Seife v. Food and Drug Administration et al
Filing
129
MEMORANDUM OPINION AND ORDER re: 93 MOTION to Strike Document No. 72 Declaration of Ian Estepan filed by Charles Seife, 69 MOTION for Summary Judgment filed by Sarepta Therapeutics, Inc, 85 CROSS MOTION for Summary Jud gment filed by Charles Seife, 74 MOTION for Summary Judgment filed by Department Of Health and Human Services, Food and Drug Administration.Accordingly, Sarepta is ORDERED to re-review its redactions to the full FOIA produc tion in accordance with this Memorandum Opinion and Order; to unredact any publicly available information; and to provide the revised redactions to the FDA. The FDA, in turn, is ORDERED to review the revised redactions to ensure they comply with this Memorandum Opinion and Order and to then provide the revised documents to Seife. Unless and until the Court orders otherwise, Sarepta and the FDA shall complete those tasks no later than June 26, 2019. Further, the parties shall promptly meet and confer in an effort to agree upon a proposed order establishing protocols (if appropriate) and rolling deadlines for the foregoing review. The parties shall submit any such proposed order (or competing orders) no later than April 3, 2019. Fin ally, within one week of (1) the June 26, 2019 deadline for the production of documents re-reviewed in accordance with this Memorandum Opinion and Order and (2) the Supreme Courts decision in Food Marketing Institute, whichever is later, the partie s shall submit a joint letter addressing whether the Court should (a) require or allow the parties to submit supplemental briefs in connection with the summary judgment motions; (b) deny the current motions without prejudice to filing new motions; or (c) decide the current motions based on the existing submissions. In the meantime, given the wait for the Supreme Court, the current motions will be administratively terminated. The Clerk of Court is directed to terminate Docket Nos. 69, 74, 85, and 93. SO ORDERED. (Signed by Judge Jesse M. Furman on 3/27/2019) (ne)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
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CHARLES SEIFE,
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Plaintiff,
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FOOD AND DRUG ADMINISTRATION, et al.,
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Defendants.
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17-CV-3960 (JMF)
MEMORANDUM OPINION
AND ORDER
JESSE M. FURMAN, United States District Judge:
This case arises out of a request, pursuant to the Freedom of Information Act (“FOIA”), 5
U.S.C. § 552, for information from the Food and Drug Administration (“FDA”) regarding the
testing and approval process for Exondys 51, a drug created by Sarepta Therapeutics, Inc.
(“Sarepta”) for the treatment of Duchenne Muscular Dystrophy (“DMD”), a rare neuromuscular
disease. See Docket No. 1. Pursuant to a stipulation between the parties, the FDA produced
over 35,000 pages of documents to Plaintiff Charles Seife, some of which were redacted
pursuant to FOIA Exemption 4 (“Exemption 4”) for documents containing “trade secrets and
commercial or financial information obtained from a person and privileged or confidential.” 5
U.S.C. § 552(b)(4); see Docket No. 91 (“Seife 56.1 Resp.”) ¶¶ 51, 52; Docket No. 39. Now
pending are cross-motions for summary judgment — filed by Seife, the FDA, and Sarepta
(which was granted leave to intervene) — regarding the propriety of those redactions. See
Docket Nos. 69, 74, 85; see also Docket Nos. 44, 47. The Court is reserving judgment on those
motions pending the Supreme Court’s decision in Food Marketing Institute v. Argus Leader
Media, which concerns the meaning of “confidential” in FOIA Exemption 4. See Pet. for Cert. at
i, No. 18-481 (U.S. Oct. 11, 2018), cert. granted, 139 S. Ct. 915 (2019). 1
There are, however, two matters that the Court can — and, to take advantage of the delay
in waiting for the Supreme Court, should — resolve now. First, Seife filed a motion to strike
two declarations of Ian Estepan, the Chief of Staff and Head of Corporate Affairs at Sarepta.
Docket No. 94 (“Pl. Mem.”), at 1; Docket No. 112 (“Pl. Reply”), at 15-16, 19; see Docket No. 72
(“Estepan Decl.”) ¶ 1; Docket No. 105 (“2d Estepan Decl.”). 2 Whether or not a motion to strike
is filed, “[o]n a motion for summary judgment, a district court may rely only on material that
would be admissible at trial.” Rubens v. Mason, 387 F.3d 183, 189 (2d Cir. 2004). That is, a
district court may rely on an affidavit or declaration when deciding a motion for summary
judgment only if it is “made on personal knowledge, set[s] out facts that would be admissible in
evidence, and show[s] that the affiant or declarant is competent to testify on the matters stated.”
