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Author: Richard Jaffe

The Short of it on California Medical Exemptions under SB 277, and a bit on the Possibly Soon to be Mandatory COVID Vaccine

The Short of it on California Medical Exemptions under SB 277, and a bit on the Possibly Soon to be Mandatory COVID Vaccine

I have written many posts explaining California medical exemptions written under SB 277 which was in effect from January 1, 2016, until December 31, 2019.   See http://rickjaffeesq.com/2019/09/23/caesar-has-spoken-the-cali-department-of-public-health-provides-answers-to-some-of-your-questions-about-vaccine-medical-exemptions/

http://rickjaffeesq.com/2020/06/10/will-my-childs-california-permanent-medical-exemption-be-valid-next-year-if-she-changes-schools/

I keep on getting questions about it. Unfortunately, I don’t have the time or capabilities to respond to questions of individual families, so let me lay it out as plainly as I can once again with some caveats.

If your child had a medical exemption written during the time was SB 277 in effect AND your child was in a grade span, the exemption should be valid throughout the entire duration of that grade span, if your child remains in the same school.

Let’s unpack that: That means:

If your child had an SB 277 ME but was not in a grade span (i.e. wasn’t in school or K or T K) then the SB 277 ME is not valid when your child enters the first-grade span or changes a grade span. For example, if the date of the ME is 2017 or 2018 and and your ME exempt child is starting school now or next year, you’ll need an SB 276/714 ME, but they are now obtained via the new forms and procedures on-line. However, almost no physicians are willing to write ME’s under the new law because of the change in the law, including that if a physician writes more than 5, she gets reported to the Medical Board, and because any ME beyond ACIP guidelines can (and likely will) get rejected by the CDPH, so what’s the point of docs writing them, or so they think.

The short of it is that Medical Exemptions for broader than ACIP guidelines are over in California, at least in terms of new ones.

What about if my child moves schools within the same grade span. Will my child’s SB 277 ME remain in effect?

My view was that under the statute, the new school was required to honor an otherwise valid SB 277 ME. However, I have heard of many instances in which the schools have simply refused to honor these ME’s. I am not aware of anyone filing suit challenging such a school action. I have also heard legal justifications for denying SB 277 ME’s from grade span transfer students.  So, if you have to move your child, be aware that your SB 277 ME may not be honored.

And of course, under SB 277, ME’s only continue until the end of the grade span. Once your child enters a new grade span, she needs a new ME under the fully implemented SB 276/714 process.

The Context

Even before pandemic world, there were many stories about schools rejecting seemingly valid ME’s because the writing physician was a known and infamous ME writer, or because the physician had died, or just because the child seemed perfectly healthy. So you shouldn’t be surprised that this would continue now that we live in the world of the pandemic with all the hope and faith in the COVID vaccines.

What about the mandatory COVID vaccine as a requirement to attend school?

By now, you have all heard that the LA country school district is requiring a COVID vaccine for school entrance when school begins.

Let me be very precise, mandatory school vaccination is legal and constitutional in the state of California, as well as every single state in the United States. You may not like it or agree with it, and you may want to wish it were not true, or maybe you are working to overturn it, but it is a fact, and especially in these days, it is important that people acknowledge basic facts and existing law.

BUT

As you also all know, as of now, both COVID vaccines being administered are Emergency Use Authorization approved only, which means they are technically “investigational.” I have talked about this before.  See.http://rickjaffeesq.com/2020/12/24/mandatory-covid-vaccination-is-it-coming-and-is-it-legal/

It is not obvious that a state or municipal government authority has the power to mandate an investigation pharmaceutical agent (in this case a biologic rather than a drug, and I say agent rather than a vaccine because technically, an mRNA product cannot be a vaccine because there is no antigen; it works more like a change to the body’s operating system, or so it has been explained to me).

