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The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

Since my last update about these cases in early August, not much has happened, which is to be expected in federal civil litigation. Nonetheless, here is an update.

Let’s start with what hasn’t happened

1. There has been no announced agreement in either case that the defendants have stopped treating patients with their SVF, stem cell therapy which the FDA claims are unapproved new drugs, adulterated and misbranded, pending the final decision by the judges in these injunction actions.

2 The FDA hasn’t filed a motion for a preliminary injunction against either company to stop them from treating patients until the judges’ final rulings.

The FDA sure isn’t litigating these cases like these clinics are a big public threat. There are a few well-publicized cases of harm from U.S. Stem Cells patients, and there is much made of the fact that California group was using a dangerous toxic substance in processing their “drug” product. But as I’ve said in some previous posts, the FDA has bigger fish to fry.

See my post at:”>”>

Of course, it’s a complicated subject for a federal judge, and maybe the FDA is worried about losing in the abbreviated hearing process of a preliminary injunction motion. Maybe the thinking is “do it right and take your time.” If so, I can’t argue with it.

Here is what has happened

U.S. Stem Cell

The defendants filed an answer in August. It largely parallel’s the answer in the California case, which isn’t surprising since the same big firm is lead counsel in both cases. Here is the Answer:


There is one big difference: U.S. Stem Cell’s answer contains a demand for “a jury trial as permitted by law.”

No such request was contained in the California Stem Cell Treatment answer. Getting the case away from a judge and into a jury’s hands would be a good thing for a defendant in this type of case, so did the California lawyers miss an opportunity?

I don’t think so. Injunction cases aren’t decided by juries; they are decided by judges. I think the Florida lawyers just tossed out a jury request and the docket just mechanically picked it up and the mechanical/automated software spit out the jury trial forms deadline. My guess and prediction is that down the road the jury trial issue will be addressed and rejected by the judge, even if the case gets that far.

The case is set for trial during a two week period starting June 10, 2019.

The more relevant deadline is March 11, 2019, which is the summary judgment motion deadline. Seems a safe bet that the FDA will file a summary judgement motion for a final judgment. (FYI: That’s how the Regenerative Sciences case was resolved). The feds will do some discovery, nail down via admissions and depositions what the company does and doesn’t do – most notably, being cGMP compliant – which establishes adulteration. The feds will get in admissible form the label instructions for use, which establishes misbranding, and obtain admissions and deposition testimony of the facts of how the product is processed, and how/for what indications it’s being used, which should establish non-compliance with the main regulatory requirements for drug status, i.e., more than minimal manipulation and non-homologous use, (at least under the FDA guidance documents.)

With those facts established in admissible form in discovery, there probably won’t be any factual issues to be tried by the judge (or jury). That makes the case amenable to resolution via summary judgement.

The defenses challenge is to find a disputed issue of fact on which the judge has to hear factual testimony from the parties at a trial. In this case, it will be a challenge, but there are some possibilities. The defense has smart lawyers and will figure it out, if there’s something to be figured out. And who knows, they might even come up with a legal basis to move the case sideways.

I’d look to have the defense seek a delay to filing papers in opposition to the summary judgment motion, figure a month. (Anything beyond that would probably interfere with the early June trial setting.) That would make a decision on the summary judgement motion in May. That’s how and when I’d see this case wrapping-up unless defense counsel figures out a way to derail or slow down the proceedings. Speaking as a defense lawyer, sometimes delay is the best you can hope for, because who knows what the future will bring. This point is aptly made in a fable I related at the beginning of my chapter on cancer doctor Stanislaw Burzynski’s several decades war with the FDA and the Texas medical board in Galileo’s Lawyer. It’s a good story. Here it is for those who have an immediate need for a smile.


Sometimes horses learn to fly, and a year or two could present an entirely new regulatory reality.

California Stem Cell

The parties filed a joint preliminary statement, which sets forth the claims and defenses, lists the witnesses, and the documents (and of course it can be amended as more information becomes available through discovery), and sets forth a proposed case schedule. The parties are looking at a trial in late July to early August, subject to the Court’s availability. They are proposing a motion deadline of late May. Here is the joint statement. castemcelljtdiscovery

There is a scheduling conference with the judge on Tuesday, October 1, 2018, at which point proposed deadlines will be adopted or changed.

The legal issues related in the joint statement are as expected and as discussed in prior posts, namely whether the defendants’ procedure is an unapproved new drug or not regulated by the FDA because it’s a same day surgical procedure, with not more than minimally manipulated autologous cells, given for a homologous use and all the practice of medicine and lack of jurisdiction stuff thrown in. The relevant trial documents are the 483 inspectional observations, communications between the parties and the final guidance documents pertaining to these issues, as well as patient complaints. Predictably, the defense seems to want to have some patients testify, and I’m always in favor of that. Look to the government to seek to stop that, because hey, that’s how they roll.

Yawn. I warned you it’s like watching grass grow.

Since the discovery process does not normally result in the publishing or making public, documents or other information revealed in discovery, I think nothing exciting is going to happen in these two cases (or nothing we will hear about) until summary judgement papers are filed (unless the lawyers come up with an interesting delay strategy). The Florida judge did refer the case out to mediation, but that’s a non-starter. U.S. Stem Cell isn’t stopping, and the FDA isn’t going away until it stops the Florida operation.

So any more news from the FDA in the stem cell field will be about other lawsuits or collateral things, like its cracking down on private stem cell clinics using to promote their clinics via patient funded clinical trials, per a recent post by the big dawg.

(And for the record, I don’t have a problem with the feds restricting to IND clinical trials, or at the very least, requiring disclosure that the trials are not FDA approved and that the “participants” pay for the treatment. That seems fair and reasonable.

I’m also very much in favor of the private stem cell clinics providing accurate and complete information about their operations, including that their treatments are not FDA approved, are not considered to be safe and effective by institutional authority, and that anecdotal evidence is not considered scientifically reliable, or even disclosing that there is no government review or verification that the statements made by the clinics on their web sites are true (like what the supplement manufacturers have to state). And I also don’t have a problem with the FDA or the FTC going after any health care facility which puts out materially false information to fraudulently induce patients to undergo the treatment. I’m all about providing the patients with accurate and complete information and let them make an informed choice, because it’s their bodies and their body parts we’re talking about).

So in sum about the status of the FDA’s two pending injunction cases: the millstones (wheels) of justice grind exceeding slow . . . . (you know the rest).

Rick Jaffe, Esq.

For those who don’t: “The wheels of justice grind exceeding slow, but they grind exceedingly fine.” The odds favor the millstone over Mendal in these cases, so per Damon Runyon, “The fight isn’t always to the strong, or the race to the swift, but that’s the way to bet.”


Should Cali. Bioidentical Hormone Docs be Worried About Prudence Hall’s Medical Board Sanction?

Should Cali. Bioidentical Hormone Docs be Worried About Prudence Hall’s Medical Board Sanction?

Fairly Short Answer: Maybe, but for sure, it should cause BHRT docs to learn from the case and re-examine their protocols and systems in treating, following-up and referring-out patients for diagnostics.

Bioidentical Hormone Replacement Therapy (BHRT) is a huge business now. It was invented by Jonathan Wright back in the late 1970’s, but it only took off after Suzanne Somers wrote her trilogy of books about it around twenty years ago. Since that time, Ms. Somers has become the poster girl for why women should be on BHRT. This is a G rated blog, so I’ll spare you the details of the many ways she claims that BHRT has helped her, but let’s just say that she’s an effective poster girl.

Ok, I can’t resist, here is a cartoon I found about BHRT. Not sure how it applies to this post, but I like it and it’s an good take-off of one of the all-time great movie lines (from “When Harry Met Sally”).

Now to business:

At the end of August, BHRT doctor Prudence Hall entered into a stipulated settlement with the Medical Board of California which put her on probation and included another term which might cause her continuing problems.

