Browsed by
Author: Richard Jaffe

Northern District of New York Grants a Preliminary Injunction Against the NY State Emergency Mandatory COVID Vaccination Order with Did Not Contain a Religious Exemption/Accommodation

Northern District of New York Grants a Preliminary Injunction Against the NY State Emergency Mandatory COVID Vaccination Order with Did Not Contain a Religious Exemption/Accommodation

Previously, a Northern Disrict of New York federal district judge issued a TRO against New York State from enforcing its COVID vaccine mandate for all New York state health care workers. The original emergency order issued by the Health Commission had the religious exemption in it, in addition to the medical exemption. But the subsequent order issued by the health department removed the religious exemption. The failure to provide a religious exemption was the basis of the injunction lawsuit. The district judge granted the TRO back in September. Today, the judge granted a preliminary injunction stoping the state from implementing the vaccine vaccine order pending hearing/trial on the merits.

Here is the decision. Of course, you will all love it.

Dr. A v. Hochul NDNY Injunction Order(2)

The court applied the strict scrutiny test and held that the state failed to meet that test. Among the reasons was that the order allowed exemption on medical grounds and did not explain why there couldn’t also be a religious exemption. In legal terms, that meant it couldn’t show that the order was the least restrictive means to achieve the compelling state interest. The court also pointed out that Commissioner Zucker’s prior order had the religious exemption in it. So what changed in the eight days between the two orders?

The court engaged in an extensive discussion of the First Amendment Free exercise clause and its relationship to Title VII dealing with employment discrimination based on religion. Honestly, I’m going to have to read that part more than the two times I already read it to figure it out.

I am not quite prepared to say that an employee COVID vaccine mandate has to have a religious exemption/accommodation, either under the Free exercise clause of the First Amendment or Title VII which prohibits discrimination against religious practices by employers. My hesitancy has two reasons: First, I think what might have done New York in was the fact that the original order had it, and it seems unreasonable and arbitrary to remove it in an order issued by the health department eight days later.

Second and more importantly, a Brooklyn federal judge reached the opposite result on the same emergency order. That decision, you will recall, was stayed by the Second Circuit recently. Oral argument on the appeal of the denial of the injunction will be heard by the Second Circuit on Thursday. Being a higher court reviewing the same emergency order, the Second Circuit’s decision should be controlling.

But for sure, that the Second Circuit stayed the emergency order pending the oral argument and specifically acknowledged the TRO in this case, plus the preliminary injunction in this Northern District case is a promising sign to those NY health care practitioners who want a right to seek a religious accommodation to the vaccine mandate. But more than that, it’s tough to say. But it could be that not to have the possibility of a religious exemption/accommodation may be too much even for an inherently conservative judiciary. And if so, well, that might open up all kinds of possibilities down the road for lawyers and lay folk, beyond New York and maybe even beyond the employment context.

Rick Jaffe, Esq.

More Action On the Vaccine Mandate Front including some Good News on the Religious Exemptions/Accommodations

More Action On the Vaccine Mandate Front including some Good News on the Religious Exemptions/Accommodations

It seems like each day brings new lawsuits and/or decisions on the mandatory vaccination issue.

Yesterday, the Sixth Circuit denied the Michigan university’s attempt to stay the district court’s preliminary injunction barring the university from denying student athletes from participating in sports activities because they were unvaccinated Here is the decision.


People opposed to mandatory vaccination and in favor of a strong if not absolute right to a religious exemption will be pleased for many reasons. Lawyers in the field will be pleased because the appellate court used/ratified the strict scrutiny test, which basically means the subject law/regulation/action will most likely be struck down (unless the state can prove a compelling state interest and that the rule was the least restrictive means possible.)

The effect of the decision is that these athletes (and presumably any other athlete whose religious exemption was denied), cannot be stopped from playing sports because they are unvaccinated if they had filed a religious exemption which was denied. I am not completely sure about this because the record in the case was unclear about a few important things, like whether the religious exemptions were denied or granted but the accommodation was that they couldn’t play or practice, but still maintained their scholarships.

There was not a fully developed record on the need for the vaccine for public safety. The rationale for the denial of the exemption/accommodation was unclear and not compelling to the appellate court since there was neither a general student vaccine mandate, nor was there a vaccine mandate for students participating in intramural sports. A more thought-out and coherent policy might have survived constitutional scrutiny, but who knows. But, I do read these inconsistencies as being important to the appellate court in reaching its decision.

