Medical Device Expert Witness
Thomas J. Green is available as an expert witness for cases involving high-reliability military, space and medical device applications.
Having spent time in industry, government research labs, and academia, Tom has gained considerable expertise regarding the materials and processes used in the microelectronic packaging of such devices.
He has developed a strong perspective on the many possible causes of device failures as well as hermetic package sealing and hermeticity testing of hybrids and other types of hermetically sealed implanted Class III medical devices.
Tom is an experienced expert witness at both deposition and trial. He has hadled patent cases and product liability cases related to Class III medical implants. One case in particular involving a cochlear implant failure can be found here.
“Class III implants may fail in the body due to loss of hermeticity. A hermetic seal is effectively an airtight seal that prevents moisture from penetrating the device cavity and interfering with the sensitive microelectronics contained inside. If moisture builds up inside a device implanted in the human body it may fail prematurely and have to be surgically removed. There have been and continues to be problems with hermeticity and high levels of moisture inside implanted Class III medical products.”
Hermeticity and high moisture inside implanted Class III medical products continues to be a problem.
Two such examples are as follows:
- In the past implanted pacemakers failed in patients, as reported in a Medical Device Alert (#MDA/2005/047) … "Hermeticity failure may lead to ingress of body fluids, which may adversely affect the operation of electronic circuits and device performance."
- Cochlear implants have also failed after surgical implant and according to the FDA (news release P04-92)…”some of the devices may malfunction due to moisture.”