Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy.

People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which narcotics such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a Sept. 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost two weeks passed before she was allowed to bring her baby home, the story said.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The U.S. Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the FDA in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI.

The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study co-authored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The U.S. Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two co-sponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

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When the Consumer Product Safety Commission announced that poorly designed baby loungers could suffocate babies, it warned consumers to immediately stop using them.

But when it comes to medical devices, the Food and Drug Administration and manufacturers routinely allow doctors and hospitals to continue using equipment that, as the government sees it, could injure or kill the patients it’s supposed to help. KFF Health News recently highlighted the issue of non-recall recalls in an examination of MitraClip, a cardiac implant.

In 2016, medical device giant Abbott issued a recall for the device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” an FDA notice said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves.

In a notice, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

The company told KFF Health News that the device has been proved safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

Medical device recalls can include “removals,” in which the device is pulled from where it is used or sold, and “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California at San Francisco and former editor in chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo multiple recalls while still on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

In some cases, a medical device that is the subject of a recall can remain on the market safely with a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices can provide unwarranted reassurance and leave the public at risk, Dhruva said.

“Depending on the risks and benefits of the device versus the alternatives, it may be better to actually remove the recalled device from clinical use and the market,” Redberg said.

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“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.

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In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

Oz did not respond to a request for comment on that statement.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,'” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

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In the emails, David Morens, a career federal scientist now on administrative leave, described deleting messages and using a personal email account to evade disclosure of correspondence under the Freedom of Information Act.

“i learned from our foia lady here how to make emails disappear after i am foia’d but before the search starts, so i think we are all safe,” Morens wrote in a Feb. 24, 2021, email. “Plus i deleted most of those earlier emails after sending them to gmail.”

The pressure is on as Fauci himself prepares to appear June 3 before a House subcommittee exploring the origins of covid-19. The NIH, a $49 billion agency that is the foremost source of funding in the world for biomedical research, finds itself under unusual bipartisan scrutiny. The subcommittee has demanded more outside oversight of NIH and its 50,000 grants and raised the idea of term limits for officials like Fauci, who led the National Institute of Allergy and Infectious Diseases, an NIH component, from 1984 to 2022.

Lawmakers are likely to put Fauci on the spot about Morens’ emails at a time when Republicans are questioning NIH’s credibility and integrity. Even Democrats have cautioned the agency’s leaders.

“When people don’t trust scientists, they don’t trust the science,” Rep. Deborah Ross (D-N.C.) told Morens.

The subcommittee has yet to turn up evidence implicating the NIH or U.S. scientists in the pandemic’s beginnings in Wuhan, China. Nor has its work shed light on the origin of the virus.

But in a May 28 letter to NIH Director Monica Bertagnolli, the subcommittee’s chairman, Rep. Brad Wenstrup (R-Ohio), said the evidence “suggests a conspiracy at the highest levels of NIH and NIAID to avoid public transparency regarding the COVID-19 pandemic.”

Rep. Jill Tokuda, a subcommittee Democrat from Hawaii, said the evidence shows no such conspiracy. She predicted the bipartisan criticism of Morens, 76, will give way to “a clash of intentions” at the hearing as Republicans try to pin covid on Fauci.

“For them, I think this is their moment to, again, bring a lot of these baseless, false allegations to the front,” Tokuda said.

On May 29, Wenstrup asked Fauci to turn over personal e-mails ahead of his testimony.

Here are things to know as the subcommittee gears up for Fauci’s appearance.

What Is the Subcommittee Looking For?

The Select Subcommittee on the Coronavirus Pandemic is supposed to be investigating how the pandemic started and the federal government’s response. That includes such hot-button issues as vaccination policies and school closures.

A central question is whether the covid virus leaped from animals to humans at a market in Wuhan, China, or spread from a leak at the nearby Wuhan Institute of Virology. The Wuhan lab received funding from an NIH grant recipient called EcoHealth Alliance.

The congressional probe is in some ways an extension of the nation’s political, cultural, and scientific battles arising from the pandemic.

The Republican-led subcommittee has been examining NIH’s performance and that of Fauci, who advised both former President Donald Trump and President Joe Biden, becoming the face of many of the government’s most polarizing pandemic policies.

