Regen Biologics, Inc. v. Sebelius ( 2012 )

SUMMARY MEMORANDUM AND OPINION; NOT INTENDED FOR PUBLICATION IN
THE OFFICIAL REPORTERS
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
IVY SPORTS MEDICINE, LLC,
Plaintiff,
v. Civil Action No. 11-cv-1006 (RLW)
KATHLEEN SEBELIUS, et al.,
Defendants.
MEMORANDUM OPINION 1
Plaintiff Ivy Sports Medicine, LLC (“Ivy”) has moved this Court for an Order requiring
the U.S. Food and Drug Administration and other Defendants in this action (collectively “FDA”)
to supplement the administrative record with certain materials purportedly missing. For
purposes of this ruling, the Court will assume the reader is familiar with the factual assertions
and arguments made by the parties, and will not recite them here. Before the Court is Ivy’s
Motion for Supplementation of Administrative Record to Include Materials Omitted by Agency
(Dkt. No. 36). For the reasons set forth below, the Motion is granted in part and denied in part.
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This unpublished memorandum opinion is intended solely to inform the parties and any
reviewing court of the basis for the instant ruling, or alternatively, to assist in any potential future
analysis of the res judicata, law of the case, or preclusive effect of the ruling. The Court has
designated this opinion as “not intended for publication,” but this Court cannot prevent or
prohibit the publication of this opinion in the various and sundry electronic and legal databases
(as it is a public document), and this Court cannot prevent or prohibit the citation of this opinion
by counsel. Cf. Fed. R. App. P. 32.1. Nonetheless, as stated in the operational handbook
adopted by our Court of Appeals, “counsel are reminded that the Court’s decision to issue an
unpublished disposition means that the Court sees no precedential value in that disposition.”
D.C. Circuit Handbook of Practice and Internal Procedures 43 (2011).
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SUMMARY MEMORANDUM AND OPINION; NOT INTENDED FOR PUBLICATION IN
THE OFFICIAL REPORTERS
WHAT CONSTITUTES THE ADMINISTRATIVE RECORD
When reviewing agency action, the APA requires a court to review “the whole record or
those parts of it cited by a party.” 5 U.S.C. § 706. Although FDA regulations define the
administrative record as the material “on which the Commissioner relies to support the action,”
21 C.F.R. § 10.3, the Supreme Court and this Circuit indicate the record should not be so
narrowly construed. Instead, a court must review “the full administrative record that was before
the [FDA] at the time [it] made its decision.” American Bioscience, Inc. v. Thompson, 243 F.3d
579, 582 (D.C. Cir. 2001) (alteration in original) (citing Citizens to Preserve Overton Park, Inc.
v. Volpe, 401 U.S. 402, 420 (1971)). A fair review by this court requires it to have “neither
more nor less information than did the agency when it made its decision.” Walter O. Boswell
Mem’l Hosp. v. Heckler, 749 F.2d 788, 792 (D.C. Cir. 1984). Thus information considered,
even if not relied upon, may need to be included in the record. See Fund for Animals v.
Williams, 391 F. Supp. 2d 191, 196-97 (D.D.C. 2005) (citing cases) (Urbina, J.).
STANDARD FOR SUPPLEMENTING ADMINISTRATIVE RECORD
There is a strong presumption that the agency properly compiled the administrative
record. “Supplementation of the administrative record is the exception, not the rule.” Pacific
Shores Subdivision, Cal. Water Dist. v. U.S. Army Corps of Eng’rs, 448 F. Supp. 2d 1, 5
(D.D.C. 2006) (Facciola, Mag. J.). “Therefore, absent clear evidence to the contrary, an agency
is entitled to a strong presumption of regularity, that it properly designated the administrative
record.” WildEarth Guardians v. Salazar, 670 F. Supp. 2d 1, 5 (D.D.C. 2009) (citations omitted)
(Kollar-Kotelly, J.). “Were courts cavalierly to supplement the record, they would be tempted to
second-guess agency decisions in the belief that they were better informed than the
administrators empowered by Congress and appointed by the President.” Amfac Resorts, LLC v.
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SUMMARY MEMORANDUM AND OPINION; NOT INTENDED FOR PUBLICATION IN
THE OFFICIAL REPORTERS
U.S. Dep’t of the Interior, 143 F. Supp. 2d 7, 11 (D.D.C. 2001) (Lamberth, C.J.) (quoting San
Luis Obispo Mothers for Peace v. NRC, 751 F.2d 1287, 1325-26 (D.C. Cir. 1986) (en banc)).
In addition, a motion to supplement the record should not merely guess about who
has seen the documents at issue. A party moving to supplement the administrative record “must
do more than imply that the documents at issue were in the [agency’s] possession”; they “must
prove that the documents were before the actual decisionmakers involved in the determination.”
