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Category: Stem cells regulation

stem cell mis-regulation

FDA v. California Stem Cell case update

FDA v. California Stem Cell case update

Honestly, I lost interest in this case after the federal judge in the Florida US Stem Cell case granted summary judgement to the FDA and issued a permanent injunction barring the use of the stem cell/SVF product, which is basically the same stuff used by the California group. I assumed that the California federal judge would agree with the Florida judge. I am still making that assumption, but I did learn a few interesting things from my cursory review of the summary judgment papers which have been filed. Also, I heard some misinterpretations of what has recently happened in the case, so I thought it might be helpful to set people straight.

The Schedule

In federal court, the parties propose an initial schedule which is accepted, rejected or modified by the court. It is everyone’s rough guess of how long it will take to get to a trial. But things change. It is extremely common for scheduling orders to be revised, meaning deadlines and trial settings are pushed back, by months, or many months, and there are sometimes several successive revisions to scheduling orders.

In this case, the Government complied with the then current scheduling order and filed its motion for summary judgment in early July. The judge took a quick look at the papers, and he probably reviewed the docket in the Florida stem cell case. On his own, he pushed back the hearing on summary judgement to December. That meant the original trial date had to be put off as well.

The judge ordered to parties to meet and confer and come up with a new trial date and other deadlines. The parties couldn’t agree on much. Interestingly, the Defendants asked for a quicker hearing than the judge ordered December hearing, because of the uncertainty and resulting financial problems the case was creating for the defendants’ business. The judge declined, and set the trial date in February 2020.

That was fine for the Government because it is not expecting there to be a trial, based on its view of the law, and its recent summary judgement win in the US Stem Cell case on similar facts.

The fact that the trial date has been pushed back until February 2020 has no legal significance because 1. As stated, trials get put back all the time in federal cases, and 2. The Government (and most likely the judge) doesn’t think there will be a trial.

What I learned from the Government’s Summary Judgment Papers

Caveat: because of the press of other business, I only took a quick look at the papers. My impression was the Government’s papers were very similar to the papers it filed in the US Stem Cell cases. However, the papers did relate two facts which I was not aware of.

First, in 2018 the Government obtained a court order seizing the company’s toxin laced stem cell/SVF vacinia product, based on a finding that the product was misbranded. It is unlikely that this judge will reach a different result, on that product at least. The people who make misbranded products get injunctions issued against them for producing misbranded drugs.

Second, the company is (or had been) expanding some of its patients stem cells. I don’t get it. We know from appellate authority in the Regenerative Sciences case that is illegal. These two facts make a much stronger case for the Government than the facts in the Florida case. Here is the Government’s Motion for Summary Judgment (without the declarations and exhibits)
govtsumj

What I learned from the Defendants’ Summary Judgment Papers

While I thought the Government’s papers in this case were basically the same as what it filed in the Florida case, I think the defense papers in this case are much stronger than in the Florida case. Same firm in both cases, but different lawyers.

Don’t get me wrong, the Florida defense papers were perfectly fine, well written and extremely competent. However, I think the California summary judgment papers presented a more compelling defense, notwithstanding the fact that they had some bad facts to deal with. (Lander’s declaration states that they are not doing these two bad things anymore, or hadn’t as of the date of the FDA’s complaint). The California defense also had the advantage of their clients being actual board-certified surgeons, rather than the morons in Florida who thought it was a good idea to have a nurse practitioner inject people’s eyeballs with stem cells. Still, I thought the California papers were excellent and told a very compelling story. Hats off to the defense team.

Here is the Defendants’ Summary Judgment Response, and the principal declarations:

sumjopposition
landerdec
gurwitzdec

I really liked the expert report attached to the attorney’s affidavit. I do not recall if it was submitted in the Florida case. If it was, it made alot more sense here since the defendants are surgeons and make a better case for a surgery exception, than in Florida case where (I presume) NP’s are not licensed to practice surgery.

Will the Defense’s excellent papers make a difference?

The defense has some very bad facts to overcome (expansion of cells, and using a toxin in a product which has been determined by a judge in the same district to a misbranded drug), and the recent US Stem Cell decision dealing with a product which is closer to being FDA compliant under applicable law.

So, despite, the excellent job on the papers by defense counsel, as an old Louisiana friend of mine used to say: “You can’t make chicken salad out of chicken [explicative deleted].” And that’s about how I see it. We’ll have the answer probably mid-to late January, 2020.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The US Stem Cell Judge Denies the Motions to Intervene by the SVF Owners Subject to….?

