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Tag: same day surgical procedure

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Yesterday, California federal district court judge Jesus G. Bernal on his own adjourned the the FDA’s trial against Cell Surgical Network (“CSN”) and their owners Mark Berman and Elliot Lander. The parties were ordered to meet and confer about a new trial date to take place after November, 2020. The trial had been scheduled to commence on July 28th. Because of my deep interest in the case, I have been checking the Riverside Ca. Covid-19 numbers and once the numbers started to rise, and based on what has been happening in California in general (which is another area of interest and which I write about), I was pretty sure the the judge would have to knock the case off the docket. This is too big and too important to do via Zoom, and the judge really had no choice. Too bad, as this is for sure the most important stem cell case in the country right now, and in general, and for reasons having to do with my stem cell work, I was really hoping to get some clarity, or more specifically, another ruling similiar to the judge’s seminal summary judgement decision.

For my own needs, I have recently reviewed some of the pre-trial filings in the case, and in particular the proposed findings of facts and conclusions of law filed by the parties. (Findings of fact and conclusions of law are the main documents filed in a bench trial. In a jury trial, the parties would file proposed jury instructions. But in a bench trial, the findings of fact and conclusions of law are what the parties expect to show fact wise, and what they argue how the law applies to the facts, and of course, present the proposed outcome. In case you were wondering, there is no federal (7th Amendment) right to a jury trial in cases in which the relief is equitable, like injunctions and declaratory judgments).

CSN’s findings and conclusions, prepared by Venerable’s LA office’s team headed by Celeste Brecht are about the best I have ever seen in an FDA case (or maybe in any case). They clearly lay out CSN’s position in the case. If you want to understand exactly what the defendants did and why they think all of it is legal, and how the FDA improperly used industry guidance procedures to substantively change the law without going through the proper and required procedure, then read this document. (I know I am being alittle redundant, but I just love saying how the government acted improperly; it’s a defense lawyer’s thing, and spoiler alert, I’m not done yet!) Here it is.

csnproposedfindings

This document also cogently and succinctly lays out the evolution of the same day surgical procedure exception, from whence MSC/SVF procedures were considered 21 CFR 1271.15 EXEMPT, to the FDA’s illegal transformation of the procedure and a person’s body part into an illegal, unapproved, adulterated and misbranded drug.

In all my years doing this law thing, this one action, (and did I mention that it was illegal and improper?) is the single stupidest thing I’ve ever seen. Your body part removed and reimplanted during the same surgical procedure is a drug! In my opinion, this is perhaps the most extreme case of over regulation and lack of common sense that I have ever seen in the field.

For a long time, I thought the FDA would get away with its improper transformation, and that this case would reach a similiar result as the US Stem Cell case in Florida, because of the deference federal courts are required to give federal agencies like the FDA when it interprets its own regulations. However, in 2019, (after a few Justices gave some heart warming hints), the Supreme Court came out with a couple decisions which limit deference to laws and regulations which were ambiguous. This might well prove to be the death-knell of the FDA’s decade plus effort to (improperly) rewrite the the same day surgical exception.

So getting back to Venerable’s findings of fact and their succinct history of the FDA’s regulation of this issue, here it is:

“Regulatory History of the SSP Exception
6. Until 1997, the FDA exerted little to no control over human cellular and tissue-based products.
7. In 1997, the FDA introduced Guidance providing that:
the agency would not assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.
(Ex. 88 (emphasis added).)
8. In 2001, the FDA then promulgated the Same Surgical Procedure Exception (“SSP Exception”) based on the 1997 Guidance.
9. The SSP Exception exempts from any FDA regulation:
[A]n establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.
21 C.F.R. § 1271.15(b).
10. The FDA has not amended the SSP Exception since its promulgation.
11. HCT/Ps are defined as “articles containing or consisting of human cells or tissue that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 C.F.R. § 1271.15(b).
12. In 2014, the FDA released a draft guidance that sought to create ambiguity in the SSP Exception. (Ex. 89.)
13. The draft guidance proposed substantive changes that interpret the SSP Exception to exclude surgical procedures that would otherwise qualify for exemption by requiring that the patient’s transplanted HCT/P be implanted in its
“original form,” which is very narrowly defined and otherwise limits the types of surgical procedures that would fall within the SSP Exception. (Id.)
14. The “original form” language is not included anywhere in the regulation, see 21 C.F.R. § 1271.15(b). Instead, the SSP Exception unambiguously states that a tissue or human cell is not a drug if it is removed from an individual and then re-implanted in the same individual.
15. The FDA adopted the draft guidance, which was improperly signed by Ana Abrams, in December 2017. (Ex. 87.)”

Ahh, this is music to my ears and will be to many in the stem cell field (on this side of the fence anyway). Only thing that’s needed is the judge’s signature. But alas, that can’t/won’t happen until sometime after November. We’ll all have to stay tuned until then.

Rick Jaffe, Esq.

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 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