here is the link to the campaign update on the case.
Rick Jaffe, Esq.
here is the link to the campaign update on the case.
Rick Jaffe, Esq.
For those of you who want to listen to Kelly Sutton’s medical board hearing, here is the call-in information:
+1 916-245-8850,,220074720# United States, Sacramento
Phone Conference ID: 220 074 720#
You will only be able to listen and not see the hearing. It should start at 9 o’clock and it will continue with various breaks until somewhere between four and five. The hearing will probably last 3 to 3 1/2 days. The board only has one witness, its expert, Dr. Deborah Lehman who is a highly credentialed pediatric infectious disease specialist and professor from UCLA.
Final preparations today and this weekend.
Rick Jaffe, Esq.
Apparently tomorrow, the Los Angeles Unified School district is requiring all teachers to wear masks all day in school and is also requiring weekly COVID testing with the PCR test. I know this because I’ve been getting emails and calls to my cell today from teachers wanting to obtain/assert a “religious exemption” to the mask requirement.
First, I have a few choice words for the person who posted my cell phone number and said it was a good idea to call me on the weekend.
Second, there is no such thing as a religious exemption to a health and safety public school employee mandate. Employers are required under federal employment law to offer a reasonable accommodation to a work condition, IF there is a reasonable accommodation to be made that will not adversely affect public health in the judgment of the employer.
In the COVID world, that mainly means work at home or work alone, if that is viable. Obviously, there are jobs where that is not viable like food servers and airline flight personnel, and I would argue teachers when schools have reopened for in-person learning. Accordingly, I do not think there is a reasonable accommodation to a mask requirement for a school teacher, especially since the students are also required to wear a mask. Students and their parents would get pretty heaved off if everyone in the school had to wear a mask except the teacher. That’s just not going to fly.
And I don’t care what biblical verse you quote because it will sound as pretextual as it is. And by the way, it is probably not a good idea to say you object to covering your face because Muslim women do it and you are not a Muslim. (actual statement from an inquiring teacher)
And no, I am not interested in representing any of you teachers who want to exercise your religious freedom not to wear a mask even though all your students are wearing them. I want to see every school opened, and if the authorities are going to require everyone to wear a mask, that’s ok with me, as long as they open the schools and keep them open.
The required PCR testing issue is more complicated. As you all know, it is only EUA allowed not FDA cleared, which under federal law means or should mean that it can’t be compulsory, meaning mandated by the federal government.
As I stated in prior posts, California has a statutory Nuremberg Code, but I haven’t looked at it hard in the context of a test and I think there is some wiggle room even with respect to therapies.
The issue has been litigated in New York when New York City required the PCR test for teachers. But, the judge refused to grant a preliminary injunction stopping it, which was what I thought he would do. I am sure the judge wanted the schools to be reopened and he wasn’t going to be the one to hold that up and substitute his layman public health judgment for the judgment of the public health officials who were responsible to protect the health of the students, teachers and everyone else in the schools. Judges typically reflect the established scientific consensus; they do not normally take the minority view or any view other than what those entrusted with making these decisions decide.
So I am inclined to think that the California courts would uphold the PCR test, or at least, not grant a preliminary injunction stopping a school district from requiring it. If that were to happen, I think it would take more than a set of papers back and for and an oral argument on a motion for a preliminary injunction. Why? because… you guessed it, they want to get and keep the schools open, and the safest play for any judge to do that is not to interfere with the decision of the authorities, and if that means bending some state or federal language to kick the can down the road, that’s what will be done.
I’d like to say that I wish the LA teachers who are “religiously” opposed to wearing a mask good luck tomorrow, but I won’t because I don’t wish them good luck. They will not receive a warm reception from the authorities. Or at least I hope they won’t because I want the school to open and stay open, and if the kids have to wear masks, so should the teachers.
