Risky heart pump shows how FDA fails patients on medical device regulation

fdahvad-230x300The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to compel safety fixes, and inadequately informs the public and medical community about problem products.

If that sounds like too broad and harsh an indictment of poor performance by a purported watchdog agency, just read the deep dig by ProPublica, the Pulitzer Prize-winning investigative journalism site, into the FDA’s record with the HeartWare Ventricular Assist Device, or HVAD.

ProPublica details the unacceptable actions that put thousands of patients at risk with a heart pump that cost $80,000, required major surgery, and that the FDA knew had significant problems but still allowed highly vulnerable people to have implanted. As reporter Neil Bedi found:

“As (product manufacturers) HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so. The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device. Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.

“The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses. For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily. When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death. Meanwhile, the processes to inform the public through formal FDA notices and messages to health care providers repeatedly failed and left patients in the dark about known problems with the HVAD.”

Agency officials have defended their actions, arguing that 80% of device makers respond to the FDA and fix identified problems. They also insisted that they were protecting patients while working with the HVAD maker — in fact, meeting with company officials more than 100 times (!) to discuss problems.

The agency argued that the device (shown above, in FDA illustration) served patients in dire circumstance — those with failing hearts and needing a major mechanical assist to pump blood. As ProPublica reported, however, this contention overlooks that this device had a successful competitor available on the market:

“In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.”

Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies medical device regulation, ripped the FDA for its handling of the HVAD:

“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices. How can you not take action on a warning letter with these serious issues with very sick patients?”

Bedi reported that the FDA knew early on that the HVAC maker would pose serious oversight problems for the agency and then patients:

“[The FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval. Among the findings, a federal inspector expressed concerns that engineering staff ‘were not completely reviewing documents before approving them’ and found one employee assigned to monitoring device quality had missed several required monthly trainings … Then, in 2014, the FDA found more serious lapses … For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure. The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.

“Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as ‘adulterated,’ meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action … The 15-day deadline passed, and the FDA never penalized the company. The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device.”

The harm to patients is real and sustained from the shaky heart pump, ProPublica reported, noting:

“The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will also provide technical support and troubleshooting for patients and medical staff. Medtronic said it will also offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary. Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.”

In my practice, I see not only the harm that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous devices, notably those of the medical kind.

As treatments, prescription drugs, and medical devices become more complex, uncertain, and costly, patients — and doctors and hospitals, too — find themselves relying on the supposed expertise, experience, and judgment of FDA regulators. Taxpayers will fork over huge sums this year to fund the sprawling agency and its $6.5 billion budget. The bottom-line expectation is that FDA bureaucrats work for us, the people, and not to coddle, encourage, or further enrich wealthy corporations that make medical devices or prescription drugs.

Jeanne Lenzer, a seasoned medical investigative reporter, has found that 32 million Americans — about one in 10 of us — have at least one medical device implanted in our bodies. These include artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. Most patients — indeed most of the public — may think federal regulators subject all this hardware to rigorous quality and safety testing.

That’s a wrong assumption. And though medical devices may be helping change and save many lives, Lenzer and others also warn they are harming and even killing too many patients. Under pressure from pro-business, anti-regulatory politicians and lawmakers, federal regulators have allowed a “Wild, Wild West” to flourish in the medical device business, she has argued.

The U.S. Congress may have plenty on its plate already, dealing with the coronavirus pandemic and its fallout, as well as voting rights, and numerous other pressing issues. But lawmakers must haul some FDA chiefs into hearings and ask what the heck is going on with oversight of medical devices.

President Biden also must end his silence and nominate a fulltime chief for the FDA — especially because the agency’s new leader has a lot of work to do to ensure the agency does the work it must to rein in Big Pharma and medical device makers from imperiling the lives of patients and their loved ones.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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