The US Stem Cell Judge Denies the Motions to Intervene by the SVF Owners Subject to….?

On July 31st, the US Stem Cell judge issued an “Omnibus Order” denying “without prejudice” all of the SVF’s Motions to Intervene in the case.
Here is her order:
orderdenyingintervention

What is happening is confusing, even to an FDA litigator like me. But, for what it’s worth, here is my explanation of what’s going on and why we’re here, (whereever “here” is).

First, I think that neither party specifically informed the judge that the company was banking SVF product for its patients and possibly people who were not patients, but just used US Stem Cell as an SVF bank). I do not know why that happened/didn’t happen.

After it obtained summary judgement, the government prepared an order requiring all SVF product in the Defendants’ possession to be destroyed. So far as I can tell, neither party informed the judge about the banked product for customers.

The defendants did not inform its SVF banking customers of the problem, until after the judge signed the injunction order, whereupon the defendants told its customers that their body material was about to be destroyed per the court’s order, and encouraged them to write to the judge via the clerk’s office.

The clerk received over two hundred letters and at least two motions to intervene, one of which was filed by a South Florida law firm purporting to represent many of the SVF banking customers.

After the judge started seeing these letters from the SVF banking customers, she did what she probably thought was the only thing she could do, given the procedural posture of the case, (namely, that there was a final judgement); she issued a stay of the part of the injunction order relating to the banking customers’ SVF, pending the filing of an appeal by the defendants of her permanent injunction order and judgment.

If the defendants appeal, then the judge’s stay continues until the court of appeals (the Eleventh Circuit) makes some applicable ruling on the case. If the defendants do not appeal, her stay of the destruction order automatically dissolves, and the destruction will take place under the FDA’s supervision, per the final permanent injunction.

Here is what my gut tells me is going to happen (meaning this is not a researched deep analysis).

If the defendants file a timely appeal (and I hope and suspect they will), that should essentially end the district court’s involvement in the case, as technically, I don’t think she will have jurisdiction on the case once a timely appeal is filed. She may issue another clarifying opinion telling the intervenors to try to intervene in the appeal, but that is about all I expect to happen in the district court, unless and until the court of appeal reverses and remands all or a part of the case back to the district court.

And I will go out on a limb and make a prediction about will happen in the court of appeals.

The part of the injunction order enjoining the defendants from performing SVF transplant procedures will be affirmed.

However, if correctly litigated, the part of the judge’s order mandating the destruction of the banked SVF product will or should be reversed on the grounds that the district court never acquired jurisdiction over the material/failure to join an indispensable party/the relief granted exceeded the claims in the lawsuit, or some combination thereof, as will be argued by the intervenors. That part of the case will be remanded for further proceedings. At that point, I would hope to see a settlement between the FDA and the SVF banking customers.

Well, maybe there is some wishful thinking going on here, but I think that is the way it could play out, if it goes that far.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Should you be worried if you banked your SVF/Stem Cells?

Should you be worried if you banked your SVF/Stem Cells?

The injunction entered by the Florida federal district court judge in the US Stem Cell case ordered the company to destroy all of the SVF product which it was storing for their patients and SVF banking customers. I did not think that was right, in large part because the owners of the stored product were not parties to that lawsuit. See my previous post: http://rickjaffeesq.com/2019/07/22/breaking-new-on-the-us-stem-cell-case-svf-destruction-order-stayed-and-svf-owners-intervene-in-the-suit/

here is the final injunction order:
permanentinjunctionorder

The basis of the judge’s destruction order was that the material is an unapproved new drug basically because the separation of the SVF from the fat from which it was derived constitutes more than minimal manipulation and is not even a stem cell. The FDA also claimed that US Stem Cell was using the product in their patients for non-homologous use, but that may or may not carry over into SVF banking because there is no use homologous or otherwise in banking, and won’t be until the client wants the cell back for reimplantation, arguably anyway. The other problem the court had with the product, (also adopting the FDA’s position), is that the material was not produced in accordance with Current Good Manufacturing Practices, which made the drug product adulterated under FDA law.

As I reported recently, the judge stayed the part of the injunction ordering the destruction of the banked SVF product pending appeal, even though she thought the product was FDA illegal and the owners did not have any rights to their body parts.

In case you have any doubt about how unimpressed the judge was with the rights of patients/consumers to control their own body parts (or something derived therefrom), here are the judge’s words and you can decide for yourself.

