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What the Washington post article really did was shed light on the fact that FORSURE Us Stem Cell is one of if not the leader in adipose stem cell therapy and education In the US.
It also for the first time gave legal opinions from experts who say that this COULD POSSIBLY not end well for the FDA.
Lastly it exposed that Kristin has made connections inside the White House (Roger stone and the newsmax guy) and that the president is aware of this lawsuit currently or ones like it and he does not approve.
Will see how it plays out but I’m actually thankful they wrote the article. Confirmation that we’re the leader coming from the Washington post sounds legit.
And I loovveeeee this comment towards the end about Trump not letting the FDA get away with this!
“Meanwhile, Comella is continuing her campaign against the FDA. In addition to meeting with Stone, Ruddy and the White House official, she said she managed to get a message directly to the president.
Roy Hinman, a doctor who was trained by Comella and runs 45 clinics throughout Florida, said he had a 15-second exchange with Trump in July, during a photo op at a rally in Tampa.
Hinman said he praised Trump’s effort to decrease government regulation and warned him that agencies such as the FDA were undermining his agenda by using guidances and policy letters to crack down on businesses.
The president, Hinman said, “looked at me and said, ‘I know what they’re trying to do and they’re not going to get away with it.’ ”
The White House did not respond to requests for comment about Hinman’s account. In an interview, Gottlieb, who recently resigned and is set to leave office Friday, said he has seen no sign of White House interference.
“We’ve had broad support up the line,” he said, “for the actions we’ve taken.”
If you were ever wondering if USRM was the leader of the industry, that JUST GOT CONFIRMED BY THE WASHINGTON POST!
“With $6.7 million in revenue last year, U.S. Stem Cell operates three clinics and has trained doctors at 150 others, making it one of the most influential stem cell companies in the nation. Over the past year, it has hired a top law firm to defend against the lawsuit, and cultivated formidable allies with close ties to President Trump, including GOP operative Roger Stone and Newsmax chief executive Christopher Ruddy.
Kristin Comella, the company’s chief scientific officer, said she met late last year with a White House official, whom she declined to identify, to press the administration to get the FDA to back off. The White House did not respond to a request for comment.”
:) can you believe that “one of the most influential stem cell companies in the nation” is right here before our eyes?!
Kristin is getting GRILLED in the media and harassed by news outlets outside of her gym. With what she brings to the company, for me to stay, I would accept nothing less than what I felt it was worth to stand on the forefront of this onslaught. The outstanding share increase has been minimal over the last two years.
I can’t call will happen, I’m no expert there are companies with bigger inside issues and less potential revenue intake in the OTC that trade in the dollars so to think we could not get there..
We saw 17. with nearly the same amount of outstanding shares before the lawsuit and senator crap
Yeah super hard to call. Especially with the opportunity for partnerships whether they win or lose either here or overseas. So with that in mind also, makes it super tough to call. 1$ will change lives :)
USRM response:
Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 1 of 9
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 US STEM CELL, INC., US STEM CELL CLINIC, LLC, AND KRISTIN C. COMELLA’S REPLY IN FURTHER SUPPORT OF THEIR MOTION FOR SUMMARY JUDGMENT
I. Introduction.
The Defendants’ SVF Surgical Procedure is not subject to regulation by the FDA. The Defendants do not “manufacture” anything, let alone a “drug.” Instead, they use a patient’s own cells, cells that are not transformed into anything else. The Defendants do not expand the cells; they do not combine the cells with a drug; they do not add genes to the cells. Nothing about these cells is materially changed during the Defendants’ SVF Surgical Procedure. The cells are just taken out of a person’s body, isolated, and put back into that person’s body approximately thirty minutes after removal. To call this process the “manufacture” of a “drug” stretches the meaning of those terms beyond recognition.
The Defendants’ SVF Surgical Procedure thus fits well within the SSP Exemption. The plain language of the SSP Exemption exempts procedures that occur during a single sitting in
Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 2 of 9
which the human cell or tissue that is put back into the patient is not significantly altered from the form in which it naturally exists in the same patient’s body. That is what happens here; nothing more.
II. Defendants’ SVF Surgical Procedure is not subject to regulation by the FDA.
A. Defendants’ SVF Surgical Procedure falls within the SSP Exemption.
The language of the SSP Exemption is plain on its face—if a party’s procedure satisfies the four elements of the SSP Exemption, it is exempt from all regulation by the FDA. Namely, a party is exempt from regulation provided the party’s procedure “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).
Here, Defendants’ SVF Surgical Procedure is exempt from regulation. Indeed, in its Opposition, Plaintiff does not even dispute that Defendants’ SVF Surgical Procedure satisfies the first three criterion of the SSP Exemption. Specifically, the parties do not dispute that the SVF Surgical Procedure involves HCT/Ps, is for autologous use (i.e., the procedure must involve transplanting HCT/Ps into the same patient from whom the HCT/Ps were removed), and occurs during a single sitting.
The only real dispute here—a legal one—involves whether the Defendants’ SVF Surgical Procedure uses “such HCT/Ps.” It does. The cells put back into the patient during the procedure are the cells taken out.
B. “Such HCT/Ps” cannot mean “what is removed from the patient”; it must mean “what is put back in.”
The plain language of the SSP Exemption means that “such HCT/Ps” are the HCT/Ps implanted back into the patient. The FDA, however, argues that “‘such HCT/Ps’ describes the antecedent HCT/P’s” removed from an individual. Dkt. No. 49 at 4. Thus, under the FDA’s view,
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even though the SVF cells remain unchanged, they nevertheless constitute different HCT/Ps from the adipose tissue, which is first removed from the patient. Accordingly, as the FDA would have it, the SSP Exemption does not apply.
FDA’s interpretation is problematic on several, common sense levels. First, if the FDA’s interpretation is accepted, then a cell could never satisfy the definition of “such HCT/Ps,” despite the fact that the “C” in “HCT/P” stands for cells. A cell is always a component of something else; a cell can only be removed from a patient along with that something else. To put that cell back into the patient, then, it must be isolated in some way from the tissue that surrounds it. Nothing in the record suggests otherwise. But, if the FDA’s interpretation of the SSP Exemption is correct, then a “Cell” can never be subject to the SSP Exemption. This cannot be the FDA’s intended interpretation in crafting this regulation. If so, then why apply the SSP Exemption to anything other than “Tissue”? Why, in other words, include “Cells” in the SSP Exemption at all?
Second, the FDA’s own “current thinking” on the SSP Exemption—as memorialized in its 2017 Guidance—is inconsistent with the FDA’s litigation position. In that Guidance, the FDA states that HCT/Ps that undergo “rinsing, cleansing, sizing, or shaping that does not change its ‘original form’” are “such HCT/Ps.” Thus, according to the FDA’s “current thinking,” the HCT/P that is put back into the patient will not be the exact HCT/P that is taken out; some of the HCT/P that was taken out will be discarded. That “current thinking,” though, does not square with the FDA’s litigation position. By “rinsing, cleansing, sizing, or shaping” the “antecedent HCT/Ps,” a procedure would, by definition, alter the form of the HCT/Ps removed from the body. Common sense thus tells you that “rinsing, cleansing, sizing, or shaping” the HCT/Ps renders them something different from “such HCT/Ps,” thereby putting the procedure outside of the SSP Exemption. The FDA thus cannot make the regulation, its current thinking, and its litigation
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Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 4 of 9
position all line up. The only way to square all of the relevant terms—“such;” “rinsing, cleansing, sizing, or shaping;” “original form”—is to interpret the SSP Exemption as the Defendants do. When the unit of comparison is the HCT/P that is put back in—as Defendants contend—then any “rinsing, cleansing, sizing, or shaping” does not alter the “original form” of the HCT/Ps taken from the body. The “rinsing, cleansing, sizing, or shaping” affects only the tissue that is discarded, and not the tissue that is put back into the patient, which is what happens here. Because the SVF is unchanged from the time it is removed from the body (as part of the adipose tissue, some of which is discarded) until it is put back into the body, it remains “in the form removed from the body.” Dkt. No. 41-1 at 13. The SVF is, therefore, “such HCT/Ps.”
Third, avoiding common sense, the Government looks to “legalese,” in the form of legal dictionaries, to define the term “such.” That is improper. A legal definition is not the plain meaning of a term. Plaintiff boldly asserts that Defendants “cherry pick[ed] from several dictionary definitions,” but, ironically, concludes that the ordinary or plain meaning of a word is, instead, the “legal definition” of a word. Dkt. No. 49 at 6. This reading of ordinary or plain meaning is contrary to the interpretation of other federal courts. See, e.g., Dish Network Corp. v. Arch Specialty Ins. Co., 989 F. Supp. 2d 1137, 1144 (D. Colo. 2013), aff’d sub nom. Dish Network Corp. v. Arrowood Indem. Co., 772 F.3d 856, 875 (10th Cir. 2014) (“Not only should strained constructions be avoided in favor of common constructions, but technical and legal definitions should also be avoided. In other words, the plain meaning of the words should be employed in a lay manner consistent with what would be understood by a person of ordinary intelligence.”), and Schumacher v. Cargill Meat Sols. Corp., 515 F.3d 867, 871 (8th Cir. 2008) (“In the absence of a statutory definition or clear contrary legislative intent,” the court turned to Merriam-Webster’s
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Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 5 of 9
Collegiate Dictionary to ascertain the “commonly understood meaning” of a term because it is a “commonly used dictionary.” (internal citation omitted)).
Instead, “[w]hen a term has no statutory or administrative definition, we look to its ordinary or natural meaning.” Sumpter v. Sec’y of Labor, 763 F.3d 1292, 1296 (11th Cir. 2014). Although courts occasionally utilize legal definitions when a regulation uses a “legal term of art,”1 “such” is certainly not a “legal term of art.” Indeed, the fact that many other legal dictionaries do not contain definitions for the word “such” only solidifies this point. See Bouvier’s Law Dictionary; see also Ballentine’s Law Dictionary, 3rd Edition. Consequently, the word “such” should be construed in the “lay manner consistent with what would be understood by a person of ordinary intelligence”— not the legal manner. Therefore, the non-legal definition of “such,” which is considered “of a kind or character of that or those indicated or implied,” “of the same class, type or sort,” and “like or similar,” should be used. See Such, Webster’s New International Dictionary; see also Such, Merriam-Webster Dictionary, https://www.merriam-webster.com/dictionary/such (last visited Mar. 29, 2019); Such, Dictionary.com, https://www.dictionary.com/browse/such (last visited Mar. 29, 2019).
Accordingly, the SVF cells naturally existing in an individual’s body at the time of removal constitute “such HCT/Ps” when implanted into the same individual’s body as part of the SVF Surgical Procedure. In short, the Defendants’ SVF Surgical Procedure falls within the SSP Exemption, and Plaintiff has not demonstrated otherwise. Thus, Defendants’ SVF Surgical Procedure is exempt from regulatory oversight by the FDA.
1 Morris v. Nielsen, 17-CV-04001 (NGG), 2019 WL 1260622 (E.D.N.Y. Mar. 17, 2019) (“when a regulation uses a phrase or word with an established legal meaning—a legal “term of art”— courts should assume the regulation incorporates that meaning absent evidence to the contrary.”)
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Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 6 of 9
C. The Government’s claims that the Defendants’ interpretation of the SSP Exemption will cause the sky to fall are hyperbole.
In its Opposition, the government seeks to characterize the Defendants’ sensible interpretation of the SSP Exemption as an attempt to apply the exemption so broadly as to nullify its impact. The Government makes the wild claim that the Defendants’ interpretation would allow anyone to take HCT/Ps, do anything to them, and use them in any surgical procedure at any time. Not so. Materially altering the relevant HCT/Ps, combining the relevant HCT/Ps with drugs, injecting the HCT/Ps into patients other than the patient from whom they are taken, using the HCT/Ps in separate surgical procedures—none of those things would qualify for the SSP Exemption under the Defendants’ interpretation. It is simply an exaggeration to claim, as the Government does, that the Defendants’ interpretation creates some kind of “vast loophole.” Dkt. No. 49 at 8.
Nor would the Defendants’ interpretation exclude from regulation procedures that the Government seems concerned about, at least in its briefing. Nothing in that interpretation would allow for the unregulated use of “expand[ed] cells or tissues.” Dkt. No. 49 at 13. Expanding cells or tissues would fall outside of the SSP Exemption as those HCT/Ps would be materially changed. Even further, the HCT/Ps at issue in United States v. Regenerative Scis., LLC, a case in which the defendants sought to apply the same SSP Exemption, still would not qualify for the SSP Exemption as that procedure involved the addition of antibiotics. 741 F.3d 1314 (D.C. Cir. 2014).
The Defendants’ interpretation of the SSP Exemption is appropriately limited, and applies to the Defendants’ SVF Surgical Procedure, a limited procedure that allows a licensed medical professional to relocate unaltered cells from a patient’s body into another part of that same patient’s body, on the same day and in the same facility. That SVF Surgical Procedure is hardly a “vast loophole.”
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Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 7 of 9
III. Conclusion
For the foregoing reasons, this Court should grant Defendants’ Motion for Summary Judgment.
