Heart Device Manufacturer Sued over Unenforced Recall

After a manufacturer of Implantable Cardio-Defibrillators and Cardiac Resynchronization Therapy devices placed an unenforced mass recall on their products, a class action of patients using the cardiac monitors sued the company for failing to notify them. Though the company made multiple types and tracking specifications of CRT-Ds and ICDs, each of them had experienced battery failures during use, causing severe injuries and death among numerous patients. Not all of the device users received notice of the recall, however, and many alleged that the manufacturer had endangered their health and safety by not fully enforcing the recall. Someone with expertise in the medical device industry was needed to comment on industry standards, as well as any risks the company could have reasonably known about its ICDs and CRT-Ds before the recall was put into place.

Question(s) For Expert Witness

1. Please describe your experience as it relates to cardiac devices like the ones described above.

Expert Witness Response E-032781

I have nearly thirty years experience in the medical device industry, working in Research and Development and regulatory industries. As a former engineer, I designed and researched a variety of medical devices, including cardiac monitors, and also have experience in failure mode investigation.