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,
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(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
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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
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