Rick Jaffe, Esq.
addendum: for those who complain that it’s a free country or should be, and no one should have to wear a mask. What I can say is the law is otherwise. Your personal freedom ends or is limited by consideration of the person next to you. You don’t have the right to endanger other people. And, no one or small group of individuals have the right to make their own determinations about what endangers other people. That is left to the people who have been hired to make those decisions with very, very limited review by the courts. Bottom line, wear a mask if you are required to or quit and do something else that does not require it.
For the last many months, my friend, colleague, and behind-the-scenes advisor on both the UC flu mandate case and Ken Stoller’s Medical Board case has been telling me about some massive lawsuit he was preparing. Well, it has finally arrived. Greg and ace SoCAL litigator Ray Flores have filed a federal constitutional lawsuit in the Eastern District of California against one defendant, the President of the United States. The lawsuit is basically asking him to remove all vaccine mandates in the entire country. I said it was bold. There is a preliminary injunction hearing set for late February.
Leaving the merits aside, this lawsuit serves two very important functions for those who have concerns with the mandatory vaccination program. First, the papers contain the most comprehensive and documented exposition of the problems with the country’s entire mandatory vaccination system that I have ever seen (and I’ve seen a lot). Along the way, it seeks judicial recognition of the negative role childhood vaccines have played in children’s health, and it seeks to affirm the vax vs unvax study published by Paul Thomas and James Lyons Weiler. (Now you see how bold this lawsuit is.)
Second, it perfectly manifests and voices the indignation and frustration which a growing number of Americans have with the COVID vaccine rollout and the fear that it will be made mandatory and further erode the rights of citizens. Win, lose, or draw, I see Greg’s papers as a clarion call to the vaccine concerned community, and it will be received as most welcome.
And finally, it’s a hella of a read, and it will make your day!
Here is a link that has all the papers filed in the case.
FYI: this is a community-supported lawsuit and not funded by any organization, so if you can help support this project financially, please do. There is a “donate” button on the web site.
GO get ’em, Greg and Ray!
Rick Jaffe, Esq.
OK, it’s time to get into it: This will be a neutral overview to give a basic understanding of the law based on three critical distinctions: federal vs. state, EUA vs. vaccine licensure, and state vs. private party.
The Feds vs. the State (and counties and municipalities)
Question: Since Joe Biden has already said he doesn’t think the vaccine should be mandatory, doesn’t that end the discussion?
Answer: Unfortunately not, because of relevant legal principle No. 1. Public health mandates emanate from the government’s police power, and that is mostly a state law concept. There is no general federal police power. Whatever power the feds have to regulate things come from other powers specified in the Constitution like the power to regulate interstate commerce which comes from the commerce clause. This principle was first articulated almost two hundred years ago in Gibbons v Nash. For the legally inclined, here is the decision. https://scholar.google.com/scholar_case?case=1173503503763993716&q=Gibbons+v.+Ogden&hl=en&as_sdt=6,33. For everyone else, here is Chief Justice Marshall’s description of the state’s police powers meaning that “immense mass of legislation,” as he put it, “which embraces everything within the territory of a State, not surrendered to the federal government,” includes “quarantine laws” and “health laws of every description.”
The Bottom line, as powerful as he may be when he becomes president, I don’t think he has the power to keep the COVID vaccine voluntary. Similarly, if he were to change his mind, I don’t think he (or Congress) has the right to make it fully mandatory, at least for citizens who do not cross state lines. Since the feds regulate interstate commerce, if the federal government was so inclined, I suppose it could require the vaccine for interstate travel. While that might be subject to constitutional attack, I think it would at least be arguably within their powers under the commerce clause to do it. Again, leaving aside the issue about whether it would violate another constitutional right (like the right to bodily integrity or privacy). Also, the commerce clause sometimes gets stretched pretty far, so if for example, the pandemic took a really ugly turn, who knows what the feds could try to do.
In support of this view -of the state-based police power and the right to mandate vaccines – think about every case you can recall on vaccine mandates. Every single one I can think of which was filed in federal court dealt with a municipal or state mandate.
The bottom line for me is that I don’t think that the federal government can order that the COVID vaccine be voluntary or mandate that every resident of every state must take it.
