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Thank you good sir!
Alo interesting but not sure what to make of it. Today I bought 41,500 shares at .0225. They all executed at once. It does not show on the chart or record at ALL. Can anyone explain to me how or why that would happen? I definitely made the purchase as the new shares are added to my total...?
Basically what I thought USRM lawyers would say in regards to the attempt to block testimony of former patients.
You can’t have it both ways, either the safety is relevant or it isn’t and FDA already made it an issue, so if it’s an issue so much, then let’s get some patients in here to talk about safety and effacy. Let’s also look at our peer reviewed studies.
Touché
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA FT. LAUDERDALE DIVISION
CASE NO.: 18-CV-61047
UNITED STATES OF AMERICA, Plaintiff,
v.
US STEM CELL CLINIC, LLC, a Florida limited liability company,
US STEM CELL, INC., a Florida profit corporation, and
KRISTIN C. COMELLA and THEODORE GRADEL, individuals,
Defendants.
DEFENDANTS’ OPPOSITION TO PLAINTIFF’S MOTION IN LIMINE TO EXCLUDE TESTIMONY OF ANECDOTAL SAFETY AND/OR EFFICACY
Defendants US Stem Cell Clinic, LLC (“USSCC”), US Stem Cell, Inc., and individual Kristin C. Comella (collectively, “Defendants”) hereby oppose Plaintiff’s motion in limine to exclude anecdotal testimony from Defendants’ witnesses regarding the safety and/or efficacy of the Defendants’ SVF Surgical Procedure at issue in this action.
I. PLAINTIFF’S MOTION IN LIMINE SEEKS TO IMPROPERLY USURP THIS COURT’S DISCRETION TO WEIGH ALL RELEVANT EVIDENCE
Plaintiff asks this Court to exclude certain testimony regarding the safety and efficacy of the surgical procedure at issue here. Specifically, Plaintiff argues that this testimony should be excluded because any probative value presented “is substantially outweighed by danger of unfair prejudice, confusing the issues, [or] misleading the jury.” Chavez v. Arancedo, No. 17-20003-Civ- TORRES, 2018 WL 4627302 (S.D. Fla. Sept. 26, 2018) (citing Fed. R. Evid. 403) (emphasis added).
Case 0:18-cv-61047-UU Document 66 Entered on FLSD Docket 04/12/2019 Page 2 of 5
This argument is wholly unavailing as this is a bench trial—not a jury trial. Thus, any concerns of unfair prejudice, confusion of the issues, and misleading the jury are not present. Indeed, exclusion of evidence on the basis of “unfair prejudice,” as Plaintiff seeks here, is considered a “useless procedure” in a bench trial proceeding. See Gulf States Utils. Co. v. Ecodyne Corp., 635 F.2d 517, 519 (5th Cir.1981).1 As the court in Gulf States recognized, “in a bench trial, the . . . judge can also exclude those improper inferences from his mind in reaching a decision.” Id. The Eleventh Circuit has deemed exclusion of evidence on the basis of “unfair prejudice” inapplicable to bench trials. See also U.S. v. Vigne, 571 F. App’x 932 at n.2 (11th Cir. 2014) (“[Rule 403 balancing] has ‘no logical application to bench trials.’”); Health First, Inc. v. Hynes, 628 F. App’x 723, 724 (11th Cir. 2016) (“[W]e assume that, in a bench trial, the trial judge can exclude improper inferences from his mind in reaching a decision.” (internal quotations omitted)).
This Court is more than capable of assessing all relevant evidence and determining what evidence to consider and what evidence to reject. It is not Plaintiff’s role to limit what this Court considers. Accordingly, Plaintiff’s motion in limine should be denied.
