Tragic Death Linked to Insulin Pump Malfunction

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."

Medical Device Malfunctions Investigation

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.

Medtronic Faces Criticism and Lawsuits Over Insulin Pump Issues

During an inspection at Medtronic's plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren't investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an "insulin-induced coma" that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man's home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. "Simply too little, too late," the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic Faces Questions About Pump Safety

Medtronic declined to answer written questions about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones "redesigned to reduce the risk of damage" and "fulfilled all pump replacement requests at no cost to customers."

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Separate but equal

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has "substantial equivalence" to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was "not intended to evaluate the safety and effectiveness of medical devices" and said "a move away from the 510(k) clearance process should occur as soon as reasonably possible."

More than a decade later, that hasn't happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA's Device Approval Process Under Scrutiny

According to recent data from the FDA, approximately 3,000 low- to moderate-risk devices are cleared for sale each year through the 510(k) review process. This process requires device makers to pay a standard FDA fee of around $22,000. In contrast, only about 30 devices receive approval each year through the more stringent premarketing requirements, which cost nearly $500,000 per device.

Diana Zuckerman, president of the National Center for Health Research, has highlighted that many doctors are unaware that devices cleared for sale have not undergone clinical trials to establish their safety. She states, "Doctors are shocked to learn this. Patients aren't going to know it when their doctors don't."

When questioned about the 510(k) program, the FDA stated that it believes in the program's merits and will continue to work on improving the safety and effectiveness of devices cleared through this process. However, the FDA does not release detailed data on which devices manufacturers use as a basis for demonstrating substantial equivalence, making it difficult for researchers to analyze any potential problems.

Concerns over the 510(k) Process

In a recent lawsuit, two former Medtronic sales executives in California have raised concerns about the abuse of the 510(k) process.

The lawsuit alleges that the FDA approved the Puritan Bennett 980 (PB 980) ventilator in 2014 based on its substantial equivalence to the PB 840, an earlier mechanical ventilator that was widely used in the industry.

However, the whistleblowers claim that the PB 980 has completely different internal components and operates using different mechanisms, making it substantially different from the PB 840.

Medtronic's subsidiary company, Covidien, made this claim despite the significant differences in the devices.

Medtronic has responded to the allegations by stating that it believes the claims are baseless and has filed a motion to dismiss the case. The lawsuit is currently pending.

The whistleblowers argue that the PB 980 ventilator had been experiencing dangerous malfunctions for years before it was recalled in late 2021.

According to the lawsuit, one ventilator even emitted smoke in an intensive care unit, and the whistleblowers were informed by a hospital that the wheels on the ventilator cart could potentially fall off during transport.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a "manufacturing assembly error" that the company said may cause the ventilator to become "inoperable."

Medtronic said in an email that the ventilator "has helped thousands of patients around the world," including playing a "critical role in the global response to the COVID-19 pandemic."

Late warnings

The FDA operates a massive database, called MAUDE

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody's guess.

Experts and lawmakers are emphasizing the need for the FDA to improve its ability to detect safety problems more quickly. They argue that this is crucial in order to prevent potential harm and save money in the long run.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have been advocating for the inclusion of unique device identifiers on Medicare payment claim forms for several years. This would enable better tracking of products that have failed or pose safety risks. Grassley stated in an email to KFF Health News that this is a "commonsense step we can take up front to mitigate risk, improve certainty, and save money later."

Medical Device Oversight: A Global Perspective

In a world where medical devices play a crucial role in patient care, the issue of oversight and regulation is a topic of concern. While some countries have implemented measures to ensure the safety and efficacy of medical devices, others lag behind.

One such country is the United States, where device manufacturers are not required to demonstrate that their new products are better than those already on the market. This lack of regulation has led to troubling findings from overseas, which are often cited in product liability lawsuits.

Australia, along with a dozen other nations, has taken a different approach. They maintain registries that compare the performance of medical devices against competitors, with the goal of not paying for care involving substandard devices. This proactive measure helps identify issues early on and protects patients from potential harm.

For example, the Australian surveillance network detected deficiencies with the Medtronic PB 980 ventilator, leading to a six-month suspension of its use until Medtronic addressed the problems. This collaboration between the Australian health authority and Medtronic highlights the importance of patient safety and the need for ongoing improvement in medical device technology.

Similarly, registries in Australia and other countries revealed durability problems with Exactech's Optetrak knee implants years before a major recall. This information, if shared globally, could have potentially prevented harm to patients.

It is clear that different countries have varying levels of oversight when it comes to medical devices. While some prioritize patient safety and take proactive measures, others rely on the market to regulate itself. As the global medical device industry continues to evolve, it is crucial that all nations prioritize patient safety and work together to ensure the highest standards of care.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it's not available to them.

"Exciting features"

While the FDA clears thousands of devices for use based on the "substantial equivalence" premise, manufacturers often tout "new and exciting features" in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing Campaigns and Legal Barriers in Direct-to-Consumer Advertising

Marketing campaigns directed at prospective patients may receive little scrutiny. According to a Government Accountability Office report, the FDA has limited resources to actively monitor the volume of direct-to-consumer advertising.

Legal barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn't have agreed to the procedure.

He lost when the judge cited a legal doctrine called "learned intermediary." The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device's risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt blindsided. "They never gave me any warning about what could happen down the road," he said in an interview. "I never had a chance to have my day in court."

The family of PeeWee Gautney is also encountering difficulties in pursuing the insulin pump lawsuit.

In late March 2020, Medtronic sent Gautney a generic letter, less than two months before his passing, advising him to ensure that the ring was properly locked in place. A week later, Gautney responded, assuring the company that everything was fine, according to court records.

Wiggins, 33, Gautney's daughter and a neonatal respiratory therapist, believes that a crack in the retainer ring caused it to release an excessive amount of insulin, which her father may not have realized.

"It should never be the patient's responsibility to determine if there is a problem," Wiggins stated.

Medtronic has refuted the claim that the pump malfunctioned and caused Gautney's death. In a motion for summary judgment filed in September, Medtronic argued that the FDA approved the device despite the known risk of incorrect dosage administration, as the benefits were deemed to outweigh these risks. The motion is currently pending.

Medtronic Faces Legal Battle Over Insulin Pump Safety

Medtronic, a leading medical device manufacturer, is facing a legal battle over the safety of its insulin pumps. The company has cited a legal doctrine that grants the Food and Drug Administration (FDA) sole oversight authority over devices receiving premarket approval. This doctrine preempts any product defect claims brought under state laws, allowing manufacturers to avoid liability for patient injuries.

However, Wiggins, a patient who suffered injuries due to a Medtronic insulin pump, hopes to challenge this doctrine. Her lawyer argues that a FDA warning letter from December 2021 reveals that Medtronic violated safety and manufacturing standards. The lawyer believes that the company downplayed the hazards associated with its insulin pumps, while exaggerating the benefits.

The outcome of this legal battle is uncertain, as federal courts are split in applying the preemption defense. However, Wiggins and her lawyer are determined to hold Medtronic accountable for the injuries caused by their insulin pump.

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KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.