It’s complicated because of the interplay of state and federal law. However, California has codified the Nuremberg Code which requires informed consent for (and rejection of) experimental procedures, which by definition is what EUA is. So theoretically, the LA county mandate, if it goes into effect, should be determined to be illegal. But of course, expect LA County (and others who follow its lead) to vigorously argue for the legality of it, probably keying into the issue of therapeutic intent.).

Also, I believe as part of the compromise in eliminating the personal belief exemptions, the legislature in SB 277 agreed to reinstate the PBE in the future for any new vaccine added to the school vaccine schedule. That should provide an additional argument against mandating the COVID vaccine for school children, which is why it wouldn’t shock me if the Legislature attempted to remove this provision during the new session due to the pandemic. That could be the next legislative battle for the vaccine concerned in California.

Rick Jaffe, Esq.

 

 

 

 

 

 

 

 

California Federal Constitutional Challenge to Vaccine Mandates Filed; Preliminary Injunction Hearing Set for Late February; GO GET ‘EM Greg and Ray!

California Federal Constitutional Challenge to Vaccine Mandates Filed; Preliminary Injunction Hearing Set for Late February; GO GET ‘EM Greg and Ray!

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.

The Control Group Litigation

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.

 

 

 

 

Stem Cell End of the Year Legal Update

Stem Cell End of the Year Legal Update

As those in the field remember, in the fall of 2017,  with greatest of largesse, the FDA proclaimed that it would exercise its enforcement discretion and give all but the most egregious/dangerous private stem cell clinics three years to come into compliance with its view that autologous based stem cells, even if administered during the “same surgical procedure” were in violation of the FDA’s revised interpretation of its 21 CFR 1271 regulations.

The FDA’s reimaged view of its power to regulate surgical procedures transmogrified these clinics from 1271.15 exempt from FDA drug regulation into dangerous and evil promoters of unapproved, misbranded, and adulterated drugs, subject to warning letters and civil injunction actions.

The elegance of the transformation was that the FDA only had to change one word in the stem cell regulations. The fact that the FDA may not have had to power to revise its governing regulations, has not yet been litigated, but it will be, most likely next year with the trial of the FDA’s case against the Cell Surgical Network and its founders Mark Berman and Elliot Lander.

But this trial will be very different from the summary judgment disposition in the US Stem cell case in large part because we no longer live in a world of Chevron deference to an administrative agency’s interpretation of its own regulations. It is now a fair fight in terms of judges analyzing and interpreting FDA law and regulations. and that is most unwelcome news for the FDA.

Speaking of the Cell Surgical Network case, as you know, it has already been put off twice (at least).  It had been set for November but was adjourned for the same pandemic reason as it was previously adjourned. Right now, it is set for later in January, with a pre-trial conference in early January. Here is the judge’s November order putting the case off.  031134257294.

The trial will obviously not go forward live and in-person in three weeks, so the only question is whether the defense can convince the court to hold a videoconference trial. I have it on good authority that the defendants are anxious (if not giddy) about getting on with the trial, as well they should be given the judge’s decision denying the FDA summary judgment. While I don’t think the defendants will necessarily be completely exonerated, given the judge’s summary judgment decision, as long as he doesn’t change his mind, I expect the judge to exonerate them on the principle charge and hold that SVF is an exempt surgical procedure under 21 CFR 1271.15, and deny the FDA’s request for a permanent injunction stopping them from administering the treatment, so long as it doesn’t include anything else in it.

So far, the judge has been reluctant to hold a video trial. I don’t see why he would abandon that reluctance now and hold a video hearing in January, given what is happening with increased cases, hospitalizations, and deaths. So, for the reasons I didn’t think the case would go forward in November, I’m going with that it’s not going to go forward in late January either.

Beyond that case, the FDA continues to send out warning letters, and the clinics keep on finding more exotic tissue products to administer to keep one step ahead of the FDA’s enforcement actions. I am not aware of any newly filed injunction actions. Given the pandemic, it wouldn’t shock me if 2021 turns out to be quiet on the FDA front save for the relatively cost effective warning and untitled FDA letters.

