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Author: Richard Jaffe

Five Things the FTC won’t like about Private Stem Cell Clinic Advertising and What it Can do About it

Five Things the FTC won’t like about Private Stem Cell Clinic Advertising and What it Can do About it

There have been some recent musings about what the FTC (Federal Trade Commission) might think about how the private stem cell clinics are advertising their treatments.

See https://ipscell.com/2018/12/upside-down-sometimes-wacky-fine-print-on-stem-cell-clinic-sites/

The post quotes advertising claims and disclaimers from a few of these websites and wonders what the FTC might think of this. I’m guessing the author already knows the answer, but for those who don’t, here are the five things the FTC is going to have a problem with any stem cell clinic employing the advertising/disclaimers commonly used by these web sites:

1. Lack of adequate substantiation for the claims and implied claims

Under FTC law, claims made by businesses (including medical businesses, to the extent the FTC choses to assert jurisdiction over them) require adequate substantiation. In the medical field that means that the claims have to be supported by well-controlled clinical trials. (Of course, FDA approval would do the job as well.) My guess is that at least initially and without a fight, the FDA wouldn’t think any of the autologous MSC/SVF claims made by the stem cell clinics have adequate substantiation, and hence the FTC would view all such claims and implied claims of efficacy as false advertising.

2. Use of testimonials

Most of these clinics use testimonials from successfully treated patients. The FTC doesn’t particularly like testimonials, and it thinks that disclaimers following testimonials that “results may differ” or that the “testimonial doesn’t imply success in your or any other case” are not usually adequate to negate the implied efficacy claim.

3. Lack of clear and conspicuous disclaimers

Most of the disclaimers in these web sites are at the end of the page, require scrolling down, and are in small print. From the FTC’s point of view, that’s a violation of its clear and conspicuous disclaimer policy.

(Here it is: https://www.ftc.gov/system/files/documents/plain-language/bus41-dot-com-disclosures-information-about-online-advertising.pdf

4. Disclaimers which are contradicted by the claims

The author points out that the there is an inconsistency between the claims made and the disclaimers. If the FTC agrees, that would also be a problem, especially as the claims are prominent and the disclaimers/caveats are not.

5. Based on all of the above individual problems, the FTC might well conclude that the overall net effect of these web sites constitutes false advertising, perhaps even if there was no clear and conspicuous disclaimer problem. The FTC is big on looking at the overall effect of a web site as viewed from the average person, and if it concludes that the overall effect is to make one or more therapeutic claims which is (are) not substantiated, then that’s a problem for the FTC which becomes a problem for the claim-making clinic.

So, what can the FTC do about it?

We’ve seen one example already, where it forced a settlement from a stem cell clinic.

What happens if an offending clinic doesn’t settle?

The FTC has two options. It can bring a federal injunction lawsuit in the district in which the stem cell clinic operates. Second, and the preferred approach seems to be to bring an administrative action in Washington, D.C. before an FTC employed administrative judge. All these FTC judges do is apply FTC law to businesses which other agency employees have determined has violated FTC law. Let’s just say that for a litigator (and a client) it’s not the best possible forum. Practically what that means is that if you’re in an FTC administrative proceeding and what you’ve done is in violation of an FTC guideline, you’re going be found in violation of FTC law, enjoined and probably fined.

So, what does all this mean for the private stem cell community?

The bad news for the clinics is that FTC cases are much easier cases to pursue than FDA cases, since they don’t require a week or two site visit by multiple federal investigators. It can all be done by FTC investigators at their desks. The good news for the clinics is that the FTC, like the FDA has limited resources, and heretofore, medical clinics have not been a FTC high priority, and I sort of doubt that will change in a big way, because they have overlapping jurisdictional authority with some other government agencies which have more direct and obvious oversight, like the FDA, medical boards and the consumer fraud divisions of the state attorney generals offices.

I’m curious why all these agencies haven’t sat down together and figure-out and implement a comprehensive approach and prioritizing to the private stem cell clinic issue. That’s what I’d do. Or maybe it’s coming. We’ll see.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

The free pass given by the federal and state authorities on private stem cell clinic’s publicly professed exuberance (aka web site advertising) is coming to an end.

By early 2019, I expect both federal and some state regulators to bring lawsuits and/or announce settlements with more than a few private stem cell clinics, many of which are affiliates of the two stem cell networks which are currently defendants in the FDA injunction lawsuits in California and Florida.

Having looked over a web site or two, it might be time for you folks to rethink your marketing strategy. The authorities have a different and quite technical view of what constitutes false advertising and what constitutes substantiation of actual and implied claims. And don’t even get me started on their view on implied claims. It’s not to be believed.

It’s the end of the year and now would be a good time to implement a correction plan for advertising which is likely to be viewed by the authorities as deceptive trade practices, for a couple reasons. First, of course it’s always to better to comply with what the authorities think is the law, which is better than having to duke-it-out with the authorities in an injunction action brought by the FDA/FTC or the state’s attorney general office, because it’s not really a fair fight. There might be arguments to be made in defense of some commonly made stem cell claims. However, per the above, the best choice is not to have to make them.

