items that are "typical of broader classes of documents within
the pool." See In re United States Dep't of Defense,
848 F.2d 232, 237 (D.C.Cir. 1988). In this way, representative sampling
"has the advantage of assuring that the documents in the sample
do indeed typify the broader pool." Id. The D.C. Circuit held
that it is within the trial judge's discretion to choose random
or representative sampling, as the specific case may require.
See id. at 237-38.
In support of its request for a representative sample index,
the FDA states that it will index the FDA-generated documents
relating to any one of the 35 IND files or, in the alternative,
select one of the files at random to index. See Def.'s Mot. at
11. According to the FDA, "an index of the FDA-generated
documents in one IND would be representative of the
FDA-generated documents in all xenotransplantation IND's [sic]
. . . because the same types of FDA-generated documents are
found in every xenotransplantation IND file." Id. (citations
omitted). In addition, the FDA states that because it will
assert the same exemptions for documents in the indexed IND as
it would for the same types of documents in the other INDs, the
plaintiff will be able to rely on the sample Vaughn index
"with a high degree of confidence that it is representative of
the greater universe of FDA-generated documents responsive to
its request." Id. (citing Bonner, 928 F.2d at 1151).
CRT does not contest that the FDA would have to review over
240,000 pages of material to index all withheld documents. CRT
does question, however, whether the documents contained in one
IND are representative of the documents in the other 34 INDs.
Accordingly, CRT asks that the court allow it to choose at least
five INDs from which such a sample Vaughn index would be
prepared. See Pl.'s Reply at 11. Of course, this would require
the FDA to index about 35,000 pages of documents, which would
still be unduly burdensome to the agency. Cf. Dowd v.
Calabrese, 101 F.R.D. 427, 437 (D.C. 1984) (holding that the
preparation of an index of 15,000 pages of materials would be
At this stage of the litigation, the court will accord the FDA
deference in its description of the documents in each IND as
"essentially uniform." To further ensure the representativeness
of the sample, however, the court will allow CRT to choose the
IND to be indexed, with the exception of any Novartis IND.
C. Exclusion of any Novartis IND
Although Novartis has no objection to the plaintiffs request
for a Vaughn index, it asks that any records relating to any
Novartis IND be excluded from the Vaughn index. See Novartis
Pharms. Corp.'s Response to Pl.'s Mot. Requesting a Vaughn
Index at 2. Novartis explains that until CRT filed this suit,
the FDA had not regulated any Novartis INDs as
xenotransplantation INDs. Thus, Novartis states that:
until there is a resolution of the issue of whether
FDA-generated records relating to or referring to any
Novartis IND are within the scope of [CRT's] modified
request, Novartis believes that all such records
should be excluded from the requested Vaughn index
or, at a minimum, that any such records included in
the index be identified in such a way that they do
not directly or indirectly identify the Novartis INDs
or their subject.
Id. Neither the FDA nor CRT has responded to or opposed
Novartis's request. Accordingly, the court will instruct the FDA
to comply with Novartis's requested limitation.