In Re Seroquel Products In Re Seroquel Products Liability LitigationLiability Litigation

United States District United States District Court for the Middle Court for the Middle

District of FloridaDistrict of Florida

20072007

PartiesParties

►Class PlaintiffsClass Plaintiffs Multi district plaintiffs who took Seroquel, Multi district plaintiffs who took Seroquel,

an anti-psychotic medication and are now an anti-psychotic medication and are now suing AstraZeneca for unknown side suing AstraZeneca for unknown side effects such as diabetes.effects such as diabetes.

►AstraZeneca (referred to as AZ)AstraZeneca (referred to as AZ) Pharmaceutical corporation who produced Pharmaceutical corporation who produced

Seroquel.Seroquel.

How did we get here?How did we get here?

► Transferred to the Middle District of Florida on July Transferred to the Middle District of Florida on July 10, 2006.10, 2006.

► The Court sets up first pretrial hearing and The Court sets up first pretrial hearing and discovery conference for September 7, 2006.discovery conference for September 7, 2006.

► AZ requested 60 days to format the Investigational AZ requested 60 days to format the Investigational New Drug/New Drug Application which was New Drug/New Drug Application which was prepared for the FDA and was center to the case.prepared for the FDA and was center to the case.

► At the next status conference of November 20, At the next status conference of November 20, 2006, the Court requested that the parties meet 2006, the Court requested that the parties meet and confer about discovery protocol and formatting, and confer about discovery protocol and formatting, and submit an agreed upon proposal regarding the and submit an agreed upon proposal regarding the same by December 5, 2006.same by December 5, 2006.

How did we get here?How did we get here?

► Instead, the parties did not meet and they Instead, the parties did not meet and they submitted competing proposals.submitted competing proposals.

► The parties met with each other The parties met with each other for the first for the first timetime on December 5, 2006, three days before on December 5, 2006, three days before the status conference and discussed what the the status conference and discussed what the format of electronic documents should be.format of electronic documents should be.

► At the status conference, the parties finally At the status conference, the parties finally agreed and proposed a joint motion which agreed and proposed a joint motion which became Case Management Order No. 2 became Case Management Order No. 2 (CMO2), which stated that AZ would give to (CMO2), which stated that AZ would give to the Plaintiffs in a timely manner and a useable the Plaintiffs in a timely manner and a useable format the documents that the Plaintiffs would format the documents that the Plaintiffs would need.need.

What was supposed to be What was supposed to be givengiven

►Organizational charts of the entire corporate Organizational charts of the entire corporate structure.structure.

►Organizational charts of the Seroquel team.Organizational charts of the Seroquel team.► The drug safety team of the last 10 years.The drug safety team of the last 10 years.► List of 80 custodians.List of 80 custodians.► List of databases concerning document List of databases concerning document

production and preservation.production and preservation.► Timing for interviews of IT personnel.Timing for interviews of IT personnel.► And the agreed upon format of the And the agreed upon format of the

custodian’s files.custodian’s files.

After CMO2After CMO2

►AZ failed to produce what was expected of AZ failed to produce what was expected of it in a timely manner or a useable format.it in a timely manner or a useable format. Did not produce many of the organizational Did not produce many of the organizational

charts.charts. The New Drug Application was in an The New Drug Application was in an

unreadable and unsearchable format.unreadable and unsearchable format. Failed to specify the databases that would be Failed to specify the databases that would be

relevant.relevant. Documents of the custodians was not Documents of the custodians was not

produced in a timely manner or a readable produced in a timely manner or a readable format.format.

What Rules are at issue?What Rules are at issue?

► Federal Rule of Civil Procedure 26(f)Federal Rule of Civil Procedure 26(f) ““The parties are expected to confer, not only on The parties are expected to confer, not only on

the nature and basis of their claims and defenses, the nature and basis of their claims and defenses, but also to discuss ‘any issues relating to but also to discuss ‘any issues relating to disclosure or discovery or electronically stored disclosure or discovery or electronically stored information, including the form or forms in which information, including the form or forms in which it should be produced.’”it should be produced.’”

Committee Notes: this rule is specifically tailored Committee Notes: this rule is specifically tailored to hasten discovery, and make sure that to hasten discovery, and make sure that formatting issues are taken care of from the start formatting issues are taken care of from the start of the litigation, so that the lawsuit will not be held of the litigation, so that the lawsuit will not be held up.up.

What Rules are at issue?What Rules are at issue?