II. PLAINTIFF HAS PLACED ANECDOTAL EVIDENCE OF SAFETY AND EFFICACY AT THE CENTER OF THIS CASE AND SHOULD NOT BE ABLE TO HAMSTRING DEFENDANTS’ ABILITY TO REBUT THAT EVIDENCE
Moreover, Plaintiff’s attempt to paint as irrelevant anecdotal evidence regarding the safety and efficacy of the SVF Surgical Procedure is unavailing. Indeed, at every opportunity, Plaintiff has taken it upon itself to bring the Court’s attention to various isolated, anecdotal adverse events that have allegedly occurred due to Defendants’ procedures. For example, in its Complaint, Plaintiff discusses alleged “adverse events,” describing three patients who experienced problems
1 In Bonner v. City of Prichard, 661 F.2d 1206 (11th Cir. 1981) (en banc), the 11th Circuit adopted as binding precedent all of the decisions of the former Fifth Circuit handed down before the close of business on September 30, 1981.
Case 0:18-cv-61047-UU Document 66 Entered on FLSD Docket 04/12/2019 Page 3 of 5
after receiving the Defendants’ surgical procedure. Again, in Plaintiff’s Motion for Summary Judgment, Plaintiff discusses various isolated, anecdotal “adverse events,” expending an entire section of its memorandum in support of its motion—titled “Adverse Medical Events”—to reiterate the events outlined in its Complaint. Dkt. No. 42 at 10. Then, in yet a third instance, in Plaintiff’s Opposition to Defendants’ Motion for Summary Judgment, Plaintiff again discusses isolated, anecdotal “adverse events,” stating that “Defendants’ product has, indeed, been associated with serious adverse events such as blindness and vision impairment.” Dkt. No. 49 at 1. Just two weeks ago, in its Statement of the Case included as part of the parties’ Joint Pretrial Stipulation, Plaintiff alleged that Defendants’ SVF Surgical Procedure leads to “devastating outcomes,” is associated with “serious adverse events,” and may lead to “calamities.” Dkt. No. 55 at 2.
If one thing is clear here, it is that Plaintiff seeks to portray the Defendants’ business practices as those of lawless renegades. Nothing could be further from the truth. Testimony from satisfied patients to rebut the incorrect characterization of Defendants’ business practices—which, based on its filings, appears to be part of Plaintiff’s case in chief—is certainly relevant. Therefore, testimony demonstrating safety or efficacy is relevant and admissible, and should not be excluded.2
CONCLUSION
Plaintiff’s concerns that this Court may confuse the issues or be misled are misplaced. This Court has the authority to hear all evidence and make decisions regarding the weight attributable to each piece of evidence. Therefore, Plaintiff’s motion in limine should be denied.
DATED: April 12, 2019 Respectfully Submitted,
/s/ Isaac J. Mitrani
2 If, however, this Court determines that Defendants’ anecdotal evidence of safety and efficacy should be excluded, this Court should exclude Plaintiff’s anecdotal evidence as well.
Case 0:18-cv-61047-UU
Document 66
Entered on FLSD Docket 04/12/2019
Page 4 of 5
Isaac J. Mitrani
Florida Bar No. 348538
Loren H. Cohen
Florida Bar No. 303879
MITRANI, RYNOR,
ADAMSKY & TOLAND, P.A.
301 Arthur Godfrey Road, Penthouse Miami Beach, FL 33140
Tel.: 305-358-0050
Fax: 305-358-0050 imitrani@mitrani.com lcohen@mitrani.com dbitran@mitrani.com ctenn@mitrani.com miamidocketing@mitrani.com
Todd A. Harrison (admitted pro hac vice) Todd H. Halpern (admitted pro hac vice) Stephen R. Freeland (admitted pro hac vice) Mary M. Gardner (admitted pro hac vice) Venable LLP
600 Massachusetts Avenue NW Washington, DC 20001
Attorneys for Defendants US Stem Cell Clinic, LLC, US Stem Cell, Inc., and Kristin C. Comella
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA FT. LAUDERDALE DIVISION
CASE NO.: 18-61047-CIV-UNGARO/O’SULLIVAN
UNITED STATES OF AMERICA, Plaintiff,
v.
US STEM CELL CLINIC, LLC, a Florida limited liability company,
US STEM CELL, INC., a Florida profit corporation, and
KRISTIN C. COMELLA, individual, Defendants.
