United States v. US Stem Cell Clinic, LLC, 19-13381

Citation987 F.3d 1021
Decision Date11 February 2021
Docket NumberNo. 19-13381,19-13381
Parties UNITED STATES of America, Plaintiff - Appellee, Jan Aitken, Carol Barrows, David H. Buckles, et al., Intervenors - Appellants, v US STEM CELL CLINIC, LLC, a Florida limited liability company, US Stem Cell, Inc., a Florida profit corporation, Kristin C. Comella, individually, Theodore Gradel, individually, Defendants - Appellees.
CourtUnited States Courts of Appeals. United States Court of Appeals (11th Circuit)

Kathleen Ann Daly, Law Office of Kathleen A. Daly, PA, West Palm Beach, FL, for Intervenors - Appellants Katherine Leemon, Ira Leemon, Virginia Porowski, James Porowski, Angie Martin, Tara Russell, Greg Maske, Porter Broughton, Manny Camacho, Amanda A. Camacho, Jayne Federmeyer, Allen Hewitt, Ross Johnson, Kurt Wimberg, Lisa Brady Grant, Ann-Toy Broughton and Jean Hewitt.

Adam C. Jed, U.S. Department of Justice Civil Division, Appellate Staff, Washington, DC, for Plaintiff - Appelle.

Jacob Joseph Givner, Esther Sarah Meisels, Givner Law Group, LLP, Aventura, FL, Marissa Ximena Kaliman, Off Lease Only, LLC, North Lauderdale, FL, for Intervenors - Appellants Jan Aitken, Carol Barrows, David H. Buckles, Barbara Burns, Stephanie Ciaramitaro, Evelyn L. Clough, Samuel Colacurio, Eric C. Congiardo, Lydia Cronin, Allison L. Cronin, Paul Decker, Robert Demane, Camilla J. Foreman, Jan Gimian, Darro Grieco, Gail Grill, Naota Hashimoto, Luz C. Hernandez, Laurel L. Hodory, Gregory O. Hudgins, Alan D. Hudson, Karen J. Jeffries, James L. Jeffries, Maureen Jones, Michael L. Kelby, Mary Klucarich, Deanna M. Lawrence, Suzanne M. Lawrence, Jeffery Masters, Margarita Mattingly, Elaine Murin, Bernadette Newlon, Kathryn L. O'Harrow, Robert I. Orenstein, Michael K. Pool, Kathleen Rogers, Reid Runzheimer, Mary Sczepaniak, Shannon E. Seth, Deborah Simmons, Charmie Smith, Judith Smith, Christen Streufert, Linda T. Taylor, John M. Temple, Thomas Thibodeau, Anthony J. Thynne, Dawn Washkewicz, Pam Washkewicz, Steven Waterman, Nancy Weaver, Kurt Wellner, Renate Wilson, Dawn Winslow, Joyce Yeargan, Charles Yeargan, Sada Fenton, Darcy Goette, Fay Magennis, Edwin Noble, Frank Poucher, Kurt Wuellner, Sarah Anderson, Dooley Ming, Sharon Kuster, Kathryn Morrow, George Nemecz, Leah Simpson, Scot Simpson, Chloe Spencer, Stephan Spencer, Mollie N. Thibodeau and Enrique Corral.

Jacob Joseph Givner, Givner Law Group, LLP, Aventura, FL, Marissa Ximena Kaliman, Off Lease Only, LLC, North Lauderdale, FL, for Intervenors - Appellants Gay D. Surney, Francis Magennis and Olivia Newsome Grieco.

Michael S. Blume, Venable, LLP, New York, NY, Loren H. Cohen, Isaac Jaime Mitrani, Mitrani Rynor Adamsky & Toland, PA, Miami Beach, FL, Stephen Ray Freeland, Mary M. Gardner, Todd H. Halpern, Todd A. Harrison, Venable, LLP, Washington, DC, for Defendants - Appellees US Stem Cell Clinic, LLC, US Stem Cell, Inc. and Kristin C. Comella.

Loren H. Cohen, Isaac Jaime Mitrani, Mitrani Rynor Adamsky & Toland, PA, Miami Beach, FL, Stephen Ray Freeland, Mary M. Gardner, Todd H. Halpern, Todd A. Harrison, Venable, LLP, Washington, DC, for Defendant - Appellee Theodore Gradel.

