CareToLive v. FDA

RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit Rule 206
File Name: 11a0005p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
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Plaintiff-Appellant, -
CARETOLIVE, A Not for Profit Corporation,
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No. 09-4084
v.
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Defendant-Appellee. -
THE FOOD AND DRUG ADMINISTRATION,
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Appeal from the United States District Court
for the Southern District of Ohio at Columbus.
No. 08-00005—Gregory L. Frost, District Judge.
Argued: December 8, 2010
Decided and Filed: January 6, 2011
Before: MARTIN, NORRIS, and COOK, Circuit Judges.
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COUNSEL
ARGUED: Kerry M. Donahue, BELLINGER & DONAHUE, Dublin, Ohio, for
Appellant. John J. Stark, ASSISTANT UNITED STATES ATTORNEY, Columbus,
Ohio, for Appellee. ON BRIEF: Kerry M. Donahue, BELLINGER & DONAHUE,
Dublin, Ohio, for Appellant. John J. Stark, ASSISTANT UNITED STATES
ATTORNEY, Columbus, Ohio, for Appellee.
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OPINION
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BOYCE F. MARTIN, JR., Circuit Judge. CareToLive filed a request with the
Food and Drug Administration, which we will refer to generally as the FDA, under the
Freedom of Information Act seeking copies of letters sent between its medical experts
regarding Provenge, an immunotherapy treatment for late stage prostate cancer. The
FDA was slow to respond to this request, and CareToLive filed a lawsuit demanding the
1
No. 09-4084 CareToLive v. The Food and Drug Administration Page 2
immediate production of responsive documents. The district court stayed proceedings
while the FDA responded to the request and delivered responsive documents. The FDA
then moved for summary judgment based on having fulfilled CareToLive’s request,
which the district court granted. CareToLive now appeals the grant of summary
judgment in favor of the FDA and asserts that the district court erred by denying it
discovery. However, CareToLive has not identified any material question of fact as to
the adequacy of the FDA’s search. Additionally, the district court did not abuse its
discretion by denying CareToLive leave to conduct discovery. Therefore, we AFFIRM
the decision of the district court.
I.
CareToLive is an association of cancer patients, patient families, doctors,
investors, and advocates focused on helping men suffering from late stage prostate
cancer. This lawsuit arose as a result of the FDA’s decision denying a Biologics License
Application for Provenge. Immunotherapy treatments, like Provenge, train the body’s
immune system to recognize cancer cells and attack them. Although the FDA advisory
panel had initially recommended approving Provenge, the agency did not follow that
recommendation. After the FDA’s initial denial, CareToLive suspected foul play and
filed a request under the Freedom of Information Act with the FDA on August 15, 2007.
The request sought:
A copy of all letters written to the FDA (or prepared by the FDA) and
purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming in
between March 29th 2007 and April 30th of 2007, regarding the
[Biologics License Application] submitted for Provenge also known as
Sipuleucel-T including the envelope or other means of communication
whereby the FDA received such letters and a copy of any record of those
letters then being disclosed to any media or other persons or specifically
a publication called “The Cancer Letter,” including the means of
communication to the Cancer Letter of the Scher, Hussain and Fleming
letters from the FDA or its employees to outside persons, publications or
companies.
No. 09-4084 CareToLive v. The Food and Drug Administration Page 3
Although he was not named in the request, CareToLive suggests that Dr. Richard Pazdur
was the FDA’s “cancer czar” and at the center of the alleged improprieties. The doctors
specifically identified in CareToLive’s request appear to be Dr. Pazdur’s advisors.
The FDA’s Division of Freedom of Information received the request on
September 11, and advised CareToLive by letter the same day that the request had been
received.1 CareToLive’s request was the 8,316th request under the Freedom of
Information Act that the FDA had received that year. The FDA’s Division of Freedom
of Information initially forwarded the request to the Center for Biologics Evaluation and
Research because the request sought records relating to an unapproved biological
product regulated by that Center. The request was also sent to the Office of the
Commissioner, Office of the Executive Secretariat because it sought records relating to
agency correspondence.
