In re: seroquel products

1. M.D. Fla. 2007 In re: seroquel products 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 court’s deadlines for complete electronic formatting of the NDA and IND applications • These were already electronic so formatting shouldn’t 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 doc’s being produced with searchable load files, bate’s stamped TIFF’s 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 client…commensurate 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 procedure…such as: • Schedule for production or organizational charts • Identification of AZ’s first round of 8 chosen witnesses • AZ’s identification of relevant databases (including informal interviews with AZ’s 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 date…which 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 format…plaintiffs 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 databases…not 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 take…such 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 • AstraZenaca’s failures: • Secretative nature of keyword searches • No discussion with plaintiff’s 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 party’s 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 AZ’s 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 AZ’s violation of the Court’s explicit order in CMO2 that the Plaintiff’s were to interview AZ’s 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 AZ’s 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 AZ’s efforts, or lack thereof, worthy of having sanctions being imposed?