According to The Wall Street Journal, the FDA is becoming increasingly concerned about the continuing and increasing number of hardware and software problems associated with insulin pumps, small devices worn by many diabetics to continuously deliver insulin, as an alternative to shots. Incredibly, over the last five years, there have been 18 recalls of insulin pumps, including recalls by manufacturers Johnson & Johnson, Medtronic, Inc., and Roche Holding AG. Tomorrow, the FDA is convening an advisory panel of experts to discuss what needs to be done to “minimize risks associated with the devices in these situations.”
These insulin pumps are typically used by diabetics who have Type 1 diabetes who produce little to no insulin naturally. The FDA has reported that the use of these pumps has tripled since 2002.
In the last two years alone, there have been nearly 17,000 adverse event reports filed and 12,000 injuries related to insulin pumps, many resulting in death. In fact, in 41 adverse event reports claiming the device resulted in death, the circumstances surrounding the death involved diabetic coma and incorrect blood sugar measurements.
Moreover, adverse events from medical devices are typically underreported to the FDA so the number of injured patients from these products is substantially greater than 12,000. This is an incredibly high number of adverse events for a device that is so critical to so many diabetics.
Many additional questions need to be asked besides those posed to the FDA advisory committee tomorrow concerning what to advise a patient when their device is recalled. The more significant questions that need to be asked are (1) why wasn’t the FDA calling for expert advisory meetings 10,000 injuries earlier; (2) what is causing these products to continually malfunction; and (3) why are the device manufacturers continuing to produce, sell and market defective products? These devices can obviously increase the quality of life for thousands of diabetics – but no diabetic would trade this benefit for the risk of their device malfunctioning.
If you’ve been injured as a result of defective insulin pump, do not hesitate to contact Pogust, Braslow & Millrood, LLC, so we can evaluate your potential claim.