“As an initial matter, the Court is not persuaded that any party has a property interest in the SVF Product warranting a stay of the Order of Permanent Injunction. First, the law is unsettled as to a party’s rights in its biological tissue. See, e.g., Greenberg v. Miami Children’s Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064, 1075 (S.D. Fla. 2003) (explaining that “[t]he property right in blood and tissue samples also evaporates once the sample is voluntarily given to a third party.”). And, in this case, any such rights would be governed by the contractual relationship between Defendants and each individual patient, which rights are not addressed properly in this lawsuit. Second, as explained in the Court’s Order on the Parties’ Motions for Summary Judgment, the SVF Product is not the same as the patients’ stem cells; rather, the SVF Product is a separate product created by Defendants through a proprietary and complex multi-step processing procedure. See D.E. 73. Lastly, in-line with well-settled and recently affirmed Supreme Court precedent, in the Court’s Order on the Parties’ Motions for Summary Judgment, the Court deferred to the FDA’s scientific expertise and its interpretation of the FDCA that the SVF Product is an adulterated and misbranded drug. See D.E. 73; Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (affirming Auer v. Robbins, 519 U.S. 452 (1997)). Accordingly, the Court is not persuaded that any party has a property interest in the SVF Product because it is an adulterated and misbranded drug. See United States v. Ellis Research Labs., Inc., 300 F.2d 550, 554 (7th Cir. 1962) (“We find no merit in defendants’ argument that the injunction sought and granted is an unconstitutional and unwarranted exercise of the regulatory powers exercised by the United States under the Act in question . . . they can have no vested interest in a business activity found to be illegal.”) (emphasis added).”

Here is the judge’s complete stay order:
staydestructionorder

I think there are sound and compelling arguments to be made in response to the judge’s opinion, and sooner or later, in this or another case, I am confident they will be made.

So, the question arises what, if any effect the judge’s decision will have on patients who have banked their SVF (or some other stem cell derived product) with other stem cell banks. There are technical, theoretical and practical answers to this.

The technical legal answer is that a district court decision is not binding in other districts. The reasoning of the decision might be persuasive, but the decision itself is not binding. In fact, I think even a judge in the same district court can disagree. That is especially the case here since the owners of the material were not parties to the lawsuit, and I think that makes the judge’s decision on this particular point much less persuasive.

My prediction is that eventually the patients/SVF owners of material held by US Stem Cells will become parties to the appeal. If so, once the Eleventh Circuit decision comes out (in about a year) that decision will be precedential and binding unless another court of appeals takes a different position. So much for the technical/legal.

As to the theoretical, I suppose the FDA could take that decision and start looking at all the stem cell banking operations to determine which of them are manufacturing adulterated drugs (and that would probably be most or all of them I would guess) even though these materials are not imminently going to be injected into patients. However, I do not see that happening.

The reality is the FDA has a lot on its plate in the stem cell field. There are many hundreds of these private stem cell clinics out there operating in violation of FDA law. The 2017 FDA guidance document stated reason for not taking action against all these clinics is that it wanted to give the industry a three-year window to come into compliance, (and that was damn nice of them if you ask me). But in actuality, the FDA does not have the manpower to investigate and prosecute them all. So as Siddhartha says, “If you have nothing to eat, you should fast.”

Apart from the autologous MSC dervied stem cell clinics, there are dozens and probably hundreds of clinics providing allogeneic based products. All of these places are treating patients with what the FDA would consider illegal drugs. The MSC based autologous stem cell banks are just “manufacturing” and storing the material for possible future use. (And honestly, I just do not get why older people store their stem cells. I’ll address that in another post). But back to the point, I have to believe that the low risk profile of these stem cell banks puts them way down on the potential enforcement list.

I think the FDA’s next target is much more likely to be clinics that provide birth related derived products (i.e. umbilical cord stem cells, cord and placental tissue, and more exotic products) used in alleogeneic therapy. But more about that later.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Breaking New on the US Stem Cell Case: SVF Destruction Order Stayed and SVF Owners Intervene in the Suit

Breaking New on the US Stem Cell Case: SVF Destruction Order Stayed and SVF Owners Intervene in the Suit

Last week was busy in the US Stem Cell case and some much needed help arrived.

First, to their credit, the defendants in the case moved to stay the SVF destruction order for the product it was banking for patients/customers. Although the judge was skeptical that these people had a prioprietary interest in their banked SVF product, she did grant the stay, on technical grounds, basically saying that she’ll continue the stay until the later of the expiration of the defendant’s time to appeal her final decision, or if they do appeal, until the Eleventh Circuit Court of Appeals dissolves her stay pending appeal. The bottom line is that so long as the defendants appeal the final decision, the SVF product will not be destroyed well into the appeal process. That is certainly good news for the people who have banked their SVF with the company. Here is the judge’s order:
staydestructionorder

I haven’t done a deep dive into the cases she cited, but I think the judge is oversimplying things, and their are serious arguments to be made. More simply put: I think she is wrong on the law or or at least wrong on the equities involved.

