In Re: Gardasil Products Liability Litigation

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UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NORTH CAROLINA
CHARLOTTE DIVISION
3:22-md-03036-RJC
IN RE: GARDASIL PRODUCTS LIABILITY
LITIGATION
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MDL No. 3036
THIS DOCUMENT RELATES TO
ALL CASES
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THIS MATTER comes before the Court on the Plaintiffs’ Motion to Compel (the
“Motion”). (Doc. No. 36). Defendants Merck & Co., Inc. and Merck Sharp & Dohme LLC
(together, “Merck”) oppose the Motion. For the reasons stated herein, the Motion is GRANTED
IN PART and DENIED IN PART.
I. BACKGROUND
This is multi-district litigation (“MDL”) involving allegations “that [P]laintiffs . . .
developed Postural Orthostatic Tachycardia Syndrome (POTS), [Primary Ovarian Failure
(POF)/Primary Ovarian Insufficiency (POI)], and various other injuries as the result of an
autoimmune reaction to [Merck’s] Gardasil vaccine.” (Doc. No. 1). In addition to this MDL, there
are several individual state court actions in California with similar allegations against Merck. Prior
to this MDL, the parties in the California state court actions engaged in extensive discovery,
including related discovery disputes and negotiations. Ultimately, the Parties agreed that Merck’s
discovery responses from the California actions will be available to the Plaintiffs in this MDL, and
that the Parties will resolve related discovery disputes universally in this MDL. On November 18,
2022, Plaintiffs filed the Motion to Compel, in short, arguing that certain of Merck’s prior
productions and interrogatory responses are deficient. (Doc. No. 36). Merck opposes the Motion.
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(Doc. No. 48). The Court heard oral arguments on the Motion and opposition on February 28,
2023.
II. LEGAL STANDARD
Under Federal Rule Civil Procedure 26(b)(1), parties may obtain discovery regarding any
nonprivileged matter that is: (1) relevant to any party’s claim or defense; and (2) proportional to
needs of the case. In considering proportionality, courts consider (1) the importance of the issues
at stake in the action; (2) the amount in controversy; (3) the parties’ relative access to relevant
information; (4) the parties’ resources; (5) the importance of the discovery in resolving the issues;
and (6) whether the burden or expense outweighs its likely benefits. Fed. R. Civ. P. 26(b)(1).
Information need not be admissible to be discoverable. Id. Under Federal Rule of Civil Procedure
37(a), a propounding party may move for an order compelling discovery where a party fails to
respond or provides an evasive or incomplete response. The person “resisting discovery, not the
party moving to compel discovery, bears the burden of persuasion.” Kinetic Concepts, Inc. v.
ConvaTec, Inc., 268 F.R.D. 226, 243 (M.D.N.C. 2010) (collecting cases). The decision to compel
discovery is within the “broad discretion” of the district court. Cook v. Howard, 484 Fed. App’x
805, 812 (4th Cir. 2012).
III. DISCUSSION
Plaintiffs’ Motion asks the Court to compel: (1) further productions to Request for
Production (“RFP”) numbers 3–4, 10, 18–19, 32, 45–49, 55–56, 60–65, and 71–74; and (2) further
responses to Interrogatory numbers 36, 78–80, and 86–87. The Court’s ruling or direction on each
is below.
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No. Request Summary Ruling
RFP No.
62
Compel the entirety of
Merck’s Gardasil
Adverse Events
Databases, including
the Merck Adverse
Event Reporting and
Review System
(“MARRS”).
GRANTED. The information in MARRS is relevant to Plaintiffs’ claims and
Merck’s defenses. Plaintiffs’ and their experts should have the same
opportunity as Merck to review and analyze the entirety of the data. The
discovery is also proportional to the needs of this MDL. Each proportionality
factor in Rule 26(b)(1) leans in Plaintiffs’ favor. Additionally, Merck’s
conceded during oral arguments that this request does not cause any undue
burden, aside for the need to redact certain information, which is largely,
although not entirely, automated.
RFP
Nos. 3–
4, 18–
19, 60–
61 &
63–65
Compel Merck to
produce all Gardasil
studies and analyses in
Merck’s possession,
including all related
communications and
case report forms
(“CFRs”) for patients
during clinical trials.
DENIED IN PART. Plaintiffs’ request to compel Merck to produce paper
CFRs is denied. Producing paper CFRs would cause an undue burden on
Merck and would be duplicative since the information is largely available in
electronic format.
As to Plaintiffs’ remaining requests, the Court finds Plaintiffs’ requests on their
face are overly broad. Health & Beauty Techs., Inc. v. Merz Pharma GmbH
KGaA, No. 7:18-CV-117-FL, 2018 WL 6345369, at *7 (E.D.N.C. Dec. 5,
2018). (“As a practical matter, Defendants cannot search every email inbox of
every employee.”). However, given the MDL posture, the need and
proportionality for discovery in this case is greater than what Merck provided
in single-plaintiff cases. Thus, the Court will require the Parties to meet and
confer in an effort to reach agreement on additional search terms and/or running
searches through additional custodial or non-custodial files for responsive
documents to these requests. During these meet and confers, the Court expects
both Parties to engage in the necessary discussions to facilitate meaningful
negotiations, such as identifying specific, relevant custodial or non-custodial
files where needed. The Court instructs both Parties to engage in good faith,
reasonable discussions keeping in mind the proportionality factors that the
Court considers, and that the Court will not require Merck to search every, or
close to every, custodial and non-custodial file, but will require additional
searches than previously completed given the significant posture of this MDL.
