Browsed by
Category: Stem cells regulation

stem cell mis-regulation

The Private Stem Cell Field Moves On; Maybe This Time They’re Be Smarter or More Cautious

The Private Stem Cell Field Moves On; Maybe This Time They’re Be Smarter or More Cautious

With the recent Summary Judgment decision in the US Stem Cell case, my prediction is that the fat-based stem cell business will slow down and eventually cease to be a thing.

Here is the judge’s decision
http://rickjaffeesq.com/wp-content/uploads/2019/06/USRM-lawsuit.pdf

Lawyers will tell potential entrants into the field that a federal judge has held the use of autologous fat-based products to be illegal, at least pending and barring a different result in the FDA’s companion case in California. However, I do not think that is likely.

As to the existing MSC/SVF practices, hard choices have to be made, especially for those not associated with the US Stem Cell network and who currently operate below the state and federal radar screen: Continue with business as usual, or stop and move on to the next thing.

Because of the FDA’s operational practices and limitations, I do not see it as a major deterrent to existing fat-based clinics, at least not until the expiration of the 3-year grace period the FDA granted the industry when the stem cell industry guidance documents were issued in late 2017. Presumably, the small, under-the-radar clinics will have until late 2020 to come into compliance (which they will never be able to do, so read, go out of buisness).

For sure, the FDA will continue its enforcement activities, especially against the US Stem Cell affiliates, and then against the California stem cell affiliates if there is a summary judgment in that case. However, if a clinic is making money and getting good feedback from the patients about results, some may decide to continue with the product and model, at least until the end of the 2020 grace period.

I menitoned state radar screen because some of the state attorney general’s offices are starting to become players via consumer protection laws,following the FTC’s widely reported multi-million dollar consent agreement against a California stem cell operation back in October, 2018.

Here is the FTC’s announcement of the settlement.
https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic

That case, and others that might follow might make some of these clinics rethink their position, or at least clean-up their websites, and that would be a very, very good idea. State (and federal) consumer protection target the clinics where it hurts, their pocketbooks. I would expect these types of actions might be a bigger factor than even the FDA, in the short to medium term. In large part because this is low hanging fruit for the AG’s and results in easy and favorable PR. Many AG’s are looking at what’s next, and the common job path is AG, then Governor or senator, then who knows.

And the states have other tools to deal with the MSC/SVF model, which they are starting to use.

Sooner or later, the entire MSC/SVF field is going to move on (and many in the field already have done so). My work has given me the opportunity to review the MSC/SVF operations, documentation and adverstising practices. I hope the players creating the new business model do not make the same mistakes as were made in the MSC/SVF model. But, I am guessing that the same forces which drove the soon-to-be-old model, will also drive the new one, and the same mistakes and same government reactions will surface. But we’ll see.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Florida Federal Judge Grants Summary Judgment to the FDA against US Stem Cell; Game Over except for the obligatory appeal

Florida Federal Judge Grants Summary Judgment to the FDA against US Stem Cell; Game Over except for the obligatory appeal

The U.S. Stem Cell summary judgment decision has just come down. It’s 30 plus pages.
here it is.
USRM lawsuit

Result: FDA 1, US Stem Cell 0. Game over except for the appeal, which will take at least a year.

I haven’t had a chance to closely read the decision yet, but I am expecting that the judge accepted the FDA’s position in toto. The judge has or will issue a final judgment, and then the case goes up to the court of appeals, starting with the filing of a notice of appeal.

The big question

Will the company comply with the injunction order? My guess is that the lawyers will tell the company that it’s over, (unless some court issues a stay of the judgment, and I think that’s unlikely).

It’s one thing to defy the FDA’s asserted position in a warning letter and guidance documents. It is an entirely different thing to violate a federal court injunction order. That carriers civil and criminal contempt penalties and a ticket to a federal trial (bench for civil contempt, and a jury for criminal contempt). Done that, it’s not fun for the client.