Before JORDAN, MARCUS, and GINSBURG,* Circuit Judges.

GINSBURG, Circuit Judge:

Two groups of patients who deposited tissue in a stem-cell "bank" appeal the denial of their respective motions to intervene pursuant to Federal Rule of Civil Procedure 24 in a suit between the corporation running the bank and the United States Food and Drug Administration. The district court did not reach the question whether the patients met the requirements for intervention. Instead, it found their motions were premature and denied them without prejudice. Because the district court's order was not a "final decision" within the meaning of 28 U.S.C. § 1291, we lack jurisdiction to consider the patients’ appeal.

I.

US Stem Cell, Inc. (the Corporation), is a Florida-based company that offers stem-cell therapies

that purportedly treat a host of diseases and conditions. US Stem Cell Clinic, LLC, a subsidiary of the Corporation, provides the treatments. Separately, the Corporation operates a stem-cell bank where patients can store stem cells for later use in treating chronic conditions. The patient-appellants have each deposited stem cells in the bank.

In 2018 the FDA sued the Corporation, the Clinic, and an individual associated with both companies. It alleged the defendants’ operations at the Clinic amounted to the misbranding and adulteration of drugs in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 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 stem-cell products until they obtain approval from the FDA, D.E. 83 ¶ 7, and (2) destroy all stem cells in their possession within 30 days, D.E. 83 ¶ 10. The court stayed the destruction provision pending a potential appeal by the defendants.

In July 2019 the patients moved to intervene either as-of-right or permissively. The patients also sought to extend the stay of the destruction provision in the district court's order. If permitted to intervene, the patients would ask the district court to declare either that their stem cells at the bank are outside the scope of the injunction or that destruction of their stem cells would violate their rights under the Fifth Amendment to the Constitution of the United States.

The district court denied the motions without prejudice in an omnibus order, explaining:

[B]oth the relief requested by the putative intervenors and the appropriate forum for their intervention is entirely dependent upon whether Defendants appeal .... As such the Court is unable to rule on the [m]otions at this time.

United States v. US Stem Cell Clinic, LLC , No. 0:18-cv-61047, 2019 WL 4647746, at *1 (S.D. Fla. July 31, 2019).

Shortly thereafter the defendants filed a timely notice of appeal, which is pending in this court. As such, the stay of the destruction provision of the injunction remains in place.

II.

The patients argue we have jurisdiction to hear their appeal from the omnibus order under this circuit's "anomalous rule."* Where that rule applies, we exercise "provisional jurisdiction" to determine whether a district court erred in denying intervention as of right under Rule 24(a), or clearly abused its discretion in denying permissive intervention under Rule 24(b). E.g. , Fox v. Tyson Foods, Inc. , 519 F.3d 1298, 1301 (11th Cir. 2008). If we discover no reason to reverse the district court, then "our jurisdiction evaporates" and we dismiss the appeal. Id.

In the past, we have applied the anomalous rule in cases where a motion to intervene was considered on its merits and denied with prejudice. We have explained that "such a determination is a ‘final decision’ under 28 U.S.C. § 1291 that ‘ends the litigation on the merits’ for the intervenor." Meek v. Metro. Dade Cty. , 985 F.2d 1471, 1476 (11th Cir. 1993) (citations omitted), abrogated on other grounds , Dillard v. Chilton Cty. Comm'n , 495 F.3d 1324 (11th Cir. 2007). This case is different. Here, the district court did not reject the patients’ arguments under Rule 24 or otherwise determine the patients were not entitled to intervene. Rather, it merely stated it was "unable to rule on the motions at this time." The anomalous rule does not reach this situation because the patients’ motions were not denied. Cf. Smith v. SEECO, Inc. , 865 F.3d 1021, 1025 (8th Cir. 2017) (holding denial of a motion to intervene was not appealable where the district court did not make a "final determination," but instead deferred consideration until "a more appropriate stage in the litigation"); Grilli v. Metro. Life Ins. Co. , 78 F.3d 1533, 1538 (11th Cir. 1996) (holding an order was not final in part because the district court "anticipated further proceedings with respect to the...

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