United States v. U.S. Stem Cell Clinic, LLC, Case No. 0:18-cv-61047-UU

CourtUnited States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
Writing for the CourtURSULA UNGARO, UNITED STATES DISTRICT JUDGE
Citation403 F.Supp.3d 1279
Parties UNITED STATES of America, Plaintiff, v. US STEM CELL CLINIC, LLC, et al., Defendants.
Docket NumberCase No. 0:18-cv-61047-UU
Decision Date03 June 2019

403 F.Supp.3d 1279

UNITED STATES of America, Plaintiff,
v.
US STEM CELL CLINIC, LLC, et al., Defendants.

Case No. 0:18-cv-61047-UU

United States District Court, S.D. Florida.

Signed June 3, 2019


403 F.Supp.3d 1282

James Alan Weinkle, United States Attorney's Office, Miami, FL, Roger J. Gural, United States Department of Justice, Washington, DC, for Plaintiff.

Loren Harley Cohen, Isaac Jaime Mitrani, Mitrani, Rynor, Adamsky & Toland, P.A., Miami Beach, FL, Mary M. Gardner, Pro Hac Vice, Stephen R. Freeland, Pro Hac Vice, Todd H. Halpern, Pro Hac Vice, Todd A. Harrison, Pro Hac Vice, Venable LLP, Washington, DC, Michael S. Blume, Pro Hac Vice, Venable LLP, New York, NY, for Defendants.

ORDER ON MOTIONS FOR SUMMARY JUDGMENT

URSULA UNGARO, UNITED STATES DISTRICT JUDGE

THIS CAUSE is before the Court upon Plaintiff's Motion Summary Judgment ("Plaintiff's Motion"), D.E. 42, and Defendants' Motion for Summary Judgment ("Defendants' Motion" and together with Plaintiff's Motion, the "Motions"). D.E. 41. The Court has reviewed the Motions, the pertinent portions of the record and is otherwise fully advised in the premises. For the reasons discussed infra , Plaintiff's Motion is GRANTED and Defendants' Motion is DENIED.

I. Factual Background

Unless otherwise indicated, the following facts are undisputed.

A. Defendants and their Operations

Defendants1 US Stem Cell Clinic, LLC (the "Clinic") and US Stem Cell, Inc. are Florida corporations. D.E. 42-1 ¶¶ 1-2; D.E. 50-1 ¶¶ 1-2. The Defendants are engaged in the business of providing a therapeutic treatment in which a patient's adipose tissue (fat) is extracted, processed to isolate certain stem cells, and injected back into the same patient to treat a range of neurological, autoimmune, and orthopedic illnesses. D.E. 42-1 ¶¶ 5-8; D.E. 50-1 ¶¶ 5-8. Defendant Kristin Comella ("Comella") is the Chief Scientific Officer of both the Clinic and US Stem Cell, Inc. D.E. 26 ¶ 22.

B. Stromal Vascular Fraction & Defendants' Procedure

Adipose tissue is a connective tissue composed of clusters of adipocyte cells (fat cells), surrounded by a reticular fiber network, interspersed with blood vessels and

403 F.Supp.3d 1283

white blood cells. D.E. 42-1 ¶¶ 11-12; D.E. 50 ¶¶ 11-12; D.E. 42-4 ¶ 23; D.E. 45-5 at 6. Adipose tissue also contains stem cells including stromal and vascular stem cells known as the "stromal vascular fraction." ("SVF"). Id.

At the Clinic, Defendants utilize a multi-step procedure to separate the SVF from the other component cells of the adipose tissue. First, healthcare professionals working for Defendants extract a patient's adipose tissue via a "tumescent liposuction" procedure. D.E. 42 ¶ 9; D.E. 50-1 ¶ 9. Then, a "cell wash solution" is added to the extracted adipose tissue to remove blood cells. D.E. 45-2 at 8. This cell wash solution is purchased from manufacturers outside of Florida and is labelled "not for human therapeutic use." D.E. 50-1 ¶ 16; D.E. 53-1 at 10. Next, a solution containing a collagenase enzyme is added to the adipose tissue; this digests the collagen and fiber network connecting the cells in the adipose tissue. D.E. 1 ¶ 10; D.E. 26 ¶ 10; D.E. 42-4 ¶ 19. The enzyme solution is purchased from a manufacturer located outside of Florida. Id. ; D.E. 53-1 at 18-19. Next, the tissue and enzyme mixture is centrifuged for five minutes, which separates the adipocytes and other components from the SVF. D.E. 42-4 ¶ 19; D.E. 45-2 at 8, 23-24. Then, to further isolate the SVF from the enzymatically-digested components of the adipose tissue, the mixture is filtered via a strainer, which allows only the SVF to pass through. D.E. 42-4 ¶ 19; D.E. 45-2 at 8, 25-26. The mixture is then centrifuged again to concentrate it and is combined with a platelet-rich plasma solution or saline. D.E. 42-4 at 8; D.E. 45-2 at 31. This solution, now composed almost exclusively of SVF, is transferred to a syringe to be injected into the patient on the same day it is extracted. Id.

