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Category: SB 277

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

vaccineimage
The elimination of the PBE (personal belief exemption) via SB 277 has put a lot of pressure on vaccine concerned California pediatricians to write medical exemptions for the children of vaccine concerned parents. The recently dismissed San Diego federal anti-SB 277 lawsuit showed that at least one school board is collecting information about the docs who write these medical exemptions and will forward the information to the medical board for prosecution.

Based on some non-binding legislative history, and some personal discussions with legislators, the vaccine concerned community was hoping that the medical board could not or would not assert jurisdiction over docs who write these exemptions. That seemed completely unrealistic to me based on my experience dealing with medical boards. These guys just don’t give up jurisdiction on their licensees’ conduct.

In case you had any doubts, the board has made it official in its recent executive summary. Here is its position which couldn’t be clearer:
“The passage of two legislative bills increased the Board’s authority to investigate allegations of misconduct. * * *
In addition, SB 277 (Pan and Allen, Chapter 35) effective January 1, 2016, deleted the personal belief exemption from the existing immunization requirements. The Board will investigate any complaints in which a physician may not be following the standard of care in these two new areas.”
(From page 6: http://www.mbc.ca.gov/Publications/Annual_Reports/annual_report_2015-2016.pdf)

So there you have it. It’s basically open season on docs who write full vaccine exemptions, because according the pediatrician groups and the CDC, there are almost no medically justifiable reasons to excuse a child from all childhood vaccinations.

So what can be done about it? In the very short term, nothing really. Many pediatricians will probably be wary of writing medical exemptions.

Still, here are a couple hints. If your child had some prior vaccinations and had a serious adverse event associated with (not necessarily provably caused by) a prior vaccine, you may be able to obtain an exemption from the right doc, which decision would be literature supported. Make sure you bring documentary proof of the prior adverse event(s). The doc will need it for his records. Prior auto immune problems in the child or family members? That might help as well. Again, bring documentation. Help your pediatrician make the case and help him document the exemption. That’s the best protection for you and your doc. Admittedly, right now there is no medical board authority indicating that this would justify or exculpate a doc who writes an exemption on this basis, but I hope to change that within the next six months, in connection with my work on the current medical board case I’m working on, so stay tuned.

Next, an obvious mid-term solution is to amend SB 277 by making medical exemption decisions unreviewable by the medical board. As stated, there is some legislative history indicating that SB 277 was not intended to have the medical board second-guess the decisions of docs who write these medical exemptions. Realistically, passing such an amendment is a long-shot, but it’s time, energy and money better spent that filing another frivolous SB 277 constitutional challenge. (By the way, whatever happened to the dismissed San Diego federal lawsuit which was supposed to be refiled October 1st?) My suggestion: start working your legislators to get some feedback on whether it’s a possibility. If it is, that’s where the community should put its efforts and money.

Finally, there’s a soon-to-be publicly announced group of vaccine concerned docs, which is open to the public. It’s called Physicians for Informed Consent.

Check out their Facebook page at https://www.facebook.com/search/top/?q=physicians%20for%20informed%20consent.

Here is their web site. www.physiciansforinformedconsent.org

These folks have done more good for the vaccine concerned community even before they’ve officially started than all the lawsuits combined, but I can’t talk about that now. Go to their Facebook page, sign up and support them. They have and will continue to make a difference.

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

Using your own stem cells, tissue and body parts without FDA interference should be a no brainer and a slam dunk, but it isn’t. I mean it’s your own body. How can the federal government interfere with your privacy and autonomy right to use parts of your own body as a treatment? The short answer is they can and if the FDA gets its way, future patients are not going to be able to use their own cells and tissue as tens or hundreds of thousands of patients, including breast reconstruction patients, have been doing for years.  Here is how the FDA is going to stop you from using your own stuff (stem cells and tissue like fat, or what the FDA calls “Human Cells, Tissues and Cellular and Tissue-Based Products” or “HCT/P’s as the federales call it.) But first some short regulatory history

How the FDA thinks of your body parts

Until the 1990’s, removing and reinserting body parts wasn’t regulated by the FDA, other than making sure that it was collected and maintained in a safe and sterile way. But then stem cells started to become a popular research field, and all the hype started about the magical therapeutic power or potential of stem cells. So in the late 1990’s the FDA started making noises about regulating stem cells and other human tissue. That would include both your own stems cells (called in medical and regulatory parlance “autologous”, and someone else’s stem cells or tissue (“allogenic”).

In 2005, the FDA published its final rules concerning HCT/P’s.  (Here is the link to 21 CFR 1271, for the legally curious.  (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271)

The regulations created three different regulatory pathways for HCT/P’s; some were considered “new drugs” which required full FDA approval, which is a hideously expensive and unreasonably long endeavor. (This is sometimes referred to as the 351 pathway); some just required that the facility using the stem cells or other tissue register with the FDA (sometimes referred to as the 361 pathway), and if the stem cells or other tissue was removed and reinserted into the person in the “same surgical procedure,” the FDA didn’t regulate it at all because it was the practice of medicine which supposedly the FDA doesn’t regulate.