This decision was based on the “free exercise” part of the First Amendment religious protection. This means the case only applies to state actors. So it would not be precedent for private universities.

The other question I have and I think remains open is whether the government has to have in place a religious exemption/accommodation for students under the free exercise clause. New York state removed the actual religious exemption to mandatory vaccination a couple years ago and that law survived a constitutional challenge, and no one seemed too concerned about the free exercise rights of NY public school students.

There is some language in the Sixth’s opinion indicating or implying that public entities do not have to grant a religious exemption, but if it does, it couldn’t discriminate against students on the basis of their religious practices. If you’re alittle fuzzy about how this all fits together, join the club.

Per my previous post, I think the Second Circuit’s upcoming hearing on October 14th on the NY state health care workers’ religious exemption might give us a better understanding about some of these issues. There was a more developed record on that preliminary injunction case than in this Michigan case That case nominally involved the Civil Rights act. I am also unclear about how the Free exercise clause works with the Civil Rights act which appears to be the basis of the employee challenges to the vaccine mandates on religious grounds.

One good thing about all these decisions is that the more they conflict with each other, the more likely the Supremes are going to have to weigh in and straighten out this mess.

The way I read the legal landscape, the Supremes don’t necessarily have to take up a Jacobson challenge, but they are going to have to set some rules and decide whether there is a right to a religious exemption to a vaccine mandate and if so, what are the minimum procedure requirements which a school or employer has to utilize, and how deep can they can inquire to determine the applicant’s sincerity of the religious beliefs, if at all.

To date, the best arguments seems to be based on religion rights. The worst on a liberty right, control over one’s body and informed consent. The first two of which are settled law (for now at least) based on Jacobson. The last has not gotten any traction in the courts. That’s how I see it anyway.

Another interesting if expected development is that Kaiser was just sued in a California federal court based on its vaccine mandate. You all will really love that complaint since it raises essentially all the scientific and legal arguments made in all prior cases, like natural immunity is better than vaccine induced immunity, the vaccine doesn’t protect against transmission, etc. It’s all there and you will love reading it. Here it is.

Rick Jaffe, Esq.

Next Week We May Actually Know Something about Whether the Religious Accommodation to the Covid Vaccine is Meaningful

Next Week We May Actually Know Something about Whether the Religious Accommodation to the Covid Vaccine is Meaningful

I confess to being alittle confused about the meaning and effect of the religious accommodation to the Covid mandate. Let me start by telling you what I do know and what some of you might not know, appreciate or accept.

I don’t care what people call it, it is not an exemption, in the sense that if you get one, you necessarily go back to pre-Covid life at your job. Rather, it is an accommodation which employers have to consider making under federal law.

The accommodation, if it is granted, does not guaranty you keep your exact same job under the same conditions you worked pre-Covid. The accommodation require weekly testing and masks. It may require reassignment to another job that does not include the level of interaction with co-workers or invitees (customers or patients) that you had before Covid times. It could stick you in a room away from all other vaccinated employees. United Airlines’ religious accommodation is indefinite unpaid leave!

It is up to the employer to frame the reasonable accommodation, and also to decide whether it is even possible to make a reasonable accommodation.

That is the difference between a religious (or disability) accommodation under and a medical exemption under this federal law. And of course, the religious and disability accommodation under this federal law is quite different from the religious or personal belief exemption which many states have for mandatory school vaccination requirements. Those are actual exemptions, meaning if your child has one, he/she goes to school like all other children.

I also know that in general, the law allows employers to make inquiries to determine whether the employee really has a sincerely held religious belief in opposition to the Covid vaccines. However, I don’t know how deeply the questioning can go. I have heard of employers asking employees whether they were vaccinated as a kid and whether their kids are vaccinated. Relative to the fetal tissue issue, I hear about questions about whether the employee uses the many common drugs (including Motrin and Benadryl) where their development involved the use of fetal cells.

Some companies and state entities require a letter from the religious organization. While that could be considered evidence, I don’t think that will survive as a prerequisite, as a statutory matter, since membership in an organized religious is not required to seek or obtain a religious exemption, or so I read the applicable EEOC rules.

I am also not sure what kind of process is required under the law (and that would be the Civil Rights Act which protects against discrimination based on religious practices). I think we may get some answers to this and some other questions next week based on two related cases involving New York State health care practitioners.