Second, there could be medical board implications for physicians who consent to or have a judicial finding of false advertising. That opens-up a whole other front, and who needs that!

In short, now is a good time.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

A few days ago, the big dog blogged that a San Diego TV station was reporting that the Medical Board of California (MBC) has announced its intention to form a task force to “investigate” private stem cell clinics, presumably following the Federation of State Medical Board’s (Federation) report on the subject.

Here is the post:
https://ipscell.com/2018/11/medical-board-of-california-task-force-to-investigate-stem-cell-clinics/

The intended or unintended implication is that all these clinics are about to be shut down by the MBC. But let’s take a breath.

What effect does this MBC proposed action actually have?

Short term: None. Task forces take time, even non-government task forces like the Federation’s stem cell task force took a year, and all it did was produce a relatively benign report.

It’s way more complicated when a state agency wants to study something, because the end result could change the law, create a new regulation or prompt agency action. Implementing a state agency’s task force’s recommendations requires either a new statute passed by the legislature, or an agency approved regulation, policy statement or guideline (like the compassionate use medical marijuana guideline). Anything substantively new by a state agency requires a lengthy administrative process involving input from the stakeholders and the public at large, through public comment and/or hearings. And that takes a lot of time and effort.

So, like I said, in the short term – say a year or eighteen months (at the very least) – I don’t see any change in the MBC’s practices resulting from its announcement that it will be setting up a task force to study/deal with the issue.

What could the MBC do after studying the issue?

A possible answer might come from the Federation’s 11 recommendations contained its task force report.

(Here is a pdf of the entire task force report. The recommendations start on page 10)

fsmb-stem-cell-workgroup-report[1]

The Federation’s first and main recommendation

The Federation’s first and central recommendation relates to the core issue in the private stem cell clinic model, namely the lack of clinical trial evidence supporting the efficacy of stem cell intervention for the conditions promoted/treated.

The Federation’s recommendation relating to this core issue is that there be a “appropriate rationale” or a “basis in theory” to use the “unproven” therapy and that unproven stem cell therapy should only be given when “proven treatment modalities have been exhausted.”

There are many facets and complexities to this recommendation. For example, the notion of “proven” modalities is a vast oversimplification of the state of medical knowledge in many serious diseases. Many “proven modalities” are not curative. For example, many cancer chemotherapeutic agents are only “proven” to extend median survival by a clinically insignificant period of time (like six to eight weeks), or provide no increased survival, but only have a proven palliative benefit. (Don’t even get me started about how cytotoxic chemotherapy gets approved based on evidence of palliative benefit.) Risperdal may be a standard of care treatment for autism, but it’s not a cure, it just suppresses some of the symptoms (and usually causes side effects as bad or worse than the behavior it’s meant to supress).

Nonetheless, in some sense, the Federation’s recommendation that “unproven” stem cell therapy only be used after proven modalities have been exhausted will be easy to satisfy by the private stem cell industry. Most of the patients who go to private stem cell clinics have incurable chronic conditions or fatal diseases which are refractory to other forms of treatment. There is no cure for MS or autism, and many MS patients and some autistic kids receive stem cell treatments for their conditions. Anecdotal evidence and solid theory supported by pre-clinical studies about how stem cells can affect some of these serious and terminal conditions likely supply the rationale for treatment under the Federation’s recommendation.

Many of the Federation’s other recommendations are innocuous, like raising awareness among physicians about the state of the law on stem cells, making sure physicians and patients engage in “shared decision-making,” making sure physicians don’t charge excessive fees (good luck with that, since boards don’t normally get involved in the cost of medical services).

There is a recommendation that medical boards review stem cell advertising claims and pursue false advertising physicians. That might be a good idea, but probably not practical since most boards are underfunded and investigations are complaint driven. There are not yet board investigative departments which search out false advertising by physicians. Maybe there should be, but I just don’t think that’s going to happen. So I think anti-private stem cell clinic forces are going to have to find another way to have the boards go after the stem cell advertising doctors.

An obvious recommendation was that the medical boards monitor FDA warning letters and investigate those involving “unscrupulous and unprofessional practices” relating to providing stem cells. The problem, as I’ve oft stated in prior posts, is that the the FDA doesn’t have the resources to do more than a couple of warning letters in the stem cell field in a given year. So, if the anti-private stem cell folks were looking to this recommendation to dramatically curtail private stem cell clinics, they will likely be disappointed and will have to figure out a work-around.

In short, my opinion is that the Federation’s recommendations, even if implemented in toto by the MBC, are not likely to slow down the proliferation of the private stem cell clinics. While there might be some things which the MBC could do to stop or slow them down in California, it’s going to have to do more than just adopt the Federation’s recommendations to get the job done.

Like what you ask?

Well, that’s not my job, so I’ll let the smart and competent people working at the Medical Board and the Attorney General’s office figure out what they can and should do to implement its task force’s recommendations. However, that will be many moons from now, and that is a long time in the stem cell world. By that time, I think other things are going to happen, both to the good and bad in terms of regulatory enforcement and developments in standard of care.