State vs. Private Party mandates
The simple of it is that the relevant constitutional rights and protections only restrict governmental action. Originally, these protections (the first 10 Amendments) only applied to and limited the Federal government. The 14th Amendment made the protections afforded by the earlier amendments applicable to the states.
That means that an employee of a private company can’t sue her employer for a violation of her federal constitutional rights like the right to bodily integrity/privacy. That’s just not a thing. However, there are various federal and state statutes that accord some of the same protections, like unlawful employment or housing discrimination and disability-based discrimination.
It is black-letter Federal employment law that while an employer can mandate its employees to take a vaccine, employers are required to offer a “reasonable accommodation” if feasible, on religious and disability grounds. That happens a lot in the flu vaccine context and usually takes the form of a mask requirement (prior to the pandemic anyway). Of course, as a result of the pandemic, some health care facilities have eliminated that accommodation. I am not aware of any successful lawsuits challenging a private employer’s vaccine mandate in the pandemic time frame. I suspect there might be some litigation that will challenge an employer’s finding that a reasonable accommodation cannot be made for empolyee health reasons.
Emergency Use Authorization vs. Full Vaccine Licensure: Can the State or a private party (private school or non-government employer) force people to take the COVID vaccine?
I have previously posted about EUA. https://wp.me/p7pwQD-PB
In short, a product approved by the FDA under EUA is still investigational and not approved under a New Drug Application or licensed as a biologic (as in the case of vaccines).
Let’s start with the relatively straightforward question of whether after COVID vaccines are licensed, can they be made mandatory?
Right now, I’d have to say yes, both for government and private employers, at least based on existing precedent, starting with Jacobson. Government employees can raise constitutional claims, private party employees cannot. All employees have accommodations for religious and disability. But contrary to what some have said, these are accommodations not exemptions. The accommodation (at least in the case of the flu shot) is a mask. However, the employer has the right to claim that an accommodation cannot safely or practically be made. It wouldn’t surprise me if some employers take that position if the pandemic continues after the vaccines are licensed. The above is the status of the current law.
Can the law change? Possibly, and I predict there will be such challenges which attempt to distinguish Jacobson and the smallpox vaccine (which had been used for over 120 years by the time Jacobson was decided) from the current situation and a newly approved COVID vaccine which I assume will have thousands of documented and publicized adverse events and is based on a new technology which appears to modify a person’s genetic material (or so I am told).
What about the Nurenberg Code, the Helsinki thing, and all the other international proclamations covering human experimentation? Can’t they be used to stop my employer from forcing me to get a Covid vaccine?
None of these codes have the force of law in the US, and I am not aware of a US decision that reached a result based on any of these codes. Could a court look to one of these codes for guidance in a newly licensed COVID vaccine? Possibly. Will that be argued in challenges to the licensed vaccine if it is mandated? Absolutely.
Now let’s consider legal challenges to a mandatory EUA status vaccine
There are informal indications that the feds do not think a EUA product should be mandatory, but as indicated above, mandatory vaccination is almost exclusively a matter for state or local governments (or private employers). I am already hearing rumblings that some private employers are considering mandating the COVID vaccine, and not necessarily after they are fully licensed. That situation would directly implicate the Nurenberg code and the other doctrines, but as stated, none of these have the force of law, until there is a US decision rejecting a EUA mandatory vaccination policy, all or in part based on these international codes.
If you live in California, you’re in luck, because California has actually formally codified the Nuremberg Code into its state law. Here it is: http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=20.&title=&part=&chapter=1.3.&article
The statute would seem to apply to an investigational drug or vaccine, even one with EUA status, but there is no relevant case law yet. This is where I see the next vaccine battle in California for sure. I also see legal challenges in New York if a governmental entity or an employer attempts to force citizens or employees to take the EUA vaccine. However, given the short supply of the vaccine, I don’t think the issue will come up until late spring at the earliest. Let’s hope not anyway. Until then, let’s see how the safety and AE profile plays out in the next few months.
Happy holidays to all.