The US Stem Cell affiliates throughout the country are going to have to do some hard thinking about this, at least those who haven’t moved on yet from SVF products derived from fat.

I’ll write about this again, once I have reviewed the judge’s decision closely. While I think this decision is legally significant, practically, it will have less effect than the regulators might expect, because, as I’ve said many times before, this was expected and many in the field have moved on to new HCT/P’s and here we go again, from the beginning.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

US Stem Cell Pre-Trial Conference Now Set for June 7th, so look for a decision before then, or another court ordered adjournment

US Stem Cell Pre-Trial Conference Now Set for June 7th, so look for a decision before then, or another court ordered adjournment

On May 9th, the judge in the U.S. Stem Cell case put off the pre-trial conference from May 29th until June 7th, meaning she’s not quite done with the summary judgment decision and needs alittle more time. It’s a big complicated case with alot of papers flying back and forth. Normally judges try to decide summary judgment motions in 60 days or so. If she issues her decision in early June, that would be basiclly two months since the cross motions were submitted.

She has to know that if she grants summary judgment (presumably to the Government), it’s going up on appeal. So, no doubt she’s going to do everything in her power to get it right and make her decision as bulletproof as possible.

I don’t think you can read too much into these couple of court ordered delays. Federal courts run on very tight schedules. And by comparison, the California stem cell litigation which I think was filed the same day as this Florida case, is still a couple months away from the summary judgment deadline. So she’s still moving her case pretty quickly, is how I see it.

So be patient. It’s coming!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

US Stem Cell Case Update: Judge Puts off Pre-Trial Conference for Three Weeks

US Stem Cell Case Update: Judge Puts off Pre-Trial Conference for Three Weeks

Yesterday, May 9th, the Judge in the FDA’s case against US Stem Cell and Kristin Comella entered an order changing the pre-trial conference date from May 17th until June 10th. The trial has been pushed back from June 10th until June 24th.

Why: The obvious reason is that she hasn’t finished her decision on the parties’ cross motions for summary judgment, and there’s no point having a pre-trial conference with summary judgment motions pending. So, she’s giving herself another couple weeks to finish. The defense could read into this that at least she’s not going to copy the FDA’s position in toto. But probably more likely, she understands that this case is going up on appeal, either way, so she wants to make sure she gets it right, because it’s a big deal.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The Niche Weighs in on the Manhattan Stem Cell Clinic’s Answer to the AG’s Lawsuit, and Some Breaking News!

The Niche Weighs in on the Manhattan Stem Cell Clinic’s Answer to the AG’s Lawsuit, and Some Breaking News!

I represent the Manhattan stem cell doctor whom the NY AG has recently sued for false advertising and fraud.

Her is the NY Times story about the lawsuit:

https://www.nytimes.com/2019/04/04/health/stem-cells-lawsuit-new-york.html

I decided not to comment as part of the mass media’s coverage of the AG’s filing the lawsuit, because I needed to take a hard look at the complaint and think carefully about any response.

I did, and put together an Answer and Counterclaims. Here is my prior post which has the Answer and Counterclaims/

http://rickjaffeesq.com/2019/04/22/breaking-news-manhattan-doc-in-ny-ag-case-files-answer-targeting-the-fda-and-says-new-yorkers-have-a-privacy-right-to-the-treatment-and-a-first-amendment-right-to-info-about-it/

I’ve been in the law biz a long time, and hint, I helped make some of the law in the field of cutting-edge medicine, and even some of the law which could be directly applicable to this case. I don’t do predications on my own cases, but I do think my defense raises some important and interesting issues about, among other things, the suitability of a fraud and deceptive trade practice lawsuit when the alleged victims are patients who are required to receive informed consent. Are patients who received adequate informed consent victims? How about patients who have benefitted from the treatment and are happy with the results?

I also pointed out that many people take FDA-proven safe and effective treatments and die of their disease. Do they get a refund? Do patients have the right to use their own body parts for treatment of chronic conditions and incurable diseases? Who should control what kind of information patients and prospective patients receive from these medical practices for cutting-edge surgical based procedures?