►Sedona Principles, Second EditionSedona Principles, Second Edition ““The parties should confer early in The parties should confer early in

discovery regarding the preservation and discovery regarding the preservation and production of electronically stored production of electronically stored information when these matters are at information when these matters are at issue in the litigation and seek to agree on issue in the litigation and seek to agree on the scope of each party’s rights and the scope of each party’s rights and responsibilities.responsibilities.

The IssuesThe Issues

►Four particular issues:Four particular issues: The production of the New Drug The production of the New Drug

ApplicationApplication The organizational charts production (Not The organizational charts production (Not

discussed in this excerpt) discussed in this excerpt) The database productionThe database production The custodial productionThe custodial production

The New Drug ApplicationThe New Drug Application

► AZ gave Plaintiffs the IND/NDA in an unusable AZ gave Plaintiffs the IND/NDA in an unusable format: there was no metadata; they came in format: there was no metadata; they came in multi page TIFF documents, some of which multi page TIFF documents, some of which contained 20,000 pages; no bates numbering; contained 20,000 pages; no bates numbering; over 8% of the entire production was in one over 8% of the entire production was in one document which could only be opened at a document which could only be opened at a powerful workstation; and there were no load powerful workstation; and there were no load filesfiles

► This caused the production to be unreadable This caused the production to be unreadable and unsearchable.and unsearchable.

► Plaintiffs themselves fixed the problem by Plaintiffs themselves fixed the problem by reformatting it over 2 months time.reformatting it over 2 months time.

Database ProductionDatabase Production

► AZ failed to identify all of the relevant AZ failed to identify all of the relevant databases, only giving 15 (Plaintiffs later databases, only giving 15 (Plaintiffs later found out that there were at least 59 found out that there were at least 59 relevant databases.)relevant databases.)

► AZ argued that it followed the CMO2 and AZ argued that it followed the CMO2 and listed the databases that fit with the list of listed the databases that fit with the list of categories that the Plaintiffs gave them.categories that the Plaintiffs gave them.

►However, this was proven false when AZ’s However, this was proven false when AZ’s own representative testified that they never own representative testified that they never planned on producing any more databases.planned on producing any more databases.

Custodial ProductionCustodial Production

► AZ was “purposefully sluggish” in producing AZ was “purposefully sluggish” in producing documents from its custodians.documents from its custodians.

► They waited until May of 2007 to produce They waited until May of 2007 to produce these documents, and failed to produce these documents, and failed to produce many emails, voicemail, faxes, videos and many emails, voicemail, faxes, videos and other such documents.other such documents.

► The documents were unsearchable.The documents were unsearchable.►Over 10 million pages were finally produced, Over 10 million pages were finally produced,

5 months after the deadline had passed for 5 months after the deadline had passed for production.production.

The Court’s DecisionThe Court’s Decision

► The Court says that all of this basically could The Court says that all of this basically could have been avoided if the parties would have have been avoided if the parties would have met with each other and hashed out these met with each other and hashed out these problems before hand, or, in other words, problems before hand, or, in other words, actually followed Fed R. Civ. P. 26.actually followed Fed R. Civ. P. 26. AZ would not allow its IT people to talk with the AZ would not allow its IT people to talk with the

IT people of the Plaintiffs.IT people of the Plaintiffs. Both the Plaintiffs and AZ had an unwillingness to Both the Plaintiffs and AZ had an unwillingness to

meet and confer, but AZ failed to bring people to meet and confer, but AZ failed to bring people to the table at specific times to help solve these the table at specific times to help solve these issues.issues.

ConclusionConclusion

►The Court said that AZ was “purposely The Court said that AZ was “purposely sluggish” in producing anything to the sluggish” in producing anything to the plaintiffs, benefiting AZ by limiting the plaintiffs, benefiting AZ by limiting the Plaintiffs’ review of these documents.Plaintiffs’ review of these documents.

►The Court finds that sanctions are The Court finds that sanctions are warranted against AZ, but does not warranted against AZ, but does not state the amount or nature because it state the amount or nature because it is not yet seen what effects they have is not yet seen what effects they have had on the Plaintiffs.had on the Plaintiffs.

QuestionsQuestions

► Is it fair to punish one side of a litigation for Is it fair to punish one side of a litigation for failing to meet and confer, when, especially failing to meet and confer, when, especially in this case, both sides are to blame for the in this case, both sides are to blame for the “failure to communicate?”“failure to communicate?”

► Throughout the case, the Court focuses on Throughout the case, the Court focuses on the fact that most of the production from AZ the fact that most of the production from AZ was unsearchable. If there was a full was unsearchable. If there was a full production, do you believe sanctions would production, do you believe sanctions would be necessary if the production was be necessary if the production was unsearchable?unsearchable?