The extensive procedural requirements of the U.S. courts for companies active on the American market were in place even before the recent Volkswagen exhaust scandal. However, the life sciences sector is affected by the e-discovery requirements just as much if not more so than the automotive industry that is currently the focus of attention. Plaintiffs were granted powers similar to those of state prosecutors with the amendment of the Federal Rules of Civil Procedure (FRCP) in 2006 – and not only in product liability lawsuits. Requests for information were expanded to include electronically stored information (ESI) which has far-reaching consequences for how information is handled in the company. A plaintiff (with the support of the courts) may demand the surrender of all relevant ESI from the defendant. This applies to standard e-mails as well as Office documents and text messages on smartphones, online content, and social media posts. Failure to deliver the information within the imposed deadlines or even the inability to identify relevant information and safeguard it against changes can lead to heavy penalties and the loss of the case, regardless of how the evidence may point. Public authorities and other jurisdictions are increasingly expecting compliance with e-discovery standards within the scope of requests and investigations as well. Only certain procedures are now being accepted for internal searches and the evaluations of documents.
A comprehensive regulatory, organizational, and technical response to these requirements is essential in view of the numerous legal risks in the life sciences sector due to patent lawsuits, liability and cartel proceedings, and disputes regarding the protection of intellectual property. This risk is escalated further by the vast number of documents that need to be produced and retained due to strict regulatory requirements in the pharmaceuticals industry. The transfer of these data volumes to a cloud for cost reasons represents an additional challenge in case of e-discovery.
A company-wide information management system tailored specifically to these requirements can help ensure that all documents in the company are retained and accessible as long as necessary for operational and legal purposes, after which they are then destroyed securely and in a legally compliant manner. Legal and IT departments have to have intimate knowledge of the procedural and technical requirements and meet them as well. This ensures that relevant documents can be identified, evaluated, and delivered quickly and cost effectively with special software tools. Only then it is possible to accurately predict the company’s legal and financial risks. If this is not the case, costs and fines can quickly reach into the billions, negatively affecting the image and bottom line of the company.