Here is the stipulation, attached to which is the Accusation (Cali. board term for board complaint)

Hall, based in Santa Monica, has some celebrity patients and has been interviewed as Suzanne’s BHRT doctor in a few of Suzanne’s books, so Hall is apparently, (somewhat perjoritively) considered to be the hormone doc “to the stars.” As a result, Hall’s board sanction was widely reported in the press. Here is the LA Times story about her sanction.

Hall’s press agent responded to the LA Times article. Judge for yourself how effective the response was.

A few words about the sanction, then some comments about the Accusation, and what California BHRT physicians should learn from the case.

The Settlement

When a medical board thinks a physician mistreated one or more patients over a period of time, it automatically charges the doctor with gross negligence and repeated acts of negligence (and sometimes incompetence, for good measure). There’s also almost always a charge for bad record keeping. That’s what the board did in this case (save for incompetence).

Hall’s case involved two patients, and there was significant harm alleged in one, namely, delay in the diagnosis of cancer.

Unless you’re very lucky or very good, (and I’m happy to report that I’ve been at least one of those), the minimum settlement terms the board will agree to is a lengthy probation period (technically, license revocation, stayed pending a probation period, usually 3-5 years), a practice monitor, and extra CME courses.

If the board has concerns that the doctor might not possess sufficient knowledge or skills to practice safely within the standard of care, it will also require that the physician submit to an extensive skills evaluation program by the UC San Diego PACE program.

The rub is that the PACE skill evaluation condition in a settlement also includes a provision that the doctor will abide by PACE’s recommendations. Sometimes PACE recommends practice limitations/exclusions during the term of probation, or even more, like skill enhancement prior to resumption of practice.

Lawyers who don’t routinely represent CAM/integrative physicians tell their physician clients that the PACE evaluation is no big deal. And it isn’t, if the physician is boarded in the area he/she practices, is CME current in the standard of care in the field, generally practices in accordance with the standard of care of the specialty, and just made some errors of judgment or missed a diagnosis which led to the sanction.

But it’s different with CAM/integrative physicians because they don’t follow the standard of care, and often don’t even know the details of standard of care because it’s not how they practice. I’ve seen CAM docs prohibited from areas of practice which they think they know based on a PACE finding of lack of competence, stemming from their inability to acknowledge or follow the standard of care. But that’s largely unknown to lawyers unfamiliar with CAM/integrative physicians, because it’s not a problem which their standard of care physician clients normally have.

Dr. Hall’s settlement contains the aforedescribed PACE term, and so her skills and knowledge about hormone replacement therapy will be evaluated, and PACE will decide whether she can continue with her Bioidentical Hormone approach to female complaints. My advice to her is take the evaluation seriously, maybe even prepare some, and take a different tone than what is evidenced in her PR response mentioned above. If she doesn’t, she may find herself limited to writing scripts for Premarin and Prempro, if that.

I won’t go through the Accusation in detail but I will point out the highlights in the two patient cases, both of which involve BHRT

Patient LH

1. The board thinks that BHRT is unproven and can cause uterine cancer, perhaps especially in patients having a family history of it.

My comment: The patient was diagnosed with uterine cancer after several years of BHRT given by Hall. There is no way to prove causation in an individual case like this, but in light of Hall’s alleged diagnostic failures, the board was going to come down hard on her for giving it and letting the cancer develop undetected under her (regrettably) limited watch.

2. The board didn’t agree with Hall’s determination that the patient was perimenopausal.

3. The board didn’t appreciate her diagnosing the patient with low thyroid and low D3 at the initial visit, prior to lab work.

My comment: It’s very common for CAM docs to make a preliminary diagnosis of low thyroid based on symptoms alone, and do an empiric trial of thyroid replacement. Bad luck that it happened in a patient who developed uterine cancer after several years of BHRT with inadequate follow-up and some apparent bad decisionmaking.

4. The board was unhappy that the patient received hormone therapy (estrogen, Progesterone, DHEA, Pregneolone, Testosterone) as well as D3, thyroid replacement and iodine despite normal lab values. (Gulp!)

My comment: This is of course disturbing since this kind of presentation and therapy recommendation is common in the BHRT crowd.

5. The board was critical of Hall for an office pelvic ultrasound and her interpreting it without having any post medical school training.

My comment: That’s disturbing since it’s a common practice among BHRT physicians who specialize in women’s problems.

6. The board faulted Hall for not ordered an endometrial sampling (uterine biopsy) after prolonged bleeding, and for not even requiring the patient to come in for an office visit, and was in general disturbed by Hall’s lack of appropriate follow-up of increasingly alarming symptoms consistent with uterine cancer (in part my interpretation).

My comment: This is the big deal and the reason for the heavy sanction. I think the board felt that Hall didn’t understand one of the most fundamental rules in this kind of case. If you can’t establish an alternative source of bleeding, the presumption is that it is some kind of uterine cancer. The first priority is to rule out uterine cancer which is normally and definitively done by sampling. Reliance on an in-office pelvic ultrasound, interpreted in-house by someone without advanced training is not enough.

7. The board was very critical of her use of hormones which resulted in “supratherapeutic levels.”

8. The Board was unhappy about the fact that despite all the hormone therapy, changes to the therapy, and reporting of symptoms over a three year period, there were only 3 office visits over a three year period.

My comment: that seems too few to me, given all the changes to the therapy and the increasing symptoms.

There was much less discussion of the second patient, MS. The board’s main issues were:

1. Diagnosing the patient with hypothyroidism without clinical evidence, and then prescribing thyroid which caused supratherapeutic levels without giving proper informed consent or doing a thyroid exam. According to Hall, part of the rationale for the thyroid therapy was weight loss.

2. Lack of coordination of care with other health care practitioners, including the patient’s psychiatrist, which the board didn’t like, since the patient had some suicidal tendencies, and there was no consideration of what effect the thyroid meds would have on her psychiatric drugs.

3. Like in the other case, the board didn’t agree with Hall’s determination that the patient was perimenopausal.

4. And as in the other case, the board didn’t like all the hormones without documented findings of clinical deficits.

5. The board didn’t like the fact that Hall did a “baseline” pelvic ultrasound prior to initiation of BHRT, because the patients didn’t have any symptoms. The board called that negligence.

My comment: I think the board is wrong. At worse, it’s reasonable defensive medicine, and it contradicts or is at odds with the board’s position in the other case. It seems to me that if there is a possibility that BHRT (or any hormone replacement therapy) might cause or contribute to uterine cancer, why not do a baseline ultrasound? If there’s an abnormal thickening, that might be relevant information or more likely, a contraindication.

6. The patient was under Hall’s care for about a year and received a lot of BHRT, thyroid and other medications. After going to Scripps weight management and an endocrinologist, most of Hall’s medication recommendations were terminated or dramatically cut back (thyroid), indicating that Hall’s treatment recommendations were inappropriate or no longer needed.

Finally, the Board didn’t like the fact that Hall called herself an endocrine specialist even though she wasn’t boarded in endocrinology.

So what are the lessons from this settlement?

1. At a minimum, I think every California BHRT doc should read the Accusation, at least to know what the board thinks about some of the things you folks are doing.

2. I think it’s clear that the first patient filed a complaint (and/or sued) because of a failure to diagnosis her uterine cancer over a three year, three visit period. Better follow-up and appropriate, timely diagnostic procedures might have avoided the complaint, or if not, would have lessened the need for the PACE skills reevaluation.

a. So the specific lesson to be learned is what you folks should already know: Unexplained (or abnormally longer than expected bleeding, or even questionable bleeding) requires further work-up, because the presumption is that it’s cancer, and cancer must be ruled out.

b. The definitive and gold-standard diagnostic test is a sampling. Abdominal pelvic ultrasound is not a substitute because it’s not sufficiently evidence based. (Ok you can’t get that from the Accusation, but this is my opinion)

c. Even transvaginal ultrasound done and interpreted in-house by someone without advanced training does not appear to be acceptable according to the board’s position in this case.