The FDA’s 2005 regulations introduced two biologic/analytical binary concepts which it uses as criteria for determining which of the three regulatory pathways applied to a particular use of an HCT/P: Homologous vs. non homologous and minimally manipulated vs. more than minimally manipulated.

To oversimply, a use of an HCT/P is homologous if the use of the material in the donor location is the same as in the recipient location. When the FDA regulations were first put out in 2005, there was some vagueness or flexibility in what constituted the same or homologous use.  The regulations stipulated that if the use was homologous, the use might only require registration under the 361 regulatory pathway (and if a number of other requirements were met). But if the HCT/P use was non-homologous (meaning that the use the cell had in the donor location was different from the intended use in the recipient location), then regulatory magic turned your HCT/P into a 351 new drug with the aforementioned hideously expensive and unreasonably long consequences. Seems crazy, but that was the reg.

Now you usually can’t just take stem cells out of your body; they have to be separated from fat, bone marrow, or blood. That means after you take out the material, the stem cells or other material is separated, using either a chemical agent or a mechanical process (like a centrifuge). Usually there is also other processing needed before the material is reimplanted.

The processing of the material gave rise to the second binary concept, minimal manipulation vs. more than minimal manipulation of the HCT/P.  If the cells are not more than minimally manipulated, the procedure could be done with just 361 facility registration (assuming homologous use and several other technical requirements set out in the 1271.1 (Here’s the link to the regulation if you’re turned-on by that kind of thing.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.10 )

But if the cells were more than minimally manipulated, then you are thrown back to the new drug path. Remember, we’re talking about your own stuff. Under the rule, there was some ambiguity as to what was or wasn’t minimal manipulation. Back when the rules first became effective, I had a client who wanted to take out fat, separate the mesenchymal stem cells and reinsert the cells back. To me, it seemed legal under the rules. I called the FDA a couple times to make sure I was right, and everyone at the agency I talked to agreed. But that was then.

Since that time, there has been an explosion of stem cell clinics taking fat from people and reinjecting the stem cells. Worse from the FDA’s point of view, many of these clinics were making all kinds of miraculous cure claims. Problem was there was no proof that the claims were true for most of the diseases or problems claimed to be cured or helped by stem cells. That made the FDA unhappy, which is bad thing. (Trust me, I know how bad it is when the FDA gets unhappy).

Long story short: the FDA decided to clamp down on all of these clinics, and used two of its most effective tactics.

First, it sent cease and desist letters (what the FDA calls a “warning letter”) to a couple of the most visible offenders. (Hit the big guys first to scare-off everyone else). The FDA publishes all warnings letters, and that got the industry’s attention.

Second, in the last year or two, the FDA issued four draft guidance documents “clarifying” the meaning the two key terms homologous/non homologous use and more than minimally manipulated (or not). But the FDA didn’t just clarify these terms; it rewrote the rule to knock-out some of the most popular and effective medical procedures, perhaps most importantly, the most popular post mastectomy breast reconstruction procedure with flap surgery.

No point getting too much in the weeds of how the feds did it (see my last post if the legal weeds is your thing.

http://rickjaffeesq.com/2016/09/13/fda-draft-stem-cell-guidance-documents-exposed-improper-rulemaking-bad-science-heartless-public-policy/

But here is the most egregious example that shows the abject stupidity of what the FDA is trying to do:

Flap reconstructive breast surgery takes fat (usually belly fat) and builds up the breast. Under the guidance documents, the main function of fat is structural. The main function of a breast (in a woman) is lactation.  (Some presenters of the female persuasion who presented at the stem cell public hearing were really annoyed about that characterization).  Lactation is a different function than the function of belly fat (structural). Therefore the use the flap procedure is non-homologous, which means the use has to obtain full FDA approval before it can be used outside of FDA approved clinical trials. Many of the presenters used this as an example of why the draft guidelines are wrong. (more details in my last post: http://rickjaffeesq.com/2016/09/13/fda-draft-stem-c…ss-public-policy/ ‎)

The fact that tens of thousands of women have had this procedure and are walking around feeling better about themselves is irrelevant to the FDA.

I’d like to meet the idiot who came up with this. Better still, I’d like to put him/her/them in a room with a few mastectomy patients who need the flap surgery, and let them explain to the patients why their belly fat and breasts are any of the FDA’s business.

Remember when I said that the FDA told me that docs can take fat out, separate the stem cells and reimplant them without FDA oversight if it was done during the same surgical procedure? Well that’s out the window now. Under the guidance documents, separating the stem cells from the fat constitutes “more than minimal manipulation” of the HCT/P and requires full-on FDA approval because your stem cells are now an unapproved drug and they can’t be reinjected into you without being approved by the FDA.

I get that the FDA is concerned about clinics making unsubstantiated claims. There are also a few well-publicized incidents of harm, most notably some clinic which apparently let a nurse practitioner inject stem cells in the eyeballs of patients. What idiot decided that was a good idea? Still, the remedy to that kind of problem is or could be a combination of civil actions by the patients, criminal prosecution, professional licensure proceedings, or state action to shut the place down. As to claims, The FTC has jurisdiction to deal with false claims issue, as does the state under state consumer deceptive trade practice laws.

