Litigation Update: New York's Covid Therapeutics Case

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New York’s response to the Covid-19 pandemic has been widely criticizedtriggered an FBI investigation, and repeatedly landed the state before the Supreme Court.  The latest criticism comes coupled with litigation alleging that New York State’s Department of Health (NYHD) is illegally discriminating on the basis of race in administering antiviral medication for covid treatment. 

On December 27, 2021, the NYHD issued guidelines for the administration of the antivirals paxlovid and molnupiravir.  Citing the short supply of both treatments, the NYHD directed that the drugs could only be administered to patients with Covid who also had “a medical condition or other factors that increase their risk for covid.”  While New York’s guidelines link to the CDC’s “People with Certain Medical Conditions” page to describe “risk factors for severe illness,” New York specifically added consideration of race as a factor for prescription. 

The guidelines state: “Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from Covid-19.”

As a result, in some cases identically situated "whites" and non-white are ineligible or eligible for certain treatments.  Although the NYHD disputes the characterization of their guidelines as impermissibly racially discriminatory, many lawsuits have been filed challenging the guidelines as impermissible and illegal race discrimination. The first of those lawsuits was filed by Professor William Jacobson of Cornell who joins us to discuss the pending litigation in New York and in other states across the country.

 

Featuring:

Prof. William Jacobson, Clinical Professor of Law and Director of the Securities Law Clinic, Cornell Law School; President, Legal Insurrection 

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As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.

Event Transcript

Dean Reuter:  Welcome to Teleforum, a podcast of The Federalist Society's practice groups. I’m Dean Reuter, Vice President, General Counsel, and Director of Practice Groups at The Federalist Society. For exclusive access to live recordings of practice group Teleforum calls, become a Federalist Society member today at fedsoc.org.

 

 

Ryan Lacey:  Welcome to The Federalist Society’s virtual event. This afternoon, Wednesday, March 30, 2022, we have a Litigation Update on New York’s COVID Therapeutics Case. My name is Ryan Lacey, and I’m an Assistant Director of Practice Groups at The Federalist Society. As always, please note that all expressions of opinion are those of our expert on today’s call.

 

Today, we are fortunate enough to have an excellent guest speaker, Professor William Jacobson, whom I’ll introduce briefly. William Jacobson is a Clinical Professor of Law and Director of Securities Law at Cornell University. Prior to joining the Cornell Law Faculty in 2007, Professor Jacobson had a highly successful civil litigation and arbitration practice in Providence, Rhode Island. Professor Jacobson has argued cases in federal and state courts, including the Court of Appeals in the First, Fifth, and Sixth Circuits, and the Rhode Island Supreme Court.

 

After our speaker has given his remarks, we will turn to you, the audience, for questions. If you have a question, please enter it into the Q&A feature at the bottom of your screen, and we will handle questions as we can towards the end of today’s program. With that, thank you for being with us today. Professor, the floor is yours.

 

Prof. William Jacobson:  Thank you. Thank you for having me. I appreciate this opportunity. This presentation regards a lawsuit that I brought as the named plaintiff against the state of New York regarding COVID therapeutic guidelines that were issued at the end of December. I was hoping to come here as something of the conquering hero, telling you how successful it’s been. But a few days ago, the case was dismissed on the basis of lack of standing. And I want to go through with you what the case was about, what the allegations were, what the defenses were, and what the court ruling was. And I think this has extremely important implications moving forward.

 

So I’m going to share my screen and just walk through a few slides that I think will hopefully make this clear for you. So the first issue came up in late December of 2021, right when COVID was surging at Cornell and elsewhere. I forget which latest variant it was, but the most recent variant. In fact, Cornell went to a semi-lockdown. And right around that time, the Department of Health issued guidance on use of oral antiviral treatments. So these are monoclonal antibodies but given orally, which was something that was new at that time. There were only two drugs that had recently been approved for oral use at that time.

 

And the key problem with the guidance was this portion right here, which is that they are authorized for patients who meet certain criteria. So really, a threshold to get through the door to even be considered for use of these medications, you had to be age 12 or older—no controversy there—you had to test positive for COVID, you had to have mild to moderate symptoms, and you had to be able to start treatment within five days of the symptoms. And that, I think, becomes very important and will become very important in the future as to who has standing and who does not have standing because this is a -- these were medications that had to be prescribed immediately within five days of onset of symptoms.

