Unproven stem cell clinic firm US Stem Cell and many others are apparently facing potential malpractice lawsuits. How it came to light via US Stem itself is somewhat surprising.
US Stem Cell and malpractice notice
The news popped up in an SEC filing by US Stem Cell, which I wasn’t even sure was still active as a business. The publicly-traded firm, whose stock price hovers near $0.00, listed several legal proceedings in this newest SEC filing. I’ll have more on those in a minute. A reader sent me a heads-up on the SEC filing.
Here’s the part with the surprise:
“On February 2, 2023, the Company received a notice of intent to initiate medical malpractice litigation. The Company is reviewing the notice and responding accordingly. The company was one of 11 entities and persons served with the notice.”
Eleven?
How do they happen to know and mention in the SEC filing that 10 other firms and/or people will be facing possible medical malpractice litigation too?
Who else is facing potential malpractice suits?
Who are these other firms or people?
Is there some connection between all eleven of them including US Stem?
It’s going to be interesting to find out who and what firms are involved.
Note that according to the SEC filing, former leader Kristin Comella is now running an independent entity called US Stem Cell Clinic, “On February 10, 2021, as part of a settlement agreement, the Company transferred its entire member interest in U.S. Stem Cell Clinic, LLC to Dr. Kristen Comella as settlement for $100,000 of accrued interest owed to Dr. Comella.”
This could be confusing for people since both firms’ names contain the phrase “US Stem Cell”.
Other US Stem legal proceedings
The list of other legal proceedings of US Stem Cell reminds us of the firm’s past issues including some patients.
- US Stem will pay hundreds of thousands related to the case of Jeannine Mallard.
- They said they had to pay $100,000 of an insurance deductible related to the case of Patsy Bade. Does US Stem Cell still have malpractice insurance? Is there tail coverage?
- There’s another case mentioned where they will have to pay $500,000 but it doesn’t mention specifics of plaintiffs, etc.
- A case involving a suit by Brenda Leonhardt appears to be pending based on the SEC document.
What is US Stem doing now? Comella?
Overall, this firm is likely to remain in the news for years to come even if they aren’t involved anymore in stem cell clinic offerings.
Their website lists some other efforts including one related to a 2009 IND. I’m not clear on the status of this clinical program. For example, one called Myocell, when searched on Clinicaltrials.gov, pulls up four results but they have “unknown” statuses. A search for another product, Adipocell, finds just one old completed trial with its last update being in 2009.
The SEC filing lists this staggering financial situation amid doubts about the company’s future: “As of December 31, 2022, we have accumulated a deficit of approximately $139.8 million.”
Kristin Comella also had a new business incarnation as Regenerwave at one point, but it’s hard to tell what’s going on with it since the website isn’t working.
A four-month old YouTube interview with her suggests she’s still doing some kind of stem cell stuff. Maybe something outside the scope of the FDA lawsuit that led to a permanent injunction? Perhaps autologous bone marrow? New companies are mentioned.
Yes, this is a fascinating development to put it mildly IMO !!
Eleven defendants to be potentially named in what appears to be “one combined med-mal lawsuit” and obviously involving some sort of harmed patient who received some sort of apparent “stem cell treatment” via the way it is described.
Some may wonder “why so long from the US Stem Sec notice” and yet no lawsuit formally filed yet ? My guess is, this med-mal lawsuit will be in FL since US Stem is in FL and as you stated, Kristin Comella operated their partially owned clinic US Stem Cell Clinic LLC and they also operated several other FL based clinics such as the Palm Beach Clinic in partnership with a firm named GACP LLC, etc.
Both CEO Tomas and Kristin Comella acted as “consultants to run the various GACP clinics they planned to roll-out in large numbers” per prior sec filings. Thus, IMO this lawsuit is potentially going to involve one of those clinics of which US Stem Cell Inc and US Stem Cell Clinic LLC and/or Kristin Comella and CEO Mike Tomas had a hand in running and managing.
