In Re: Gardasil Products Liability Litigation

1
UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NORTH CAROLINA
CHARLOTTE DIVISION
3:22-md-03036-RJC
)
IN RE: GARDASIL PRODUCTS LIABILITY ) MDL No. 3036
LITIGATION )
) THIS DOCUMENT RELATES TO
) ALL CASES
)
)
)
FIRST CASE MANAGEMENT ORDER
IN ACCORDANCE WITH this Court’s Third Pretrial Order (Doc. No. 58), the
undersigned enters the following agreed discovery schedule and procedures for the selection of
cases for the Initial Bellwether Pool:
I. Phase I: General and Initial Bellwether Pool Discovery
1. The parties agree to the following discovery schedule for general and Initial
Bellwether Pool discovery:
February 28, 2023
Parties to simultaneously exchange list of
cases in which their client does not waive
Lexecon. Within one week of exchange,
parties to meet and confer regarding whether
bellwether selection will be limited to cases
where both parties waive Lexecon.
June 1, 2023 Selection of 16 bellwether cases (“Initial
Bellwether Pool”) for core initial workup
June 30, 2023 Plaintiffs’ case-specific amended pleadings
in 16 bellwether cases due
July 21, 2023 Merck’s case-specific answers in 16
bellwether cases due
December 14, 2023 Written discovery deadline
February 15, 2024
Close of fact discovery (all Merck fact
discovery and Initial Bellwether Pool core
initial workup)
Case 3:22-md-03036-KDB Document 77 Filed 03/10/23 Page 1 of 6

2
2. Pursuant to the Third Pretrial Order, selection for the Initial Bellwether Pool
shall be limited to a select pool of Plaintiffs in this MDL who allege either of the following
injuries: Postural Orthostatic Tachycardia Syndrome (“POTS”) or Primary Ovarian Failure
(“POF”)/Primary Ovarian Insufficiency (“POI”).
3. The pool of cases eligible for inclusion in the Initial Bellwether Pool shall be
limited to cases filed and pending in MDL No. 3036 by February 28, 2023.
4. The two cases currently pending in MDL 3036 that were originally filed in the
Western District of North Carolina, Hilton (Case No. 5:22-CV-00030) and Bergin (Case No.
3:22-CV-00117), shall be included in the Initial Bellwether Pool.
5. Plaintiffs shall select five bellwether cases for inclusion in the Initial Bellwether
Pool. Merck shall select five bellwether cases for inclusion in the Initial Bellwether Pool. Other
than Hilton and Bergin, a plaintiff’s Plaintiff Fact Sheet must have been served on Merck by
and/or due by the dates identified in the Plaintiff Fact Sheets Order in order for that case to be
eligible for inclusion in the Initial Bellwether Pool.
6. At 12:00 pm Eastern Time, on June 1, 2023, Co-Lead Counsel will exchange
emails identifying the Parties’ respective selections. If the Parties’ selections overlap, meaning
that both Parties selected the same case, an additional case will be selected at random pursuant
to Section I, Paragraph 7 of this Order.
7. An additional four cases (as well as any additional cases to be selected at random
pursuant Section I, Paragraph 6 of this Order) shall be selected for the Initial Bellwether Pool
at random from the remaining pool of Plaintiffs alleging POTS or POI/POF. At 2:00 pm Eastern
Time, on June 1, 2023, Merck’s Co-Lead Counsel (or a designated representative) will provide
Plaintiffs’ Co-Lead Counsel (or a designated representative) with an alphabetical list (by
Case 3:22-md-03036-KDB Document 77 Filed 03/10/23 Page 2 of 6

3
Plaintiffs’ last names) of remaining cases eligible for selection in the Initial Bellwether Pool
with each case consecutively assigned a number beginning with the number 1 (e.g., 1 through
100). At 4:00 pm Eastern Time, on June 1, 2023, the Co-Lead Counsel for the Parties (or their
respective designated representative(s)) will join a recorded video conference during which
random selections of cases will be made using the numbers from the numerical list provided by
Merck via a mutually agreed online number randomizer displayed on a shared screen, until 16
total Initial Bellwether Pool cases are selected.
8. “Core initial workup” in the 16 Initial Bellwether Pool cases as referenced in
Section I, Paragraph 1 above shall be limited to case-specific written discovery and depositions
of the plaintiff(s), plaintiff’s parents if the plaintiff received any Gardasil doses as a minor
(meaning when under the age of 18), the health care provider(s) who recommended each
Gardasil dose for plaintiff, and one treating physician of each party’s choosing. The Parties shall
meet and confer on whether additional case specific discovery, including Merck Sales Force
depositions, is appropriate for “core initial workup” in any bellwether case on a case-by-case
basis.
9. After a case is selected for inclusion in the Initial Bellwether Pool, that case can
only be voluntarily dismissed with prejudice.
10. If an Initial Bellwether Pool case selected by Plaintiffs is voluntarily dismissed,
it shall not be replaced.
11. If an Initial Bellwether Pool case selected by Merck is voluntarily dismissed by
Plaintiffs more than 120 days before the close of discovery, Merck shall identify a replacement
case within 14 days of the dismissal.
12. If a randomly selected Initial Bellwether Pool case is voluntarily dismissed more
Case 3:22-md-03036-KDB Document 77 Filed 03/10/23 Page 3 of 6