Some Perspective

Admittedly the Accusation contains some alarming comments by the Board about BHRT. However, in the end, the main complainant was alleged to have received bad medical care and follow-up which resulted in a substantial delay in the diagnosis of a serious and life threatening cancer. Based on apparently inadequate follow-up and testing, I think a complaint would have been filed and warranted even if the doctor was conventional and the therapy was Premarin. So despite the Board’s general negative comments about BHRT, the reality is if you’re vigilant in your follow-up and attuned to changes, chances are you won’t be faced with this kind of problem.

The second case shows what happens when conventional practitioners look at how a BHRT doctor works. That’s alittle troubling, because many BHRT doctors might have treated the patient the same way, or maybe not. Take a look at the facts in the Accusation and you tell me. However, I don’t think the hypothyroid diagnosis and thyroid prescription would have justified a PACE skills evaluation. I think the first case was the driving force behind that.

But for what it’s worth, I sometimes get the sense that some BHRT docs have too much blind faith in BHRT and don’t sufficiently appreciate issues brought forth by their patients, because of the aforementioned faith in the treatment. And for those folks, my therapeutic recommendation is increased skepticism and more vigilance in following their patients.

Rick Jaffe, Esq.

Cali. Medical Board has a new tactic to expand investigations against Vaccine Exemption-Writing Docs

Cali. Medical Board has a new tactic to expand investigations against Vaccine Exemption-Writing Docs

It’s been two years since California rescinded the personal belief vaccine exemption, so since the fall of 2016, vaccine-concerned (VC) parents of school aged kids have needed to find a physician to write vaccine medical exemptions for their children.

Right after the new law went into effect, the California Medical board filed charges against one of the most prominent VC docs, Bob Sears, for writing a court-case related letter excusing a child for all future vaccination based on the mother’s report of two serious adverse events. The non-custodial father filed the complaint. The case made many docs who wrote exemptions nervous and caused some lawyers to advise their doctor clients to stop writing exemptions. Some became more nervous when Dr. Sears agreed to a significant board sanction, (including monitoring of his practice) earlier this summer. Unfortunately, despite the sanction and monitoring, according to Dr. Sears’ facebook page, the board is investigating him for several other complaints involving exemptions. (In full disclosure, I worked on Bob’s case for awhile, but everything in this post is based on publicly available information).

While all this was happening, the medical board and other state and county health agencies were looking for information about other doctors who were writing medical exemptions. They haven’t been very successful, in part because of federal school privacy laws which restrict schools from releasing student medical information,(The law’s acronym is “FERPA”), and perhaps more importantly, because one California lawyer has made it his personal crusade to help parents protect their children’s school privacy rights. (That would be Greg Glaser, Esq.)

FERPA and Greg’s protection has made it somewhat difficult for the board to take action against other doctors, because the board needs a complaint about a specific patient to open an investigation. Normally, a complaint-based investigation is limited to the patient who is the subject of the complaint. Once there is a complaint, the Board can obtain the physician’s medical records for the patient who is the subject of the complaint, either by the consent of the parents, or via a subpoena for the records served on the doc. Many docs have refused to comply with these subpoenas, citing patient privacy and lack of patient consent. Recent court cases have ordered physicians to produce patient medical records, even over the objections of the patients/parents. That makes California like all or almost all other states, in that a medical board can obtain patient medical records for a pending board investigation, and investigations are commenced by someone filing a complaint regarding a specific patient.
The normal board practice in California and other states has been to limit the investigation to the subject of the complaint.

But apparently not any more!

The board has just served a California doctor with something called “Investigative Interrogatories” and is demanding that the physician give the name and contact information of every patient for whom the physician has written a medical exemption. This seems unprecedented in California medical board practice or case law, and arguably beyond the board’s statutory authority, but that’s what the board is doing.

Why is the board doing it? Like I said, it’s been two years since the elimination of the personal belief exemption, and the board has only disciplined one doctor, despite the fact that there are still many thousands of seemingly healthy children who are medically vaccine exempt. So maybe the board is feeling the heat from the Legislature or the state and county departments of health. And because of federal FERPA school privacy laws, the aforementioned Greg Glaser, Esq., and the fact that the board can’t investigate without a specific complaint, the board may see this new tactic as a faster and more efficient process to identify the main vaccine exemption writing docs and bring them before the board on charges on dozens (or more) cases at one hearing. Seems like this could be a big problem for the vaccine writing docs.

I’ve been tasked to stop it.

If the board doesn’t back down, we’ll end up in court, or more likely two courts (superior court and the appellate court), as the loser will surely appeal.

It’s going to be interesting.

Stay Tuned!

Rick Jaffe, Esq.

And by the way, if a vaccine exemption writing doctor complies and turns over the contact information of every patient who has received an exemption, seems like a good bet that the board investigators will start calling the families of every medically vaccine exempted patient and seek their permission for their physician to release the medical records. I predict no parents will agree to do so (except perhaps post-divorce pro-vax, non-custodial parents). Absent parental consent, the medical records of these patients will be subpoenaed by the board. The doctor may resist, but ultimately the courts are likely to grant the board’s request to enforce the subpoena. After the records are reviewed by a conventional doctor, there will be a recorded interview with the physician with medical board personnel asking about the rationale for all these exemptions. A few months after the interview, a board complaint (called an Accusation in California) will be filed, charging the doctor with incompetence, gross negligence, and repeated acts of negligence in writing vaccine exemptions not in accordance with the standard of care, which means the contraindications listed on each vaccine’s label (which includes the package insert). That is essentially the opinion of the main pediatric and family medicine trade associations and the CDC. News flash: these groups basically don’t think there is any medical justification for writing a vaccine exemption for a healthy child. So a doctor facing one of these Investigative Interrogatory requests might be better off trying to stop this before it snowballs into a mega case involving dozens or hundreds of patients.


Ohio Takes Action against the CBD Industry

Ohio Takes Action against the CBD Industry

The Ohio Board of Pharmacy has just passed a regulation that CBD products can only be sold in state licensed dispensaries.
Here is the new regulation.

Although around 50 licenses have been issued, currently there are no dispensaries in operation and it is estimated that it will take many months before the dispensaries pass the necessary inspections to operate. So what happens until the dispensaries open? Here’s what the board says:

“Until dispensaries are operational, no one, including board licensees, may possess or sell CBD oil or other marijuana related products. Violation of Ohio Revised Code or Ohio Administrative Code can subject a licensee (person or entity) to administrative or criminal action.” Gulp!

And just to remind you. CBD is still illegal under federal law and can’t be sold as a dietary supplement in interstate commerce. My earlier post on CBD discussed the federal status. Here it is:

Still not convinced? here are two Q&A’s from the FDA’s website page on marijuana:

“2. Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
There is an exception to sections 201(ff)(3)(B)(i) and (ii) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.

13. Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added?
A. No. Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.”

Translation: CBD is not a dietary supplement, it’s a schedule I drug. And that’s regardless of the oft asserted but incorrect safe harbor of less than .3 percent THC.

I’m sure you’ve noted that the FDA treats THC and CBD as the same, at least from a regulatory point of view, them both being illegal.
That’s what I’ve been telling people in my post and verbally, that the THC content is irrelevant in determining whether the product is legal. It’s just about what part of the plant is used as I explained in my prior post.

The good news: Neither the DEA nor the FDA seem to be in a particular hurry to stop companies from selling CBD oil or people using it.
One partial reason for this might be that the FDA has just approved a purified CBD oil product called, Epidiolex, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

In the short term, I don’t think much will change, and the companies will still push out huge quanities of CBD products, but maybe not so much in Ohio. It will be interesting to see what kind of enforcement action is taken. I suspect the Ohio Board of Pharmacy has limited resources, so if anything will be done, I would expect it would come from the AG’s office, as it has a bigger stick and more resources.

