The opinion
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
SANDOZ, INC., et ano., Civil Action No.: 19-10170
Plaintiffs,
v.
UNITED THERAPEUTICS CORP., et ano.
Defendants.
OPINION AND ORDER OF THE
SPECIAL DISCOVERY MASTER
______________________________________
REGARDING DEFENDANT’S MOTION
TO ADD FOUR DOCUMENT
CUSTODIANS
LINARES, J.
This matter comes before the Special Master by way of Defendant’s Motion to Add Four
Additional Document Custodians (“Def. Br.”), which was submitted on December 23, 2020.
Plaintiffs Sandoz and RareGen both submitted Oppositions to Defendant’s Motion (“Sandoz
Opp.” and “RareGen Opp.”, respectively) on January 7, 2021. Defendant submitted a brief
Reply to Plaintiffs’ Oppositions on January 14, 2021 by way of email. The Special Master has
reviewed the submissions and the relevant controlling law, and for the reasons set forth below
hereby GRANTS Defendant’s Motion.
I. FACTS
The Special Master presumes the parties’ familiarity with the facts and procedural
posture of this matter. As such, the Special Master will only recite the facts pertinent to the
subject dispute.
Based on the discovery exchanged to date, Defendant proposes adding four document
custodians; three from Plaintiff Sandoz and one from Plaintiff RareGen. (See generally Def. Br.).
Specifically, Defendant asks that Ms. Carol Lynch (“Lynch”)1, Mr. Craig Osten (“Osten”)2, and
Mr. Mike Fraser (“Fraser”)3 from Sandoz be added as document custodians. (Def. Br. at 1).
Additionally, Defendant also requests that Mr. Paul Manning (“Manning”)4 from Plaintiff
RareGen be added as well. (Id.).
Lynch is the President of Sandoz U.S., and, Defendant asserts, is the equivalent of
Defendant’s President Michael Benkowitz, who is already a document custodian in this action.
(Id. at 3). Osten is Plaintiff Sandoz’s Chief Financial Officer, and Fraser is Plaintiff Sandoz’s
Vice President for Strategy and Innovation. (Id. at 7). Finally, Manning is one of Plaintiff
RareGen’s three founding directors. (Id. at 6).
Defendant outlines specific reasons why each of these individuals should be added as a
document custodian. The Special Master discusses each request separately below.
II. LEGAL STANDARD
Rule 26 governs discovery demands, including those that relate to document custodians.
See Fed. R. Civ. P. 26. Subsection (b)(1) provides that “[p]arties may obtain discovery regarding
1 Defendant asks that Lynch’s custodial file encompass any and all relevant, nonprivileged documents from March
2018 to present.
2 Defendant asks that Osten’s custodial file encompass any and all relevant, nonprivileged documents from June
2018 to present.
3 Defendant asks that Frasher’s custodial file encompass any and all relevant, nonprivileged documents from April
2018 to present.
4 Defendant asks that Manning’s custodial file encompass any and all relevant, nonprivileged documents from
January 2018 to present.
[] nonprivileged matter[s] that [are] relevant to any party’s claim or defense and proportional to
the needs of the case.” Id. at (b)(1). Any party objecting to a discovery demand must show that
the demand is not relevant and/or is disproportionate to the needs of the case. See Baier v.
Princeton Office Park, L.P., 2018 WL 5253288, at *4 (D.N.J. Oct. 22, 2018).
III. ANALYSIS
Defendant advances a general theory that is applicable to each of the proposed document
custodians. (Def. Br. at 2-3). Specifically, Defendant believes that the information gathered
from the four proposed document custodians will shed light on Plaintiffs’ decision to launch its
generic version of treprostinil before it secured a subcutaneous delivery method. (Id.).
Defendant goes on to showcase how each of the proposed document custodians likely has
additional information that will provide insight on Plaintiffs’ decision to launch the generic drug.
(See generally Def. Br.)
