US Stem Cell Inc (USRM)

[Dragon Lady]

If you link me to the precedent they have to overturn, I can evaluate the likelihood of success - I’m in law school currently.

Sure - no problem. I'm well versed in "the law" myself, I won't give specifics.

The background is this - I'll try and lay it out:

1) The FDA had been eyeballing "stem cells" and specifically "stem cell clinics" for quite some time (clear back to at least 2015 for sake of argument), though they never really did much about them, or to them, despite 100's of clinics proliferating across the country. Sent a few warning letters, blah blah - toothless, nothing much done.

2) A Stem cell "clinic" can use various methods that all sort of fall under the umbrella of "stem cell treatment" from cord blood, to platlet rich plasma (PRP), to placenta derived cells (not from the same person being treated at the clinic) to umbilical cord cells and then FAT DERIVED CELLS aka "Stromal vascular fraction" or SVF. THAT IS THE KEY, SVF !

3) The FDA meddled around for years and around 2017 they publish a "guidance document" (these are documents often used to telegraph a regulatory agencies "thinking" and way they lean on how they will regulate a certain field, businesses, etc) - and they, the FDA gets a burr up their butts MAINLY ABOUT SVF aka FAT DERIVED STEM CLINICS ONLY !

4) The FDA eventually SINGLES OUT TWO, only TWO COMPANIES who operate "stem cell clinics using SVF" out of literally hundreds across the nation- one was USRM this company (U.S. Stem Cell Inc) and then a CA company "California Stem Cell Centers" (whatever they're called) and the FDA via the DOJ (FDA has no legal/law enforcement, they always defer to the DOJ and these are CIVIL MATTERS, NOT criminal) - they filed TWO LAWSUITS nearly at the same time seeking injunctive action/relief - one against US STEM CELL and one against the CA Clinic chain (Dr Mark Berman, Dr Elliot Landers) - and they file um in the Federal district court(s) - FL and CA respectively.

5) The USRM case moved rapidly (CA is the slowest courts in the land) - and a single judge, Ursula Ungaro she granted SUMMARY JUDGEMENT TO THE FDA against U.S. Stem Cell.

The entire case hinges on a few key parts of CODIFIED LAW (NOT "guidance documents" which the FDA "Tried" to invoke and use- can not do that w/o the legislator making them LAW!) - sections 1271 and a few other areas of the FDA codes which deal with "SAME DAY SURGICAL PROCEDURES" and regulations of "TISSUES, CELLS etc" - and IF they meet certain criteria and are "autologous" (TAKEN FROM THE PATIENT, then replaced BACK INTO THE SAME PATIENT) and "not modified" (homologous) under 1271 - it's a SAME DAY PROCEDURE and FDA HAS ZERO regulatory powers over those. THAT IS THE "CASE" in a nut shell.

IF you go to a U.S. Stem Cell clinic- they remove a small amount of abdomen "fat" they minimally process it, then they centrifuge it and spin out/separate what is the HIGHLY CONCENTRATED STEM CELL "GOO" from fat and blood and tissue trash essentially. That takes only about 15 minutes and is done right ON THE PREMISES/IN THE OPERATING SUITE and then THOSE PATIENT'S OWN CELLS ARE RE-INJECTED BACK INTO SAME PATIENT aka 1271 SAME DAY PROCEDURE !

Analogous to a VEIN GRAFT (NOT FDA regulated under 1271) or a tissue burn graft (NOT regulated) - the list of similar procedures is long.

BUT FOR WHATEVER REASON - the FDA got head strong and is "trying" to claim that the mere act of a enzyme digestion and centrifuge to SEPARATE SAME CELLS REMOVED (just that they're messy mixed into some body fat) and REIMPLANT TO SAME PATIENT ON SAME DAY = a "NEW DRUG" and thus would need FDA IND and clinical trials blah blah blah. The FDA's "claims" is supposedly that USRM and other clinics are "MANUFACTURING A NEW DRUG" and would be regulated as same- such as a new antidepressant or cholesterol med or blood pressure med etc which is RIDICULOUS ON ITS FACE !

VEIN GRAFTS (SAME FDA codified sections regulating tissues and cells) = saline washed and cleaned, snipping, cutting, throwing away much of what is removed = NOT the same as what came out of patient ALL gets put back in, and NOT in same place for same use = simple example of many the Defense is using, and rightfully so. Aka NOT FDA REGULATED, NOT "DRUGS" and qualify as SAME DAY SURGICAL PROCEDURES regulated by simple, routine "practice of medicine" by any physician, hospital, clinic, etc

SO - SUMMARY JUDGEMENT IN FL DISTRICT COURT AGAINST USRM - and they APPEAL IT TO THE 11th CIRCUIT (FL, GA, AL) and it's a long wait on the docket of course (1 yr essentially)- AND THEY ARE GETTING ORAL ARGUMENTS (next Wed) - that means the 3 judge APPELLATE PANEL IS SERIOUS, as they limit oral arguments to very few cases. Most of the time- they write/render their opinion ONLY ONE THE WRITTEN BRIEF SUBMITTED !!