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffesquire@gmail.com

Private stem cell clinics should start worrying about some new regulatory players

Private stem cell clinics should start worrying about some new regulatory players

Up until very recently, the FDA has basically been the sole regulatory threat to the private/for-profit stem cell clinics, via published guidance documents, site inspections, warning letters and the recent federal civil injunction cases against the two biggest stem cell operations.

See my posts about the status of these cases at:
http://rickjaffeesq.com/2018/09/26/update-on-fda-injunction-cases/

As an aside

It’s no coincidence that the defendants in both of these injunction cases have many dozens of so-called “affiliate” stem cell clinics throughout the country. Both operations offer training, start-up expertise, as well as sell supplies and equipment to the affiliates. Creating an almost McDonald’s-like business model for the delivery of what the FDA contends is illegal stem cells has to make the FDA very unhappy. It’s going to be interesting to see what happens to these affiliates after the conclusion of these two cases, (but more about that later).

Apart from the FDA, some new regulator/players have recently surfaced. The FTC recently hit one stem cell clinic with a huge fine. The FTC regulates commercial advertising, and I would expect it to get more involved in the stem cell field for two reasons: First the FDA doesn’t have the resources to control/eliminate the private stem cell field. It takes too long and it’s too manpower intensive to go through the process of site inspection, warning letter and injunction lawsuits. They are just too many clinics out there. In contrast, all the FTC has to do is review web sites from the comfort of its local offices, send out letters requesting adequate substaniation for the claims and implied claims, and when it doesn’t show up, swing its big regulatory stick.

Second, to my mind, the real problem in the private stem cell field is not actual danger/harm of the procedure. As I explained in another post, there are surprisingly few serious adverse events from stem cell transplants.

See: http://rickjaffeesq.com/2018/08/09/some-perspective-on-private-stem-cell-clinics-and-the-fdas-response/

The real problem is the unsupported advertising claims made by some of the clinics. But commercial advertising is not really the FDA’s bailiwick. Furthermore, I think the FDA’s regulatory jurisdiction over any autologous, same day surgical procedure is questionable under the existing regulations and for public policy reasons, and its interpretation of the regulations are unclear, and not in accordance with scientific and medical practice realities. Under the right set of circumstances, I think the courts would give the FDA some pushback on its assertion of jurisdiction over these procedures and its interpretation of the regulations, but unfortunately, the two existing lawsuits are not the right vehicles to make the case.

Be that as it may, the FDA is still fundamentally ill-suited to be the sole or even the primary regulatory authority reigning in the stem cell wild west, (which as I continue to argue, is or should be primarily a state law medical practice issue). I predict that some new players will publicly surface soon, and that would be state agencies, particularly in the big stem cell states like California and New York (and probably Florida as well). It’s already quietly happening now in California and New York. I can’t say much publicly about either state because of ongoing matters, but clinics in those two states should watch out! What I can say is that I expect some states to scrutinize the claims made by the private stem cell clinics, and see how they line-up with state law, and if they don’t, then I would expect to see some state agency press releases about settlements or filed lawsuits. Some of these settlements or lawsuits may impact the clinic owners beyond the four corners of the state action.

Circling back to the FDA’s two pending injunction cases and the “affiliates” of the defendants, has anyone noticed that in the complaints, the FDA seems to be lumping the affiliates together with the named defendants? What’s that about? I’ve got my suspicions, but we’ll have to wait to see what happens after after the district court judges issue the injunctions.

So here is my prediction about the stem cell field in 2019

Between the two federal injunction cases which I expect to be resolved mid-2019, the regulatory responses resulting therefrom, and the new regulatory players who will surface in the next few months, the stem cell regulatory and enforcement landscape this time next year is going to look very different and more challenging to these clinics than it is right now.

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

Cali. Medical Board is Closing in on Vaccine Exemption Writing Physicians

Cali. Medical Board is Closing in on Vaccine Exemption Writing Physicians

Several vaccine writing California physicians are now under investigation by the California Medical Board. By that I mean that the Board has issued subpoenas to obtain the medical and/or school vaccination records of kids who obtained vaccine exemptions from these physicians. In some cases, the Board investigation is a result of a complaint filed by a parent (usually in a divorce situation where one parent is pro and the other is antivax/vaccine concerned) or by an HMO which acts as the child’s PCP. In other cases, the Board has issued a subpoenas to a school district to identify physicians who have written vaccine exemptions.

In terms of the Board’s ability to obtain patient medical records, the state of the law is that despite the California constitutional right to medical records privacy, in recent times, the California courts have consistently granted the Board access to patient medical records over the patients’ objection.

My view is the fight to protect patient medical records from Board disclosure is basically over in California (except for psychiatric records which are covered by a specific evidentiary privilege which has a higher burden of proof than regular medical records). That brings California in line with pretty much every other state in the country which requires a physician to comply with a board subpoena for medical records, irrespective of the patient’s wishes.

I have no doubt that in all of these investigations, the Board will obtain the medical records of the specific children who are subject of the Board subpoenas.

