Case Study: Global Pharmaceutical and Medical Device Company
Conducting A Large, Complex Managed Review With An Intricate Quality Control Process
Facing an investigation by the FDA, a large pharmaceutical and medical device company engaged Special Counsel to review more than a quarter of a million documents in just under two months.
- Assembled a document review team with 180 document review attorneys
- Delegated responsibilities to individual members of our experienced Project Manager team, ensuring attention to detail and establishing accountability
- Reviewed and produced batches of documents on a tiered, rolling basis to meet the strict deadline
- Worked with outside counsel to meet stringent quality control guidelines
- Provided detailed reports throughout the review
Special Counsel delivered a successful Managed Review. Twenty-eight percent of the documents underwent our stringent quality control process, resulting in an on-time delivery, a 97 percent accuracy rate and $58,700 cost savings to the client.
To be able to focus on the case, not the extensive document review, while ensuring the deadline was met and accuracy was maintained.
180 Document Review Attorneys
286,000+ Complex Technical Documents Reviewed
8 Weeks to Perform the Review
100 Issue Tags Required
97% Accuracy Rate
58,700 Total Savings
Read the full case study:
A large pharmaceutical and medical device company with manufacturing plants worldwide was under investigation by the United States Food and Drug Administration. Plaintiffs brought a shareholder derivative suit on behalf of their investors, asserting that fraudulent public statements were made by the company and its management that adversely affected the company's stock price.
The company engaged Special Counsel to review more than 250,000 highly complex documents within an eight week period. The documents needed over 100 issue tags, 12 separate subject and content matters, and rolling productions and redactions.
The inflexible timeline imposed by the court to review the client's electronically stored information, along with a complex coding template, posed a considerable challenge. Special Counsel's Delivery Team presented the client with options that all but guaranteed meeting the court-mandated deadline.
The client received an influx of additional documents two weeks later, requiring a significant expansion of the team. To quickly ramp-up for the review and to generate significant cost savings, Special Counsel recommended hosting the review in one of its National Delivery Centers. The state-of-the-art review facility, equipped with Special Counsel's proprietary SightManager® supervision and video-conferencing technologies, allowed outside counsel to interface with the remote team just as effectively as if all parties were sitting onsite.
Special Counsel calculated the size of the team needed to meet the client's objective based on the case protocol, review tool provided, document format and historical data gathered from hundreds of managed reviews. Special Counsel's Delivery Team quadrupled the number of document reviewers in less than two weeks and ultimately employed a total of 180 document review attorneys working under the leadership of our Project Management Team, which was comprised of one Lead Case Manager and three Project Managers.
Each member of the Project Management Team was delegated responsibilities based on their areas of expertise and previous experience. Under the guidance of the Lead Case Manager, one Project Manager supervised all administrative tasks for the case. He focused on creating detailed reports for the client that included nightly updates on individual attorney accuracy, total documents reviewed, hot documents and responsive rates. He created and distributed batches of documents for review and also performed final quality control on batches of documents prior to release for production.
A second Project Manager served as a substantive resource for the team. He created and updated a nightly decision log sent to counsel with team inquiries. This Project Manager also handled all communications with the hosting vendor including searches, highlighting, lockouts and latency. These decision logs were of paramount importance as they aided in the creation of an audit trail for a defensible review.
A third Project Manager worked closely with the Lead Case Manager to supervise the quality control workflow and oversee the quality control work performed on the 180 person team. This role entailed composing and maintaining internal quality control records, sending feedback to individual team members as necessary and sampling and monitoring the Quality Control Team's work product. As another crucial part of the audit trail, The Project Manager kept detailed logs and counsel was provided a record that documented each step in this process.
With their individual responsibilities clear, each Project Manager was accountable for a designated area of quality assurance. These areas included checking for incorrect or missed responsiveness calls, privilege calls, issue tags, validations, conflict tagging and redactions. By implementing these processes and procedures, Special Counsel allowed the attorney of record to focus on the strategy of the case and not the logistics of eDiscovery.
Batches of documents were produced to opposing counsel on a tiered basis. The Project Managers implemented strategies to segregate documents needed on this rolling basis to meet the client's production deadlines. In total, the case consisted of 43 custodians that were sent to counsel in 14 separate releases.
Accuracy is of utmost importance to Special Counsel and was a focal point of the workflow and quality control process implemented. Our Lead Case Manager coordinated and worked with outside counsel to meet their quality control guidelines for all batches reviewed. As obstacles were encountered, the Project Management Team quickly coordinated with counsel for feedback and guidance in order to reorganize the workflow or refresh training when needed, ensuring that both the randomized as well as targeted searches were effective in meeting counsel's internal standards.
Special Counsel provided the client with nightly reports on each individual team member's review rate and quality of performance. The Lead Case Manager worked closely with the team to ensure that all reviewers were held to stringent performance standards. Implementing a tiered approach to quality control, the Delivery Team delivered a high level of accuracy, exceeding the expectations set forth by counsel.
Working extensively with counsel and the hosting vendor, the Lead Case Manager ensured the review tool platform was set up to maximize efficiency. She created the quality control and quality assurance structure for the client and ensured quality assurance searches were performed daily. This yielded constant feedback to the review team and was instrumental in providing in-depth communication to the client. By implementing these processes and procedures, Special Counsel delivered a timely, high-quality managed review.
Outcomes / Highlights
Special Counsel's Delivery Team created a workflow that was flexible yet thorough and met the changing dynamics of this case. By focusing on the quality control process and providing clear communication, the Project Management Team lowered error rates and maximized efficiency.
Some of the highlights of this engagement included:
- A total of 286,564 documents reviewed in total
- 28 percent of documents underwent Special Counsel's standardized quality control procedure, quality assurance targeted searches and privilege review searches
- Our approach resulted in an accuracy rate of 97 percent
- The client realized $58,700 in overall savings
"Thank you to all of you for how hard you worked. You conquered every obstacle and kept on going, illustrating the depth of our relationship and true partnership. We could not have gotten those productions out of the door without your dedication, diligence and flexibility."