 

And here’s the problem from my point of view and from our point of view was that in addition to all these other four, which were noncontroversial, you had to have a medical condition or other risk factors that increased your likelihood of severe illness. And so, anybody seeking this medication would have to show a risk factor. And New York State Department of Health said being nonwhite race or Hispanic/Latino should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death.

 

So the way they set this up was that if you were nonwhite or Hispanic/Latino—and they don’t define what nonwhite means—but if you were nonwhite or Hispanic/Latino and you satisfied the first four criteria, you automatically satisfied the fifth, which is the personal risk factor. But if you did not qualify, if you were so-called white—however they would define that—you had to show something personal to yourself. You had an additional hurdle that you had to overcome in order to be able to receive -- be qualified, be authorized for this treatment. And I found that to be problematic because it was imposing a racial litmus test for the provision of emergency medical care.

 

So I filed suit in United States District Court for the Northern District of New York. I don’t know if it’s the first time I’ve ever been a named plaintiff, but it’s certainly the biggest case in which I’ve ever been a named plaintiff. So it was me, filed as a class action on behalf of other people who would be denied treatment under the New York State guidelines against the commissioner of the New York State Department of Health. I was represented by able counsel. Some of these names may be familiar to Federalist Society members. I’ll just leave that on the screen for a second. But the lead entity representing me was America First Legal as well as additional individual attorneys and law firm of Consovoy McCarthy.

 

We filed the complaint, and the complaint alleged three causes of action: one, that the racial preferences violated the Fourteenth Amendment, that it did not provide equal protection under the law on the basis of race; that it violated Title VI, the Civil Rights Act of 1964, again because of racial discrimination; and that it actually violated also the provisions of the Affordable Care Act, also known as Obamacare, which had antiracism provisions in it. And those were our three claims. We filed a motion for preliminary injunction, and there was a cross motion to dismiss.

 

And I think the defenses were very interesting. One, the Department said that the guidelines were merely suggestive, not mandatory. And so, they said, “Well, this is just our advice to people.” The other provisions in the guidelines made it clear that these were mandatory. Plus, there were provisions in New York State law which could subject a physician to sanctions for failing to follow New York State Health Department guidelines. So we didn’t think that this was really true in terms of them being voluntary. And even if true, we argued that this still violates the law because you cannot have the government suggesting racial discrimination in medicine or anything else, and then when the government does it, it’s not merely a suggestion.

 

They also argued that race as a risk factor was justified. And New York really stood alone here. There were several other states that had implemented similar guidelines around the same time. And after demand letters, similar to what was sent to New York State, those states backed down. Minnesota’s the one that’s coming to mind, but there were several other states as well. So other states, when confronted with the argument that this is unlawful racial discrimination, walked it back, either completely eliminating it or simply changing the language to water down the mandate.

 

But the New York State Health Department, in their statements to the media, were completely defending this law, saying it was justified. And I’ll get to it in a second, but they did receive amicus help here from the American Medical Association and a coalition of other groups who argued that the use of race when determining allocation of these medications was justified, and notwithstanding the law, they would justify it as medically necessary. And I think that’s extremely important because that is a trend we are seeing in the medical industry that’s played itself out in these New York State guidelines.

 

They also moved to dismiss on the grounds that it was moot because they said there’s no longer a therapeutic shortage. These medications are no longer in short supply. And therefore, even though they never revoked the guidelines, they said that no one would actually end up being deprived of the medication because we had more than enough to go around for everybody. They said that since our lawsuit, they have removed the guidance from their website. But they didn’t say they’ve revoked it or replaced it or superseded it, but they said, “It’s no longer on our website, and therefore, no doctor would think they need to comply with this.” And they also said, “And by the way, we also are not going to enforce it.” So they tried to moot the case by saying, “Yes, it’s still technically on the books, but we’re not enforcing it, and we’ve taken it off our website.” And we didn’t think that made a difference. Certainly, it was capable of repetition. There’s that whole line of cases, and it had not been revoked. But mootness was really their main point.

 

But they also did assert, and I think equal emphasis, on the issue of standing, that it was simply too speculative for me as a plaintiff to argue that there was a real case or controversy, that I had actually been harmed in some way, that I had suffered any meaningful or legally cognizable harm from these because there would have to be several steps that I would have to go through in order to be harmed. And essentially, what they set up was a test, that unless I got COVID and unless I was denied the medication, I’ve suffered no harm. And we argued for a variety of reasons that that wasn’t the legal test here, that the damage—the actionable damage—took place by being subjected to a differential standard -- a different standard based on race regardless of whether or not I got the medication. So even if I ended up getting it, I would still have to show something based on their racial classifications that somebody else would not have to show. And so, they argued that this was all too speculative. It might happen. It might not happen. And really, nobody who hasn’t been denied medication could sue.