What will the records reveal? My guess is that in almost all cases, vaccine exemptions were given to healthy children who have a family history or genetic disposition to serious autoimmune conditions. The family history or specific genetic abnormalities, according to the exemption writing physicians, make these children susceptible to severe adverse effects from any and all childhood vaccines, and justify an exemption from all childhood vaccines for some period of time. (This is a distinct minority view at this time).

So, what’s going to happen with these investigations?

(I can speak with some authority because there has only been one Board case, and I worked on it.)

First, after the medical records are reviewed by a Board consultant, the physician will be “invited” to a recorded interview to answer questions from the consultant, the board investigator and the Deputy Attorney General assigned to the case explaining the rationale for the exemption.

(I would advise the physician to be very well prepared for the interview because as the saying goes, “Anything you say will be held against you in a court of [administrative] law.”)

The medical records and the recorded interview will be submitted to two outside medical experts. Both will be pediatricians (if the physician is a pediatrician), and one will be an infectious disease sub specialist. The Board likes to use UC affiliated physicians for added gravitas.

Both will conclude that the exemption was not medically indicated because in essence, there is no medically valid justification for a blanket vaccine exemption for a completely healthy child. Rather, there are specific vaccine contraindications based on each vaccine’s labels, according to the CDC, APA and a bunch of other entities involved in the vaccine issue (to put it neutrally).

Within 60 days from the Board’s receipt of the second expert’s report, an accusation (California term for medical board complaint) will be filed against the exemption writing doctor.

At some point the physician will either fold and accept a stayed revocation/5-year probation or the case will be tried before an administrative law judge who will issue a proposal for decision which proposal will then be reviewed by the Board.

When will this all happen?

My guess is that the accusations against the doctors currently being investigated will be filed by early to mid-2019. At least one of the cases (hint, the one I’m involved in) will go to hearing by late 2019, making the Board’s decision in late 2019 to early 2020. The board has a few months to consider the ALJ’s proposed decision. At that point, the vaccine concerned community and the exemption writing physicians should have an idea of whether these vaccine exemptions will be allowed or are Board disciplinable offenses.

It’s going to be interesting, and there will be some surprises, I promise!

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

MD/DC Clinics and “Fraudulent Incorporation”

MD/DC Clinics and “Fraudulent Incorporation”

It’s been some time since I’ve lasted written about MD/DC clinics and how they can turn into fraudulent operations. Here are two of my last couple of articles from Dynamic Chiropractic.

https://www.dynamicchiropractic.com/mpacms/dc/article.php?id=46387
https://www.dynamicchiropractic.com/mpacms/dc/article.php?id=46096

In the last few years, there has been an uptick in federal criminal prosecutions and insurance company lawsuits against medical clinics alleged to be controlled by someone other than the MD clinic owner. So it seems like time for an update by me. Having been involved in this field for almost thirty years, my take is that while some things have changed, the important things, in terms of the method of operation and the government and insurance companies’ response really haven’t changed in any legally significant sense.

For instance, in the old days, some chiro consultants found the MD to act as the MD professional corporation owner. In one well-known and egregious case, an MD was the paper owner of several dozen different clinics in several states. The carrier sued one of those clinics, the MD, the chiro consultant, and (gulp) the lawyer who taught the model and set it up. The case lasted almost twenty years, (ending just last year), and resulted in a large judgement against the consultant and attorney. I may give my take on that case in another post but here is the case:

https://law.justia.com/cases/new-jersey/appellate-division-unpublished/2015/a0636-12.html)

I think the days of one MD being the paper owner of so many clinics may be over. In the current illegal MD/DC iteration, the MD rubber stamp might only be involved in one medical practice. But, a rubber stamp, or a rose by any other name . . . .

In the old days, there was a lot of classic insurance fraud at some of these clinics, like unnecessary services, up coding, unbundling, and improper “incident to” billing. Maybe and hopefully that’s been cleaned-up, in some cases at least. However, the carriers still scrutinize MD/DC clinics and other alleged nominal physician controlled clinics because they have this crazy idea that the chiropractors or non-physicians are actually running them. The carriers have gone after some of these clinics based on a “fraudulent incorporation” theory, even if all the care provided is medically necessary and there is no specific fraudulent billing. (That’s a big Gulp!)

This fraudulent incorporation theory goes to the heart of the MD/DC model, the model being that through corporate interrelationships, management and other business service agreements, the money generated by the medical clinic finds its way to the chiropractor in the MD/DC venture (or to the non-MD business people who control the clinics).

In these clinics, the money needs to go first to the medical clinic (i.e., care is billed through the medical corporation) because of carrier imposed restrictive limitations on chiropractic, or because there are now entire areas of insurance reimbursed care which have to be provided by a physician-owned entity, like New York no-fault accident law medical care.

But that aside, the ultimately reality is that there’s a lot of money in medicine, and chiropractors (and regular business folk) try to get in on the action. The MD/DC clinic was largely originialy developed (in my opinion) to do just that, and business people created similar corporate structures to achieve that goal also. I’m not saying they all are illegal, but what I will say is that it is viewed as a problematic business model which sends up red flags to prosecutors and insurance companies.

It’s interesting to see how this fraudulent incorporation legal theory evolved and metastasized from the state civil insurance law to federal criminal law.