As you know, an upstate NY federal judge issued a TRO against the enforcement of the NY state vaccine mandate for state health care employees. However a Brooklyn federal district judge refused to grant a preliminary injunction against the same law. Complicating things but making it much more interesting, last week, the Second Circuit stayed the enforcement of the regulation until it heard the appeal of the denial of the preliminary injunction, (which it will do on October 14th, one day before the preliminary injunction hearing in the upstate NY case.

This time, I think the Second Circuit is going to have to write an extensive opinion. But of course, the next day, the Northern District’s case goes to the injunction hearing. So does the Second Circuit rule from the bench and write later? Where would that leave the Northern district judge? To me it’s a mess, which is not necessarily a bad thing if you’re challenging the mandates. And if you are against vaccine mandates and for the religious accommodation, a temporary win is still a win, (until there is a substantive loss).

There is still much that has to be played out and case law to be made in terms of the contours of the religious accommodation and the required process and its limitations. But what I am not seeing in the end game is all employees who obtain such an accommodation have the exact same employment circumstances they had pre Covid, and that is something that needs to be considered by those employees waiting for the results of these cases.

I also don’t see the courts overturning the ability of companies and governments to decide that based on the job and the circumstances, there is no reasonable accommodation that can be made.

And for many reasons, I think the courts are going to be reluctant to start second-guessing employers on these decisions, if for no other reason to avoid the possibility that the courts would be inidated with these cases, directly or indirectly through a judicial appeal of a federal employment (EEOC) administrative process. But I do expect the courts to start to set out some basic principles about how employers have to handle the religious accommodation process and set some boundries and guidelines.

Rick Jaffe, Esq.

Cancer Doc Stanislaw Burzynski explains his theory of cancer and his targeted gene therapy approach (and my worlds collide)

Cancer Doc Stanislaw Burzynski explains his theory of cancer and his targeted gene therapy approach (and my worlds collide)

For those of you who don’t know about him, Stanislaw Burzynski has been treating advanced cancer patients since the late 1970s with a novel peptide compound he discovered (and later synthesized). In the last dozen or so years he has been on the cutting edge of multi-agent targeted gene therapy in what is called personalized cancer treatment. Along the way, he has run into a quantum level more trouble with governments and other institutions than any other maverick health care practitioner in the world. Stan and his patients who demanded access to his non-FDA approved treatment originated the right to try/expanded access to investigational treatments back in the mid-90s, first with expanded compassionate use under the Clinton Administration, ultimately leading to the right to try movement which is now federal law and the law of most states. (Full disclosure for those of you who don’t know, I was involved in many of these battles for a few decades, as detailed in Chapter 2 of Galileo’s Lawyer.)

Forty five years later, he’s still treating advanced cancer patients and still looking for funding to do the phase 3 clinical trials (for DIPG a very nasty and fatal childhood cancer).

Documentarian Eric Merola has done a series of movies and interviews with Stan starting ten years ago. The first one won some awards but was hated by the mainstream cancer establishment.

Recently, Eric has put together a series of interviews with Stan. Here is a link to Stan’s explanation of his theory of cancer been a genetic disease and how it should be treated and why it’s so tough to treat.

In this Covid crazy world we live in, we should remember that there are other important issues and battles to be fought.

Stan’s wife, Barbara, who co-founded the Burzynski enterprise (a clinic and a drug manufacturing facility) died a few weeks ago of Covid. She was 80 and unvaccinated. The disease attacked her lungs and she passed within two weeks. Stan went through some very tough times fighting the federal and state governments. Barbara was his most vociferous supporter and kept him on track with grace and inner strength.

I am a long-time health freedom advocate who is active in the vaccine mandate field. But I’d be lying if I said it hasn’t given me pause to think, especially as we now pass the 700k death number (for those who accept this or any statistics from the government). Health freedom has a cost.

There are a number of YouTube interviews in Eric’s series about Dr. Burzynski. You will find them interesting and aligned with how you think about things. Stan is a unique voice in the cancer field, and someone who will be viewed by history as a pivotal part of the health freedom movement. So check them out.

Rick Jaffe, Esq.

