Taylor et al v. Bristol-Myers Squibb Company, Inc. et al

Filing 202

MEMORANDUM OPINION & ORDER: 1) Plas Motion to Compel and for Sanctions (DE 479 ) is GRANTED IN PART as following: a) Redactions of date of death and treatment duration to Exhibits 11, 12, and 13 of Motion and Exhibit 3 to Reply where those dates are expressed as a number of days rather than a calendar date; b) Redactions for "nonresponsiveness" to Exhibit 14 that are part of email chain entitled "June 16, 2014 Email from Krisztina Debreczeni to Rachpal Malhotra, et al. "; c) Exhibits 9 of Motion and Exhibits 6, 7, 8, 9, and 10 to Reply, to extent these are publicly available documents; 2) Plas Motion to Compel and for Sanctions (DE 479 ) is DENIED IN PART as following: a) Redactions of pharmocovig ilance information not related to heart failure and/or increased risk of adverse cardiac events; b) Redaction of OneNote files due to "nonresponsiveness"; and c) The request for sanctions. Within 14 days either party may appeal this decision to Judge Caldwell pursuant § 636(b)(1)(A) and FRCP 72(a). Signed by Magistrate Judge Matthew A. Stinnett on 8/19/2020. Associated Cases: 5:18-md-02809-KKC-MAS et al. (TDA) cc: COR

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UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CENTRAL DIVISION
LEXINGTON

IN RE: ONGLYZA (SAXAGLIPTIN)
AND KOMBIGLYZE XR
(SAXAGLIPTIN AND METFORMIN)
PRODUCTS LIABILITY LITIGATION

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MASTER FILE NO. 5:18-MD-2809-KKC
MDL DOCKET NO. 2809
ALL CASES

MEMORANDUM OPINION AND ORDER
This matter comes before the undersigned to handle another discovery dispute. Plaintiffs
filed a Motion to Compel and for Sanctions. [DE 479]. Defendants filed a Response [DE 503]
and Plaintiffs replied [DE 508]. Defendants filed a motion for Leave to File a Sur-Reply, which
the Court granted. [Sur-Reply at DE 519]. This matter is now ripe for a decision.
I.

CURRENT DISPUTE1

A full recitation of the facts leading to this dispute is well-documented in the record. [See,
e.g., DEs 490 and 399]. The parties are currently engaged in discovery on the issue of general
causation, attempting to answer the question of whether the prescription drugs manufactured by

1

The Court refers to the documents at issue throughout by the exhibit numbers as
designated by the parties in the document, to the extent possible, regardless of how they are
designated on the docket. As noted in footnote 2, the designation of contested documents in the
motion, response, reply, and sur-reply is convoluted, to say the least. Further muddying the murky
waters, the docket reflects the motion was filed redacted at DE 479 and 480 and unredacted at DE
483; the response was filed at 503; the reply was filed redacted at DE 512 and unredacted at DE
513; the sur-reply was filed at DE 519. The Court has attempted to be as coherent and consistent
as possible in its references to the docket.

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Defendants caused the users to have a cardiac event or be at a higher risk for a cardiac event. The
parties have found themselves at yet another impasse in a discovery dispute. Plaintiffs allege
Defendants have used FED. R. CIV. P. 26 and the parties’ Stipulated Protective Order [DE 171] as
justification to redact documents in discovery improperly. More specifically, Plaintiffs allege
Defendants have repeatedly produced the same discovery in various stages of redaction, requiring
Plaintiffs to “review, re-review, and re-review again the same set of documents” which
“demonstrate[s] that Defendants’ ulterior motive is exploitation of the discovery process to conceal
and obstruct at Plaintiffs’ expense.” [DE 479 at Page ID # 3630].
Plaintiffs describe the documents at issue in the instant motion as “exemplars.” However,
the Court cannot and will not make sweeping declarations about documents and redactions not
before it. The Court cannot determine the propriety of redactions sight unseen.2 The Court will
only rule on the redactions and other issues raised regarding the documents before it.3 Hopefully