Dated: April 1, 2019
Respectfully submitted,
/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
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., Kristin C. Comella and Theodore Gradel
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Case 0:18-cv-61047-UU Document 60 Entered on FLSD Docket 04/01/2019 Page 8 of 9
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on April 1, 2019, a true and correct copy of the foregoing Defendants’ Reply in Further Support of their Motion for Summary Judgment 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
8
Case 0:18-cv-61047-UU
Document 60 Entered on FLSD Docket 04/01/2019 Page 9 of 9
Roger J. Gural
Trial Attorney
Consumer Protection Branch United States Department of Justice P.O. Box 386
Washington, DC 20044 Roger.gural@usdoj.gov
Counsel for United States of America
Of Counsel:
Rebecca K. Wood
Chief Counsel
Food and Drug Administration
Perham Gorji
Deputy Chief Counsel for Litigation
Michael D. Helbing
Associate Chief Counsel for Enforcement
United States Dept. of Health and Human Services Office of the General Counsel
White Oak 31, Room 4426A
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
James A. Weinkle
Assistant United States Attorney Office of the United States Attorney 99 N.E. 4th Street, Suite 300
Miami, FL 33132 james.weinkle@usdoj.gov
Counsel for United States of America
SERVICE LIST
9
FDA response
Case 0:18-cv-61047-UU Document 59 Entered on FLSD Docket 04/01/2019 Page 1 of 11
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 and THEODORE GRADEL, individuals,
Defendants.
PLAINTIFF’S REPLY IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT
The Government brought this action to enjoin US Stem Cell Clinic, LLC (“USSCC”), US Stem Cell, Inc., and Kristin C. Comella (collectively, “Defendants”)1 from violating the law and endangering patients. In its Motion for Summary Judgment, the Government established that Defendants violate the Federal Food, Drug, and Cosmetic Act (“FDCA”) by manufacturing an adulterated and misbranded drug that is neither approved nor licensed by the Food and Drug Administration (“FDA”) and has never been shown to be safe or effective for any indication. Pl.’s Mot. for Summ. J. and Supp. Mem. of Law (D.E. 42) (“Pl.’s MSJ”) at 11-20. Defendants’ Opposition (D.E. 51) makes clear they do not dispute the evidence establishing their violations. Instead, Defendants argue they are largely exempt from FDCA regulation based on an incorrect and unsupportable reading of two provisions in 21 C.F.R. Part 1271.
1
The Government’s Motion for Summary Judgment also sought relief against individual Theodore Gradel. Mr. Gradel and the Government have agreed to terms of a consent decree that, if entered by this Court, would resolve the allegations against Mr. Gradel. See D.E. 47.
Case 0:18-cv-61047-UU Document 59 Entered on FLSD Docket 04/01/2019 Page 2 of 11
Defendants’ opposition confirms that the parties’ disagreements on summary judgment center on “two fundamental legal issues.” Defs.’ Opp’n. to Pl.’s Mot. for Summ. J. (D.E. 51) (hereinafter “Defs.’ Opp’n.”) at 1 (emphasis added). Specifically, Defendants claim: (1) that their stromal vascular fraction (“SVF”) product qualifies for reduced regulation as a “361 HCT/P” under 21 C.F.R. § 1271.10(a); and (2) that the phrase “such HCT/P’s” in the same surgical procedure (“SSP”) exception codified at 21 C.F.R. § 1271.15(b) should be interpreted to apply in this case. Although Defendants incorrectly characterize certain aspects of the manufacture of their SVF product, the parties agree on all facts material to resolving the legal questions at issue and thus deciding summary judgment. The undisputed facts show Defendants remove adipose tissue from a patient and transform it through enzymatic digestion and other manufacturing processes into something substantially different than the adipose tissue they remove. Defendants’ establishment thus does not qualify for the SSP exception. Similarly, the undisputed facts demonstrate that Defendants’ SVF product is more than minimally manipulated and not intended for homologous use, and thus does not qualify for regulation as a “361 HCT/P.”
Because the material facts are not in dispute and Defendants persist in violating the FDCA, the Government is entitled to summary judgment.
ARGUMENT
A. Defendants Are Responsible for Violating the FDCA
As explained in the Government’s Motion for Summary Judgment (D.E. 42) (“Government’s motion”), Defendants openly violate the FDCA, which makes it illegal to manufacture and sell drugs that are produced without adhering to current good manufacturing practice (“CGMP”) and further forbids the manufacture and sale of drugs that do not have labeling that bears adequate directions for use. See Pl.’s MSJ at 11-20; 21 U.S.C. §§ 331(k), 351(a)(2)(B), 352(f)(1). Drugs, such as Defendants’ SVF product, that fail to meet these requirements are “adulterated” and “misbranded.” See 21 U.S.C. §§ 351(a)(2)(B), 352(f)(1); Pl.’s MSJ at 11-20.
Although Defendants claim they need not follow these provisions of law, they do not dispute the underlying facts necessary to establish these violations. Defendants admit their employees or contractors use their SVF product to address patients’ symptoms of various serious diseases and medical conditions. Pl.’s Stmt. of Material Undisputed Facts in Supp. of Pl.’s Mot.
2
Case 0:18-cv-61047-UU Document 59 Entered on FLSD Docket 04/01/2019 Page 3 of 11
for Summ. J. (D.E. 42-1) (“Pl.’s SMUF”) ¶ 7. This renders the SVF product a drug2 that is “held for sale” under the FDCA. See 21 U.S.C. § 321(g)(1)(B); Pl.’s MSJ at 11-13. Defendants do not dispute that the saline they use in their SVF product has traveled in interstate commerce, Pl.’s SMUF ¶¶ 18-19 & 39, nor do they argue that the presumption of interstate commerce established by 21 U.S.C. § 379a has been overcome. Pl.’s MSJ at 13-14. Further, Defendants do not dispute the fact that they fail to comply with CGMP for drugs, Pl.’s SMUF ¶ 31, which renders their SVF product adulterated by law. See 21 U.S.C. § 351(a)(2)(B); 21 C.F.R. Parts 210-211 (drugs); 21 C.F.R. Parts 600-680 (additional standards for biological products); see Pl.’s MSJ at 14-16. Finally, Defendants admit that they do not label their SVF product with indications for use, dosages, or routes of administration. Pl.’s SMUF ¶ 20. As a result, Defendants’ SVF product is misbranded. See 21 U.S.C. § 352(f)(1); 21 C.F.R. § 201.5; Pl.’s MSJ at 16-17. Nor do Defendants argue that they lack the authority to prevent or promptly correct the legal violations documented by FDA inspections. See Pl.’s MSJ at 25-28. Thus, although Defendants mistakenly claim they need not comply with the FDCA, they do not dispute the facts that show they adulterate and misbrand their SVF product while it is held for sale after shipment of one of its components in interstate commerce. 21 U.S.C. § 331(k); see Pl.’s MSJ at 11-16.
B. Defendants’ SVF Product Does Not Qualify as a “361 HCT/P”, and the “Same Surgical Procedure Exception” Does Not Apply
Defendants fail to satisfy their burden of demonstrating that any provisions in 21 C.F.R. Part 1271 shield their illegal behavior. See United States v. Regenerative Scis., 741 F.3d 1314, 1322 (D.C. Cir. 2014) (holding that defendants “ultimately bear the burden of establishing that [21 C.F.R. § 1271.10(a)] applies”).
1. Defendants’ SVF Product Fails to Meet All of the Criteria in 21 C.F.R. § 1271.10(a) for Regulation Solely under Section 361 of the PHSA and 21 C.F.R. Part 1271
2 Defendants’ unsupported assertion that “[c]ells that are naturally occurring in a person’s body, which are then reinserted into that person’s body, are simply not a drug,” Defs.’ Opp’n. at 2, is wrong as a matter of law if, as here, those cells are part of a product intended to cure, mitigate, or treat disease. See 21 U.S.C. § 321(g)(1)(B); United States v. Regenerative Scis., LLC, 741 F.3d 1314, 1319 (D.C. Cir. 2014) (recognizing the FDCA’s “wide-ranging definitions” of drug and biological product and rejecting the defendants’ assertion that they were merely performing a “procedure”); United States v. Loran Med. Sys., 25 F. Supp. 2d 1082, 1086 (C.D. Cal. 1997); see also 21 C.F.R. § 1271.20.
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To be regulated only under Section 361 of the PHSA and 21 C.F.R. Part 1271 (known as a “361 HCT/P”) instead of the FDCA, an HCT/P must satisfy four criteria in 21 C.F.R. § 1271.10(a). Failure to satisfy any one of these criteria renders an HCT/P ineligible for the Section 361 regulatory scheme. Here, Defendants’ SVF product is not a 361 HCT/P because it is not intended for homologous use and it is more than minimally manipulated. Pl.’s MSJ at 22-25.
a. Defendants’ SVF Product is Not Intended for Homologous Use
Defendants make no attempt to refute the Government’s argument that their SVF product fails to satisfy the homologous use criterion in 21 C.F.R. § 1271.10(a)(2). As set out in the Government’s motion, the HCT/P that Defendants inject into patients—their SVF product—is not intended to perform the “same basic function or functions” as the adipose tissue they take from patients, “as reflected by the labeling, advertising, or other indications of [Defendants’]
objective intent.” Pl.’s MSJ at 23-24; see 21 C.F.R. §§ 1271.3(c), 1271.10(a)(2).
Defendants attempt to skew this analysis by disregarding the adipose tissue they remove from patients and focusing exclusively on particular cells isolated from that adipose tissue during their multi-step manufacturing process. Defs.’ Opp’n. at 14. This reading defies logic. As explained in the Government’s motion, assessing homologous use requires starting with the HCT/P—i.e., the adipose tissue—that Defendants remove from patients, not the subset of cells that later become SVF. Pl.’s MSJ at 23-24. Only by comparing the SVF product injected into a patient to the adipose tissue recovered from the patient can one determine whether the HCT/P performs the “same basic function or functions in the recipient as in the donor.” Id.; see
21 C.F.R. §§ 1271.3(c), 1271.10(a)(2). The facts show here that it does not. Pl.’s MSJ at 23-24. Moreover, even accepting Defendants’ starting point and ignoring the adipose tissue actually removed from patients, the SVF cells do not perform the same basic function in the donor as Defendants purport them to perform in the recipient. Under 21 C.F.R. § 1271.10(a)(2), determination of whether an HCT/P is intended for homologous use depends on “labeling, advertising, or other indications of the manufacturer’s objective intent.” 21C.F.R. § 1271.10(a)(2). Here, Defendants market their product to treat a variety of serious diseases or conditions, including, but not limited to, amyotrophic lateral sclerosis (“ALS”), Parkinson’s disease, spinal cord injuries, stroke, traumatic brain injury, lung disease, and diabetes. Pl.’s SMUF ¶ 7. Despite their vague references to the “regenerative functions” of SVF, Defendants have not—and cannot—demonstrate that treating the serious diseases listed above is a “basic
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function” of SVF cells as they exist in adipose tissue. Thus, even under Defendants’ strained reading of the regulations, Defendants’ SVF product is not intended for homologous use, and it fails to satisfy 21 C.F.R. § 1271.10(a) on that basis alone.
b. Defendants’ SVF Product is More than Minimally Manipulated
Although further analysis of 21 C.F.R. § 1271.10(a) is unnecessary in light of Defendants’ failure to satisfy the homologous use criterion, Defendants also fail to meet their burden to show that the SVF product is minimally manipulated. See Pl.’s MSJ at 22-23. Minimal manipulation is defined by regulation in two different ways, depending on whether it is being applied to structural tissue or cells or nonstructural tissues. As applied to structural tissue, such as adipose tissue, minimal manipulation is “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement”; for cells or nonstructural tissues, minimal manipulation is “processing that does
not alter the relevant biological characteristics of cells or tissues.” 21 C.F.R. § 1271.3(f).3
To determine whether an HCT/P is more than “minimally manipulated,” the regulation requires that the relevant characteristics of the HCT/P removed from the patient be compared before and after processing. 21 C.F.R. § 1271.3(f)(1) (discussing whether the original relevant characteristics of structural tissue has been altered as a result of processing). Defendants focus again on the SVF cells that are later isolated through their manufacturing process, but the only logical starting point for the minimal manipulation analysis must be the adipose tissue removed from the patient. Comparing the characteristics of the end result of the Defendants’ processing to the purported characteristics of cells that are not accessible absent that processing would undermine the purpose of the minimal manipulation criterion. HCT/P’s whose original relevant characteristics have been meaningfully altered present heightened risk and require greater regulation to ensure their safety and efficacy above and beyond the need, as with 361 HCT/P’s, to control the risk of communicable disease. 66 Fed. Reg. 5447, 5449-50 and 5457 (Jan. 19,
2001); see 21 C.F.R. §§ 1271.3(f), 1271.10(a)(1), and 1271.20.
3 The details of Defendants’ processing of adipose tissue are not in dispute. Defendants first recover adipose tissue from a patient through a mini-liposuction and then digest that tissue with an enzyme. Pl.’s SMUF ¶ 9-10. Defendants then perform other manufacturing processes, including centrifugation and filtration, before resuspending the resulting materials with saline to obtain their SVF product. Pl.’s SMUF ¶ 10, 12, 39; see generally Declaration of Kristin Comella (D.E. 45-1) (“Comella Decl.”) Ex. A (D.E. 45-2); Pl.’s SMUF ¶ 40.
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Starting, as the regulation logically requires, with the adipose tissue Defendants recover from patients, it is clear that Defendants’ processing constitutes far more than minimal manipulation of that tissue. The relevant characteristics of a structural tissue such as adipose tissue4 relate to its utility for reconstruction, repair, or replacement. See 21 C.F.R. § 1271.3(f)(1); Decl. of Carolyn Yong, Ph.D. (D.E. 42-4) (“Yong Initial Decl.”) ¶¶ 31-32. As noted in the Government’s motion, Defendants alter the original relevant characteristics of the adipose tissue by changing its bulk, lipid storage capacity, and its utility to provide cushioning and support to the body, all of which are essential to the tissue’s utility for reconstruction, repair, or replacement. Pl.’s MSJ at 22-23; Yong Initial Decl. ¶ 29-33. Thus, the SVF product is more than minimally manipulated.
