Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-12-05393/USCOURTS-caDC-12-05393-0/pdf.json

Parties Involved:
Boehringer Ingelheim Pharmaceuticals, Inc.
Appellee
Federal Trade Commission
Appellant

Document Text:

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued October 14, 2014 Decided February 20, 2015

No. 12-5393

FEDERAL TRADE COMMISSION,

APPELLANT

v.

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.,

APPELLEE

Appeal from the United States District Court

for the District of Columbia

(No. 1:09-mc-00564)

Mark S. Hegedus, Attorney, Federal Trade Commission, 

argued the cause for appellant. With him on the briefs were 

Jonathan E. Nuechterlein, General Counsel, David C. Shonka, 

Principal Deputy General Counsel, John F. Daly, Deputy 

General Counsel for Litigation, and Leslie Rice Melman, 

Assistant General Counsel for Litigation. David L. Sieradzki, 

Attorney, entered an appearance.

Lawrence D. Rosenberg argued the cause for appellee. 

With him on the brief was Michael Sennett.

Before: ROGERS, GRIFFITH and WILKINS, Circuit Judges.

Opinion for the Court filed by Circuit Judge WILKINS.

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WILKINS, Circuit Judge: In 2009, the Federal Trade 

Commission initiated an antitrust investigation into a patent 

settlement agreement between Boehringer Ingelheim 

Pharmaceuticals, Inc. (“Boehringer”), a brand-name 

pharmaceutical company, and Barr Industries (“Barr”), a 

generic drug manufacturer. As part of its investigation, the 

FTC issued an administrative subpoena seeking various 

documents relating to the settlement. When Boehringer failed 

to comply, the FTC initiated an enforcement proceeding in the 

District Court for the District of Columbia. See FTC v. 

Boehringer Ingelheim Pharm., Inc., 286 F.R.D. 101 (D.D.C. 

2012). Although Boehringer ultimately certified compliance 

with the subpoena, it withheld hundreds of responsive 

documents under the work product doctrine and the attorneyclient privilege. After the FTC objected, the District Court

reviewed in camera a sample of the contested documents, and 

found that almost all were properly withheld under the work 

product doctrine or the attorney-client privilege. On appeal, 

the FTC challenges the District Court’s application of the 

work product doctrine. 

The FTC first asserts that the District Court erred as a 

matter of law when it concluded that settlement documents 

pertaining to a co-promotion agreement between Boehringer 

and Barr were prepared “in anticipation of litigation,” as 

required under the work product doctrine. According to the 

FTC, this conclusion cannot be reconciled with Boehringer’s 

representation that the co-promotion agreement involved 

payment for other services apart from Barr’s agreement to 

dismiss the patent litigation. We reject the FTC’s argument

and hold that a settlement term may have independent 

economic value and still be considered part of a settlement for 

purposes of work product protection. In addition, we find that 

the District Court reasonably concluded that the bulk of the 

contested co-promotion materials were prepared “in 

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anticipation” of the Boehringer-Barr litigation. The sole

exception is a small group of documents drafted after the 

settlement was executed, which the District Court did not 

explicitly address. Accordingly, we generally affirm the 

District Court’s findings on this issue but remand for further 

consideration with respect to the post-settlement documents.

The FTC next argues that the District Court committed 

legal error by applying an overly expansive definition of 

“opinion” work product, which is highly protected, as 

opposed to “fact” work product, which is substantially less so. 

Because we agree that the District Court misapprehended the 

proper distinction between fact and opinion work product, we 

reverse and remand on this issue. 

I.

Boehringer manufactures Aggrenox and Mirapex, two

patented pharmaceutical drugs that earn hundreds of millions 

of dollars in U.S. sales each year. In 2005, Barr sought and 

received FDA approval to market generic versions of these 

drugs, which led Boehringer to sue Barr for patent 

infringement. See Boehringer Ingelheim Int’l GmbH v. Barr 

Labs. Inc., Civ. Action No. 05-700-JJF (D. Del. filed Sept. 26, 

2005). Barr, in turn, contended that Boehringer’s patents 

were invalid. While the Delaware litigation was pending, 

Boehringer and Barr entered into settlement negotiations. 

Boehringer’s senior vice president and general counsel, Marla

Persky, served as its lead negotiator during these discussions. 

FTC Investig. Hr’g Tr. at 70-71, J.A. 755-56. To this end, 

Persky and her staff engaged in both legal and business

activities, including evaluating possible litigation outcomes, 

considering potential antitrust concerns, and evaluating and 

negotiating the business terms of the settlement. Id. at 

113-16, 118, 120-23, J.A. 772-80. 

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On August 11, 2008, the two companies settled their 

dispute on the following terms: Barr would refrain from 

marketing its generic versions of Aggrenox and Mirapex in 

the immediate future, but Boehringer would permit Barr to 

enter the market several months ahead of the expiration of 

Boehringer’s patents. Boehringer, 286 F.R.D at 105; see also

Aggrenox Settlement Agreement, J.A. 871-83; Press Release, 

J.A. 886-88. In the meantime, under a related co-promotion 

agreement, Barr would help Boehringer promote Aggrenox to 

medical professionals in exchange for certain specified fees 

and royalties on Aggrenox sales. Boehringer, 286 F.R.D at 

105; see also Co-Promotion Agreement, J.A. 889-930.