2

The Court can scarcely determine the propriety of the documents it can see because the
parties have unfortunately failed to consistently identify the relevant documents. In some
instances, the parties refer to the documents by the Bates Stamp number but do not note the
document’s exhibit number (e.g., “Plaintiffs first received the problematic, redacted document
when Defendants clawed back and replaced the cited EU Risk Management Plan document with
the redacted version (ONG007258693).” [Reply, DE 513 at Page ID # 7256]); in other instances,
the parties refer to the document at issue generally but give the Court no indication of where or
whether it can be found in the record (e.g., “Defendants also redacted non-responsive material
from two reports from a software analytics tool used by the AstraZeneca pharmacovigilance
department to analyze data from several sources and databases to track potential safety signals for
various medications.” DE 503 at Page ID # 7060). Additionally, the exhibits were mis-numbered
in some instances (see, e.g., DE 480-19, document designated as Ex. 10 is Ex. 11, to the best of
the Court’s understanding). Exhibits 5C-F and 6C-F are never specifically mentioned but are
attached to the Motion. Ultimately, the above-described inconsistencies have greatly impaired the
Court’s ability to provide a narrowly-tailored opinion as the arguments raised by the parties.
3
These disputed documents are attached to Plaintiffs’ Motion to Compel [DE 479 and 480]
as Ex. 3, 5A-E, 6A-F, 7, 8, 9, 11, 12, 13, and 14 and Reply [DE 512 and 513] at Ex. 3, 4, 6, 7, 8,
9, and 10. Exhibits 1, 2, 4, 10, 15, 16, 17 and 18 to the Motion [DE 479 and 480] and Reply [DE
512 and 513] Ex. 1, 2, and 5 are supporting documents and the Court’s understanding is that
Plaintiff does not raise a discovery issue related to these documents.
2

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the Court’s ruling will provide some guidance to the parties on the Court’s view of these issues to
avoid similar disputes in the future.
II.
A.

ANALYSIS

SAXAGLIPTIN EU RISK MANAGEMENT PLAN 13 JAN 20144 AND OTHER RE-PRODUCED
DOCUMENTS 5
As noted above, Plaintiffs complain that Defendants produced the same documents several

times with varying redactions, causing Plaintiffs to have to expend time and resources to re-review
those documents numerous times.

Plaintiffs admit Defendants re-produced the EU Risk

Management Plan, removing the contested, “technical glitch” redactions. [DE 513 at Page ID #
7257]. Plaintiffs complain the “timeline [of the correction] is curious.” [DE 513 at Page ID #
7257]. Although the Court understands Plaintiffs have a grievance about how and when these
documents were produced, the documents were produced with the problematic redactions
removed. It does not appear there is any remaining dispute regarding the production of the EU
Risk Management Plan. Thus, this issue is moot.
The Court directs Defendants to be more careful in their document production in the future;
however, there is no indication Defendants did anything other than make an honest mistake and
then attempt (albeit clumsily) to correct the error.6

4

DE 479 and 480 at Ex. 3, 7, and 8.
DE 479 and 480 at Ex. 5A-F and Ex. 6A-F. Neither party addresses Ex. 5C-F or 6C-F.
It appears there is a typographical error in Plaintiffs’ brief at DE 479 and 480, n. 23, referencing
breaking the exhibits into six parts, 5A-B and 6A-B. Based on the Bates Stamp numbers, it appears
this should have referenced Exhibits 5A-F and 6A-F. Accordingly, the Court’s ruling in Section
C applies to Exhibits 5A-F and 6A-F.
6
The Court agrees that if Defendants’ production and redaction errors continue to
accumulate, they will look less like “honest mistakes.”
5

3

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B.

DATE OF DEATH AND TREATMENT DURATION REDACTIONS7
Plaintiffs next argue Defendants have wrongfully redacted death dates and treatment

durations, both unquestionably critical to the question of causation before the Court. Defendants
marked these redactions as “Protected Health Information” (“PHI”) pursuant to the parties’
Stipulated Protective Order at DE 171. On the one hand, the Court agrees that the specific calendar
date of death qualifies as protected health information pursuant to the parties’ Stipulated Protective
Order. [DE 171 at ¶1(e)]. The death and treatment dates at issue in Plaintiffs’ motion, on the other
hand, are dates provided in number of study days, not calendar dates. Thus, the information would
fall outside the rigors of the Stipulated Protective Order crafted by the parties. Defendants counter
the information is unnecessary as Plaintiffs have this information in “Defendants’ production of
the unredacted, eCTD version of the Onglyza FDA clinical trial submissions” and should “easily
cross-reference[]” the documents to determine the study day of death. [DE 503 at Page ID # 7056].
Defendants acknowledge they offered to provide this death information if Plaintiffs would
withdraw the instant motion.
The Court cannot conceive how this information—that Defendants have provided in
another format and offered to produce here—is information that must be redacted. Defendants
should not take the extra step of redacting this information and then force Plaintiffs to untangle the
redactions by “cross-referencing” the data with other documents. The obviously less burdensome
course is for Defendants to remove the redactions.8

7

DE 479 and 480 at Ex. 11, 12, and 13; DE 513 at Ex. 3 (mislabeled as Ex. 1).
The least burdensome course would have been for Defendants not to make baseless
redactions in the first place, and when they did, for Plaintiffs to be willing to negotiate a solution
rather than file a baseless motion for sanctions.
8

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C.

