Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ared-4_03-cv-01507/USCOURTS-ared-4_03-cv-01507-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

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Doc. No. 982.

2

Doc. No. 982, Ex. A.

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Doc. No. 979.

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IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF ARKANSAS

WESTERN DIVISION

 : MDL DOCKET NO. 4:03-CV-1507-WRW

IN RE: :

PREMPRO PRODUCTS LIABILITY :

LITIGATION : ALL CASES

ORDER

Pending are NIH’s Motion to Quash Subpoena (Doc. No. 979) and Defendant Wyeth’s

Motions to Compel (Doc. Nos. 981, 1008). Oral argument was heard at the February 24, 2006

status conference and additional papers have been submitted since then.

I. BACKGROUND

In a November 16, 2005 subpoena served on the Custodian of Records at NIH and Dr.

Roussow, Wyeth requested, among other things, “the meeting minutes and reports of any

standing or ad hoc committees or groups at NIH (including advisory committees to the WHI

study) that relate to the WHI clinical trials.”1 NIH produced some of the requested documents

but withheld other documents, including the minutes of the WHI advisory committees, on the

ground that the documents were protected by the agency deliberative process privilege.2

 

NIH filed a Motion to Quash in support of its position.3

 Specifically, NIH requested the

subpoena be quashed to the extent that it requests the minutes of the WHI Data and Safety

Monitoring Board (“DSMB”) and the minutes of the WHI NHLBI Ad Hoc Review Group.

Case 4:03-cv-01507-BRW Document 1073 Filed 03/20/06 Page 1 of 4
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Doc. No. 1043.

5

Doc. No. 1054.

6

Id..

7

Id. at Ex. B.

8

Id.

9

See State of N.D. ex rel. Olsen v. Andrus, 581 F.2d 177, n.8 (8th Cir. 1978) (“In light of

the FOIA’s broad policy in favor of disclosure and the narrow construction given to the Act’s

exemptions, courts have generally exhibited an intolerant attitude toward administrative secrecy

that appeared capricious.”).

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II. DISCUSSION

In response to NIH’s privilege claim, Wyeth has provided the Court with three sets of

DSMB minutes, which were attached to Plaintiffs’ expert reports.4

 Wyeth claims that this

evidence constitutes a waiver of the deliberative process privilege. NIH contends that “[i]t is not

known how the Plaintiffs obtained certain minutes of the DSMB, but the NIH did not publish the

same on the internet.”5

 NIH further suggests “[i]t would appear that a disclosure of certain

DSMB minutes was made pursuant to a FOIA request”6

 and that the “documents released were

redacted, in accordance with the nine (9) FOIA exemptions, to protect information exempted

from disclosure.”7

 Irregardless (sic), NIH asserts that the privilege was not waived. I find that

NIH’s position is without merit.

NIH admits that it may have disclosed DSMB minutes pursuant to an FOIA request to a

“private individual.”8 However, there is no evidence suggesting that NIH was compelled to

comply with the FOIA request. Unless a court forced NIH to provide the documents, NIH

cannot claim that such disclosure was involuntary. Furthermore, NIH’s lack of documentation

regarding these disclosure, pursuant to the FOIA request, is troublesome.9 Finally, these minutes

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10Doc. No. 1043, Ex. A, B, C.

11Doc. No. 1054.

12FTC v. Warner Communications, Inc., 742 F.2d 1156, 1161 (9th Cir. 1984).

13Id. (citations omitted).

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have very few redactions -- mostly limited to the names of specific DSMB members making

statements and “outcome data not in public domain.”10 NIH contends that “efforts were made to

protect any privileged or exempted information by redacting that not required to be produced.”11

Based on this statement, it appears that NIH is conceding that sections it did not redact were not

entitled to exemption under the FOIA. 

Furthermore, the deliberative process privilege is not an absolute privilege, but a

qualified privilege.12 The Ninth Circuit Court of Appeals has recognized that, because the

privilege is qualified:

A litigant may obtain deliberative materials if his or her need for the materials and

the need for accurate fact-finding override the government’s interest in

non-disclosure. Among the factors to be considered in making this determination are:

1) the relevance of the evidence; 2) the availability of other evidence; 3) the

government’s role in the litigation; and 4) the extent to which disclosure would

hinder frank and independent discussion regarding contemplated policies and

decisions.13

After reviewing the documents and hearing argument, it seems to me that these factors weighs in

Wyeth’s favor. Specifically, I feel that the minutes may be relevant since the WHI study is at the

center of this litigation; the evidence is not available through another means; and disclosure does

not chill debate among doctors involved in the NIH or the WHI advisory committees.

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CONCLUSION

While the documents at issue may very well be predecisional and deliberative, the fact

that this is a qualified privilege and the fact that NIH has previously disclosed minutes lead me

to conclude that the deliberative process privilege does not provide a blanket protection to the

minutes requested by Wyeth. Accordingly, NIH’s Motion to Quash Subpoena (Doc. No. 979) is

DENIED and Defendant Wyeth’s Motions to Compel (Doc. Nos. 981, 1008) are GRANTED. 

NIH is directed to produce the transcripts at issue. However, NIH will be permitted to redact

information (e.g. names, “outcome data not in the public domain,” etc) that it feels is specifically

entitled to privilege, as long as the redactions are as narrow as they were for the documents

released in response to the FOIA request.

IT IS SO ORDERED this 20th day of March, 2006.

/s/ Wm. R.Wilson,Jr. 

UNITED STATES DISTRICT JUDGE

 

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