Basic stem cell scientist and mega-stem cell blogger Paul Knoepfler, has just weighed-in on my Answer and Counterclaims. Here is his analysis:

https://ipscell.com/2019/05/ny-stem-cell-clinic-pushes-back-on-lawsuit-by-ag/

I take this guy very, very seriously.

I’m curious to hear what people who read my posts think about his analysis. In particluar, I’m interested about how different what the unproven private clinics are offering compared what I believe to what the equally unproven therapies the major hospitals are doing as discussed in my Answer. How much sense does it make medically speaking, to differentiate what the big places are doing from the smaller clinics? Do these distinctions only exist in the fantasy word of the FDA, versus the real medical world?

As is my wont, I’m going to mull over his analysis very carefully, and then I’m going to mull it over some more, and then probably make a substantive response to the Big Dawg, taking into account feedback from the professionals who follow both of us.

One piece of breaking news

Today, May 1st, the case was assigned to the highly regarded Commercial Division of the New York Supreme Court. The Commerical Division handles large dollar and especially significant lawsuits. It was the AG’s call to have the case assigned there, and I saw no reason to object.

The judge assigned is Judge Jennifer Schecter. She received some recent acclaim for telling Donald Trump that he’s not above the law, and allowed the defamation lawsuit filed against him by Sumer Zervos to proceed. Win, lose or draw, any state court judge who’s willing to put the head of the federal government in his place is ok by me. Should be really interesting. (If I were doing the screenplay, the twist would be that they actually met, not on the Apprentice, but in my client’s stem cell clinic waiting area; they both received complete informed consent and would testify at the trial for us, in a cross-over type episode/trial before the same judge. That won’t happen, but who knows what twists and turns there may be in this case.)

Stay Tuned!

Rick Jaffe
rickjaffeesquire@gmail.com

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Earlier this month, the New York Attorney General’s Office filed a false advertising case against a Manhattan Stem Cell clinic owned by Joel Singer, M.D. The clinic offers autologous stem cell transplant procedures for a wide variety of medical conditions. The clinic used to be affilated with the California Cell Surgical Network run by Mark Berman and Elliot Lander, who as you know, are defendants in one of the two FDA’s civil injunction lawsuits.

Here is the Washington Post article about the case.

https://www.washingtonpost.com/national/health-science/fda-sends-letters-to-20-companies-in-attempt-to-rein-in-stem-cell-industry/2019/04/03/7e01556e-564e-11e9-8ef3-fbd41a2ce4d5_story.html?utm_term=.e6c968d5d4c1

It was also reported in the New York Times

https://www.nytimes.com/2019/04/04/health/stem-cells-lawsuit-new-york.html

and the New York Post.

The articles reported that they couldn’t reach the clinic or its attorneys for comment.

The clinic’s attorney just filed the answer to the complaint. It’s not half bad, but you can judge for yourself.

Here it is.
singerfiledanswer

STAY TUNED!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision).

No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject to FDA drug requirements because the law doesn’t apply to them because it’s the practice of medicine and it’s a same day exempt surgicial procedure under 21 CFR. 1271.15.

The papers filed on both sides are excellent. The arguments were clearly made, and professionally and forcefully highlight the differences between the parties’ position.
I don’t think there was any more to be said on behalf of the defendants.

High quality papers like these help the judge make a decision, and I’m sure are appreciated by the court. So, congrats to both sides for a job well-done.

Look to a decision by late April.

Still, I don’t think that a Government win will have the effect the FDA or the anti-private stem cell clinic folks are hoping for. The industry has already, or is in the final process of moving on to the next HCT/P’s, and some of these puppies are likely to be harder for the FDA to stop under the current regulations and guidance documents. And, even if not, the whole process is going to have to start over again, the outcry from the stem cell establishment, inspections, delays, warnings letters, lawsuits. My prediction is that we will be well into the mid-2020’s before we’re at the same point with the next batch of products, at least if the FDA follows its current game plan. That’s going to make some folks happy, and others, not so much.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

US Stem Cell Case Update; No breaking news but . . . .