Follow me here:

In the early 2000’s, State Farm filed a federal civil action in New York seeking a ruling that it didn’t have to pay no-fault accident claims from a few related medical clinics because supposedly the medical clinics were fraudulently incorporated. The allegation was that two businessmen hired physicians to act as the nominal owner of the clinics, and that these two non-physicians actually ran the clinics. Of course similar allegations had been made against MD/DC clinics in criminal cases in which there had been classic insurance fraud as evidence of the overall fraudulent scheme.

Significantly and chillingly, State Farm didn’t claim that the care rendered was medically unnecessary or improper, and it didn’t even claim that the care was rendered by someone not authorized to provide the treatment. In short, there was no allegation that there was anything wrong with the care. Rather, the claim was that the medical corporation was a sham because the corporation’s medical business wasn’t run by the physician owner, but by the businessmen. Because of that, State Farm argued that it didn’t have to pay for any of the care. (It’s a very creative argument. You have to love these insurance companies. I know I do.)

The federal district court dismissed the case, holding that State Farm had to pay the claims so long as the providers who rendered the case acted within the scope of their licenses. Well that seems like a logical and pretty reasonable approach to me. However, State Farm appealed to the federal Second Circuit Court of Appeals.

The clinics argued that the formalities of the clinic ownership was all that mattered. The law requires that a physician-owned clinic had to provide the care, in fact a physician owned the corporation and the corporation provided the care, so that’s it, end-of-story.

State Farm argued that the business men’s actually running the medical practice violated the corporate practice of medicine doctrine (“CPM,” which prohibits anyone other than physicians from practicing medicine). According to State Farm , the CPM violation meant that all the claims were fraudulent and it didn’t’ have to pay anything. Because it was an unsettled issue of state law, the federal appellate court asked the highest state court in New York to decide (confusingly called the Court of Appeals, and just to make it more confusing, the trial courts in New York are called the “Supreme Court.”)

The question asked was whether an allegedly fraudulently incorporated medical corporation is entitled to be reimbursed by insurers. The Court of Appeals answered no. The Court of Appeals then ruled that the CPM doctrine prohibits a non-physician from owning or controlling a medical corporation, that technical ownership was not sufficient, and that the realities, not the formalities determine whether there has been a CPM violation, and if there was a violaiton, then the clinic is not entitled to be paid anything by the carrier.
That’s a tough decision, given that there was no allegation of improper billing or improper medical care.

Although the actual owners of the clinics were not chiropractors, the case still impacts them, because the operative legal point is that under a fraudulent incorporation theory, it doesn’t matter if the actual owner is a layman or a health care practitioner other than a medical doctor.

The problem is that the owner isn’t a medical doctor, and that care is billed under the medical corporation’s name which in reality is controlled by a non-physician. That is (or could be) illegal in states which have a CPM doctrine and limit certain kinds of care to physicians, And while the case only deals with New York no fault law, I think it would apply, at least to any case where care has to be or purports to be delivered by a medical practitioner, or so the government will argue.

So at least from the time of this case (State Farm v. Mallela, 794 N.Y.S. 2 700 (2005)), insurance companies have had this weapon against MD/DC clinics in New York, even if all the care was medically necessary and successful. And, for better or worse, this case has garnered respected and precedential status throughout the country, even though it only technically interprets and applies to New York law no- fault insurance law.

Therefore, in any state which has a CPM doctrine and limits or excludes chiropractors from some form of reimbursed care like no-fault, or limits chiropractic care, or reimburses at a lower level than physician reimbursement, this case is a possible weapon against an MD/DC clinic which provides care to classes of patients or injuries which have to be provided by a medical corporation. After this case, a number of other civil cases in New York were filed against similar run operations, many of which clinics specialized in no-fault.

The next big thing is what happened to a medical doctor who rented out her license to a couple of business folk for 1500 bucks a week. Two businessmen had set up a number of medical clinics to provide medical care to accident victims under New York no fault. They hired physicians for $1500 per week to be the nominal owners of the medical corporation providing the services. Eventually Allstate’s SIU (special investigative unit) zeroed in on these entities and had the medical doctor owner submit to an examination under oath about her role at the clinics. She falsely testified about her role, and claimed to have seen patients which Allstate knew she hadn’t.

The SIU turned the case over to the US Attorney’s office and several dozen people were indicted, including the physician. The doctor wanted the jury instructed that “ownership” is limited to who is the technical owner of the medical corporation’s stock. The district court rejected the request and gave the economic realities view in State Farm v Mallela. The physician (and all the others) were convicted of health care fraud and conspiracy to commit heath care fraud. The physician appealed, and her main argument was that her formality of ownership jury instruction was not given, and it was error for the judge to give the broader, economic realities instruction. Needless to say the Second Circuit rejected her argument and affirmed her conviction. The case is U.S. v. Gabinskaya, 829 F.3d 127 (2nd Cir. 2016).

Here is a pdf of the decision: United States v. Gabinskaya, 829 F.3d 127 (2nd Cir., 2016) (1)

Again, even though the case doesn’t involve chiropractors, and is limited to New York no-fault, it, and the cases it cites and cases cited by it will be used as guidance and precedent by federal prosecutors as they view MD/DC clinics, at least as a legal basis for rejecting the notion that corporate formalities offer some immunity or insulation against fraud prosecution against MD/DC clinics.