 

There was an amicus brief filed by a coalition of groups—the National Medical Association, American Medical Association, Medical Society of the State of New York, American College of Physicians, and a dozen or so other groups. So the medical industry intervened by way of an amicus brief to argue that these racial classifications were justified medically. And their concluding line was that only by accounting for the increased risk of severe illness from COVID that BIPOC individuals face will their assigned risk group actually reflect their level of risk.

 

But there were other things in there. There was an affidavit put in by someone from the Health Commissioner’s office who argued that race was not in itself a risk factor. It was more the societal implications—I think he called it markers—that race is a marker for other sort of things. I’m not sure if he used the term or somebody else did. But the point is they were not arguing that someone got COVID because they were nonwhite, but that being nonwhite was a marker of various societal risk factors. And the amicus brief said the same thing. They were very clear that being nonwhite is not a genetic condition, in their words, that would subject one to COVID, but there were essentially societal factors that would put somebody more at risk.

 

And, of course, our response was that these guidelines were not neutral, that they could not withstand strict scrutiny because there were other things the state could have done that would not have invoked race. So, for example, the state could have said that you test everybody who comes in for diabetes. For argument’s sake, that might be a risk factor for complications from COVID. But you can’t assume that because a particular racial group has a higher incidence of diabetes that that means that every person of that race who walks into your emergency room has diabetes. So the state could have imposed race-neutral conditions that would have accomplished the same result that would have protected people who do, in fact, have increased race-related health problems. But they didn’t do that. They just created a test of skin color.

 

The court ruled just a few days ago—last Friday, actually. And the court dismissed it on the grounds of standing—did not reach the merits of our claim, did not decide whether these were racially discriminatory or otherwise. Court found that there was no action taken by me that showed that I would actually seek oral treatment. So it was not enough that I put in a declaration saying that if I get COVID, I will seek it. I needed to prove that I’d actually sought these medications in order to -- and that it was not enough, as we argued, that I was put at substantial risk of harm in order to meet the injury in fact requirement.

 

The court talked about a case that we cited that we think felt was on point—we still think is on point—a Second Circuit precedent that held that in the case of risk of deadly disease. And that case involved mad cow disease—that in risk of deadly disease, mere enhanced risk is enough to meet the standing requirement, that you don’t need to show you got the deadly disease, and you don’t need to show you were rejected medical treatment for the deadly disease, that being put at moderately increased risk of a deadly disease was enough to show standing. And we argued that I was at that risk, not just because I’m part of the general population, but I also work at an institution which had a well-reported, newsworthy outbreak of COVID on the campus. And because I worked in a high-risk environment, that certainly put me at increased risk from these guidelines.

 

The Baur case, which is the case which I think will be the subject of further discussion if this does get appealed, talked about the exposure to an enhanced risk of disease may qualify as injury, in fact. That involved consumer food and drug safety suits. But I don’t see why it wouldn’t apply to something like this because that was a case where someone had not yet contracted mad cow disease but was at increased risk of it from a defective product. The court here distinguished Baur, said that it was, itself, limited to food and drug safety suits. Although, the court did note that the Second Circuit did seem willing to extend it beyond food and drug safety suits involving harmful products but did not find that pertinent to my case in the analysis for my case.

 

So the court’s conclusion was that my theory of future injury was too speculative to satisfy the well-established requirement that threatened injury must be certainly impending. And the court said that the following things had to happen before I or anybody could file suit contesting such guidelines, be they racially discriminatory or not—that you have to contract COVID, you have to suffer mild to moderate symptoms, you have to be deemed by a doctor to be clinically appropriate, and there needs to be a shortage in antiviral treatment. So unless you can show all those things, you cannot sue.

 

The court did not address, and I think one of the issues here, is the emergency nature of this medical situation. The drugs are only effective if given within five days of symptom onset. So who would have time to go through these and be able to get to court? So what this decision does essentially is makes it, not impossible, but extraordinarily difficult for anyone to ever challenge this sort of guideline. And the court also found that in light of the discretion afforded to doctors and the current lack of any shortage, the court finds that it’s way too speculative and certainly is not impending harm to me.

