Browsed by
Category: Uncategorized

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.

 

 

 

 

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.

 

 

Status Report on the Ken Stoller Medical Board Case (and Other Similiar Cases)

Status Report on the Ken Stoller Medical Board Case (and Other Similiar Cases)

Some have asked for an update on Ken Stoller’s medical board case, and the other board cases I am working on, so here it is.

The Closing Arguments by the parties were submitted to the ALJ on November 9th.

I won’t bore you all with our closing which gets into the weeds of the ten cases, but for grins, here is the introduction. I decided to start by abstracting the whole case and our position.

“To begin, let’s present the core facts of the case in the abstract, like a conceptual symbolic logic problem, devoid of the messy vaccine issues.

A state has a statute which sets-up the physician as a gatekeeper for something people can or cannot do based on a statutorily created physician opinion letter. The statute (or an amendment to it) specifically says that physicians can use “x” factor in making the judgement call as to whether to issue the letter.

There is a federally created general guideline on the subject of the state’s law, which is recognized by a majority of physicians in the country. However, it is much more restrictive than the (amended) state law. The federal guideline consists of a simple chart listing the few factors that do or could justify the physician letter. Unfortunately, x factor is not on the chart. Therefore, using x factor is consistent with the state’s statute, but inconsistent with the national standard.

Some additional abstract facts: Some state statutes (say New Jersey, for example) specifically say that physicians can only write the letter if the national standards are met, and there are no exceptions. But alas, our state is not one of them, perhaps because the state legislature was not intelligent enough to know that it could have followed the New Jersey model and explicitly limited physician letter writing to the national standard which does not include x factor. Or, perhaps there was some political reason requiring the legislature to allow physicians to use x factor to get the bill passed, even though x is not on the national chart. But ultimately it does not matter. As inconsistent as it may be with the national standard, x factor is in the state statute for physician letter writing.

What is the state medical board’s position about this inconsistency, and what guidance does the board give to help physicians to understand the new amended law? None, because it is not what it does, or so it says.  The board leaves it up to each physician to decide how he/she will exercise discretion and use or not use x factor.

A legal fact: Our state has a minority view defense to charges of negligence, gross negligence and incompetence.

When the (amended) law was being debated, the bill’s author emphatically stated to the lower legislative house that even an extreme x factor could be the basis of a physician exercising his discretion and write the letter. He even said that he has been in contact with the medical board and that he received the board’s assurance that using x factor will not cause problems for physicians with the board, which he said should reassure the members of the legislature whom he was trying to convince to pass his bill.

Sitting next to the bill’s author when he made those statements is the physician who is now testifying against the physician for using x factor. He testifies at the disciplinary hearing that there is a national standard, and physicians are not permitted to use x factor in making the letter writing determination because to do so would be a violation of the standard of care. He says that it doesn’t matter what the law actually says, because there is a nationally recognized community standard (i.e. standard of care), and every physician in the state has to follow the national guidelines which do not include x factor, let alone extreme x factor. He insists that only community standards apply, and no physician can rely on the fact that x factor is listed in the law, because there is a national community standard and that standard applies to all physicians in the state. Why? Because there is a community standard, and all physicians are required . . . and on and on it goes into an infinite regressive circular loop.

When the board’s expert is asked why the bill’s author said extreme x would support a letter, he said he didn’t know, but he does say that what the author really meant was that the physician had the power (or technical legal ability) to write the letter, but it would still be a violation of the standard of care, which the board could prosecute and Voila, here he is testifying against the doctor.

Viewed thusly in the abstract, this is not a close case.”

Basically, our view is that SB 277 created a statutory standard of care and allowed physicians to write ME’s beyond ACIP guidelines, and the standards used by Ken and other like-minded physicians are within a minority view standard of care permissible under California law (Bus. and Prof. Code 2234.1).

The judge has 30 days (from November 9th) to submit a proposed decision to the Board. As of mid last week, she had not submitted the decision. The decision gets reviewed by the Board and specifically a panel and eventually it gets to the entire board. The next scheduled full board meeting is in February, but it’s possible the board could act before that date.

The basic choices the members of the board has it to approve the ALJ’s proposed decision or non-adopt it. If the latter, the board members review the record and the parties are give a chance to argue (live or more like on papers) for or against the proposed decision.

Any sanction against Ken’s license means the revocation of all of his ME’s (theoretically at least, but because the change from SB 276 to SB 714 removed the filing of ME’s with the CDPH, it is possible that some of his ME’s could continue to be in force because some might slip in between the cracks, as it were. But for planning/awareness purposes, if you have an ME from him, and his license is sanctioned in this case, you should assume your child’s exemption will be revoked by the school, especially since schools have been rejecting ME’s since the passage of SB 276/714. Of course, some of this does not apply right now  due to the pandemic and lock-downs, but eventually things will get back to normal, so even if your child is not affected right now, it’s something to keep in mind.