C. Marketing

Defendants make numerous claims about the health benefits of their SVF therapy. Defendants assert that the SVF therapy can treat neurological, autoimmune, orthopedic and degenerative diseases, including, inter alia , Parkinson's disease, Amyotrophic Lateral Sclerosis ("ALS"), lung disease, heart disease, and diabetes. D.E. 50-1 ¶ 24. Defendants also claim that their SVF therapy has "proven to be a better alternative for people facing debilitating conditions such as COPD [chronic obstructive pulmonary disease ], Degenerative Disc Disease, Osteoarthritis and many others where traditional medicine falls short ...." D.E. 43-1. These claims have been made in brochures, websites, YouTube videos, and other media. D.E. 50-1 ¶¶ 23, 25, 26.

D. FDA Inspections

Plaintiff, the United States Food and Drug Administration (the "FDA") inspected the Clinic over the course of six different visits from October 22, 2015 through December 7, 2015, and another seven visits between April 10, 2017 and May 11, 2017. D.E. 50-1 ¶¶ 29-30; D.E. 45 ¶¶ 13-17. The results of these inspections were memorialized in two "Form FDA-483's," detailing observations made by FDA inspectors regarding the SVF therapy. Among these observations were that: Defendants had not established a system for monitoring environmental conditions to prevent contamination during aseptic processing of the SVF, Defendants did not test the SVF for objectionable microorganisms, and that the label for the SVF did not contain indications for use, dosage, routes of administration or side effects. D.E. 50-1 ¶¶ 20, 32-33, 44; D.E. 53-17; D.E. 53-18.

Comella responded to the FDA on December 28, 2015, and May 16, 2017, asserting that Defendants were not required to comply with FDA regulations because the businesses were subject to statutory exceptions including, most importantly, the

403 F.Supp.3d 1284

"same surgical procedure exception" contained in 21 C.F.R. § 1271.15(b). D.E. 45 ¶¶ 15, 18. On August 24, 2017, the FDA issued a warning letter to Defendants, re-iterating that during the inspections, FDA investigators had found the Clinic to be non-compliant with FDA regulations and disagreeing with Comella's assertions that Defendants were exempt from the FDA's adulteration and misbranding regulations. D.E. 43-8. The FDA warned that failure to take corrective action could lead to regulatory actions without further notice. Id. On August 29, 2017, Comella responded to the warning letter, disputing the FDA's findings and re-iterating that the Clinic was exempt from FDA regulation. D.E. 45 ¶ 20; D.E. 26 ¶ 52.

II. Legal Standard

Summary judgment is authorized only when the moving party meets its burden of demonstrating that "the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56. When determining whether the moving party has met this burden, the Court must view the evidence and all factual inferences in the light most favorable to the non-moving party. Adickes v. S.H. Kress & Co. , 398 U.S. 144, 157, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970) ; Rojas v. Florida , 285 F.3d 1339, 1341-42 (11th Cir. 2002).

The party opposing the motion may not simply rest upon mere allegations or denials of the pleadings; after the moving party has met its burden of proving that no genuine issue of material fact exists, the non-moving party must make a showing sufficient to establish the existence of an essential element of that party's case and on which that party will bear the burden of proof at trial." See Celotex Corp. v. Catrett , 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ; Poole v. Country Club of Columbus, Inc. , 129 F.3d 551, 553 (11th Cir. 1997) ; Barfield v. Brierton , 883 F.2d 923, 933 (11th Cir. 1989).