The basic lesson of these cases is that economic and business realities determine whether these type of operations are (or can ever be) legal. Some of the cases set forth 13 factors which establish substantial control over the medical corporation (which places the operation into federal felony land), but ultimately it’s going to come down to the facts and circumstance of each operation. My hunch is that not a lot of these operations will be on the good side of the law, but I’ll give my analysis of these factors another time.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

Do you have ED? (not the guy thing, but rather endocannabinoid deficiency)

Do you have ED? (not the guy thing, but rather endocannabinoid deficiency)

The absolute best part of my job is that I get to work on really interesting medico legal issues, interact with very smart experts who know their stuff.
In July, I tried a California medical board case for a doctor who recommended medical marijuana to five-year-old who was having severe mood disorder problems at home and school. The doc saw the patient back in 2012, before the CBD oil explosion, and it was also back when the closest diagnosis for this kind of behavior was ADHD/bipolar, even though bipolar wasn’t normally diagnosed in children that young. In part based on the recognition of this diagnositic conundrum, and other similar problems, in 2015 the American Psychiatric Association in the DSM-V made up a new label for kids who had chronic or episodic mood disorder, and named it disruptive mood dysfunction disorder (DMDD). But that’s not the interesting part.

One of our experts was a leading practitioner/expert on medical marijuana, Jeff Hergenrather, who is the head of the California medical marijuana physician group, a researcher, extremely knowledgeable on the subject, and an all-around good guy.

The Board’s experts testified about all the harm that marijuana could cause children. In many of my cases, I use what I call a fractal defense, meaning, I go a quantum level deeper than the other side, like a different fractal level of magnification. I felt this would be a good case to go deep, so I had Jeff explain to the judge the endocannabinoid system and how it functions. I thought it was incredibly interesting, important, and it’s something which most layman and even most conventional physicians don’t know anything about. So I thought it was worthy of a post.

I can’t put it any better than Jeff did in his testimony, so for all those wondering whether they have any ED (endocannabinoid deficiency) disorder, here’s what it is:

“BY MR. JAFFE:
Q Doctor, in your opinion, based on your years of experience using cannabis, is it generally a safe medication?
A Yes. It is remarkably safe.
Q What kind of information or explanation would you need to give to the Court in order to explain your opinion that cannabis is a generally safe medication? What type of explanation, I’m asking.
A I would want the Court to understand that this is a — cannabis works in our bodies in a system in the body, augmenting a natural system that’s already there.
Q What’s that system called?
A That system is called the endocannabinoid system.
Q What is the function of the endocannabinoid system? And you’re saying in humans?
A Well, it’s not only in humans. The endocannabinoid system is seen throughout the animal kingdom, so it’s seen — probably excluding insects, but it’s seen all the way into the oceans, in primitive creatures, hydra, sea squirts, and when you look at the genes of these animals, you can see that they have an endocannabinoid system. The system is there to bring the body into balance, to modulate the body, to help it to come into balance. So it’s really what fits the word homeostasis. The endocannabinoid system brings us into homeostasis.

Q What are the components of that system, physiologically?
A It’s based on a receptor, which is like a socket, and molecules that fit in that socket called the endocannabinoids. So these are small molecules that fit into the protein receptors. These receptors reside in two areas of the body. One is in the brain and in the nervous system and the other is in the immune system. So wherever they are in the body and in the — in the brain and in the immune system, they modulate the way that these systems work.
Q “Systems” meaning what system?
A The nervous system and the immune system. They modulate the way these systems work in the bodies, so they bring them into balance. Otherwise, the body would tend to go haywire, literally, overactivated if you get nervous, and the nerves can’t turn off again. Then you burn up nerves. You literally damage the nerves. So the endocannabinoid system is there to protect the body, to protect the brain, and to protect and modulate the way the immune system works as well.
So it’s a very key system. It’s been evolving along for — it’s thought to be for 600 million years along with the evolution of all these sea creatures through the animal kingdom, the amphibians, and the reptiles and the mammals. We see this system in these animals and we know that the natural cannabinoids are responsible for bringing that system, that body, back into balance.
So its main roles are to help us eat and to sleep and to relax, which is both mental and physically relaxing, and to forget in a helpful kind of a way, but it does have a role in helping forget or — I’ll talk more about that — and to protect, and the protective role is very interesting because there are mobile endocannabinoids in this immune system that are circulating cells and they are going around the body looking for problems, either abnormal cells or cells that are cancerous, and when they come upon them, they program the cell death of those cells and rid them from the body. So they’re key to the health of an organism of a human, to have a healthy endocannabinoid system working in the body.