Rick Jaffe, Esq.
For those following the Ken Stoller Medical Board case, here is the latest: The ALJ submitted her proposed decision to the Board on December 8th, that would be last Tuesday. Unfortunately, we are not allowed to see her decision until the earlier of 35 days from its submission to the Board or when the Board issues its decision.
An ALJ’s proposed decision is reviewed by one of two board panels (panel A and B). The next quarterly public board meeting is in early February, but I think these proposed decisions can be reviewed and decided outside of the scheduled quarterly meetings, and I am betting that that will happen in this case.
Here are the basic possibilities:
1. The ALJ finds departures from the standard of care and imposes the standard sanction of stayed revocation with 5 years probation, and other conditions (for sure, additional CME course work, probably a practice monitor, possibly some kind of skills/competency evaluation via the UCSD highly regarded PACE program). If that is what the ALJ decides, I would expect the Board to quickly adopt her decision and issue the final order. I think that could well happen before Christmas. The order will be effective 30 days after the signed board final order. At that point, legally the CDPH and the schools have a statutory basis to revoke or not honor (in the case of schools) all of his ME’s.
2. Option 2, because of the unusual nature of the case (there sure appeared to be a different standard of care created by SB 277 and argued by Senator Pan) it is possible that the ALJ could find standard of care violations but impose a substantially less severe and non-disciplinary guideline standard penalty. The only thing the disciplinary guidelines recognize less severe than stayed revocation is a letter of reprimand. Normally that is only available for a single case involving a simple departure from the standard of care. However, recently the Board issued one of these sanctions to a doc who wrote more than one ME’s. I don’t know the details about the circumstances of that case (she wasn’t my client). If that happens, I’m guessing the Board will try to change the sanction. If they don’t, then it would become a sort of a de facto precedent for all of the other board cases against ME writing physicians (and I have four more cases awaiting hearings on this issue). A letter of reprimand still achieves the goal of rendering all of Ken’s ME’s revocable, revoked, or not honored by any school that finds about the Board order.
3. Option 3: Ken is exonerated because the judge finds that the Board did not prove its case by clear and convincing evidence. It would be great if the Board were to sign off of that result, but that’s not likely. If that what the ALJ finds, the Board panel will issue a non-adoption order and decide the case itself after supposedly reviewing the entire transcript and all the exhibits. The case will be set for an oral hearing sometime in the next several months. Panel A records and puts on the Board’s web site these hearings. Panel B does not.
Under any of these scenarios, dollars to donuts there is an appeal (writ of administrative mandated in California writ practice terminology) in Ken’s future, but we take this one step at a time.
For what it’s worth, if there were a legal computer judge, I think it would be option 3. I don’t think the Board made its case. There is a statutory standard of care concerning writing ME’s which is different from the community ACIP based standard. The Board’s expert, Dean Blumberg, despite his impressive credentials, knew nothing about that standard of care.
Beyond SB 277, California Board law expressly allows physicians to render treatment and provide advice based on a minority or a complementary and alternative standard of care. We proved that there is such a standard regarding issuing ME’s and that Ken’s use of genetic testing in addition to considering family history of autoimmune problems (expressly sanctioned by SB 277 and its principal sponsor, Pediatrician Senator Richard Pan) established the standard. His medical records contained all the basics of a proper medical intervention (H&P and clear and complete SOAP notes, including extensive informed consent).
It’s really that simple. BUT we live in extraordinary times and there is much fear and hope for vaccines to end the pandemic. Cases are decided by people, most of whom are still sheltering in their homes awaiting for the vaccines to allow them and the country to get back to normal. It would take a very strong-willed and independent judge to set aside all of what’s going on, and we shall see.
Rick Jaffe, Esq.
The impact of the Supreme Court’s recent shift on restrictions on religious services involving New York’s limitations on church and other religious services has reached California. Here is my post about that case: https://wp.me/p7pwQD-OS
Yesterday, a Kern Country Superior Court judge granted similar relief to a Catholic priest in Father Trevor Burfitt v. Gavin Newsom.