This is playing out pretty much as I have expected. As I have often previously said, the FDA does not have the resources to eradicate the private stem cell field. There are market forces at play that are far more powerful than one overtaxed federal agency. The demand for these services is just too great. More importantly, apart from one spectacularly stupid clinic, the safety profile of the treatments doesn’t lend itself to the FDA amassing broad public support for its efforts. The longer these clinics (including major hospitals) use these treatments, the more people will continue to use their own body parts for conditions refractory to other forms of treatment, regardless of what the FDA tries to do. (and, for understandable reasons, it doesn’t seem to be trying all that hard now.)

I think this will continue throughout 2021. By late 2022, I think we’ll have some appellate court authority to resolve what I expect to be the conflicting decisions between Florida and California courts (again, assuming the California federal judge does not change his mind). I hear that the Ninth Circuit (which is where the California stem cell case will be heard on appeal) now has a conservative majority, because of all the federal appellate judges Trump has appointed. Conservative judges are typically more pro personal freedom over one’s own body, (at least as long it does not involve a fetus).

Between the lessening impact of Chevon deference to administrative agencies, and the fact that the FDA probably did not have the authority to amend its regulations, there is a fairly good chance that the California judge’s approach will prevail on appeal. If the California case reaches the Supreme Court, I expect and predict the six conservative justices, and in particular, Alito and Gorsuch to be strong advocates for a person’s freedom to use his/her own body parts without government interference. Look to Gorsuch to write the majority or a separate concurring opinion, and it will be strong and clearly draw a line in the sand of where the Government cannot go.

In short, expect more of the same in 2021, with the California case pushing back on the FDA’s current view on autologous same-day surgical procedures for the above reasons.

Beyond the Feds

Lately, chiropractors are getting into the stem cell space, ownership wise. I think that is unfortunate, at least for public perception reasons. Plus, I hear a lot of talk about dead cells in these chiro-owned operations, and that is very disturbing. I have considerable experience in the MD/DC format. I could have made a ton of money setting up these chiro owned stem cell clinics. However, it is just too easy for these operations to run afoul of state and federal criminal statutes, so I stay away from the MD/DC legal set-up business.  I give them all the same answer: “Stay in your own lane.” As evidenced by how popular these chiro/MD stem cell clinics have become, other attorneys have made a different decision.

In 2020, we have had some state attorney general action against private stem cell clinics in the form of consumer protection/deceptive trade practices cases against clinics.  That will surely continue, somewhat, but we live in difficult times and they will have their hands full and the pandemic will probably slow things down, at least in terms of new cases.

I think the big issue in 2021 will be whether states can use the FTC’s adequate substantiation requirement under the FTCA as a grounds for liability in a state consumer protection case, in the absence of a statute which does not specifically allow adequate substantiation as a basis of liability under a consumer protection law. I don’t think they can, and more to the point, that is the position I will be taking in my New York stem case filed by Leticia James. By April, I should have some indication of whether I am right or wrong.  So, stayed tuned.

LIke all of you are thinking, let’s hope for a better next year.

Rick Jaffe, Esq.

 

 

 

 

 

 

 

 

Mandatory COVID Vaccination: Is it Coming and Is it Legal?

Mandatory COVID Vaccination: Is it Coming and Is it Legal?

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.

 

 

 

 

 

 

 

 

Stoller Decision Watch In Progress

Stoller Decision Watch In Progress

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.

Breaking News: Gov. Newsom’s Shackles on Religious Services are Removed (Temporarily Anyway)

Breaking News: Gov. Newsom’s Shackles on Religious Services are Removed (Temporarily Anyway)

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.

 

And so it begins: “UK warns people with serious allergies to avoid Pfizer vaccine after two adverse reactions”

And so it begins: “UK warns people with serious allergies to avoid Pfizer vaccine after two adverse reactions”

This will all play out in the media. Like I said yesterday, let the chips fall where they may.

https://www.reuters.com/article/health-coronavirus-britain-vaccine-idUSKBN28J1D1?taid=5fd0bfca0bc2ea000145b4c5&utm_campaign=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_source=twitter

 

Rick Jaffe, Esq.