US Stem Cell Case Update; No breaking news but . . . .

Per the Court’s scheduling order, the parties filed their pre-trial materials yesterday, March 29th, including what’s called the Joint Pre-trial Stipulation (“JPTS”) which lays out for the Judge what each party’s contentions are, lists disputed and agreed-to facts and legal issues. It’s about as good of a summary of the case as the judge or the public will get prior to trial.

Because federal court cases like this have tight scheduling orders, it’s not an infrequent occurance that the pre-trial materials have to be filed before the judge resolves dispositive motions (i.e., summary judgment), and or even as in this case, where the pre-trial filing deadline is earlier than the submission deadline for the final response (called a reply) in summary judgment. In this case, the summary judgment replies aren’t due until the end of next week.

I explain this because while the pre-trial filings give a road map to the scheduled trial, both sides are arguing in their summary judgment papers that a trial is not necessary. I think they are right, and I’ve predicted that the judge will agree with them on this point.

That all being said, the JPTS provides a clear and succinct distillation of each’s side’s position, both factual and legal, what’s agreed to and what’s not, and that makes the document invaluable for anyone involved in the private stem cell clinic business, as well as anyone opposed to them.

For the ADHD among you, here is the essence of the case, as taken from the Government’s statement of the case:

“Defendants are violating the FDCA in two basic ways. First, Defendants’ SVF product is adulterated because Defendants are not abiding by CGMP. FDA inspections of USSCC in 2015 and 2017 revealed serious and obvious CGMP violations by USSCC. CGMP requirements are designed to ensure that drugs (including biological products) have the identity, strength, quality, purity, and other attributes for safe and effective use. Here, the evidence shows that Defendants violated CGMP by failing to aseptically process their SVF product to prevent microbiological contamination or test the product for sterility and for the presence of endotoxins (which can cause fevers and other health complications), among other violations. Because Defendants’ SVF product is not manufactured, processed, packed, or held in compliance with CGMP, it is adulterated. See 21 U.S.C. § 351(a)(2)(B). Second, Defendants’ SVF product is misbranded. Under 21 U.S.C. § 352(f)(1), a drug’s labeling must bear adequate directions for use. If it does not, the drug is misbranded. Specifically: (1) the SVF product does not bear labeling that contains information required for adequate directions for use, as defined in 21 C.F.R. § 201.5; (2) the SVF product is an unapproved prescription drug that is not excepted from labeling requirements requiring directions under which a lay person can use the drug safely; and (3) it is currently impossible to draft adequate directions for use because there is no scientifically valid evidence to show that the SVF product is safe or effective for any indication.

Defendants do not dispute the evidence of these violations. Defendants admit that they use their SVF product to address patients’ symptoms of neurological, autoimmune, orthopedic, and degenerative diseases and conditions, which makes it a “drug” under the FDCA. See 21 U.S.C. § 321(g)(1)(B), (C) (“drug” includes all articles “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body of man or other animals.”). Defendants admit that FDA’s 2015 and 2017 inspections of USSCC found that their manufacture of the SVF product does not comply with CGMP. And Defendants further admit the relevant facts about the labeling of their SVF product and the required information that is missing. Nor is there any question that Defendants’ SVF product contains at least one component that has been shipped in interstate commerce. These undisputed facts establish that Defendants’ unapproved SVF product is an adulterated and misbranded drug under the FDCA. See 21 U.S.C. §§ 351(a)(2)(B) & 352(f)(1).”

The defendants’ statement of the case explains what they do and why they are right about their three defenses.

There is one other noteworthy thing which came out in the JPTS (and Defendant’s summary judgment papers).