Rick Jaffe, Esq.

King Canute and why the FDA will never stop the private stem cell clinics

King Canute and why the FDA will never stop the private stem cell clinics


But first, two predictions:

Prediction 1

The FDA will win its injunction cases against US Stem Cell, and the California Stem Cell Treatment Centers, and obviously these injunction decisions will be bad precedent for the private stem cell industry.

Prediction 2 (and the big one)

The injunction decisions, even after the Court of Appeals affirms both injunctions -which will happen – will not stop or even slow down the explosive growth of the private clinic stem cell industry.

And the lesson of King Canute tells us why

Seeing the FDA’s relatively timid efforts to date reminds me of King Canute putting his throne at the sea’s edge and commanding the incoming tide to stop. (It didn’t.)

The FDA will have about as much success as King Canute had. (Of course, if the king sat by the beach for 24 hours, tides being what they are, it might have appeared that the sea was listening to him for some portion of the day. Maybe that’s taking the analogy too far, or maybe not.)

For sure, the FDA is going to win its current injunction actions in a relatively short period of time, (a year or eighteen months ish) in part because these cases are being defended by the same big firm, and big firms are masters of linear defense thinking. In cases like this, linear thinking will lead to permanent injunctions.

But these two cases aside, the FDA’s problem is that even now there are just too many clinics for too few FDA resources. It is estimated that there are around six to seven hundred clinics providing some kind of stem cell treatment. I think there are more, because some are flying under the radar screen, and the counting methodology is based on Internet searches.

To understand why the FDA’s task is impossible, consider what’s involved in getting to the place the FDA is in these two injunction cases.

Each FDA case starts with a site visit by multiple (usually three) FDA inspectors (usually called “consumer safety officers”). They spend anywhere from one to three weeks at the clinic. At the end of the visit, the facility receives a 483 inspectional observations report. Then there is a lengthy administrative process: a response by the clinic, consideration of the response by the FDA. If the response is inadequate, (and it always is), a warning letter is sent, but that will be many, many months after the site visit, because a warning letter involves much internal review from a couple different levels of employees and divisions.

Then the clinic has an opportunity to respond to the warning letter. Then there is a further administrative/bureaucratic process for reviewing the clinic’s response to the warning letter. Assuming, (as is always the case), the clinic’s response is inadequate, the FDA has to decide what to do about it, and that’s a further administrative review process.

If the FDA decides to proceed with litigation, it involves its counsel’s office and then the civil division of the US Attorney’s Office in the district in which the stem cell clinic operates.

The US Attorneys’ Office acts as the lawyer for the FDA which is the client. This involves another layer of bureaucracy. US Attorneys’ Offices are usually very busy places, and the lawyers in the civil division usually have big case dockets involving a wide variety of federal matters. They are a very smart and experienced bunch of people, but they are overworked, have to deal with many demanding federal judges and demanding clients who think their agency’s business and the agent’s case is the most important thing in the world.

The FDA’s practical problem here is that most US Attorneys’ Offices throughout the country have not dealt with stem cell cases, so there is some learning curve, which eats up more time. For sure, the US Attorneys’ Offices are aided by the FDA’s counsel’s office, and the FDA investigators, but still, it’s more inefficient than say federal administrative agency cases which are filed in the District of Columbia District Court, which handles many federal administrative cases and the DC US Attorneys’ Office which works on many cases in the same fields involving the same legal issues.

Consider that the two clinics/networks facing injunctions are notorious and have been known by the FDA for years. And yes, the FDA has also sent a few other warning letters to stem cell clinics over the past few years, but it’s not a big number relative to the number of clinics out there. Even if the feds up their game, and file more cases which are in the pipeline, what’s that number going to be? Five, seven? It’s not going to be 50 or even 20, given all of the above and the fact that CBER only has around 1100 total employees. (By comparison CDER (the drug division) has over 4,000 employees.)

Of course, the FDA has graciously said that it’s going to give these clinics three years to come in compliance, and is only now going after the most egregious violators who pose the greatest risk to patients.

That’s a very laudable position, but it reminds me of Siddhartha’s statement “when you have nothing to eat, the best thing to do is to fast.”

Apart from the sheer number of clinics, here are some other reasons why the FDA won’t be able to stop the tide of stem cell clinics:

2. The stuff works, and too many people are being helped

Not in all conditions or in all people, but basically I think the market has spoken and continues to speak by virtue of the fact that there are so many clinics out there and so many more coming online. You can’t fool all the people all the time.

The alternative is that everyone who gets stem cells is a moron, especially those who keep going back for retreatment, like MS patients. The MS stem cell patients are obviously delusional because they don’t understand that the clinical benefit they supposedly achieved every time they do their stem cell treatments is happenstantial/just a temporal correlation with their treatments and not caused by it, or is a placebo effect.

But here’s the thing, most of the MS stem cell patients have tried and failed multiple prior conventional therapies. So obviously these stem cell clinics have just happened to discover a better acting placebo. Ultimately, the bed rock mantra from the stem cell scientific community is, wait for it, “It’s just anecdotal evidence and not science.”

But I digress.

I think stem cells treatment is like medical marijuana. Regardless of all the studies showing that drug abusers suffer side effects and brain damage, there are so many people who have benefited from medical marijuana that the feds have been unable to stop the explosive growth of the use of medical marijuana, and many states have passed laws allowing it, despite its continued illegality under federal law.

I think we are seeing the same thing in stem cells, but to a lesser degree and we’re earlier in the cycle because 1. It’s a much more recently developed therapy than cannabis, 2. You have to go to a medical clinic to get stem cells, where it’s possible to get cannabis without a physician’s recommendation. 3. Stem cells are of course a quantum level more expensive than medical marijuana.

But it is the same societal forces at work. Ultimately, over time people know when something can benefit them. I think that’s one of the benefits of the internet; it’s all out there, the good and the bad. Obviously, this is a heresy for scientists but, respectfully, the scientist and the scientist policymakers on this issue are like King Canute thinking that they can affect the stem cell tide with all their unproven and harm talk. And speaking of harm:

3. There’s not enough harm from stem cell treatments

In all the years that stem cells have been given outside of clinical trials, there just isn’t enough harm to create the necessary groundswell of support to stop it.
In my last post, I discussed the publicly reported serious adverse events around the world from stem cell treatments.

Here is that post:

Here are the numbers: one US death, 10 or 11 other deaths throughout the world, and a total of less than 40 serious adverse events, in the world from the presumed tens of thousands of people who have received stem cell treatments. Those are extremely low numbers for a medical intervention.

Contrast that to over 42,000 deaths from opioid abuse in 2016. After I did that post, the 2017 numbers came out and they are even worse, over 70,000 deaths, the large majority of which were from FDA opioids.

Yes, the institutional stem cell industry and its spokesmen are decrying the venality, villainy and danger of these stem cells clinics, but their own numbers show that it’s not all that dangerous, at least compared to real societal drug problems like the opioid crises.

4. There’s too much money to be made in the field, and it’s quite easy for physicians (and others) to get into the field

Stem cell establishment folk will argue that money/greed is the primary reason why the FDA might have trouble eliminating the private stem cell clinics. No doubt there is a great deal of money to be made in the field. And greed often is a factor in big bucks enterprises. The treatments are expensive ($6,000 to $18,000). It’s a high margin business. Best of all, it’s a strictly cash business, meaning no insurance, and that’s as good as it gets for a health care practitioner, just ask the cosmetic surgeons. So for sure, the money is an important reason why many clinics won’t be scared off by two injunction cases, even when they result in permanent injunction orders.