While this type of settlement deal is not necessarily

unlawful, see FTC v. Actavis, Inc., 133 S. Ct. 2223, 2237-38

(2013), such a settlement may be subject to antitrust scrutiny 

if it appears that the patent-holding firm – here, Boehringer –

was using the co-promotion agreement as a vehicle to avoid 

legitimate competition. Id. at 2236-37. And, indeed, the 

specific terms of this settlement raised the suspicions of the 

FTC that Boehringer was simply paying Barr off in order to 

delay the entry of generics into the market. Boehringer, 286 

F.R.D at 105. The FTC initiated an investigation and served 

Boehringer with a subpoena duces tecum. Id. After 

Boehringer failed to meet a deadline for production, the FTC 

filed a petition in district court for an order enforcing the 

subpoena. Id. 

Boehringer ultimately completed production and certified 

compliance with the subpoena, although it withheld nearly a 

quarter of identified responsive documents as protected by the 

attorney-client privilege, the work product doctrine, or both. 

Id. at 106. The FTC was not satisfied with Boehringer’s 

response and objected that many of the withheld documents 

fell outside the scope of these privileges. Id. It specifically

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challenged Boehringer’s refusal to produce documents 

containing financial analyses of the Aggrenox co-promotion 

agreement, forecasting analyses of alternative time lines for 

generic entry into the market, and financial analyses of the 

business terms of the settlement agreement. Id. at 108. The 

FTC also challenged Boehringer’s withholding of several 

other categories of documents not at issue in this appeal. See

id. at 112 (discussing emails, notes, and reports on strategic 

decisions and other issues; emails containing legal advice or 

requests for legal advice; transmittal emails; and duplicate 

documents); Appellant’s Br. 12-16 (limiting challenge on 

appeal to financial documents analyzing litigation settlement 

and co-promotion agreement).

By agreement of the parties, Boehringer submitted a 

sample set of documents in camera to the District Court. 

Boehringer, 286 F.R.D at 106. After reviewing the 

documents, the District Court issued a decision largely 

upholding Boehringer’s work product claims. Id. at 108-12. 

The District Court first explained why the financial 

analyses and forecasts fell within the scope of the work 

product doctrine. It began by observing that work product 

developed for the purpose of settling a lawsuit falls within the 

scope of materials prepared “in anticipation of litigation,” as 

required under Rule 26. Boehringer, 286 F.R.D. at 107, 109; 

see FED. R. CIV. P. 26(b)(3) (protecting from disclosure 

materials “prepared in anticipation of litigation”). The 

documents analyzing litigation outcomes and the settlement 

terms were, therefore, plainly work product. Boehringer, 286 

F.R.D. at 109. As for the co-promotion agreement materials, 

the court found that the co-promotion agreement was 

“integral” to the global settlement deal and therefore also 

belonged in the class of materials prepared in anticipation of

litigation. Id. 

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The District Court next considered whether the materials 

sought were fact work product, which may be discovered 

under certain circumstances, or opinion work product, which 

is subject to strict protection. Id. at 109-10. It found that 

although the materials resembled financial reports that might 

be prepared in the standard course of business, the specific 

reports were prepared using “information and frameworks”

provided by Boehringer counsel and reflected, at minimum, 

counsel’s opinions as to what data were important in 

determining an acceptable settlement. Id. at 109. On these 

grounds, the District Court concluded that the materials 

constituted opinion work product, deserving of the utmost 

protection. Id. at 110. The District Court further found that 

the FTC had not demonstrated the sort of “overriding and 

compelling” need required to pierce opinion work product 

protection. Id. at 109-10. Because the District Court found 

that the documents were wholly protected under the work 

product doctrine, it did not reach Boehringer’s attorney-client 

privilege claims with respect to any of these financial 

documents. See id.

The FTC contends that the District Court erred in two 

ways. It first argues that the District Court failed to properly 

consider whether many of these materials – particularly, the 

financial analyses of the Aggrenox co-promotion agreement

and materials produced after the settlement agreement was 

executed – actually were prepared “in anticipation of 

litigation.” It next asserts that even if all of the contested 

documents are work product, then they are, at most, fact work 

product and therefore may be discovered by the FTC upon a 

showing of substantial need and undue hardship. 

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II.

We review a district court’s decision to enforce an 

administrative subpoena for abuse of discretion. See U.S. 

Int’l Trade Comm’n v. ASAT, Inc., 411 F.3d 245, 253 (D.C. 

Cir. 2005). A district court necessarily abuses its discretion if 

it applies the incorrect legal standard, a question that is 

reviewed de novo. See Conservation Force v. Salazar, 699 

F.3d 538, 542 (D.C. Cir. 2012); FTC v. Church & Dwight 

Co., 665 F.3d 1312, 1315 (D.C. Cir. 2011).

A district court’s factual findings are reviewed for clear 

error. Boca Investerings P’ship v. United States, 314 F.3d 

625, 629 (D.C. Cir. 2003). A finding is clearly erroneous, 

even where there is record evidence to support it, if “the 

reviewing court on the entire record is left with the definite 

and firm conviction that a mistake has been committed.”

Awad v. Obama, 608 F.3d 1, 6-7 (D.C. Cir. 2010) (internal 

quotation marks omitted). 

III.

A.

The Supreme Court first articulated the federal work 

product doctrine in Hickman v. Taylor, 329 U.S. 495 (1947), 

where it was asked to define the reach of the pre-trial 

deposition and discovery mechanisms established by the thennew Federal Rules of Civil Procedure. These rules, which 

required each party “to disgorge whatever [relevant, nonprivileged] facts he has in his possession,” dramatically 

expanded the scope of pre-trial discovery. Id. at 507. Under 

a literal reading of the Rules, a party would be entitled to 

discover any non-privileged trial preparation materials, such 

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as attorney notes from witness interviews, created by his 

opponent in that litigation. See id. at 506.

