If the product must be shipped for each expert to examine, handling the evidence properly requires that anyone coming into contact with the evidence track its exchange, location, and that appropriate release and acceptance forms are completed. There also should be an agreement among the parties as to how much time each party has available to examine the product at issue and the order in which the examinations will occur. In addition, consideration should be given to having an agreement that all initial examinations be limited to nondestructive testing. Often the parties may agree to share any factual data (e.g., photographs or measurements) produced by each expert after individual examinations take place.
Thought should be given to preserving evidence at every step. Preserving medical device evidence means storing it in a safe place while it is being examined and also storing and shipping it under appropriate conditions so that the evidence will not be adversely affected.
For example, some devices need to be stored in a particular fluid for preservation (e.g., saline, formalin). Additional considerations should be given to separately storing and packaging various subcomponents so that each part is accounted for and the individual parts do not adversely affect each other if all parts are packaged together.
It is important for experts to understand where and in what conditions the subject product has been stored and preserved before they received the product for their initial examination. For example, when dealing with a medical device that has been explanted from a patient, the interested parties need to be aware of how the device was initially handled after it was removed from the patient and if it was cleaned at the health care facility. If the product is an explanted device, experts need to treat the device as a biohazard and follow safety precautions, even if it has been "cleaned" at the health care facility. This requires that the experts have the appropriate training and biosafety processes and resources in place to handle the device during its examination.
If the parties are interested in doing analyses that require destructive testing, there needs to be an agreement as to whether the product will be divided first among the interested parties (if feasible) or whether the analyses will be done by a third party in the presence of the various experts involved. If the product is to be divided among all interested parties, there needs to be a protocol as to how that will be done, and all parties involved need to have reviewed and agreed to that protocol. Involving your technical expert early in this process is very important because there might be technical challenges to conducting further analyses if the device is not divided appropriately (e.g., direction, shape, amount). If the product will be analyzed destructively by a third party in the presence of all the experts, there should be an agreement as to what analyses will be performed, the protocols that will be followed, who will conduct the analyses (including vetting the third party's credentials and certifications), and where the analyses will be conducted. The recommended approach is to have all experts involved in such an endeavor review the protocol with an eye toward avoiding surprises. In some situations, published industry standards might be helpful to ensure proper preservation of evidence and thorough detailing of destructive analyses.
As an example of destructive analysis, if the subject device is a metal orthopedic implant, metallurgical analyses might be recommended as one of the destructive analyses to be conducted. In this case, the device will likely be sectioned into smaller pieces, then prepared and analyzed using specialized techniques. The protocol for such an analysis should include details about how the sectioning and preparation will take place, where cuts will be made, and how the process will be documented. These details become particularly crucial in the event additional parties later become involved in the matter. Good documentation should allow anyone after the fact to piece together what was done, how, and what the device looked like prior to the work.
With proper care and communication, everyone involved in a product liability case will have the opportunity to thoroughly analyze the device in question. This allows experts to collect and consider the evidence necessary to develop and defend their opinions. Medical devices often present additional challenges regarding the preservation and handling of evidence, but your expert should have the training and expertise to help you navigate those challenges.
Keywords: litigation, expert witnesses, medical devices, product liability, evidence, preservation
Marta L. Villarraga, Ph.D., and William Kane, Ph.D., are with Exponent, Inc., in Philadelphia, Pennsylvania.