In re Zantac (Ranitidine) Prods. Liab. Litig.
In re Zantac (Ranitidine) Prods. Liab. Litig.
2022 WL 19919674 (S.D. Fla. 2022)
March 15, 2022
Reinhart, Bruce E., United States Magistrate Judge
Summary
The Court granted the Motion to Seal certain documents produced in response to subpoenas issued by the Brand Defendants, after an in camera review of the materials. The Court sealed pages MSK00000249 through MSK00000251, MSK00010152, and MSK00010156 through MSK00010164 and any portion of Exhibit 59 that includes information from these pages. The Motion to Seal was otherwise denied.
Additional Decisions
IN RE: ZANTAC (RANITIDINE) PRODUCTS LIABILITY LITIGATION
CASE NO. 20-md-2924-RLR
United States District Court, S.D. Florida
Signed
March 14, 2022
Entered March 15, 2022
Reinhart, Bruce E., United States Magistrate Judge
ORDER ON MOTION TO SEAL [ECF No. 5267]
*1 Non-parties Memorial Sloan Kettering Cancer Center and Lior Braunstein, M.D. (“Movants”) move to seal documents related to the Brand Defendants’ Opposition to Valisure LLC's Motion to Quash. See ECF No. 5272. There were 58 numbered exhibits to the Opposition, plus a demonstrative aid used at the hearing on the Motion to Quash.
In response to subpoenas issued by the Brand Defendants, Movants produced the documents that were marked as the 58 exhibits. Movants designated the documents as “Highly Confidential – Attorneys’ Eyes Only – Subject to Protective Order,” as permitted by this Court's Confidentiality Order (PTO 26). See ECF No. 780. They now move to seal all of the materials. For the reasons stated below, the Motion to Seal is GRANTED IN PART and DENIED IN PART.
I. PTO 26
PTO 26 allows a person responding to a subpoena to apply confidentiality designations to responsive material. As relevant here, material can be designated as “Highly Confidential Information – Outside Counsel's Eyes Only – Subject to Protective Order” if its disclosure would “cause a substantial risk of a significant competitive or commercial disadvantage to the Producing Party, including but not limited to information that reflects: the Producing Party's competitiveness in the market; sales or marketing strategies; research and development materials; or non-public dealings with or internal deliberations concerning any regulatory body such as the FDA or other authority.” ECF No. 780 ¶(B)(7). Applying that designation limits the receiving party's ability to use or disclose the material:
Information specifically designated as “Highly Confidential Information – Outside Counsel's Eyes Only – Subject to Protective Order” may be shared only with (i) Plaintiffs’ attorneys of record in the Litigation, including clerical, secretarial, and other staff employed or retained by Plaintiffs’ counsel, (ii) outside counsel for a party, including counsel's clerical, secretarial, and other staff employed or retained by such counsel and (iii) the persons listed in paragraphs 3(iii)-(ix) above.
Id. ¶(D)(7).[1] PTO 26 applies only to discovery; it does not control the use of designated material in judicial proceedings. PTO 26(H)(1) (“The use of Confidential Information or Highly Confidential Information at trial or other proceeding shall not be governed by this Confidentiality Order. See Local Rule 5.4(a).”).
There is “a general presumption that criminal and civil actions should be conducted publicly ... includ[ing] the right to inspect and copy public records and documents.” Chicago Tribune Co. v. Bridgestone/Firestone, Inc., 263 F.3d 1304, 1311 (11th Cir. 2001); see also S.D. Fla. Local Rule 5.4(a) (“Unless otherwise prohibited by law, Court rule, or Court order, proceedings in the United States District Court are public and Court filings are matters of public record.”). Courts must be “resolute” in enforcing this presumption. Callahan v. United Network for Organ Sharing, 17 F.4th 1356 (11th Cir. 2021).
*2 “[M]aterial filed with discovery motions is not subject to the common-law right of access, whereas discovery material filed in connection with pretrial motions that require judicial resolution of the merits is subject to the common-law right.” Chicago Tribune Co., 263 F.3d at 1312, n.11 (footnote symbol omitted) (“[D]ocuments filed in connection with motions to compel discovery are not subject to the common-law right of access.”); see Romero v. Drummond Co., 480 F.3d 1234, 1245 (11th Cir. 2007) (“Material filed in connection with any substantive pretrial motion, unrelated to discovery, is subject to the common law right of access”).
