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UNITED STATES DISTRICT COURT (ECF)

SOUTHERN DISTRICT OF NEW YORK

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 : MASTER FILE

IN RE: : MDL NO. 1789

 : 1:06-MD-1789 (JFK) (JCF)

FOSAMAX PRODUCTS LIABILITY :

LITIGATION :

- - - - - - - - - - - - - - - - - - : MEMORANDUM

This Document Relates To All Actions: AND ORDER

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JAMES C. FRANCIS IV

UNITED STATES MAGISTRATE JUDGE

This is a multidistrict litigation that was consolidated in

this district for purposes of discovery. The plaintiffs, through

the Plaintiffs’ Steering Committee, allege that the prescription

drug Fosamax, manufactured by Merck & Co., caused adverse effects,

in particular, osteonecrosis of the jaw. During discovery, the

plaintiffs subpoenaed Dr. Bruce M. Psaty, who participated in a

drug safety report issued by the National Academy of Sciences (the

“Academy”). Dr. Psaty now moves to quash the subpoena pursuant to

Rule 45(c)(3) of the Federal Rules of Civil Procedure. 

Background

A. Factual History

The Academy is a private, non-profit corporation charted by

Congress in 1863. See 36 U.S.C. §§ 150301-150304. It is dedicated

to furthering science for the general welfare. (Declaration of Dr.

E. William Colglazier dated December 19, 2008 (“Colglazier Decl.”),

attached as Exh 3 to Dr. Bruce M. Psaty’s Motion to Quash Third

Party Subpoena (“Motion to Quash”), ¶ 6). Often commissioned by

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U.S. government agencies, the Academy establishes committees to

conduct research and assess issues of scientific concern, including

public health. (Colglazier Decl., ¶¶ 6, 9). The Committee on the

Assessment of the U.S. Drug Safety System (the “Drug Safety

Committee”) was one of the committees established by the Academy’s

Institute of Medicine. (Declaration of Dr. Kathleen Stratton dated

December 19, 2008 (“Stratton Decl.”), attached as Exh. 2 to Motion

to Quash, ¶¶ 3, 5). The Drug Safety Committee was created at the

request of the U.S. Food and Drug Administration (the “FDA”) to

conduct an independent assessment of drug safety in the United

States. (Stratton Decl., ¶ 5). 

In 2004, the Academy asked Dr. Psaty to serve on the Drug

Safety Committee. (Motion to Quash at 2). He accepted, knowing

that, like all Committee members, he would not be compensated for

his work. (Stratton Decl., ¶ 4). Dr. Psaty served on the Drug

Safety Committee for 15 months between 2004 and 2006. (Motion to

Quash at 2).

During his tenure, Dr. Psaty participated in a detailed

examination of the current drug safety system in the United States.

(Stratton Decl., ¶ 7). In September 2006, the Committee released

its findings in a detailed report, “The Future of Drug Safety:

Promoting and Protecting the Health of the Public” (the “Drug

Safety Report”). (Drug Safety Report, attached as Exh. 4 to Motion

to Quash). This 317-page report contains recommendations for

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improving national drug safety, many of which involve proposals to

change the structure and activities of the FDA’s Center for Drug

Evaluation and Research. (Stratton Decl., ¶ 7). The report did

not focus on any single drug or category of pharmaceuticals. (Drug

Safety Report at 25-26). In particular, it did not study Fosamax.

B. Procedural History

The Plaintiffs’ Steering Committee served Dr. Psaty with a

deposition subpoena on December 1, 2008. (Subpoena of Bruce Psaty,

M.D., Ph.D., attached as Exh. 1 to Motion to Quash). On December

22, 2008, Dr. Psaty filed this motion to quash in the United States

District Court for the Western District of Washington. Thereafter,

a United States Judicial Panel on Multidistrict Litigation denied

Dr. Psaty’s request to vacate a previous decision to include this

case among the actions consolidated for discovery in this district.

(Transfer Order dated June 9, 2009 at 1). The motion to quash is

therefore before this Court for determination. 

Discussion

A. Rule 45(c)(3)

Under Rule 45(c)(3), a subpoena may be quashed if it requires

“disclosing a trade secret or other confidential research,

development, or commercial information.” Fed. R. Civ. P.

