Victim Of Defective Medical Device Wants Manufacturer To Take Responsibility

Michael Mulvihill says he received 22 electric shocks within a span of 53 minutes from a faulty Medtronic defibrillator. The defibrillator had been implanted to address an irregular heart beat and pulse rate a little over a year prior to the incident. He says that he hopes no one else has to go through the pain and agony that he experienced because of the fractured lead, and that Medtronic is held responsible for the injuries they cause to patients like him. (0:27)

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Doctor Says Safety Concerns Over Med Devices May Still Remain Despite FDA Approval

William H. Maisel, MD, MPH, is a practicing cardiologist at the Beth Israel Deaconess Medical Center, and Assistant Professor of Medicine at Harvard Medical School. He is also the Founder and Director of the Medical Device Safety Institute. He says that unanswered questions regarding device safety and effectiveness sometimes linger even following FDA approval. He notes that this creates the potential for a large number of patients to be exposed to a newly approved product in the absence of long-term follow-up data. (0:17)
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Manufacturer-FDA Relations Need Change, Says Harkin

Sen. Tom Harkin (D-Iowa) says that the FDA conducts its approval process with minimal resources and does not have adequate funds to "genuinely ensure [medical] devices are safe, or to properly and effectively reevaluate approvals as new information becomes available." He says that the FDA expects manufacturers to provide information about their products and once those products are on the market, it expects the manufacturers to track and monitor for any problems. He believes that without the threat of product liability, there is not much incentive for manufacturers to report any problems found to the FDA or the public. (0:39)
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