In re: seroquel products

1
In re seroquel products

• M.D. Fla. 2007

Michael Clarke 9/21/09
2
Parties

• Plaintiff
• Mr. Haller others (Plaintiffs) - contend
  injury by failing to provide their prescribers
  adequate warnings concerning the risks of
  Seroquel.
• Defendant
• AstraZenaca (AZ) An international
  pharmaceutical company maker of Seroquel, a
  drug used to treat the symptoms of psychotic
  conditions in adults and children who are at
  least 10 years old.

3
Case Overview

• This is an action brought on by Plaintiffs to
  impose sanctions upon AZ based on failure to
  timely comply with numerous discovery obligations
  since the inception of this litigation. Four
  categories
• Failure to product in, in a readable format, key
  elements of databases in 11/06 as ordered, and
  not producing a key element until 06/07.
• Contends that AZ failed to product organization
  charts by 1/06 as ordered, and withheld majority
  of them until 3/14/07
• Failed to identify all relevant databases which
  it was obligated to identify in 1/07, instead
  identifying only a fraction of them to date of
  trial.
• AZ waited until mid-May to begin production of
  the overwhelming majority of the documents and
  the documents actually produced have significant
  errors of omission and were not readable or
  searchable.

4
Timeline of Events

• Aug. 2006 Judge entered an order setting first
  pretrial status and discovery conference for
  9/7/06.
• 60 day extension granted to AZ to eliminate the
  possibility of being unable to meet courts
  deadlines for complete electronic formatting of
  the NDA and IND applications
• These were already electronic so formatting
  shouldnt have been too much of an issue, but
  extension was still granted.
• Nov. 20, 2006 Court requested that the parties
  meet and confer to submit either agreed
  proposals to cover document preservation,
  production protocol and resolution of the issue
  about formatting of things already produced by
  12/5/06.
• Instead of a unified proposal, the parties
  submitted competing proposals apparently without
  a good faith conference
• Dec. 5, 2006 parties finally began discussion
  as to the electronic docs being produced with
  searchable load files, bates stamped TIFFs and
  various metadata fields.

5
Timeline of Events

• Dec. 2006 Parties filed a Joint Motion to adopt
  two case management orders (CMO2)
• It is the stated policy of AZ counsel, and its
  clientcommensurate with the goals of these MDL
  cases, get to Plaintiffs counsel in a timely
  manner and in a format usable, the necessary
  production documents that the opposing side will
  need to help them develop, evaluate, and
  understand their cases for purposes of ultimate
  prosecution and/or dismissal of cases.
• Jan. 2007 Judge entered CMO2, setting forth
  specific undertaking and obligations regarding
  provision of discovery without the need for
  separate requests under the rules of
  proceduresuch as
• Schedule for production or organizational charts
• Identification of AZs first round of 8 chosen
  witnesses
• AZs identification of relevant databases
  (including informal interviews with AZs IT
  staff)
• The required format for electronic documents
  (including required metadata fields)
• Deduplication of documents

6
Timeline of Events

• April 26, 2007 Plaintiffs filed their Motion to
  Compel Defendants to provide the first eight
  custodial files and all other custodial files
  produced to datewhich was denied by the court
• Court denied motion without prejudice to allow
  parties to confer in good faith and in extenso
  on the issues described in the motion
• The court also set an evidentiary haring on the
  matters raised in the motion for 6/13/07,
  stating
• ANY PARTY WHOSE CONDUCT NECESSITATES THE
  EVIDENTIARY HEARING SHOULD EXPECT THE IMPOSITION
  OF SANCATIONS FOR ANY UNREASONABLE OR
  INAPPROPRIATE CONDUCT OR POSITION TAKEN WITH
  RESPECT TO THESE MATTERS.