The panel called for the government to cut off EcoHealth’s funding, a process the Department of Health and Human Services recently initiated.

EcoHealth’s president, Peter Daszak, was Morens’ friend and the recipient of many of the emails under scrutiny. A wildlife biologist credited with helping to develop the first covid antiviral drug, remdesivir, Daszak said he and his organization did nothing wrong.

“We were so accurate in our predictions that a bat coronavirus would emerge from China and cause a pandemic, that when it did, we’re dragged in front of the crowd with their pitchforks and blamed for it,” Daszak said in an interview.

What’s at Stake for NIH?

The Republican-led subcommittee is challenging NIH’s credibility. The agency performs and funds a wide variety of medical and scientific research, work that is often the foundation of new medicines and other treatments, and has long enjoyed bipartisan support from Congress. The agency is home to the “Cancer Moonshot,” a Biden priority.

As head of NIAID and a presidential adviser, Fauci helped guide the public during the pandemic on measures to avoid infection, such as mask-wearing and maintaining physical distance.

But at a May 22 hearing, Wenstrup said Fauci’s NIAID “was, unfortunately, less pristine than so many, including the media, would have had us all believe.”

In his letter to Bertagnolli, Wenstrup said there was evidence that a former chief of staff of Fauci’s might have used intentional misspellings — such as a variant of “EcoHealth” — to prevent emails from being captured in keyword searches by FOIA officials.

Wenstrup’s office did not respond to questions or an interview request.

An aide to the top Democrat on the subcommittee, Rep. Raul Ruiz of California, said he was unavailable for an interview.

Why Were Morens’ Emails Alarming?

The emails show a pattern of trying to shield communications from public disclosure.

“We are all smart enough to know to never have smoking guns, and if we did we wouldn’t put them in emails, and if we found them we’d delete them,” Morens wrote on June 16, 2020.

“The best way to avoid FOIA hassles is to delete all emails when you learn a subject is getting sensitive,” he wrote on June 28, 2021.

Some of Morens’ emails included sexual or sexist remarks, including one from December 2020: “Beverage is always good, and best delivered by a blonde nymphomaniac.” In another email, discussing how former Centers for Disease Control and Prevention Director Rochelle Walensky got her job, he remarked, “Well, she does wear a skirt.”

Morens apologized at the May 22 hearing and called some of what he wrote “misogynistic.”

“Some of the emails I’ve seen that you all have provided look pretty incriminating,” he testified.

Asked if he ever sent information related to covid to Fauci’s personal email, he said he didn’t remember but might have.

Morens said some of his comments were “snarky jokes” intended to cheer up his friend Daszak, the EcoHealth president, who was receiving death threats over media coverage of his organization’s relationship with the Wuhan lab.

Morens testified that he didn’t knowingly delete official records.

Ross, the North Carolina representative, said the emails “inflict serious damage on public trust for the entire scientific enterprise.” She said the dangers can be seen in eroding public confidence in vaccines, contributing to recent outbreaks of measles.

Rep. Debbie Dingell (D-Mich.) said Morens showed disdain for the Freedom of Information Act. The subcommittee’s investigation has been an unfounded effort to pin the blame for the pandemic on NIH and NIAID, and Morens’ emails have helped blur the issues, she said.

Do the Emails Reveal the Origins of Covid?

No, as Democrats have emphasized.

In a way, Morens’ correspondence undercuts allegations that people at the top of NIAID covered up a lab leak in Wuhan.

None of Morens’ emails describe any effort to suppress evidence of a lab leak and, in an email sent from a private account, he ridiculed the idea, calling it “false to the point of being crazy.” But the subcommittee’s senior Democrat, Ruiz, criticized Morens for dismissing the lab leak theory.

“Unless and until we see specific evidence on the origins” of the virus that causes covid, “the scientific process requires that we examine all possible hypotheses with objectivity,” Ruiz said.

KFF Health News senior correspondent Arthur Allen contributed to this report.

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Algorithms make it possible for companies to fix prices without explicitly coordinating with one another, posing a new test for regulators policing the market, said Lina Khan, chair of the Federal Trade Commission, during a media event hosted by KFF.