The Supreme Court rejected this literal reading, holding 

that compelled disclosure of attorney work product would 

“contravene[] the public policy underlying the orderly 

prosecution and defense of legal claims.” Id. at 510. The 

Court explained that in performing one’s duties as a lawyer:

[I]t is essential that a lawyer work with a certain degree 

of privacy, free from unnecessary intrusion by opposing 

parties and their counsel. Proper preparation of a client’s 

case demands that he assemble information, sift what he 

considers to be the relevant from the irrelevant facts, 

prepare his legal theories and plan his strategy without 

undue and needless interference. 

Id. at 510-11. Readily compelling the disclosure of such work 

product to opposing counsel would lead to “[i]nefficiency, 

unfairness and sharp practices.” Id. at 511.

Hickman clarified that discovery of an attorney’s work 

materials was permitted only in limited circumstances. Id. A 

party seeking such materials must establish “adequate reasons 

to justify production through subpoena or court order,” and 

even then, discovery is limited to “relevant and nonprivileged facts.” Id. at 511-12 (emphasis added).

Hickman was later codified in substantial part in Rule 

26(b)(3) of the Federal Rules. Rule 26 provides that a party 

generally may not discover “documents and tangible things 

that are prepared in anticipation of litigation or for trial by or 

for another party or its representative[.]” FED. R. CIV. P.

26(b)(3)(A). Such discovery is permissible, however, if “the 

party shows that it has substantial need for the materials to 

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prepare its case and cannot, without undue hardship, obtain 

their substantial equivalent by other means,” so long as 

counsel’s “impressions, conclusions, opinions, or legal 

theories” are not disclosed. FED. R. CIV. P. 26(b)(3)(A)-(B); 

see FED. R. CIV. P. 81(a)(5) (providing that the Federal Rules 

apply to proceedings to enforce an administrative subpoena). 

The work product protection is broader than the attorneyclient privilege in that it is not restricted solely to confidential 

communications between an attorney and client. In re Sealed 

Case, 676 F.2d 793, 808-09 (D.C. Cir. 1982). It is narrower, 

however, insofar as the doctrine protects only work performed 

in anticipation of litigation or for trial. See Senate of Puerto 

Rico v. Dep’t of Justice, 823 F.2d 574, 586 (D.C. Cir. 1987) 

(“The work product doctrine does not extend to every written 

document generated by an attorney . . . rather, work product 

covers only documents prepared in contemplation of 

litigation.”) (internal quotation marks omitted). A document 

prepared as work product for one lawsuit will retain its 

protected status even in subsequent, unrelated litigation. See 

FTC v. Grolier Inc., 462 U.S. 19, 27-28 (1983); In re Murphy, 

560 F.2d 326, 333-35 (8th Cir. 1977) (holding that materials 

prepared for patent settlement retained work product 

protection in subsequent antitrust litigation).

B.

1.

When considering whether a document is prepared “in 

anticipation of litigation,” this Court employs a “because of”

test, inquiring “whether, in light of the nature of the document 

and the factual situation in the particular case, the document 

can fairly be said to have been prepared or obtained because 

of the prospect of litigation.” United States v. Deloitte LLP,

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610 F.3d 129, 137 (D.C. Cir. 2010) (internal quotation marks 

omitted); accord 8 CHARLES ALAN WRIGHT ET AL., FEDERAL 

PRACTICE & PROCEDURE § 2024, at 502 (3d ed. 2010). Where 

a document would have been created “in substantially similar 

form” regardless of the litigation, work product protection is 

not available. Deloitte, 610 F.3d at 138 (quoting United 

States v. Adlman, 134 F.3d 1194, 1195 (2d Cir. 1998)). 

The FTC does not challenge the District Court’s ruling 

that documents created by Boehringer for the purpose of 

settling the patent infringement litigation are protected work 

product. It takes issue, however, with the District Court’s 

finding that the materials relating to the co-promotion 

agreement fall within the category of protected settlement 

documents. 

The FTC points out that Boehringer has represented that 

the co-promotion agreement, despite being part of the 

litigation settlement, was a “fair arms-length business 

arrangement” that had independent economic value apart 

from the litigation settlement. April 6, 2010 Letter from 

Boehringer counsel to the FTC, J.A. 577; FTC Investig. Hr’g 

Tr. 112-13, J.A. 991-92. The FTC contends that the 

purported “arms-length” nature of the co-promotion 

agreement logically compels a finding that the related 

documents would have been created “in substantially similar 

form” irrespective of the patent infringement litigation. 

Appellant’s Br. 21, 33-41. According to the FTC, Boehringer 

may not point to the independence of the co-promotion 

agreement from the litigation settlement for purposes of its 

antitrust defense while relying on the interdependence of 

these agreements to avoid discovery. 

We find no merit in the proposition that any settlement 

term that has some independent economic value to both 

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parties must always be treated as an ordinary (non-litigation) 

business transaction for purposes of work product protection. 

Common sense and practical experience teach that settlement 

deals routinely include arrangements that could be isolated 

from the overall agreement and stand on their own but were 

nonetheless crafted for the purpose of settling litigation. 

Indeed, the Supreme Court’s refusal in Actavis to hold reverse 

payment settlement agreements presumptively unlawful 

anticipates that a reverse payment could “represent payment” 

for “other services” aside from a party’s agreement to end 

litigation yet still be part of the settlement. 133 S. Ct. at 2237. 