45(c)(3)(B)(i). The plaintiffs argue that they “[do] not seek to

discovery [sic] confidential information about the deliberations of

the committee.” (Plaintiff Steering Committee’s Response to Dr.

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Psaty’s Motion to Quash Third Party Subpoena (“Plaintiffs’ Memo.”)

at 2). Instead, they contend that they merely seek to reduce

public statements made by Dr. Psaty to “testimonial format.”

(Plaintiffs’ Memo. at 2).

As the parties’ representations about what might be asked

during deposition differ, it is unclear whether the subpoena of Dr.

Psaty would in fact elicit confidential information. This thus

creates a degree of uncertainty as to whether Rule 45 on its face

provides a sufficient basis for quashing the subpoena. Rule 26(c),

however, potentially provides a complementary source of authority.

Indeed, the Advisory Committee Notes state that Rule

45(c)(3)(B)(i), which “protect[s] . . . from unnecessary or unduly

harmful disclosures of confidential information[,]. . . corresponds

to Rule 26(c).” Fed. R. Civ. P. Rule 45 advisory committee’s notes

(1991); see also Insulate America v. Masco Corp., 227 F.R.D. 427,

432 (W.D.N.C. 2005)(“A non-party . . . may seek from the court

protection from discovery by the overlapping and interrelated

provisions of Rules 26 and 45 . . . .”). Thus, I must consider not

only Rule 45, but also Rule 26(c).

B. Rule 26(c)

Rule 26(c) allows courts to issue an order “to protect a party

or person from annoyance, embarrassment, oppression, or undue

burden or expense . . . .” Fed. R. Civ. P. 26(c). In analyzing

motions for a protective order, courts weigh the need of the party

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seeking the discovery against any undue hardships created by

permitting it. See In re Initial Public Offering Securities

Litigation, 220 F.R.D. 30, 36 (S.D.N.Y. 2003); Apex Oil Co. v.

DiMauro, 110 F.R.D. 490, 496 (S.D.N.Y. 1985). Because relevant

evidence carries a presumption of admissibility, the burden of

proof for a Rule 26(c) order rests with the party seeking

protection. See Condit v. Dunne, 225 F.R.D. 100, 106 (S.D.N.Y.

2004). Ultimately, if the court finds that undue hardships

outweigh necessity, it may quash the subpoena altogether or enforce

it on limited terms or with other conditions. See Fed. R. Civ. P.

26(c); American High-Income Trust v. AlliedSignal Inc., No. 02 Civ.

2506, 2006 WL 3545432, at *2 (S.D.N.Y. Dec. 8, 2006).

1. Relevance

As a threshold matter, the evidence sought to be discovered

must be relevant. See Condit, 225 F.R.D. at 105-06. The Federal

Rules of Evidence defines relevant evidence as “evidence having any

tendency to make the existence of any fact that is of consequence

to the determination of the action more probable or less probable

than it would be without the evidence.” Fed. R. Evid. 401. Thus,

the threshold for establishing relevance is minimal. See United

States v. Khan, 787 F.2d 28, 34 (2d Cir. 1986); see also Condit,

225 F.R.D. at 105 (“Although not unlimited, relevance, for purposes

of discovery, is an extremely broad concept.”). 

Here, Dr. Psaty allegedly made public comments in connection

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with his participation on the Drug Safety Committee. (Plaintiffs’

Memo at 2). As noted above, the study did not investigate Fosamax

or any other commercial drug, nor did it study the potential

adverse effects of any particular drug. (Drug Safety Report at 25-

26). Rather, it issued recommendations about improving national

drug safety and procedures of the the FDA’s Center for Drug

Evaluation and Research. (Stratton Decl., ¶ 7). At best, the

information sought from Dr. Psaty is tangentially related to the

plaintiffs’ allegations that osteonecrosis is caused by Fosamax.

Indeed, the plaintiffs do not even specify the public comments of

Dr. Psaty that they hope to reduce to a form admissible at trial.

But, because the threshold for demonstrating relevance is low, I

will assume that the plaintiffs have met it and will proceed to

weigh necessity and hardship. 