The Second Circuit Grants a TRO until the appeal is heard on October 14th

The Second Circuit Grants a TRO until the appeal is heard on October 14th

The Second Circuit in the We the People health care worker case granted a TRO but it is not a separate or independent TRO. Here is the language of the decision:

“Plaintiffs-Appellants move for a temporary injunction pending resolution of this appeal, prohibiting enforcement of New York State’s regulation requiring vaccination of specified healthcare workers. IT IS HEREBY ORDERED that the motion is GRANTED IN PART and DENIED IN PART. See Roman Catholic Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 66 (2020). Appellees are hereby ENJOINED, pending resolution of the appeal or further order of this Court, from enforcing the mandate against persons claiming religious exemptions, in a manner that would violate the terms stated in the temporary restraining order entered by the district court in Dr. A v. Hochul, No. 21-cv-1009 (N.D.N.Y. Sept. 14, 2021).

The motion is otherwise DENIED. IT IS FURTHER ORDERED that the appeal will be heard by the panel sitting on October 14, 2021 beginning at 9:00 a.m. Each party will be allotted 10 minutes of argument time. Appellants’ brief is due on October 4, 2021 at 9:00 a.m. Appellees’ brief is due on October 7, 2021 at 5:00 p.m. The reply brief, if any, is due on October 8, 2021 at 5:00 p.m.”

Plaintiffs/Appellants wanted a separate TRO in the case. I guess they got it, and specifically they got the TRO until the appeal is heard on October 14th. The court also told the state that they shouldn’t violate the Northern District’s TRO. The court specifically cited the Cuomo case which enjoined the former governor on public restrictions which adversely affected religious practices. Opponents of mandatory vaccination and in favor of religious exemptions should be pleased. I didn’t see that coming from the tone of the oral argument, and I guess it once again shows how serious the courts take the whole free exercise of religious concept.

Of course, all these injunctions are just against the state, not against private health care facilities, because the free exercise clause, like all federal constitutional amendments only applies to government action.
But a W is a W.

Rick Jaffe, Esq.

The Oral Argument in the We The People Health Care Workers Case is over; decision pending

The Oral Argument in the We The People Health Care Workers Case is over; decision pending

The oral argument in the stay of the New York State regulation mandating Covid vaccination (with no religious exemptions) has just finished. The judges took the case under submission, meaning they will issue a decision sometime in the very near future. (I am thinking by the close of business today, or tomorrow at the latest).

I learned a couple of new things: First, there are currently three TROs barring enforcement of the regulation, the Northern District federal case as well as two state cases.
Second, the original emergency rule issued by the state health commissioner had a religious exemption, but the formal rule which went through the whole administrative rule-making process did not.

My impression: First, the judges were concerned about the paucity of the factual record before it. They wanted to know how rare or few medical exemptions had been given out compared to how many religious exemptions there might be. The State was forced to look to prior vaccine mandates. Because it was just audio, it was hard to follow which judge was saying what. One judge for sure was going to rule against the plaintiffs. The same or another judge was concerned about the lack of practical effect that a stay would have since the plaintiffs were covered by the three TROs currently in effect. Plaintiffs’ counsel didn’t have a good response to that concern for the simple reason that he couldn’t tell the court what I think was the real reason for seeking a stay/injunction of the regulation from the appellate court. If the second circuit granted the injunction then it wouldn’t matter what would happen at the lower courts in the other cases. The state-wide injunction would continue in effect until at least the formal appeal of the Brooklyn federal district courts order to the Second Circuit was heard and decided. Tactically, it was a smooth move.

After hearing the argument, I don’t think the panel will reach the merits of the case. I think they will deny the injunction request either without explanation or a short explanation that it is unnecessary because of the other three TROs and because courts do not issue extraordinary relief unless it is absolutely necessary (or to protect the status quo) and that is simply not the case here because plaintiffs counsel was forced to admit that all of his clients are still working and are covered by the injunctions in the other cases. To me that was the kiss of death to plaintiffs’ request.

Also, I think what’s going through the panel members’ minds is that the record is just too sparse to say anything on the merits. So when in doubt, punt. In this case, that means deny the request and say as little as possible to give the other courts room to cogitate and consider a fuller record.

If I am right, the good news will be that it won’t be a negative substantive opinion, which in this legal environment isn’t half bad.

Rick Jaffe, Esq.

So What Case is going to be heard at the Second Circuit Tomorrow?

So What Case is going to be heard at the Second Circuit Tomorrow?