“I think we could be entering a somewhat novel era of pricing,” Khan told reporters.

Khan is regarded as one of the most aggressive antitrust regulators in recent U.S. history, and she has paid particular attention to the harm that technological advances can pose to consumers. Antitrust regulators at the FTC and the Justice Department set a record for merger challenges in the fiscal year that ended Sept. 30, 2022, according to Bloomberg News.

Last year, the FTC successfully blocked biotech company Illumina’s over $7 billion acquisition of cancer-screening company Grail. The FTC, Justice Department, and Health and Human Services Department launched a website on April 18, healthycompetition.gov, to make it easier for people to report suspected anticompetitive behavior in the health care industry.

The American Hospital Association, the industry’s largest trade group, has often criticized the Biden administration’s approach to antitrust enforcement. In comments in September on proposed guidance the FTC and Justice Department published for companies, the AHA said that “the guidelines reflect a fundamental hostility to mergers.”

Price fixing removes competition from the market and generally makes goods and services more expensive. The agency has argued in court filings that price fixing “is still illegal even if you are achieving it through an algorithm,” Khan said. “There’s no kind of algorithmic exemption to the antitrust laws.”

By simply using the same algorithms to set prices, companies can effectively charge the same “even if they’re not, you know, getting in a back room and kind of shaking hands and setting a price,” Khan said, using the example of residential property managers.

Khan said the commission is also scrutinizing the use of artificial intelligence and algorithms to set prices for individual consumers “based on all of this particular behavioral data about you: the websites you visited, you know, who you had lunch with, where you live.”

And as health care companies change the way they structure their businesses to maximize profits, the FTC is changing the way it analyzes behavior that could hurt consumers, Khan said.

Hiring people who can “help us look under the hood” of some inscrutable algorithms was a priority, Khan said. She said it’s already paid off in the form of legal actions “that are only possible because we had technologists on the team helping us figure out what are these algorithms doing.”

Traditionally, the FTC has policed health care by challenging local or regional hospital mergers that have the potential to reduce competition and raise prices. But consolidation in health care has evolved, Khan said.

Mergers of systems that don’t overlap geographically are increasing, she said. In addition, hospitals now often buy doctor practices, while pharmacy benefit managers start their own insurance companies or mail-order pharmacies — or vice versa — pursuing “vertical integration” that can hurt consumers, she said.

The FTC is hearing increasing complaints “about how these firms are using their monopoly power” and “exercising it in ways that’s resulting in higher prices for patients, less service, as well as worse conditions for health care workers,” Khan said.

Policing Noncompetes

Khan said she was surprised at how many health care workers responded to the commission’s recent proposal to ban “noncompete” clauses — agreements that can prevent employees from moving to new jobs. The FTC issued its final rule banning the practice on Tuesday. She said the ban was aimed at low-wage industries like fast food but that many of the comments in favor of the FTC’s plan came from health professions.

Health workers say noncompete agreements are “both personally devastating and also impeded patient care,” Khan said.

In some cases, doctors wrote that their patients “got really upset because they wanted to stick with me, but my hospital was saying I couldn’t,” Khan said. Some doctors ended up commuting long distances to prevent the rest of their families from having to move after they changed jobs, she said.

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One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.

The government database, called “Open Payments,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

The panel voted almost unanimously that the benefits of the device outweigh its risks. Abbott announced on April 2 that the FDA had approved TriClip, which is designed to treat leakage from the heart’s tricuspid valve.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device.

But some familiar with the process, including people who have served on FDA advisory committees, said the payments should have been disclosed at the Feb. 13 meeting — if not as a regulatory requirement, then in the interest of transparency, because the money might call into question committee members’ objectivity.

“This is a problem,” Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email. “They should or must disclose this due to bias.”

The Open Payments database records several kinds of payments from drug and device makers. One category, called “associated research funding,” supports research in which a physician is named a principal investigator in the database. Another category, called “general payments,” includes consulting fees, travel expenses and meals connected to physicians in the database. The money can flow from manufacturers to third parties, such as hospitals, universities, or other corporate entities, but the database explicitly connects doctors by name to the payments.

At the public meeting to consider the TriClip device, an FDA official announced that committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members.