In addition, there are models out there which are not physician driven, witness the new chiropractor based stem cell model. That is only one of several models which has opened the field up to non-physicians. Good luck trying to stop it King Canute. I’m not making a judgment here, just an observation and a prediction.

Reason Number 5: The FDA does wholesale well, but this is retail and that’s a whole different ballgame

The FDA primarily regulates pharmaceutical companies making drugs and vaccines, device manufacturers, and it also regulates the nation’s blood supply. It does a reasonable job of that given its limited resources. (And by the way, regulating the nation’s blood supply is a really, really important job for CBER, which is the FDA division which also regulates tissue based products and entities like stem cell clinics. Does anyone think it would be a good idea to transfer a bunch of FDA personal from protecting our blood supply, which affects everyone in the country going under the knife or who gets a transfusion, to shut down a few more stem cell clinics?)

The thing about trying to regulate retail clinics as drug manufactures is that the drug source is different; it walks in with the patients. The technology necessary to process the “drug” is relatively simple and cheap. Moreover, the training necessary to administer the drug/biologic is easily obtained, relatively cheap and quick (many would say much too quick, but that’s another topic and another one of my stories).

In market and economic terms, this is a low barriers to entry business model, and especially, to reiterate, because the patient comes in with his/her own drug supply and the clinic just processes it. This is just another part of the tidal forces facing the FDA.

And the last reason why the FDA will never stop the private stem cell clinics:

They are a moving target, and the target is starting to move on from fat

Readers of my book will know that I was involved in the original iteration of private stem cells business model, namely umbilical cord blood from blood banks. (See chapter 9 of Galileo’s Lawyer about the first stem cell criminal investigation )

Autologous from fat is the second, much more popular model, and as readers of my posts know, I was involved in the beginning of that too.

But the field has been reading the tea leaves, meaning the warning letters and the guidance documents administrative process, and it is starting to move on. The new iteration is autologous bone marrow based products, which are claimed to be exempt under 21 CFR 1271.15. (I haven’t looked hard at the issue yet, but I expect to in the future, for one reason or another.)

It took the FDA 12 years to publish final autologous fat guidance documents. It will likely take the FDA less time to work through the bone marrow model, but some of these clinics are going to slip through the cracks, either because of limited FDA resources, low risk of harm, or because they actually do meet the 1271.15 exemption criteria (essentially, homologous use, not more than minimally manipulated, and provided in the same surgical procedure).

My prediction is that the better, smarter, more informed clinics will end up being in compliance, others will not.

But one way or the other, we’re going to go through the same process as what happened with autologous fat derived stem cells, and that’s going to take a significant amount of time.
And so we start again.

Rick Jaffe, Esq.

Post Script
In case some of you never heard of King Canute, he was King of Denmark, England and Norway in the early 11th century. There is an apocryphal story about him putting his throne at the edge of the sea, ordering the incoming tide to stop before the water got to the throne. A common misunderstanding was that his hubris led him to think that he was so powerful that he could stop the tide from coming in. Admittedly, I was one of those so misinformed until I did some deep research (ok, Wikipedia).

Turns out the actual version of the apocryphal story (assuming that such a thing matters in apocryphal stories) is that he knew he couldn’t affect the tides, and that only God could, but he did it to shut-up his retinue who thought he was all powerful.

If so, then maybe the whole FDA analogy/metaphor to King Canute doesn’t even apply (or maybe it still does).

Some perspective on private stem cell clinics and the FDA’s response

Some perspective on private stem cell clinics and the FDA’s response

Last week, a highly regarded reporter from a major east coast national newspaper reached out to me to talk about stem cells. She had read some of my posts and thought they were interesting, but I could tell that she didn’t agree with basically anything I said in support of patients’ rights to access their own body parts.

She asked me why I thought the FDA hadn’t filed a preliminary injunction against US Stem Cells and the California Stem Cell treatment center. I hadn’t really thought about the why. But my immediate reaction was that the FDA has bigger fish to fry. She understood immediately and almost simultaneously we both said “the opioid crises.” Maybe it’s that’s simple and suggests that some perspective is needed as stem cell thought leaders and the press lament the proliferation of the for-profit stem cell clinics and attempt to shame and cajole the FDA to shut down all the these lowlife stem cell profiteers (their words and sentiment).

So how much harm are the private stem clinics doing?

A recent study tweeted by the Big Dog entitled “Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem-Cell Based Interventions” was published in Stem Cell Translational Medicine. Here is a pdf of the study.

Bauer_et_al-2018-STEM_CELLS_Translational_Medicine (1)

The authors did a google search of all reported AE’s and stem cells. They separated the AE’s into two categories: AE’s reported in the medical literature and those reported in the mass media. There were a total of 35 serious AE’s, including 11 deaths. Two of the deaths were from direct injection into the brain, another was from a stem cell injection into the right carotid artery. Well, I’ve finally found people with less common sense than the folks who thought that having a nurse practitioner inject stem cells into both eyeballs of patients was a good idea.

None of these three above described deaths occurred in the US, and only one of the total 11 reported deaths occurred in a U.S. clinic. I can’t tell from the article how strong of a causal connection there was, but most of the listed deaths appear to this layman to be strongly presumptively caused by the stem cell intervention. (AE’s are just associations and do not necessarily demonstrate causation because of co-morbidities in the treated.) But let’s make the reasonable assumption that all the reported deaths and other serious AE’s were caused by the stem cell interventions.

Thirty five reported serious AE’s in the world based on medical literature and mass media

We don’t know the denominator, i.e., how many stem cell interventions there have been, but I have to believe it’s a big number, at least tens of thousands of stem cell interventions throughout the world. But who is to say that all serious stem cell AE’s are reported. So let’s double the number and double it again. That’s 140 serious AE’s with 44 deaths and 4 in the US. (Mindful that this is just an extrapolation based on nothing, and the real numbers are 35, with 11 deaths, one of which was in the United States.)

Under the real reported numbers or the hypothesized extrapolation, it’s not a big number.

What about the benefit of stem cell treatments?

I’ve interacted with many physicians using different forms of stem cells and I’ve spoken to many, many patients. Although it will fall on deaf ears, and it’s not science, many of these doctors and patients actually believe that stem cell treatments have a demonstrable clinical benefit in individual patients.

Of course not in every disease

I haven’t personally seen any interesting and hopeful results in ALS. MS patients tell me that stem cells have helped them, but they all seem to need periodic retreatment, and I’ve never heard of a MS patient being cured by stem cells.

I’ve heard about some semi-miraculous results in autism, and know of one case where stem cell treatments appears to have normalized a moderately autistic child.

The biggest benefits I’ve heard about are in the orthopedic field, joints and ligaments. I’m not a scientists, but I’m betting that the orthopedic applications of stem cells will prove out, perhaps even without extensive clinical trials. It seems to work that well. I’m guessing that sooner rather than later most regular orthopedists are going to have to use it, damn the FDA or lose market share.

But lets’ forget about the benefit or possible benefit of stem cells and look at the other side of the ledger.

How many people die of drug overdose each year?

Seems like the best number available is 60,000 drug overdose deaths, with 42,249 deaths due to opioids (in 2016). Here’s the article from where these numbers come.

These numbers are insane! As the article points out, opioid deaths now eclipses the number of women who die each year of breast cancer.

By way of reference, auto accidents cause around 37,000 fatalities a year, but basically everyone in the country can be a victim in an auto accident, but obviously only people taking opioids can die of an opioid overdose. So the denominator in auto accidents is very substantially larger, meaning that the chances of an opioid user dying of opioids is a lot higher than the changes of dying in a car accident, even though the total number of deaths are not that far apart.

Here are some war comparative data points: over 58,000 US soldiers died in the Vietnam War, over 54,000, in the Korean War, 4500 in the Iraq war.