Beyond Ken’s case, I represent four other NorCal physicians under scrutiny by the Board. There is a formal accusation against one of them, but no date has been set yet for a hearing, probably because of the pandemic. Two other physicians have had their Board interviews and accusations against them will be filed in the next month or three I suspect. One physician is awaiting the Board interview.  Bottom line for those parents who have ME’s from NorCal docs: I don’t don’t think ME’s written by any of these docs will be revoked during the 2020-2021 school year, just because of timing issues, unless one or more of these cases are settled, and for most of them, that’s not likely to happen in the next few months.

Bottom line: We are waiting for the ALJ’s/Board’s decision in the Stoller case. The ALJ’s decision will be publicly available 30 days after she submits it to the Board, whether or not the Board issues its final decision by that time.

This is the first litigated case on these broader than ACIP ME’s, since all previously charged physicians had signed consent agreement agreeing to be sanctioned (and that would be none of my clients). I have a pretty good idea of the Board’s view on the issues, but no idea how the ALJ will rule. I think we made our case, but you never know. Fingers crossed.

Rick Jaffe, Esq.

 

 

The Supreme Court Does an About Face on Church/Synagogue Restrictions

The Supreme Court Does an About Face on Church/Synagogue Restrictions

As you all know by now, on Wednesday night the Supreme Court stayed enforcement of NY Governor Cuomo’s restrictions on religious gatherings, in Roman Catholic Diocese of Brooklyn, New York v Andrew Cuomo. It is is just an temporary stay pending appeal, so technically it is not necessarily the Court’s final word on the matter, but nonetheless it is extremely significant as a predictor of future cases. It also may have significance for those interested in the mandatory vaccine issue.

But first and foremost, the decision demonstrates  the first principle of Constitutional interpretation, namely, the Constitution means what five justices say it means at any given time, and that can change radically in a short period of time, because of circumstance, the most important one being the make-up of the Court.

In the Summer of 2020, the Supreme Court twice upheld restrictions on religious services based on deference to the government’s police power.  The vote was 5-4. The Chief Justice joined the liberals to form the majority. Uber liberal Justice Ginsberg is gone, replaced by a highly religious arch conservative. To the surprise of few, the Court’s decision Wednesday night went the other way, with the same vote tally. The new religious conservative justice created the new majority, with Chief Justice Roberts, who was previously the swing vote in the cases in the summer (and many other cases), is now the dissenter-in-chief, and likely will be so in many future decisions.  That all is obvious, but there is more to the decision

One of the main mantras of the vaccine concerned is the misplaced reliance by the state and federal courts on Jacobson, which has achieved landmark case status for the proposition that the state can impose vaccine mandates over the privacy and bodily integrity rights of individuals, and in particular children attending school.  What the courts failed to acknowledge, according to the vaccine concerned, is that the regulation challenged in Jacobson imposed a $5 fine ($140 in today’s money) for non compliance.  So it really was not a true mandate, but rather a reasonable choice. But the courts relying on Jacobson either forgot about that or did not see its importance. That is until Justice Gorsuch’s concurring opinion in this case.  Much to chagrin of Chief Justice Roberts, Justice Gorsuch engaged in a extensive analysis of Jacobson, and was quite dismissive. Here are his words which will warm the cockles of the hearts of all vaccine concerned:

“Why have some mistaken the Court’s modest decision in Jacobson for a towering authority that overshadows the Constitution during a pandemic. In the end, I can only surmise that much of the answer lies in a particular judicial impulse to stay out of the way in times of crises. But if that impulse may be understandable or even admirable in other circumstances, we may not shelter in place when the Constitution is under attack. Things never go well when we do.” (page 5-6 of the his concurrence).

Boy, can this guy write! But alas, he also seemed a little dismissive of unstated, penumbra privacy/substantive due process rights underlying Reverend Jacobson’s position. But then, arch conservatives like Gorsuch are not big on judges creating rights, (I think mostly because of the abortion issue).

Justice Gorsuch’s frustration with the court’s prior two  decisions upholding religious gatherings restrictions, which was voiced publicly albeit perhaps indirectly by Justice Alito in a speech to the Federalist Society, is best summed up by how Justice Gorsuch ended his concurrence:

“It is time – past time- to make plain that, while the pandemic poses many grave challenges, there is no world in which the Constitution tolerates color-coded executive edicts that reopen liquor stores and bike shops but shutter churches, synagogues, and mosques.”

Here is the decision with all the concurrences and dissents. You should read it, especially Justice Gorsuch’s opinion because it draws a line in the sand, and he is telling us all how he and the four other conservative judges (aka the majority) will be looking at religious restrictions and probably other restrictions during the pandemic, and every other case that comes before the Supreme Court.

20a87_4g15(1)

Rick Jaffe, Esq.