Preserving Products Involved in Adverse Events

Published by Jenny Covington J.D.

Question: What can a company do to minimize the chance of spoliation of evidence after an adverse event?

Answer: Spoliation of evidence is the intentional or negligent withholding, hiding, altering, or destroying of evidence relevant to a legal proceeding. There are five best practices a company should consider following in order to minimize the risk of spoliation of evidence claims after an adverse event. First, it should work towards good public relations—that is to say it needs to communicate effectively and strategically with its reporting facility and/or clinicians and patients and gather as much information about the adverse event as possible. A company should be straightforward and helpful when addressing concerns, assuring customers and regulatory agencies that their concerns are being investigated. In doing so, it should avoid making any rushed conclusions about its product or the adverse event involving the product. It should be sure to keep its legal department in the loop regarding these communications as statements can easily be misinterpreted.

Second, a company should attempt to procure the product, if possible. If the product is still implanted in the patient, the company should try to obtain as much information as possible from clinicians, patients, and medical records. When doing so it should request that surgical videos, x-rays, MRIs, cat-scans, and other testing records are preserved. If the device has been explanted, the company should try to obtain as much information as possible regarding the explantation procedure, including the medical records, photographs, or videos of the procedure. If the device is available for whatever reason, the company should investigate who has possession—the facility or the patient—of the device. If the facility is resistant to turn it over, the company may want to offer some compensation or a replacement product. After receiving the product, the company should endeavor to carefully document the chain of custody and the manner of storage.

Third, a company should preserve and protect the product once it is in custody. It is important that the product be stored so that it can (as best as is possible) be preserved in its post-incident condition. The company should consider for instance how the product will be cleaned prior to storage, the type of container in which it will be stored, and the temperature under which it will be stored. A company should work with its technical personnel to verify the best procedures for storing the product and to document the procedures. It should also strive to preserve and protect the records associated with the product, including where it was manufactured, where it was sold, how it was distributed, and medical records regarding its implantation, alleged problem, and explanation.

Fourth, a company should consider developing written protocols regarding any testing or analysis that is to be performed on the product. Before developing an inspection protocol, all non-destructive testing options should be considered, and the state of the document should be carefully documented. Product investigators should attempt to understand the product’s design and manufacturing process as well as the circumstances surrounding the incident. Creating the protocol should be a collaborative process between the legal, regulatory, R&D, and manufacturing departments. It is important to get a signed written agreement from the consumer and/or reporting facility in the event destructive testing is necessary. Otherwise, any analysis performed on the products should be done so as to not destroy any features that may become the subject of litigation.

Fifth, throughout the process of procuring and preserving the product, a company should do its best to preserve communications, which are privileged. It is important for companies to involve legal counsel in important discussions regarding products involved in adverse events as they may be able to help the company preserve certain assessments, conclusions, and in-house opinions as attorney/client privileged information. This privilege helps protect these important communications from discovery requests.

Jenny Covington J.D. of Bowman and Brooke focuses on the defense of commercial litigation, intellectual property, and products liability matters.

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