When comparing the Stem Cell AE article’s charts with the drug watch article on opioids, I’m going to guess that the medium age of death of the 42,249 U.S. opioid overdose deaths is probably at least three decades younger than the 11 reported world wide stem cell deaths, and that my friends is a tragedy.

And when an FDA approved drug (or class of approved drugs, namely synthetic opioids like fentanyl) kills 42,249 young people in one year, that my friends is a national crises requiring the strongest possible response from the agency which (perhaps mistakenly) approved these drugs for use in humans.

The fact that there are 500, 700 or even 1000 or more clinics using stem cells on patients not in accordance with FDA guidance document interpretations of FDA regulations, and that there have been 35 reported world-wide serious AE’s, (including one death in the U.S.) is not a national crises and does not require the strongest possible response from the FDA.

Rather, it is a regulatory issue which needs to be addressed, balancing the risks and benefits, and also considering that we’re talking here about using a person’s own body parts as the basis of the therapy. As I’ve said repeatedly, that makes it different, or at least it should. Admittedly, the regulators and Congress do not seem to agree, yet.

But on the other hand, that might help explain why the FDA is not “balls to the walls” going after all or even a significant percentage of these operations despite the pleas of the stem cell establishment and the press. If so, as painful as it is for me to say, I’m grateful that the FDA realizes that it has bigger fish to fry.

Rick Jaffe, Esq.

Some things in the private stem cell clinic debate are complicated, but some aren’t

Some things in the private stem cell clinic debate are complicated, but some aren’t

I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action.

But I don’t.

I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have been under Florida law, it is an inexcusable lapse of judgement. Plus, the clinic had already settled several malpractice lawsuits and is facing at least one more lawsuit involving a patient.

I am an advocate for a patient’s right to use his/her own stem cells, but that doesn’t mean that a clinic which continues to cause serious harm to patients has the right to keep injuring them.

In my opinion, US Stem Cells has done serious and irreparable harm to patients, and it needs to be stopped now, not in next few years, which seems like the FDA’s current time table. I don’t often agree with the big dog (aka Paul Knoepfler) but on this issue, I do. See his post at

How the Florida clinic can be stopped sooner rather than later

One of the stem cell luminary thought leaders, Bernie Siegel mentioned to me his hope that the latest big malpractice case against US Stem Cells might shut the place down. I told him I didn’t think so. Here’s why:

Malpractice claims are typically covered by malpractice insurance, and I have to believe given the clinic’s past experience, the first bill it pays after rent is its malpractice policy premium. It’s surely tough being sued, but when you’re not paying to defend and not paying the settlement amount, it’s not quite as tough, and is not a business ending event. So I don’t think any single or even a small number of malpractice lawsuits will do the job.

More effective would be fraud or deceptive practices lawsuits. These most likely won’t be insurance covered, at least not by malpractice insurance. I think there has been at least one such case filed against the clinic by a Miami law firm. I’m rooting for the plaintiff in that case. But these cases take time, and often times, the cases are settled. And insurance or not, I assume these Florida clinic folks have made a ton of money from their stem cell patient business, and they also have a training and franchise operation of sorts, so I wouldn’t expect even a fraud lawsuit or two to put them out of business, not in the short term at least.

So where does that leave those that want to see this clinic gone now?

We have to circle back to the FDA and think about what the agency would need to do to stop this clinic now(ish). And while some parts of the proposed plan may seem harsh, shocking and almost unbelievable, all these tactics have been used against me and my physician/clinic clients in the past by the FDA and other federal agencies.

1. Get the FDA’s OCI (Office of Criminal Investigations) involved

The FDA site inspection which resulted in a form 483 inspectional observations last year establishes what the clinic is doing. The statutes as interpreted by the final guidance documents establish probable cause that the FDA criminal trifecta has been violated (introducing into interstate commerce an unapproved new drug, misbranding and adulteration). The prior warning letter and the injunction complaint establish sufficient knowledge and intent to support a probable cause finding that the crimes are felonies. That should be enough for a federal magistrate to sign-off on a search warrant.

2. Execute the search warrant and take all the clinic’s patient records. If the clinic wants to see the medical records, it will have to come down the local FDA’s office and copy them.

3. Have the warrant search for non-FDA cleared medical devices or any other devices used in connection with the alleged criminal activity. (The latter is not a slam dunk.) That might/would stop the clinic from processing the fat into the stem cell SVF (stromal vascular fraction) product.

4. Invite the Florida medical board to participate in the raid. I don’t know whether the board has taken any action against the nurse practitioner and the supervising doctor yet, but if it hasn’t, there’s probably a decent case for an interim suspension proceeding against both. These proceedings are done ex parte, meaning it’s like a star chamber, done without telling the doctor in advance of the suspension.

5. Start interviewing the clinic’s patients. Many will be supportive of the clinic, including some who have received no benefit, but some won’t be.

6. Interview all the clinic’s employees and vendors/suppliers. OCI has some interesting interviewing techniques which in effect threaten criminal prosecution to people doing business with the target without technically threatening them, but the vendors get the message.

As I said, some or all of this might seem like legal thuggery, but me and my clients have been on the receiving end of all of them (Many of these tactics are discussed in chapters 2 and 9 in my book, Galileo’s Lawyer.). Combined, these tactics will get the clinic’s attention in a way which hasn’t heretofore happened. The other purpose of my discussing this is to show the FDA’s investigative tool box in cases where it really wants someone gone.

Other Government and private actors

US Stem Cells is a public company and that opens up another line of attack. The continued publicity already has and will continue to generate some interest by the SEC (Securities and Exchange Commission) which is looking into the company’s reporting documents (10K’s and 10Q’s). It’s probably a safe bet that the company’s disclosures were inadequate. With all the federal attention, some class action firm might file a shareholder’s suit, and that kind of suit burns a lot of cash for the public company.

The private lawyers who have filed civil malpractice or fraud lawsuits or are contemplating filing will be circling in the air waiting for any government action and especially any agency or judicial decision, which will make the civil fraud or SEC claims easier and faster to resolve favorably. To that end:


The FDA and the US Attorney’s Office should do what they should have done in the beginning, file a preliminary injunction motion, and request a hearing as soon as practical.

That’s going to present some interesting conundrums for the clinic’s principals. Do they testify? If they do, they can’t lie, or they’ll be charged with perjury. Can they say they didn’t know what they were doing is illegal? They can say it, but the judge doesn’t have to believe it. I doubt they’ve been told by an FDA attorney that what they’re doing is legal, so there won’t be an “advice of counsel” defense. Ultimately, they will either be forced to testify and most likely further incriminate themselves, or they’ll fold their tent and go away. (I’d bet on the former.)

If they don’t close down, then the final step is a criminal indictment, and that will put a whole new complexion on things. There’s a saying in criminal law. “You can beat the rap, but you can’t beat the ride.”

But in this case, once the blinded patients and the other injured patients testify, a preliminary injunction case, the permanent injunction case and a criminal trial are effectively over. No reasonable judge or jury is going to let these people continue.

And that’s why this is such a horrible case for stem cell advocates like myself. The idea that these people are the poster children for patients’ unfettered access to their own stem cells is disconcerting. That this case might set precedent for all same-day surgical procedure clinics should be distressing to all such clinic operators.

Therefore, best case scenario for both sides of the debate would be for the Florida clinic to voluntarily shut its doors now. Since that’s not going to happen, next best case scenario for everyone (including and especially patients) is that the clinic be shut down by the government as soon as possible.

And after that happens, the plaintiffs attorneys circling above will swoop down pick the clinic and its operators clean. If the clinic operators have an asset protection plan involving family members or family trusts, there will be fraudulent conveyance lawsuits.