Defendants subvert the purpose of the minimal manipulation criterion by focusing exclusively on a single purported characteristic, which they describe as the “regenerative functions” of certain cells within adipose tissue. Even if Defendants’ characterization of the regenerative abilities of SVF cells were assumed to be true,5 Defendants’ argument still would fail because it ignores the fact that the definition of minimal manipulation focuses on “the tissue’s utility for reconstruction, repair, or replacement.” 21 C.F.R. § 1271.3(f)(1) (emphasis added). Through their manufacturing process, Defendants destroy adipose tissue to isolate SVF cells. They then dispose of all other parts of the original tissue. Defendants do not dispute that their processing alters (and eliminates) the tissue’s ability to provide cushioning and support and its capacity for lipid storage, drastically impacting its utility for reconstruction, repair, and replacement. Because Defendants so significantly alter the original relevant characteristics of the adipose tissue removed from patients, it is indisputably more than minimally manipulated.6
4 Although Defendants dispute which HCT/P should serve as the reference point for the minimal manipulation analysis (adipose tissue or the cells obtained from processing adipose tissue), they do not dispute that adipose tissue is structural tissue, see Defs. Opp’n at 12 (referring to “structural adipose tissue”), or that it has been substantially altered by Defendants’ processing.
5 Although it is not relevant to the resolution of this motion for the reasons discussed above, the Government disputes Defendants’ broad characterizations of the regenerative properties of adipose-derived stem cells and adipose tissue. See Tr. of Dep. of Carolyn Yong, Ph.D (Feb. 21, 2019) (“Yong Depo. Tr.”) at 91:4-20; Decl. of Todd H. Halpern in Support of Defs.’ MSJ, Ex. 4 (D.E. 45-7) (“Yong Rebuttal Expert Report”) at 7-9.
6
manipulation standard unless all original relevant characteristics were altered. In reality, the
Defendants’ interpretation essentially would result in all HCT/P’s meeting the minimal 6
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2. The SSP Exception at 21 C.F.R. § 1271.15(b) Does Not Apply to the SVF Product
As explained at length in the Government’s Opposition to Defendants’ Motion for Summary Judgment (D.E. 49) (“Pl.’s Opp’n.”), Defendants’ establishment does not qualify for the SSP exception, which applies to “an 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) (emphasis added); see generally Pl.’s Opp’n. at 4-10 (discussing use of adipose tissue as the antecedent for “such HCT/P’s”). There is no dispute that Defendants’ manufacturing process starts with the removal of a structural tissue from the body; namely, the patient’s adipose tissue (fat). Pl.’s SMUF ¶ 5; Comella Decl. Ex. A at 9 (slide entitled “Adipose Extraction”). There also is no dispute that Defendants’ SVF product as injected into the patient is not adipose tissue, a structural tissue, or tissue at all. Pl.’s SMUF ¶¶ 10-13, 45-46.
Defendants erroneously claim that adipose tissue is not the antecedent HCT/P “remove[d] . . . from an individual” and thus is not the proper starting point for an analysis under the SSP exception. Defs.’ Opp’n. at 9-11. Defendants improperly focus instead on some of the cells in adipose tissue that are later isolated after Defendants extensively process that tissue.7 As the Government explained in its Opposition to Defendants’ Motion for Summary Judgment, Defendants simply ignore the plain meaning of the regulatory text. Even if the regulation were ambiguous, FDA’s longstanding interpretation of the regulation should be given effect. See generally Pl.’s Opp’n.8
original relevant characteristics of an HCT/P can be significantly altered even by losing one relevant characteristic—here adipose tissue’s ability to provide cushioning and support. Thus, Defendants’ focus on alleged regenerative properties as an alterntative characteristic is misguided, even assuming such properties were truly a characteristic of the original HCT/P and not altered by Defendants’ processing. See Defs.’ Opp’n. at 13-14.
7 In support of many of their arguments, Defendants cite to the unsworn expert report of Dr. Elliot Lander. Dr. Lander is himself a defendant in a similar enforcement action involving adipose-derived SVF products pending in the Central District of California. United States v. California Stem Cell Treatment Center, Inc., . . . and Elliot B. Lander, M.D., No. 5:18-cv-01005 (C.D. Cal. filed May 9, 2018). Because of the financial and reputational interests Dr. Lander has in the matters being litigated here, the Court should treat his statements with skeptical caution.
8
Plaintiff disputes Defendants’ contention (Defs.’ Opp’n. at 7-9) that Defendants’ manufacturing process does not change the SVF cells. See Pl.’s Opp’n. at 8-9, n.4; Suppl. Decl. of Carolyn Yong, Ph.D. (D.E. 49-2) ¶¶ 4-5; Pl.’s Resp. to Defs.’ Statement of Material Undisputed Facts (D.E. 49-1) ¶¶ 6-7. However, that unsupported claim is not relevant to the
7
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Defendants now appear to have performed an about-face on this issue. In their Motion for Summary Judgment, Defendants appeared to recognize that “such HCT/P’s” in the SSP exception language referred to the HCT/P’s removed from the patient. Defs.’ MSJ at 11-12. In their opposition brief, Defendants now assert that the phrase “such HCT/P’s” refers to the “HCT/P’s in the form implanted back into the patient.” Defs.’ Opp’n. at 9. Defendants’ new position is even more untenable than their previous position. By way of illustration, inserting Defendants’ new definition into the text of the SSP exception for “such HCT/P’s” leads to this unintelligible result:
an establishment that removes HCT/P’s from an individual and implants HCT/P’s in the form implanted back into the patient into the same individual during the same surgical procedure.
Defendants’ newly adopted position creates a tautology and renders the phrase “such HCT/P’s”—the core of this legal dispute—completely meaningless.
Defendants’ expansive interpretation would allow the narrow SSP exception to entirely swallow FDCA’s drug approval process for any product manufactured from a patient’s HCT/P. Under Defendants’ revised interpretation, an establishment could remove any HCT/P from any part of a patient, perform any number and type of manufacturing steps on that tissue in relation to any purported surgical procedure (regardless of the risk associated with any of those steps), inject the end product into any part of the patient, and then invoke the SSP exception as long as the end product contained some derivative of the original HCT/P (no matter how wildly different
resolution of the cross-motions for summary judgment, because it relates to Defendants’ flawed legal interpretation of the SSP exception.
Defendants further assert that their collagenase enzyme simply “cleanses and separates” SVF cells from adipose tissue. Def.s’ Opp’n at 7. Destroying adipose tissue must qualify as more than cleansing and separating by any reasonable interpretation of those terms. As at least one court has recognized, the use of an enzyme to break down adipose tissue before reinjecting some of the cells from that tissue back into the patient raises reasonable “concerns about the impact [the] enzyme might have on cells that might be reintroduced into the human body.” See Cytori Therapeutics v. FDA, 715 F.3d 922, 927-28 (D.C. Cir. 2013) (upholding FDA’s determination that a medical device used to harvest stem cells from adipose tissue was not substantially equivalent to a device that isolated stem cells from blood and bone marrow). Defendants have not submitted data to FDA to alleviate such reasonable concerns in any application to the agency. Pl.’s SMUF ¶¶ 21- 22.
8
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the end product). This interpretation, whereby all processed HCT/P’s would qualify for the SSP exception, is patently absurd and could result in untold harm to patients.
Defendants’ varying interpretations of the SSP exception also ignore the distinction Part 1271 makes between tissue and cells. By definition, HCT/P’s are “articles containing or consisting of human cells or tissues . . . .” 21 C.F.R. § 1271.3(d) (emphasis added). The significant difference between HCT/P’s that are “structural tissue” and HCT/P’s that are “cells or nonstructural tissues” is further reflected by two distinct definitions used to determine whether HCT/P’s are minimally manipulated under 21 C.F.R. § 1271.10(a)(1). See 21 C.F.R. § 1271.3(f). Losing sight of Part 1271’s important distinction between cells and tissues, Defendants’ competing readings of the SSP exception would lead to another absurd result. Even though Defendants’ SVF product does not satisfy the criteria for reduced regulation as a 361 HCT/P under 21 C.F.R. § 1271.10(a) (see Section B.1, supra), Defendants’ interpretation of the SSP exception would allow them to avoid FDA regulation entirely by removing one type of HCT/P— structural tissue—and transforming it into another HCT/P the regulations treat differently—in this case, a cellular product. Because the SVF product is unquestionably more than minimally manipulated, Pl.’s MSJ at 22-23, a fortiori, the SSP exception cannot apply to Defendants’ establishment.
Rather than adopt Defendants’ tortured reading of these regulations and create a vast loophole in the FDCA with the potential for serious public harm, this Court should interpret the SSP exception consistent with its inherent plain meaning, read in the appropriate context of “the whole law, . . . its object and policy.” John Hancock Mut. Life Ins. Co. v. Harris Tr. & Sav. Bank, 510 U.S. 86, 94-95, (1993); see Gilbert v. Alta Health & Life Ins. Co., 276 F.3d 1292 (11th Cir. 2001); see also Cremeens v. City of Montgomery, 602 F.3d 1224, 1227 (11th Cir. 2008) (“We apply the canons of construction to regulations as well as to statutes.”). Simply put, Defendants remove an HCT/P, adipose tissue, and do not reimplant “such HCT/P” into their patients. They instead inject an SVF product that fails to retain any semblance of the original adipose tissue’s ability to provide cushioning and support to parts of the body. The SSP exception cannot apply to Defendants’ establishment.
C. Defendants’ Other Arguments are Irrelevant to the Resolution of this Matter
Defendants also raise arguments irrelevant to resolving this motion. Primarily, Defendants discuss studies that they claim show the “safety and efficacy” of their SVF product
9
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in an attempt to refute allegations that their practices could “endanger patients.” Defs.’ Opp’n. at 3-5. Defendants’ argument turns the drug approval process on its head by suggesting that FDA bears the burden to prove that an unapproved product is unsafe or ineffective before bringing an enforcement action. See Defs.’ Opp’n at 3-5; Pl.’s SMUF ¶ 21. The law requires exactly the opposite. See 21 U.S.C. § 355(a). If Defendants believe their SVF product is safe and effective, they should submit the proper data to FDA and seek approval to allow it to be marketed legally.9
Further, Defendants fail to understand that a drug can “endanger patients” in different ways. Drugs like Defendants’ SVF product that have not been shown to be safe and effective obviously could endanger patients directly if they are not safe. Such drugs also may harm patients indirectly if they are not effective, because patients may forego other, proven treatments. Even approved products that have been shown to be safe and effective in adequate and well- controlled studies can still endanger patients if they are not produced under conditions that comply with CGMP and labeled with adequate directions for use. For all of these reasons, the FDCA prohibits the manufacture and sale of adulterated and misbranded drugs—prohibitions that Defendants blithely argue should not apply to them and their products.10
CONCLUSION
Defendants are violating well-established law and endangering the public by manufacturing an adulterated and misbranded experimental drug. It is clear from the plain language of 21 C.F.R. Part 1271 that no exception applies. The Government therefore requests that this Court grant its motion for summary judgment and permanently enjoin Defendants from causing the adulteration and misbranding of their drugs in violation of the FDCA.
9 It is not necessary for this Court to resolve Defendants’ claims of safety and efficacy to grant summary judgment in favor of the Government. Whether a drug is safe and effective is relevant to just one of three independent bases for establishing that the SVF product fails to bear adequate directions for use. See Pl.’s MSJ at 17-19, n.8; Decl. of Larissa Lapteva, M.D. (D.E. 42-5), ¶¶ 14-32. Because Defendants admit that they do not label their SVF product with indications for use, dosages, or routes of administration, Pls. SMUF ¶ 20, the SVF product is misbranded even if it were generally recognized as safe and effective—which it is not. Pl.’s MSJ at 16-17.
10 Nor can the safety and efficacy of Defendants’ SVF product be ensured by the Florida Board of Medicine. State health departments and medical boards play an important role in overseeing medical practices, but that responsibility is complementary to, not exclusive of, FDA’s authority to safeguard the safety and effectiveness of products used by physicians. See 21 U.S.C. § 393(b)(2)(B); Regenerative Scis., LLC, 741 F.3d at 1319-21.
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Case 0:18-cv-61047-UU
Document 59
Entered on FLSD Docket 04/01/2019 Page 11 of 11
DATED: April 1, 2019.
JOSEPH H. HUNT Assistant Attorney General
JAMES M. BURNHAM
Deputy Assistant Attorney General Civil Division
GUSTAV W. EYLER
Acting Director
Consumer Protection Branch
ROGER J. GURAL
Roger J. Gural
Trial Attorney
Consumer Protection Branch United States Department of Justice P.O. Box 386
Washington, DC 20044
Tel.: 202.307.0174
Email: roger.gural@usdoj.gov
Counsel for United States of America
Of Counsel:
ROBERT P. CHARROW General Counsel
STACY CLINE AMIN
Chief Counsel
Food and Drug Administration
Deputy General Counsel
Department of Health and Human Services
PERHAM GORJI
Deputy Chief Counsel for Litigation
MICHAEL D. HELBING
Associate Chief Counsel for Enforcement United States Food and Drug Administration Office of the Chief Counsel
White Oak 31, Room 4426A
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: 240.402.6165
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
Counsel for United States of America
11
New pacer docs out, responses by each party for motion toward summary judgement. Bravo Venable Law firm & Issac Mitarti IMO
Now we wait
To be clear: I’m no legal expert AT ALL, I’m just reading what the filings tell me from my pacer account. If anyone else knows different or if I’m wrong about the court proceedings, feel free.
And heavy prayers and meditation forsure lol
Lol how about 1.5 mil in revenue every quarter for the last two years. And plenty of patient testimonials as well as a 676 page peer reviewed study on the science and asipocell. Seems real to me. The fact that the FDA has their cross hairs on USRM should tell you that they are a real company. Government doesn’t waste money going after small fish in the pond :)
This is a federal case not a state case. She is a federal judge. If we win all the FDA could do is appeal the ruling or try to take it to the Supreme Court and that can happen whether we win in trial or by summary judgement. Trial does not save us fro appeal.
