In Re Seroquel Products Liability Litigation

1. In Re Seroquel Products Liability Litigation United States District Court for the Middle District of Florida 2007

2. 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.

3. How did we get here? • 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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?