The point is that there are a lot of options for dealing with places which do crazy things, harm patients, or make outrageous claims. The solution shouldn’t be that FDA closes down the entire autologous transplant industry because of some exceptional bad examples. Describing this as overkill is an understatement.

So here’s what needs to be done. The FDA has to rescind the draft guidance documents and start over. In the interim, the FDA should get the hell away from my stem cells and other body parts and yours too, at least if we want to take them out and put them back in our own bodies.

What can you do about it? Plenty

The public hearing of the FDA’s stem cell guidance documents ended last Tuesday, September 13, 2016, but the public comment period is open until September 27th.

If you think you might ever need to use your own stem cells or other body parts in the future, or if you know anyone how might need them, or if you think that what the FDA is doing is a bad idea, then write, fax or email the FDA and tell them. Here are some possible points:

  1. Withdraw the four HCT/P guidance documents
  2. Get out of the business of regulating a person’s use of his own body parts
  3. Any opinions  you might have about where they should place their draft guidance documents, or such other opinions you might have on this regulatory exercise, mindful of the rules of polite discourse, based on your discretion and/or temperament.

Maybe if a few hundred thousand people contact these jokers, they might get the message.

 

Where to send your comment?

Here is the information I found about sending comments:

“Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2015-D-3719 for “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments.”

If you want to go the email route: do one or both:

CBERPublicEvents@fda.hhs.gov

Or go to Federal eRulemaking Portal:  http://www.regulations.gov.

FYI: here is the sub heading from the eRulemaking Portal:

Make a difference. Submit your comments and let your voice be heard.

That’s good advice.

Here is the FDA Federal Register Notice about the Hearings, where you can read the written comments, and more details on submission of comments.

http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM497048.pdf

If you want more details about the issue or love the weeds, here is a link to all my recent posts on this topic. They’re in reverse chronological order, so start with the last one “Are stem cells over?”

http://rickjaffeesq.com/category/stemcells/

 

Tally ho!

 

Rick Jaffe

www.rickjaffe.com

 

(To Clinton Miller, I hope we can do you proud.)

 

 

Self-Dismissal of SB 277 Lawsuit: Smartest thing they’ve done so far: Is it a one-of or are they on a roll?

Self-Dismissal of SB 277 Lawsuit: Smartest thing they’ve done so far: Is it a one-of or are they on a roll?

 

I’ve been very skeptical of the federal SB 277 lawsuit and preliminary injunction motion, for technical legal and substantive reasons. (See my prior posts:

http://rickjaffeesq.com/2016/06/10/cali-anti-vaxer-friends-heres-probably-unwanted-possibly-useful-advice/

http://rickjaffeesq.com/2016/06/14/190/

http://rickjaffeesq.com/2016/08/21/time-get-real-sb-277-real-battle-will/

http://rickjaffeesq.com/2016/08/26/shocker-sb-277-preliminary-injunction-motion-denied/)

Well the powers-that-be finally did something smart; they voluntarily dismissed the case before the state had a chance to file a dismissal motion and before the judge terminated the case for good, or in legal parlance, “with prejudice.”

So what’s next? Based on Tim Bolen’s recent post, http://bolenreport.com/sb-277-lawsuit-case-dismissed/#more-4880, it looks like the case will be refiled with factual allegations on the two points which I (and any other experienced federal civil litigator) would deem necessary to try to allege a valid claim, namely, challenging herd immunity, and the alleged severe harm and danger of vaccines to significant numbers of recipients. (Which is not to say there is any realistic chance of success, but whatever chance there is has to involve these two factual contentions.)

Looking into my crystal ball, here is what’s going to happen, (or what’s not going to happen.)

  1. Think you’re getting rid of Judge Sabraw by refiling, think again.

Now that the federal lawsuit has been dismissed, it’s over, meaning, someone has to file a new lawsuit, pay another filing fee, serve the defendants again, and the rest. Normally, judges are assigned on a random basis, and there are a number of federal judges in the southern district, so one might think the odds favor getting another judge on the new case.

However, if the new case is filed on behalf of some of the same plaintiffs, and the defendants will be the same, and the same lawyers, then it’s a related case, and probably should be so designated in the initial filing, but even if not, the state will probably point that out right quick. Related cases go to the judge hearing or who heard the other case. Call it judicial efficiency or not allowing judge shopping.

So, prediction number 1 is that if the case is filed again in the southern district, it will end up with the same judge, and we already know what he thinks about whether there is any set of circumstances in which the beliefs or rights of the few can supersede the rights and health of the many.

Hint: The only way to make sure the same judge won’t hear the new case is to file in another California district court. There are three others, and Santa Barbara isn’t in the Southern District. Sure, you might be accused of forum shopping, and all the judges read the same law books, so it probably won’t matter, but if the goal is to get a different judge, a different district is the way to go.