You know how TV network shows sometimes have crossover episodes? You know when the the LA NCIS agents work a case with New Orleans NCIS agents, and the case spills over from one show to the other. Well we’ve got a crossover in this case. US Stem Cell’s primary expert witness is Elliot Lander, otherwise known as Defendant Elliot Lander in the Government’s parellel case in California against the Berman and Lander’s stell cell clinic and organization. It’s not surprising since the venerable Venerable law firm is involved in both cases. Still, it’s alittle disspointing, though not surpirsing to see the lack of third-party support for the defendants.

Of all the arguments made by the Government, I think the toughest one to overcome is the adulteration argument based on all the cGMP violaitons. In my view, it’s not financially feasible for a medical clinic to be cGMP compliant, unless the clinic is attached to a drug manufacturing facility. There have been only one or two guys in the country that have pulled that off (one of whom was my long time fomer client). I don’t think there is any private stem cell operation that could do that.

So, you’re the judge in this case, and both sides agree that the way the injected product is processed doesn’t meet the FDA’s manufacturing standards in part because of drug safety concerns embodied in regulations to protect the public against dangerous, adulterated products. What do you do? Tell the company to go with god, and hopefully the lack of compliance with the standards which govern safe drug processing won’t kill or hurt anyone, because of defendant’s three arguments about why the rules don’t apply to them?

To me, the only interesting part of this case is what the FDA does after a permanent injunction is entered. I have to believe that through discovery, the feds now have a list of all the affilate/co-investigators (and in the California case as well). Is a letter, a copy of the permanent injunction and a proposed consent agreement in the future of these co-investigators? What can these folks do, if anything, to protect themselves?

What action will the state medical boards take against some of these doctors once there is a federal court injunction holding that the procedure is illegal under federal laws, which are both civil and criminal violations. Most states have a law which makes a violation of state or federal law, a sanctionable violation of the state medical licensing act. I’ve had some success resisting this type of argument in the FDA context, but seems likely it will be employed when all the facts line-up.

And that’s what keeps me up at night about this case.

Here is the JPTS. It’s well-worth a close reading for anyone involved or interested in the field.

jtpto

ptorderwitnessesandexhibits

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

US Stem Cell Co-Defendant Gradel Throws in the Towel; Mediation fails (big surprise)

US Stem Cell Co-Defendant Gradel Throws in the Towel; Mediation fails (big surprise)

The consent order of defendant Theodore Gradel has been filed. He is no longer involved with the company and has agreed to a permanent injunction enjoining him basically being in what the FDA considers to be the illegal private stem cell clinic business.

here it is: gradelconsentdecree

On top of that, the mediation between the FDA and US Stem Cells and its remaining individual defendant, Kristin Comella has failed. No surprise here.

What does that mean?

Well it’s obviously not good news for Comella or the future of her company. I had thought that the Judge was sending her a message in her denial of the joint motion to cancel mediation, that now would be a good time to fold. If so, the message wasn’t received.

My guess is that the judge will use the consent order as a basis of the summary judgment order she issues against the defendants, meaning the language of the permanent injunction order.

Look to the judge to accept the FDA’s position in toto, now more than ever since one of the two individual defendants has already accepted the FDA’s position. Interestingly, the consent agreement was also signed by the primary or local counsel for all defendants. Technically, it means nothing that the attorneys fighting a case for the two remaining defendants have agreed to the relief requested in the lawsuit for a third defendant. But still . . . . I incorrectly predicted a separate firm would be signing the consent agreement.

The only thing different between this case and the Regenerative Sciences case on which there is binding or almost binding federal circuit court authority is that the Colorado clinic expanded its HCT/P’s, so it didn’t have the same-day surgical procedure exception going for it (21 CFR 1271.15).

But the FDA guidance documents say, imply, or are being interpreted by the FDA to reject the 1271.15 exception to US Stem Cell Clinic because it is not the same HCT/P. In other words, the HCT/P which is extracted via liposuction (belly fat containing MSC’s) are not the same HCT/P which are reimplanted (some MSC processed SVF). That view is consistent with the FDA’s new “more than minimal manipulation” position in its guidance documents.

