On January 21st, Master MacLeod of the Ontario Superior Court of Justice issued an order which allowed the parties to a complex e-discovery to proceed. He cited the Sedona Canada Principles and issued a limited order after considering the potential costs and the impact on individual privacy rights that would be associated with a definitive order for more fulsome production.
In litigating a class action claiming product liability damages caused by a heart valve, the plaintiffs brought a motion to challenge the defendants’ production of (1) two clinical trials databases which included adverse events data, (2) questionnaires used to collect adverse event data and (3) a data entry database associated with the adverse events databases. The two clinical trials databases were maintained by the University of Pittsburgh (a non-party) pursuant to a research agreement. Likewise, the questionnaires were held by clinicians thoughout the world pursuant to research agreements. The defendants’ legal rights to the data entry database (called “POP”) were less clear, a significant complication given the University’s residence in a foreign jurisdiction.
There was no dispute that 28 “freezes” of the adverse events databases (representing data stores at a point in time) included highly relevant information, but the plaintiffs claimed that the defendants’ production effort was too slow and that the defendants’ manner of production did not allow them to assess the data’s validity. One of the defendants’ key objections: the University had redacted patient initials and birth-dates from the production. The University did not adduce evidence on the motion, but the defendants argued on the University’s behalf that it would be exposed to liability and a potential breach of U. S. federal or state privacy legislation if it provided the data in unredacted form. The defendants also raised the costs the University was bearing and would additionally bear if further, more fulsome production was to be ordered.
Master MacLeod considered the competing demands and said that the production “solution” should meet four criteria. He said:
- The data produced to the plaintiffs must be substantially the same data as that which has been reviewed by the defendants’ own experts. If not then the plaintiff and defendant experts are being asked to draw conclusions based on different information.
- The forensic continuity of the data must be demonstrable such that any issues about authenticity or accuracy can be readily answered.
- The process of redaction must not leave the data less meaningful or useful. While the exact birth-dates and initials of the patients may not be necessary to analysis of data, it will for example be critical that data attributable to specific patients can still be tracked and where there are associated slides or tissue samples or other medical records produced in the litigation this can be matched to the data in the same way as previous to the redaction.
- The process of redaction must not unduly delay production.
Master MacLeod held that the current manner of production did not meet the criteria. In particular, he took exception to the fact that the defendants’ experts were apparently working with original and unredacted data, which he said could put the plaintiffs at a disadvantage. The defendants’ use of unredacted information may also have led him to conclude that patient privacy, while warranting protection, may ultimately need to yield to “the imperative of justice.”
Master MacLeod’s order was limited in that it merely established a process and criteria to allow the e-discovery to proceed. The key part of the order, for example, read:
In the event the data cannot be produced in redacted form in a timely fashion or if the redactions can be shown to compromise the integrity of the data or if the redacted data is significantly different than the data available to the defence experts, the plaintiff expert is to be given access to complete and accurate copies of the 28 data freezes as well as a current set of data.
There are other aspects of the order that are of significance. For example, Master MacLeod reasoned that the POP database (being potentially controlled by a non-resident) was analogous to deleted or residual electronically stored information as that term is used in Sedona Canada Principle 6. He said, “Only if [the plaintiffs] cannot answer the questions accurately and there remain important unexplained anomalies in the AVERT data should it be necessary to consider production of the POP database.”
For more on the Sedona Conference‘s Sedona Canada Principles and for a summary of Master MacLeod’s 2006 order in this same case, see the LexUM E-Discovery Canada website.
Andersen v. St. Jude Medical Inc., [2008] O.J. No. 430 (QL) (S.C.J.).
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