In re Seroquel Products Liability Litigation

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

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

3. 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

4. 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

5. 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

6. 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

7. 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 e-mails 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’

8. 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 9th, paid $198 million in damages to some 18,000 individuals.

9. 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?