2. Necessity

The first step of the balancing inquiry is to determine the

necessity of the evidence to the party seeking discovery. It is a

question of degree, and a strong showing of necessity may overcome

a claim of substantial hardship. See Dow Chemical Co. v. Allen,

672 F.2d 1262, 1270 (7th Cir. 1982). In measuring a party’s need

for evidence, courts look to a variety of factors, including the

need to prepare an adequate defense or establish a claim, the

availability of alternative evidence, the need to cross-examine

expert witnesses, and the need for underlying data. See Deitchman

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v. E.R. Squibb & Sons, Inc., 740 F.2d 556, 561-63 (7th Cir. 1984);

In re: Silicone Gel Breast Implants Products Liability Litigation,

No. CV 92-P-10000S, 1996 WL 1358526, at *2 (N.D. Ala. April 11,

1996); Plough Inc. v. National Academy of Sciences, 530 A.2d 1152,

1159 (D.C. App. 1987). 

In the present case, the plaintiffs have failed to demonstrate

a need for Dr. Psaty’s testimony. The subpoena is solely based on

a desire to “reduce . . . to testimony” some of Dr. Psaty’s public

statements. (Plaintiffs’ Memo. at 2, 7). The plaintiffs have not

claimed that alternative evidence is unavailable. They do not

assert any need to obtain the underlying data used to produce the

conclusions in the Drug Safety Report. There is no showing that

Dr. Psaty’s testimony is needed to cross-examine experts nor to

establish a claim. As a result, the plaintiffs have not

demonstrated a substantial need for deposing Dr. Psaty.

3. Undue Burden

Discovery may be blocked if permitting it would create an

undue burden that outweighs its necessity. See Solarex Corp. v.

Arco Solar, Inc., 121 F.R.D. 163, 169 (E.D.N.Y. 1988). The burden

encompasses both the personal hardship to the subpoenaed party and

the wider social consequences of permitting discovery. See id.

a. Personal Hardship

Personal hardship would result if Dr. Psaty were compelled to

testify. In general, third parties are afforded more sympathy in

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weighing the burden of discovery because they have no personal

stake in the litigation. See Fears v. Wilhelmina Model Agency,

Inc., No. 02 Civ. 4911, 2004 WL 719185, at *1 (S.D.N.Y. April 1,

2004). Moreover, courts are wary of compelling testimony from

third party researchers because it risks inadvertent disclosure of

protected information. See Dow Chemical, 672 F.2d at 1276; Solarex

Corp., 121 F.R.D. at 179-80. Any accidental disclosure could

disrupt a researcher’s relationships at work and even jeopardize

his career. See Dow Chemical, 672 F.2d at 1276.

Here, Dr. Psaty has no interest in the litigation. Forcing

his appearance at a deposition carries the risk of disclosing his

role in private, internal matters of the Academy. Under these

circumstances, Dr. Psaty would suffer personal hardship if the

subpoena is upheld.

b. Social Consequences

While upholding the subpoena would create hardship for Dr.

Psaty, the resulting social impact would be far more serious.

Compelling testimony from a third party researcher risks chilling

participation in beneficial public research. See Dow Chemical, 672

F.2d at 1273-76; Plough, 530 A.2d at 1156-57. There is a serious

danger that permitting discovery in these situations “inevitably

tend[s] to check the ardor and fearlessness of scholars, qualities

at once so fragile and so indispensable for fruitful academic

labor.” Sweezy v. New Hampshire, 354 U.S. 234, 262 (1957).

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In Plough, the court addressed this potential chilling effect.

See Plough, 530 A.2d at 1156-58. There, defendant Plough Inc., a

pharmaceutical manufacturer, faced allegations that its aspirin

caused the plaintiff to develop Reye Syndrome. Id. at 1154. To

support these claims, the plaintiff cited a government study

validated by the Academy. Id. Plough then subpoenaed the Academy,

seeking documents reflecting confidential deliberations and

preliminary drafts underlying the Academy’s review. Id. In

upholding the lower court’s decision to quash the subpoena, the

court credited the Academy’s claim that its “ability to convince

volunteers to serve on its committees would be impaired, since

individuals would be reluctant to serve if they knew their comments

were subject to disclosure.” Id. at 1156-57. The court further

reasoned that 

[e]ven limited disclosure of the preliminary conclusions,

hypotheses, thoughts and ideas ventured by Committee

members prior to their being tested and criticized would

not only embarrass those members, it would discourage

members of [Academy] committees in the future from

expressing themselves freely during their deliberations,

and might cause some potential volunteers to refrain from

participating in [Academy] studies altogether.