Kristin and USRM REQUESTED summary judgement themselves. Both sides did.
Usrm thinks they have enough evidence here to end this case without going to trial.
So does the FDA so they also filed for summary judgement because they feel the same way about their case.
If the judge decides that neither of them are right then she will proceed with trial. If she feels that either of their arguments (which I have posted on this board for all to see) are valid she will likely grant it. If she thinks neither of them have a point she will let it proceed to trial.
Really not that difficult to understand
That’s not official yet. Summary judgement responses due on 4/1 and 4/2. Those filings yesterday are the proceedings if she does not rule summary judgement either way
Read my last post about the definition and the exemption
Basically. Not sure that argument will hold up in federal court.
And on the whim that the judge doesn’t grant summary judgement and allows it to go to trial, then allows this this motion:
Then the word “such” and it’s definition comes into question. And I like Venable law firm and their experienced Ex-FDA lawyers to thoroughly explain that definition.
“In 2001, the FDA codified its new regulatory regime, finalizing its formal intent to exempt certain procedures from 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.”
“Finally, the HCT/Ps that are removed from the patient must remain “such” HCT/Ps when transplanted back into the patient. That is exactly what happens here. Plaintiff has erroneously asserted that the HCT/Ps transplanted back into the patient during the SVF Surgical Procedure are not “such” HCT/Ps because they are not identical to the HCT/Ps removed from the patient. Essentially, Plaintiff asserts that “such” should be interpreted to mean “same” or “identical.” This position, however, is explicitly contradicted by the plain, unambiguous language of the SSP Exemption. Moreover, it violates established canons of interpretation and is plainly contradicted by the Plaintiff’s own expert.
It is a well-established canon of interpretation that, where a term is not defined in a regulation, a court should look to its plain meaning.6 Sumpter v. Sec’y of Labor, 763 F.3d 1292, 1296 (11th Cir. 2014) (“When a term has no statutory or administrative definition, we look to its ordinary or natural meaning.”); Schwarz v. City of Treasure Island, 544 F.3d 1201, 1214 (11th Cir. 2008) (“Because there is no statutory or administrative definition of ‘residence,’ we look to its ordinary, everyday meaning.”). Here, “such” is not a defined term in the FDA’s regulatory scheme. Therefore, the court should look to the common dictionary definition of “such” to interpret its meaning.
6 Canons of construction applicable to statutes apply with equal force to regulations. Cremeens v. City of Montgomery, 602 F.3d 1224, 1227 (11th Cir. 2008) (“We apply the canons of construction to regulations as well as to statutes.”); Alboniga v. Sch. Bd., 87 F. Supp. 3d 1319, 1339 (S.D. Fla. 2015) (“Courts must employ the same canons of construction when construing regulatory language as apply to statutory construction.”); see also Miami Heart Inst. v. Sullivan, 868 F.2d 410, 413 (11th Cir. 1989) (applying canons of statutory construction to regulations promulgated under the Medicare Act).
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A review of dictionary definitions of “such” reveals that “such” does not mean “identical” or “same.” Instead, the standard definition of “such” indicates relatedness. Specifically, “such” is defined as “of a kind or character of that or those indicated or implied,” “of the same class, type or sort,” and “like or similar.” See Such, Webster’s New International Dictionary; see also Such, Merriam-Webster Dictionary, https://www.merriam-webster.com/dictionary/such (last visited Mar. 3, 2019); Such, Dictionary.com, https://www.dictionary.com/browse/such (last visited Mar. 3, 2019). Accordingly, the plain language of the regulation clearly indicates that the implanted SVF cells (i.e., the HCT/Ps) are not required to be identical to the removed SVF cells, only related.
Moreover, pursuant to another established canon of interpretation, where a regulation uses two different terms in the same provision, those terms must have different meanings. McCarthan v. Dir. of Goodwill Indus.-Suncoast, Inc., 851 F.3d 1076, 1089 (11th Cir. 2017). Here, the FDA used the terms “such” and “same” in the one sentence that defines the SSP Exemption. Indeed, the FDA used the term “same” twice after using the term “such.” 21 C.F.R. § 1271.15(b) (“. . . that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.” (emphasis added)). Thus, contrary to Plaintiff’s position, “such” necessarily cannot mean “same” here.
Here, the evidence is undisputed that the implanted SVF cells are related to the SVF cells that are initially removed from the patient; accordingly, the Defendants’ SVF Surgical Procedure satisfies the fourth criterion of the SSP Exemption. Indeed, as the Plaintiff’s expert acknowledges, the SVF cells are simply isolated and removed from the patient’s body. Halpern Decl., Exh. 1 (Yong Expert Report) at 6. In fact, the parties further agree that the SVF cells—both before and after they are isolated from the adipose tissue as part of the SVF Surgical Procedure—are composed of different cell types, including stem and progenitor cells, granulocytes, monocytes,
12
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lymphocytes, endothelial cells, pericytes, and stromal cells. See Statement at ¶¶ 9, 10; see also Halpern Decl., Exh. 1 (Yong Expert Report) at 4, 11; id., Exh. 2 (Lander Rebuttal Expert Report) at 5, 10–11. Thus, there is no dispute that the SVF cells exist in the human body prior to removal and are composed of the same cellular types both before removal from the individual and after transplant during the SVF Surgical Procedure.”
Case 0:18-cv-61047-UU Document 58 Entered on FLSD Docket 03/29/2019 Page 1 of 5
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 and THEODORE GRADEL, individuals,
Defendants.
PLAINTIFF’S MOTION IN LIMINE TO EXCLUDE TESTIMONY OF ANECDOTAL SAFETY AND/OR EFFICACY
Plaintiff, United States of America, by and through its undersigned counsel and pursuant to Rule 403, Federal Rules of Evidence, hereby moves for an Order In Limine limiting any anecdotal testimony of Defendants’ witnesses regarding safety and/or efficacy on the grounds that such testimony is wholly irrelevant to any issue of fact or law in this action and could only serve to mislead and confuse the finder of fact. In support thereof, Plaintiff states as follows:
PROCEDURAL HISTORY
1. On May 9, 2018, the United States filed its Complaint (D.E. 1) pursuant to the Food, Drug, and Cosmetic Act (“FDCA”) seeking to restrain Defendants US Stem Cell Clinic, LLC, US Stem Cell, Inc., and individuals Kristin C. Comella and Theodore Gradel from violating 21 U.S.C. § 331(k) by causing articles of drug to become adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B), and misbranded within the meaning of 21 U.S.C. § 352(f)(1) while held for sale after shipment of the drugs or one or more of their components in interstate commerce.
2. On July 6, 2018, Plaintiff received Defendants’ initial disclosures. Those disclosures only identified Defendant Comella and two FDA employees as individuals with
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knowledge relating to the claims, defenses, and events at issue in this action. Defs.’ Initial Discl. at 2.
3. On August 3, 2018, Defendants filed their Answer (D.E. 26) claiming the affirmative defense, among others, that “the SVF procedure falls within the ‘same surgical procedure exception.’” Ans. at 10.
LEGAL STANDARD
Under a motion in limine, evidence is excluded “only if the evidence is clearly inadmissible for any purpose.” Acevedo v. NCL (Bahamas) Ltd., 317 F. Supp. 3d 1188, 1192 (S.D. Fla. 2017) (citing Stewart v. Hooters of Am., Inc., No. 8:04-cv-40-T-17-MAP, 2007 WL 1752873, at *1 (M.D. Fla. June 18, 2007)). Under FRE 401, “evidence is relevant if it has the tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence. Dallis v. Aetna Life Ins. Co., 768 F.2d 1303, 1305 (11th Cir. 1985). Under FRE 403, a district court can exclude relevant evidence “if its probative value is substantially outweighed by danger of unfair prejudice, confusion of the issues or misleading the jury. Dallis, 768 F.2d at 1305. Rule 403 is “an extraordinary remedy which the district court should invoke sparingly.” United States v. Dodds, 347 F.3d 893, 897 (11th Cir. 2003) (citing United States v. Elkins, 885 F.2d 775, 784 (11th Cir. 1989)). Lastly, the district court should view the evidence “in a light most favorable to its admission, maximizing its probative value and minimizing its undue prejudicial impact.” Id.
ARGUMENT
The parties fundamentally disagree whether the SVF product is subject to FDA oversight. Plaintiff contends that SVF is subject to regulation under the FDCA, including the FDCA’s adulteration and misbranding provisions. Compl. at 1. On the other hand, Defendants claim that the procedures performed at its establishment are “regulated by the Florida Board of Medicine.” Defs.’ Corrected Oppn. to Pl.’s Mot. for Summ. J. at 5. In neither situation will anecdotal testimony of safety and/or effectiveness, by patients, treating physicians, or others, establish any fact that is of consequence to the resolution of this action.
First, evidence of safety and/or efficacy, anecdotal or otherwise, does nothing to answer the legal question of whether or not the SVF product is subject to FDA regulation. That question largely hinges on the two exceptions that Defendants claim apply to their activities—neither of
1
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which is affected by a determination of the safety or efficacy of the underlying product. See, e.g., Pl.’s Mot. for Summ. J. (D.E. 42) at 5-6, 20-23.
Second, should FDA regulations apply, neither safety nor efficacy is an element of the adulteration charges here. Generally, to prove a charge of adulteration, the government must show that: (1) the SVF product is a drug; (2) the SVF product was held for sale after the SVF product or one or more of its components had moved in interstate commerce; and (3) Defendants performed, or caused to be performed, one or more acts which resulted in the SVF product being adulterated (such as failing to comply with CGMP).
To prove a charge of misbranding, the government must show that: (1) the SVF product is a drug; (2) the SVF product was held for sale after the SVF product or one of its components had moved in interstate commerce; and (3) Defendants performed, or caused to be performed, one or more acts which resulted in the SVF product being misbranded. Although the government’s misbranding charge is based on a lack of adequate directions for use, which may depend on data about the product’s safety and/or effectiveness, see, e.g., Pl.’s Mot. for Summ. J. (D.E. 42) at 16-20 (discussing that safety and effectiveness data are relevant to some, but not all, of the government’s theories of misbranding), those directions must be based on data derived from well-controlled scientific testing. See United States v. Undetermined Quantities of Articles of Drug, 145 F. Supp. 2d 692, 702 (D. Md. 2001) (“Essentially, in the absence of investigations or clinical data demonstrating the safety and efficacy of the drugs, there can be no adequate instruction for their safe use.”); United States v. Miami Serpentarium Labs., Inc., 1981-82 FDC L. Rptr. Dev. Trans. Binder ¶ 38,164 at 38,931 (S.D. Fla. Mar. 30, 1982) (“Adequate directions for use—including indications, contraindications, dosages, routes of administration, warnings, side effects, and necessary collateral measures—are premised on a body of animal and clinical data derived from extensive, scientifically controlled testing.”). It is also a bedrock principle of FDCA law that anecdotal evidence is insufficient to demonstrate safety and efficacy. See, e.g., 21 C.F.R. § 314.126 (“Reports of adequate and well-controlled investigations provide the primary basis for determining whether there is ‘substantial evidence’ to support the claims of effectiveness for new drugs.”). Thus, any anecdotal evidence that Defendants’ witnesses may provide, particularly about their experiences with Defendants’ SVF product, is irrelevant to the resolution of any question of law that must be decided.
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Third, there is no need to weigh any anecdotal evidence of safety and/or efficacy, because this action does not concern a drug approval decision by FDA; Defendants have not submitted any new drug applications or biologics license applications to FDA, and now is not the time to conduct a mini-trial about an approval that has neither been sought nor granted.
Finally, if Defendants are not subject to FDA regulation—a contention that Plaintiff denies—the Florida Board of Medicine is not a party to this action. Therefore, there is no need to conduct a mini-trial to attempt to show compliance with as-of-yet unspecified State of Florida safety or medical regulations—especially when the Board’s position on Defendants’ compliance is unknown, and in any event, not charged in this action and unnecessary to resolving this action.
CONCLUSION
Because anecdotal testimony of efficacy or safety will not resolve any relevant factual or legal matter at issue in this case, and because such testimony will inevitably lead to confusing the issues and misleading the finder of fact, such testimony should not be allowed at trial.
LOCAL RULE 7.1 CERTIFICATE OF GOOD FAITH CONFERENCE
The undersigned Trial Attorney, counsel for Plaintiff, United States, hereby certifies that he has conferred with Ms. Mary Gardner, Esq., counsel for Defendants, and is authorized to represent that the Defendants oppose the relief requested in this motion.
DATED: March 29, 2019.
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
JOSEPH H. HUNT Assistant Attorney General
JAMES M. BURNHAM
Deputy Assistant Attorney General Civil Division
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Case 0:18-cv-61047-UU
Document 58
Entered on FLSD Docket 03/29/2019
Page 5 of 5
4
GUSTAV W. EYLER
Acting Director
Consumer Protection Branch
ALAN PHELPS Assistant Director
ROGER J. GURAL
Roger J. Gural
Trial Attorney
Consumer Protection Branch United States Department of Justice P.O. Box 386
Washington, DC 20044
Tel.: 202.307.0174
Email: roger.gural@usdoj.gov
Counsel for United States of America
It looks like the evidence they want to seal is patient testimony saying that the safety and effacay have no relevance to the case at hand which is a violation of policy.
My guess is that USRM’s lawyers or hopefully the judge is reasonable in saying that you can’t have it both ways. In the FDA’s summary judgement argument they tried to bring in the three blinded ladies. And now your saying it has no bearing in court.
Can’t have it both ways..