Fed. R. Civ. P. 56(c)(4); see also Presbyterian Church of Sudan v. Talisman Energy, Inc., 582
F.3d 244, 264 (2d Cir. 2009); Fed. R. Evid. 602. In deciding an evidentiary question, a court
may “strike portions of an affidavit that are not based upon the affiant’s personal knowledge,
1
Strictly speaking, Food Marketing Institute involves a FOIA request governed by pre2016 FOIA, while this case involves a request governed by the statute as amended in 2016. See
5 U.S.C. § 552(a)(8)(A)(i); FOIA Improvement Act of 2016, Pub. L. No. 114-185, 130 Stat. 538;
see also Docket No. 128. Nevertheless, the Court believes that it is prudent to await the Supreme
Court’s possible guidance in light of the similarity of the FOIA statute pre- and post-amendment.
See, e.g., Cause of Action Inst. v. U.S. Dep’t of Justice, 330 F. Supp. 3d 336, 355 (D.D.C. 2018)
(noting the Department of Justice’s argument that the 2016 Act “does not alter the scope of the
information covered by the exemption”).
2
The motion also seeks to strike a paragraph from the declaration of Nancy Sager, a
director at the FDA, on the ground that it is derived from one of the Estepan declarations. Pl.
Mem. 1; see Docket No. 77 (“Sager Decl.”) ¶ 37 (“The information redacted . . . is exempt from
disclosure under FOIA Exemption 4 because, as Sarepta claims in the Declaration of Ian
Estepan . . . , the information is confidential commercial information that would cause
competitive harm to Sarepta if disclosed.” (emphasis added)).
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contain inadmissible hearsay or make generalized and conclusory statements.” Hollander v. Am.
Cyanamid Co., 172 F.3d 192, 198 (2d Cir. 1999), abrogated on other grounds by Schnabel v.
Abramson, 232 F.3d 83 (2d Cir. 2000). Alternatively, it may, without granting a motion to
strike, simply “decline[] to consider evidence” from the inadmissible declarations. Fabrication
Enters., Inc. v. Hygenic Corp., 64 F.3d 53, 59 n.5 (2d Cir. 1995).
Applying these standards, Seife’s motion is denied to the extent that it seeks to strike the
Esteban declarations in their entirety. The declarations establish that Estepan spent fifteen years
investing in healthcare, through which he learned “what types of information about drug
development are of interest to investors and commercially valuable.” 2d Estepan Decl. ¶ 7.
Estepan “regularly communicate[s] with investors . . . about investments in Sarepta vis-à-vis its
competitors” and “closely track[s] the evolving competitive landscape in DMD.” Id. ¶¶ 23, 24.
He also regularly reviews “medical literature regarding DMD,” “reports of nonclinical and
clinical trials,” and “submissions to the FDA and other regulators”; and he frequently “visit[s]”
and “consult[s] with” Sarepta’s scientific, medical, and technical personnel. Id. ¶¶ 13, 14, 16,
17, 19. All of that qualifies Estepan to testify to the competitive harms that the disclosures at
issue could cause, even if he does not understand the precise scientific value of the disclosures.
See, e.g., NRDC v. U.S. Dep’t of Interior, 36 F. Supp. 3d 384, 402 n.10 (S.D.N.Y. 2014) (holding
that a declaration is based on personal knowledge even though “the declarants did not know, but
c[ould] only infer,” the relevant conclusion). It also qualifies Estepan to testify to actions he
supervises, rather than directly conducts. See, e.g., Carney v. U.S. Dep’t of Justice, 19 F.3d 807,
814 (2d Cir. 1994) (holding that affidavits from a supervising employee are sufficient.). Many of
Seife’s arguments to the contrary go to credibility rather than admissibility. Thus, Seife’s motion
to strike is DENIED to the extent it seeks to strike the Esteban declarations in their entirety. The
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Court will, as necessary, resolve Seife’s challenges to the particular paragraphs of the
declarations when deciding the parties’ motions for summary judgment.