Government and private action could trigger a voluntary bankruptcy proceeding by the corporate clinic/franchise entity. If so, the bankruptcy trustee will hire an attorney whose main job will be to claw-back all the money paid to the insiders, at least in the year prior to the filing, and probably longer. Ultimately, the lawyers (on both sides) will get it all.

That’s how I see it playing out if the FDA decides to take the case more seriously.

Of course, this is just my opinion and speculation based soley on publicly available information viewed through the lens of my 35 years working my side of the street.

What effect would all of the above have on the other private stem cell clinics?
Probably make them much more careful in what they do, say, and who they do it to. And even for a guy on my side of the street, that’s a good thing.

Post Script: I’ve recently read that these people have a new marketing idea and targeted audience: They’re doing penis stem cell injections.
Here we go again!

Rick Jaffe, Esq.

Update on the FDA’s Stem Cell Injunction Cases

Update on the FDA’s Stem Cell Injunction Cases

Watching a federal civil case progress is usually about as interesting as watching grass grow, except that grass grows faster. It’s been around three months since the FDA filed permanent injunction actions against the country’s two most notorious stem cell clinics/networks, California Stem Cell Treatment Center/Cell Surgical Network and US Stem Cell Clinic and network.

The most interesting thing about the cases so far is what hasn’t happened. The FDA has not filed a motion for a preliminary injunction in either case, and there is no indication in the record of either case that the defendants have voluntarily stopped treating patients with what the FDA claims is an illegal treatment. (I’m not in direct contact with either defendant or their counsel, so I can’t say whether or not there has been some private agreement, but I doubt there has been, because the community would have heard about it.)

If these clinics are still treating patients, then since it could take at least another year before the district court makes a decision, that leads me to conclude that that the FDA is in no particular hurry to shut them down. That would be consistent with the FDA’s stated policy when it issued the final guidance documents that it would give some of the private stem cell clinics as long as three years to come into compliance with FDA law, meaning obtaining an IND to treat patients. Of course that would mean that the for-profit clinics couldn’t charge for the stem cells, unless the clinics obtains FDA permission for cost recovery of the actual cost to treat each patient. (Yea, like that’s going to happen.)

So let’s look at the grass and see what’s grown so far

California Stem Cell Treatment Center

The defendants put in their answer, but it doesn’t say much

A defendant served with a federal civil complaint has to put in an answer which responds to the factual allegations and at least lists the legal and equitable defenses. Federal practice adopts what is called “notice pleading,” which means that neither the complaint nor the answer have to tell the complete story or provide all the details of the claims or defenses. When the plaintiff is the government and is trying to stop a defendant like here, invariably the government lays out its case in detail, both for the benefit of the judge, and to start the process of trying to convince the defendant to give up before trial.

In criminal cases, defendants oftentimes hide the ball, meaning they don’t tell the prosecutors what their theory of the defense is. For example, we just learned yesterday at the opening argument that Paul Manafort’s defense to his money laundering and tax evasion case is to blame his underling, Rick Gates. You can do that in criminal cases because there is almost no discovery and a defendant doesn’t have to file a written answer explaining how the case will be defended. He just announces “not guilty” at the arraignment (the reading of the criminal charges in the courtroom).

In civil cases, there is little if any hiding the ball, at least if the plaintiff’s counsel is competent and does proper discovery. And there’s really no reason to hide the ball in an injunction case, since there is no jury and the judge makes the decision.

So how did the California Stem Cell Treatment Center answer? It was pro forma. It denied the material and inculpatory allegations and/or said they were legal conclusions not requiring an answer. The answer listed some conclusory defenses, like lack of subject matter jurisdiction over the procedure because it is an exempt “same day surgical procedure,” and raised the ever present but meaningless violation due process defense. It also raised a Tenth Amendment claim, which I assume in this context means that the procedure is governed by the state law via the medical board. It also raises the patients’ right to privacy. I wish them luck with that. I’ve unsuccessfully trying to get various courts to acknowledge that right for twenty-five years. Other than gun rights, the courts have not been excited about expanding constitutional rights. The Supreme Court had the chance in 1979 to create a patient’s constitutional right to unapproved Laetrile treatment in the Rutherford case, but Justice Thurgood Marshall, writing for the court, refused to even consider the right based on a thin technicality.

What isn’t in the answer is the defense story or argument. As indicated, that’s certainly not required in an initial answer, but still, this is a high profile case, involving serious and important legal and policy issues which effect many millions of people. The case is going to be watched by everyone in the field, both for and against private stem cell clinics. I was hoping that the extremely formidable and high power legal team would come out swinging for many reasons, not the least of which is that there may only be one person needed to be convinced. I think it was a wasted opportunity to start making the case, especially since cases like these are not linear; they are multidimensional. And I speak from some experience.

A scheduling conference is set for October where discovery parameters and deadlines will be set. Until then, and thereafter, we’ll probably be watching the grass grow. The only way it will get more interesting is if the FDA changes its mind and moves for a preliminary injunction, or the defense realizes they are going to have to do something different than just competently and cautiously respond to government papers.

The US Stem Cell Clinic/Network case

The defendants acknowledged receipt of the papers (service, in legal parlance) in early May. In early July, three days before their answer was due, the defense lawyers (2 big time law firms and at least six lawyers have already appeared in the case) asked for a month’s extension to file an answer because the lead counsel firm was very busy, had scheduled vacations and couldn’t find the time to do an answer in two months. The judge wasn’t happy about it or the proffered excuses. She didn’t give them the full month, but gave them almost three weeks. Their answer is due August 3, 2018. I hope they go big and strong.

So far, seems to me that both cases are off to a slow and weak start. I’m hoping this changes because right now, for better, but mostly for worse, these two cases are the tip of the FDA’s spear aimed at the hearts of people wanting stem cell treatments outside of clinical trials. I hope these folks are up to the challenge.

Rick Jaffe, Esq.

It’s Surprisingly Quiet on the California Vaccine Front

It’s Surprisingly Quiet on the California Vaccine Front

It has now been two years since California rescinded the PBE (Personal Belief Exemption) for vaccinating school kids (SB 277). Let’s take a quick look back and see what can be learned from what has and hasn’t happened.

1. The Legal Challenges to the law were a complete bust
From the get-go, I was extremely critical of the lawsuits challenging the law. (See my earliest posts in the SB 277 section of this web site). The bottom line was/is that so long as it continues to be “accepted science” that 1. Vaccines are safe and effective and serious side effects are rare, and 2. Herd immunity is a thing, no California court will overturn the people’s will (expressed through their duly elected state legislators) to limit PBEs. No U.S.court has ever done so, and for the above two reasons, no U.S. court will ever do so, until the scientific consensus changes PERIOD

Thankfully, the vaccine-concerned have moved on from that folly, after all the challenges were rejected.

2. Here’s some good news: There haven’t been a slew of disciplinary actions against vaccine exemption writing docs (yet)

So far as I am aware, the only physician who has been disciplined for writing a vaccine exemption type letter is Dr. Bob Sears, but that was based on a case before the new vaccine law came into effect. People were afraid that all the docs writing these exemptions would be “targeted” by the board, but that hasn’t happened yet.

A perhaps interesting and important digression about how medical board cases start

Despite how it may seem to those being prosecuted, the medical board doesn’t go out and look for doctors to sanction. Medical board investigations are complaint generated and driven. The board receives information from patients, co-treating physicians, insurance companies and state agencies which either are complaints or contains information that the board determines is a violation of some law or regulation that the board enforces. (In some relatively rare cases, the board itself is the source of the information, like when a physician is on probation and thinks the doc violated a term of probation.)

Even in the vaccine context, someone has to complain to the board about a doctor writing a vaccine exemption.

Advice to California exemption writing docs: Never write an exemption for a child unless both parents request it/are on-board with it, especially if the parents are divorced.

