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

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

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

Let’s start with what hasn’t happened

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

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

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

See my post at:

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

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s.

The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well, the final documents are out and the feds didn’t (lossen them up). The final guidance documents are at least as bad as the drafts, and in one important respect, worse.

Here is the main guidance document on minimal manipulation and homologous use.
https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf

The FDA also issued a final guidance document on same day surgical procedures, but practically speaking, that one is irrelevant, based on the main guidance document. And that’s because, per many of my previous posts, the two critical concepts which determine the legality/illegality of the delivery of HCT/P’s to patients outside of clinical trials are: homologous vs. non homologous use, and more than minimally manipulation (“MMM”).

What’s a Non Homologous Use? Answer: It’s what you’re all doing!

If there is one sentence in the FDA guidance document which sums up the FDA’s position on the use of HCT/P’s by the heretofore unregulated clinics, this is it:

“If an HCT/P is intended for use as an unproven treatment for a myriad of diseases or conditions, the HCT/P is likely not intended for homologous use only.” (Page 15 of “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use”, here is the link again: https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf )

To remind you, if the use is non-homologous, (meaning not the same function as from where the HCT/P derived), it’s a drug, requiring the IND/NDA path, and the non-homologous use of which is a violation of the regulation, the law which leads to bad things.

Every unregulated stem cell clinic that I am aware of falls within this FDA statement, and I wouldn’t get my hopes up based on the FDA’s “likely” qualification. If you’re using an HCT/P to cure a disease and it’s not something like hematopoietic cells or bone marrow for blood conditions, blood related cancers, or immune system issues, your use is non-homologous according the guidance documents (draft and final).

When is an HCT/P More than Minimally Manipulated? Answer: Every process used on an HCT/P unless there is scientific proof to the contrary

The nastiest thing in the final guidance document is that the FDA has created in effect an irrebuttable presumption that anytime you do anything to an HCT/P, it’s MMM unless there is information that that the process is minimal manipulation, or as the FDA puts it:

“Please note that if information does not exist to show that the processing meets the definition of minimal manipulation, FDA considers the processing of an HCT/P to be “more than minimal manipulation”, (which basically makes the HCT/P a drug)

For structural tissue like fat, MM is defined by the FDA as “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement.”

For sure, when you separate the mesenchymal stem cell (“MSC”) from the adipose substrate, that’s MMM, let alone when the MSC is further processed into something like SVF or some other derivative product.

Prior to the draft guidance documents and even under the draft guidances, you were more or less free to argue that what you were doing to the HCT/P was not changing its relevant characteristics or MMM (more than minimally manipulating it), and then presumably force the FDA to prove that you were. Under the final guidance document, if there’s no “information” that what you’re doing is MM, then it’s not.

What Kind of Information is Needed Exactly?

Frankly, I’m not sure. Part of my uncertainty is there is some fuzziness, in my mind at least, about what are the relevant characteristics, etc. It’s an FDA created concept or administrative conclusion, rather than a biological fact or physical thing like a stem cell or HCT/P. Or it’s a question of where you draws the line. So is there a new business in creating “information” that some process doesn’t alter relevant characteristics?

How broad is the Guidance Document? Answer: Broad enough to cover basically any human tissue used by the unregulated clinics.

The guidance document covers almost every conceivable human tissue except some specific things like vascularized human organs, blood and blood components as listed in the regs, secretions or extracts like milk or other bodily fluids, bone marrow not MMM and a couple other things which are not of interest to the unregulated stem cell clinics. All other human tissue is subject to the guideline and the resulting restrictions. (See footnote 3 of page 2 of the guidance document for the list of excluded products).

So is there any Good News in the Final Guidance Document? Maybe, if you’re a Super Optimist

Perhaps to lessen the sting to the unregulated stem cell clinics, (or more cynically, to give them a false sense of hope), right in the beginning of the guidance document, the FDA says that in some cases it will use its enforcement discretion, and not enforce its interpretation of the regulations for three years to give stakeholders time to decide whether they are in compliance with the law or need to go the IND/NDA route. Later in the document, the FDA lists some factors which it will use to decide who it will not go after during these three years. (See pages 21-22).

The good of it is that autologous use lowers the risk.

The really bad of it is that high on the FDA hit list is non-homologous uses for serious and life threatening diseases and where the HCT/P’s are delivered by “high risk” methods like IV, infusion and some other methods. (See page 21 paragraph V B). The FDA considers the unapproved use of HCT’s for such life threatening conditions particularly nefarious since it might delay patients receiving “safe and effective medical treatment.” That’s an unfunny joke because the main, if not the only reason people seek out HCT/P treatment is because there are no safe and effective treatment for such conditions.

So basically, if you’re using HCT/P’s for curing or mitigating diseases other than blood or immune conditions, I’d say you’re not going to be the beneficiary of the FDA’s enforcement discretion largess.

Does that mean you should expect to receive a visit or letter from the FDA in the next year or three?

Not necessarily. There are hundreds of you clinics out there. It takes a lot of man-hours (sorry, person-hours) by many line investigators and back office federales to do each investigation. The FDA’s resources are insufficient to open up investigations and engage in the process of finding violations for anywhere near the number of clinics out there.

So what’s going to happen?

The FDA will continue with the administrative process of the high profile clinics which it has recently targeted. I think it will start the investigatory process with a few other high visibility clinics, as time and person-power permits. This will reinforce the message that the FDA is out there and remind the clinics that what they are doing is illegal (according to the FDA).

It will probably take almost a year or two before there is a judicial decision on the validity or enforceability of the guidance document. A safe bet is that the FDA will bring an injunction action against one of these clinics for not, in effect, closing. Injunction cases are tried to the judge, not a jury.

If the first case involves the Florida clinic where a nurse practitioner injected eyeballs with HCT/P’s and caused blindness, well you don’t have to have a crystal ball to know the result. Like I say, bad cases make bad law.

It’s going to interesting times for the unregulated stem cell folks.

More to follow.

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