The ruling held that the Governor’s order failed the strict scrutiny test, and hence the court granted a preliminary injunction by the Governor from enforcing any order which “fails to treat houses of worship equal to the favored class of entities.” The decision pretty much follows the Supreme Court’s decision in the Cuomo case.
Here is the order. Burfitt-Win. It is not the final decision in the case, but I suspect the case will never go to trial and that in light of this decision and the recent Supreme Court’s decisions. (There was another one after the Cuomo case. Here is my post about that one: https://wp.me/p7pwQD-Pl)
Yesterday was a good day for Californians wishing to go to religious services, and also for those who think that the restrictions go too far. The big unanswered question is will the new conservative majority in the Supreme Court be as skeptical about other kinds of prohibitions or mandates.
Rick Jaffe, Esq.
This will all play out in the media. Like I said yesterday, let the chips fall where they may.
Rick Jaffe, Esq.
Short Answer: No one knows yet.
As many of you know or can guess, EUA status does not mean that the safety and efficacy of the drug or biologic has been proven to the FDA’s standards of proof which are normally required for a drug or biologic to be marketed and introduced into interstate commerce. The FDA’s granting EUA status only means that the product”‘may be effective’ to prevent, diagnose, or treat serious or life-threatening diseases.” In case you are interested, here is the FDA’s Guidance Document on EUA which explains this and many other things about the process: EUAGuidance
What about safety? Your quote only references effectiveness, what about safety?
Both EUA pending vaccines (Pfizer and Moderna) are supported by Phase 1/safety clinical trials. Phase 1 clinical trials are relatively small (a couple of hundred participants at most, usually) and give some indication of the short-term safety profile of the study product. More safety data is amassed via Phase 2 and 3 trials. Of course, since the clinical trials only started in July, there is no extensive data on long-term safety, yet. But we are in a pandemic and that’s the difference between EUA and full-on NDA drug approval or a license for a biologic.
FYI: I am (and have been throughout my legal career) one hundred percent in favor of faster access to investigational drugs. So, I am one hundred percent in favor of EUA as a regulatory concept. I am also one hundred percent in favor of EUA for these two vaccines, if the FDA grants EUA to them or any other vaccine which passes through the EUA process, so long as the vaccines are not mandatory.
I’m not even concerned about informed consent, (as heretical as that may sound to many of you). There are basically two kinds of people, neither of which needs informed consent. Based on various polls, somewhere between 50 and 60 percent of people say they are willing to take EUA approved COVID vaccines, just because the government says it is safe and effective (even though, as indicated, the government is not actually saying that). These people don’t need informed consent because they trust the public health authorities.
Somewhere between 40 and 50 percent of people are not willing to take a EUA approved vaccine because they are anti-vaxxers, vaccine concerned, have concerns about the rushed process, don’t want to be guinea pigs for the first-ever mRNA based vaccine or some other reason. There just isn’t enough information available yet to change the minds of these people, (and honestly, for some, I think there is no possible information that could change their minds.) I suspect in six months to a year, if there is still a pandemic, and the media is not reporting deaths or horrible long terms side effects, some portion of this group may get the shots.
So here is the bottom line: The FDA’s EUA authorization doesn’t change the fact that these products are investigational and have not proven to be safe and effective for NDA drug approval or biological licensure, and there is no getting around that fact. That makes the tens or hundreds of millions of people taking these EUA approved products participants in history’s largest clinical trial to answer the question as to whether these products are safe and effective to do whatever they are supposed to do. (And frankly, I am confused about what that is. Is it to stop the vaccine recipient from contracting the disease? probably not. Is it to stop the recipient from transmitting the disease? probably not. Now, the endpoint seems to reduce the risk of death or serious disease).
Let the chips fall where they may
As you all know, health care workers and the aged will be the first to receive the vaccines. I just watched a 90-year-old English woman receive the first Pfizer vaccine shot under a EUA. Like it or not, the choice of recipients will provide very valuable safety and efficacy data.