JOINT MOTION TO WITHDRAW JURY DEMAND
Pursuant to Federal Rule of Civil Procedure 38(d), the parties consent and hereby move to withdraw the Jury Demand of right contained in Defendants’ Answer (D.E. 26) as Plaintiff has represented that it does not intend to seek monetary damages in the instant action.
DATED: April 12, 2019
JOSEPH H. HUNT Assistant Attorney General
JAMES M. BURNHAM
Deputy Assistant Attorney General Civil Division
GUSTAV W. EYLER
Acting Director
Consumer Protection Branch
ALAN PHELPS Assistant Director
Respectfully Submitted,
ARIANA FAJARDO ORSHAN UNITED STATES ATTORNEY
JAMES A. WEINKLE
Assistant United States Attorney Florida Bar No. 0710891
99 N.E. 4th Street, Suite 300 Miami, Florida 33132
Tel.: 305.961.9290
Email: James.Weinkle@usdoj.gov
Case 0:18-cv-61047-UU Document 65 Entered on FLSD Docket 04/12/2019 Page 2 of 3
/s/ Roger J. Gural____
ROGER J. GURAL
Roger J. Gural
Trial Attorney
Consumer Protection Branch United States Department of Justice Washington, DC 20044
P.O. Box 386
Tel.: 202.307.0174
Email: roger.gural@usdoj.gov
Counsel for United States of America
Todd A. Harrison (admitted pro hac vice) Todd H. Halpern (admitted pro hac vice) Stephen R. Freeland (admitted pro hac vice) Mary M. Gardner (admitted pro hac vice) Venable LLP
600 Massachusetts Avenue NW Washington, DC 20001
Attorneys for Defendants US Stem Cell Clinic, LLC, US Stem Cell, Inc., and Kristin C. Comella
/s/ Isaac J. Mitrani___
Isaac J. Mitrani
Florida Bar No. 348538
Loren H. Cohen
Florida Bar No. 303879
MITRANI, RYNOR,
ADAMSKY & TOLAND, P.A.
301 Arthur Godfrey Road, Penthouse Miami Beach, FL 33140
Tel.: 305-/358-0050
Fax: 305/358-0050 imitrani@mitrani.com lcohen@mitrani.com dbitran@mitrani.com ctenn@mitrani.com miamidocketing@mitrani.com
Two new documents.
Hyperbole
So is that 8,000 number that was posted by Joey correct?
I hope she rules on summary judgement.
And yes to the new lawyer joining the team, hiring EX-FDA lawyers and Ex DOJ lawyers is genius
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA FT. LAUDERDALE DIVISION
CASE NO.: 18-CV-61047
UNITED STATES OF AMERICA, Plaintiff,
v.
US STEM CELL CLINIC, LLC, a Florida limited liability company,
US STEM CELL, INC., a Florida profit corporation, and
KRISTIN C. COMELLA and THEODORE GRADEL, individuals,
Defendants.
DECLARATION OF ISAAC MITRANI IN SUPPORT OF DEFENDANTS’ UNOPPOSED MOTION TO CONTINUE TRIAL DATE
I, ISAAC MITRANI, declare under penalty of perjury pursuant to 28 U.S.C. § 1746 that:
1. I am an attorney and managing director of the law firm of Mitrani Rynor Adamsky Toland, P.A., with offices at 301 Godfrey Road, Penthouse, Miami Beach, Florida 33140, attorneys for Defendants US Stem Cell Clinic, LLC; US Stem Cell, Inc.; Dr. Kristin C. Comella (collectively, the “Defendants”). I am over the age of eighteen and understand the nature and obligations of a declaration made under the penalty of perjury. I have personal knowledge of the facts contained in this Declaration, and if called as a witness, I could and would testify competently under oath as to such facts. I submit this declaration in support of Defendants’ Motion to Continue the Trial Date.
2. I intend to serve as trial counsel for Defendants, along with Michael Blume (pro hac vice pending) and Mary M. Gardner of Venable LLP.