So here’s the deal. We the Patriots as plaintiffs filed two lawsuits in Brooklyn federal court recently. The teachers’ lawsuit challenged the NYC vaccine mandate. The other suit by the group and some health care workers challenged the state vaccine mandate for state health care workers.
Here is the complaint in that health care workers’case. show_multidocs(3)

The district court denied injunctions in both cases. A circuit court judge on Friday granted a stay or administrative injunction in both cases so that the court of appeals panel could take up both cases tomorrow. Last night, the court of appeals denied the stay and denied the request for an injunction pending appeal in the teachers’ case. So the teachers’ case is effectively over (unless they try for an emergency injunction before the Supremes, or they decide to continue to litigate the case despite the denial of the preliminary injunction by both the district and appellate courts).

So that leaves the health care workers’ case against the state, which will be argued tomorrow morning. Complicating things, another federal district judge (in the northern district of New York) issued a TRO barring the same state vaccine mandate for state health care workers on September 14th (Here is my post about that case. ).

The court of appeals noted that that case is not before it in terms of tomorrow’s hearing. While that might be technically true, the argument tomorrow and the panel’s decision will certainly impact the northern district’s case as it involves the same law. The only issue the court of appeals will hear tomorrow is the first amendment free exercise issue. The law doesn’t appear to give health care workers an option for a religious accommodation/exemption. It does allow for medical exemptions. The plaintiffs have a problem with that.

Per previous posts, the only winning arguments on these vaccine issues seem to be those involving religious free exercise, at least in terms of TROs. I believe this is the first court of appeals to address the issue.

I think the second circuit’s decision will be outcome determinative in the northern district case. Meaning, if the panel affirms the Brooklyn district court’s denial of the preliminary injunction against the state law, I expect the state will send the Northern District judge a copy of the decision and seek the vacature of the TRO. If the panel grants the injunction, then the Northern district case is moot because the panel (a higher court) would have already granted the relief sought in the upstate NY case. I think these cases are about legal/constitutional issues only so I don’t see the need for the panel to send the case back for an evidentiary hearing, mostly because the law doesn’t allow for religious exemptions supposedly. So the constitution either requires it or it doesn’t.

Of course, you all know (but hate and don’t accept it), the courts have held that there is no constitutional right to a personal belief exemption. The right to a religious exemption has been litigated in New York after the religious exemption was removed a couple of years ago. So to me, the odds are that the panel is going to affirm the denial of the preliminary injunction.

I don’t see how the courts could deny constitutional protection for the religious rights of kids, but grant their parents employed by the state those rights. I think a medical exemption is different from a constitutional point of view, and even Jacobson at least implied that such a right exists. I think a religious accommodation/exemption is different and more akin to a personal belief against vaccination. EXCEPT of course that there are specific constitutional protections for the exercise of religion, and that might well be a huge difference. Will it be enough? We should find out tomorrow because I think the Court understands that the state and its health care workers need clarity on the issue ASAP.

Rick Jaffe, Esq.

All Eyes are on Tomorrow’s Second Circuit’s hearing in Maniscalco v. City of New York (Second Update)

All Eyes are on Tomorrow’s Second Circuit’s hearing in Maniscalco v. City of New York (Second Update)

Tomorrow, Wednesday, September 29th, a three-judge panel of the Second Circuit Court of Appeals will hear arguments on continuing the stay of NY City’s vaccine mandate for school teachers and other school employees.

To recap, the district court denied a preliminary injunction motion on 9/23, but a circuit judge issued a stay of the vaccine mandate the next day to allow a three-judge panel to consider the matter. So right now there is a stay of the mandate until the panel hears the matter tomorrow morning.

UPDATE: The panel has just dissolved the stay of enforcement, meaning the mandate is now in effect. The court also denied the preliminary injunction pending appeal so the motion is over (and the stay is dissolved and the mandate is in effect). Here is the new order. Maniscalco TRO dissolved

However, there appears to be a companion case involving New York City health care workers which will be heard tomorrow by the same panel. The Court is only going to consider the First Amendment freedom of religion argument. Meaning all other arguments raised have already been decided by the judges.

(End of the update, now back to what I had previously written. Unfortunately, as you can see, the panel did not give any explanation of its decision. But you can read the below for my views about why it did what it did.)

Here is the stay, the district court’s decision denying the injunction and plaintiffs’ complaint.

Maniscalco Expedited Motion Pending Appeal

First question: How much can you read into the fact that one circuit court judge issued a stay?