7
Timeline of Events

• June 8, 2007 Evidentiary hearing cancelled
  based upon Joint Statement of Resolved Issues and
  Notice that a Hearing is not Required, filed the
  previous day.
• AZ represented to Plaintiff that corrections
  would be made to the problems Plaintiffs
  identified in the Motion to Compel
• Load files, metadata, bates numbering, page
  breaks, excel spread sheets, and blank docs
• CANDA would also be produced
• Parties would continue to confer on the database
  production
• July 3, 2007 Plaintiff filed for their Motion
  for Sanctions upon on AZ

8
Legal Framework

• Discovery Plans Any discovery plan must
  address issues relating such information,
  including (1) the search for it and its location,
  (2) retrieval, (3) form of production, (4)
  inspection, (5) preservation, and (6) use at
  trial.
• Rule 26 (f) (3) 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 of
  ESI, including the form or forms in which it
  should be produced.
• This rule was amended in 2006, to direct the
  parties to discuss discovery of ESI during their
  discovery-planning conference.
• FRCP 26(b)(2)(C)(iii) allows the court to limit
  or modify the extent of otherwise allowable
  discovery if the burden outweigh the likely
  benefit.

9
Analysis

• IND/NDA not produced until 6/07, and not in an
  usable formatplaintiffs contended they had to
  spend nearly 2 months to make it suitable for
  review
• Unusable format
• No metadata was retrieved
• there were multi-page TIFF images
• no bates numbering
• 8 of discovery in one document only openable on
  particular high-power workstations
• no load files

10
Analysis

• Database Production AZ only identified 15
  databasesnot all as required by CMO2.
  Additionally AZ not releasing others without
  Requests for Production.
• CMO2 required, by 1/07, AZ provide Plaintiffs
  with a list of databases of the following 14
  types
• (p.192 - 3rd paragraph)
• Testimony from two witnesses indicate that there
  was a failure to communicate and
  posturing/petulance of both sides not indicative
  of the profession.
• This step is one of a cooperative undertaking,
  not part of the adversarial give and takesuch
  disputes should not entail endless wrangling
  about simply identifying what records exist and
  determining their format
• It is not appropriate to seek an advantage in the
  litigation by failing to cooperate in the
  identification of basic evidence.

11
Analysis

• Custodial Production Plaintiffs contend AZ
  waited until Mid-May 2007 to begin production of
  the overwhelming majority of the documents from
  the custodians and the documents produced have
  significant errors of omission and are not
  readable or searchable
• AZ performed unreasonable keyword searches
• Supposed to be a cooperative procedure and
  Plaintiffs were not involved with it at all
• AZ undertook procedure in secret
• AZ missed deadlines and produced ESI late
• No page breaks were inserted for 3.75 million
  pages

12
Analysis

• AstraZenacas failures
• Secretative nature of keyword searches
• No discussion with plaintiffs as required by
  Rules 26 34
• A party is responsible for the errors of its
  vendors (Sedona Principles)
• Failure to bring appropriate personnel to the
  table at appropriate times to resolve
  non-adversarial issues
• Production completed as of 6/30/07, of roughly 10
  million pages of documents was unusable as per
  the Rules

13
Issues regarding eDiscovery

• Disclosure of Information AZ intentionally
  released information last minute and that
  information in many instances was unusable
• This is not an adversarial process, it should be
  undertaken in a cooperative nature.
• Sanctions
• Standard for imposing sanctions is Bad Faith

14
Outcome

• Ultimately, the court reached the conclusion that
  AZ was purposely sluggish in its production to
  plaintiffs. 
• Purposely Sluggish as a discovery deadline
  or trial date draws near, discovery conduct that
  might have been considered merely discourteous
  at an earlier point may well breach a partys
  duties to its opponent and the court.
• The court noted that the sluggishness had
  benefited AZ and prejudiced the plaintiffs by
  limiting the time available to for review and
  follow up investigation.
• Therefore, prejudice was presumed. No
  consideration was given to AZs attempt to blame
  its vendor the court responded with citations to
  appellate decisions holding that continued
  reliance on an ineffective vendor is itself
  subject to sanctions.

15
Outcome

• Court finds sanctions are warranted for AZs
  violation of the Courts explicit order in CMO2
  that the Plaintiffs were to interview AZs IT
  Employees, and if they still had questions after
  the interview, would identify the issues for
  which the still needed info and AZ was to
  identify an IT employee with the relevant
  knowledge.
• Sanctionable under Rule 37(b)(2) based on AZs
  non compliance with a court order,
  notwithstanding a lack of willfulness or bad
  faith, although such factors are relevant to the
  sanction to be imposed for the failure.

16
Questions

• Where is the line drawn in the eDiscovery arena
  regarding the requirements of what one must do in
  production of ESI?
• Was AZs efforts, or lack thereof, worthy of
  having sanctions being imposed?