  1. Preliminary Injunction? fugetaboutit! That ship has sailed.

The dismissed lawsuit was filed before the school year started in the first year SB 277 effected kids. So there was at least an arguable urgency, which is a prerequisite for the extraordinary remedy of a preliminary injunction. However, by the time the new case is filed (supposedly by October 1st) vaccination decisions for this school year have already been made, thereby eliminating the urgency of an expedited decision.  Any other arguable urgency would just be a pretext and won’t fly.  And even the impending school year didn’t work because the urgency was self-inflicted or a tactical decision (which is what the judge said).

Further, the whole “preserve the status quo ante” crap in the prior injunction is a joke and a non-starter in a public health case. Why? Justified or not, SB 277 was a legislative response to one very well publicized disease outbreak (and there were supposedly others).  No judge in his right mind is going to “preserve the status quo ante” by stopping a law specifically designed to prevent future disease outbreaks, not even if Jesus Christ shows up and argues for it.

Anyone who doesn’t understand this is either too close to the vaccine issue or has spent too much time doing field research on the medical marijuana issue.

And let’s not forget that a judge has already denied a preliminary injunction motion involving all or some of the same plaintiffs, defendants and lawyers. The idea that the same or even a different judge is going to reach a different outcome because of some new alleged facts in a complaint is, let’s just say, naïve.

  1. How about a Jury Trial? Not a Chance

Bypassing all the abstruse jurisprudence, there is no 7th Amendment jury trial right when you’re trying to overturn a statute. Those decisions are made by a federal district judge.

  1. So what’s Going to Happen in the New Lawsuit(s)

I get that the vaccine concerned community has a strongly held belief against vaccines, that they are toxic, hurt thousands of people and that vaccines haven’t been proven effective by scientific standards of controlled clinical trials. I also get that they think that the herd immunity concept is unproven superstition.  I am neither an anti vaxer nor pro all vaccines. Also,  I’m not a vaccine lawyer,  and there is no point for a guy like me wading into the scientific dispute or pseudo dispute since I’m just an outsider looking into this controversy. But I have spent my entire professional career litigating cutting-edge and novel legal/medical issues. In that (depressingly long) time, I’ve been thrown out of some of the finest federal courts, and have even prevailed once in a while. So on the litigation part, I’ve very confident about my ability to understand and predict litigation outcomes.

My crystal ball tells me that no federal (or state) judge is going to stop SB 277 because of any complaint or declaration (sworn statement)  supporting the complaint that may be filed. To think otherwise, in my opinion, is based on a non-objective/uncritical view of the case law, and/or a misunderstanding of the limited role of judges in matters of public health, even in the face of an alleged scientific controversy and a minority view of the overall danger of vaccination, even if that minority view eventually turns out to be true and accepted.

Further, none of these cases will ever see a bench trial and all will be dismissed under Federal Rule 12 b.

Bottom line, I do not believe that there is any viable direct legal challenge to SB 277. Indirect, maybe, where the two concepts are successfully challenged in a court case, but relief in such a suit won’t be the judicial overturning of the law. That will only come when there is some recognition/validation of the vaccine concerned’s position on the two key issues of herd immunity and vaccine harm/schedule.

In law, there are just some alleged wrongs or government actions which don’t have a judicial remedy. For the last hundred years, unfettered freedom from vaccination has not been recognized by the judiciary and will not be so recognized given the current view of vaccine science/safety, however wrong the VC community thinks the mainstream consensus view is.

So guys, file away. It’s sometimes important to empower a community even if the boost/feeling is short-lived. The vaccine concerned will certainly feel good about the new filings, and will feel that their heartfelt beliefs are being considered, and that could be a good thing and the lawyers filing these cases will be viewed as heros, (for awhile anyway).

But at the end of the day, the result will be the same as in all of the other cases. And there will be more of the same kind of explanations/excuses or different explanations/excuses, or fulminations about how we live in a police state and there will be more fragmentation of the VC community as they point fingers at eachother assessing blame for failed strategy. But none of those explanations or heartfelt beliefs or fingerpointing is going to change the “established” scientific facts or the law, until there is a change in the worldview, but I’ve said that before.

Rick Jaffe

Shocker! SB 277 Preliminary Injunction Motion Denied

Shocker! SB 277 Preliminary Injunction Motion Denied

In an 18 page decision, Judge Sabraw denied the vaccine concerned plaintiffs’ motion for a preliminary injunction. Big surprise! He also set out the grounds why he will dismiss the case, after the defendants file their motion to dismiss, which I would guess would be in the next week or two.

Unfortunately, the law has been clear for a hundred years, up to an including last year’s New York case. States are not required to have a personal belief exemption or a religious exemption to vaccines because the rights of the few are subservient to the the health of the many. That’s just established law. Until the vaccine concerned present a case to a court that 1. herd immunity is wrong and 2. vaccination damage to kids is horrible, understated or underreported and that the programs are massively unsafe and do not prevent disease, no judge is going to overturn a state’s decision to remove PBE’s or religious exemptions.  The injunction motion did not have any real record or evidence to support such a finding, so it was doomed or dead on arrival

Maybe the vaccine concerned will never accept the decision, the appeal decision or the law, but it doesn’t matter. This lawsuit is going to be dismissed, before the end of the year, the appeal will be denied, just like in Phillips v. New York (which is pretty similiar to this case and suffers from the same legal and record defects) and the  Supreme Court will not grant certiorari, just like in Phillips.