Probably not much. This is an important issue that had a deadline before the panel could hear the issue, so I think it was prudent and reasonable to issue the stay which will only delay the mandate by less than two days, (if the stay is vacated by the panel).
So I don’t think people should read too much into what may only be a two-day stay.

The big question: What’s the panel going to do?

I have read the lower court’s opinion which summarizes the plaintiffs’ arguments, but I have not reviewed the filings by the parties. But I have seen the papers in other vaccine mandate cases. More importantly, I do have some very specific opinions about what the law is and how these cases are decided by judges.

The plaintiffs’ main argument appears to be that that they have a fundamental right to employment which is violated by the NYC department of education vaccine mandate which does not allow for alternative compliance via testing. They also argue the lack of alternative compliance which option other city employees have is discriminatory and irrational. Finally, they make the now oft-used antibody argument. (I’ve had COVID so I have the antibodies so I don’t need the vaccine or there is no proof that it is necessary and natural immunity is better than vaccine immunity).

I think the panel will deny the continued stay and allow the case to proceed. Meaning, the vaccine mandate will go into effect requiring NYC school personal to be vaccinated or be fired.

Here is my reasoning.

First, I do not think whatever fundamental right to work there is or may be in a general sense, applies to a person who is opposed to vaccines (or this vaccine) in the face of a vaccine mandate. (This case does not technically involve the religious accommodation, as pled). I’m not going too far out on a limb here because that is what all the judges have said who have dealt with the issue (i.e. the federal district judge in Indiana, the Sixth Circuit reviewing the Indiana’s district judge’s decision, the Houston federal judge, and two judges in the Central District of California, the Ninth Circuit panel reviewing one of the central district judge’s decisions. And of course, this is the thrust of the Brooklyn District judge Brian Cogan’s decision.)

Digging deeper, once a judge decides that there is no fundamental right, then the judge uses a rational relationship test, which practically means that the regulation survives. What that means methodologically is that the courts can speculate about possible justifications for the law. More importantly, under a rational relationship test, the courts defer to the decision-makers to make the decisions.

There is basically no second-guessing of a decision-maker under a rational relationship test. That is the reason why most constitutional cases are all about the standard of review. It is often said, that if it’s strict scrutiny the law/regulation/policy usually gets struck down, and if the test is a rational relationship, the law or rule is upheld.

Analogously, with equal protection arguments, if a rule involves a fundamental right or a suspect class, strict scrutiny applies. If not, then the test is rational relationship and the regulation is upheld.

Finally, with respect to the antibody argument, I think the answer is simple: Judges don’t feel comfortable deciding scientific or public health issues. They defer to the regulators who are assisted by experts. I think that is the fundamental strategic mistake made in many of these cases; namely, thinking that some judge or group of judges are going to wade into scientific issues, especially when you are arguing against mainstream science. If that’s your argument, you’re going to lose (in my opinion anyway, and regrettably I speak from some experience on this issue).

That is what I see happening tomorrow, and I think we will have an answer tomorrow at the end of the hearing.

Rick Jaffe, Esq.

More Good News on the Religious Exemption Front! NY Federal Judge Issues a TRO Against the Denial of Religious Exemptions; Now it’s getting interesting and Maybe it’s an end-around Jacobson in this and other such actions

More Good News on the Religious Exemption Front! NY Federal Judge Issues a TRO Against the Denial of Religious Exemptions; Now it’s getting interesting and Maybe it’s an end-around Jacobson in this and other such actions

At 10:00 AM this morning, a Northern District of NY federal judge signed a TRO stopping the new Governor and the Department of Health from a bunch of things relating to religious exemptions being denied to state health care workers.

Here is the order.


Here is the complaint. It is interesting because it’s not only about the religious exemption but also about natural immunity. Thomas More Society NY FED Hospital Pleading!!!

This might be a good template for other such actions for many reasons, not the least of which is that it seems to circumvent Jacobson, which is limited to upholding the constitutionality of state vaccine mandates under the state’s police power.

This is a different issue. There is a federal statute that accords certain religious accommodations/exemptions to employer mandates, the contours and processes are murky and undefined. Cases like this one invoke the constitutional buzzword “religion” and there is the aforementioned federal statutory basis that gets the attention and serious consideration of the Courts. Not enough attention on a straight state mandate because of Jacobson . But based on a right to practice religion under federal law, well that is apparently a whole different issue. Now, two federal courts have temporarily stopped states from interfering with the religious rights of workers.