The common law right of access may be overcome by a showing of good cause, which requires “balanc[ing] the asserted right of access against the other party's interest in keeping the information confidential.” “[W]hether good cause exists ... is ... decided by the nature and character of the information in question.” In balancing the public interest in accessing court documents against a party's interest in keeping the information confidential, courts consider, among other factors, whether allowing access would impair court functions or harm legitimate privacy interests, the degree of and likelihood of injury if made public, the reliability of the information, whether there will be an opportunity to respond to the information, whether the information concerns public officials or public concerns, and the availability of a less onerous alternative to sealing the documents. A party's privacy or proprietary interest in information sometimes overcomes the interest of the public in accessing the information.
Romero, 480 F.3d at 1246 (citations omitted) (brackets in original). Also, a court should consider “whether the records are sought for such illegitimate purposes as to promote public scandal or gain unfair commercial advantage.” Comm'r, Alabama Dep't of Corr. v. Advance Loc. Media, LLC, 918 F.3d 1161, 1169 (11th Cir. 2019) (quotation omitted) cited in Callahan, 17 F.4th at 1363. A desire “to keep indiscreet communications out of the public eye” is not enough to demonstrate good cause. Callahan, 17 F.4th at 1364.
Separately, Rule 26(c) of the Federal Rules of Civil Procedure permits the Court, upon a showing of good cause, to protect “a party or person from annoyance, embarrassment, oppression, or undue burden,” including by requiring that “confidential ... commercial information ... be revealed only in a specified way.” This authority includes the ability to order that documents filed with the Court be kept under seal. See Chicago Tribune Co., 263 F.3d at 1313; Callahan, 17 F.4th at 1363, n.2 (citing Fed. R. Civ. P. 26(c)(1)). The party asking for sealing bears the burden of justifying it. Chicago Tribune Co., 263 F.3d at 1313.
Movants argue there is good cause to seal the disputed materials. They argue these materials “include highly sensitive confidential communications, pre-publication peer-review, and analysis concerning Dr. Braunstein and his colleagues’ scientific research study regarding ranitidine use and potential NDMA carcinogenicity, and drafts of the study and peer review communications and related discussions.” ECF No. 5267 at 4. They also argue that public disclosure of these materials would have a “chilling effect” that “would both hamper Dr. Braunstein and other scientific researchers in pursuit of their analysis and would deprive the public of the public of scientific discovery stemming from such efforts.” Id. Movants do not dispute that the public right of access applies to the contested exhibits. Nor do they argue that the Brand Defendants are acting in bad faith or otherwise abusing the discovery process. C.f. Callahan, 14 F.4th at 1364-65.
*3 I have conducted an in camera review of the materials. A brief summary of each follows:
1. Exhibit 9
This exhibit comprises an email thread from April 2019 between representatives of Valisure and Dr. Braunstein. They are discussing the formation of a working relationship between Valisure and Movants. The communications do not reveal Dr. Bronstein's research methods or scientific conclusions.
2. Exhibit 18
This exhibit is an email thread between representatives of Valisure and Dr. Braunstein in May 2019. They are discussing the wording of a press statement to be issued by Valisure about ranitidine. Although a scientific report is referenced, no report is part of Exhibit 18.
3. Exhibit 19
This exhibit is a continuation of the email thread from Exhibit 18. It references upcoming meetings between Valisure and federal government officials.
4. Exhibit 24
This exhibit contains an email thread arranging and discussing a news media interview by Dr. Braunstein in August 2019.
5. Exhibits 25 and 26
These exhibits are communications in September 2019 from two medical publications declining to publish a manuscript submitted by Dr. Braunstein. Other than noting that the manuscript's title was “Ranitidine and potential N-nitrosodimethylamine (NDMA) carcinogenicity,” the communications do not discuss the substance of the manuscript.
6. Exhibit 28
The contested portion of this exhibit is an excerpt from Dr. Braunstein's deposition. The excerpt concerns Dr. Braunstein's communications with, and knowledge of, a lawyer who represents plaintiffs in Zantac litigation. Dr. Braunstein did not recall any communications with the lawyer.
7. Exhibit 32
This exhibit contains editorial comments from a medical publication about Movants’ manuscript. Beginning on page MSK00000249 and ending on page MSK00000251, it contains substantive editorial and peer-review comments.
8. Exhibit 36
This exhibit is an email thread in October 2019 that summarizes the results of a survey of 51 individuals by a lawyer from Florida who is related to the founder of Valisure. The survey was for marketing to potential Zantac plaintiffs. Dr. Braunstein does not provide any substantive comments.
9. Exhibit 39
This exhibit is an email from David Light, the founder and CEO of Valisure, to Dr. Braunstein on November 6, 2019. It discusses Mr. Light's views on the pros and cons of publishing a ranitidine-related paper. Dr. Braunstein does not respond to the email.