Case 0:18-cv-61047-UU Document 64-1 Entered on FLSD Docket 04/11/2019 Page 2 of 2
3. As I am admitted to the bar of the United States District Court for the Southern District o f Florida and have tried cases before the Southern District o f Florida for over thirty years, I intend to serve as an integral part ofthe Defendants' trial team.
4. I am unable to work on June 10, 2019, the first scheduled day of trial, due to religious observance o f the Jewish holiday o f Shavuot.
5. Moreover, I am unable to attend trial from June 14, 2019 to June 17, 2019, as I am scheduled to attend my son's graduate school graduation in California and will be traveling and attending graduation activities during that time period.
I declare under penalty ofperj that the foregoing is true and correct.
Dated: April 11, 2019
I think that’s more to do with making sure that if it goes all the way to trial, that nothing is scheduled on the dates mentioned in the motion because the one of the attorneys can’t be there on one day for religious reasons and one another because of the graduation of his son.
Thank you for the correction. I was just reading what was otcmarkets.com
Thanks again
I don’t know if it is or isn’t but when I checked in comparison to other stem cell companies with similar floats and when I check it with other stem cell stocks that are in the dollars, the number was comparable to those companies.
No worries, happy to spread the info!
No problem good sir
No problem, happy to help. There are 540 shareholders according to OTC markets and we all deserve transparency as much as possible.
So grateful dude.
Imagine if this case was going on in 2003 sheesh
If I weren’t able to keep such taps on what’s going on in the case and around the world with stem cell therapy via social media, alternative news outlets and the internet, i can’t say that I’d have the nuts to have my money here.
Thankful for innovation
We’ve already established why Gradel signed the agreement. He should’ve never been served a lawsuit to begin with.
Formalities at this point
Still awaiting summary judgement from Judge Usrsula Ungaro
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA FT. LAUDERDALE DIVISION
CASE NO.: 18-CV-61047
UNITED STATES OF AMERICA, Plaintiff,
v.
US STEM CELL CLINIC, LLC, a Florida limited liability company,
US STEM CELL, INC., a Florida profit corporation, and
KRISTIN C. COMELLA and THEODORE GRADEL, individuals,
Defendants.
DEFENDANTS’ UNOPPOSED REQUEST FOR HEARING
Pursuant to Local Rule 7.1(b)(2), Defendants US Stem Cell Clinic, LLC, US Stem Cell, Inc., and individual Dr. Kristin C. Comella request the opportunity to present oral argument on each party’s Motion for Summary Judgment (Dkt. No. 41 and 42). Upon submission of the parties’ motions for summary judgment, oppositions thereto, and replies in further support, Defendants appreciate that the parties and the Court are likely to benefit from an in-person hearing regarding the complex legal and scientific issues presented by the parties in the motions. Defendants believe that an allotment of one hour will be sufficient time for this hearing. Plaintiff has represented that it believes the motions can be decided on the written record, but does not oppose the relief requested.
DATED: April 10, 2019 Respectfully Submitted,
/s/ Isaac J. Mitrani Isaac J. Mitrani
Florida Bar No. 348538
Case 0:18-cv-61047-UU
Document 61
Entered on FLSD Docket 04/10/2019
Page 2 of 3
Loren H. Cohen
Florida Bar No. 303879
MITRANI, RYNOR,
ADAMSKY & TOLAND, P.A.
301 Arthur Godfrey Road, Penthouse Miami Beach, FL 33140
Tel.: 305-358-0050
Fax: 305-358-0050 imitrani@mitrani.com lcohen@mitrani.com dbitran@mitrani.com ctenn@mitrani.com miamidocketing@mitrani.com
Todd A. Harrison (admitted pro hac vice) Todd H. Halpern (admitted pro hac vice) Stephen R. Freeland (admitted pro hac vice) Mary M. Gardner (admitted pro hac vice) Venable LLP
600 Massachusetts Avenue NW Washington, DC 20001
Attorneys for Defendants US Stem Cell Clinic, LLC, US Stem Cell, Inc., and Kristin C. Comella
LOCAL RULE 7/1 CERTIFICATE OF GOOD FAITH CONFERENCE
The undersigned attorney, counsel for Defendants, hereby certifies that she has conferred with Mr. Roger Gural, Esq., counsel for Plaintiff, and is authorized to represent that Plaintiff believes the motions can be decided on the written record, but does not oppose the relief requested.