TRADE SECRETS9
Plaintiffs raise the issue of improper “trade secrets” redactions in their motion as related to

Exhibits 7, 8, and 9 of the Motion [DE 479 and 480] and Exhibits 6, 7, 8, 9, and 10 to the Reply
[DE 512 and 513]. [DE 483 at Page ID # 6940].10 Plaintiffs argue Reply Exhibits 6, 7, 8, 9, and
10 [DE 512 and 513] are publicly available documents and therefore improperly redacted. The
Court cannot determine if Plaintiffs make the same argument about Motion Exhibit 9, although it
appears they do.11
Defendants heavily rely on the Stipulated Protective Order as a basis for their redactions,
even where the documents are publicly available. [DE 519 at Page # 7573-74]. In Defendant’s
view, “redactions of manufacturing processes are explicitly allowed under the Stipulated
Protective Order, which provides authority for them regardless of whether a separate ‘trade secrets’
standards is met.” [DE 503 at Page ID # 7058 n. 13].
The Stipulated Protective Order [DE 171] permits Defendants to redact any
“manufacturing methods or processes, including quality control procedures, and proprietary
formulas” from documents designated as “Confidential Discovery Material” [DE 171 at Page ID
# 851, ¶ 2(e)(3)]. Peeling the onion of defined terms in the Stipulated Protective Order, the Court
finds that the “term ‘Confidential Discovery Materials’ means all Documents or Discovery
Materials produced or discovered in response to discovery requests propounded by Plaintiffs that
are designated Confidential” and the “term ‘Confidential’ means any information which is in the
possession of a Producing Party who believes in good faith that such information is entitled to

9

DE 479 and 480 at Ex. 9; DE 512 and 513 at Ex. 6, 7, 8, 9, and 10.
Plaintiffs note Exhibit 8 is an unredacted version of Exhibit 7, thus, it appears any dispute
regarding these documents is moot.
11
Exhibit 9 at DE 479 and 480 is mentioned once in a footnote.
10

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confidential treatment under applicable law.” [DE 171 at Page ID # 850, ¶ 1(f) and 1(d),
respectively].
There is no dispute between the parties that Defendants have designated Exhibit 9 of the
Motion [DE 479 and 480] and Exhibits 6, 7, 8, 9, and 10 to the Reply [DE 512 and 513] as
“Confidential.” Therefore, they are “Confidential Discovery Material” as defined in the Stipulated
Protective Order. Thus, the true dispute between the parties appears to be the designation of these
exhibits as “Confidential.”
Initially, the Court once again stresses its frustration at deciphering the relevant documents
in dispute beyond the generalities set forth in the motion practice.1213 The Court’s view, however,
is that any document that is publicly available is not properly designated as “Confidential” under
the Stipulated Protective Order. Defendants do not deny Plaintiffs’ claim that the disputed “trade
secret” or “manufacturing process” redactions are public information.

Defendants dispute

Plaintiffs’ assertion that Ex. 7 and 8 to the Reply are publicly available documents but admit that
the redacted information in those documents is publicly available. Defendants are silent as to
whether the remaining documents with “trade secret” redactions are publicly available, leading the
Court to conclude Plaintiffs’ arguments are true. A publicly available document or information
cannot be “entitled to confidential treatment under applicable law[]” as defined in the Stipulated