Deal with it,  and maybe it’s time for a Plan B.

Here is the Judge’s decision. He’s right on the money, based on the law, and the record before him.

denialinjunction

 

Rick jaffe

 

Is it time to get real about SB 277 and where the real battle will be?

Is it time to get real about SB 277 and where the real battle will be?

Based on the transcript of the oral argument/hearing on the preliminary injunction motion in the federal challenge to California SB 277 (the removal of the personal belief exemption), it seems pretty clear that the judge is going to follow the law, and that’s bad news for the vaccine concerned. The judge was polite to the plaintiffs’ counsel and acknowledged the deep and heartfelt beliefs of all those who support the legal challenge, but he is going to deny the motion, as he should, based on the law.   The plaintiffs’ lawyers did an excellent job, but the law and equities were against them, and there just isn’t a good enough record to make it even a close case.

Here is what I think the judge is going to say.

To get a preliminary injunction the plaintiff has the burden to show immediate irreparable injury in the absence of relief, likelihood of success on the merits, and a balance of equities weighing in favor of the granting of an injunction.

One of the biggest impediments to a preliminary injunction here is that the case/motion was filed way too late. The judge keyed into this right at the beginning. SB 277 was passed over a year ago and became effective over six months ago. You can’t get a preliminary injunction if the need for speed is self-inflicted. Plaintiffs’ counsel did his best to explain away the delay, but the facts are the facts. Tellingly, the state’s lawyer asked the judge if he needed to address the delay issue, and the judge said he didn’t.

On the merits, the judge’s questioning of plaintiffs’ counsel made it clear he didn’t think that the state  has a constitutional obligation to provide a religious exemption to vaccination, and then made a classic a fortiori argument, saying that a personal belief exemption (PBE) is just a lesser or watered-down version of a religious exemption. So if the First Amendment doesn’t require a religious exemption to vaccination, it surely doesn’t require a PBE. Then he said that if a state isn’t constitutionally required to give a religious exemption or PBE, how can it be unconstitutional to take the exemption away? This is one of the reasons the judge will say that plaintiffs have not demonstrated a likelihood of success on the merits.

As to the “hybrid rights” argument, It seems like it has been at least heavily criticized and it is probably bad law, because the opinion articulating the hybrid rights theory was apparently withdrawn. It’s never a good thing to cite and rely on a decision which has been withdrawn.  The judge will reject the hybrid rights doctrine as no longer being good law.

The judge gave short shrift to the federal statutory arguments. He’ll find that they are lacking as a matter of law, I suspect.

What about the state constitutional right to education? A federal judge is not going to give a federal injunction based on a state right where there is a serious risk of harm to public health if the injunction is granted. The state’s attorney quoted language from an opinion that the rights of the few don’t justify jeopardizing the health of the many. Of course, the vaccine concerned dispute that this is the case, but the record i.e. the evidence submitted, doesn’t come close to give the judge the comfort he would need to stop the state from implementing this major public health statute. Like I said in a previous post, unless and until the herd immunity theory is refuted or at least seriously questioned (by the scientific community), no judge is going to overturn a legislature that has decided to eliminate a PBE.

So what’s going to happen to the federal case? The transcript gives a hint about that too. The judge mentioned the state’s anticipated motion to dismiss the case. My guess is that the state is in the final stages of preparing the dismissal motion papers, and is just awaiting the judge’s order denying the preliminary injunction so the state can incorporate and toss back the judge’s own words.

My prediction is that the judge will grant the state’s motion to dismiss, with prejudice on all the federal claims, and without prejudice on all the state claims. Translation: he’s going to allow the plaintiffs to refile the state claims in state court.

What about the plaintiffs’ appeal of the denial of the injunction? Not a chance in hell it will be granted. The appellate court will give deference to the self-inflicted delay finding, and the appellate judges will go along with the legal conclusions that there is no federal first amendment right to a PBE, there is no hybrid rights violation (and hybrid rights is not a thing) and that the asserted state constitutional right to education isn’t directly implicated by SB 277 and/or it’s better left to the state courts.

What about the U.S. Supreme Court? There is zero chance the Supreme Court will exercise its discretionary jurisdiction (grant certiorari) on a denial of a preliminary injunction motion on a matter of where public health is arguably protected by the denial of the injunction, especially given federal and state law on the vaccination issue, and the delay in bringing the motion. The Supreme Court doesn’t overturn denials of preliminary injunctions, at least not on a record like the one in this case.

So while I think this case certainly has made the vaccine concerned feel good, and it did a great public service in uncovering what the Santa Barbara school district (and probably others) are planning, (reporting docs who write a lot of medical exemptions), ultimately, the case is a feel good distraction from where the real, important and possibly winnable battle is going to be.