If the record presents factual issues, the Court must not decide them; it must deny the motion and proceed to trial. Envntl. Def. Fund v. Marsh , 651 F.2d 983, 991 (5th Cir. 1981). Summary judgment may be inappropriate even where the parties agree on the basic facts, but disagree about the inferences that should be drawn from these facts. Lighting Fixture & Elec. Supply Co. v. Cont'l Ins. Co. , 420 F.2d 1211, 1213 (5th Cir. 1969). If reasonable minds might differ on the inferences arising from undisputed facts, then the Court should deny summary judgment. Impossible Elec. Techs., Inc. v. Wackenhut Protective Sys., Inc. , 669 F.2d 1026, 1031 (5th Cir. 1982) ; see also Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ("[T]he dispute about a material fact is ‘genuine’ ... if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.").

Moreover, the party opposing a motion for summary judgment need not respond to it with evidence unless and until the movant has properly supported the motion with sufficient evidence. Adickes , 398 U.S. at 160, 90 S.Ct. 1598. The moving party must demonstrate that the facts underlying the relevant legal questions raised by the pleadings are not otherwise in dispute, or else summary...

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6 practice notes
  • United States v. U.S. Stem Cell Clinic, LLC, No. 19-13276
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • June 2, 2021
    ...applied. The district court rejected those arguments and granted the FDA's motion. United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279, 1287-98 (S.D. Fla. 2019).Regarding the same surgical procedure exception, the district court first held the HCT/Ps implanted into the patient ......
  • United States v. Genesis II Church of Health & Healing, Case No. 20-21601-CIV-WILLIAMS
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • August 3, 2020
    ...is satisfied when the product is used for purposes other than personal consumption. See United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279, 1298 n.11 (S.D. Fla. 2019) ("Courts have interpreted ‘held for sale’ as meaning any use beyond personal consumption."). Here, the Governm......
  • NEW INNOVATION MODELS IN MEDICAL AI.
    • United States
    • Washington University Law Review Vol. 99 Nbr. 4, April 2022
    • April 1, 2022
    ...the patients with an antibiotic that had been shipped in interstate commerce); see also United States, v. U.S. Stem Cell Clinic, LLC, 403 F. Supp. 3d 1279, 1283, 1298 n.l 1, 1300 n.12 (S.D. Fla. 2019), aff'd, 998 F.3d 1302, 1304 (11th Cir. 2021) (affirming jurisdiction of FDA to enforce FDC......
  • United States v. Genesis II Church of Health & Healing, Case No. 20-21601-CIV-WILLIAMS
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • July 9, 2020
    ...is satisfied when the product is used for purposes other than personal consumption. See United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279, 1298 n.11 (S.D. Fla. 2019) ("Courts have interpreted ‘held for sale’ as meaning any use beyond personal consumption."). Here, the Governm......
  • Request a trial to view additional results
4 cases
  • United States v. U.S. Stem Cell Clinic, LLC, No. 19-13276
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • June 2, 2021
    ...applied. The district court rejected those arguments and granted the FDA's motion. United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279, 1287-98 (S.D. Fla. 2019).Regarding the same surgical procedure exception, the district court first held the HCT/Ps implanted into the patient ......
  • United States v. Genesis II Church of Health & Healing, Case No. 20-21601-CIV-WILLIAMS
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • August 3, 2020
    ...is satisfied when the product is used for purposes other than personal consumption. See United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279, 1298 n.11 (S.D. Fla. 2019) ("Courts have interpreted ‘held for sale’ as meaning any use beyond personal consumption."). Here, the Governm......
  • United States v. Genesis II Church of Health & Healing, Case No. 20-21601-CIV-WILLIAMS
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • July 9, 2020
    ...is satisfied when the product is used for purposes other than personal consumption. See United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279, 1298 n.11 (S.D. Fla. 2019) ("Courts have interpreted ‘held for sale’ as meaning any use beyond personal consumption."). Here, the Governm......
  • United States v. US Stem Cell Clinic, LLC, No. 19-13381
    • United States
    • United States Courts of Appeals. United States Court of Appeals (11th Circuit)
    • February 11, 2021
    ...§§ 301 et seq. In June 2019 the district court granted summary judgment for the FDA, United States v. US Stem Cell Clinic, LLC , 403 F. Supp. 3d 1279 (S.D. Fla. 2019), and issued a permanent injunction requiring, among other things, that the defendants: (1) refrain from distributing any ste......

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