To the extent the Parties cannot reach agreement with these directions then they
may file the necessary motions. If the Parties are unable to reach agreement,
their motion(s) must include specific requests and arguments as to each
disputed discovery item (i.e. identification of the specific custodial or non-
custodial files to be searched or not to be searched and the specific additional
search terms to be run or not to be run, etc.).
RFP No.
32
Merck’s full regulatory
file, including the
Chemistry
Manufacturing and
Control (“CMC”)
section, in eCDT
format.
GRANTED IN PART and DENIED IN PART. Plaintiffs’ request for the
CMC section of the regulatory file is denied. Plaintiffs failed to demonstrate
that the specific information contained within the CMC section is relevant and
proportional to the needs of this case. To the extent the information is relevant,
it can be discovered through other means. As proposed by Merck during oral
arguments, the Court will require Merck to provide the batch records for the
vaccines given to Plaintiffs provided that the Plaintiffs provide the necessary
information to Merck.
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No. Request Summary Ruling
Plaintiffs’ request for the regulatory file in eCDT format is granted to the extent
it already exists in such format. Specifically, any portions of the regulatory file
that are already in the eCDT format must be reproduced in that eCDT format.
Given the defenses, the regulatory file in native format is relevant and
proportional to the needs of this MDL. The Court is not persuaded that the
burden presented by Merck’s counsel during oral arguments is necessary and
unavoidable.
RFP
Nos.
45–49
All documents
concerning Gardasil
labels, including
internal discussions and
proposed revisions and
redline edits concerning
the labels.
The Court finds Plaintiffs’ requests on their face are overly broad. Health &
Beauty Techs., Inc. v. Merz Pharma GmbH KGaA, No. 7:18-CV-117-FL, 2018
WL 6345369, at *7 (E.D.N.C. Dec. 5, 2018). (“As a practical matter,
Defendants cannot search every email inbox of every employee.”). However,
given the MDL posture, the need and proportionality for discovery in this case
is greater than what Merck provided in single-plaintiff cases. Thus, the Court
will require the Parties to meet and confer in an effort to reach agreement on
additional search terms and/or running searches through additional custodial or
non-custodial files for responsive documents to these requests. During these
meet and confers, the Court expects both Parties to engage in the necessary
discussions to facilitate meaningful negotiations, such as identifying specific,
relevant custodial or non-custodial files where needed. The Court instructs
both Parties to engage in good faith, reasonable discussions keeping in mind
the proportionality factors that the Court considers, and that the Court will not
require Merck to search every, or close to every, custodial and non-custodial
file, but will require additional searches than previously completed given the
significant posture of this MDL.
To the extent the Parties cannot reach agreement with these directions then they
may file the necessary motions. If the Parties are unable to reach agreement,
their motion(s) must include specific requests and arguments as to each
disputed discovery item (i.e. identification of the specific custodial or non-
custodial files to be searched or not to be searched and the specific additional
search terms to be run or not to be run, etc.).
RFP
Nos.
55–56
All documents and
communications
concerning Merck’s
causality assessments
for Gardasil or any of its
ingredients.
The Court finds Plaintiffs’ requests on their face are overly broad. Health &
Beauty Techs., Inc. v. Merz Pharma GmbH KGaA, No. 7:18-CV-117-FL, 2018
WL 6345369, at *7 (E.D.N.C. Dec. 5, 2018). (“As a practical matter,
Defendants cannot search every email inbox of every employee.”). However,
given the MDL posture, the need and proportionality for discovery in this case
is greater than what Merck provided in single-plaintiff cases. Thus, the Court
will require the Parties to meet and confer in an effort to reach agreement on
additional search terms and/or running searches through additional custodial or
non-custodial files for responsive documents to these requests. During these
meet and confers, the Court expects both Parties to engage in the necessary
discussions to facilitate meaningful negotiations, such as identifying specific,
relevant custodial or non-custodial files where needed. The Court instructs
both Parties to engage in good faith, reasonable discussions keeping in mind
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No. Request Summary Ruling
the proportionality factors that the Court considers, and that the Court will not
require Merck to search every, or close to every, custodial and non-custodial
file, but will require additional searches than previously completed given the
significant posture of this MDL.
To the extent the Parties cannot reach agreement with these directions then they
may file the necessary motions. If the Parties are unable to reach agreement,
their motion(s) must include specific requests and arguments as to each
disputed discovery item (i.e. identification of the specific custodial or non-
custodial files to be searched or not to be searched and the specific additional
search terms to be run or not to be run, etc.).
RFP
Nos.