Thus, given all that – it is my understanding that in FL, in order to file a med-malpractice lawsuit there is required a quite extensive and thorough pre-notification stage that occurs per FL law. Moreover, the lawyers involved most likely do a thorough search for all insurance policies that may (or may not) exist to decide if the case has a decent probability to “settle” for enough payment to make it worth their extensive time and work to bring and try and win such a lawsuit. There are statute(s) of limitations and many other factors that come into play also I’d suspect too. Thus, it would not be unusual IMO for a few months to pass before such a lawsuit is “filed as a formal complaint in the appropriate FL court” if it is indeed FL based.
As to Comella – she indeed was morphing what was (past tense) U.S. Stem Cell Clinic LLC into a new version called “Regenerwave” and even had it to where one entered the old website usstemcellclinic.com and it would auto-redirect to regenerwaveclinic.com. That website now also appears dead and gone though ?
I did a check of the FL Secretary of State and US Stem Cell Clinic LLC is still “active” and filed and up to date and indeed, Kristin Comella is still the owner/manager of same.
The prior long time address of US Stem Cell Clinic LLC was 1290 WESTON ROAD
SUITE 203A, WESTON, FL 33326.
Comella has changed the address now on the FL SOS filings to: 9874 Yamato Road
122, Boca Raton, FL 33434
I took that and searched the FL SOS site and Google maps etc and found that it appears Comella is moving to Boca Raton to open a new clinic there – named “Infinite Impact” and she’s registered it as a d/b/a (doing business as) in FL tied to US Stem Cell Clinic LLC etc.
And yes, it appears they have a newly built website up now and it’s got a “Pre Grand Opening” banner on it. infiniteimpacthealth.com
It appears very similar to prior Comella “stem cell clinics” with a IMO new “tilt” of adding this sort of “Biohacking stuff” but shows 100% for sure Comella appears she will still be doing “stem cell treatments” of various kinds also. I can not find who the main physician will be yet to be the resident licensed medical doctor of this facility however ?
That’s what I can find on all this and this as stated, very, very interesting potential new lawsuit with such a massive list of potential defendants apparently initially named in some “pre notification letter” US Stem Cell Inc received and potentially totaling eleven businesses/entities and/or individuals.
This article offers a perspective and explanation of the U.S. District Court Judge Jesus Bernal in Stem Cell Treatment Center, court ruling in California.
MEDPAGEToday (contains quotes by Paul Knoepfler PhD)
09/07/22 “Judge Rules in Favor of Stem Cell Clinic
— Decision likely to be appealed, but could still have implications for FDA regulation”
https://www.medpagetoday.com/special-reports/features/100571
@Neil
That case is already in appeal before the CA Ninth Circuit. It will likely take approx 1.5 to 2 yrs more to a final ruling, being that the 9th Circuit federal appellate court is one of the most backed-up in the nation. That case can be found here:
https://www.pacermonitor.com/public/case/46663774/USA_v_California_Stem_Cell_Treatment_Center,_Inc,_et_al
It’s far from over on that case – as the precedent was set against US Stem Cell Inc and US Stem Cell Clinic LLC when they lost at the east coast based 11th circuit court of appeals (Jurisdiction over FL).
The 11th is located in Washington D.C. and the 3 panel judge who ruled in favor of the FDA-DOJ were some very, very big hitters when it came to regulatory law. The Sr judge who wrote the 11th circuit final opinion was judge Douglas Ginsburg, a long, long time sitting Sr appellate judge and highly respected on all things “federal regulatory matters” etc.
The 9th is likely to give a fair amount of deference to the 11th before deciding which way to go. Appellate courts can “split” across the nation – but the 11th is as stated, sort of thee power court for all things D.C. based “regulatory” thus the 9th circuit is going to give some serious thought IMO before splitting with the already written final brief and decision of the 11th.
Only higher court in the land after that – would be an appeal to SCOTUS thee Supreme Court who can “take the case” or choose to “reject hearing it” as they have total control over what cases they take or refuse from the lower appellate courts they supervise.