Upon our review of the record, we find no clear error in 

the District Court’s factual finding that the co-promotion 

agreement was “integral” to the broader settlement. 

Boehringer, 286 F.R.D. at 109. Accordingly, the District 

Court did not err in drawing the legal conclusion that the copromotion agreement materials were prepared “in anticipation 

of” the patent litigation and were therefore entitled to work 

product protection.

The FTC posits that our ruling on this point could lead to 

gamesmanship by counsel in future cases. It imagines a 

scenario in which parties engaged in litigation settlement 

discussions could tack on an unrelated side deal for the 

purpose of evading regulatory scrutiny. See Appellant’s 

Reply Br. 12-13, 17. While we do not have occasion to rule 

on such facts, we note that the work product doctrine is “an 

intensely practical one, grounded in the realities of litigation 

in our adversary system.” United States v. Nobles, 422 U.S. 

225, 238 (1975). We do not reach the question of whether the 

work product protection is available in the hypothetical 

situation where settlement terms run far afield of the 

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underlying litigation, or where there is evidence, not present 

here, of gamesmanship or abuse.1

2.

The FTC also raises a temporal objection to many of the 

withheld documents. It notes that the District Court

characterized the documents as having been prepared “to 

assess settlement option[s].” Boehringer, 286 F.R.D. at 109. 

This finding is inconsistent with the dates on many documents

(including at least eight submitted in camera) that were 

prepared after the settlement agreement was executed. See

Index of Challenged Entries at 36, J.A. 703. 

Boehringer concedes that many documents were created

after settlement negotiations concluded. See Appellee’s Br. 

15. It asserts, however, that these materials contain 

information initially prepared in anticipation of the settlement, 

related to other pending litigation, or involving requests for or 

the provision of legal advice. Id. While Boehringer articulates potentially viable grounds for protection, these grounds 

are not the reasons articulated by the District Court, which

characterized all of the documents as having been created in 

anticipation of the Boehringer-Barr litigation and settlement. 

Boehringer, 286 F.R.D. at 109. We therefore remand for 

consideration of whether these documents were, in fact, 

created in anticipation of litigation.2

 

 1

 Because we find that the documents are protected, we do not 

reach Boehringer’s alternative argument that the co-promotion 

agreement materials are protected because counsel used them to 

evaluate potential antitrust liability. 

2

 The FTC also suggests that documents created prior to the 

commencement of settlement negotiations cannot be related to the 

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C.

As noted, Rule 26 distinguishes between opinion work 

product, which reveals “the mental impressions, conclusions, 

opinions, or legal theories of a party’s attorney or other 

representative concerning the litigation,” and fact work 

product, which does not. FED. R. CIV. P. 26(b)(3)(B); see In 

re Sealed Case, 124 F.3d 230, 235-36 (D.C. Cir. 1997), rev’d 

on other grounds sub nom. Swidler & Berlin v. United States, 

524 U.S. 399 (1998). The District Court, after reviewing 

financial analysis documents submitted in camera, concluded 

that the documents contained information that, while 

primarily factual in nature, gave insight into the highly 

protected mental impressions of counsel. Boehringer, 286 

F.R.D. at 109-10. Specifically, it found that the documents 

revealed not only what data the attorneys were seeking, but 

also “information and frameworks” developed by counsel. Id. 

at 109. On this basis, it ruled that the documents contained 

only opinion work product and fact product inextricably 

intertwined with counsel’s opinions and thus were wholly 

protected from disclosure. Id. at 110.

The FTC argues that the District Court applied an overly 

broad definition of opinion work product. After carefully 

reviewing the materials submitted in camera and the record as 

a whole, we agree.

When a factual document selected or requested by 

counsel exposes the attorney’s thought processes and theories, 

it may be appropriate to treat the document as opinion work 

product, even though the document on its face contains only 

 

settlement. Appellant’s Br. 6, 33. We find no merit to this 

proposition. To the contrary, one would expect a company’s 

attorneys to discuss settlement strategy internally before entering 

into negotiations with opposing counsel.

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facts. See Dir., Office of Thrift Supervision v. Vinson & 

Elkins, LLP, 124 F.3d 1304, 1308 (D.C. Cir. 1997) (“At some 

point . . . a lawyer’s factual selection reflects his focus; in 

deciding what to include and what to omit, the lawyer reveals 

his view of the case.”). At the same time, however, “not 

every item which may reveal some inkling of a lawyer’s 

mental impressions . . . is protected as opinion work product.” 

In re San Juan Dupont Plaza Hotel Fire Litig., 859 F.2d 

1007, 1015 (1st Cir. 1988). Opinion work product protection 

is warranted only if the selection or request reflects the 

attorney’s focus in a meaningful way. See Dir., Office of 

Thrift Supervision, 124 F.3d at 1308; In re San Juan Dupont 

Plaza Hotel Fire Litig., 859 F.2d at 1015 (heightened 

protection is triggered only if “disclosure creates a real, 

nonspeculative danger of revealing the lawyer’s thoughts”). 

And where a document contains both opinion and fact work 

product, the court must examine whether the factual matter 

may be disclosed without revealing the attorney’s opinions. 