On November 6, the Center for Biologics responded with records. The Office
of the Commissioner, Office of the Executive Secretariat responded on January 24, 2008
that it had not found any responsive records.
While these searches were pending, the Division of Freedom of Information also
sent CareToLive’s request to the Division of Information Disclosure Policy in the FDA’s
Center for Drug Evaluation and Research because the Center for Biologics indicated that
additional records might be found there. The Division of Information Disclosure
received the request on October 15, 2007 and assigned it to its “Complex Track.”
Requests that can be answered quickly with readily available documents and do not
require any searching or redaction are considered simple, and placed on a faster track
known as the “Simple Track.” In contrast, if searching or redaction will be required, the
request is placed on the “Complex Track.”2 The Division of Information Disclosure
1
This delay appears to have occurred because CareToLive sent the request to the FDA’s
Cincinnati District Office and not directly to its Division of Freedom of Information as required by
21 C.F.R. § 20.40(a) (2010).
2
The division between the “Simple” and “Complex” tracks appears to be based primarily on
whether another party has previously requested the information and not on the type of request made. If
another party has previously made the same request, the request is “Simple” because the FDA can simply
resend the documents it has already found, reviewed, and redacted.
No. 09-4084 CareToLive v. The Food and Drug Administration Page 4
believed that CareToLive’s request sought documents not readily available and would
require searching and possibly redacting. On December 4, the Division of Information
Disclosure left a telephone message with CareToLive’s counsel stating that it follows
a first-in/first-out, two track policy to respond to Freedom of Information Act requests
and it would process CareToLive’s request accordingly. The Division of Information
Disclosure left the same message again on December 31.
Not content to wait, CareToLive filed a lawsuit in the Southern District of Ohio
on January 2, 2008 seeking immediate production of all documents responsive to its
request. On May 22, the district court granted the FDA’s motion to stay proceedings and
ordered the Center for Drug Evaluation to provide responsive documents no later than
May 18, 2009. On May 18, the Division of Information Disclosure delivered one
additional responsive document. The FDA also filed a motion for summary judgment
the same day, based on its compliance with CareToLive’s request for documents.
CareToLive subsequently filed a motion for discovery, which was also titled as
a partial memorandum in opposition to the FDA’s summary judgment motion. After
briefing concluded, the district court granted the FDA’s motion for summary judgment
and denied CareToLive’s motion for discovery.
II.
We review de novo a district court’s grant of summary judgment in a Freedom
of Information Act proceeding. Rugiero v. U.S. Dep’t of Justice, 257 F.3d 534, 543 (6th
Cir. 2001). Summary judgment is appropriate if there is no genuine issue of material
fact and the moving party is entitled to judgment as a matter of law. Id. “The moving
party has the initial burden of proving that no genuine issue of material fact exists,” and
we must draw all reasonable inferences in the light most favorable to the nonmoving
party. Vaughn v. Lawrenceburg Power Sys., 269 F.3d 703, 710 (6th Cir. 2001). A mere
scintilla of evidence is insufficient to create a material question of fact and defeat a
motion for summary judgment; “there must be evidence on which the jury could
reasonably find for the [non-movant].” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
252 (1986).
No. 09-4084 CareToLive v. The Food and Drug Administration Page 5
A. The Act’s Requirements to Search for Responsive Documents.
The Freedom of Information Act generally requires federal agencies to promptly
make records available after receiving a request that reasonably describes the records
and is made in accordance with the agency’s published rules governing such requests.
5 U.S.C. § 552(a)(3)(A) (2006); Rugiero, 257 F.3d at 543. The agency may only
withhold or limit the availability of records that fall within one of the Act’s specific
exceptions. 5 U.S.C. § 552(d); Rugiero, 257 F.3d at 543. These exceptions are to be
narrowly construed, Rugiero, 257 F.3d at 543 (citing Dep’t of Interior v. Klamath Water
Users Protective Ass’n, 532 U.S. 1, 7-8 (2001)), and do not apply in this case. The Act
reflects “a general philosophy of full agency disclosure unless information is exempted
under clearly delineated statutory language.” Dep’t of the Air Force v. Rose, 425 U.S.