I’ll post it
Sounds about right good sir
It was unopposed by USRM
Case 0:18-cv-61047-UU Document 52 Entered on FLSD Docket 03/27/2019 Page 1 of 4
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA
Case No.: 0:18-cv-61047-UU UNITED STATES OF AMERICA,
Plaintiff, v.
US STEM CELL CLINIC, LLC, et al., Defendants.
_____________________________/
ORDER
THIS CAUSE is before the Court upon Plaintiffs’ Unopposed Motion to Seal (the “Motion”). D.E. 44. The Court has reviewed the Motion, the pertinent portions of the record and is otherwise fully advised of the premises.
On March 11, 2019, Plaintiff, the United States of America, filed its motion for summary judgment. D.E. 42. In support of that motion, Plaintiff also filed a declaration (the “Declaration”) of Elizabeth A. Waltrip, the District Director for the Florida District Office, and the Program Division Director of the Office of Biological Products Operations, Division 1, Food and Drug Administration (“FDA”). D.E. 43. In the instant Motion, Plaintiff seeks to seal certain attachments to the declaration. Plaintiff broadly describes the documents as falling into two categories: inspection documents, and medical records.
Pursuant to Local Rule 5.4(b)(1), a motion to seal must set forth “the factual and legal basis for departing from the policy that Court filings are public and that describes the information or documents to be sealed (the ‘proposed sealed material’) with as much particularity as possible, but without attaching or revealing the content of the proposed sealed material . . . The motion to file
under seal shall specify the proposed duration of the requested sealing.” “The operations of the 1
Case 0:18-cv-61047-UU Document 52 Entered on FLSD Docket 03/27/2019 Page 2 of 4
courts and the judicial conduct of judges are matters of utmost public concern.” Landmark Commc’ns, Inc. v. Virginia, 435 U.S. 829, 839 (1978). “The common-law right of access to judicial proceedings, an essential component of our system of justice, is instrumental in securing the integrity of the process.” Chicago Tribune Co. v. Bridgestone/Firestone, Inc., 263 F.3d 1304, 1311 (11th Cir. 2001). Once documents produced in discovery are used “in connection with pretrial motions that require judicial resolution of the merits,” the filed material becomes “subject to the common-law right.” Romero v. Drummond Co., 480 F.3d 1234, 1245 (11th Cir. 2007) (quoting Chicago Tribune, 263 F.3d at 1312)); see also Rushford v. New Yorker Magazine, Inc., 846 F.2d 249, 252 (4th Cir. 1988) (even though protective order provided some confidentiality to discovery, once the materials become part of a motion, they “lose their status of being ‘raw fruits of discovery’”) (emphasis added).
Nevertheless, “The common law right of access may be overcome by a showing of good cause, which requires balancing the asserted right of access against the opponent’s interest in keeping the information confidential. Whether good cause exists is decided by the nature and character of the information in question.” Romero, 480 F.3d at 1246 (internal quotations and alterations omitted). In determining whether “good cause” exists, Courts consider the following factors:
(1) whether allowing access would impair court functions or harm legitimate privacy interests,
(2) the degree of and likelihood of injury if made public,
(3) the reliability of the information,
(4) whether there will be an opportunity to respond to the information, (5) whether the information concerns public officials or public concerns,
2
Case 0:18-cv-61047-UU Document 52 Entered on FLSD Docket 03/27/2019 Page 3 of 4
(6) the availability of a less onerous alternative to sealing the documents,
(7) whether the records are sought for such illegitimate purposes as to promote public scandal or gain unfair commercial advantage,
(8) whether access is likely to promote public understanding of historically significant events, and
(9) whether the press has already been permitted substantial access to the contents of the records.
Id. Here, Plaintiff argues that good cause exists to seal the documents indefinitely. First, Plaintiff notes that FDA regulations prohibit it from disclosing this information. Under 20 C.F.R. Part 20 Information submitted to the FDA that “fall[s] within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.” 21 C.F.R. § 20.61. Similarly, pursuant to § 20.63, medical files which constitute an unwarranted invasion of personal privacy are also protected from public disclosure.
Plaintiff also argues that there is good cause to seal the inspection documents because they were obtained during the FDA’s investigation and contain highly sensitive commercial information such as the firm’s training program, processing steps, and operations, specifications of components, the identities of third-party manufacturers who are not party to the litigation and descriptions of the contents medical records of non-party. Revelation of this information would be a windfall for competitors, discourage cooperation with the FDA, and provide little cognizable benefit to the public. As to the medical documents, these records reveal diagnosis and treatment of existing medical conditions and adverse events of non-parties. Their revelation would not only constitute an invasion of privacy, but would also discourage cooperation with the FDA in the future. Given the sensitive nature of the information, the Court agrees that good cause exists to seal the inspection documents and medical records. Accordingly, it is
3
Case 0:18-cv-61047-UU Document 52 Entered on FLSD Docket 03/27/2019 Page 4 of 4
ORDERED AND ADJUDGED that the Motion, D.E. 44, is GRANTED. Plaintiff shall file an unredacted copy of the attachments to Director Waltrip’s Declaration with a notice of sealed filing in accordance with Local Rule 5.4 by Friday, March 29, 2019. it is further
ORDERED AND ADJUDGED that Attachments 1, 11-12, 14-75, 77-78, and 80-81 to Director Waltrip’s Declaration are sealed for the duration of this litigation and until further ordered by this Court or otherwise if its designation is challenged and reversed by the Court. ALL DEADLINES REMAIN IN FULL FORCE AND EFFECT.
DONE AND ORDERED in Chambers, Miami, Florida, this _26th_ day of March, 2019.
Copies Provided to Counsel of Record
4
Things I wanted to say but held back out of fear of being called a hater..
Lol ok well you know what stock I’m referring to. The one your always watching
Just passing by. I would’ve emailed you this question but I forgot your contact.
Just for reference purposes, what was it again that you said you felt have Celz the advantage over the other company you and I are also in? I remember you said you felt they were in a better position to succeed but I can’t remember what your logic was. Remind me..?
Fun fact: in 2012 judge Ursula Ungaro ruled that Gov. Rick Scott’s attempt to force drug testing on federal employees “unconstitutional” turning it down.
Seems she’s a judge of the people
The recent uptick in post on their IG promoting how busy they’ve been may be insight into their confidence in the case. Just maybe.
Business as usual today in the Villages:
https://www.instagram.com/p/Bvg5J7AHBs1/?utm_source=ig_share_sheet&igshid=bkuaeslwp6ip
USRM RESPONSE: Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 1 of 22
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 US STEM CELL, INC., US STEM CELL CLINIC, LLC, AND KRISTIN C. COMELLA’S RESPONSE TO PLAINTIFF’S STATEMENT OF UNDISPUTED MATERIAL FACTS
Pursuant to Local Rule 56.1(a), Defendants US Stem Cell, Inc., US Stem Cell Clinic, LLC, and Kristin C. Comella (collectively “Defendants”) respectfully submit their Response to Plaintiff’s Statement of Undisputed Material Facts (“Plaintiff’s Statement”).
1. Defendant US Stem Cell Clinic, LLC, (“USSCC”) is a Florida limited liability company, with its principal place of business located at 12651 Sunrise Blvd., Suite 104, Sunrise, Florida 33323, within the jurisdiction of this Court. Defs.’ Answer to Pls.’ Compl. [ECF No. 26] (hereinafter “Ans.”) ¶ 4; Waltrip Decl. ¶ 4.
RESPONSE: Defendants dispute that US Stem Cell Clinic, LLC is located at 12651 Sunrise Blvd., Suite 104, Sunrise, Florida 33323, as the Clinic has since moved to 1290 Weston Road, Suite 203a, Weston, Florida 33326. Defendants otherwise do not dispute Paragraph 1 of Plaintiff’s Statement.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 2 of 22
2. Defendant US Stem Cell, Inc., is a Florida profit corporation with its principal place of business at 13794 Northwest 4th Street, Suite 212, Sunrise, Florida 33325, within the jurisdiction of this Court. Ans. ¶ 17; Waltrip Decl. ¶ 12.
RESPONSE: Defendants do not dispute Paragraph 2 of Plaintiff’s Statement.
3. Defendant Kristin C. Comella is the Chief Scientific Officer of both USSCC and US Stem Cell, Inc. Ans. ¶ 22; Waltrip Decl. ¶ 8, Attachment (“Att.”) 1 at 13, Att. 11 at 9. She is responsible for overseeing the daily operations at USSCC, including but not limited to overseeing patient scheduling and hiring and firing employees. Ans. ¶ 22; Waltrip Decl. ¶ 8; Defendants’ Responses to Plaintiff's First Requests for Admissions (“RFA Resp.”) ¶ 12. She has stated that she wrote the procedures for the process for isolating SVF from adipose tissue and administering it to patients, and she has trained doctors on the extraction, isolation, and clinical applications of SVF. Ans. ¶ 22; Waltrip Decl. ¶ 8; see also RFA Resp. ¶ 13. She performs her duties at USSCC’s Sunrise facility, within the jurisdiction of this Court. Ans. ¶ 22; Waltrip Decl. ¶ 8. Defendant Kristin C. Comella does not have a medical degree and is not a licensed physician. RFA Resp. ¶ 38.
RESPONSE: Defendants dispute that Defendant Kristin C. Comella independently wrote the procedures for “isolating SVF from adipose tissue” as she did not independently write the procedures for isolating adipose-derived stromal vascular fraction cells from adipose tissue. Instead, she collaborated with physicians and scientists to create the procedures. Dkt. No. 45-1; see also Defs. RFA Resp. ¶ 13. Defendants also dispute that Defendant Kristin C. Comella singlehandedly trains doctors on the extraction, isolation, and clinical applications of SVF. Instead, she participates in the training of doctors, but only provides training regarding regenerative medicine. Defs. RFA Resp. ¶ 13. Defendants further dispute the description of
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 3 of 22
Defendant Kristin C. Comella’s role in the daily operations of USSCC; she is not responsible for patient scheduling. See Defs. RFA Resp. ¶ 12.
4. Defendant Theodore Gradel is a minority investor in USSCC. Defs.’ Answers to Pl.’s First Set of Interrogs. (“Interrog. Resp.”) No. 7; see Waltrip Decl. ¶ 9, Att. 11 at 7 and 9. He has been a “managing member” of USSCC. RFA Resp. ¶ 18. As of November 13, 2017, Defendant Theodore Gradel was listed with the Florida Division of Corporations as an “authorized person” and a “manager” for USSCC. RFA Resp. ¶¶ 7-18; see Waltrip Decl. ¶ 9, Att. 13. He participated on behalf of USSCC in an FDA inspection of USSCC in 2015. Interrog. Resp. No. 7; Waltrip Decl. ¶ 9, Att. 11 at 30. He was identified to FDA investigators as an individual to whom correspondence regarding USSCC should be sent. Waltrip Decl. ¶ 9, Att. 1 at 9; Att. 11 at 7. Defendant Theodore Gradel does not have a medical degree and is not a licensed physician. RFA Resp. ¶ 39.
RESPONSE: Defendants dispute that Mr. Theodore Gradel is currently listed as a managing member of Defendant US Stem Cell Clinic, LLC or is currently a minority investor in Defendant US Stem Cell Clinic, LLC. Defs. RFA Resp. ¶ 18. Moreover, Defendants dispute that Mr. Gradel is currently listed with the Florida Division of Corporations as an “authorized person” and a “manager” for Defendant US Stem Cell Clinic, LLC. Defs. RFA Resp. ¶¶ 17, 18. Finally, Mr. Theodore Gradel’s involvement in the actions underlying this case are not material to the disposition of Plaintiff’s Motion for Summary Judgment as Mr. Gradel has signed a consent decree, which has been submitted for the Court’s approval. Dkt. No. 47.
5. USSCC recovers adipose tissue from a patient and administers to the same patient the “stromal vascular fraction” (“SVF”) processed from the adipose tissue. RFA Resp. ¶ 11; Waltrip Decl. ¶ 4, Att. 12; see also Ans. ¶ 5; RFA Resp. ¶ 8.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 4 of 22
RESPONSE: Defendants dispute that Defendant US Stem Cell Clinic, LLC personally conducts any portion of the SVF Surgical Procedure or that the procedure involves processing the SVF cells from adipose tissue. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC recover stromal vascular fraction (“SVF cells”), which are naturally occurring in adipose tissue, and administer to the same patient the recovered SVF. Dkt. No. 45-1.
6. Defendants’ SVF product is intended for autologous use, which refers to the “implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered.” Ans. ¶ 6; see 21 C.F.R. § 1271.3(a).
RESPONSE: Defendants dispute that the SVF Surgical Procedure is a “product,” as it is a medical procedure, not a drug or biological product. Defendants otherwise do not dispute the remainder of Paragraph 6 of Plaintiff’s Statement.
7. USSCC administers SVF to patients to address symptoms of various neurological, autoimmune, orthopedic, and degenerative medical conditions and/or diseases, including, but not limited to, amyotrophic lateral sclerosis (“ALS”), Parkinson’s disease, spinal cord injuries, stroke, traumatic brain injury, chronic obstructive pulmonary disease (“COPD”), lung disease, and diabetes. RFA Resp. ¶ 9; Waltrip Decl. ¶ 6, Atts. 2-10; see also Ans. ¶ 7.
RESPONSE: Defendants dispute that Defendant US Stem Cell Clinic, LLC personally conducts any portion of the SVF Surgical Procedure. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants otherwise do not dispute the remainder of Paragraph 7 of Plaintiff’s Statement.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 5 of 22
8. USSCC administers SVF to patients using a variety of methods, including intravenously or by injection into specific areas of the body. Ans. ¶ 8. USSCC administers SVF to patients at the USSCC facility at 12651 Sunrise Blvd., Suite 104, Sunrise, Florida 33323. Ans. ¶ 8; see Waltrip Decl. ¶ 4.
