Sunday, February 25

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

(Oona Tempest/KFF Health News)

Coping with diabetes, Carlton “PeeWee” Gautney Jr. count on a digital gadget about the size of a deck of playing cards to pump insulin into his blood stream.

The pump, made by gadget maker Medtronic, linked plastic tubing to an insulin tank, which Gautney set to launch dosages of the essential hormonal agent throughout the day. Gautney, a motorbike lover, worked as a dispatcher with the authorities department in Opp, Alabama.

The 59-year-old dropped dead on May 17, 2020, because– his household thinks– the pump malfunctioned and provided a deadly overdose of insulin.

“There’s a huge hole left where he was,” stated Gautney’s child, Carla Wiggins, who is taking legal action against the maker. “A huge part of me is missing out on.”

The wrongful-death suit declares the pump was “malfunctioning and unreasonably hazardous.” Medtronic has actually rejected the pump triggered Gautney’s death and submitted a court movement for summary judgment, which is pending.

The pump Gautney depended upon was amongst more than 400,000 Medtronic gadgets remembered, beginning in November 2019, after the business stated in a recall notification that damage to a retainer ring on the pump might “cause an over or under shipment of insulin,” which might “be harmful or might lead to death.”

As the recall played out, federal regulators found that Medtronic had actually postponed acting– and cautioning clients of possible dangers with the pumps– regardless of generating 10s of countless problems about the rings, federal government records reveal.

Over the previous year, KFF Health News has actually examined medical gadget breakdowns consisting of:

  • Synthetic knees produced by a Gainesville, Florida, business that stayed on the marketplace for more than 15 years regardless of product packaging problems that the business stated might have triggered more than 140,000 of the implants to wear too soon.
  • Metal hip implants that snapped in 2 inside clients who stated in claims that they needed immediate surgical treatment.
  • Last-resort heart pumps that FDA records state might have triggered or added to countless client deaths.
  • And even an oral gadget, utilized on clients without FDA evaluation, that suits declared has actually triggered disastrous damage to teeth and jawbones. CBS News co-reported and aired television stories about the hip and oral gadgets.

The examination has actually discovered that a lot of medical gadgets, consisting of lots of implants, are now cleared for sale by the FDA without tests for security or efficiency. Rather, makers need to merely reveal they have “significant equivalence” to an item currently in the market– an approval procedure some professionals deem greatly worn-out and filled with dangers.

“Patients think they are getting an implant that’s been shown safe,” stated Joshua Sharlin, a previous FDA authorities who now is a specialist and professional witness in drug and medical gadget guideline. “No, it hasn’t,” Sharlin stated.

And when those gadgets reach the market, the FDA has a hard time to track breakdowns,

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