352, 360-61 (1976).
An agency responding to a request under the Act must make a good faith effort
to conduct a search for the requested records using methods reasonably expected to
produce the requested information. Rugiero, 257 F.3d at 547 (citing Campbell v. U.S.
Dep’t of Justice, 164 F.3d 20, 27 (D.C. Cir. 1998)). “At all times the burden is on the
agency to establish the adequacy of the search.” Id. “‘The factual question . . . is
whether the search was reasonably calculated to discover the requested documents, not
whether it actually uncovered every document extant.’” Grand Cent. P’ship v. Cuomo,
166 F.3d 473, 489 (2d Cir. 1999) (quoting SafeCard Servs., Inc. v. SEC, 926 F.2d 1197,
1201 (D.C. Cir. 1991)).
To meet this burden, “the agency may rely on affidavits or declarations providing
reasonable detail of the scope of the search. In the absence of countervailing evidence
or apparent inconsistency of proof, [such affidavits] will suffice to demonstrate
compliance with the obligations imposed by the [Act].” Id. (internal quotations and
citations omitted); see also Weisberg v. U.S. Dep’t of Justice, 627 F.2d 365, 371 (D.C.
Cir. 1980) (agency affidavits that “do not denote which files were searched, or by whom,
do not reflect any systematic approach to document location, and do not provide
information specific enough to enable [the requester] to challenge the procedures
No. 09-4084 CareToLive v. The Food and Drug Administration Page 6
utilized” are insufficient to support summary judgment). This inquiry focuses not on
whether additional documents exist that might satisfy the request, but on the
reasonableness of the agency’s search. Id. District courts typically dispose of Freedom
of Information Act cases on summary judgment based on affidavits from the agency
describing the search procedures that it followed before allowing the plaintiff to conduct
discovery. Id. at 544.
CareToLive challenges the entirety of the FDA’s response but places the most
emphasis on the Center for Drug Evaluation’s search, which was processed through its
“Complex Track,” took over two years to perform, and only located one additional
responsive document. However, the detailed affidavits that the FDA submitted to the
district court establish the adequacy of its search. These affidavits describe the
procedures the FDA used to process CareToLive’s request and to ensure that it
appropriately responded to the request. They describe how the FDA determined which
offices and departments to search for responsive documents and identify the specific
offices, departments, and places searched. In Rugiero, we remarked that affidavits
describing similar searches “appear[ed] to be the model of responsiveness under the
[Freedom of Information Act].” Rugiero, 257 F.3d at 547. As in Rugiero, here, the
uncontraverted assertions in the FDA’s affidavits establish that the FDA satisfied the
requirements in the Act to conduct a reasonable search for responsive documents.
Considering the evidence in a light most favorable to CareToLive, as we must,
there is no genuine issue of material fact as to the adequacy of the FDA’s search.
Although the burden is on the FDA to establish that it conducted the search in good faith
using methods to reasonably identify and produce the requested documents, id., here,
CareToLive has not come forth with any evidence to rebut the FDA’s showing, cf. Baker
& Hostetler LLP v. U.S. Dep’t of Commerce, 473 F.3d 312, 318 (D.C. Cir. 2006)
(holding that requestor’s assertion that an adequate search would have yielded more
documents is mere speculation insufficient to rebut affidavits describing search process
agency performed). Although agencies must respond to requests under the Act, they are
not required to open their doors and invite the public in to peruse their records. For that
No. 09-4084 CareToLive v. The Food and Drug Administration Page 7
reason, our review focuses on the adequacy of the agency’s search, and not on the
chance that additional documents exist. Although we are mindful that CareToLive is
necessarily at a disadvantage because it does not have access to the documents it claims
were not produced, that does not absolve CareToLive of its responsibility to demonstrate
that there is a material question of fact as to the adequacy of the FDA’s search.