RESPONSE: Defendants dispute that Defendant US Stem Cell Clinic, LLC personally conducts any portion of the SVF Surgical Procedure. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants otherwise do not dispute the remainder of Paragraph 8 of Plaintiff’s Statement.
9. Under Defendants’ current procedures, Defendants recover adipose tissue from patients in dedicated examination rooms located at USSCC’s Sunrise, Florida facility. Ans. ¶ 9. The tissue recovery is accomplished by a mini-liposuction procedure, whereby a syringe is used to recover adipose tissue. Ans. ¶ 9; see generally Waltrip Decl. Att. 12.
RESPONSE: Defendants dispute that Defendants personally conduct any portion of the SVF Surgical Procedure. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants further dispute that the licensed healthcare professionals employed by or contracting for Defendant US Stem Cell Clinic, LLC to perform the SVF Surgical Procedure recover only adipose tissue from patients; instead they recover adipose-derived SVF cells naturally occurring in adipose tissue from patients. Id. Defendants otherwise do not dispute the remainder of Paragraph 9 of Plaintiff’s Statement.
10. After recovering adipose tissue from the patient, Defendants process adipose tissue in a manner that causes many components of the tissue to be broken down or discarded.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 6 of 22
Ans. ¶ 10; see generally Waltrip Decl. Att. 12. The process involves the addition of a solution containing an enzyme that has traveled in interstate commerce to isolate cellular components through enzymatic digestion. Id.; Waltrip Decl. ¶ 14, Att. 1 at 19, Att. 19. It also includes an incubation period, several washing steps, centrifugation, and filtration. Ans. ¶ 10; see Waltrip Decl. Att. 12. Defendants’ process employs various types of equipment, including, but not limited to, syringes, cell wash bags, conical tubes, an incubator, a centrifuge, and a filter. Id.
RESPONSE: Defendants dispute that Defendants personally conduct any portion of the SVF Surgical Procedure. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants further dispute that the licensed healthcare professionals employed by or contracting for Defendant US Stem Cell Clinic, LLC recover only adipose tissue from patients; instead they recover adipose-derived SVF cells naturally occurring in adipose tissue from patients. Id. Defendants also dispute that the SVF is processed. Defendants otherwise do not dispute the remainder of Paragraph 10 of Plaintiff’s Statement.
11. Adipose tissue is predominantly composed of adipocytes and surrounding connective tissues that provide cushioning and support to the body. Yong Decl. ¶¶ 16, 30.
RESPONSE: Defendants dispute that adipose is predominantly composed of adipocytes and surrounding connective tissues. Instead, adipose tissue is composed of stromal and vascular cells, including adipose stem cells (mesenchymal stem cells), hematopoietic stem cells, pericytes, endothelial/progenitor cells, white blood cells, fibroblasts, adipocytes, and surrounding connective tissue. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)) at 5, 10– 11. Moreover, Defendants dispute that adipose tissue provides only cushioning and support to the body. Instead, adipose tissue possesses original characteristics other than cushioning and support,
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 7 of 22
including endocrine and regenerative characteristics. The regenerative functions of the cells contained within adipose tissue are widely recognized in the scientific community as capable of repairing and regenerating damaged tissues. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)) at 6–7.
12. Defendants’ processing of patients’ adipose tissue removes adipocytes from the adipose tissue. RFA Resp. ¶ 29; Yong Decl. ¶¶ 17, 19, 23, 26, 32; see Waltrip Decl. Att. 12. Defendants’ processing also removes the reticular fiber network and interspersed small blood vessels from adipose tissue. Yong Decl. ¶¶ 23, 26, 32; see Waltrip Decl. Att. 12.
RESPONSE: Defendants dispute that Defendants personally conduct any portion of the SVF Surgical Procedure. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants dispute that the SVF Surgical Procedure removes only adipocytes, reticular fiber network, and interspersed small blood vessels from adipose tissue as Defendants’ SVF Surgical Procedure also removes the stromal vascular fraction, which is naturally occurring in the patient’s adipose tissue. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)) at 5, 10–11. Defendants also dispute that the SVF is processed.
13. After Defendants process adipose tissue into SVF, the SVF product no longer retains its original form whereby adipocytes are surrounded by a reticular fiber network and interspersed small blood vessels. Yong Decl. ¶ 23; see Waltrip Decl. Att. 12.
RESPONSE: Defendants dispute that Defendants personally conduct any portion of the SVF Surgical Procedure and that the SVF is processed or constitutes a product. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants dispute that the SVF Surgical
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 8 of 22
Procedure involves processing adipose tissue into SVF and that the SVF “no longer retains its original form whereby adipocytes are surrounded by a reticular fiber network and interspersed with small blood vessels.” The SVF that is isolated as part of the SVF Surgical Procedure is naturally occurring in the adipose tissue and retains its original form throughout the SVF Surgical Procedure. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)).
14. USSCC patients are treated with SVF on the day that their adipose tissue is recovered. Ans. ¶ 11.
RESPONSE: Defendants do not dispute that patients at Defendant US Stem Cell Clinic, LLC are treated with SVF on the day that the SVF naturally occurring within their adipose tissue is recovered.
15. Defendants US Stem Cell, Inc. and its Chief Scientific Officer, Defendant Comella, provided training to physicians regarding the removal of adipose tissue from a patient and the separation of adipocytes from SVF. Ans. ¶ 18.
RESPONSE: Defendants dispute that Defendant Kristin C. Comella singlehandedly trains doctors on the extraction, isolation, and clinical applications of SVF. Instead, she participates in the training of doctors, but only provides training regarding regenerative medicine. Defs. RFA Resp. ¶ 13. Defendants further dispute that Defendants US Stem Cell, Inc. and its Chief Scientific Officer, Defendant Comella “train physicians regarding the removal of adipose tissue,” as the procedure involves recovery of the naturally occurring SVF contained the adipose tissue. Dkt. No. 45-1.
16. US Stem Cell, Inc., receives in interstate commerce cell wash solution that USSCC uses in its process for isolating SVF from patients’ adipose tissue. Ans. ¶ 20; Waltrip Decl. ¶ 15, Att. 1 at 10 and 20. When received by US Stem Cell, Inc., from its supplier, the solution is in
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 9 of 22
1-liter bottles that are labeled “not for human therapeutic use.” Ans. ¶ 20; Waltrip Decl. ¶ 15, Att. 1 at 20, Att. 25. US Stem Cell, Inc., then aseptically divides the solution into 125 milliliter bottles. Ans. ¶ 20; Waltrip Decl. ¶ 15, Att. 1 at 20. US Stem Cell, Inc., provides the cell wash solution to USSCC for use in manufacturing USSCC’s SVF product by transporting it from US Stem Cell, Inc., to USSCC by car, as needed. Id.
RESPONSE: Defendants do not manufacture or process a product. Defendants otherwise do not dispute Paragraph 16 of Plaintiff’s Statement.
17. US Stem Cell, Inc., assembles adipose extraction kits, which are comprised of, among other things, a plastic beaker, syringes, a conical tube, and a filter. Ans. ¶ 21; Waltrip Decl. ¶ 16, Att. 1 at 9-10, 18. As needed, US Stem Cell, Inc., then transports the adipose extraction kits by car to USSCC for use in Defendants’ process for isolating SVF from adipose tissue and administering it to patients. Id.
RESPONSE: Defendants dispute that Defendants personally conduct any portion of the SVF Surgical Procedure and that the SVF is a product. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants also dispute that the SVF is processed. Defendants otherwise do not dispute Paragraph 17 of Plaintiff’s Statement.
18. Defendants manufacture the SVF product using one or more components, including sodium chloride injection, shipped in interstate commerce from places outside the state of Florida. Waltrip Decl. ¶ 11, Att. 1 at 10-11, Atts. 14 through 18; see RFA Resp. ¶¶ 1-7.
RESPONSE: Defendants do not manufacture a product. The only “components” of the SVF are the patient’s naturally occurring adipose-derived SVF. Defendants otherwise do not dispute Paragraph 18 of Plaintiff’s Statement.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 10 of 22
19. Components of the SVF product received from outside of Florida include, for example, 0.9% Sodium Chloride Injection, USP, which was manufactured in Georgia. Waltrip Decl. ¶ 11, Att. 1 at 10-11, Atts. 14 through 18; see RFA Resp. ¶¶ 1-7.
RESPONSE: Defendants do not manufacture a product. The only “components” of the SVF are the patient’s naturally occurring adipose-derived SVF. Defendants otherwise do not dispute Paragraph 19 of Plaintiff’s Statement.
20. The labeling for the SVF that Defendants administer to patients lacks indications for use, dosages, routes of administration, and side effects. Ans. ¶ 12; Waltrip Decl. ¶ 7, Att. 1 at 39.
RESPONSE: Defendants dispute that Defendants personally conduct any portion of the SVF Surgical Procedure and that the SVF is a product that requires labeling. Instead, licensed healthcare professionals employed or contracting for Defendant US Stem Cell Clinic, LLC administer the SVF Surgical Procedure. Dkt. No. 45-1. Defendants otherwise do not dispute Paragraph 20 of Plaintiff’s Statement.
21. FDA has not licensed or approved USSCC’s SVF. Ans. ¶ 15; Joneckis Decl. ¶ 14.
RESPONSE: Defendants do not dispute Paragraph 21 of Plaintiff’s Statement.
22. There are not now, nor have there ever been any approved new drug applications (“NDAs”) filed with FDA pursuant to 21 U.S.C. § 355(b) or (j) for Defendants’ SVF. Ans. ¶ 16; Joneckis Decl. ¶ 4. There are not now, nor have there ever been any approved biologics license applications (“BLAs”) filed with FDA pursuant to 42 U.S.C. § 262 for Defendants’ SVF. Id. There are not any Investigational New Drug Applications (“INDs”) in effect under 21 U.S.C. § 355(i), for Defendants’ SVF. Id.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 11 of 22
RESPONSE: Defendants do not dispute Paragraph 22 of Plaintiff’s Statement.
23. As of October 15, 2018, USSCC's website, http://usstemcellclinic.com, stated that the company “offer[s] a variety of therapies to address symptoms for some of the most common conditions” including “neurological . . . autoimmune . . . degenerative” and other conditions, including but not limited to, ALS, Parkinson’s disease, spinal cord injuries, stroke, traumatic brain injury, rheumatoid arthritis, congestive heart failure, kidney disease, and liver disease. RFA Resp. ¶¶ 40-43; Waltrip Decl. Att. 4 at 1, 2, 10, 13, and 17.
RESPONSE: Defendants do not dispute Paragraph 23 of Plaintiff’s Statement.
24. Records collected during FDA inspections document Defendants’ manufacture of the SVF product to treat patients with, for example, ALS, Parkinson’s disease, COPD, heart disease, and pulmonary fibrosis. RFA Resp. ¶¶ 44-47; Waltrip Decl. ¶ 6, Atts. 2-10, 35 at 2 and 6, 37 at 2 and 5, 38 at 1 and 4, and 40 at 2 and 7. Between December 2015 and April 2017, USSCC manufactured over [REDACTED] of the SVF product at USSCC’s Sunrise, Florida facility. Waltrip Decl. ¶ 19.A, Att. 1 at 3.
RESPONSE: Defendants do not manufacture a product. Defendants otherwise do not dispute Paragraph 24 of Plaintiff’s Statement.
25. A USSCC brochure that markets the SVF product provides that “[s]tem cell therapy may promote the regeneration of healthy tissue, bone, or cartilage” and “has proven to be a better alternative for people facing debilitating conditions such as COPD, Degenerative Disc Disease, Osteoarthritis, and many others where traditional medicine falls short of delivering satisfactory results.” RFA Resp. ¶ 48; Waltrip Decl. Att. 2.
RESPONSE: Defendants do not market a product. Defendants, otherwise, do not dispute Paragraph 25 of Plaintiff’s Statement.
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 12 of 22
26. In a video posted on www.youtube.com (“YouTube”), Defendant Kristin Comella, representing US Stem Cell, Inc.’s corporate predecessor Bioheart, Inc., said, “At Bioheart, we focused on utilizing . . . fat-derived stem cells, originally focusing on patients with cardiac indications, patients who have had a heart attack or have developed congestive heart failure, and then have moved into other indications, including things like COPD, or lung disease; things like diabetes or limb ischemia; and also injuries, things like spinal cord injuries and orthopedics.” RFA Resp. ¶ 49; U.S. Stem Cell Clinic: Meet Kristin Comella, https://www.youtube.com/watch?v=lsFYmiwbMZM (last accessed March 9, 2019).
RESPONSE: Defendants do not dispute Paragraph 26 of Plaintiff’s Statement.
27. There have been no adequate and well-controlled studies performed with the Defendants’ SVF product demonstrating that it is safe or effective for any indication. Lapteva Decl. ¶¶ 29-32.
RESPONSE: Defendants dispute the statement that they create a product. Defendants also dispute that there have been no adequate and well-controlled studies performed on SVF, as adequate and well-controlled studies have been performed on procedures such as Defendants’ SVF Surgical Procedure demonstrating that it is safe and effective. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)).
28. Defendants’ SVF product is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Lapteva Decl. ¶¶ 29-32.
RESPONSE: Defendants dispute the statement that they create a product. Moreover, whether Defendants’ SVF Surgical Procedure is generally recognized as safe and effective is a legal
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 13 of 22
conclusion, not a statement of fact. Further, adequate and well-controlled studies have been performed by experts on procedures such as Defendants’ SVF Surgical Procedure demonstrating that it is safe and effective. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)).
29. FDA inspected USSCC from October 22 through December 7, 2015. Ans. ¶ 50; Waltrip Decl. ¶ 10, Att. 11. At the end of that inspection, FDA issued a list of inspectional observations (“Form FDA-483”) to Defendant Kristin Comella. Ans. ¶ 50; Waltrip Decl. ¶ 24, Att. 28. On December 28, 2015, Defendant Kristin Comella responded to the FDA Form-483 on behalf of USSCC. Ans. ¶ 50; Waltrip Decl. ¶ 25, Att. 77.