6) KEY EVENT TAKES PLACE - MAJOR KEY: AFTER USRM received SUMMARY JUDGEMENT which essentially SHUT DOWN/STAYED THEIR CLINIC BUSINESS and large revenues and profits from same, the CA CLINIC CHAIN FINALLY GOT THEIR CASE MOVED THROUGH THE CA COURT and the FDA "tried" EXACT same "MOTION FOR SUMMARY JUDGEMENT" but the CA judge Jesus Bernal said, "NOPE, NOT EVEN CLOSE - this is going to a bench trial at a minimum" = INDIRECT WIN FOR USRM as now you have TWO Federal courts w/ two differing opinions on IDENTICAL ARGUMENTS presented by the FDA. THE CA case - you could literally take the USRM case/complaint written by the FDA and change a few names and few lines- that's how identical it is !!

SO, NO DICE FOR FDA IN CA - and it's now awaiting at least a bench trial and it's CLEAR that Judge is "leaning" to "FDA YOU MAKE NO SENSE, HAVE NO RIGHTS HERE" !

USRM is having ORAL ARGUMENTS right as the CA CASE hits this key milestone- thus IN THEIR WRITTEN APPEAL, USRM CITES IN FULL (as an addendum) THE ENTIRE CA Judge ruling on HIS VIEW/OBJECTION TO THE FDA ! The 11th Circuit thus has a SITTING JUDGE TO READ AS PART OF THE APPEAL- and why he, IN CA, doesn't "buy it" what the FDA is pushing -

7) Moreover- another BIG KEY is the "Chevron doctrine" specifically came up in CA, aka "Deference" to a "regulatory agency" which has been BIG TIME getting whacked in court cases lately, including up to the SUPREME COURT !

It's the concept of given broad, far reaching plenary powers to un-elected big "agencies" who suddenly OVER-REACH and start regulating the shit out of everything via never ending expansion of "rules" but NOT LAW as written and properly passed BY A LEGISLATOR = the only way "law" can exist, NOT BY WRITING A "RULE BOOK" at an "agency" in this case the FDA. So, DEFERENCE and CHEVRON DOCTRINE and lack of being impressed by same also cited by CA judge in CA Case = huge whack at FDA over-reach also.

8) THAT IS WHERE IT'S AT !

USRM and the CA Clinic chain are using the EXACT SAME LEGAL FIRM- a powerhouse mega firm out of Washington D.C. named Venable, well, well known and who is "tight" with Congress, etc. USRM then has a local trial lawyer and law firm they've used for years, Issac Mitrani (Harvard Law - he's top shelf) who will make the actual oral arguments for them as he's admitted to practice in FL obviously and before the 11th Circuit and Venable as a "team" will be pro hac vice admitted as "our supporting legal team" -

THAT IS IT:

Here's all the key items on the cases- starting with the USRM State level case, then their FEDERAL APPEAL BRIEF and then the links to the CA CASE - it's a LOT of 1271 and HCP jargon- you need to be familiar with FDA regs and terminology for tissues and cells and same day, etc. I'm familiar with all of it -

USRM State court case: Result SUMMARY JUDGEMENT TO PLAINTIFF aka FDA:

https://www.pacermonitor.com/public/case/24475300/United_States_of_America_v_US_Stem_Cell_Clinic,_LLC_et_al

https://www.courtlistener.com/docket/6591638/united-states-v-us-stem-cell-clinic-llc/

USRM FEDERAL APPEAL- their entire brief as submitted. FEDERAL APPEALS ARE EXTREMELY RIGID in page count allowed, addendums allowed, exhibits allowed, formatting etc. They are REASONABLY SHORT and must be TIGHTLY AND CLEANLY "TO THE POINT" written - as APPELLATE JUDGES have massive docket loads in their courts and don't want their time wasted:

https://www.pacermonitor.com/view/4ZUDN7Y/USA_v_US_Stem_Cell_Clinic_LLC_et_al__11cae-19-13276__11013175.0.pdf

THAT LEGAL BRIEF/APPEAL RIGHT THERE LINKED ABOVE = USRM FOR A MASSIVE WIN IMO - it's a WRECKING BALL ON THE FDA and the bullshit LOWER COURT "SUMMARY JUDGEMENT". It's CRYSTAL CLEAR ON "the law", it's tight, short and makes CLEAR the FDA "made law" where none exists !!


THEN THE CA CASE aka PARALLEL NEAR MIRROR IMAGE CASE ON THE OPPOSITE COAST (CA to FL - about as far apart as one can get in the USA !):

https://www.pacermonitor.com/public/case/24469480/United_States_of_America_v_California_Stem_Cell_Treatment_Center,_Inc_et_al

https://www.courtlistener.com/docket/6550705/united-states-v-california-stem-cell-treatment-center-inc/

COMMENTARY ON JUDGE in CA DENYING SUMMARY JUDGEMENT :

https://ipscell.com/2020/01/in-landmark-step-judge-does-not-defer-to-fda-in-stem-cell-clinic-chain-case-orders-full-trial/

THE LAW FIRMS INVOLVED:

https://www.venable.com/services/practices/food-and-drug-law

USRM and their FL local firm/trial lawyer who will make their oral argument next Wed at the 11th Circuit:

http://www.mitrani.com/attorneys/isaac-j-mitrani/

THAT IS IT in a nut shell - good luck.

IMO, USRM IS GOING TO BEAT THE FDA ON APPEAL - their brief is air tight, it's sound in LAW and the FDA CONTRADICTS THEMSELVES PROFUSELY and "made law" out of "guidance documents" = a big ole NO-NO !!