CareToLive does not identify any additional offices or departments where the FDA
should have searched for documents. All that CareToLive offers are conclusory
allegations that “there must be additional documents” because of Dr. Pazdur’s role and
that the search was not actually conducted as described. However, conclusory
allegations that the FDA did not conduct a detailed search are insufficient to create a
material question of fact precluding summary judgment. The Act does not require that
agencies account for all of their documents, so long as they reasonably attempt to locate
them. To defeat a motion for summary judgment the requestor must identify specific
deficiencies in the agency’s response, which CareToLive has failed to do.
The closest CareToLive comes to creating a material question of fact is with the
search conducted at the FDA’s Center for Drug Evaluation. CareToLive asserts that the
search was inadequate because it took nearly two years to complete yet only turned up
one document. Additionally, CareToLive points out that the FDA only billed it forty
cents for reproduction charges, and nothing for the cost of this search. While the low
billing is unexpected and unusual, it does not create a material question of fact regarding
the adequacy of the FDA’s search in light of the detailed affidavits it submitted.
As the Sager Declaration, which describes the procedures the Center for Drug
Evaluation followed to conduct the search, explains, CareToLive’s inquiry was placed
on the “Complex Track” because it involved searching and redaction. Although
CareToLive argues that this was a narrowly tailored, simple inquiry, it has not offered
anything to establish that the requested documents had previously been provided to
another requestor or that gathering these documents would not require searching or
redaction. Therefore, it appears that the Center for Drug Evaluation properly placed the
No. 09-4084 CareToLive v. The Food and Drug Administration Page 8
request in its “Complex Track” even if, in common parlance, CareToLive made a simple
request.
The Sager Declaration sufficiently describes the steps that the Center for Drug
Evaluation undertook to respond to CareToLive’s request and explains that the search
only took a little over one month to complete. The two year delay was due to a backlog
from other requests that the Center for Drug Evaluation had received before
CareToLive’s. If a search really took an agency two full years to complete and only
turned up one responsive document, perhaps that would suggest that the search was not
done in good faith in a manner intended to locate responsive documents and summary
judgment would not be appropriate. However, this search did not take two years. It took
less than one month after the Center for Drug Evaluation began processing it.
Additionally, although CareToLive argues that the search only turned up one document,
the record suggests that the search uncovered numerous documents. Several people had
been copied on the correspondence CareToLive requested, and only one of these
documents had not already been given to CareToLive from one of the FDA’s other
departments. Therefore, we cannot infer from the delay or failure to find additional
responsive documents that the search was not reasonably designed to uncover responsive
documents.
The Center for Drug Evaluation’s bill for only forty cents in reproduction charges
is unexpected but does not suggest that the search procedures described in the Sager
declaration were not followed. In contrast to this invoice, the Center for Biologics billed
CareToLive $100.45 for 2.75 hours of search time. The Office of the Executive
Secretary billed CareToLive $404.75. Although the Center for Drug Evaluation’s failure
to charge for the search, standing alone, might be some evidence that it did not conduct
a detailed search, this single irregularity does not overcome the detailed averments set
forth in the Sager Declaration. That declaration explains that the Center for Drug
Evaluation fulfilled its duties under the Act and conducted a reasonable search for
responsive documents.
No. 09-4084 CareToLive v. The Food and Drug Administration Page 9
B. Recovering Deleted Files.
CareToLive also argues that in order to comply with the Act the FDA must use
an information technology expert and attempt to recover electronic documents that have
been deleted. Although Dr. Pazdur explained in his affidavit that he shredded the
physical copies of responsive memos within one month of receiving them and also
deleted any electronic copies, CareToLive asserts that an information technology
specialist would be able to retrieve electronic copies from Dr. Pazdur’s computer.
CareToLive also argues that, as a federal agency, the FDA maintains a network with
backup copies of Dr. Pazdur’s e-mails even if he deleted them from his local machine.