“The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place,” she said. “This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest.”

Abbott “has no influence over who is selected to participate in FDA advisory committees,” a spokesperson for the company, Brent Tippen, said in a statement.

Diana Zuckerman, president of the National Center for Health Research, a think tank, said the FDA shouldn’t have allowed recipients of funding from Abbott in recent years to sit in judgment of the Abbott product. The agency takes too narrow a view of what should be disqualifying, she said.

One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

Asked in an interview if a reasonable person could question the impartiality of committee members based on the Abbott payments, Selzman said: “People from the outside looking in would probably say yes.”

He noted that Abbott’s money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: “There’s probably a better way to provide transparency.”

The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee reviewing Pfizer’s covid-19 vaccine had been a Pfizer consultant.

Appearance Issues

FDA advisory committee candidates, selected to provide expert advice on often complicated drug and device applications, must complete a confidential disclosure report that asks about current and past financial interests as well as “anything that would give an ‘appearance’ of a conflict.”

The FDA has discretion to decide whether someone with an “appearance issue” can serve on a panel, according to a guidance document posted on the agency’s website. Relationships more than a year in the past generally don’t give rise to appearance problems, according to the document, unless they suggest close ties to a company or involvement with the product under review. The main question is whether financial interests would cause a reasonable person to question the member’s impartiality, the document says.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, an FDA explainer says.

If the FDA finds a conflict of interest but still wants the applicant on a panel, it can issue a public waiver. None of the panelists voting on TriClip received a waiver.

The FDA’s approach to disclosure contrasts with rules for conferences at which doctors earn credit for continuing medical education. For example, for a recent conference in Boston on technology for treatment of heart failure, including TriClip, the group holding the meeting directed speakers to include in their slide presentations disclosures going back 24 months.

Those disclosures — naming companies from which speakers had received consulting fees, grant support, travel expenses, and the like — also appeared on the conference website.

‘Unbridled Enthusiasm’

The FDA has designated TriClip a “breakthrough” device with “the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease” compared with current treatments, an agency official, Megan Naber, told the advisory committee.

Naber said that for breakthrough devices, the “totality of data must still provide a reasonable assurance of safety and effectiveness” but the FDA “may be willing to accept greater uncertainty” about the balance of risks and benefits.

In a briefing paper for the advisory committee, FDA staff pointed out findings from a clinical trial that didn’t reflect well on TriClip. For example, patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the report. Tippen, the Abbott spokesperson, didn’t respond to a request for comment on those findings.

The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits.

Hauptman said during the meeting that the question of safety was “very, very clear” but added: “I just felt the need to pull back a little bit on unbridled enthusiasm.” Who will benefit from the device, he said, “needs better definition.”

Hauptman, dean of the University of Nevada-Reno School of Medicine, is connected to 268 general payments from Abbott totaling about $197,000 in the Open Payments database. Some payments are listed as going to an entity called Keswick Cardiovascular.

Hauptman said in an email that he followed FDA guidance and added, “My impartiality speaks for itself based on my vote and critical comments.”

Some committee members voted in favor of the device despite concerns.

Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, is linked to 77 general payments totaling about $53,000 from Abbott and worked on research supported by about $10,000 from the company, according to Open Payments.

“I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks,” he said in the meeting.

In an email, he said of his Abbott payments: “All was disclosed and reviewed by the FDA.” He said that he “can be impartial” and that he “openly expressed … concerns about the treatment.”

Mitchell Krucoff, a professor at Duke University School of Medicine, is connected to 100 general payments totaling about $105,000. Some went to a third party, HPIC Consulting. He also worked on research supported by about $51,000 from Abbott, according to Open Payments.

He said during the meeting that he voted in favor of the device on all three questions and added that doctors have “a lot to learn” once it’s on the market. For instance: By using the device to treat patients now, “do we set people up for catastrophes later?”

In an email, Krucoff said he completed a “very thorough conflict of interest screening by FDA for this panel,” which focused not only on Abbott but also on “any work done/payments received from any other manufacturer with devices in this space.”