See Deloitte, 610 F.3d at 139 (remanding case to district court 

to assess whether a redacted version of a document containing 

opinion work product could be disclosed); In re Sealed Case, 

146 F.3d 881, 888 (D.C. Cir. 1998) (same).

In Sealed Case (1997), for example, we held that attorney 

notes of preliminary interviews with a witness were not 

necessarily opinion work product, as the mere fact that an 

attorney had chosen to write a fact down was not sufficient to 

convert that fact into opinion work product. 124 F.3d at 

236-37. Rather, there must be some indication that the lawyer 

“sharply focused or weeded the materials.” Id. at 236. After 

in camera review of the documents in that case revealed that 

much of the information contained therein “could be 

classified as opinion only on a virtually omnivorous view of 

the term,” we reversed and remanded to the district court for 

reexamination. Id. at 236-37. 

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As in Sealed Case, many of the documents at issue here 

contain only factual information requested or selected by 

counsel. Much of what the FTC seeks is factual information 

produced by non-lawyers that, while requested by Ms. Persky 

and other attorneys, does not reveal any insight into counsel’s

legal impressions or their views of the case. 

In holding to the contrary, the District Court implied that 

an attorney’s mere request for a document was sufficient to 

warrant opinion work product protection. In discussing 

financial reports, the court noted that the reports were 

“prepared at the behest of [Boehringer] attorneys,” who 

requested the use of “certain data.” Boehringer, 286 F.R.D. at 

110. The District Court further noted that “[r]evealing the 

data chosen for this analysis would necessarily reveal the 

attorneys’ mental impressions, including, at a bare minimum, 

that the attorneys believed such analyses of that data was [sic] 

necessary or important to determining an appropriate 

settlement.” Id. 

As is plain from the District Court’s decision, the 

materials in the joint appendix, and Boehringer’s in camera

submissions, however, counsel’s requests were often general 

and routine. And indeed, the District Court noted that the 

documents requested by the FTC are “the sort of financial 

analyses one would expect a company exercising due 

diligence to prepare when contemplating settlement options.” 

Id. In many documents, the only mental impression that can 

be discerned is counsel’s general interest in the financials of 

the deal. But such interest reveals nothing at all: anyone 

familiar with such settlements would expect a competent 

negotiator to request financial analyses like those performed 

here, and Boehringer does not attempt to hide this interest in 

its briefs. There is no “real, nonspeculative danger of 

revealing the lawyer’s thoughts” when the thoughts are 

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already well-known. In re San Juan Dupont Plaza Hotel Fire 

Litig., 859 F.2d at 1015.

Moreover, as Ms. Persky observed in her testimony

before the FTC, questions about whether the agreements 

made financial sense were a matter of business judgment, not 

legal counsel. See FTC Investig. Hr’g Tr. at 68, J.A. 590. In

fact, the financial parameters of an acceptable settlement were 

provided by Boehringer’s board of directors and its business 

managers. Id. A company may select an executive who is a

lawyer to negotiate the business terms of a settlement; this

does not mean that the lawyer’s thoughts relating to financial 

and business decisions are opinion work product when she is 

simply parroting the thoughts of the business managers. 

The District Court also reasoned that many of the 

documents were created using specific “information and 

frameworks” provided by Boehringer counsel. Boehringer, 

286 F.R.D. at 109. In many documents, however, the 

“information and frameworks” provided have no legal 

significance. For example, in several documents, the

“frameworks” provided by counsel are simply time frames for 

requested financial data – for example, forecasting in x-month 

intervals. Boehringer posits that disclosing these time frames 

could reveal something of legal significance, but it has failed 

to explain how. Where an attorney’s mental impressions are 

those that “a layman would have as well as a lawyer in these 

particular circumstances, and in no way reveal anything 

worthy of the description ‘legal theory,’” those impressions 

are not opinion work product. In re HealthSouth Corp. Sec. 

Litig., 250 F.R.D. 8, 11 (D.D.C. 2008) (quoting In re John 

Doe Corp., 675 F.2d 482, 493 (2d Cir. 1982)).

Where it appears that the focus or framework provided by 

counsel is obvious or non-legal in nature, it is incumbent upon 

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the party claiming opinion work product protection to explain 

specifically how disclosure would reveal the attorney’s legal 

impressions and thought processes. The District Court failed 

to demand such a showing from Boehringer and instead 

concluded categorically that the contested documents were 

highly protected opinion work product. This was error.

D.

1.

The District Court’s error matters because, as noted, a 

party’s ability to discover work product often turns on 

whether the withheld materials are fact work product or 

opinion work product. A party generally must make an 

“extraordinary showing of necessity” to obtain opinion work 

product. In re Sealed Case, 676 F.2d at 811; see also Dir., 

Office of Thrift Supervision, 124 F.3d at 1307 (observing that 

opinion work product is “virtually undiscoverable”). By 

contrast, “[t]o the extent that work product contains relevant, 

nonprivileged facts,” the work product doctrine “merely shifts 

the standard presumption in favor of discovery and requires 

the party seeking discovery to show ‘adequate reasons’ why 

the work product should be subject to discovery.” In re 

Sealed Case, 676 F.2d at 809 (emphasis added) (quoting 

Hickman, 329 U.S. at 512). This “adequate reasons” test 

corresponds to Rule 26(b)(3)’s requirement, adopted in 1970, 

that a party seeking fact work product demonstrate that “it has 

substantial need for the materials to prepare its case and 

cannot, without undue hardship, obtain their substantial 

equivalent by other means.” FED. R. CIV. P. 26(b)(3)(A)(ii); 

see In re Sealed Case, 676 F.2d at 809 n.59.