4
than 120 days before the close of fact discovery, the Parties shall identify a replacement case
via an agreed online randomizer using the procedure in Section I, Paragraph 7 above.
13. If a randomly selected Initial Bellwether Pool case is voluntarily dismissed less
than 120 days before the close of fact discovery, the case will not be replaced.
14. If an Initial Bellwether Pool case selected by Merck is voluntarily dismissed less
than 120 days before the close of fact discovery, Merck may identify a case for removal from
the Initial Bellwether Pool.
II. Phase II: Daubert and Summary Judgment Motions
1. The Parties agree to the following schedule for (i) the Parties’ general causation
expert discovery and Federal Rule of Evidence 702 Daubert motions and (ii) Merck’s general
causation and preemption motion for summary judgment:
March 14, 2024 Plaintiffs’ general causation expert reports due
April 11, 2024 Merck’s general causation expert reports due
May 23, 2024
Deadline for general causation expert
discovery (with Plaintiffs’ experts to be
deposed first)
July 8, 2024
General causation Rule 702 Daubert motions
due
General causation and preemption motion(s)
for summary judgment due
August 22, 2024
Oppositions to general causation Rule 702
Daubert motions due
Oppositions to general causation and
preemption motion(s) for summary judgment
due
September 23, 2024
Replies in support of general causation Rule
702 Daubert motions due
Replies in support of general causation and
preemption motion(s) for summary judgment
due
2. Rule 702 Daubert motions in this phase will be limited to the issue of general
Case 3:22-md-03036-KDB Document 77 Filed 03/10/23 Page 4 of 6

5
causation related to the two alleged bellwether injuries: POTS and POF/POI. Summary
judgment motions in this phase will be limited to the issues of general causation and preemption
related to the two alleged bellwether injuries: POTS and POF/POI.
3. Upon completion of briefing, a stay of any further discovery will be entered
pending the Court’s rulings on the parties’ Rule 702 Daubert motions and Merck’s motion(s)
for summary judgment.
4. If (i) an Initial Bellwether Pool case selected by Merck or (ii) a randomly
selected Initial Bellwether Pool case is dismissed during the stay, Merck may, within 14 days
of the dismissal, identify a case for removal from the Initial Bellwether Pool.
5. If an Initial Bellwether Pool case selected by Plaintiffs is dismissed during the
stay, the case shall be removed from the Initial Bellwether Pool and will not be replaced.
6. If the Court grants Merck’s motion(s) for summary judgment, the parties will
submit letters to the Court proposing next steps within 21 days of entry of the Order.
III. Phase III: Case-Specific Bellwether Discovery
1. Phase III of this Order will be applicable to the extent that the Court denies
Merck’s motion(s) for summary judgment submitted in Phase II.
2. At this time, the Parties generally agree to the below schedule if Merck’s motion(s)
for summary judgment is denied. If Merck’s motion(s) for summary judgment is denied, within
21 days, the parties shall meet and confer and submit a proposed date-certain schedule and
protocol for any remaining case-specific bellwether discovery, to include the specifics of
proposed logistics for the selection of 10 cases from the 16 in the Initial Bellwether Pool for
expert workup and the subsequent selection of 6 cases from the 10 cases selected for expert
workup for trial-readiness.
Case 3:22-md-03036-KDB Document 77 Filed 03/10/23 Page 5 of 6

6
4 months after motion for summary
judgment ruling
Deadline for remaining fact discovery in 16
bellwether cases
7 days after completion of remaining fact
discovery
Selection of 10 cases for remaining expert
discovery from 16 bellwether cases
30 days after selection for expert discovery
Plaintiffs’ case-specific and other non-
general causation expert reports due in 10
cases
30 days after Plaintiffs’ expert reports due Merck’s case-specific and other non-general
causation expert reports due in 10 cases
60 days after Merck’s expert reports due Deadline for completion of remaining case-
specific expert discovery in 10 cases
7 days after expert discovery deadline Selection of 6 trial-ready cases from 10
expert discovery workup cases
30 days after selection
Case-specific and other non-general
causation Rule 702 Daubert motions due in
6 trial-ready cases
Summary judgment motions (on issues other
than general causation and preemption) due
in 6 trial-ready cases
30 days after Daubert and Summary
Judgment Motions
Oppositions to case-specific and other non-
general causation Rule 702 Daubert motions
due in 6 trial-ready cases
Oppositions to summary judgment motions
(on issues other than general causation and
preemption) due in 6 trial-ready cases
30 days after Daubert and Summary
Judgment Motion Oppositions
Replies in support of case-specific and other
non-general causation Rule 702 Daubert
motions due in 6 trial-ready cases
Replies in support of case-specific summary
judgment motions (on issues other than
general causation and preemption) due in 6
trial-ready cases
SO ORDERED.
Signed: March 9, 2023
Case 3:22-md-03036-KDB Document 77 Filed 03/10/23 Page 6 of 6