10. Exhibit 40
This exhibit is an excerpt from Dr. Braunstein's deposition in October 2021. He answers a question about whether a study conducted by a different scientist concluded that ranitidine increases the risk of cancer. He does not express any opinion about that conclusion, nor does he discuss his own thought processes or research.
11. Exhibit 41
This one-page exhibit is an email thread between Dr. Braunstein and David Light on November 15, 2019 (MSK00010152). Dr. Braunstein asks Mr. Light to review an article that is in final pre-publication form. It does not disclose the substance of the article. It does discuss some of Dr. Braunstein's analytic methods.
12. Exhibit 42
*4 This exhibit is an email from Dr. Braunstein to Michael Bretholz on November 18, 2019. It attaches a draft of an article written by Dr. Braunstein.
13. Exhibit 44
This exhibit is an email from David Light to Dr. Braunstein on December 3, 2019. Attached are some sources of information for Movant to review. It also contains Mr. Light's thoughts on the proper strategy for Dr. Braunstein's upcoming call with the FDA.
14. Exhibit 49
This exhibit is an email thread from late December 2019 among Mr. Light, Dr. Braunstein, and a second Valisure person. They are discussing a potential press statement by Valisure related to ranitidine and Dr. Braunstein's upcoming published article.
15. Exhibit 50
This exhibit is an email on January 9, 2020, from a medical publication to Dr. Braunstein notifying him of concerns about the validity of the submitted article and notifying him that the article will not be published at the present time.
16. Exhibit 59
This exhibit is a timeline that was used as a demonstrative exhibit at the hearing on Valisure's Motion to Quash. Its content is based on the preceding 58 exhibits.
There is good cause to seal three of these exhibits in part, because they disclose Movants’ mental impressions, thought processes, and private scientific methods. Three pages of Exhibit 32 contain editorial and peer-review comments on a scientific article submitted for publication by Dr. Braunstein. Exhibit 41 contains Dr. Braunstein's comments on his analytical methods. Exhibit 42 contains an unpublished draft of a scientific article (MSK00010156-MSK00010164).
Movants have not shown good cause to seal the remainder of the contested exhibits, except insofar as Exhibit 59 incorporates the sealed portions of Exhibits 32 and 42. Exhibit 9 is a discussion about a business collaboration; it does not reveal Dr. Braunstein's mental impressions, research methods, or scientific conclusions. Exhibits 18, 19, 24, 44, and 49 relate to providing information to government officials or the news media. Exhibits 25, 26, and 50 are communications from medical publications declining to publish an article. Exhibit 28 is Dr. Braunstein's deposition testimony that he did not recall communicating with a plaintiffs’ attorneys who might be pursuing Zantac cases. Exhibit 40 is his testimony about what someone else's study concluded Exhibit 36 contains survey results that were not generated by Movants and about which Dr. Braunstein does not provide substantive comments. Exhibit 39 is an email discussing David Light's thought processes, but not Dr. Braunstein's.
Many of these communications do not relate to scientific research or development. Some are not communications by Dr. Braunstein. None disclose Movants’ mental impressions, thought processes, or confidential scientific methods. The Romero factors all weigh against sealing these materials. Allowing access would not impair court functions or harm Movants’ legitimate privacy interests. To the extent there is a likelihood of injury to Movants, it is primarily reputational. They have not shown that unsealing these materials will affect their (or others’) ability or willingness to conduct scientific research in the future. The reliability of the information has not been challenged. Movants will have the opportunity to respond in the public forum. Although not a significant factor in my analysis, this information provides context about the pending Zantac MDL, which is a matter of significant public interest.
*5 WHEREFORE, it is ORDERED that the Motion to Seal is GRANTED as to pages MSK00000249 through MSK00000251, MSK00010152, and MSK00010156 through MSK00010164 and any portion of Exhibit 59 that includes information from these pages. The Motion to Seal is otherwise DENIED.
DONE and ORDERED in Chambers at West Palm Beach, Palm Beach County, in the Southern District of Florida, this 14th day of March 2022.
Footnotes
Subparagraph 3 permits “Highly Confidential Information – Outside Counsel's Eyes Only – Subject to Protective Order” material to “be shown and delivered to the following people within this Litigation as necessary:
...
(iii) judges, court reporters, court personnel, special masters, referees, other court-appointed officials, or videographers present at trial, conferences, hearings, arguments, or depositions held in this Litigation, including any appeals related thereto[.]”