Although both of these assertions may be true, there is no factual evidence in the record
supporting them and, therefore, CareToLive did not meet its burden of coming forth with
evidence to rebut the FDA’s showing. Additionally, performing an invasive search for
deleted electronic documents is unnecessary in this case because the FDA maintains that
other individuals were copied on these letters and it has, from these other sources,
already delivered copies of these documents to CareToLive in response to its inquiry.
Any documents it might be able to recover from Dr. Pazdur’s computer or its servers
would merely be cumulative of items already in CareToLive’s possession. In light of
CareToLive’s request and the FDA’s response, the FDA need not attempt to recover
these deleted files to meet its burden of conducting a reasonable search.
Although some of our sister circuits have required that agencies attempt to
recover electronic files to respond to certain requests, CareToLive’s request and the facts
of this case do not require such a search. In Baker & Hostetler, for example, the D.C.
Circuit implied that an agency may be required to attempt to retrieve electronic
communications, but held that the agency’s response to the request under the Freedom
of Information Act was sufficient because it included affidavits explaining why it was
unable to recover the deleted e-mails, and the requestor did not rebut that explanation.
473 F.3d at 318; accord Fox News Network, LLC v. Bd. of Governors of The Fed.
Reserve Sys., 639 F. Supp. 2d 384, 397 (S.D.N.Y. 2009), vacated on other grounds, 601
F.3d 158 (2d Cir. 2010) (holding that the agency’s “failure to use computer experts to
No. 09-4084 CareToLive v. The Food and Drug Administration Page 10
search for these [deleted] files does not render the search inadequate”). In this case, Dr.
Pazdur deleted electronic copies of messages that are responsive to CareToLive’s
request. But, as noted above, the record does not contain any factual evidence to suggest
that the FDA can retrieve these documents. Additionally, there are no factual allegations
in the record to suggest that even if these deleted documents were recovered, they would
be items the FDA had not already provided to CareToLive. Even if we assume that it
is possible to recover the electronic files Dr. Pazdur deleted, the FDA’s failure to do so
in this case does not render its search unreasonable.
Independently bringing in an information technology expert to attempt to retrieve
these files is particularly unnecessary because CareToLive did not specifically request
deleted documents—or any documents—from Dr. Pazdur’s computer. If the request had
more specifically addressed documents on Dr. Pazdur’s computer, and there were no
other copies of these documents available then, perhaps, the FDA might be required to
retrieve the items or provide affidavits explaining why retrieval is impossible. However,
an agency’s search must only be reasonable under the circumstances, and when the data
retrieved would only be cumulative of items already produced, attempting to perform
this type of data retrieval is unnecessary. See Grand Cent. P’ship, 166 F.3d at 489(noting that “an agency’s search need not be perfect, but rather need only be
reasonable”); Schrecker v. U.S. Dep’t of Justice, 349 F.3d 657, 663 (D.C. Cir. 2003)
(holding that the “adequacy of an agency’s search is measured by a standard of
reasonableness, and is dependent upon the circumstances of the case”).
Government employees delete e-mails and electronic documents every day and,
as evidenced by the facts of this case, government agencies are already burdened with
a backlog of Freedom of Information Act requests. Adopting CareToLive’s position
could potentially cripple agencies by requiring that after following their normal search
procedures, they must have an information technology expert scan relevant computers
and servers for additional information that might have been deleted. This is manifestly
not what the Act intends and we decline to require it in this case. See Wilbur v. CIA, 355
F.3d 675, 678 (D.C. Cir. 2004) (noting that “the fact that responsive documents once
No. 09-4084 CareToLive v. The Food and Drug Administration Page 11
existed does not mean that they remain in the [agency’s] custody today or that the
[agency] had a duty under [the Freedom of Information Act] to retain the records”);
Yeager v. DEA, 678 F.2d 315, 321 (D.C. Cir. 1982) (“A requester is entitled only to
records that an agency has in fact chosen to create and retain.”). When faced with a
request such as this, an agency need not attempt to recover electronic data that has been
deleted in order to meet its requirement of performing a reasonable search.
