US Stem Cell Inc (USRM)

[Dragon Lady]

USRM: ATTORNEY ARTICLE - ONE DEFENDANT SIGNED DECREE !!

Holy crap...A MAJOR SMACK-DOWN IT LOOKS LIKE FOR Comella and the gang...

Attorney Jaffe who is a bona fide expert lawyer in the stem cell "clinic" and general "stem cell" litigation field...just wrote an updated article explaining in great detail what has transpired regarding the Judge denying the motion BY BOTH PARTIES to end mediation....and it ain't looking good for USRM and Comella and gang.....

rickjaffeesq.com/2019/03/20/breaking-news-in-the-us-stem-cell-injunction-case/

Attorney Jaffe read ALL FILINGS and ALL DOCUMENTS on Pace and explains what took place...and it's a WIN FOR THE FEDS....CLEARLY....

One of the defendants...ole mystery man Theodore Gradel apparently has SIGNED THE DOJ/U.S. Attorney and FDA "CONSENT DECREE"...meaning per his legal council he's throwing in the towel and WANTS OUT of this legal action...it also PERFECTLY EXPLAINS THE SEC 8-K in which Tomas in his usual vague-speak BS language stated, "And we took over additional clinic ownership to now 49%" blah blah blah.....

http://search.sunbiz.org/Inquiry/CorporationSearch/GetDocument?aggregateId=flal-l14000123949-9b6a17cd-f497-4f9d-bf75-70db01851fa8&transactionId=l14000123949-7314e37e-90f1-4889-a5e3-8bc17b12cf52&formatType=PDF

THAT "clinic ownership percentage change" was ole Theodore Gradel bailing the hell out of the Comella and gang clinic biz....Gradel was an original PART OWNER and LLC MANAGER when Comella and gang formed the first clinic...he's on the FL Secretary of State documents above...it's why the DOJ SUED HIM AS ONE OF THE KEY DEFENDANTS and now it looks like he's saying "DONE..I WANT OUT..I'LL SIGN THE CONSENT DECREE" I don't want what's coming.....

Here is entire text of the fine new piece by expert attorney Richard Jaffe Esq...again...a stem cell litigator and bona fide law expert...

QUOTE FROM JAFFE:

"BREAKING NEWS IN THE US STEM CELL INJUNCTION CASE!

March 20, 2019 Richard Jaffe

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, Thomas 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.

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END QUOTE of fact based update by an expert attorney.....

It's a STUN GUN BLOW TO USRM and Comella and gang....

THE ONLY REASON THE Judge DENIED THE MOTION TO SKIP MEDIATION...is because ONE DEFENDANT Theodore Gradel former clinic CO-OWNER and PARTNER TO Comella has apparently JUST CAVED AND SIGNED THE DECREE...so the logical thing for the Judge was to say to the U.S. Attorneys...

GO BACK IN AND WORK THE OTHER'S OVER (Comella) A LITTLE LONGER...and see if you can GET THEM TO SIGN AND END THIS W/O WASTING THIS COURT'S TIME....and there ya have it....

ELSE...the Judge will rule in a short time here and most likely GRANT A WIN TO THE UNITED STATES as indicated by what is transpiring...

This has near ZERO CHANCE of going to any fantasy "jury trial" and the Judge more than likely GOES AGAINST Comella and gang...ESPECIALLY SINCE Comella's own FORMER CO-CLINIC-OWNER and long time partner just admitted via SIGNING THE DECREE and can now be used as a witness against her and agrees the government likely has an air tight case per his own legal council...

GOVERNMENT: ONE

USRM/COMELLA: ZERO

NOT looking good here if you ask me...this looks to be going down in flames soon....real soon.....super smoker FED/DOJ STYLE....

And all the bullshit disinformation that the FEDS are going to "walk away" or the "Judge is going to dismiss this" or the "U.S. case is weak" and blah blah blah is PURE BULLSHIT...

The new info breaking today DISPROVES IT ALL...the U.S. looks to have a ROCK SOLID CASE...ground zero nuke strike style....BOOOM.....

Looking more and more like USRM and Comella are at GROUND ZERO with the clock ticking down...BOOM...BOOM and OUT GO THE LIGHTS is what I see coming..TOTAL DESTRUCTION...Fed style.......