FTI Technology Navigates Pandemic Challenges and State Secrets Restrictions in Vast Cross-Border Pharmaceutical Investigation
Following a 2019 Food & Drug Administration recall of a drug that was thought to contain a harmful contaminant, numerous lawsuits were filed against the pharmaceutical manufacturer in multiple states. The matter eventually consolidated into class action litigation, triggering a widespread investigation spanning three countries. Over the course of more than 18 months, FTI Technology’s Digital Forensics & Investigations team conducted the investigation across numerous facilities and more than 80 custodians, overcoming complex challenges relating to cross-border data transfer issues, Chinese state secrets restrictions and global data privacy regulations.
The corporation and its law firm engaged FTI Technology in the early months of the coronavirus pandemic, after their initial provider was unable to deliver the localized support and expertise needed to kick-off the investigation in China, where the client was headquartered, and the majority of its data was stored. With international travel locked down, onsite support at the client’s multiple Chinese facilities could only be provided by local team members. When the data collection shifted to focus on the client’s U.S. operations, most U.S. states had locked down, and FTI Technology’s team had to establish a remote collection methodology that could accommodate the matter’s scale and data security requirements.
In addition to addressing logistical barriers, the team also supported the client in meeting extensive data handling challenges, including converting hundreds of thousands of paper documents and lab notes into a digital format for use within the analysis and review platform. Given the nature of the case, the data set also included sensitive information including intellectual property and trade secrets, which required the implementation of specific access and security controls during data collection, review, transfer and production. Similarly, additional reviews and removal of certain information were needed to maintain compliance in China with the State Secrets Law and other data protection laws, and in Europe under GDPR.
FTI Technology maintains a robust team of digital forensics, investigations and e-discovery experts throughout Asia Pacific. With outside counsel unable to travel to client sites in China, the local FTI Technology team in Shanghai quickly became valued advisors for the local client and their international counterparts. The month before on-site collections began, the team conducted daily calls to establish trust and develop the foundation for a successful and efficient investigation, including scope, organization and data charts, custodian questionnaires, collection processes and other documentation.
On-site collections were conducted using FTI Technology’s proven methodologies and completed in half the estimated time. Once all of the data from within China was collected, the team provided key solutions and services including:
- Implementation of a secondary, portable database that remained on-site at the client location and other security controls including air-gapping and encryption to ensure confidential R&D, source code and other IP did not leave the company. The team ran search terms within the database and exported anything that was designated for top secret review only, so a select team of approved lawyers and investigators could review for relevancy to the investigation and redact information as needed before it was loaded back into the primary database.
- Custom templates, mobile phone collection processes and redaction data filtering processes to overcome various data-related challenges and limitations.
- Enabled and oversaw high-pressure in-country responsiveness review of nearly 1 million documents across two Chinese law firms. FTI Technology worked as an intermediary between the firms, U.S. outside counsel and the client to ensure collaboration and consistency in processes.
- Developed a complex customized process and formulas to accommodate search using highly complicated and nuanced keywords and search parameters.
- Supported the involvement of a third local law firm to conduct a separate state secret review leading up to the transfer of documents to the U.S.
- Established a team of more than 40 managed document reviewers to re-review the documents for responsiveness, privilege and quality control once they arrived in the U.S. and finalize the production set.
- Managed subsequent reviews and rolling productions ordered by the court following the initial production deadline, including conducting data collection, review and compliant cross-border data transfer of more than 400GB of data for a custodian in Europe.
This ongoing matter represents one of the largest and most restrictive matters FTI Technology’s teams have encountered. Despite countless challenges and an aggressive opposing side, the team has delivered across every requirement.
- Provided local expertise and support in China when other providers couldn’t, ensuring forward progress for a highstakes investigation and establishing a trusted advisory relationship with the client and outside counsel, amid numerous global restrictions due to the coronavirus pandemic.
- Ensured on-time and defensible collection, review and production of hundreds of thousands of highly sensitive paper and electronic documents, following extensive controls to maintain confidentiality, protect IP, ensure data privacy compliance, overcome logistical issues and maintain constant alignment with Chinese law.
- Delivered numerous, rolling productions under seven unique bates schemes pertaining to various plaintiff complaints, regional sub-groups and the client’s numerous corporate entities.