71–74
All documents and
communications that
relate to, discuss, or
mention published
articles or medical
opinions (including, but
not limited to, drafts
and red-line versions)
concerning Gardasil, or
any of its ingredients,
that Merck or its agents
helped draft, edit, write,
ghostwrite, ghost-edit,
or finance.
GRANTED IN PART. To the extent Merck has readily available lists of the
names of its Gardasil key opinion leaders (KOLs) and their renumerations
related to Gardasil, as Plaintiffs suggest in their reply, then Plaintiffs’ request
is granted as to all Gardasil KOLs. Otherwise, as directed below, the Parties
shall meet and confer on this issue.
The Court finds Plaintiffs’ requests on their face are overly broad. Health &
Beauty Techs., Inc. v. Merz Pharma GmbH KGaA, No. 7:18-CV-117-FL, 2018
WL 6345369, at *7 (E.D.N.C. Dec. 5, 2018). (“As a practical matter,
Defendants cannot search every email inbox of every employee.”). However,
given the MDL posture, the need and proportionality for discovery in this case
is greater than what Merck provided in single-plaintiff cases. Thus, the Court
will require the Parties to meet and confer in an effort to reach agreement on
additional search terms and/or running searches through additional custodial or
non-custodial files for responsive documents to these requests. During these
meet and confers, the Court expects both Parties to engage in the necessary
discussions to facilitate meaningful negotiations, such as identifying specific,
relevant custodial or non-custodial files where needed. The Court instructs
both Parties to engage in good faith, reasonable discussions keeping in mind
the proportionality factors that the Court considers, and that the Court will not
require Merck to search every, or close to every, custodial and non-custodial
file, but will require additional searches than previously completed given the
significant posture of this MDL.
To the extent the Parties cannot reach agreement with these directions then they
may file the necessary motions. If the Parties are unable to reach agreement,
their motion(s) must include specific requests and arguments as to each
disputed discovery item (i.e. identification of the specific custodial or non-
custodial files to be searched or not to be searched and the specific additional
search terms to be run or not to be run, etc.).
RFP No.
10
All communications
(either internally or
with third parties)
concerning replacing
The Court finds Plaintiffs’ requests on their face are overly broad. Health &
Beauty Techs., Inc. v. Merz Pharma GmbH KGaA, No. 7:18-CV-117-FL, 2018
WL 6345369, at *7 (E.D.N.C. Dec. 5, 2018). (“As a practical matter,
Defendants cannot search every email inbox of every employee.”). However,
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No. Request Summary Ruling
any of the Gardasil
ingredients.
given the MDL posture, the need and proportionality for discovery in this case
is greater than what Merck provided in single-plaintiff cases. Thus, the Court
will require the Parties to meet and confer in an effort to reach agreement on
additional search terms and/or running searches through additional custodial or
non-custodial files for responsive documents to these requests. During these
meet and confers, the Court expects both Parties to engage in the necessary
discussions to facilitate meaningful negotiations, such as identifying specific,
relevant custodial or non-custodial files where needed. The Court instructs
both Parties to engage in good faith, reasonable discussions keeping in mind
the proportionality factors that the Court considers, and that the Court will not
require Merck to search every, or close to every, custodial and non-custodial
file, but will require additional searches than previously completed given the
significant posture of this MDL.
To the extent the Parties cannot reach agreement with these directions then they
may file the necessary motions. If the Parties are unable to reach agreement,
their motion(s) must include specific requests and arguments as to each
disputed discovery item (i.e. identification of the specific custodial or non-
custodial files to be searched or not to be searched and the specific additional
search terms to be run or not to be run, etc.).
ROG
No. 36
Provide a complete
answer to Interrogatory
36 regarding the
Gardasil label.
GRANTED IN PART. Merck’s reference to large numbers of documents is
insufficient to comply with Rule 33(d). The Court expects Merck to make a
reasonable, good faith effort to respond to the interrogatory.
ROG
Nos. 78-
80
Provide a complete
answer to
Interrogatories 78-80
identifying third parties
and employees.
GRANTED IN PART. Merck’s reference to large numbers of documents is
insufficient to comply with Rule 33(d). The Court expects Merck to make a
reasonable, good faith effort to respond to the interrogatories.
ROG
No. 86
Provide a complete
answer to Interrogatory
86 regarding medical
journal articles
concerning Gardasil.
GRANTED IN PART and DENIED IN PART. The parties shall comply
with the Court’s directions regarding RFP Nos. 71–74. The Court expects
Merck to make a reasonable, good faith effort to respond to the interrogatory.
However, Plaintiffs’ request for an “exhaustive list” is overbroad.
ROG
No. 87
Provide a complete
answer to Interrogatory
87 regarding a list of
KOLs.
GRANTED IN PART. To the extent Merck has readily available lists of the
names of its KOLs, then Plaintiffs’ request is granted as to all Gardasil KOLs.
Otherwise, the Parties shall comply with the Court’s directions regarding RFP
Nos. 71–74.
IV. CONCLUSION
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IT IS, THEREFORE, ORDERED that Plaintiffs’ Motion to Compel (Doc. No. 36) is
GRANTED IN PART and DENIED IN PART.
Signed: March 19, 2023
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