most reports suggest that the public health community still favors vaccination. Whether these views will change over the next few months remains to be seen.

That consensus view held much weight with the Supreme Court here, as well, as the HHS case tells us:

‘Healthcare workers and public health organizations overwhelmingly support the Secretary’s rule,”

The question is not whether persuasion is better than mandates – as some would have us believe. The question is, when persuasion doesn’t work, or when there isn’t time to find out if it does, are we legally allowed to compel vaccination (as undesirable as this may be). The answer is clearly yes - under certain circumstances.

The fact of the matter is that evidence exists demonstrating that mandates work. They may not be pretty or desirable – but they work, as recent data from Canada shows.

"We have also demonstrated at the federal level that vaccine mandates work, 99% of public servants, almost 99% of public servants at the federal level are either fully vaccinated or soon to be fully vaccinated," Jean-Yves Duclos, Canadian Health Minister

And mandates are, under the right circumstances, entirely legal and constitutional. To wit, the Supreme Court has allowed state laws mandating healthcare worker vaccines to stand in states such as Maine and New York.  The issue now facing the court is: does the federal government have this same power?

The legal issues will continue, regardless of the upcoming Supreme Court decisions: What will happen when state court decisions conflict with federal standards? Florida and Montana state laws ban vaccinating health care workers; Maine requires it- even eschewing religious objections. Whose laws govern? Does the federal pre-emption doctrine apply? Will Supreme Court precedent be legally reliable, or will the justices change their stripes depending on whose views they wish to curry? As unthinkable as this might be, evidence suggests it may be the case.

[1] Federal judge in Texas blocks Biden's vaccine mandate for federal workers The Hill

[2] Public Health Law: Power, Duty, Restraint Univ. of California Press