RESPONSE: Defendants do not dispute Paragraph 29 of Plaintiff’s Statement.
30. FDA investigators inspected USSCC’s facility in Sunrise, Florida, from April 10 through May 11, 2017. Ans. ¶ 51; Waltrip Decl. ¶ 10. At the close of the inspection, FDA investigators issued a Form FDA-483 to Defendant Kristin Comella. Ans. ¶¶ 43, 51; Waltrip Decl. ¶ 24, Att. 27. Kristin Comella responded to the FDA Form-483 on behalf of Defendants on May 16, 2017. Ans. ¶ 51; Waltrip Decl. ¶ 26, Att. 78.
RESPONSE: Defendants do not dispute Paragraph 30 of Plaintiff’s Statement.
31. Defendants’ operations for manufacturing SVF were not in full compliance with FDA’s current Good Manufacturing Practice regulations for drugs (“CGMP”) at the time of FDA’s October 22, 2015 to December 7, 2015 inspection or FDA’s April 10, 2017 to May 11, 2017 inspection. RFA Resp. ¶¶ 23-24; Waltrip Decl. ¶¶ 19, 21 (and Attachments cited therein); Melhem Dec1. ¶¶ 13-51.
RESPONSE: Defendants do not manufacture SVF. Moreover, whether Defendants’ operations were in compliance with FDA’s current Good Manufacturing Practice regulations is a
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 14 of 22
conclusion of law, not a statement of fact. Defendants otherwise do not dispute Paragraph 31 of Plaintiff’s Statement.
32. As of the date of FDA’s April 10-May 11, 2017 inspection, USSCC did not manufacture its SVF product under aseptic conditions. Melhem Decl. ¶¶ 16-23; Waltrip Decl. ¶ 19.A, Att. 1 at 25-26, 27-28, Att. 12 at 1, Att. 30 at photos 20-21, Att. 32 at 2.
RESPONSE: Defendants do not manufacture a product. Defendants also dispute that they do not undertake the SVF Surgical Procedure under aseptic conditions. Defendants otherwise do not dispute Paragraph 32 of Plaintiff’s Statement.
33. As of the date of FDA’s April 10-May 11, 2017 inspection, USSCC did not perform bioburden testing of its SVF product to check for the presence of objectionable microorganisms. Melhem Decl. ¶¶ 24-27; Waltrip Decl. Att. 1 at 27.
RESPONSE: Defendants do not manufacture a product. Defendants otherwise do not dispute Paragraph 33 of Plaintiff’s Statement.
34. On August 24, 2017, FDA issued a Warning Letter to USSCC. Ans. ¶ 52; Waltrip Decl. ¶ 24, Att. 76. Defendants submitted two responses to the Warning Letter: the first signed by Defendant Kristin Comella and the second signed by counsel to USSCC. Ans. ¶ 52; Waltrip Decl. ¶¶ 27-28. Atts. 79-80.
RESPONSE: Defendants do not dispute Paragraph 34 of Plaintiff’s Statement.
35. On June 16, 2015, a patient with macular degeneration experienced eye pain and blurry vision during treatment with Defendants’ SVF product. Waltrip Decl. ¶ 23.a, Atts. 73- 74. The patient went to the emergency room, where she was diagnosed with intraocular pressure of over 90 mm Hg in her right eye and 73 mm Hg in her left eye. Waltrip Decl. ¶ 23.a, Att. 73 at 3, Att. 74 at 10. She suffered bilateral detached vitreous with vitreous opacities and was diagnosed
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with bilateral vitreous hemorrhages, ocular hypertension, and uveitis. Waltrip Decl. ¶ 23.a, Att. 73 at 1, Att. 74 at 8.
RESPONSE: Defendants dispute that the SVF is a product. Defendants otherwise do not dispute Paragraph 35 of Plaintiff’s Statement.
36. On the same day, June 16, 2015, another patient with macular degeneration suffered the loss of sight in both eyes after Defendants’ SVF product was injected into both eyes in the same day. Waltrip Decl. ¶ 23.b, Att. 74 at 2-8, see, generally, Att. 75. The day after the patient’s treatment with Defendants’ SVF product, a physician documented multiple hemorrhages in both eyes. Waltrip Decl. ¶ 23.b, Att. 74 at 3, Att. 75 at 2. On June 29, 2015, a physician determined that the patient had detached retinas and was legally blind at 20/400 in both eyes, even after being corrected with glasses. Waltrip Decl. ¶ 23.b, Att. 74 at 3, Att. 75 at 2.
RESPONSE: Defendants dispute that the SVF is a product and that a causal link was established between the SVF Surgical Procedure and the patient’s blindness. Defendants otherwise do not dispute Paragraph 36 of Plaintiff’s Statement.
37. On May 15, 2016, a patient received intravitreal injections of Defendants’ SVF product for treatment of macular degeneration. Waltrip Decl. ¶ 23.c.; Att. 81 at 2; see Att. 74 at 12. After the treatment, the patient suffered complete vision loss. Id.
RESPONSE: Defendants dispute that the SVF is a product. Defendants also dispute that the patient referenced in Paragraph 37 received SVF injections on May 15, 2016, and that a causal link was established between the SVF Surgical Procedure and the patient’s blindness. Defendants otherwise do not dispute Paragraph 37 of Plaintiff’s Statement.
38. In March 2017, the New England Journal of Medicine (NEJM) published a report on the three “serious adverse events” involving “linding visual outcomes” experienced
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by Defendants’ patients, described in paragraphs 35-37 above. See Ajay E. Kuriyan, et al., Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD, 376 NEW ENG. J. MED. 1047, 1050 (Mar. 16, 2017), available at http://www.nejm.org/doi/ful1/10.1056/NEJMoa1609583#t=article (last accessed: March 9, 2019). The NEJM report acknowledged that experimentation on patients in this manner could lead to “devastating outcomes.” Id. The NEJM report noted that the patients’ complications were “probably due to the stem-cell preparations” and that some may have been caused “when enzymes such as trypsin [ ] used in the preparation of the stem cells [ ] contaminate the injections.” Id. at 1052. The NEJM report also acknowledged the “toxic effects . . . caused by the injected material, which may have included the enzymes used in the preparation.” Id.
RESPONSE: Defendants dispute Plaintiff’s selective quotation of a “Brief Report” published in the New England Journal of Medicine, which did not involve the personal examination of the patients at issue, did not draw any definitive conclusions regarding the safety or efficacy of the SVF Surgical Procedure, and did not determine that the SVF Surgical Procedure caused the patient’s surgical complications.
39. Defendants take the SVF isolated in the process described in “Adipose Derived Stem Cell Isolation: A Step-By-Step Guide” (Waltrip Decl. Att. 12), and resuspend it in saline to produce the SVF product. Waltrip Decl. Att. 12 at 30; see RFA Resp.¶¶ 1, 3-6.
RESPONSE: Defendants dispute that the SVF is a product. Defendants otherwise do not dispute Paragraph 39 of Plaintiff’s Statement.
40. The document entitled, “Adipose Derived Stem Cell Isolation: A Step-By-Step Guide” (Waltrip Decl. Att. 12) accurately describes the steps that employees of Defendant USSCC
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took as of May 11, 2017 to obtain and isolate SVF in a form in which it can be administered to patients. RFA Resp. ¶ 11.
RESPONSE: Defendants do not dispute Paragraph 40 of Plaintiff’s Statement.
41. Scientific literature documents the harmful effects that may occur as a result of administering adipose tissue-based products using routes of administration such as those intended for Defendants’ SVF product. Lapteva Decl. ¶ 35. Those harmful effects include administration site reactions such as swelling, tendonitis, and intra-articular pain, as well as systemic reactions manifested by transient fever, facial flushing and myalgia, and pulmonary embolism. Lapteva Decl. ¶ 35 (citing Pak J et al, Safety reporting on implantation of autologous adipose tissue-derived stem cells with platelet-rich plasma into human articular joints. BMC, Musculoskelet Disord, 2013;14-337; Siennicka K et al, Adipose-derived cells (stromal vascular fraction) transplanted for orthopedic or neurological purposes: are they safe enough? Stem Cell International, 2016 Article ID 5762916; Lalu MM et al, Safety of cell therapy with mesenchymal stromal cells (SafeCell): a systematic review and meta-analysis of clinical trials. PLoS ONE 2012;7 (10): e47559; Rodriguez JP et al, Autologous stromal vascular fraction therapy for rheumatoid arthritis: rationale and clinical safety. Int Arch Med, 2012, 5:5; Jung JW et al, Familial occurrence of pulmonary embolism after intravenous adipose tissue-derived stem cell therapy. Yonsei Med J, 2013;54: 1239-96; and Tatsumi et al, Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biomedical and Biophysical Research Communications 2013, 431; 203-209).
RESPONSE: Defendants dispute Plaintiff’s selective citation to inapposite scientific studies, and failure to include reference to those studies that support the safe and effective use of procedures such as Defendants’ SVF Surgical Procedure. Defendants do not, however, dispute that
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the SVF Surgical Procedure, like all surgical procedures, has potential side effects.
42. Medical expertise, licensure, and appropriate subspecialty training are required to diagnose the diseases and condition(s) to be treated and to determine the appropriate therapeutic intervention(s) for each of the diseases and conditions listed in paragraph 7 above. Lapteva Decl.
¶ 35.1.
RESPONSE: Paragraph 42 is not material to the disposition of Plaintiff’s Motion for
Summary Judgment, and does not constitute a statement of facts, but rather of conclusion of law. Regardless, Defendants do not dispute Paragraph 42 of Plaintiff’s Statement.
43. Medical expertise, licensure, and/or appropriate training are also required to administer the products through the intended parenteral routes of administration described in paragraph 8 above. Lapteva Decl. ¶ 35.1.
RESPONSE: Paragraph 43 is not material to the disposition of Plaintiff’s Motion for Summary Judgment, and does not constitute a statement of facts, but rather of conclusion of law. Regardless, Defendants do not dispute Paragraph 43 of Plaintiff’s Statement.
44. As of the date of FDA’s April 10-May 11, 2017 inspection, USSCC did not establish a system for monitoring environmental conditions to prevent contamination during aseptic processing. Melham Decl. ¶¶ 28-31.
RESPONSE: Defendants do not dispute Paragraph 44 of Plaintiff’s Statement.
45. Adipose tissue is typically defined as a connective tissue composed of clusters of cells (adipocytes) surrounded by a reticular fiber network, also known as reinforced basement membrane, and interspersed small blood vessels, divided into lobes and lobules by connective tissue septa. The reinforced basement membrane, is comprised of various types of fibrous collagen and resembles the walls of a 3-dimensional (3D) closed-cell foam, with each adipocyte occupying a
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pore cavity of the foam. Additionally, adipose tissue contains other cells, including preadipocytes, fibroblasts, vascular endothelial cells, and macrophages. Yong Decl. ¶ 15
RESPONSE: Defendants dispute that adipose tissue is “typically” defined as a connective tissue composed of clusters of adipocytes surrounded by a reticular fiber network. Instead, adipose tissue is a tissue composed of stromal and vascular cells, including adipose stem cells (mesenchymal stem cells), hematopoietic stem cells, pericytes, endothelial/progenitor cells, white blood cells, and fibroblasts, adipocytes and surrounding connective tissue. Dkt. No. 45-5 (Dr. Elliot Lander’s Rebuttal Expert Report (dated Jan. 22, 2019)) at 5, 10–11. Defendants otherwise do not dispute Paragraph 45 of Plaintiff’s Statement.
46. Under Defendants’ current procedures, an enzyme mixture that specifically degrades collagen (collagenase) is added to the washed adipose tissue in order to disrupt and digest the reinforced basement membrane to dissociate the cellular contents of the adipose tissue. The digested tissue undergoes a series of processing steps including centrifugation, to separate non- adipocyte cellular and digested structural components of the tissue from dissociated adipocytes and free lipids, followed by filtration whereby the non-adipocytic cells (SVF) are isolated from the digested structural components of the adipose tissue by pushing the mixture through a strainer where the pore size effectively only allows cells with a certain diameter to pass, i.e., the digested structural components of the adipose tissue are filtered out. The isolated SVF is subsequently concentrated via centrifugation and finally resuspended in a solution. Yong Decl. ¶ 19.
RESPONSE: Defendants dispute that the patient’s SVF is processed. Defendants otherwise do not dispute Paragraph 46 of Plaintiff’s Statement.
Dated: March 25, 2019 Respectfully submitted, /s/ Isaac J. Mitrani
Case 0:18-cv-61047-UU
Document 50-1
Entered on FLSD Docket 03/25/2019
Page 20 of 22
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., Kristin C. Comella and Theodore Gradel
Case 0:18-cv-61047-UU Document 50-1 Entered on FLSD Docket 03/25/2019 Page 21 of 22
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on March 25, 2019, a true and correct copy of the foregoing Defendants’ Response to Plaintiff’s Statement of Undisputed Material Facts 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
Case 0:18-cv-61047-UU
Document 50-1 Entered on FLSD Docket 03/25/2019 Page 22 of 22
Roger J. Gural
Trial Attorney
Consumer Protection Branch United States Department of Justice P.O. Box 386
Washington, DC 20044 Roger.gural@usdoj.gov
Counsel for United States of America
Of Counsel:
Rebecca K. Wood
Chief Counsel
Food and Drug Administration
Perham Gorji
Deputy Chief Counsel for Litigation
Michael D. Helbing
Associate Chief Counsel for Enforcement
United States Dept. of Health and Human Services Office of the General Counsel
White Oak 31, Room 4426A
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
James A. Weinkle
Assistant United States Attorney Office of the United States Attorney 99 N.E. 4th Street, Suite 300
Miami, FL 33132 james.weinkle@usdoj.gov
Counsel for United States of America
SERVICE LIST
FDA RESPONSE:
Case 0:18-cv-61047-UU Document 49-1 Entered on FLSD Docket 03/25/2019 Page 1 of 7
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 and THEODORE GRADEL, individuals,
Defendants.