12

See n. 2. See also Ex. 9 to the Motion, which is only mentioned at the end of footnote
20 of the Motion. Neither party clearly designates whether it is a publicly available document.
13
Defendants argue the redactions in Ex. 6 has “no conceivable relevance” to general
causation in this case because they relate to other drugs. [DE 519 at Page ID # 7574]. Defendants
do not raise relevancy issues as to Exhibits 7, 8, and 9 of the Motion [DE 479 and 480] or Exhibits
7, 8, 9, and 10 to the Reply [DE 512 and 513]. Further, relevancy is not the stated reason for
Defendants’ redactions in Ex. 6 to the Reply; instead, they clearly mark it as redacted due to
“Trade Secret – Manufacturing Production.” The Court agrees that the manufacture of drugs other
than those at issue in this litigation has little to relevance to general causation in this case; however,
to the extent these are publicly available documents, the Court cannot justify Defendants’ (newlystated) relevancy redactions in Ex. 6, which is otherwise relevant.
6

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Protective Order. [DE 171 at Page ID # 850, ¶ 1(d)]. Conversely, if the document or information
is not publicly available and Defendants believe the document contains a manufacturing process
as defined in the Stipulated Protective Order, then those documents are protected.
Accordingly, the motion to compel is granted as to documents that are already publicly
available and as to redactions that are public information even where the entire document is not
public.
D.

REDACTIONS LABELED “NOT RESPONSIVE”14 15
Plaintiffs argue Ex. 1416 redacts large portions of an email that appears clearly relevant,

and implies the same problem exists in “otherwise responsive documents,” although Plaintiffs do
not identify those documents. Defendants note two examples they acknowledge are in dispute:
OneNote

files

with

responsive

and

nonresponsive

information

intermingled,

and

pharmacovigilance reports on adverse events other than cardiovascular events reported with
Saxagliptin use. Defendants address Exhibit 14 only in a footnote, stating:
Plaintiffs’ cited example (Ex. 14 to Pls.’ Mot., ONG009082955) reveals Plaintiffs’
misunderstanding regarding the nature of these files. Plaintiffs claim that the
“redacted material is clearly responsive” because Defendants allegedly redacted “a
significant portion of the top of an email chain” regarding a regulatory submission.
But the full responsive tab was produced: Dr. Edelberg copied and pasted the text

14

DE 479 and 480 at Ex. 14.
Defendants note the Court’s prior holding that “pharmacovigilance documents related to
non-cardiac adverse events . . . are not relevant to this litigation or likely lead to the discovery of
relevant evidence, and producing them would be disproportionate to the needs of this litigation at
the general causation phase[.]” [DE 399 at Page ID # 2780]. The Court agrees with Defendants
that this portion of the Court’s prior holding is instructive on whether Defendants must produce
information related to pharmacovigilance of alleged injuries or conditions other than those at issue
in this lawsuit. However, no such documents are specifically before the Court and Plaintiffs did
not raise the issue of pharmacovigilance documents in their motion, therefore there is no dispute
about these documents upon which the Court can rule.
16
ONG009082955, “June 16, 2014 Email from Krisztina Debreczeni to Rachpal Malhotra,
et al. Re: Meeting notes: DSUR SAR Line Listing Cumulative – to implement CAPA for cases
with blank investigatory causality.”
15

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of a particular email from a larger chain in that tab. The other tabs do not include
other emails in that chain.
[DE 503 at Page ID # 7061 n. 16]. Although neither party fully explains the documents at issue,
the Court gleans from this footnote that Exhibit 14 was an email saved in OneNote.
As Defendants admit, lack of relevance or responsiveness does not typically justify
redacting portions of documents. Defendants cite to Beverage Distributors, Inc. v. Miller Brewing,
Co., 2010 WL 1727640, at *4 (S.D. Ohio April 28, 2010) in support of their position that their
redactions due to nonresponsiveness are permissible. Defendants failed to notice that the court in
Beverage Distributors held the defendants in that case could not redact documents for
nonresponsiveness, and granted the plaintiff’s motion to compel. The Court noted the competing
interests involved in reaching its conclusion:
(1) that redaction of otherwise discoverable documents is the exception rather than
the rule; (2) that ordinarily, the fact that the producing party is not harmed by
producing irrelevant information or by producing sensitive information which is
subject to a protective order restricting its dissemination and use renders redaction
both unnecessary and potentially disruptive to the orderly resolution of the case;
and (3) that the Court should not be burdened with an in camera inspection of
redacted documents merely to confirm the relevance or irrelevance of redacted
information, but only when necessary to protect privileged material whose
production might waive the privilege.
Id. at *4. As suggested in Beverage Distributors, the parties here have a Stipulated Protective
Order to safeguard the information—relevant, responsive, and otherwise—that may be produced
in this litigation. In one of the examples at issue, the Exhibit 14 email, the Court cannot discern
the subject matter of the redacted portions of the documents—precisely the same problem
Plaintiffs face. “Oftentimes, ‘irrelevant information within a document that contains relevant
information may be highly useful to providing context for the relevant information.’” Shell
Offshore, Inc. v. Eni Petroleum US LLC, 2017 WL 11536165, at *5 (E.D. La. Aug. 28, 2017)
(quoting Bartholomew v. Avalon Capital Group, Inc., 278 F.R.D. 441, 451 (D. Minn. 2011)). The
8

