UNITED STATES OF AMERICA EX REL. DONALD R. GALMINES v. NOVARTIS PHARMACEUTICALS CORPORATION

Filing 137

MEMORANDUM AND/OR OPINION SETTING FORTH THE REASONS WHY THE COURT IS GRANTING MR. GORSKY'S MOTION TO QUASH (DOCKET NO. 131). AN APPROPRIATE ORDER FOLLOWS. SIGNED BY HONORABLE GENE E.K. PRATTER ON 8/19/15. 8/20/15 ENTERED AND COPIES MAILED AND E-MAILED.(rab, )

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA

UNITED STATES OF AMERICA
ex rel. DONALD R. GALMINES, et al.,
Plaintiffs,
v.
NOVARTIS PHARMACEUTICALS
CORPORATION,
Defendant.

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CIVIL ACTION

No. 06-3213

MEMORANDUM
PRATTER, J.

AUGUST 19, 2015

Mr. Galmines brings this qui tam action against Novartis Pharmaceuticals Corporation
(“Novartis”) under the False Claims Act, 31 U.S.C. §§ 3729, et seq., and the laws of several
states. Mr. Galmines asserts that Novartis engaged in “off-label” marketing for the drug Elidel,
encouraging physicians to prescribe Elidel for purposes for which the FDA had not approved
Elidel. 1 This marketing campaign resulted in submissions to the Government of false claims for
reimbursement for the unapproved prescriptions of Elidel, including Medicare and Medicaid. Mr.
Galmines also alleges that Novartis violated state “anti-kickback” statutes by providing various
rewards to physicians who prescribed high volumes of Elidel.
Mr. Galmines now seeks to depose Alex Gorsky, the former CEO of Novartis, and the
current Chairman and CEO of Johnson & Johnson. Mr. Gorsky has moved to quash the subpoena
served upon him seeking his testimony at a deposition. Mr. Gorsky argues that his motion should
be granted because, pursuant Federal Rule of Civil Procedure 45(d)(3)(A), the deposition would
pose an undue burden upon him, requiring the Court to quash the subpoena. Moreover, Mr.
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Specifically, Mr. Galmines alleges that Novartis marketed Elidel, an eczema drug, for
unapproved uses such as first-line use, infant use, preventive use, and continuous use.
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Gorsky asserts that the Court should prohibit the deposition pursuant Federal Rule 26(b)(2)(C),
which provides that the Court must limit discovery when “the discovery sought is unreasonably
cumulative or duplicative, or can be obtained from some other source that is more convenient,
less burdensome, or less expensive,” or, more generally, when “the burden or expense of the
proposed discovery outweighs its likely benefit.” Mr. Gorsky asserts that because he lacks
personal and superior unique knowledge of the facts alleged and because the information sought
could be obtained from lower level employees or through less burdensome means, his Motion to
Quash should be granted pursuant the “apex doctrine”.
The “apex doctrine” is an analytical framework used by courts in assessing whether to
permit the depositions of individuals at the “apex” of corporations and other entities. The
doctrine recognizes that depositions of high-level officers severely burdens those officers and the
entities they represent, and that adversaries might use this severe burden to their unfair
advantage. See In re Tylenol (Acetaminophen) Mktg., Sales Practices & Products Liab. Litig.,
No. 2:13-MD-02436, 2014 WL 3035791, at *2 (E.D. Pa. July 1, 2014) (“Depositions of high
level corporate executives may be duplicative, cumulative and burdensome where the person
sought to be deposed has no personal knowledge of the events in dispute.”(citing Harris v.
Computer Assocs. Int’l., Inc., 204 F.R.D. 44, 46 (E.D.N.Y. 2001)); Performance Sales & Mktg.
LLC v. Lowe’s Companies, Inc., No. 5:07-CV-00140-RLV, 2012 WL 4061680, at *3-4
(W.D.N.C. Sept. 14, 2012) (“The ‘apex doctrine,’ rooted in Federal Rule of Civil Procedure 26,
was developed as an aid in ensuring that the liberal rules of procedure for depositions are used
only for their intended purpose and not as a litigation tactic to create undue leverage by harassing
the opposition or inflating its discovery costs.”). The doctrine thus requires courts to consider
whether this severe burden is warranted by the likely benefit of the proposed discovery. See Fed.
R. Civ. P. 26(b)(2)(C) (“[T]he court must limit the frequency or extent of discovery otherwise
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allowed by these rules or by local rule if it determines that . . . the burden or expense of the
proposed discovery outweighs its likely benefit.”). To aid in this analysis, the apex doctrine
instructs courts to consider whether the high-level official has personal or superior unique
knowledge of the facts alleged and whether the information could be obtained from lower level
employees or through less burdensome means. In re Tylenol, 2014 WL 3035791, at *3.
The parties dispute which party should bear the burden under the apex doctrine. The apex
doctrine does not represent an exception to the rule that a party seeking to quash a subpoena
bears the “heavy burden” of demonstrating that the subpoena represents an undue burden. See
Frank Brunckhorst Co. v. Ihm, No. MISC. 12-0217, 2012 WL 5250399, at *4 (E.D. Pa. Oct. 23,
2012). The apex doctrine is merely a tool for guiding the Court’s analysis in determining whether