Lynch
As noted, Lynch is the President of Plaintiff Sandoz U.S. (Id. at 3). Defendant presents
various indications that Lynch, at least in part, was involved in the decision to launch the generic
treprostinil as an “IV-only” drug. (Id. at 4). Based on the discovery exchanged to date,
Defendant asserts Lynch pressured junior members of the Sandoz team to launch treprostinil in
the first fiscal quarter of 2019 and had ongoing conversations with Plaintiff RareGen’s Manning
regarding same. (Id.). Moreover, Defendant points to the fact that Lynch was also involved in
discussions with one of the specialty pharmacies, Accredo, to discuss the treprostinil launch.
(Id.).
These items of evidence, Defendant avers, indicate that Lynch did have a part in the
decision making process as it related to how and when Plaintiff Sandoz launched its generic
treprostinil. Defendant goes on to argue that obtaining Lynch’s custodial file will allow
Defendant to fully explore and understand Lynch’s role in Plaintiff Sandoz’s decision to roll out
an “IV-only” version of treprostinil. (Id.).
The Special Master agrees with Defendant. While Plaintiff Sandoz does raise a
meritorious opposition, that being that Defendant has presented very little to show Lynch’s
connection to the decision to launch in early 2019 (Sandoz Opp. at 5-7), the connection exists
nonetheless. Indeed, Defendant has provided just enough information that would leave a
reasonable person wondering whether Lynch was actually more involved in the launch of generic
treprostinil. That curiosity warrants allowing Defendant to explore Lynch’s involvement in the
launch. Such an exploration begins with reviewing Lynch’s custodial file. Therefore, the
Special Master grants Defendant’s request to add Lynch as a document custodian.
Osten and Fraser
Defendant discusses Osten and Fraser simultaneously, and, as such, the Special Master
will dispose of the request pertaining to these two individuals in the same manner. As to Osten,
Defendant notes that he was, and remains, the Chief Financial Officer of Plaintiff Sandoz. (Def.
Br. at 7). As such, Defendant avers that, based on the discovery received to date, Osten was
investigating financial incentives of, and effects of key developments from, the generic
treprostinil launch. (Id.). Defendant also points to emails where Osten was advocating the “IV-
only” launch. (Id.). Once again, Defendant avers there is enough trace evidence to warrant
further investigation.
As to Fraser, Defendant makes nearly the same argument, but based on different facts.
According to Defendant, “Fraser was directly involved in the decision to launch IV Only.” (Id.).
Defendant arrives at this conclusion by pointing to a specific email where Fraser asked Plaintiff
Sandoz’s Senior Executive Committee to “prioritize” the generic treprostinil launch. (Id.
(quoting SANDOZ_Trep_00038685)). Moreover, Plaintiff Sandoz semi-concedes that Fraser’s
custodial file may be relevant. (See Sandoz Opp. at 8 (“Of the three requested custodians, Fraser
is the only one for which there is even a colorable argument for adding. In his role as VP for
Strategy and Innovation, Fraser had some supervisory role over the treprostinil launch.”)
(emphasis added)).
In light of the above, the Special Master concludes that both Osten and Fraser should be
added as document custodians. Indeed, just as with Lynch, Defendant has set forth sufficient
pieces of evidence that warrant further exploration. With regard to Osten, Defendant has
highlighted small bits of evidence that show he was, in some capacity, monitoring the launch of
treprostinil from a financial capacity. Hence, it is not farfetched, as Plaintiff Sandoz argues, to
infer that Osten was also involved in conversations revolving around the decision to launch
generic treprostinil as IV-only and in early 2019.
The same is true for Fraser. Defendant has submitted, albeit minimal, sufficient evidence
such that an inquisitive mind is left wondering the extend of Fraser’s involvement and influence
in the generic drug’s launch. Indeed, even Plaintiff Sandoz has conceded this fact. Hence,
Fraser’s supervisory role over the launch is a sufficient reason to allow Defendant to review
Fraser’s custodial file.
Accordingly, the Special Master finds that Defendant has made a successful argument in
favor of adding Osten and Fraser as document custodians, and grants Defendant’s request as to
these two individuals.