So where is the real battle going to be for the vaccine concerned? At the California Medical and Osteopathic Boards. Some docs are going to write a lot of medical exemptions and I think accusations (board complaints) will be filed against those who write the most exemptions. That’s the place for the defense/offense.

The administrative hearings on the accusations/complaints is where, if done right, the community will have its opportunity to make its case on the two big medical/epidemiological issues; herd immunity and harm from vaccines/schedules. In my view, that’s going to be the mother of all vaccine battles. But that will require more studies/reports/analysis of VAERS data, and the widespread dissemination of the information, through all forms of media and especially documentaries and TV/U Tube type media.   World views are hard to change and take time, but they do change.

 

Rick Jaffe

Manly Advice for my Cali. Anti-Vaxer Friends

Manly Advice for my Cali. Anti-Vaxer Friends

Ok, some of you were put-off by the “anti-vaxer” moniker.  Some suggested you’re all health freedom fighters.  I’m not willing to bestow that laudatory title until I see a more cohesive, rational and convincing case made, though I’m sure I am a minority of one on this in the health freedom community.

How about the designator “vaccine-concerned” or “VC” for short? It’s neutral, accurately descriptive, and this is my post.  From now on, I am going to refer to you as “vaccine-concerned” or “VC.” I mean to include both ends of the VC spectrum, and here are the ends of the spectrum as I see it.

At one end are those who want vaccination criminalized because it harms everyone who is vaccinated. It includes people who deny that vaccines have had any benefit to mankind, and that it’s all a pharma scheme to suck money from the masses. It also includes the personal freedom people who think the government has no right to force anyone to get any vaccine or impose any consequences on the unvaccinated, regardless of the perceived consequences that the ignorant majority and conventional scientists think will be caused by the unvaccinated.

At the other end of the spectrum are the folks who are concerned that there might be too many vaccines for kids right now, who accept some preservative-free vaccines for some serious diseases, unless there are sound medical contraindications. It also includes those who will compromise their personal freedom to get inoculations before traveling to some foreign countries where diseases survive which have been long extinct in this country. This end of the spectrum also includes those who understand that the VC, who have strongly-held and metaphysically true beliefs, have to acknowledge and work within the system in which they currently represent a minority view. Indeed, these folks even understand that their views are considered by the mainstream to be anti-science and fringe. (See the just published article in the New Yorker entitled “The Mistrust of Science” by mainstream surgeon, author (and medical establishment tool), Atul Gawande.

http://www.newyorker.com/news/news-desk/the-mistrust-of-science?mbid=nl_TNY%20Template%20-%20With%20Photo%20(51)&CNDID=25050591&spMailingID=9044825&spUserID=MTA5MjQwMzU2NDMzS0&spJobID=941025627&spReportId=OTQxMDI1NjI3S0

(I have to admit that his biography of cancer, The Emperor of All Maladies was breathtaking. Haven’t read his new book The Gene, but I will. I don’t recommend any of his writings to the VC. To borrow a phrase from an email I got about the prior post, it will just make your blood boil.)

Now that we are past the nomenclature, I’d like to address a criticism most colorfully phrased by a chiro who said that I should “grow a pair,” tell the docs how to solve the problem and give the VC parents what they need. Well, I’ve taken that criticism and the metaphor to heart, and I’ve come up with a simple solution which I think satisfies the “grow a pair” admonition.

There is a loosely formed, nascent California group of vaccine-concerned physicians. They approached me to file a direct legal challenge to SB 277. I declined. The July 1st deadline is fast approaching. I’m told that VC parents don’t know what to do, and desperately need a solution.  So you want a simple and manly solution.  Here it is:  Each member of the VC group of physicians should write medical exemptions for any VC parent who comes to them.  If the physician group wants, I’m sure Tim Bolen will post the physicians’ names and contact information to make it easier for the VC parents.

I point out that the California law does not require that the exemption be signed by a board certified pediatrician.

Any California licensed physician can write the exemption, and the decision is not challengeable by the school.

VC California licensed docs have the absolute power to grant the wishes of the VC community.

Of course, it would be best if there was a doctor/patient relationship. All the statute requires is:

“a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances, including, but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt . . . .” (Emphasis added by me)

So what’s the problem?

Many VC physicians have told me that vaccines are dangerous or there are too many of them given over too short a time. These physicians are convinced that the legitimate and best scientific evidence does not support vaccination, or at least the current vaccination schedule. If so, then all you are doing is writing a letter that the child should not receive medically unnecessary or unproven preventive treatment.

In addition, VC advocates, including docs, have informed me that vaccines and/or the California vaccine mandate violates the Helsinki Declaration and the Nuremburg Code. If so, it surely violates the Hippocratic Oath because vaccines harm children, or so I am informed, and you all know the “first do no harm” thing. If forced vaccination violates these universal medical/ethical rules, which are morally superior to US law, and if the science overwhelmingly supports the rejection of vaccination (or even if science just does not support its use), as I am repeatedly told by the passionate VC community, then VC physicians have professional duty and a moral obligation to sign a medical exemption for every child of VC parents.