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Court finds, with the little information before it, that to the extent the entire email chain in Exhibit
14 has not been produced, it should be produced without redactions unless Defendants have a valid
claim of privilege justifying redactions. The entire email chain (if not already produced) must be
produced to provide the proper context of the already produced portion.
The Court agrees with Defendants, however, in their analogy that OneNote files are akin
to “opening a general filing cabinet and only producing the files that are relevant to this litigation.”
[DE 503 at Page ID # 7060]. They claim the OneNote files contain irrelevant documents about
other products Defendants manufactured at that time and have redacted those entire documents or
“tabs.” Where the redacted information is “commercially sensitive,” such as the documents in the
OneNote files that relates to drugs not at issue in this lawsuit, courts have allowed “irrelevant and
sensitive material [to be] redacted.” North American Rescue, Inc. v. Bound Tree Medical, LLC,
2010 WL 1258113, at *2 (S.D. Ohio March 25, 2010). Files from apps like OneNote, Evernote,
etc., are vastly different from an individual email. A OneNote file may contain various types of
documents and/or notes addressing numerous issues organized only by the purview of the
individual controlling the OneNote file. Where “irrelevant information within a document that
contains relevant information may be highly useful to providing context for the relevant
information,” such a holding does not necessarily ring true for OneNote files where multiple
documents and notes related to numerous issues could be contained in a single file. Shell Offshore,
2017 WL 11536165, at *5.
Thus, to the extent the redacted portions of Exhibit 14 are other tabs or files that are not
part of the email chain entitled “June 16, 2014 Email from Krisztina Debreczeni to Rachpal
Malhotra, et al.” and are not responsive to the discovery requests in this litigation, they may be

9

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properly redacted. The Court finds that this is no different than producing only the relevant files
from a general filing cabinet.
E.

MOTION FOR SANCTIONS
The Court will not grant Plaintiffs’ request for sanctions. Defendants appear to be

aggressively litigating this dispute, but so are Plaintiffs. Defendants are cautioned that they should
not continue to have so many “technical challenges” as there can only be so many “errors” in even
the most complex litigation. Moreover, the Court looks askance on Defendants’ very questionable
death date and treatment duration redactions, as explained in Section C, supra. Otherwise, the
Court cannot find issue with Defendants’ tactics.
Plaintiffs, for their part, are cautioned to consider, carefully, the necessity of a motion for
sanctions prior to filing a third. The Court does not look favorably upon such motions where
opposing counsels’ actions—while irritating—are far from sanctionable.
F.

CONCLUSION
For the reasons stated herein, IT IS ORDERED that:
1) Plaintiffs’ Motion to Compel and for Sanctions [DE 479] is GRANTED IN PART as
to the following:
a) Redactions of date of death and treatment duration to Exhibits 11, 12, and 13 of the
Motion and Exhibit 3 to the Reply where those dates are expressed as a number of
days rather than a calendar date;
b) Redactions for “nonresponsiveness” to Exhibit 14 that are part of the email chain
entitled “June 16, 2014 Email from Krisztina Debreczeni to Rachpal Malhotra, et
al.”;
c) Exhibits 9 of the Motion and Exhibits 6, 7, 8, 9, and 10 to the Reply, to the extent
these are publicly available documents;
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2) Plaintiffs’ Motion to Compel and for Sanctions [DE 479] is DENIED IN PART as to
the following:
a) Redactions of pharmocovigilance information not related to heart failure and/or
increased the risk of adverse cardiac events;
b) Redaction of OneNote files due to “nonresponsiveness”; and
c) The request for sanctions.
The undersigned enters this Memorandum Opinion pursuant to 28 U.S.C. § 636(b)(1)(A).
Within fourteen (14) days after being served with a copy of this Memorandum Opinion, either
party may appeal this decision to Judge Caldwell pursuant § 636(b)(1)(A) and FED. R. CIV. P.
72(a).
Entered this 19th day of August, 2020.

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