## Facts

- Consumers alleging injuries from Actos (pioglitazone), a prescription diabetes drug, pursued federal products-liability claims against Takeda Pharmaceuticals America, Inc. and related Takeda entities.
- The actions were coordinated in multidistrict litigation (MDL) proceedings in the United States District Court for the Western District of Louisiana.
- Plaintiffs organized a Plaintiffs’ Steering Committee (PSC) to conduct common discovery and represent plaintiffs’ shared interests in pretrial proceedings.
- Discovery involved large quantities of electronically stored information (ESI) in Takeda’s possession, making document review and production a major pretrial task.
- The PSC and Takeda negotiated a detailed protocol to use technology-assisted review (TAR) (predictive coding) as part of the process for identifying responsive, discoverable ESI.
- The protocol addressed how training and review would be conducted and included quality-control steps (including sampling/validation measures) to evaluate results.
- The parties presented the stipulated TAR protocol to the court and requested that it be approved and entered as a discovery order.

## Issues

1. Should the MDL court approve and enter the parties’ stipulated TAR protocol governing Takeda’s search for and production of responsive, non-privileged ESI?

## Decision

- The court approved the parties’ stipulated technology-assisted review protocol.
- The court entered the protocol as an order governing Takeda’s ESI search and production in the MDL.
- The ruling was a pretrial discovery order addressing the method of review and production rather than the merits of plaintiffs’ product-liability claims.

## Legal Principles

- A federal court may approve and enter a party-negotiated ESI protocol to manage discovery in complex litigation, including MDL proceedings.
- The Federal Rules of Civil Procedure generally require a reasonable discovery effort; they do not require perfection in locating every potentially responsive document.
- Proportionality under Rule 26 supports using efficient methods when the volume of ESI and the cost of manual review would be excessive compared to the needs of the case.
- Technology-assisted review can be an acceptable way to identify responsive ESI when the workflow includes meaningful quality-control measures (such as iterative training and sampling/validation) and when the process is structured to reduce disputes.
- Courts may retain continuing supervisory authority over discovery and can require the parties to confer and seek court guidance if disagreements arise during implementation of an approved protocol.

## Conclusion

In In re Actos Products Liability Litigation, the MDL court approved and entered the parties’ stipulated TAR protocol for Takeda’s ESI production, treating TAR—when coupled with agreed training and quality-control measures—as a reasonable, rules-consistent approach to managing large-scale electronic discovery in the Actos MDL.


In re Actos Products Liability Litigation, 2012 WL 7861249 (2012)