I would go even further; refusing to write exemption letters makes the VC physician complicit in what I am told is the greatest medical fraud in history, namely the perpetuation of the international vaccination hoax.  

Writing exemption letters for all-comers would be a complete and perfect solution for the California VC community. But what about the physicians writing the letters?

Sure it’s possible that the schools and medical board might not appreciate the courage and principled views of the letter writers in helping the VC exercise their Constitutional rights, but since the real science is on their side, it should all work-out in the end. As long as the medical evidence is on your side and the experts are qualified and authoritative, any competent board attorney should be able to convince the fact finder (initially an administrative law judge) of the correctness and righteousness of the VC position.  So you have nothing to worry about.

Besides, I’m told there are many California VC licensed physicians. So even if a few are lost to board sanction, the VC community could have its needs met for many years, or until the lawsuit(s) directly challenging the constitutionally of SB277 law is/are resolved in the VC’s favor, which I have been assured will happen.

 SO BALLS TO THE WALLS!  It’s time for the VC doctors to step-up and lead the fight.

I’m ready. Who’s with me?

Richard Jaffe, Esq.

(Now with a pair)

rickjaffeesquire@gmail.com

To my Cali. anti-vaxer friends: here’s some probably unwanted but possibly useful advice

To my Cali. anti-vaxer friends: here’s some probably unwanted but possibly useful advice

So in California come July 1st, there will no vaccine exemptions based on personal belief. However, there still will be a medical exemption, such as it is. My understanding is that pediatrics/public health recognizes some contraindications for specific vaccines, but very, very few (if any) contraindications for not giving a child any vaccine anytime.  I’ve heard that at least one prominent CAM healthcare attorney is advising his California CAM physician clients not to write medical exemption letters for parents who have a fear of or personal belief against vaccination. That might be prudent advice, and certainly no lawyer will get into trouble for giving it.  Obviously, this is all very bad news for anti-vaxers.

I will probably weigh-in on what I think are the medically supported justifications for the exemption another time and another forum.  For now, I’d like to talk to my anti-vaxer friends and colleagues, including those who for tactical/PR reasons characterize their views as in support of “informed consent” about the “dangers of vaccination”. You’re not going to like it, but to paraphrase Ziggy Martin in “Drive,” who’s gonna tell you when you’re too late and aren’t so great   In terms of where we are and the constitutional arguments being tossed around, well, you’re too late, wrong, and less lyrically, the imprecise hyperbolic language is not helping you focus on what may be realistically achievable.

First, the inaccurate hyperbole: California anti-vaxers claim that their kids and child care professionals are being forced by the government to be vaccinated.  Not true.  I’m from Texas, and in Texas we know what forced vaccination looks like. A couple years ago, the Texas legislature tried to force all young girls to get the HPV vaccine. The measure ultimately failed because of the public outcry against forced vaccination. California is not forcing anyone to get vaccinated. Rather, it imposes consequences (albeit draconian) for the unvaccinated; for kids, no public or private school; for adults, you can’t teach kids or be a child caregiver. That’s a big difference constitutionally and legally in general.  But in addition, by mis-framing the issue, you may be missing some realistic partial, medium-term solutions, as I’ll explain in a moment.

A lawsuit has been filed challenging the law eliminating the personal exemption. However, this lawsuit will be dismissed. Vaccination has already been upheld in California, twice before if I’m not mistaken, and the law is well within the government’s police power to protect the general health and welfare, such as it is thought to be (and I’ll get back to that also).

The new argument floating around is that the law violates anti-vaxers’ and their children’s state constitutional right to education. The courts will reject this argument. What most people don’t realize about constitutional rights is that they are not absolute, especially when they have to be weighed against competing rights and interests.  And that would apply to even the most fundamental rights.  Take the rights to life and liberty, which are as core as it gets. These rights don’t prevent the government from incarcerating or even executing criminals, and the rights don’t stop the government from drafting soldiers in times of war.

We all have First Amendment rights, but they don’t extend to shouting fire in a theater (unless of course there is a fire in the theater.) The most recent high visibility case involving weighing competing rights is that idiot Alabama clerk who refused to sign marriage licenses for gay couples because it supposedly interfered with her First Amendment rights of freedom of religion. Apart from the fact her position violated the basic constitutional premise of separation of church and state, whatever individual freedom of religion right she has does not allow her to violate the equal protection rights of gay couples. The court had no difficulty subordinating her individual religious beliefs/rights to the equal protection rights of the many.

(And to anticipate, the courts will hold that the law does not violate the equal protection rights of the anti-vaxers. To make a long story short, because this is a matter of public health and because anti-vaxers are not a federally “protected class” like race, gender, and now sexual preference, the courts will apply what’s called a rational relationship test in adjudging an equal protection claim against the law. This is the kiss-of-death to a constitutional challenge. Under a rational relationship test, the state only has to show or hypothesize that there is some possible, arguable, theoretical, potential rational basis to the law, and the courts bend-over backwards to find that a law has a rational basis.)