 

So I think that what this -- there are two other cases, by the way, that were brought against New York State. In one case, Roberts v. Bassett, brought in the Eastern District of New York just a few days before our decision was dismissed for lack of standing. I think the court’s reasoning there was a little different than in our case. But Roberts v. Bassett was dismissed. And there is a third pending case, foundation for—I forget what FAIR stands for—but FAIR v. City of New York pending in the Southern District of New York where there has been no decision yet. In that case, both the city of New York and the state of New York have been sued.

 

I think what this presents moving forward is how the law and how the courts will address the use of race in medical treatment because that is the trend. If you follow what’s going on in medical schools, there is an increased trend to doing or advocating what the state of New York did here. And I think the fact that the American Medical Association and numerous other physician associations came to the defense of the state of New York shows that this is not a problem that’s going to go away. It will manifest itself in different ways. And the issue of standing, I think, is extremely important. And I think it’s extremely important that it’s in the emergency medical care field.

 

This is a situation where people, as a practical matter, do not have time to go to court to seek to get the medication and also are being required to put themselves at substantial health risk of deadly harm by these guidelines for which there appears to be, at least under this court decision, no effective, timely remedy. I think you can imagine a circumstance where what if the state of New York determined that the use of medical defibrillators for heart attacks had a similar racial component as to who was eligible to receive those. Certainly, you would not expect somebody in a process of a heart attack to be able to challenge that. Yet, I think under this court reasoning, that person would have to be in a heart attack in order to challenge the discriminatory guidelines with regard to those medical defibrillators.

 

So that’s where we are. The case is dismissed. Whether we appeal is being considered now. And if you are in the state of New York, you have a government entity which believes that race should be a factor in the allocation of medical resources. And with that, I will stop my share screen, and I’m happy to answer any questions.

 

Ryan Lacey:  Well, thank you so much, Professor. And we’ll move on to some questions from our audience. I’ll start off with one just to get things kicked off. You mentioned the other case in that you might be appealing this decision to this mess   How far do you see this possibly going? Could it go to the Supreme Court? And how will this affect other cases, this dismissal?

 

Prof. William Jacobson:  Well, I’ll take the second part first, which is I think this will embolden other health agencies. It may even embolden the state of New York to feel that they can impose these sort of requirements because nobody can really sue to stop them, no individual, until you are in a life-threatening situation. So I think it will embolden people. I think the court, though, did not approve of these guidelines. The court never ruled that they were not violative of the law. Really, the court ruling was whether I was an appropriate plaintiff to bring suit.

 

Nonetheless, given that we’ve got two cases dismissed for standing, I don’t know what’ll happen in the third one. But I would not be shocked if, having seen two other judges do it, that judge would do it, but you never know. So I think it will embolden them. How far will it go? I mean, I certainly can’t predict that. I mean, if we do appeal, it’ll certainly go to the Second Circuit, which has already ruled in the mad cow disease field area, as to standing. And we’ll see if they are willing to extend that ruling to this situation. Whether the Supreme Court would take it, I have no idea.

 

Ryan Lacey:  I’m sure. And I forget to mention to all of our audience, you can put your questions in the Q&A function at the bottom of the screen, and I’ll read them for the professor to answer. Another question I thought of was, if a person were to contract COVID, have those moderate symptoms or mild symptoms, and be denied, on the basis of -- because of their race, this treatment but they recovered, would they then have standing after the fact, after they’re fully recovered to sue for not being able to receive this medical care?

 

Prof. William Jacobson:  Well, I think that’s an interesting question because you will have been denied it, but what is the harm that you’ve suffered? Well, clearly, you’ve suffered discrimination, so I think that might survive. Yeah. I’m not sure how that would play out for someone who got it and then recovered. Certainly, there are many reported cases of repeat COVID infections, people who’ve gotten it multiple times. And so, having gotten COVID and recovered, I’m not sure reduces the risk. In my situation, thankfully, I’ve not had it, never tested positive for it. If I had, would that have made a difference to the judge? Well, I think we may have had a decision along the lines you said, which is no harm, no foul—that, yes, you were subjected to this, but you’ve recovered. So I’m not sure how that’s going to play out. But I think we will see more of these cases.

 

Ryan Lacey:  Awesome. And I’ll move on to one of our audience questions. This one’s from Christopher [inaudible 24:31], and I do apologize if I’ve mispronounced your name. He asks, “People can check whatever race they want on most applications, and no one will ever question them. How is the state of New York planning on enforcing these guidelines if someone checks a race they more than likely are not? Was a doctor expected to tell a patient that they did not look Hispanic enough or they were too white? Would a Hispanic heritage 100 years ago in my bloodline keep me Hispanic or make me Hispanic?”