The data from the aged, who generally have more co-morbidities than the young, will be especially helpful, as callous as that seems. But hey, it’s the regulators who chose them.
Making health care workers the initial recipients makes a lot of sense because of their increased exposure to the disease and people in general, and of course, their critical role in fighting the pandemic. If the people who believe that the vaccine is really dangerous are right, then in the coming months, there should be a detectable number of hospital workers sickened by the vaccine, which should affect hospital staffing.
If the covid vaccinated aged don’t die in increased numbers, and health care worker attendance status does not drop, that would be some indication that the vaccine is not causing more harm than good, in the short term at least. If the vaccination of tens of millions of people in the coming months reduces hospitalizations and deaths during what is expected to be the peak, that would be a big win for the vaccine. And while I hope that turns out to be the case, like many reasonable people, I have my doubts because of the novel nature of the vaccines, the rushed process, and some general skepticism (enough said about that). But again, I hope the vaccines prove to be safe and effective and allow us all to get back to normalcy.
For sure, there will be confounding variables. Will the better numbers come after the expected peak, like in the summer? The authorities are already saying not to expect any big positive results for many months. Also, there is the whole false positive of the PCR testing (which is too complicated to address in this post). Still, with tens or hundreds of millions of people getting the vaccine, I think or at least hope that the data will provide important information that will allow reasonable people to figure out whether the vaccine is doing more harm than good, and whether it is helping resolve the pandemic.
I view the next six to nine months, where hundreds of millions of people will get this novel vaccine, as a decision point on the whole mandatory vaccination issue for biological licensed products. As to mandatory vaccination of these now EUA approved products, well, that happens to be the topic of my next post, so stay tuned.
Rick Jaffe, Esq.
Yesterday afternoon, Hayward Superior Court Judge Richard Seabolt issued his formal decision denying our preliminary injunction motion. Here it is: Kiel v. UC Regents HG20-072843 Order Denying Preliminary Injunction
Basically, he doesn’t think we made our case on the facts or the law. He reads all the lawsuits which upheld SB 277 (which removed the Personal Belief Exemption from California law) as strongly supporting the constitutionality of requiring adults to be vaccinated with a vaccine that is not related to the current pandemic. Seems like a reach to me, but, he’s the judge. On the facts, he thought the UC’s experts were more credible in some or in large part because their views are consistent with the CDC.
Also, things have gotten very bad pandemic wise since we filed the case back in August. In light of all the deaths, new cases, and increased hospitalization, it’s a tough sell to ask a judge to stop a public health effort that has the support of the public health establishment. (I know that some of you might think that the whole pandemic narrative is false or overblown, but I do not think that view is shared by the judiciary, even among those who have written opinions rejecting COVID restrictions like the majority of the Supreme Court which ruled (twice) in favor of church challenging church service restrictions: See my posts: https://wp.me/p7pwQD-OS and https://wp.me/p7pwQD-Pl
Technically and for whatever it’s worth, (and as the Judge pointed out) his decision is not a final decision on the merits; he’s just saying that we didn’t make our case for a preliminary injunction, based on what we presented in the motion.
We will kick around whether we go forward in some fashion with this case. But as stated, a lot has changed since we filed the case. As I previously reported, at the hearing, the Judge was quite forthcoming and candid about his feelings about people who don’t get flu vaccinated. For that reason and others, I am not seeing proceeding further litigating the case as a good use of resources. Also, much of the state is in or about to enter a shelter-in-place, and that should take at least some of the pressure off even more of the UC community opposed to the flu shot (other than health care workers who have to show up).
FWIT: The lawsuit and motion most likely caused or contributed to the UC backing down and allowing students to distance learn without taking the shot, and also allowed them to seek religious accommodations, an option which no other students in the state have regarding any vaccine. So we got something out of it.
Sometimes it’s best to take what you can get and move on to the next battle, and we all know what that will be. (Stay tuned to my next post about what the upcoming EUA for the COVID vaccine means and what it doesn’t.)
Rick Jaffe, Esq.