But getting back to the weighing of competing rights, it comes-up all the time in criminal cases. First Amendment freedom of press rights and the right of the public to know versus the due process rights of the accused. The privacy of a witness versus the sixth amendment’s confrontation clause right which requires that a defendant be given an opportunity to confront his/her accusers. In short, it is very common for judges to weigh competing rights and interests.

The California right to education is just of one of many rights and interests which the state grants and protects.  Sorry, but the reality is that an overwhelming majority of legislators and California parents believe that the current vaccination program is necessary to protect the health of children, and that allowing parents not to vaccinate their children because of personal beliefs and having unvaccinated kids in public and private schools makes their children less safe.   

There is no doubt in my mind that the new law is a valid exercise of that power, even though it affects the anti- vaxers’ education rights under the California constitution.  In the current and whatever future case there is on this issue, the courts will hold that the education rights of the anti-vaxers are subordinate to the public health and safety of the majority.   

The anti-vaxer comeback is that the majority is wrong and it’s all a conspiracy between government and big pharma; that vaccines have never been proven to be effective, don’t confer any public health benefit, or the benefit is outweighed by the risk and dangers of vaccines, that the diseases they are alleged to prevent are not as deadly as the harm vaccinations cause, and all the rest.

I confess to not knowing who is right; the majority or the anti-vaxers. But in terms of public policy and direct legal challenges, it doesn’t matter. That’s right, it doesn’t matter whether vaccination in the future is determined to be more dangerous than beneficial.  The only thing that matters right now in terms of a direct legal challenge is that there is a consensus of scientific opinion that vaccination programs are safe and highly effective, at least a consensus of conventional medicine, which, by the way, is in practicality, the same thing.

So what to do?

The first and obvious thing to do is try to change the consensus. That’s a hard process and change takes time, but it does happen, if the science supports the change. Thanks to people like Gary Taubes, David Perlmutter, Nina Teicholz, and others, the low fat, high carb diet world view is on the way out.  To that end, the new anti-vax documentary by Wakefield is a very good start. However, someone with mainstream credibility is going to have to take it to the next step. For reasons which I don’t think are justified and ironic to the extreme, Wakefield is viewed as the poster-boy for scientific fraud by the mainstream.   (The irony comes from the fact that the main accusation against him is undisclosed conflict of interest because his research was funded by an interested plaintiffs’ law firm. There is a whole literature on how Pharma has bought and paid for scientific research, and I’d bet that the biggest Wakefield medical detractors do the same thing he did, just on a much bigger scale.)

So more public broadcast and film attention is a must. But there is more, like the substance, technical part. Pretty much everything I’ve read coming from the anti-vaxers is overly emotional and not well-reasoned. It’s a big, complicated, multi-factored, nuanced problem. I think there needs to be sophisticated comprehensive analysis by people who have more than just an MD or PhD after their names. I’d like to see a panel of experts with actual experience in pediatrics, immunology, epidemiology, public health, biostatisticians, methodology, medical epistemology and heuristics get together and figure this out, do a meta-analysis what supports vaccination and put together a product which could stand-up to the mainstream and its talking heads. That kind of endeavor would take some serious funding, and you anti-vaxers are a fragmented community, so there would be financial challenges.  

Now let’s circle back to legal, mindful of why a direct constitutional challenge won’t work, and what to do about it.  As stated, the problem is the competing and superior interests of the majority’s rights. So how do we get around that? Take the majority out of the equation and maybe find a better constitutional vehicle. Right now, your only option is individual home school. I contend that anti-vaxers have a right to associate with other anti-vaxers and so do their kids, and that right to associate extends to education. Right now, the law essentially outlaws group home schooling; i.e., a private schools of similarly minded folks. I believe that law might be subject to a constitutional challenge under the first amendment freedom to associate. This would require a test case of a group, private, home school. Once it hits the radar screen, the state would likely order its closure. That would give the school and the parents standing.

Let’s assume by the time the case goes through discovery, the blue ribbon panel of actual experts with unassailable credentials finds that vaccination…. whatever it finds that’s supportive of the anti vaxer position (assuming that such is the conclusion). I think those opinions and experts have a place in the case. Now we have a trial the likes of which we haven’t seen since the Scopes monkey trial, and wouldn’t that be pretty nifty.

 Of course, that doesn’t get the anti-vaxer kids as a group back in regular schools. Instead, they are segregated.  Some anti-vaxers might think this solution makes them modern day lepers. Maybe it does, but vaccination decisions have consequences, eventually, and in California eventually is now.

Some committed anti-vaxers might find a doc willing to take the chance and write the medical exemption based on some medical pretext, but that’s a temporary, short term solution. Once the schools start seeing the same names show-up on these exemptions, they’ll notify the medical board which will take action and possibly quick action like summary suspension if there is a systematic effort to undermine public health (according to the board’s world view).   So there needs to be realistic and meaningful solutions which accommodate anti-vaxers’ beliefs, but recognize the state of consensus medical knowledge, as hard as that might be for some of my friends to swallow, at least until the world view changes. 

 I’m just saying.   

 

Richard Jaffe, Esq.

rickjaffeesquire@gmail.com