PLAINTIFF’S RESPONSE TO DEFENDANTS’ STATEMENT OF MATERIAL UNDISPUTED FACTS
Pursuant to Local Rule 56.1(a), Plaintiff United States of America respectfully submits this Response to Defendants’ Statement of Material Undisputed Facts. Consistent with Local Rule 56.1, the Government’s responses to Defendants’ Statement of Undisputed Material Facts correspond with the order and paragraph numbering scheme used by Defendants, but do not repeat the text of Defendants’ paragraphs.
1. Disputed as written. Although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government disputes Defendants’ characterization of their process for isolating their stromal vascular fraction (“SVF”) from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Decl. of Elizabeth Waltrip (D.E. 43) submitted in support of the Government’s Motion for Summary Judgment (“Waltrip Decl.”) ¶ 4; Decl. of Carolyn Yong, Ph.D. (D.E. 42-4) submitted in support of the Government’s Motion for Summary Judgment (“Yong Initial Decl.”) ¶¶ 17-20, 21, 23; see generally Exhibit A to Decl. of Kristin Comella (D.E. 45-2) (“Comella Decl.”). The Government also disputes this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.” However, whether Defendants’ agents are
1
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“licensed healthcare professionals,” and exactly when Defendants began manufacturing the SVF product, are facts not material to the pending summary judgment cross-motions.
I. Defendants’ SVF Surgical Procedure
2. Disputed as written. Although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government disputes Defendants’ characterization of their process for isolating SVF from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Waltrip Decl. ¶ 4; Yong Initial Decl. ¶¶ 17-20, 21, 23; see generally Comella Decl. Ex. A.
The Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.” However, whether Defendants’ agents are “licensed healthcare professionals,” is a fact not material to the pending summary judgment cross-motions.
The Government does not dispute that Defendants’ agents manufacture SVF and inject it into patients during a single outpatient procedure at a US Stem Cell Clinic, LLC Florida-based surgical clinic.
3. Disputed. The Government disputes that a healthcare professional “collects a patient’s stromal vascular fraction.” Rather, Defendants’ agents recover adipose tissue from patients. RFA Resp. ¶ 11; Comella Decl. Ex. A at 9 (“Adipose Extraction” step).
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government further disputes that SVF is “naturally occurring in a patient’s own adipose tissue.” Although the components that, after processing, become SVF are present in their natural state in adipose tissue, SVF does not exist as SVF in adipose tissue. Supp. Decl. of Carolyn Yong, submitted as Exhibit 1 to Plaintiff’s Opposition Memorandum (“Yong Suppl. Decl.”) ¶¶ 3-4; see Yong Initial Decl. ¶¶ 17-19.
Although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government further disputes Defendants’ characterization of their process for isolating SVF from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Waltrip Decl. ¶ 4; Yong Initial Decl. ¶¶ 17-20, 21, 23; see generally Comella Decl. Ex. A.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government further disputes Defendants’ characterization that SVF is simply
2
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“relocated” back into a patient. While the components that, after processing, become SVF are present in their natural state in adipose tissue, SVF does not exist as SVF in adipose tissue. Yong Suppl. Decl. ¶¶ 3-4; see Yong Initial Decl. ¶¶ 17-19.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.”
The Government does not dispute that the SVF Defendants derive from a patient’s adipose tissue is injected into the same patient, along with another drug component.
4. Disputed as written. The Government disputes that a “healthcare professional” “collects the patient’s SVF cells” and that tumescent liposuction “permits the liposuction of the SVF, along with the fat tissue that contains it.” Rather, Defendants’ agents recover adipose tissue from patients. RFA Resp. ¶ 11; Comella Decl. Ex. A at 9 (“Adipose Extraction” step); see Yong Suppl. Decl. at ¶¶ 3-4.
Although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government further disputes Defendants’ characterization of their process for isolating SVF from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Waltrip Decl. ¶ 4; Yong Initial Decl. ¶¶ 17-20, 21, 23; see generally Comella Decl. Ex. A.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.”
The Government does not dispute that Defendants’ agents use tumescent liposuction to recover adipose tissue that includes components that are later isolated to become SVF through the use of local, rather than general, anesthesia.
5. Disputed as written. Although it is not material to the resolution of the pending summary judgment motions, the Government disputes Defendants’ characterization of “collagenase enzymes and a centrifuge device” as “surgical tools”; they are manufacturing reagents and equipment, respectively. See Yong Initial Decl. ¶¶ 17-20, 21, 23.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.”
3
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The Government does not dispute that Defendants’ agents use manufacturing components and equipment, including collagenase enzymes and a centrifuge, to isolate SVF by removing adipocytes and other broken-down components of the adipose tissue.
6. Disputed. Although it is not material to the resolution of the pending summary judgment cross-motions, the Government disputes that there is such a thing as a “pre-collagenase SVF cell.” While the components that later become SVF are present in their natural state in adipose tissue, SVF does not exist as SVF in adipose tissue. Supp. Decl. of Carolyn Yong, submitted with Plaintiff’s Opposition memorandum (“Yong Suppl. Decl.”) ¶¶ 3-4; see Yong Initial Decl. ¶¶ 17-19.
The Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “unrelated” in the context of cells.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government does not dispute that collagenase enzymes, as used in Defendants’ process described in Comella Decl. Ex. A do not create a new cell when compared to the cell as it existed in its native state in adipose tissue.
7. Disputed as written. Although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government disputes Defendants’ characterization of their process for isolating SVF from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Waltrip Decl. ¶ 4; Yong Initial Decl. ¶¶ 17-20, 21, 23; see generally Comella Decl. Ex. A.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.”
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government does not dispute specifically that the centrifuge that Defendants’ agents use to manufacture the SVF product, as described in Comella Decl. Ex. A, does not itself change or alter the individual cells contained in SVF. The adipose tissue recovered from the patient is, however, transformed in other ways during Defendants’ manufacturing process. See Yong Initial Decl. ¶¶ 17-19, 23, 25-26, 32.
8. Disputed as written. Although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government disputes
4
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Defendants’ characterization of their process for isolating SVF from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Waltrip Decl. ¶ 4; Yong Initial Decl. ¶¶ 17-20, 21, 23; see generally Comella Decl. Ex. A.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government also disputes Defendants’ characterization that SVF is simply “relocated” back into a patient. While the components that, after processing, become SVF are present in their natural state in adipose tissue, SVF does not exist as SVF in adipose tissue. Yong Suppl. Decl. ¶¶ 3-4; see Yong Initial Decl. ¶¶ 17-19.
Although it is not material to the resolution of the pending summary judgment cross- motions, the Government also objects to this proposed fact because it is not clear what Defendants mean by the general term “licensed healthcare professionals.”
The Government does not dispute that Defendants’ agents who manufacture the SVF product and administer it to patients suspend the patient’s SVF in a sterile saline solution, at which point it is injected into the patient’s body,
9. Disputed. Although the components that, after processing, become SVF are present in their natural state in adipose tissue, SVF does not exist as SVF in adipose tissue. Yong Suppl. Decl. ¶¶ 3-4; see Yong Initial Decl. ¶¶ 17-19.
10. Disputed as written. The Government disputes that SVF is removed from the patient as SVF. See, supra, ¶¶ 3, 4, 9.
The Government otherwise does not dispute that after it is isolated from adipose tissue, the patient’s SVF is comprised of stromal and vascular cells, including adipose stem cells (mesenchymal stem cells), hematopoietic stem cells, pericytes, endothelial/progenitor cells, white blood cells, and fibroblasts, among other cells—with the adipocyte (fat) cells removed.
11. Undisputed.
II. Defendants’ Interactions with the FDA
12. Disputed. The Government objects to this fact as irrelevant. Regarding its accuracy, FDA did not inspect Defendants’ facility or speak to Defendants directly about their SVF product prior to FDA’s inspection in 2015. However, FDA communicated to the public generally about the regulations in Part 1271, including the “same surgical procedure exception” at issue in Defendants’ motion. Among other things, even before publishing a proposed rule, FDA notified the public about its proposed approach in “Proposed Approach to Regulation of
5
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Cellular and Tissue-Based Products,” FDA Dkt. No. 97N-0068 (“Proposed Approach”), available at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/Tissue/UCM062601.pdf. On May 14, 1998, after receiving comments and holding a public meeting on the Proposed Approach, FDA issued a Proposed Rule Concerning “Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products.” See 63 Fed. Reg. 26744, 26748 (May 14, 1998). On January 19, 2001, through notice and comment rulemaking, FDA issued its Final Rule concerning Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing.
66 Fed. Reg. 5447. FDA published a draft guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” in October 2014. 79 Fed. Reg. 63348 (Oct. 23, 2014).
Further, although the exact descriptive language is not material to the resolution of the pending summary judgment cross-motions, the Government disputes Defendants’ characterization of their process for isolating their SVF product from adipose tissue as a “surgical procedure.” Defendants manufacture the SVF product. See Waltrip Decl. ¶ 4; Yong Initial Decl. ¶¶ 17-20, 21, 23; see generally Comella Decl. Ex. A.
13. Undisputed.
14. Undisputed.
15. Undisputed.
16. Undisputed.
17. Undisputed.
18. Undisputed.
19. Undisputed.
20. Undisputed.
21. Undisputed.
22. Undisputed.
6
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Page 7 of 7
DATED: March 25, 2019.
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
JOSEPH H. HUNT Assistant Attorney General
JAMES M. BURNHAM
Deputy Assistant Attorney General Civil Division
GUSTAV W. EYLER
Acting Director
Consumer Protection Branch
ROGER J. GURAL
Roger J. Gural
Trial Attorney
Consumer Protection Branch United States Department of Justice P.O. Box 386
Washington, DC 20044
Tel.: 202.307.0174
Email: roger.gural@usdoj.gov
Counsel for United States of America
Of Counsel:
ROBERT P. CHARROW General Counsel
STACY CLINE AMIN
Chief Counsel
Food and Drug Administration
Deputy General Counsel
Department of Health and Human Services
PERHAM GORJI
Deputy Chief Counsel for Litigation
MICHAEL D. HELBING
Associate Chief Counsel for Enforcement United States Food and Drug Administration Office of the Chief Counsel
White Oak 31, Room 4426A
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: 240.402.6165
7
Say no more fam.
WARNING: I have NO clue how this is going to format on iHub so prepare for it to be two LONG jumbled post but I’m just going to copy and paste both sides response to the summary statement
Defendant Theodore Gradel is a minority investor in USSCC. Defs.’ Answers to Pl.’s First Set of Interrogs. (“Interrog. Resp.”) No. 7; see Waltrip Decl. ¶ 9, Att. 11 at 7 and 9. He has been a “managing member” of USSCC. RFA Resp. ¶ 18. As of November 13, 2017, Defendant Theodore Gradel was listed with the Florida Division of Corporations as an “authorized person” and a “manager” for USSCC. RFA Resp. ¶¶ 7-18; see Waltrip Decl. ¶ 9, Att. 13. He participated on behalf of USSCC in an FDA inspection of USSCC in 2015. Interrog. Resp. No. 7; Waltrip Decl. ¶ 9, Att. 11 at 30. He was identified to FDA investigators as an individual to whom correspondence regarding USSCC should be sent. Waltrip Decl. ¶ 9, Att. 1 at 9; Att. 11 at 7. Defendant Theodore Gradel does not have a medical degree and is not a licensed physician. RFA Resp. ¶ 39.
RESPONSE: Defendants dispute that Mr. Theodore Gradel is currently listed as a managing member of Defendant US Stem Cell Clinic, LLC or is currently a minority investor in Defendant US Stem Cell Clinic, LLC. Defs. RFA Resp. ¶ 18. Moreover, Defendants dispute that Mr. Gradel is currently listed with the Florida Division of Corporations as an “authorized person” and a “manager” for Defendant US Stem Cell Clinic, LLC. Defs. RFA Resp. ¶¶ 17, 18. Finally, Mr. Theodore Gradel’s involvement in the actions underlying this case are not material to the disposition of Plaintiff’s Motion for Summary Judgment as Mr. Gradel has signed a consent decree, which has been submitted for the Court’s approval. Dkt. No. 47.
Thank you for highlighting the SEVERAL ways this differs from the Regenerative Science case that some try to claim is a preview as to what is to happen to USRM.
Our main supported arguments weren’t even arguments or standing points for Regenexx. With all the facts laid out, the only question is will this Judge be corrupt in her ruling or will she just stick to the facts both scientific and previous case law. At least it’s a woman judge so hopefully she sees the innovator that Kristin is.
And if NOT then like you said, Regenexx is still very much active and a player in the stem cell market even after losing their VERY DIFFERENT case against the FDA.
Murphy is actually in the Comella vs US documentary that was posted a few months ago. So he’s still in actually.
Roger Stone is there. Kind of crazy lol
Had to update my docket!!! Thanks for the update!
The last update is on the 12th.
On the 12th the judge denied the motion to forgo mediation and mediation was to proceed as scheduled on March 18th.
I see the thing about Theodore but I see that mediation is still on and was scheduled for the 18th
When and where did you see the mediation report? There are no new document filings on the case on Pacer monitor..?
KEEP IN MIND THEY WERE NOT EVEN DOING A SAME DAY SURGICAL PROCEDURE LIKE USRM so they’re case wasn’t nearly as strong and 7 years have passed since then and so much science has been unmasked!