Second, whatever the Supreme Court may decide in Food Marketing Institute, the Court
is persuaded that Seife is entitled to at least some relief on the ground that the FDA (at Sarepta’s
request) improperly redacted information that is already public. Exemption 4 does not apply to
confidential commercial information “if identical information is otherwise in the public domain”
and “freely available” there. Inner City Press/Comty. on the Move v. Bd. of Governors of the
Fed. Reserve Sys., 463 F.3d 239, 244 (2d Cir. 2006) (internal quotation marks omitted). 3 In this
case, Seife has established — through a sample of the documents at issue — that the FDA’s
redactions are overbroad. Specifically, in response to Seife’s line-by-line challenges to the
sample redactions, Sarepta conceded that over half the sample pages — 54% by Seife’s
calculation — included improper redactions of public information; 12% of the pages with
challenged redactions have been unredacted altogether. See Docket No. 114 (“Seife Reply
Decl.”) ¶¶ 2-5. For example, in response to the twenty-two objections listed in Exhibit B to the
Kenney Declaration submitted in support of Seife’s motions, Sarepta admitted that fourteen
included incorrect redactions. See Docket No. 90 (“Kenney Decl.”), Ex. B; Docket No. 104
(“Sherwood Decl.”), ¶¶ 22-26, 28, 31, 33-35, 38-40, 42. In response to Seife’s nine pairs of
page-by-page comparisons of redactions and public information, Sarepta admitted that three
included incorrect redactions. See Kenney Decl. Ex. C; Sherwood Decl. ¶¶ 12-20. Moreover,
the mistakes were not isolated to one category of information, but rather extended to information
3
The Court is unpersuaded by Seife’s contention that the exception to Exemption 4 for
publicly available information applies to information that is “largely public” or can be “easily
discerned” based on public information. See Pl. Reply 9. The publicly available information
must be “identical.” Inner City Press, 463 F.3d at 244 (internal quotations mark omitted).
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in all four disputed categories of redactions (namely, study procedures, test results, endpoints,
and adverse events). See Kenney Decl. Ex. C.
In light of that showing, the Court concludes that Sarepta and the FDA should be required
to re-review and, as necessary re-redact, the documents that are in dispute. Sarepta’s conclusory
assertions notwithstanding, see Docket No. 101, at 28-29 (arguing that any problem with the
samples does not “render the entire review process unreliable” because its redaction process was
reliable), there is “no indication” that the samples discussed above “are not fairly representative
of the documents and proposed redactions.” Associated Press v. U.S. Dep’t of Def., 498 F. Supp.
2d 707, 709 (S.D.N.Y. 2007). To the contrary, the record indicates that the FDA and Sarepta
used the same process to redact the samples that they used for all the redactions in this case. See
Seife Reply Decl. ¶ 6; Sherwood Decl. ¶ 4; Sager Decl. ¶¶ 28-29, 31-32. It would be foolhardy
to conclude, therefore, that the problems found in the sample submitted to the Court are not
likely to be found in the other documents. It follows that Sarepta and the FDA should, while the
Court awaits a Supreme Court decision in Food Marketing Institute, be required to revisit their
redactions to the rest of the documents. See, e.g., Halpern v. FBI, 181 F.3d 279, 298 (2d Cir.
1999) (endorsing a “representative sample” approach to evaluation of FOIA disputes); cf.
Associated Press, 498 F. Supp. 2d at 709 (approving of proposed redactions in light of a review
of a “representative sample” of the documents at issue).
Accordingly, Sarepta is ORDERED to re-review its redactions to the full FOIA
production in accordance with this Memorandum Opinion and Order; to unredact any publicly
available information; and to provide the revised redactions to the FDA. The FDA, in turn, is
ORDERED to review the revised redactions to ensure they comply with this Memorandum
Opinion and Order and to then provide the revised documents to Seife. Unless and until the
5
Court orders otherwise, Sarepta and the FDA shall complete those tasks no later than June 26,
2019. Further, the parties shall promptly meet and confer in an effort to agree upon a proposed
order establishing protocols (if appropriate) and rolling deadlines for the foregoing review. The
parties shall submit any such proposed order (or competing orders) no later than April 3, 2019.
Finally, within one week of (1) the June 26, 2019 deadline for the production of
documents re-reviewed in accordance with this Memorandum Opinion and Order and (2) the
Supreme Court’s decision in Food Marketing Institute, whichever is later, the parties shall
submit a joint letter addressing whether the Court should (a) require or allow the parties to
submit supplemental briefs in connection with the summary judgment motions; (b) deny the
current motions without prejudice to filing new motions; or (c) decide the current motions based
on the existing submissions. In the meantime, given the wait for the Supreme Court, the current
motions will be administratively terminated.
The Clerk of Court is directed to terminate Docket Nos. 69, 74, 85, and 93.
SO ORDERED.
Dated: March 27, 2019
New York, New York
__________________________________
JESSE M. FURMAN
United States District Judge
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