eDiscovery document review can be time-consuming and expensive for companies. Depending on the results of the review, it also can be helpful for internal investigation or litigation purposes. To minimize the burden and maximize the benefit of document review, a good document review protocol is critical. A document review protocol is a set of instructions given to a review team, whether a law firm, in-house, contract, or other team tasked with the effort. A good document review protocol can make a large document review more accurate and efficient, whether reviewers are making responsiveness, privilege, and/or confidentiality decisions. This blog post addresses specific topics you must consider as defense counsel when drafting a protocol for mass tort or product liability cases. In these cases, a good protocol can help limit not only the scope of the lawsuit at hand but also the types of claims that can be brought.

Case Themes

A good document review protocol is essentially a crash course on the case, including plaintiff and defense themes. Consider explaining the causes of action, legal defenses, and examples of documents that might support the claims and defenses. An understanding of these claims and defenses is important to assist reviewers in identifying key documents and elevating themes in the documents for further review. For example, a review protocol may need to include an explanation on manufacturing defects and federal preemption to allow reviewers to identify documents that could be construed as evidence of a manufacturing defect, potentially altering a preemption defense. Although it is not possible or recommended to provide a comprehensive treatise on product liability and mass tort claims and defenses, a readable and brief introduction to specific case themes can ground reviewers in their review and help them better understand the case.

Product Names

The product or product name should be defined in your document review protocol. Reviewers can use the product name to make responsiveness decisions. The product at issue likely has had many names throughout its development process, however. As part of drafting the protocol, become familiar with the product code names, prototype names, chemical names, component names, active pharmaceutical ingredients, excipient names, or any other product nicknames so you can include these in your protocol and aid reviewers in making responsiveness decisions.

Timeline

In addition to the name of the product at issue in the litigation, consider providing reviewers with an overall timeline of the product-related events. These events can include the initial idea for developing the product, the design process (which can be iterative), the testing process, any redesign process and further testing, and ultimately product launch. Reviewers can use this timeline to make responsiveness decisions. For example, if there are design documents within a review population dated after the date of product launch, a reviewer can use the timeline to understand that these documents likely relate to other products and may not be responsive.

Other Products and Relevancy

Similarly, when drafting the protocol, it is important to understand products not related to the ones at issue that may appear in your custodians’ documents. Even though these products do not relate to the instant investigation or litigation, you may wish to learn enough about them to be able to draft instructions for your reviewers to identify and cull them. A well-written protocol, which identifies this information, can reduce review time by segregating your responsive documents and protecting your client from potentially producing commercially sensitive documents related to unrelated products.

Privilege Considerations

A document review protocol may also contain a privilege screen including names and terms to help identify potentially privileged documents. You may be familiar with the in-house litigation or business attorneys you work with on product at issue, but many types of attorneys touch any given product. A privilege screen list may include regulatory attorneys, internal investigation attorneys, patent attorneys, third-party consultants retained by counsel, and support staff for these individuals. These individuals may be in-house or outside counsel to your client. Your protocol should also describe any projects or investigations directed by counsel to assist with the privilege review.

PII/PHI Confidentiality

Finally, your document review protocol should consider whether customers’ confidential health information is likely to be in the scope of the document review, and if so, how to handle personally identifiable information/protected health information (PII/PHI). There are a variety of ways to determine the information you need to redact that depend on the circumstances of the case. Consider the bounds of your protective order and/or Electronically Stored Information protocol, how you will identify PII/PHI, and which standards, such as the HIPAA Safe Harbor rules, you will follow when redacting PII/PHI. It is also helpful to identify the types of documents and file types most likely to contain such data (e.g., adverse event data are often exported into large Excel files). Finally, you should also consider and work with your eDiscovery vendor to identify the most efficient redaction tools and methodologies for different file types, e.g., Blackout in native Excel files.

Trade Secrets/Confidential Business Information

Even though products liability and mass tort cases do not typically involve parties that are business competitors, in some cases you may wish to code documents with an extra layer of confidential protection. While most of the documents in your review set will be confidential, your protocol could include a second level of higher confidentiality for trade secret and commercially sensitive documents such as product formulations, financial information, and sensitive marketing plans. This higher level of confidentiality may help prevent the other side from sharing documents with experts who may work with or consult with your clients’ competitors.

Provide Early and Consistent Feedback

Consider creating a collaborative relationship between the reviewers and the individuals overseeing the review. Be sure to encourage questions from the review team and then follow through by answering those questions promptly and encourage group feedback on a regular basis. Your reviewers are going to be the experts on your document set, and by engaging in collaborative discussions, you may find out information and themes you did not learn from custodial or collection interviews. You may learn of other individuals involved in development and testing, important changes to your product timeline, or other potential claims a plaintiff may try to raise. Drafting a comprehensive document review protocol can save you review time and produce more value from the review for your client. The guidelines for general document review protocols in combination with those identified above may help you draft an appropriate review protocol for products liability and mass tort cases.