III.
In response to the FDA’s motion for summary judgment, CareToLive filed a
“partial” response to the motion and a motion for discovery under Federal Rule of Civil
Procedure 56(f). Recent amendments to the rules moved the provisions formerly found
in subdivision (f) to subdivision (d). Fed. R. Civ. P. 56 advisory committee’s note
(2010). However, the recent amendments did not modify the substance of the rule and
the district court properly denied discovery because CareToLive failed to file a proper
affidavit in support of its motion for discovery. Alternatively, because of the unique
context of a dispute under the Freedom of Information Act, CareToLive has not put forth
any factual allegations showing the FDA’s bad faith or failure to conduct a reasonable
investigation. Therefore, the district court was within its discretion to deny discovery
for this reason.
We review a district court’s discovery orders in an action under the Freedom of
Information Act for abuse of discretion. E.g., Popovich v. Sony Music Entm’t, Inc., 508
F.3d 348, 360 (6th Cir. 2007); see also, e.g., Trentadue v. FBI, 572 F.3d 794, 806 (10th
Cir. 2009) (reviewing district court’s discovery order in a case under the Freedom of
Information Act for abuse of discretion); Wood v. FBI, 432 F.3d 78, 82 (2d Cir. 2005)
(same). “‘An abuse of discretion occurs when the district court relies on clearly
erroneous findings of fact, . . . improperly applies the law, . . . or . . . employs an
erroneous legal standard.’” Popovich, 572 F.3d at 806 (quoting Surles ex rel. Johnson
v. Greyhound Lines, Inc., 474 F.3d 288, 296 (6th Cir. 2007)).
CareToLive did not file a proper affidavit and therefore failed to comply with the
requirements in Rule 56(d) for obtaining discovery. Under this Rule, a party may
No. 09-4084 CareToLive v. The Food and Drug Administration Page 12
oppose a motion for summary judgment by submitting an affidavit explaining why it
cannot present facts essential to justify its opposition. Fed. R. Civ. P. 56(d). The
document CareToLive submitted as its affidavit was only one paragraph that stated:
AFFIDAVIT BY COUNSEL FOR CARETOLIVE
Now comes Counsel for CareToLive under Federal Rule of Civil
Procedure 56(f) and swears under oath and asserts to this Court that
CareToLive is unable by affidavit to provide proof to this Court of the
existence of the requested FOIA correspondence on the computer of
FDA employee Richard Pazdur at this time without the relief and/or
discovery requested herein. With any or all of the relief requested in the
Rule 56(f) motion the Plaintiff is confident it can show that the FDA
FOIA response was not complete. Sworn to by me this 6th day of June
2009.
s/Kerry M. Donahue
This one paragraph statement by CareToLive’s attorney woefully fails to meet
the requirements of an affidavit. The statement was not sworn to before a notary public
nor signed under penalty of perjury pursuant to 28 U.S.C. § 1746. Peters v. Lincoln
Elec. Co., 285 F.3d 456, 475 (6th Cir. 2002). Additionally, the statement does not set
forth any factual basis for the relief CareToLive is seeking. Cf. Carney v. U.S. Dep’t of
Justice, 19 F.3d 807, 813 (2d Cir. 1994) (holding that bare allegations in an affidavit that
the agency withheld documents are insufficient without factual support). Rule 56(d)
recognizes that there are instances when a party lacks the necessary facts to properly
contest a summary judgment motion. However, the party must at least specify what
information it is missing. CareToLive’s affidavit is an attempt to countermand this
simple requirement. Although CareToLive may be confident that with additional
information it can show that the FDA’s response was incomplete, nothing in this
affidavit instills the same confidence in us. Without CareToLive having filed a proper
affidavit, the district court did not abuse its discretion by denying discovery.