It doesn’t matter if the sole custody parent requests it. Well, actually it does sort of matter, but if the non-custodial parent is not on-board, it is possible to very likely that the non-custodial parent will file a complaint against you, especially if there are on-going disputes between the parents. In these situations, fighting parents lash-out against a third-party like a doc. So don’t put yourself in the middle of family problems.

So who else can complain? Here’s the bad news:

County public health officials have been quietly going around the state and seeking information about which doctors are writing exemption letters and providing that information to the board. Somehow, probably illegally, they are convincing the school officials to turn over privacy protected information about students who have vaccine exemptions. It’s not a HIPAA violation once the school has the information, but it is a FERPA violation (Family Education Rights and Privacy Act). There may or may not be a private right or action for a FERPA violation, but so far, no one has taken a state or county agency to court on a FERPA privacy violation claim. (Too bad, since the case needs to be litigated.)

Based on the reporting on Dr. Bob Sears’ settlement, it appears that the board has received about 50 complaints, half of which have been dismissed or terminated, presumably without a formal board proceeding. (I haven’t heard of any exemption vaccine case having gone to a hearing yet).

Of course that means that half of the 50 board complaints are still pending. My guess is that those case involve only a handful of doctors, at most.

So what’s next on those cases?

My guess is that in the next six to nine months, the board will file accusations against a few other physicians for writing exemptions based on things like family history of autoimmune dysfunction, which I think is a popular basis for vaccine exemption.

More advice to physicians: If you’re going to use family history as a basis for an exemption, there better be very good documentation/details supporting the family history. Same, if not more so for a child’s history of prior adverse reactions. I can categorically state that it’s not enough just to record what the exemption-wanting parent says about a prior adverse reaction. Problem of course is that most adverse reactions are not worked-up because a regular pediatrician tells the parent that it will pass and advises not to come in or go to the ER.

Nonetheless, writing an exemption without at least the prior medical records which record the prior adverse event will be viewed by the board as a violation of the standard of care.

3. Indirect anti-vaccine legislation

There have been a few attempts by the pro-vaxer legislator-in-chief to pass legislation under the guise of children’s rights and other Orwellian Newspeak to abrogate the parents’ power not to vaccinate their children, but it seems like the vaccine concerned community has done a good job stopping that. But expect the attempts to continue in ever increasingly creative and indirect approaches.

The 900 Pound Gorilla

Since even before Robert Kennedy Jr. announced that he was on some to be created vaccine commission, the community has been hoping that Pres. Trump would do something about the vaccine problem, since in the past he has expressed support for the vaccine/autism connection.

Well, there’s no commission yet, and there’s not much going on in terms of presidental initiatives. But with him, you never know, and he could certainly take some game-changing action. Just don’t hold your breath.

The big unknown

I think it’s fair to say that so far, the medical board has acted deliberately, and even cautiously in dealing with the medical vaccine exemption issue. One settlement in two years, and that wasn’t even a case under the new law. Of course these cases take time, and two years from complaint to hearing is not a long time, especially if the parents don’t give permission for the release of the child’s medical records, which requires the board to go to court to get them.

So for whatever reason, we still don’t have any law or guidance about whether doctors who write exemptions for other than the labeled contraindications for each vaccine will be sanctioned by the board. What I can tell you is what you already know, namely, the standard of care for the majority of pediatricians is that there is basically never a reason to fully exempt a child from all childhood vaccination, and that following the labeled contraindications for each vaccine is the standard of care for exemption of specific vaccines, according to the speciality groups (AAP, AAFP, etc.) and the governmental agencies (CDC).

There is an argument to be made that there is another standard of care and if a doctor follows it, he/she shouldn’t be sanctioned, but my guess is that it’s going to take at least another year or two to get some board and court opinions on it.

And this just in

China is also having problems with vaccine manufacturing.

Here is a post about it which just broke today

My prediction

In the next two years we’ll get some governmental legal clarification about the contours of writing exemptions, but until then, frankly, we’re all just winging it.

Rick Jaffe, Esq.

Can a doctor recommend medical marijuana for a five-year-old in California?

Can a doctor recommend medical marijuana for a five-year-old in California?

That’s the question that will be answered in a California medical board case I am trying this week in downtown Los Angeles.

Back in 1996, California became the first state to allow for a doctor to recommend medical marijuana for patients with serious medical conditions. There was a lot of confusion initially as to what was required to issue the recommendation without getting into board trouble. The California law (called prop 215) by its terms granted physicians immunity from prosecution or even investigation based on their writing a medical marijuana recommendations. (Because it is a schedule I drug, it can’t be technically “prescribed.”).

Notwithstanding the immunity, doctors were prosecuted by the board for writing these recommendations. The administrative law judges, the medical board and the courts allowed for these prosecutions on the theory that if a doctor doesn’t follow standard medical procedure in making the recommendation, he or she is subject to discipline. To some it’s a very subtle distinction, but it does reflect the state of the law in California. Basically a physician has to go through the same kind of analysis and procedure to make the recommendation as he/she would for any other therapeutic recommendation. That means, a history and physical appropriate to the mental condition, informed consent, a treatment plan, follow up, and adequate medical records. Presumably, if the doctor does all that, then theoretically he or she shouldn’t be prosecuted or investigated, just because the treatment recommendation was medical marijuana.

Here are the facts of the case being tried this week

A father brings his son to see the physician. The father is a long-standing patient and has a prop 215 medical marijuana letter from the physician. He explains that the school has told him that his child is so disruptive they’re not going to let him back unless he’s put on medication. He is also disruptive at home. The physician examines the child, obtains history from the father, and observes the child for around 20 minutes, and then agrees to write the recommendation. The father signs a detailed informed consent, and the physician has typed medical record evidencing the history and exam, and states as the diagnosis probable bipolar/ADHD. (back in 2012 they didn’t have any better diagnostics possibilities)

The parents give the kid a small cookie with some marijuana in it before school each day.

miracle of miracles, the child is no longer disruptive in class and he becomes a model student. But it wears off towards the end of the day, so the school requests that the child receive a second dose after lunch.

The rub

The school doesn’t know the kid is on MM. The father naively goes to school and gives the teacher a MM cookie and asks that it be given to his child.

You guessed it!

The school freaks out, call the sheriff’s department, which opens up a criminal investigation of the father. It also calls CPS (child protection service) which obtains a temporary removal order for all four kids. The mother then takes the kids out of state, and the sheriff’s office pursues criminal charges against the father. The father sues back. Eventually, the family returns, the CPS order is dropped, and the father settles with his prosecutors. But there was a lot of collateral damage. The parents get divorced. The child has to be involuntarily committed for a few days because of rage and aggression (he hasn’t been on MM since it was originally given to him several years before his commitment), and he’s diagnosed with a newly established medical condition. All the kids and the father now live with his parents. The father is now being prosecuted for cultivation. The child is still on bad shape because the parents are refusing Ritalin or other drug therapy, and the doctor won’t write another MM recommendation.
(And by the way, the cops file a complaint against the doctor with the medical board.)

Those are some tough facts. Our experts think that all this harm was caused by the overreaction of the authorities. The Board of course blames the doctor. Neither of the Board’s experts appear to have any experience with small children (they are family practitioners) and neither think MM should be used for anything, because of insufficient peer review literature support.

We one of the country’s leading MM experts, Jeff Hergenrather, M.D. and a physician who ran the UC PACE program for physician training and rehabilitation. Doesn’t seem like a close case expert-wise.

There’s also the little matter that the case may have been filed 8 days after the statute of limitations expired. In fairness, I did spend some time resisting providing medical records (like over two years), but the statute of limitations is a harsh mistress.

Anyway, it should be an interesting case. If any of my friends happen to be in downtown LA this week, stop by: Office of Administrative Hearings, 320 West Fourth Street, Suite 630; Tomorrow (Wednesday) through Friday.

I’ll bring the popcorn!

Rick Jaffe, Esq.