Id. at 1157-58. Because the potential chilling effect

significantly outweighed the need, the court upheld the decision to

quash the subpoena. See id. at 1160.

Other courts, too, have acknowledged the gravity of this type

of potential chilling effect. See Dow Chemical, 672 F.2d at 1276

(upholding refusal to enforce subpoena duces tecum because

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researchers “with the knowledge throughout continuation of their

studies that the fruits of their labors had been appropriated by

and were being scrutinized by a not-unbiased third party . . .

carries the potential for chilling . . . .”); Richards of Rockford,

Inc. v. Pacific Gas & Electric Co., 71 F.R.D. 388, 390 (N.D. Cal.

1976)(quashing subpoena of third party research assistant because

“[c]ompelled disclosure of confidential information would without

question severely stifle research into questions of public policy,

the very subjects in which the public interest is greatest.”);

Apicella v. McNeil Laboratories, Inc., 66 F.R.D. 78, 85 (E.D.N.Y.

1975)(denying discovery of identity of third party author of

scientific report because “if [research] consultants were forced to

participate in searching cross-examinations, often resulting in

embarrassment and inconvenience, they would hesitate to act as

sources in the future, to the detriment of the medical community

and the public.”). 

Like the cases cited above, subpoenas of third party

researchers at the Academy raises serious concerns. The Academy is

a public, non-profit corporation dedicated to furthering science,

the general welfare, and public health. (Colglazier Decl., ¶ 6).

It relies heavily on the candor of its committee members to ensure

the free exchange of ideas paramount to producing the best reports.

(Colglazier Decl., ¶¶ 13, 18). As such, participants are assured

that their research and reviews are confidential. (Colglazier

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Decl., ¶ 13). For participants like Dr. Psaty, who was not

compensated for his work, compelling testimony about internal

committee matters would chill the crucial atmosphere of candor.

Further, it would handicap the Academy’s ability to recruit

participants, who may fear the potential for embarrassment

associated with questioning in connection with litigation. 

Of course, the plaintiffs deny any intention of eliciting

confidential information. Taken at their word, the plaintiffs

contend that they only need testimony from Dr. Psaty to reduce

certain public statements to testimony. If this is truly the case,

while the personal and social hardships would be minimized, the

plaintiffs’ showing of necessity is virtually nil. Alternatively,

if the plaintiffs actually want more from the deposition than they

assert, the corresponding undue burden would predominate because,

as discussed above, the subpoena would risk chilling participation

in beneficial public research. Thus, regardless of the plaintiffs’

intent, the subpoena presents an undue burden that outweighs the

necessity for testimony. 

C. Protective Measure

Once Rule 26(c) balancing merits protective measures, courts

have discretion in deciding what form of protection to grant. See

Fed. R. Civ. P. 26(c). In general, the subpoenaed party is

entitled to complete protection when the undue burden significantly

outweighs necessity. See Plough, 530 A.2d at 1160. Conversely,

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when it is possible to limit discovery to materials outside the

scope of 26(c) protection, a qualified protective order should be

granted. See Deitchman, 740 F.2d at 564 (finding that defendant

was entitled to limited discovery despite need to protect certain

requested material). However, if limiting discovery is impossible

or creates a risk of disclosure of the protected materials, blanket

protection is appropriate. See Dow Chemical, 672 F.2d at 1278

(affirming refusal to enforce subpoena because limited discovery

would reduce, but not eliminate, risk of disclosure). Indeed, even

a perceived risk of disclosure may merit blanket protection when

there is a potential chilling effect. See Solarex, 121 F.R.D. at

180.

In the case of Dr. Psaty, the undue burden significantly

outweighs the plaintiffs’ need for discovery, which weighs in favor

of blanket protection. While the plaintiffs have disclaimed any

intention to ask Dr. Psaty about internal Academy matters, their

vaguely asserted need creates considerable uncertainty over what

information they seek. This creates a danger that the deposition

would lead to inadvertent disclosures of protected information.

And, even if there is a guarantee that discovery will be

appropriately limited, the perception of intrusion into the domain

of the Academy would carry a substantial risk of chilling. As a

result, quashing the subpoena is the most appropriate protective

measure in this case. 

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