Q And from your answer, just to be clear, because this is like a physiology thing, the body — you’re implying that the body produces these endocannabinoids?
A That’s correct. These are molecules that are mimicked by the cannabis molecules, so we know of THC and CBD. There’s some molecules we hear about in the press. There are actually over a hundred cannabinoids in the cannabis plant and these cannabinoids are uniquely similar, almost identical, in shape to the natural endocannabinoids.
Q Produced by the body?
A Produced by the body. They’re produced on demand as a response to a stress, as a response to something needing correcting. And so the natural cannabinoids are produced, they activate the receptors, they bring the body back into balance, and then they’re broken down again.
So here’s cannabis that comes along. The same shape molecule from the cannabis plant fits into these receptors and in being there, in activating these receptors, we’re augmenting the natural cannabinoid tone of the body and in this way we’re helping the body to come back into balance.
Q What you call homeostasis?
A What I would call homeostasis.
Q Why — if the body produces these natural cannabinoids that fit these receptors, why would you ever need to what you call augment the system?
A Perfect question. The reason is that not all receptors are the same. The cannabinoids are the same we think between all animals and humans, but these receptors are a little bit different. The ones in the brain are 472 amino acids long. It clumps into a socket. The ones in the circulating cells are 360 amino acids long, a little shorter, but they’re the mobile ones and they go floating around the body in the bloodstream.
So these receptors, with one change of an amino acid, you can measure that this endocannabinoid system isn’t working as well. So many human conditions are now being recognized as endocannabinoid deficiency syndromes.
Q Really? Like what? What kind of conditions now do you think are —
A Migraine, fibromyalgia, M.S., mood disorders.

Q How are they recognized? Because that’s relevant to our case. Talk about how mood disorders are now becoming recognized as an endocannabinoid —
A Deficiency.
Q — deficiency.
A This is simply because we can see in the genes that these are not the same from person to person. There was a clever test done by a Japanese researcher called Matsunaga a few years ago and he looked at — he tested people for happiness and he gave them a questionnaire and those that tested very happy in their outlook on life, he looked at their genes and they all have the same endocannabinoid genes, a similar polymorphism, a similar shape of their cannabinoid receptor.
Similarly, we’re able to look at the genes with people with depression or other mood disorders and these other diseases that I’ve spoken of and many, many others and we can see schizophrenia as well is one of those conditions considered to be an endocannabinoid deficiency.
So by augmenting the natural system, we’re basically helping the body to bring itself back into homeostasis where it’s having a hard time doing it with its natural receptor and cannabinoids.

Q Okay. So let’s tie this in. How does that explanation of our endocannabinoid system and the lock and key, how does that help the Court understand your testimony about why cannabis is a relatively safe drug? So tie it up and then we’ll move on, because I’m sure the judge is going to want to move on.
A Sure. Well, we’re looking at — we have a situation here where the body is in need of coming in to balance and so in mood disorders and anxiety disorder, it just — a person tends to be anxious. In PTSD, you tend to dwell on aversive memories; in depression and so forth, there’s a tendency in various mood disorders to not be able to really recover very well and so we see family histories of mood disorders. The same family will have depressive disorders. The same family will have anxiety disorders or bipolar disorders and so forth.
We see that in the families and now we’re actually able to look at the genes of these people and understand this in a different way, in a better way. So these molecules and cannabis mimicking the natural cannabinoids are, in fact, bringing us into balance and helping to cure these — not cure, but to pharmacologically improve the situation for these — for these individuals, and we really — the clinicians doing cannabis medicine see this every day and it’s very impressive to be able to use cannabinoids and modulate these diseases and bring them into control with an herb.
So it’s rather remarkable. These aren’t synthetic molecules which have proven to be dangerous. They’re plant cannabinoids. They’ve evolved along for -¬the cannabis plant has supposedly been on earth for 60 million years. It’s been around and been used by human beings for probably 100,000 years, maybe 5,000 where we actually have evidence of it in the literature, but this plant has been used for many, many years, eons as far as a plant that seems to have gained a great deal of use and a degree of safety that is rather remarkable.
It’s only in the synthetic molecules that are manufactured that we actually see problems where people get into trouble and even have died with synthetic molecules.

Q Does this explanation shed any — do you have an opinion as to whether medical marijuana cannabis is safer than psychoactive drugs or is that a reasonable question?
A It is a reasonable question and, quite honestly, I have people coming to me because they have tried conventional drugs and the side effects have just been horrible and they don’t want to continue use of those drugs.
Q Okay. I’m going to ask a more refined question now, is there something in the explanation in terms of the biochemistry that you just explained that would lead you to conclude why cannabinoids natural would be inherently safer than antipsychotics or stimulants or Ritalin? I mean, what about your explanation might help explain the fact that — I don’t know — an earlier witness said that it’s a safer drug than some of the other antipsychotics, because now we can get to the biochemistry as you explained and tie it in all together, briefly, very briefly.
THE COURT: Can you do that?
THE WITNESS: I think I can do that.
THE COURT: All right.
THE WITNESS: Well, from the side of the question of
pharmacologic drugs that are very commonly used, many of them, especially in the antipsychotic division of these drugs, have boxed warnings on the drugs.
BY MR. JAFFE:
Q Black box, you mean?
A Black box warnings. They are in some cases dangerous drugs that may result in deaths and that’s why the black box warning is there. These are drugs that commonly have fairly significant side effects. They’re not tolerated by people very well and at least in my patient population, which is to some degree self-selected because they want to come and see if cannabis will work, they’ve tried conventional drugs and they’re not working. They are looking to cannabis to see if this herbal medicine can modulate their mood disorder, their mental disorder, and keep them from needing conventional drugs.
And quite honestly, this is a mix in my practice. Some people use cannabis only, quite successfully, and other people rely on both cannabis and conventional drugs to be able to maintain a good mental health. So it’s not necessarily going to work in everybody. Some people don’t like the feeling of using cannabis as a medicine, so they’ll move along and try something else.

