United States District Court, N.D. Florida, Pensacola Division
IN RE ABILIFY ARIPIPRAZOLE PRODUCTS LIABILITY LITIGATION, This Document Relates to All Cases
Casey Rodgers Chief Judge
R. JONES United States Magistrate Judge
before the Court is “Plaintiffs' Motion and
Incorporated Memorandum of Law to Conduct Limited Additional
Discovery Regarding Information Found in Recently Produced
Audit Reports, Pursuant to Court Order, ECF No. 831.”
ECF No. 847. Defendants have filed a memorandum in
opposition, ECF No. 856, and the motion is otherwise ripe for
review. For the reasons discussed below Plaintiffs'
motion is due to be granted to the limited extent discussed
in this order.
dispute underlying this motion began after OAPI produced an
October 2015 document entitled “Joint Routine PV Audit
BMS Audit of Otsuka.” The document suggested that joint
periodic audits of Otsuka were conducted from 2006 forward.
The purpose of the audits was to assess compliance with
clinical and safety pharmacovigilance at OAPI, primarily
Court first addressed the issue at the February 26, 2018
hearing. As the Court explained then, both sides presented
colorable arguments whether the audit reports were or were
not within the scope of the requests for production served by
Plaintiffs. The Court, however, determined that-at least the
October 2015 document provided to the Court-contained
information relevant to the issues in the case and therefore
should be made available to Plaintiffs.
to OAPI, the audits were initiated in 2006 and consist of
methods for the audit, results of the audit and where
appropriate corrective action taken. This audit information
is included in one document. On March 1, 2018, after
conducting a hearing, the Court granted Plaintiffs'
request for production of the audit documents and directed
OAPI to produce the audit reports so that Plaintiffs would
have the documents available for use at the 30(b)(6)
depositions scheduled for March 8 and 9, 2018. On March 5, 2018,
and within the time limits set by the Court, OAPI produced
the audit reports. The March 5, 2018, production of the
audits reports, however, was after Plaintiffs had just
completed the depositions in Japan of two Otsuka
representatives. Consequently, Plaintiffs' counsel was
not able to use the audit reports during those depositions.
production of the audit reports the 30(b)(6) depositions of
Defendants' medical affairs representatives went forward.
Although Plaintiffs had the audit reports available for the
medical affairs 30(b)(6) depositions Plaintiffs were unable
to conduct meaningful examination about the audit reports
because the medical affairs representatives were not familiar
with the audit reports since the audits concerned
pharmcovigilance and not medical affairs.
then raised the issue with the Court at the April 2, 2018
hearing, requesting for the first time, that the Court permit
Plaintiffs to conduct additional 30(b)(6) depositions from
each Defendant. Because of the nature of the issue the
Court directed the parties to brief the issue so that the
Court would be able to make a fully informed decision. The
parties have now done so.
motion presents the issue of whether the Court should permit
them to take depositions past the discovery deadline. Central
to the Court's determination is whether Plaintiffs have
exercised sufficient diligence in pursuing the requested
discovery. Because conducting the requested depositions would
occur after the deadline for discovery the Court established
in the case management and scheduling order, Plaintiffs are
required to show due diligence. See, e.g. Sosa v.
Airprint Sys., Inc., 133 F.3d 1417, 1418
(11th Cir. 1998)(good cause requires a showing
that the schedule cannot be “met despite the diligence
of the party seeking the extension.”); Williams v
Blue Cross and Blue Shield of Florida, Inc., No.
3:09cv225/MCR/MD, 2010 WL 19720, at*1 (N.D. Fla. Aug. 26,
2010). Secondly, if Plaintiffs have shown due diligence the
Court must determine whether the discovery is not just
relevant but important to the case.
first to Plaintiffs' diligence, Defendants highlight that
the existence of audits between BMS and OPC was not an
unknown earlier in this case, pointing to scribe notes
produced in March 2017, and OPC-BMS PV Agreements produced as
early as June 2016, which disclose the existence of audit
rights. While these documents certainly make reference to and
suggest that OPC and BMS had entered into agreements
explicitly authorizing data exchange and the right and
obligation to conduct audits, the PV agreements did not
disclose whether the audits were actually conducted nor the
results of the audits. Could Plaintiffs had then requested
production of the audits? Maybe so. While we are all more
informed in hindsight Plaintiffs' failure (or possibly
oversight) in not requesting production of the audit reports
themselves based simply upon the fact that BMS and OPC had
agreed that audits could be conducted does not evidence
sufficient lack of diligence to now deprive Plaintiffs of
discovery on this issue.
say there was more that should have placed Plaintiffs on
notice that there were audit reports disclosing information
relating to pharmocvigilance reporting between OPC and BMS.
Defendants point to PV audit reports for 2015, 2016 and 2014
Defendants produced in February and April 2017,
evidence that Plaintiffs were not diligent in pursuing the
requested discovery. Granted these documents disclosed the
actual results and corrective actions taken during the
audits. But these audits were limited to 2014-2016, a finite
period of time. The audit reports covering the years 2006 to
2013 were not produced until March 6, 2018, after the issue
was raised with the Court for the first time on February 26,
2018. Notably, when the issue was first raised with the Court
the fact discovery deadline had not yet expired. Certainly,
in retrospect it would have been better if Plaintiffs
requested 30(b)(6) depositions concerning the audit reports
in February before the expiration of the discovery deadline.
Although Plaintiffs did not do so at that time, it is not
unreasonable to assume that Plaintiffs believed once they
received the audits reports (which they did on March 6, 2018)
Plaintiffs could use them in the case, including using them
to examine the medical affairs representatives at their
30(b)(6) depositions. As it turned out the medical affairs
representatives did not have a clue about the audit reports
because the audit reports primarily related to
say Plaintiffs should have known that medical affairs
representatives would not have knowledge about audits so the
failure to obtain deposition discovery concerning the audits
is Plaintiffs' fault. Probably so. But Plaintiffs'
failure to anticipate this is different from a lack of
diligence. Once Plaintiffs understood that the audits might
be relevant to pharmacovigilance issues in this case,
Plaintiffs promptly requested production of the audits,