Carlton “PeeWee” Gautney Jr., a 59-year-old Alabama police dispatcher and diabetes patient, depended on a Medtronic MiniMed insulin pump to regulate his insulin levels. However, his family believes a malfunction in the pump, which was part of a major recall, led to his untimely death in May 2020 by delivering a fatal insulin overdose. His daughter, Carla Wiggins, has filed a wrongful-death lawsuit against Medtronic, which has denied responsibility.
This case is part of a broader investigation by KFF Health News into medical device malfunctions, highlighting serious concerns about the safety and oversight of such devices. The investigation reveals that the FDA approves many medical devices, including implants, based on “substantial equivalence” to existing products rather than thorough safety testing. This process has led to numerous devices being suspected of causing injuries and deaths.
Examples include faulty artificial knees, metal hip implants, heart pumps, and dental devices, all of which have caused significant harm. The FDA’s process for tracking device malfunctions is also under scrutiny, as many adverse events go unreported, and manufacturers face minimal accountability for product defects.
The investigation underscores the need for more rigorous safety standards and better oversight in the medical device industry to protect patients from potentially harmful products.
To read more, click here.
[Source: KFF News, December 21st, 2023]