Q Okay. And unless there’s some other thing I missed about the biochemistry in all this stuff, I’m going to move on. Do you think I’m —
A Briefly, we all hear about neurotransmitters such as dopamine and serotonin and adrenalin. These are common neurotransmitters in the brain. What the cannabinoids are doing is they’re modulating all of the neurotransmitter systems in the brain. They’re there as a retrograde messenger in the synapses of the brain to calm the system down.
So if in — let’s say in an anxiety, for example, if the nerve impulses are firing away and you’re very anxious, cannabinoids have an ability to turn this neurotransmitter down or off to where it relieves the anxiety or whatever the problem is. It can be a movement disorder where dopamine is involved. It can be a mood disorder where serotonin is involved. It can be an anxiety neurotransmitter where adrenalin might be involved. In any of these neurotransmitters, the cannabinoids are there to modulate the way the brain works and so it’s good across the spectrum of many diseases as an effective and safe medicine.
Q And does that, what you’re talking about, have anything — make it more or less likely that the cannabis would alter the brain chemistry or the personality of the patient? Is that a relevant — is that related in any way?
A Well, it is related but in a way that I think I should make a comment about because since we know that these cannabinoids in the plant can turn the brain down a notch to bring it into balance to down-regulate it to reduce the neurotransmission, it has an effect on the brain.
Q Okay.
A There’s no question about that. It does alter the brain while those molecules are active in the system and once they’re metabolized — in the case of most of these molecules, they’re largely metabolized when they’re inhaled over the course of three hours and when they’re ingested, they’re metabolized over the period of about eight to ten hours — and then the effects may linger for a few more hours or even a few more days before they’ve finally worn off, but then the brain goes back to its natural state, unaltered, by having had these plant cannabinoids.

Q Okay. Let’s zoom in now on that issue but on kids because the patient in this case was a child and there’s been discussion about how this cannabis can harm the patient. Let’s continue just on the biochem- — the physiology and biology and the receptors. What effect -¬how does — is there increased risk of harm in cannabis in light of the fact that it’s a child and, if so, what’s the harm or what’s the reason there is no harm? Because that’s really what we’re talking about in this case, because there’s been testimony about some of these issues.
A I see. Well, in a word, it is not a harmful substance. Just in a one phrase, it is not a harmful substance. Granted, it’s not for everybody, but it does not harm the brain. It alters the brain while the active molecules are there, but it doesn’t harm anything.
Q How about in kids? What’s the basis, a biological basis, of you’re thinking it wouldn’t harm kids? Doesn’t it kill receptors or something like that?
A No, it actually doesn’t. It does articulate with the receptor. It activates the receptor. It increases the natural cannabinoids to work better for the
Q Do children have as many of these receptors, these ethno — endocannabinoids?
A They’re born with fewer —
Q Do children have as many of these receptors, endocannabinoids receptors?
A They’re born with fewer and through the earlier years of life, these cannabinoid receptors in the brain increase in population. When we use cannabis as medicine, this population of receptors diminishes in response to having this added load of natural — of plant cannabinoid.
Q Isn’t that a bad thing?
A No, because the cannabinoids that are there as plant cannabinoids and natural cannabinoids are providing a better ability to respond to whatever the stress is.”

I think this is pretty interesting stuff, especially considering all the kids who are being diagnosed with hyperactivity and more serious emotional/behavioral problems. I hope the explosive growth in the CBD field leads to research or at least publication of case studies of kids successfully treated with CBD or cannabis for their serious behavioral issues. Imagine a world without having millions of kids on Ritalin and other similar drugs.

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

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:

http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases”>http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases”>http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases

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:

09261800

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.

mendal

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 clinicaltrials.gov to promote their clinics via patient funded clinical trials, per a recent post by the big dawg. https://ipscell.com/2018/09/fda-outlines-potential-crackdown-on-clinicaltrials-gov-offenders/

(And for the record, I don’t have a problem with the feds restricting clinicaltrials.gov 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.
www.rickjaffe.com
rickjaffeesquire@gmail.com

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.”

RAJ

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)

http://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5cDIDOCS%5c20180803%5cDMRAAAGL7%5c&did=AAAGL180803175758274.DID

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.

http://www.latimes.com/business/la-fi-doctor-hormones-disciplined-20180912-story.html

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

https://www.prnewswire.com/news-releases/dr-prudence-hall-responds-to-news-story-regarding-state-board-settlement-of-dispute-300713238.html

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.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

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.
www.rickjaffe.com
rickjaffeesquire@gmail.com

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.

RAJ