By Jerri-Lynn Scofield, who has worked as a securities lawyer and a derivatives trader. She is currently writing a book about textile artisans.
Kaiser Health News (KHN) reported yesterday in Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device that the FDA in 2007 recalled a device – the Sprint Fidelis – that 268,000 patients had embedded in their chests, to shock the heart back into rhythm in the event of abnormal heartbeats.
Note that this episode of regulatory crapification occurred in 2008 – long before Trump was inaugurated.
Alas, according to KHN:
The Sprint Fidelis was prone to giving patients random electrical jolts — and sometimes failed to fire in genuine cardiac emergencies, according to manufacturer Medtronic’s letter to doctors.
Patients who had elected to have the device installed were faced with the difficult — and potentially dangerous – choice of whether to leave the device in place, or undergo surgery to have it removed. In making that decision, patients and their doctors were kept in the dark, as:
…the Food and Drug Administration quietly took steps to keep critical information out of the public light. Shortly after the recall, the FDA and Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — now totaling 50,000 — shielded from public scrutiny.
Incredibly, this is not a one-off, rare event. The FDA allowed exemptions for other companies and devices until KHN blew the whistle:
The FDA has allowed device makers to file 1.1 million reports of injuries or malfunctions to a little-known internal FDA database since 2016, a recent Kaiser Health News investigation has found, spurring top FDA officials to pledge to open those records within weeks and shut down the “alternative summary reporting” program.
For the past two decades, the agency has granted various devices different types of so-called exemptions from reporting to their public-facing database, called MAUDE, KHN has found.
One of those exemptions covered the Sprint Fidelis. In May 2008, it was granted a “remedial action” exemption — allowed when “the manufacturer has initiated reasonable and appropriate actions to mitigate the problem(s)” and further reports of harm will not “provide any significant new data,” FDA spokeswoman Deborah Kotz said in an email. She said the FDA hasn’t granted such an exemption since 2015 and has “effectively ended the program,” and could not say whether that data would be opened to the public soon (emphasis added).
Now, I don’t know very much about medical devices and the FDA. So it’s possible that even though I wasn’t aware of this problem, those who practice medicine in this area were, and the KHN report should be discounted.
Except that’s not the case. As KHN recounted:
Six top cardiologists interviewed for this report said they weren’t aware the FDA had granted Medtronic such an exemption.
“Amazing. Really amazing,” said Dr. Robert Hauser, the Minnesota cardiologist whose research first brought the high rate of Sprint Fidelis failures to light. “It’s not in the best interest of the patients who have these devices.”
What could a patient do? Well, the patient could file a FOIA request for the information:
While doctors and patients can voluntarily report problems with the device, the FDA requires device makers to report to MAUDE the injuries they become aware of — unless they have an exemption.
Through March, Medtronic says, it logged more than 50,000 instances of harm or malfunction, with more than one problem reported for some of the 35,000 cases.
While a few reports in the MAUDE database refer to the existence of an exemption for the Sprint Fidelis, the FDA has said these “remedial action” reports are filed internally and available to the public through a Freedom of Information Act request, which can take nearly two years to process (emphasis added).
I encourage interested readers to read the full KHN story – it’s not long, and there are other sources and issues I want to address in this post.
FDA Rationale for Withholding Information: Reducing Paperwork
Ars Technica reported on the less-than-compelling rationale the FDA offered for its organised system of withholding information. So much for transparency:
The alternative reporting repository was ostensibly set up to cut down on paperwork for redundant incident reports. But its existence and use has been kept in the shadows, with many doctors, consumer advocates, and even some high-ranking employees at the FDA kept completely unaware of its existence. Now that they are aware, doctors and advocates say the concealed reports have kept necessary safety data from patients trying to accurately gauge and weigh their risks.
The list of exempted devices includes common and controversial devices. Some of these are typically implanted into patients and used in common surgeries, such as pelvic mesh, surgical staples, balloon pumps for improving circulation, breathing machines, and breast implants.
Following KHN’s investigation, the FDA announced that it will be shutting down the “alternative summary reporting” repository and ending exemptions. Former FDA official Dr. S. Lori Brown told KHN that the move is a “victory for patients and consumers.”
So this is not a one off, but an apparent policy. Stay tuned and pass the popcorn.
Coda: Keeping Foreign Regulators in the Dark
I want to close with a brief mention of another Medtronic controversy that’s sprung up in India. As reported in this 17th May account in The Hindu, Heart patients allege neglect by pacemaker manufacturer:
The world’s largest medical device manufacturer, Medtronic, appears to have decided to remain silent and continue selling its allegedly defective pacemakers in India. This puts thousands of heart patients at risk of a sudden death caused by premature battery depletion in their Medtronic pacemakers.
A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. It is a life-saving device. Medtronic, Abbott, Boston Scientific and Biotronik manufacture the leading pacemaker brands in India. In India, pacemakers cost between ₹1 lakh to ₹9 lakh, with batteries that last on average between 7-10 years.
On May 7, and in January 2019, along with a similar recall in January 2018, the U.S. Food and Drug Administration (FDA) issued warnings and recalled recalled some pacemakers manufactured and sold by Medtronic in that country after problems were detected in the device. This included pacemaker models named Azure, Astra, Percepta, Serena and Solara; CRT-Ds (Cardiac Resynchronisation Therapy-Defibrillator) such as Amplia; and ICDs (implantable cardioverter defibrillators) such as Evera.
Alas, the company never communicated this information “to medical professionals here [in India], confirmed Indian doctors and senior Health Ministry officials.” In the meantime:
“In fact, all these models are still doing brisk business in India,” said cardiologist Dr. Balbir Singh of the Medanta Mediclinic. His unit is currently dealing with at least nine patients who have returned for battery replacement, “a direct fall-out of this criminal neglect,” said Dr. Singh.
Now, in examining this issue, I noticed that the tone of The Hindu article is much more alarmist than that of an article published earlier this month in the Minneapolis Star-Tribune, After patient death, FDA warns of battery depletion in Medtronic pacemakers:
After a patient death, the U.S. Food and Drug Administration is warning about a rare battery-depletion problem in certain Medtronic pacemakers that could cause the devices to quickly lose power and trigger a medical emergency.
The FDA published an alert Tuesday that said Medtronic discovered a problem in which a crack can form in a ceramic electric component in some pacemakers, leading to rapid battery depletion possibly without triggering the replacement indicator. The issue was confirmed in three devices that had been returned to the manufacturer.
Dr. George Crossley, a Tennessee electrophysiologist who has studied device-battery problems … said the rate of failures is very low and patients shouldn’t have the devices removed if there’s no sign of a problem.
“This is really what we’ve always called a random component failure,” Crossley said, “and not something that in the past would have generated this kind of attention.
… “it would be a very crazy thing at this point for a patient to want this device removed and replaced. Their chance of getting hurt by getting a device infection with a change-out would be much higher than the chance of their experiencing a failure.”
I’m not a medical doctor, so I take no position on how serious the Medtronic battery problem is.
What certainly seems troubling to Indian health regulators is the apparent failure of the company to inform them of this problem – until those regulators requested this information from Medtronic after the FDA alert:
Dr. S. Eswara Reddy, Drug Controller General of India, said, “We are aware of the May 7 FDA alert on Medtronic pacemakers and its adverse effect on our patients. We have written to Medtronic asking them for details on how many of the allegedly defective products have been sold, and their position here in India. We have received a reply from them and it is being processed. We may soon come up with a public information/announcement about the problem.”