 

Pop Quiz: Are the Pending EUA COVID Vaccines Safe and Effective?

Pop Quiz: Are the Pending EUA COVID Vaccines Safe and Effective?

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.

 

 

 

 

 

 

 

 

The Judge Issues his Formal Order Denying our Preliminary Injunction Motion in the UC case

The Judge Issues his Formal Order Denying our Preliminary Injunction Motion in the UC case

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.

 

 

The Supreme Court Just Reverses and Sends Back Another Religious Restriction Case

The Supreme Court Just Reverses and Sends Back Another Religious Restriction Case

It is being reported that today, December 3rd, the Supreme Court reversed and sent back another case filed by a church complaining about restrictions on services, this time by the California  governor. The Court hasn’t posted the decision yet so I don’t know the details.

Here is what I figure: The district court upheld the restriction under the the Supreme Court’s prior cases in the summer. (here is my post about the South Bay case:  https://wp.me/p7pwQD-FW  )

The case  went up to the Ninth Circuit and was affirmed under the same Supreme Court precedent. After the the circuit court opinion was issued, last week the Supreme Court reversed itself in the the religious challenge to Governor Cuomo’s restrictions on churches and synagogues.  Here is my post about that: https://rickjaffeesq.com/2020/11/27/the-supreme-court-does-an-about-face-on-church-synagogue-restrictions/

So, today it seems like the Supreme Court is sending the case back to the district court (directly or indirectly through the Ninth Circuit, I’m not sure which), for reconsideration in light of last week’s opinion in the Cuomo case.

I doubt there is anything new or precedent setting. It is not an uncommon move by SCOTUS to reverse and send back a case if a new rule of law is made by it and lower courts had issued decisions under the old precedent.

You can expect to see a few more of these short or summary reversals in the coming weeks and months. Naturally, we should also start seeing some lower courts starting to apply the new rule in future religious services challenges.

And what’s the Supreme Court’s new rule?

I think it’s pretty simple and to paraphrase from Justice Gorsuch’s concurrence in Cuomo: There’s no universe in which the Constitution will permit stores and bike shops to be fully open and churches services restricted, notwithstanding differences in use or level of risk (i.e. people are in stores for less time, have less close contact in malls than people sitting in churches). Those kinds of distinctions, regardless of whether there is science behind them, violate the First Amendment’s explicit protection to practice religion without government interference.

That all is straightforward because it all comes directly from the words of the Constitution (and conservative love the actual words of the Constitution and feel they are bound by them (most of the time anyway)). The harder and unclearer issue is whether the new Supreme Court majority will protect personal freedom and privacy rights. I read Justice Alito’s speech to the Federalist society as yes to offering the same kind of protection for strict lock-downs. The fact that the majority is not willing to defer to accepted science for religious services (meaning accepting the distinction between the lower risk of shopping versus spending an hour or two in a religious service) is some indication that they won’t when it comes to non religious personal freedom issues, like lock-downs, but we will have to see how that plays out.

When we move from lock-down issues to bodily integrity rights, that could be a different story. Many of you may not know that there is no explicit privacy right in the Constitution. It was created largely by the Warren Supreme Court.  The problem is that conservatives in general don’t believe that it is the role of the courts to create new constitutional rights, or what Justice Gorsuch called penumbra rights, which are rights implicit or derived from the words of the Constitution. As indicated in my prior post, I sensed that Justice Gorsuch was somewhat dismissive of the penumbra privacy rights asserted by the Rev. Jacobson.

I don’t know how the Supreme Court will rule on these issues, especially when it comes to mandatory vaccination laws and orders, but I believe they will address the issue in the next year or eighteen months (or sooner), at least if I have anything to do with it (and I think I will).

 

Rick Jaffe, Esq.