The District Court, believing that the contested

documents contained only opinion work product or facts

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inextricably intertwined with legal opinions, confined its 

inquiry to whether the FTC had demonstrated an “overriding 

and compelling need” for those materials and concluded that 

it had not. Boehringer, 286 F.R.D. at 109-10. Because the 

FTC does not claim that it is entitled to opinion work product, 

we have no occasion to consider whether the District Court 

applied the correct standard for evaluating when opinion work 

product immunity may be pierced. 

On the other hand, the FTC does contend that it is 

entitled to any facts that can be reasonably excised from 

counsel’s legal opinions and mental processes. Because it is 

the duty of the District Court to consider whether the FTC had 

met the less demanding standard for fact work product, see 

FED. R. CIV. P. 26(b)(3)(A)(ii), the customary next step would 

be to remand the case to allow the District Court to make this 

determination in the first instance.

Each party contends, however, that we have what we 

need to decide whether the FTC has met the Rule 26(b)(3) 

standard in that party’s favor, based on other findings made 

by the District Court. Boehringer points specifically to the 

District Court’s observation that the documents contain “no 

smoking guns” and are “not in any way evidence of any 

conspiratorial intent to violate the law.” Appellee’s Br. 54 

(quoting Boehringer, 286 F.R.D. at 110). This statement, 

Boehringer argues, is “fatal” to the FTC’s claim of need. Id. 

Boehringer’s theory seems to be that a party “needs” fact 

work product only if the materials are critical to, or 

dispositive of, a key issue at trial. 

We find no merit in Boehringer’s argument, for two 

reasons. First, although some courts have demanded a 

heightened showing of a document’s relevance or probative 

value for discovery of fact work product, see Logan v. 

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Commercial Union Ins. Co., 96 F.3d 971, 977 (7th Cir. 1996),

we have never characterized Rule 26(b)(3)’s “substantial 

need” requirement in this manner. See, e.g., Dir., Office of 

Thrift Supervision, 124 F.3d at 1308; In re Sealed Case, 676 

F.2d at 809-10. Nor is such an approach consistent with the 

1970 amendments to Rule 26 or the case law that they 

codified, as we explain below. Second, even if a heightened 

relevance requirement were appropriate during discovery in a 

typical post-complaint civil lawsuit, such a rule would be 

misplaced in the investigatory context of an agency subpoena 

enforcement proceeding. See Linde Thomson Langworthy 

Kohn & Van Dyke, P.C. v. Resolution Trust Corp., 5 F.3d 

1508, 1512 (D.C. Cir. 1993); FTC v. Texaco, Inc., 555 F.2d 

862, 872 (D.C. Cir. 1977) (en banc). 

The FTC, on the other hand, maintains that the District 

Court implicitly determined that the FTC had satisfied the 

“substantial need” and “undue hardship” requirements. 

Because the District Court found that the financial documents 

are relevant to the FTC’s investigation and would provide 

unique information that the FTC cannot reasonably obtain 

elsewhere, and because we detect no error in this finding, we 

agree with the FTC. We discuss each of these points in turn.

2.

The meaning of Rule 26(b)(3)’s “substantial need”

requirement is not clear from the plain language of the rule. 

Cf. Pierce v. Underwood, 487 U.S. 552, 563-64 (1988)

(discussing the ambiguity implicit in the term “substantial”

while interpreting 28 U.S.C. § 2412(d)(1)(A)); see also A.I.A. 

Holdings, S.A. v. Lehman Bros., Civ. Action No. 97-4978, 

2000 WL 1639417, at *2 (S.D.N.Y. Nov. 1, 2000) (noting 

that “[t]he law is not well developed as to what constitutes 

‘substantial need’”); Special Project, The Work Product 

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Doctrine, 68 CORNELL L. REV. 760, 802 (1983) (“The 

substantial need requirement is the least uniformly applied by 

the courts.”). Helpfully, the Advisory Committee’s notes on 

the amendments “provide a reliable source of insight into the 

meaning of a rule, especially when, as here, the rule was 

enacted precisely as the Advisory Committee proposed.” 

United States v. Vonn, 535 U.S. 55, 64 n.6 (2002)

(interpreting FED. R. CRIM. P. 11(h)).

The “substantial need” and “undue hardship” 

requirements were added to Rule 26(b)(3) in an attempt to 

clarify and codify the tests developed by the Supreme Court 

in Hickman and by the lower courts construing former Rule 

34’s “good cause” provision. See FED. R. CIV. P. 26(b)(3) 

advisory committee’s note to 1970 Amendments (hereinafter 

Advisory Committee’s Notes), reproduced at 48 F.R.D. 487, 

500-01; see also In re Sealed Case, 676 F.2d at 810 n.59; 

WRIGHT ET AL., supra, § 2023, at 489 (characterizing Rule

26(b)(3) as “a largely accurate codification of the doctrine 

announced in the Hickman case and developed in later cases 

in the lower courts”). The Committee explained that the 

amendments were intended to require an inquiry into “the 

importance of and need for” the fact work product at issue, as 

well as “alternative sources for securing the same 

information.” Advisory Committee’s Notes, 48 F.R.D. at 

500. The Committee did not further define the “substantial 

need” and “undue hardship” concepts.

The Committee did provide guidance, however, by 

pointing to four cases that had demanded a “special showing”

to obtain trial preparation materials; it explained that the new 

“substantial need” and “undue hardship” requirements 

reflected the holdings of those cases. Id. (citing Guilford 

Nat’l Bank v. Southern Ry., 297 F.2d 921 (4th Cir. 1962); 

Mitchell v. Bass, 252 F.2d 513 (8th Cir. 1958); Hauger v. 