This case is going to proceed quickly. Per the order, the judge wants to convert the TRO into a preliminary injunction unless the state objects (and it will I think) and proceed to a permanent injunction hearing. The other thing of note is that the state’s new order and the denials do not go into effect until later this month, so the judge pointed out that despite the TRO it has no practical effect for the next few weeks, which gives the state plenty of time to react. But Leticia and her crew will be mightly busy until then.

Between, this and the whole Biden OSHA thing, for which Jacobson is also not direct precedent, well, like I said, it’s going to get interesting and those opposing the mandates may continue to get some good news.

Rick Jaffe, Esq.

Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

Here is where the case stands as of September 13, 2021:

Closing arguments were held on August 20th. The Judge set a short post-closing briefing schedule and both sides did briefs and replies, mostly on the definition of HCT/P’s. The reply briefs were submitted, per the judge’s order, on September 1st, as of which day the case was submitted and is now sub judice (legalese for pending decision by the court).

One interesting note: Of course, the Government submitted to Judge Bernal the 11th Circuit’s decision affirming summary judgment for the FDA in the Florida US Stem Cell case. That decision is on-point authority because it deals with the exact same issue; whether SVF is a new drug under 21 CFR 1271 or not. However, because the decision is in a different Circuit (California is in the Ninth Circuit), it is not binding on a California district court. Meaning the district judges in other federal circuits are not required to follow it. It is, however, entitled to weight and is considered persuasive. But the bottom line again is that it is not binding, the way a prior Ninth Circuit opinion be if there had been such on-point authority.

But the interesting thing was that the Defendants submitted another circuit court opinion in support of its position and that would be The Judge Rotenberg Education Center, Inc. v US FDA. That case did not deal with stem cells, but rather the FDA’s attempt to ban an FDA-cleared medical device for a specific use. The DC Court of Appeals in a 2-1 decision held that the FDA did not have that power under the statute. This is a different but similar issue. This case was more about the off-label use of an approved (cleared) device and whether such use was the practice of medicine which is not regulatable by the FDA. The similarity is that the defendants, in this stem cell case, are arguing that the use of SVF by physicians is the practice of medicine. So, I suppose, there is an analogy to the DC case.

I don’t think Judge Rotenberg case will be outcome determine. If Judge Bernal rules for the FDA, he will simply distinguish the case based on the obvious fact that the stimulation device was FDA cleared (approved). SVF is not FDA approved for any use. The issue in the stem cell case is whether the product is a new drug and hence requires FDA approval. That is a different issue.

On the other hand, if Judge Bernal rules for the defendants, he can certainly pull out some language from this decision to support his result and reasoning, and will surely include discussion of the practice of medicine not being regulatable by the FDA. For those of you interested in the practice of medicine vs. FDA regulation issue in the context of off-label vs restrictive use, here is the decision. You will like it.


So What’s Judge Bernal going to do?

Hell if I know.

Based on his denial of summary judgment and the sole factual question which he seemed to think needed to be addressed at a trial, it seemed to me pretty clear that he was going to rule for the Defendants. I only listened to most of the Government’s case and none of the defense case. So, I do not have a complete picture. But I am very familiar with the issues and the arguments based on the US Stem Cell cases and my own work in the field. The judge seemed annoyed a lot of the time, mostly towards the Government or so I thought. I don’t see that a lot.

From the above, I would still say that the judge was going to rule for the Defendants. The rub is of course the 11th Circuit’s opinion. It takes a brave district judge to issue a technical decision (and this will be a highly technical decision) against the FDA where there is other circuit authority in support of the FDA’s position. But then, my sense is that Judge Bernal has some libertarian tendencies and doesn’t at all mind sticking it to the man.

So what’s he going to do?

On this, I’d have to say your guess is as good as mine.

Still, I’m going with he will stick to his guns on the main issue. He might try to split the difference, since there are some other issues in the case on which he could rule for the FDA (like the toxins they added to the stem cells for some patients).

There were seven trials days, plus extensive closings, plus many papers flying back and forth post-closing. On the other hand, having ruled on summary judgment, he is very familiar with the issues. And he only really thought there was one big issue to be tried. Still in all, it could take him a couple of months to come out with his decision.

Rick Jaffe, Esq.