Manning
Finally, Manning is one of Plaintiff RareGen’s founders. Manning has produced some
documents, but only through his investment firm, PBM Capital. (RareGen Opp. at 1). Moreover,
the production was only for the first three months of 2019; the three months leading up to the
launch. (Id.).
Defendant argues that Manning should be personally listed as a document custodian as he
was actively involved in the decision to launch generic treprostinil. (Def. Br. at 6). First,
Defendant notes that the current list of document custodians from RareGen are individuals who
only dealt with operational issues and not the decision to launch. (Id.). Furthermore, Defendant
points to various emails where Manning is promoting the launch and trying to expedite it. (Id.
(quoting RareG0076081 (“Launch next week come on”); RareG0076104 (“We should launch
ASAP…”); RareG0083671 (“Shipping first week in January RIGHT”) (emphasis in original))).
Defendant asserts that these communications, along with Manning’s position at Plaintiff
RareGen, show that Manning was, in some way, actively involved in the decision to launch
generic treprostinil in early 2019.
The Special Master is inclined to agree with Defendant. Indeed, Defendant has provided
sufficient evidence tending to show that Manning did have some influence over the launch.
Hence, Defendant is entitled to investigate Manning’s involvement and to get a clear
understanding of the circumstances surrounding the decision to launch the IV-only generic
treprostinil. Accordingly, the Special Master grants Defendant’s request as to Manning.
Proportionality
Plaintiff Sandoz argues that Defendant’s request is disproportionate to the needs of this
case. (Sandoz Opp. at 8-10). The Special Master disagrees. First, the Special Master notes that
a similar argument was raised by Defendant when Plaintiffs sought additional custodians.
However, the Special Master was not persuaded by same given the magnitude of the claimed
damages. (ECF No. 249 at 3-4, 6-9) Hence, the Special Master ordered Defendant to produce
the custodial files demanded by Plaintiffs. Fairness and consistency warrants a similar outcome
here.
As discussed at length above, Defendant has made a good faith showing as to why each
individual should be a document custodian and how each person fits into its defense. Therefore,
denying Defendant the opportunity to explore these meritorious avenues would be contrary to the
spirit of Rule 26 and the broad and complete discovery it contemplates.
Finally, Plaintiffs have not presented the Special Master with any concrete evidence to
support the position that the additional document custodians would be disproportionate to the
needs of this case. For example, Plaintiffs have not advised the Special Master how many “hits”
or documents would have to be reviewed and/or produced if the aforementioned individuals were
added as document custodians. Nor have Plaintiffs described how long they estimate it will take
them to review the custodial files for privilege. Rather, Plaintiffs merely make a broad statement
of disproportionality. However, as noted above, it is Plaintiffs burden to convince the Special
Master that the discovery demanded is not proportionate to the needs of the case; a burden
Plaintiffs have not carried. Therefore, the Special Master rejects Plaintiffs’ proportionality
argument.
IV. ORDER
For the foregoing reasons, it is on this 26th day of January 2021,
ORDERED that Defendant’s Motion to Add Four Document Custodians is hereby
GRANTED; it is further
ORDERED that Plaintiff Sandoz shall produce Ms. Carol Lynch’s entire nonprivileged
custodial file from March 2018 to present within thirty (30) days of this Order; it is further
ORDERED that Plaintiff Sandoz shall produce Mr. Craig Osten’s entire nonprivileged
custodial file from June 2018 to present within thirty (30) days of this Order; it is further
ORDERED that Plaintiff Sandoz shall produce Mr. Mike Fraser’s entire nonprivileged
custodial file from April 2018 to present within thirty (30) days of this Order; and it is further
ORDERED that Plaintiff RareGen shall produce Mr. Paul Manning’s entire
nonprivileged custodial file from January 2018 to present within thirty (30) days of this Order.
SO ORDERED.
_/s/ Jose L. Linares________________________
Hon. Jose L. Linares, U.S.D.J. (Ret.)
Date: January 26, 2021