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

From KFF Health News: “Living with diabetes, Carlton ‘PeeWee’ Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

‘There’s a big hole left where he was,’ said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. ‘A big part of me is missing.’

The wrongful-death lawsuit alleges the pump was ‘defective and unreasonably dangerous.’ Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could ‘lead to an over or under delivery of insulin,’ which could ‘be life threatening or may result in death.’

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

• Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.
• Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.
• Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.
• And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have ‘substantial equivalence’ to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

‘Patients believe they are getting an implant that’s been proven safe,’ said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. ‘No, it hasn’t,’ Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.”

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