Transcript In Re Seroquel Products Liability Litigation

In Re Seroquel Products
Liability Litigation
United States District
Court for the Middle
District of Florida
2007
Parties
► Class
Plaintiffs
 Multi district plaintiffs who took Seroquel, an
anti-psychotic medication and are now suing
AstraZeneca for unknown side effects such as
diabetes.
► AstraZeneca
(referred to as AZ)
 Pharmaceutical corporation who produced
Seroquel.
How did we get here?
►
►
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►
Transferred to the Middle District of Florida on July 10,
2006.
The Court sets up first pretrial hearing and discovery
conference for September 7, 2006.
AZ requested 60 days to format the Investigational New
Drug/New Drug Application which was prepared for the
FDA and was center to the case.
At the next status conference of November 20, 2006, the
Court requested that the parties meet and confer about
discovery protocol and formatting, and submit an agreed
upon proposal regarding the same by December 5, 2006.
How did we get here?
► Instead,
the parties did not meet and they
submitted competing proposals.
► The parties met with each other for the first time
on December 5, 2006, three days before the
status conference and discussed what the format
of electronic documents should be.
► At the status conference, the parties finally agreed
and proposed a joint motion which became Case
Management Order No. 2 (CMO2), which stated
that AZ would give to the Plaintiffs in a timely
manner and a useable format the documents that
the Plaintiffs would need.
What was supposed to be given
► Organizational
charts of the entire corporate
structure.
► Organizational charts of the Seroquel team.
► The drug safety team of the last 10 years.
► List of 80 custodians.
► List of databases concerning document production
and preservation.
► Timing for interviews of IT personnel.
► And the agreed upon format of the custodian’s
files.
After CMO2
► AZ
failed to produce what was expected of
it in a timely manner or a useable format.
 Did not produce many of the organizational
charts.
 The New Drug Application was in an unreadable
and unsearchable format.
 Failed to specify the databases that would be
relevant.
 Documents of the custodians was not produced
in a timely manner or a readable format.
What Rules are at issue?
► Federal
Rule of Civil Procedure 26(f)
 “The parties are expected to confer, not only on the
nature and basis of their claims and defenses, but also
to discuss ‘any issues relating to disclosure or discovery
or electronically stored information, including the form
or forms in which it should be produced.’”
 Committee Notes: this rule is specifically tailored to
hasten discovery, and make sure that formatting issues
are taken care of from the start of the litigation, so that
the lawsuit will not be held up.
What Rules are at issue?
► Sedona
Principles, Second Edition
 “The parties should confer early in discovery
regarding the preservation and production of
electronically stored information when these
matters are at issue in the litigation and seek to
agree on the scope of each party’s rights and
responsibilities.
The Issues
► Four
particular issues:
 The production of the New Drug Application
 The organizational charts production (Not
discussed in this excerpt)
 The database production
 The custodial production
The New Drug Application
► AZ
gave Plaintiffs the IND/NDA in an unusable
format: there was no metadata; they came in
multi page TIFF documents, some of which
contained 20,000 pages; no bates numbering;
over 8% of the entire production was in one
document which could only be opened at a
powerful workstation; and there were no load files
► This caused the production to be unreadable and
unsearchable.
► Plaintiffs themselves fixed the problem by
reformatting it over 2 months time.
Database Production
► AZ
failed to identify all of the relevant databases,
only giving 15 (Plaintiffs later found out that there
were at least 59 relevant databases.)
► AZ argued that it followed the CMO2 and listed the
databases that fit with the list of categories that
the Plaintiffs gave them.
► However, this was proven false when AZ’s own
representative testified that they never planned on
producing any more databases.
Custodial Production
► AZ
was “purposefully sluggish” in producing
documents from its custodians.
► They waited until May of 2007 to produce these
documents, and failed to produce many emails,
voicemail, faxes, videos and other such
documents.
► The documents were unsearchable.
► Over 10 million pages were finally produced, 5
months after the deadline had passed for
production.
The Court’s Decision
► The
Court says that all of this basically could have
been avoided if the parties would have met with
each other and hashed out these problems before
hand, or, in other words, actually followed Fed R.
Civ. P. 26.
 AZ would not allow its IT people to talk with the IT
people of the Plaintiffs.
 Both the Plaintiffs and AZ had an unwillingness to meet
and confer, but AZ failed to bring people to the table at
specific times to help solve these issues.
Conclusion
► The
Court said that AZ was “purposely
sluggish” in producing anything to the
plaintiffs, benefiting AZ by limiting the
Plaintiffs’ review of these documents.
► The Court finds that sanctions are
warranted against AZ, but does not state
the amount or nature because it is not yet
seen what effects they have had on the
Plaintiffs.
Questions
► Is
it fair to punish one side of a litigation for failing
to meet and confer, when, especially in this case,
both sides are to blame for the “failure to
communicate?”
► Throughout
the case, the Court focuses on the
fact that most of the production from AZ was
unsearchable. If there was a full production, do
you believe sanctions would be necessary if the
production was unsearchable?