Alternatively, even if CareToLive had submitted a proper affidavit, the district
court still would not have abused its discretion by denying discovery. Claims under the
Freedom of Information Act are typically resolved without discovery on the basis of the
agency’s affidavits. See Rugiero, 257 F.3d at 544; Carney, 19 F.3d at 812 (explaining
No. 09-4084 CareToLive v. The Food and Drug Administration Page 13
that “discovery relating to the agency’s search and the exemptions it claims for
withholding records generally is unnecessary if the agency’s submissions are adequate
on their face”). If the agency satisfies its burden of establishing that it conducted a
reasonable search, the requestor must make a “showing of bad faith on the part of the
agency sufficient to impugn the agency’s affidavits or declarations,” or provide some
other evidence why summary judgment is inappropriate. Carney, 19 F.3d at 812. A
requestor is not entitled to discovery based on its hope that it might find additional
documents or its belief that the agency is withholding information. See Steinberg, 23
F.3d at 552 (remarking that “speculation that the information requested must exist also
does not establish that the search was unreasonable”).
The district court did not abuse its discretion when it concluded that CareToLive
failed to establish bad faith on the part of the FDA, and denied its motion for discovery.
CareToLive appears to allege that the FDA acted in bad faith when it (1) placed
CareToLive’s request on the “Complex Track;” (2) failed to conduct a proper search;
and (3) failed to preserve documents or attempt to recover electronic copies that have
been deleted. However, none of these actions show that the FDA acted in bad faith.
The uncontroverted evidence establishes that the Center for Drug Evaluation
placed CareToLive’s inquiry on the “Complex Track” in accordance with its two track
system. CareToLive is correct that its request was not particularly complex, but, while
the term “Complex Track” may be an inaccurate name, CareToLive’s request appears
to fall on what the FDA has defined as the “Complex Track.”3 Therefore, it was not bad
faith to classify it as such.
Similarly, allegations that the FDA failed to conduct a comprehensive enough
search, even if true, cannot be bad faith. Had the FDA not performed a thorough search,
then it would not have been entitled to summary judgment. However, a requestor cannot
3
Additionally, to the extent that CareToLive argues that it was bad faith to take nearly two years
to respond to its request, there is no evidence to support the conclusion that this was done by the FDA as
a deliberate attempt to delay or frustrate the process. The evidence suggests that the FDA’s Division of
Freedom of Information was perhaps understaffed, but not that it was acting in bad faith or processed
CareToLive’s request after it should have.
No. 09-4084 CareToLive v. The Food and Drug Administration Page 14
rely on allegations that the search was not reasonably comprehensive as a backdoor to
obtain discovery. Conclusory allegations that other undisclosed records must exist
somewhere and that the agency is deliberately concealing records do not rise to the level
of bad faith. Holding otherwise would, as discussed above, undermine other decisions
recognizing that assertions that the agency failed to produce documents are insufficient
to preclude summary judgment. See Baker & Hostetler, 473 F.3d at 318; Rugiero, 257
F.3d at 547-48.
Finally, claims that the FDA, and specifically Dr. Pazdur, intentionally destroyed
documents to avoid complying with CareToLive’s request are not supported by the
record. Dr. Pazdur’s affidavit states that he destroyed the relevant documents within one
month of receiving them, in accordance with his regular practice. CareToLive requested
documents that were sent between March 29, 2007 and April 30, 2007. However, it did
not file its Freedom of Information Act request until August 15, 2007. Accepting Dr.
Pazdur’s uncontroverted declaration that he destroyed his copies of these documents
within one month of receiving them, there is simply no evidence that the documents
were destroyed in an attempt to keep them from CareToLive when CareToLive did not
file its request until more than two and a half months after Dr. Pazdur claims to have
destroyed them.
Accordingly, the district court properly denied CareToLive leave to conduct
discovery.
IV.
The FDA’s affidavits establish that it conducted a reasonable search to locate
responsive documents and CareToLive failed to introduce evidence creating a material
question of fact as to the adequacy of the search. Therefore, the district court properly
granted summary judgment in favor of the FDA. Similarly, the district court did not
abuse its discretion when it denied CareToLive discovery. Therefore, the decision of the
district court is AFFIRMED.