Sara Lee Corp. v. Am. Bakers Ass’n, 252 F.R.D. 31, 34 (D.D.C. 2008) (Facciola, Mag. J.).
INTERVIEW NOTES
Plaintiff requests an Order to supplement the record with notes from interviews of
twenty-two current and former FDA employees conducted for a September 2009 Preliminary
Review. FDA set up the review “to determine whether changes should be made to the agency’s
policies, processes, procedures, or practices to better protect the integrity of FDA’s
decisionmaking.” (Apr. 29, 2009 Memorandum from Dr. Joshua Sharfstein, FDA003519.)
While noting the “final findings and recommendations” would likely be made public, FDA stated
the review should be conducted “[w]ith appropriate concerns for privacy.” (Id.) Two attorneys
conducted the interviews, and it appears they are the only two people who have seen the notes
taken during them. (Dkt. No. 35 Exs. A & B.)
Plaintiff’s motion to supplement the record with notes from the interviews fails to meet
the “heavy burden” required of a party moving to supplement the record. WildEarth, 670 F.
Supp. 2d at 6. First, Ivy’s argument in this litigation is that FDA acted without legal authority
when it rescinded the Substantial Equivalence Order on March 30, 2011. The interview notes
taken as part of the review in 2009 were not before the agency as part of that decision, and
therefore need not be made part of the administrative record. The record “should not
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SUMMARY MEMORANDUM AND OPINION; NOT INTENDED FOR PUBLICATION IN
THE OFFICIAL REPORTERS
include materials that were not considered by agency decisionmakers.” Pacific Shores, 448 F.
Supp. 2d at 4 (citations omitted).
Second, the interviews were part of an internal deliberative process and therefore the
FDA is entitled to withhold the notes under the deliberative process privilege. To invoke the
deliberative process privilege, the communication must be both “predicisional” and “a direct part
of the deliberative-process in that it makes recommendations or expresses opinions on legal or
policy matters.” Judicial Watch v. Dep’t of Army, 466 F. Supp. 2d 112, 120 (D.D.C. 2006)
(Urbina, J.). FDA efforts to determine whether any changes are necessary to the Agency’s
oversight and decisionmaking satisfy this test. “[D]eliberative intra-agency memoranda and
other such records are ordinarily privileged, and need not be included in the record.” Amfac,
143 F. Supp. 2d at 13 (citing cases). And while certain references to the interviews in the
Preliminary Review waive the privilege for the information made public, with respect to the
deliberative process privilege “courts have said that release of a document only waives these
privileges for the document or information specifically released, and not for related
materials.” In re Sealed Case, 121 F.3d 729, 741 (D.C. Cir. 1997).
510(k) SUBMISSIONS
Ivy also requests an Order to supplement the record with seven 510(k) submissions of
predicate meshes it identified in its premarket notification submission. The FDA states it “likely
. . . consulted specific parts of” these (and other) 510(k) submissions in order to compare them to
Ivy’s Collagen Scaffold device. (Dkt. No. 35 at 10.)
Ivy has the better argument with respect to the limited 510(k) submissions
requested. FDA consulted these documents when considering whether to rescind Ivy’s
clearance. The Agency admits it relied on certain information from underlying predicates’
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SUMMARY MEMORANDUM AND OPINION; NOT INTENDED FOR PUBLICATION IN
THE OFFICIAL REPORTERS
510(k) submissions, but claims “supplementing the record with additional materials containing
the same information is unnecessary.” (Id.) But not all of the additional material would be “the
same.”
The government’s other arguments similarly fail to persuade. FDA’s offer of including
summaries of these applications as extra-record material is insufficient. (Id. at 9.) FDA has
made no argument, and there is no indication, that it merely reviewed the summaries. Thus Ivy
is entitled to the information before the Agency. See American Bioscience, 243 F.3d at 582.
And finally, FDA’s claims of significant burden are unavailing. FDA’s reference to the size of
the record in Pacific Shores, a case involving a different agency’s actions under a different
statute, has little relevance here. Ivy is entitled to have the seven 510(k) submissions it identified
as part of the administrative record, and FDA should work expeditiously to complete the
necessary redactions.
CONCLUSION
For the foregoing reasons, Ivy’s Motion for Supplementation of Administrative Record to
Include Materials Omitted by Agency is granted in part and denied in part. An Order
accompanies this Memorandum.
Digitally signed by Judge Robert L.
Wilkins
DN: cn=Judge Robert L. Wilkins,
o=U.S. District Court, ou=Chambers
of Honorable Robert L. Wilkins,
email=RW@dc.uscourt.gov, c=US
Date: 2012.10.24 16:15:00 -04'00'
Date: October 24, 2012
ROBERT L. WILKINS
United States District Judge
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