to limit discovery under Rule 26(b)(2)(C) because the discovery can be obtained from some
other source that is more convenient, less burdensome, or less expensive. As such, the party
seeking to quash the subpoena still bears the burden of persuasion. The apex doctrine does,
however, apply a rebuttable presumption that a high-level official’s deposition represents a
significant burden upon the deponent and that this burden is undue absent the two factors set
forth in the apex doctrine, which go to the lack of a more convenient, less burdensome, and less
expensive alternative. See Performance Sales & Mktg., 2012 WL 4061680, at *3-4 (“Put simply,
the apex doctrine is the application of the rebuttable presumption that the deposition of a highranking corporate executive either violates Rule 26(b)(2)(C)’s proportionality standard or, on a
party’s motion for a protective order, constitutes ‘good cause’ for such an order as an
‘annoyance’ or ‘undue burden’ within the meaning of Rule 26(c)(1). Should the deposing party
fail to overcome this presumption, the court must then limit or even prohibit the deposition.”).
Here, Mr. Gorsky has asserted that he is a high-level official and that, per the two factors
of the apex doctrine, his deposition should be quashed because it represents an undue burden
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upon him and the corporation he represents. More specifically, Mr. Gorsky asserts that “more
convenient, less burdensome, or less expensive” alternatives exist for obtaining the sought
discovery. See Fed. R. Civ. P. 26(b)(2)(C)(i). Mr. Galmines, on the other hand, has failed to
articulate the need for Mr. Gorsky’s deposition, beyond the generic assertions that Mr. Gorsky
was involved in the marketing of Elidel and in developing the corporate response to the Food and
Drug Administration’s decision to place a “black box warning” on Elidel. In support of his
position, Mr. Galmines has filed with the Court a PowerPoint slide that Mr. Gorsky allegedly
reviewed. The slide displays the percentage of Elidel sales for off-label uses. Mr. Galmines has
also submitted an email from Mr. Gorsky to a business associate in which Mr. Gorsky
recommends editing that PowerPoint slide by changing the phrase “off-label sales” to “other
sales.”
Mr. Gamines has not articulated how Mr. Gorsky’s statement in this email ties to any
material matter in dispute. Cf. Reif v. CNA, 248 F.R.D. 448, 454 (E.D. Pa. 2008) (“The Reifs
have not demonstrated a nexus between [the CEO’s] statement and lower level management’s
decision . . . .”). More broadly, Mr. Galmines has not specifically tied any information sought
from Mr. Gorsky to any material matter in the case. Cf. Folwell v. Hernandez, 210 F.R.D. 169,
174 (M.D.N.C. 2002) (“[T]he oral deposition of a high level corporate executive should not be
freely granted when the subject of the deposition will be only remotely relevant to the issues of
the case.”). This failure to articulate a specific and substantiated argument supporting the need
for Mr. Gorsky’s deposition distinguishes this case from In re Tylenol, where Judge Stengel
denied a motion to quash because “documents, which have been produced by the defendants
during discovery, show very clearly that [the high-ranking executive] was actively involved in
decision making regarding the marketing and product development of Tylenol products . . . .
They also indicate that [he] has knowledge that is unique to him and which could not be obtained
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through the depositions of those other . . . employees not quite at the ‘apex.’” See 2014 WL
3035791, at *3. Mr. Galmines has not articulated why the information sought (whatever,
specifically, it may be) could not be obtained from lower level employees or through less
burdensome means. This silence is particularly deafening in light of the posture of discovery in
this case: Mr. Galmines has deposed six corporate representatives of Novartis and 12 fact
witnesses. Despite these multitude of depositions, the Court has not been made aware of any
efforts to ascertain from these deponents the extent of Mr. Gorsky’s personal involvement in the
alleged actions. Cf. Reif, 248 F.R.D. at 454 (granting CEO’s Motion to Quash where “[t]he
depositions, thus far, have failed to demonstrate the deponents lack the information, especially
when the pertinent questions have not been asked”).
The Court will therefore grant the Motion to Quash because “the burden or expense of
the proposed discovery outweighs its likely benefit.” See Fed. R. Civ. P. 26(b)(2)(C). However,
the Court will grant it without prejudice, such that Mr. Galmines can seek reconsideration of the
Court’s determination. Any effort for reconsideration, however, should include (1) greater
specificity in the link between the sought information and a material matter in dispute; and (2) a
proposal for a less burdensome manner of obtaining the sought information. This effort for
reconsideration should first be shared with counsel for Mr. Gorsky before seeking
reconsideration from the Court. An appropriate order follows.
BY THE COURT:

S/Gene E.K. Pratter
GENE E.K. PRATTER
United States District Judge

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