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Chicago, R.I. & Pac. R.R., 216 F.2d 501 (7th Cir. 1954); 

Burke v. United States, 32 F.R.D. 213 (E.D.N.Y. 1963)). The 

Committee also approved of a list of circumstances under 

which witness statements could be discoverable, as recited in 

a fifth case, Southern Ry. v. Lanham, 403 F.2d 119 (5th Cir.

1968). Advisory Committee’s Notes, 48 F.R.D. at 501.3

These cases indicate that a moving party’s burden is

generally met if it demonstrates that the materials are relevant 

to the case, the materials have a unique value apart from those 

already in the movant’s possession, and “special 

circumstances” excuse the movant’s failure to obtain the 

requested materials itself. See Mitchell, 252 F.2d at 518-19

(permitting discovery of opponent’s witness statements where 

witnesses refused to speak with movant); Burke, 32 F.R.D. at 

215 (permitting discovery of accident report materials where 

information contained therein was otherwise unavailable); cf.

Hauger, 216 F.2d at 505-06 (finding no “special 

circumstances” warranting disclosure of witness statements

where plaintiff had deposed those same witnesses, and 

 3 Each of these cases involved factual work product prepared by 

non-attorneys. See Lanham, 403 F.2d at 126-27 (claim agents); 

Hauger, 216 F.2d at 506 (agents); Mitchell, 252 F.2d at 518 

(investigators); Guilford, 297 F.2d at 922 (claim agent); Burke, 32 

F.R.D. at 214 (post office personnel). Although Hickman did not 

expressly apply to work product prepared by non-lawyers, these 

courts required a special showing for such materials under Rule 

34’s “good cause” provision. See, e.g., Mitchell, 252 F.2d at 

518-19; Guilford, 297 F.2d at 927; but see Hauger, 216 F.2d at 

506-07 (finding “no logical basis” for distinguishing between 

statements taken by counsel and a counsel’s agent and therefore 

applying both Rule 34 and Hickman). The 1970 amendments 

abolished the distinction between factual materials prepared by 

counsel and those prepared by non-attorneys. FED. R. CIV. P.

26(b)(3)(A); see Nobles, 422 U.S. at 254 n.16.

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plaintiff’s purported need for materials for purposes of 

impeachment was speculative); Guilford, 297 F.2d at 923-27 

(finding no “special circumstances” where plaintiff possessed 

substantially similar materials and impeachment value was 

speculative). A list of special circumstances was provided in 

Lanham, where the Fifth Circuit observed that a 

contemporaneous witness statement typically would be

discoverable if the witness was unavailable, reluctant, or 

hostile, or if the witness had a lapse of memory or deviated 

from prior statements. 403 F.2d at 128-31. 

Although each of these cases mentioned the relevance of 

the requested documents, none articulated a requirement that 

the documents be essential to the claim or probative of a 

critical element. The Advisory Committee notably did not 

cite any of the then-existing decisions demanding a 

heightened showing of relevance. Compare Republic Gear 

Co. v. Borg-Warner Corp., 381 F.2d 551, 558 (2d Cir. 1967) 

(requiring party seeking fact work product to demonstrate that 

the documents were “essential to the preparation of 

[movant’s] case on [a] critical issue” in the litigation).

Boehringer’s argument that factual work product is 

discoverable only if it contains a “smoking gun” therefore has 

no basis in the Committee notes or the cases cited therein. 

The Advisory Committee also observed that the 

substantial need and undue hardship requirements 

corresponded to the showing required under Hickman, see 

Advisory Committee’s Notes, 48 F.R.D. at 501, which further 

supports the conclusion that no heightened showing of

relevance is required. Hickman instructed that fact work 

product that is unavailable elsewhere may be discovered if it 

is admissible or could “give clues as to the existence or 

location of relevant facts” – a standard remarkably similar to 

the relevance standard under Rule 26(b)(1). Hickman, 329 

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U.S. at 511; see FED. R. CIV. P. 26(b)(1) (evidence is relevant 

if admissible or “appears reasonably calculated to lead to the 

discovery of admissible evidence”). Indeed, a mere relevance 

requirement is consonant with Hickman’s statement that 

“[m]utual knowledge of all the relevant facts gathered by both 

parties is essential to proper litigation.” 329 U.S. at 507

(emphasis added). 

Of course, this interest in liberal discovery must be 

balanced against the key goal underlying the protection for 

fact work product: that each side must undertake its own 

investigation of the relevant facts and not simply freeload on 

opposing counsel. See Guilford, 297 F.2d at 926 (work 

product rule serves to prevent a less-than-diligent litigant 

from “perform[ing] its functions either without wits or on wits 

borrowed from the adversary”) (quoting Hickman, 329 U.S. at 

516 (Jackson, J., concurring)); Nat’l Union Fire Ins. v. 

Murray Sheet Metal Co., Inc., 967 F.2d 980, 985 (4th Cir. 

1992) (characterizing the substantial need and undue hardship

requirements primarily as “an ‘anti-freeloader’ rule designed 

to prohibit one adverse party from riding to court on the 

enterprise of the other”). But neither of these competing 

interests is served when unique, relevant information is 

withheld from a party that never had an opportunity to obtain 

the information on its own. The “substantial need” inquiry 

requires a careful examination of whether non-disclosure will 

impair the truth-seeking function of discovery. See Dir., 

Office of Thrift Supervision, 124 F.3d at 1308 (finding no 

substantial need for fact work product where movant already 

possessed similar materials). A moving party need not show, 

however, that the requested documents are critical to, or 

dispositive of, the issues to be litigated.

