In re Seroquel Products Liability Litigation September 2007 Middle District of Florida

Parties Plaintiffs: 22,000 individuals injured from taking Seroquel Primary side effect: diabetes Anti-psychotic medication Defendants: AstraZeneca Pharmaceutical manufacturer

Timeline of Legal Events Nov. 20, 2006 – Parties ordered to meet and confer by Dec. 12 Dec 5. – parties discuss discovery proposals for first time Dec. 12 – Court proposes two case management ideas that are to be agreed upon Jan. 26, 2007 – Court approves CMO2, which includes production of organizational charts, 8 preliminary witnesses, identification of databases, and production methods. April 26 – plaintiffs motion to compel denied, sanctions warning issued, and evidentiary hearing set for June 13 June 8 – hearing postponed due to plaintiff reliance on AZ July 3 – motion for sanctions filed by plaintiffs

Legal Framework Complex litigation principles (Rule 26) Requesting party – narrowly tailor the request Responding party – best situated to understand, so must be forthcoming and explicit in response Then Court can balance interests to modify as needed Rule 26(f) requires parties to be familiar with their systems before the meet-and-confer to make it a meaningful process Purposefully sluggish

Plaintiff Request for Sanctions AZ failed to produce a key element of the IND/NDA, sluggish production, and not in usable format Improper due to search issues, size of documents Inability to speak with IT to improve situation is inexplicable departure from Rule 26 and Sedona principles Failure to identify all relevant databases Defendants failed to disclose all databases, they failed to respond to requests to speak with proper individuals, and they used improper witnesses to testify Though both parties bear responsibility for being improperly adversarial, AZ bears more responsibility as creator and owner of information

Additional Plaintiff Request Failure of AZ to produce meaningful custodians (those most knowledgeable with Seroquel) Waited until May 2007 to produce overwhelming Seroquel documents Key search issues, blank pages, duplicates, no metadata, no page breaks in 3.75 million pages

E-Discovery Issues Court finds numerous violations by AZ Key word search inadequate It was a secret process; needs to be informed and cooperative Attachments and s omitted Deduplication methods remain mysterious Production was purposefully slow IT for AZ was not to speak with plaintiffs about discovery methods Lead counsel for AZ not familiar with key word development, did not know who was monitoring rule compliance, unsure of QC methods used Avoiding this: by becoming familiar with AZ policies and participating meaningfully in the meet-and-confer process, many of these issues avoidable Both parties bear burden, but AZ purposefully interfered with meaningful participation and used methods of production that were absurd

Sanctions Generally disfavored by the courts Slow down litigation, take focus off primary litigation; only to be used when necessary Here necessary because: lied about future compliance, failure to use appropriate parties to facilitate agreements, the lack of page breaks was a major issue, and responsibility for failure of vendors chosen Purposefully sluggish in production of documents Unable to grant sanctions without further testimony Online research: August 9 th, paid $198 million in damages to some 18,000 individuals.

Discussion Did counsel for the plaintiffs do enough in the meet-and-confer stage to avoid liability in the subsequent months? Is it appropriate that a party be purposefully sluggish to be exposed that much liability? Should the standard be higher?