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Deaths and lawsuits expose flaws in FDA’s medical device oversight

A slew of lawsuits in the US – resulting from patients’ deaths – has highlighted the potential risks of various medical devices, most of which, including 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 on the market, a questionable approval process that’s been slammed by numerous critics and experts in their fields.

Diabetic Carlton Gautney (59) had relied on a small digital device to pump insulin into his bloodstream.

The pump, manufactured by 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 died suddenly on 17 May 2020, because – his family believes – the pump malfunctioned and delivered a fatal overdose of insulin.

His daughter, Carla Wiggins, is suing the manufacturer.

The lawsuit alleges the pump was “defective and unreasonably dangerous”, reports KFF Health News.

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”, and “be life threatening or 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 that remained on the market for more than 15 years despite packaging issues 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, necessitating urgent surgery;
• last-resort heart pumps that FDA records state may have caused or contributed to thousands of deaths; and
• a dental device, used on patients without FDA review, that lawsuits alleged caused catastrophic harm to teeth and jawbones.

The investigation has found that most medical devices, including many implants, are now cleared by the FDA without tests for safety or effectiveness, and with the makers merely having to show they have “substantial equivalence” to a product already available, an approval process some experts view as vastly overused and risky.

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.

The FDA told KFF Health News it “has a scientifically rigorous process to evaluate the safety and effectiveness of devices”.

‘Too little, too late’

The FDA approved the MiniMed 670G insulin pump in September 2016, after its most stringent safety review, a little-used process known as pre-market approval.

Jeffrey Shuren, who directs the FDA’s Centre for Devices and Radiological Health, had lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed.

The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events”.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in 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 criticised the company in a December 2021 warning letter.

Medtronic now faces 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, the company disclosed in a 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, show lawsuits filed since 2019. Some have been settled under confidential terms, others are pending or have been dismissed.

Medtronic has denied responsibility in response to the lawsuits.

In one pending case, one man using the pump allegedly fell into an “insulin-induced coma”, leading to his death in 2020. In another case, a 67-year-old collapsed at home, dying later that day in hospital.

The recall notice Medtronic sent to a 43-year-old 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 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 last year, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier – and cheaper – pathway to the marketplace. This 510(k) clearance requires manufacturers to show that 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 that “a move away from the process should occur as soon as possible”.

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

The FDA now clears about 3 000 low- to moderate-risk devices annually through 510(k) review, costing the device maker a standard FDA fee of about $22 000. That compares with about 30 approvals a year through the stricter premarketing requirements, costing nearly $500 000 per device.

Diana Zuckerman, PhD, president of the National Centre for Health Research, said even many doctors don’t realise devices cleared for sale typically have not undergone clinical trials to establish their safety.

In response to written questions, the FDA said it “continues to believe in the merits of the 510(k) programme and will continue to work to identify improvements that strengthen the safety and effectiveness of 510(k) cleared devices”.

The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence – what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyse if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands – along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation.

Just four of these hip devices have been the target of more than 25 000 lawsuits seeking damages, court records show. In 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm bells

Two former Medtronic sales executives in California argue in a whistle-blower lawsuit that the 510(k) process can be abused.

They said the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, said the whistle-blowers’ suit.

In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case”. The case is pending.

The whistle-blowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an ICU while the whistle-blowers were told by one hospital that “the wheels for the ventilator cart may actually fall off during transport”.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or malfunctioned; 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 removing its batteries, according to the suit.

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

Medtronic said the ventilator “has helped thousands of patients worldwide”, including playing a “critical role in the global response to the pandemic”.

Late warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. Manufacturers are required to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.

These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported. Just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5 000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events timeously.

The FDA said it is working to “strike a balance between assuring safety and fostering device innovation and patient access.”

Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.”

Private eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

Product liability lawsuits in America often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants  manufactured by Florida company Exactech years before a major recall.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for healthcare workers and took other steps to improve it, court records show.

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.

‘Exciting features’

While the FDA clears thousands of devices based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising, said researcher Alexander Everhart at the Washington University School of Medicine.

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.

Orthopaedic device makers have funnelled 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 directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising” shows a recent Government Accountability Office (GAO) report. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, showed the GAO report.

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

And manufacturers have drawn on the pre-emption defence to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

 

KFF Health News article – Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records (Open access)

 

See more from MedicalBrief archives:

 

Hip implants ‘just snapped in half’, allege US lawsuits

 

FDA’s ‘deceptive’ system allowed implant complaints to escape notice

 

Massive Philips recall highlights flaws in medical device surveillance

 

Billions paid out in the US to replace defective heart devices

 

Implant investigation shows costs of poor regulation and testing

 

 

 

 

 

 

 

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