 

Prof. William Jacobson:  Well, that’s one of the problems with the guidelines, is that who qualifies. They use the term nonwhite. What does that mean? They don’t define that. Hispanic/Latino, again, it might be obvious in some cases, but it might not be. How far back in time do you need to go? So I think there’s a whole other set of problems with this, not just in the medical field, but elsewhere. Tossing around terms like nonwhite or white or BIPOC, what does that all mean? This was very specific, though, in a specific medical context, but I agree. I think that’s a real problem. It could leave it up to how you self-identify.

 

Ryan Lacey:  Do you think it was kept deliberately vague in order to give doctors in the medical industry some sort of plausible deniability?

 

Prof. William Jacobson:  I’m not sure what their intent was. But that is the term. Nonwhite is a term that’s tossed around a lot. So it wasn’t surprising to see that there. So I’m not sure what their intent was. I’m not sure they thought it through that deeply, the use of that terminology. My guess would be they didn’t think it through very deeply. They just used terms they’re used to using and just assumed that it would be understood by everybody. But I agree. What is going to happen to people? At what level of skin color under these guidelines do you become nonwhite? And, of course, that lumps in the majority of the world, okay, and 30 or 40 percent of the country into a gross racial classification from which you are supposed to stereotype them and presume that they grew up in a circumstance that lacked proper healthcare, etc. So I think it’s a very pernicious sort of classification for the government to be using.

 

Ryan Lacey:  Yeah, absolutely. Gloria Leal asked, “Does this racial classification have precedent in New York? Did the composition of the court make any impact in the case?”

 

Prof. William Jacobson:  I don’t think there was precedent for this, I mean, not that we were aware of, for the state of New York doing this. It was a single-judge district court case, so there was no composition of the panel as such. And I’m not going to personalize anything to any particular judge. She wrote her opinion. It stands on its merits. It will or will not stand on its merits, but I don’t think there was anything else going on here other than a judge who disagreed with us.

 

Ryan Lacey:  No decisions like this, at least not in the last hundred years. Well, we’re now out of audience questions. But if you had any other thoughts to share on this and see if anybody else wants to ask a few more, or we could wrap up.

 

Prof. William Jacobson:  Yeah. The only thing I would say is that this is a trend. I mean, this is -- I can’t understate the significance—societal significance, maybe not legal significance—the societal significance of the American Medical Association and other groups—but they’re the best known—coming in and defending this and saying that, yes, racial classifications for allocation of scarce medical resources is justified. To me, that’s the more astounding thing than the state of New York doing it is that this is the future, according to the American Medical Association. And I think the question is going to be what role the courts will be in protecting equal treatment under the law and preventing racial discrimination. And, of course, not just in this circumstance, in so many cases, standing is the barrier that people face.

 

And I think the courts, and we hope the courts will take into account, as the Baur court did in the Second Circuit, that maybe things are a little different when it comes to a deadly disease and that the standing issue, you should not require somebody to actually contract a deadly disease before they can challenge racially discriminatory practices by the government with regard to allocation of resources to treat that disease.

 

Ryan Lacey:  And we did get one more question. I think you went over this but to reiterate. Jeffrey Wood asks, “Was this in the Southern District of New York, and have you considered appealing?”

 

Prof. William Jacobson:  This is the Northern District of New York because Ithaca is in Tompkins County, and that’s the Northern District of New York. So we didn’t have a choice to bring it anyplace else, and this would go to the Second Circuit. And are we considering appealing? Absolutely, but no appeal is filed until it’s filed. Okay? So I don’t want to make any promises that don’t get fulfilled, but we think this is an incorrect decision as a matter of law. And we are definitely looking heavily into appealing.

 

Ryan Lacey:  Awesome. Awesome. And no more questions, so -- and you’ve already been over -- I’ve already asked you to wrap up once. So I think that’ll about do it, Professor.

 

Prof. William Jacobson:  Thank you.

 

Ryan Lacey:  Well, on behalf of The Federalist Society, I would like to thank you, Professor, for the benefit of your valuable time and expertise today. And I want to thank our audience for joining us and participating with your questions. We welcome listener feedback by email at info@fed-soc.org. As always, keep an eye on our website and your emails for announcements about upcoming events and webinars. Thank you for joining us today, and we are adjourned.

 

[Music]

 

Dean Reuter:  Thank you for listening to this episode of Teleforum, a podcast of The Federalist Society’s practice groups. For more information about The Federalist Society, the practice groups, and to become a Federalist Society member, please visit our website at fedsoc.org.