4

 4 There has been a ratcheting up of the “substantial need” standard 

in recent years by some courts, due at least in part to a conflation of 

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3.

Boehringer’s argument for a “smoking gun” standard is 

problematic for a second reason. Even if such a requirement 

were justified in the context of a typical civil proceeding –

where the scope of the charges are clear – such a rule would 

be misplaced in the investigatory context here. We have 

previously observed that in an administrative subpoena 

enforcement proceeding, “[t]he district court is not free to 

speculate about the possible charges that might be included in 

a future complaint, and then to determine the relevance of the 

subpoena requests by reference to those hypothetical 

charges.” Texaco, 555 F.2d at 874. In undertaking this 

investigation, the FTC is “merely exercising its legitimate 

 

what is sufficient and what is necessary to demonstrate need. For 

example, in In re Int’l Sys. & Controls Corp. Sec. Litig., 693 F.2d 

1235 (5th Cir. 1982), the fact work product sought related to an 

“essential element” of plaintiff’s claims; the Fifth Circuit noted that 

this “could be grounds for a finding of substantial need,” but did 

not hold that such a finding was required. Id. at 1241. This 

“essential element” language nevertheless was incorporated into the 

legal standard articulated by a popular treatise, see 6 JAMES WM.

MOORE ET AL., MOORE’S FEDERAL PRACTICE § 26.70[5][c], at 26-

457 to 26-459 (3d ed. 2009), and has been applied by district 

courts, see, e.g., Fletcher v. Union Pac. R.R. Co., 194 F.R.D. 666, 

672 (S.D. Cal. 2000) (finding no substantial need for surveillance 

videos because they were not “essential to [plaintiff]’s prima facie 

case”); see also Nat’l Cong. for Puerto Rican Rights v. City of New 

York, 194 F.R.D. 105, 110 (S.D.N.Y. 2000) (collecting cases where 

materials sought were “essential” to party’s defense, were “crucial” 

to determination of liability, or carried “great probative value on 

contested issues”); Nevada v. J-M Mfg. Co., 555 F. App’x 782, 785 

(10th Cir. 2014) (relying on National Congress and the cases cited 

therein as providing minimum standards and denying discovery of 

fact work product because movant failed to show that the evidence 

“carr[ied] great probative value”).

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right to determine the facts” and to decide whether a 

complaint should issue. Id.; see also Linde Thomson, 5 F.3d 

at 1512 (“An investigation conducted by the [FTC] may 

conceivably neither culminate in litigation, nor be initially 

designed to inspire it.”). If the District Court is correct that 

the contested materials reveal an absence of conspiratorial 

intent, then the materials nevertheless may be helpful to the 

FTC in determining whether to issue a complaint in the first 

place.

4.

We turn to the FTC’s argument that the District Court 

implicitly found that the FTC had met the “substantial need” 

and “undue hardship” requirements. When it decided not to 

require Boehringer to disclose facts contained in the financial

analyses and forecasts, the District Court based this decision

on its misplaced belief that the information could not be 

disclosed without revealing protected legal opinions and 

attorney thought processes. The District Court never 

suggested that the FTC had failed to make the requisite 

showing for factual work product.

To the contrary, the District Court stated that it was 

“sympathetic to the FTC’s argument that these financial 

analyses are the only documents that could demonstrate 

whether or not [Boehringer] was using the co-promotion 

agreement to pay Barr not to compete.” Boehringer, 286 

F.R.D. at 110. The District Court then credited the FTC’s 

argument with respect to the emails that accompanied the 

financial documents, and it directed Boehringer to produce 

“factual work product that can be reasonably excised from 

any indication of opinion work product.” Id. We agree with 

the FTC that this ruling makes clear that the District Court 

found that the FTC had shown a substantial need and undue 

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hardship for materials relating to financial analyses and 

forecasts. And although Boehringer asserts that the FTC

possesses equivalent documents or could reproduce similar

analyses on its own, none of these arguments are persuasive. 

As the District Court indicated, Boehringer’s 

contemporaneous financial evaluations provide unique 

information about Boehringer’s reasons for settling in the 

manner that it did. Id.; see also United States v. Brown Univ., 

5 F.3d 658, 671-72 (3d Cir. 1993) (considering evidence of 

party’s intent when assessing the likely antitrust effects of the 

challenged conduct); Guilford, 297 F.2d at 926 (noting the 

special value of contemporaneous witness accounts).

We therefore will remand to the District Court to revisit 

the financial documents in light of the correct legal standards, 

as clarified above. The District Court should determine which 

of the sampled documents may be produced, in full or in 

redacted form, as factual work product. To the extent that any 

such documents were withheld in whole or in part on the 

alternative basis of attorney-client privilege, the District Court 

will have to determine whether this privilege independently 

bars discovery.

5

 5

 In its opening brief, the FTC asserts that the District Court abused 

its discretion in accepting and relying on in camera, ex parte

affidavits. See Appellant’s Br. 53-58. But the FTC is precluded 

from raising this issue on appeal, as it presented no explanation for 

its failure to object, much less “exceptional circumstances” to 

excuse its failure. Marymount Hosp., Inc. v. Shalala, 19 F.3d 658, 

663 (D.C. Cir. 1994) (noting that arguments not made below 

generally are deemed waived). We therefore decline to consider 

this issue.

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IV.

For the foregoing reasons, we vacate in part, affirm in 

part, and remand for further proceedings consistent with this 

opinion.

So ordered.

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