The other big news is that last week, a Florida law firm appeared in the case on behalf of some of the people whose SVF is the subject of the destruction order, via a motion to intervene. Here is the intervention motion:
interventionmotion

I’m not sure how this is going to play out since the judge has already issued a final judgement in the case. I suspect these consumers will end up being part of the appeal, which is probably what the lawyers are thinking, but we will just have to wait and see.

It’s all good news for everyone who has their SVF banked at the US Stem Cell facility. Now at least there will be someone directly protecting their interests.

I still think that the proper resolution is to allow these people to remove their property from the defendants’ possession and shipping it to some other location, probably out of the country. Initially, the FDA probably won’t like that idea, so the intervenors are going to have to find some additional means of persuasion. We will see what happens.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Chaos, Unfairness and Illegality in the US Stem Cell Case

Chaos, Unfairness and Illegality in the US Stem Cell Case

I have been following and writing about the US Stem case (and the FDA’s parallel California case) since the company received its warning letter and throughout the litigation. Last month, the judge issued the final injunction order. Here it is:
permanentinjunctionorder

The order, among other things, mandates the destruction of all SVF product in the defendants’ possession, which destruction is to be supervised by the FDA. (page 9, paragraph 10)

That caught me by surprise. I might have missed something in the pleadings and motions in the case, but I did not know or appreciate that the company was storing or banking SVF for patients, or possibly even non patients who just wanted to bank their stem cells. I wonder whether the Judge knew that.

Caveat: I haven’t seen the US Stem Cells SVF banking agreement, but I have worked on some cord banking agreements. There is one thing I am fairly confident about, and that it that the product is owned by the patient/consumer and not by the banking facility, in this case, US Stem Cell or some affiliate.

Legally, the relationship between the US Stem Cell and the SVF donor is a bailment, not unlike, (but much more complicated obviously) when you check your coat with the coat check or when you park your car in a commercial garage. The difference of course is that the entity holding the property helped create it. But that does not change the ownership issue.

Federal civil procedure defines parties as either necessary or indispensable. My impression, (rather than my considered legal analysis) is that the owner of the property would be an indispensable party, unless the bailment agreement specifically conferred on the bailee (the party holding the property in trust for the owner/bailor) granted it the exclusive right to dispose of or defend the property or something like that, and I would doubt there is such a provision in the banking agreement.

Normally, failure to join an indispensable party would be brought up by the defendant in a federal case, but I don’t think it was. I would argue that the government lawyers had an obligation to bring it up, since it the government is not just an ordinary litigant. I think the issue could also be raised by the court itself, if the court becomes aware of the issue. (Just my impression based on past work on related issues, not a considered legal opinion). I seem to recall that failure to join an indispensable party is a fatal defect to a case, whenever it is raised, even on appeal.

After the injunction order was issued, US Stem Cells notified all of its banking customers of the injunction order requiring the destruction of their property and advised them to either write to the court or hire an attorney (alittle late in my book). I’ve heard that there is a Florida attorney who is trying to find enough customers/clients to collect an adequate retainer.

The case docket lists 200 or so letters from customers who have banked their stem cells/SVF.

Here they are
usstemcellletters

letters

letters3

I think the stem cell institutional mafia should read some of these letters, and maybe it will restore some needed humility and compassion which is often lost when institutionalists concern themselves with the Public rather than actual people.

These letters from the SVF owners show the outrageous result of the Court’s order. I have to wonder whether the judge knew that the order would cause the destruction of property of people who were not parties to the lawsuit. These people’s property is being taken away from them without due process or just compensation. Last time I checked, that is illegal under the Fifth Amendment,and actionable under 42 U.S.C 1983, and could result in money damages as well as injunctive relief against the government. Who would you sue? The government and its lawyers for sure. Maybe the defendants also. But the Government is the party whose attention you need to get.

What would be the goal of the lawsuit? That’s pretty simple: Ask the judge to modify the order to allow the SVF owners to remove their property from US Stem Cell, and if necessary, have it shipped someplace else. There might be a procedural wrinkle or two to deal with first, but that’s where the case should end up.

Here’s hoping . . . .

Rick Jaffe,
rickjaffeesquire@gmail.com

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