I am highly qualified to work as an expert on this case. I have reviewed many similar devices to the one used in this case, both while at the FDA and during my current forensic work. Additionally, prior to joining the FDA and while working at NASA, I actually reviewed a heat transfer analysis performed by a colleague for the exact same device used in the procedure for this case (uterine ablation device). The fact that device #1 failed the ‘air test’ (even on repeated tries) indicates it was defective. The fact that device #2 was first tested by the rep (and passed) then handed to the physician to use is suspicious to me. This pass requirement (test before using on patient) is usually called out in the device label. A careful review of the device label is necessary to determine that procedures were followed correctly. I am able to review more records, or the device itself, to determine if it malfunctioned.

Additionally, there are many reasons the device could have malfunctioned. On first glance, I question the training of the physician to use this particular device – did the physician receive any training or was he/she relying on the representative? If the physician was properly trained to use the device, based upon the physician’s and representative’s descriptions of ‘unusual sounds’ it does indicate a malfunction in device #2. I have done expert witness work on a large number of cases involving medical devices. I have also reviewed similar cases involving transvaginal mesh, hip implants, kidney stone retrieval device, and infusion pumps. Typically there is a combination of issues that lead to the incident, including device manufacturing problem (quality related), the label on the device not being adequate, and the training/experience of the user/physician for the specific device in question. This case is right in my area of expertise and I am happy to assist.