/s/ Mary M. Gardner
Case 0:18-cv-61047-UU Document 61 Entered on FLSD Docket 04/10/2019 Page 3 of 3
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on April 10, 2019, a true and correct copy of the foregoing Defendants’ Unopposed Request for Hearing was filed with the Clerk of the Court via CM/ECF and the CM/ECF system will send a notice of electronic filing to all counsel and parties of record listed on the Service List Below.
/s/ Isaac J. Mitrani
Isaac J. Mitrani
Florida Bar No. 348538
MITRANI, RYNOR,
ADAMSKY & TOLAND, P.A.
301 Arthur Godfrey Road, Penthouse Miami Beach, FL 33140
Tel.: 305-/358-0050
Fax: 305/358-0050 imitrani@mitrani.com dbitran@mitrani.com ctenn@mitrani.com miamidocketing@mitrani.com
Attorneys for Defendants US Stem Cell Clinic, LLC, US Stem Cell, Inc., Kristin C. Comella and Theodore Gradel
Kristin and USRM requested to also submit an oral argument for their summary judgement clause :)
JUST IN CASE the scientific mumbojumbo may be too complex for layman to understand.
20 years but YES I was thinking the same thing exactly. Sounds like within the last year or two there has been 2,000 procedures alone.
THANK YOU
Newsmax story out posted by Kristin Comella. I don’t have a login so I can’t read all of the article.
“As Singer tells newsmax “if I want to take my own tissue- my own, not someone else’s - prepare it a certain way, and then put it back in my own body, that’s as sacred as free speech. From a medical ethics stand point, it’s a patients autonomy question”
https://www.newsmax.com/t/newsmax/article/910566?fbclid=IwAR0QeCGUNzaJzMiAjWeoYDnqIFZueoMy4Z-vrN28sFUDi6tNEUaEYBjqVok§ion=platinum&keywords=stem-cell-clinics-fda&year=2019&month=04&date=07&id=910566&oref=m.facebook.com
Amazing right?!
NOW 12,000 PATIENTS TREATED WITH USRM KITS
In the new interview video, Kristin states that they recently crossed the 12,000 patient threshold (33:45 min mark)
She also revealed she’ll be presenting at the SOPMED conference in June: https://sopmed.org/product/2019-conference-ticket/
New interview:
M Y O C E L L
“With the judge expected to rule any day on the government’s charge that U.S. Stem Cell is “openly violating the law and endangering patients,” legal experts say the case could constrain a lucrative industry accused by doctors, lawyers and federal officials of harming dozens of people.”
In the words of LoneWolf..
Tick tock tick tock...
The amount of publicity our suit is getting. Imagine the amount of eyes who have seen these articles. Now imagine if they WIN the case. So much free publicity :)
NFL LEGEND Eddie George and wife have fat derived stem cell therapy. Not at USRM. But his quotes about the effectiveness of the procedure :)
THIS
Agreed
Im on Comellas Facebook page. There is an overwhelming amount of support. I don’t see any negative comments in any of her recent post. There is One comment from a random lady under the roger stone post. she is not a dr. she is not a physician. She is just a lady giving her opinion. You can feel how you want about Roger Stone the same way you can feel about Donald Trump. Bottom line, he's close to the president, and Trump is the president.
More and more hospitals moving this way. More and more articles about it, word is out. Stem cells are in. They try to paint them as bad in every major news stories but they wouldn’t continue to grow if the promise wasn’t there.
https://www.pbs.org/newshour/health/why-expensive-unproven-stem-cell-treatments-are-a-new-health-care-trend