So unless this district court has a crystal ball and knows how the Supreme Court is going to rule on a pending case dealing with continued judicial deference to administrative agencies’ interpretations of their own statutes, I am going with the judge giving deference to the FDA’s interpretation of the same-day surgical exception, which knocks US Stem Cell Clinic out of 1271.15 safe harbor land.

The cross motions for summary judgement should be submitted to the court by April 5th. Expect a decision a week or three before the mid May pre trial conference.

Bottom line and practically speaking, Gradel’s consent agreement agreeing to the relief sought, which was signed-off by counsel of record for all defendants is just one more step to the inevitable, in my view at least.

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com

Breaking News in the US Stem Cell Injunction Case!

Breaking News in the US Stem Cell Injunction Case!

But first a ho hum update

Last week, both parties filed motions for summary judgment. What that means is that both sides are arguing that there is no need for a trial and that the judge can decide the case on the summary judgment papers.

The government argues of course that the defendants are violating FDA law by using their more than minimally manipulated products for non homologous use, and that it doesn’t fit within the same day surgical procedure exception (21 CFR 1271.15) because what’s being reinjected is not the same HCT/P as what was taken out.

US Stem Cell Clinic argues that it’s just a medical procedure over which the FDA has no jurisdiction, it is the same HCT/P, both out and in, and the court shouldn’t consider the FDA’s guidance documents because it did them without complying with proper administrative procedures, and also because the Supreme Court may soon reject the Chevron deference standard granted to administrative agencies.

The parties have another week to submit responses to their opponent’s motions, and then a week to reply to those responses. So look to the case being submitted to the judge for consideration around April 5th.

The pre-trial conference is mid May, and I’d look for a decision on the cross motions for summary judgement a week or two before the conference. Unfortunately, the parties have alot of paperwork due end of March, which in US Stem Cell Clinic’s case translates into a to six figure legal bill just for this month, I’d bet.

The judge has three options: Grant the government’s motion and the case is over. Grant the Defendants’ motion and the case is over. Deny both motions and the case goes to trial. Or actually there are a fourth and fifth option, which is partially grant one or the other motions and have a trial on the remaining parts of the case.

Now for the breaking news!

You’ll recall from my last update that the parties filed a joint motion to eliminate the required mediation. I thought the motion should be granted because both sides seemed intractable. Well, I was wrong about that, because something big has happened, but not formally yet.

In denying the joint motion to cancel mediation, the judge noted that one of the Defendants, Theodore Gradel, who is a co-owner of the company has entered into a consent order!

In her decision, the judge refers to the Defendants’ motion, which was filed by US Stem Cell Clinic and Kristin Comella, because as set forth in the papers:

Defendant Theodore Gradel does not join this motion for summary judgment as he has signed a consent decree, which the parties anticipate will be filed shortly for entry by the Court.”

In the judge’s order denying the cancellation of mediation, the judge asked the FDA to try again to convince the remaining defendants (read Comella) to give up, or maybe I’m reading too much into it. Here is the operative language. You decide for yourselves.

“There is no reason that the parties cannot negotiate as to the injunction requested by Plaintiff in its complaint at mediation. Indeed, it appears Defendant Theodore Gradel has entered into a consent decree. See D.E. 41. Moreover, discussion at mediation may lead to agreement or settlement of other related matters, streamlining any remaining issues for trial and/or summary judgment . ***”

We will know more once Thomas Gradel’s consent agreement is filed, but at this point, I don’t think the government is going to accept anything less than a permanent injunction, since by my calculation and judgment, a permanent injunction order is only 4-5 weeks away.

This development is not good news for Comella, and that’s an understatment. Gradel should have new counsel and he probably will now appear on the Government’s trial witness list. It makes the dismissal of the case as sought by the remaining defendants much less likely. The screws are turning.

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com