John Hirshfeld Jr., an emeritus professor of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott totaling $6,000. Two of the payments linked to him went to a nonprofit, the Cardiovascular Research Foundation, according to the database. He voted yes on all three questions about TriClip but said at the meeting that he “would have liked to have seen more rigorous data to support efficacy.”

In an email, Hirshfeld said he disclosed the payments to the FDA. The agency did not deem him to have a conflict because he had no stake in Abbott’s success and his involvement with the company had ended, he said. Through the conflict-of-interest screening process, he said, he had been excluded from prior advisory panels.

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As a joint investigation by KFF Health News and Cox Media Group television stations reported in September, the agency has harmed people it is supposed to help by reducing or halting benefit checks to recoup billions of dollars in payments it sent them but later said they should never have received.

Testifying at two Senate hearings on March 20, Social Security Commissioner Martin O’Malley said he is taking several steps to address the problem.

Starting next week, O’Malley said, the agency will stop “that clawback cruelty” of intercepting 100% of a beneficiary’s monthly Social Security check if they fail to respond to a demand for repayment.

Instead, the agency will default to withholding 10% of the recipient’s monthly benefits to recoup the debt, he said.

That would have helped Denise Woods, a Savannah, Georgia, woman who ended up living in her car after the SSA clawed back her entire monthly benefit to recoup a $58,000 overpayment. The agency restored some of her benefits after KFF Health News-CMG reported her story in December.

“People like Denise and others shouldn’t be penalized for situations they did not create,” Sen. Raphael Warnock (D-Ga.) said during one of the hearings. “I think it’s always important that we center the people as we discuss policy, remember the human face of the issues we talk about.”

On the question of who caused an overpayment — the beneficiary or someone at the agency — the burden of proof will shift from the beneficiary to the agency, O’Malley said.

The agency will make it much easier for people who believe they weren’t at fault or can’t repay the debt to seek a waiver, O’Malley said, which he later clarified means simplifying the form people must submit.

(WPXI-TV, Pittsburgh)

(WSB-TV, Atlanta)

O’Malley’s plan also includes making notices to beneficiaries easier to understand. Now, they’re “like Mad Libs designed by mad lawyers,” he testified.

In addition, the agency recently changed a policy to allow most beneficiaries to arrange repayment plans of as long as five years, up from three years, he said.

Millions of people a year have been hit with clawbacks, including retirees, people receiving Social Security disability benefits, and the poorest of the poor. The alleged debts can stretch back years or decades and reach tens of thousands of dollars or more.

At the end of the last fiscal year, uncollected overpayments totaled $23 billion.

In December, KFF Health News and Cox Media Group television stations obtained an internal agency document showing that more than 2 million Americans each year are subjected to overpayment demands, out of about 70 million beneficiaries.

O’Malley, a former Maryland governor who was sworn in as commissioner in December, had previewed his planned changes in a recent interview with KFF Health News.

On Wednesday, he appeared before the Senate Special Committee on Aging in the morning and the Finance Committee in the afternoon.

In hours of testimony, O’Malley said nothing about one of the reforms he heralded in the interview: limiting how far back in time the agency can reach to recover overpayments.

In an interview between the hearings, O’Malley said, “That’s still being unpacked and may well require a change in regulation.” He said he expected an announcement within a few months.

O’Malley said he didn’t know how far back the limit would go but noted that other agencies tend to have a look-back period of four years.

Establishing a statute of limitations is one of the most important steps the government can take to address overpayments, Boston University economist Laurence Kotlikoff, who has studied and written about clawbacks, said in an interview.

“If Social Security can’t figure out its mistakes within 18 months, it should be on them,” Kotlikoff said.

Having to repay a year and a half of benefits could cost people their homes, Kotlikoff said.

Rebecca Vallas, who has helped beneficiaries navigate overpayments as a legal aid attorney and has called for reform of clawbacks, said the steps O’Malley announced “are nothing short of historic.”

Shifting the burden of proof “is a dramatic change,” said David Camp, chief executive of the National Organization of Social Security Claimants’ Representatives. While a lot is riding on the details and how O’Malley’s plans are implemented, that change alone should lead to “a very different experience” for anyone challenging a clawback, Camp added.

(WSOC-TV, Charlotte)

In the past, there has been a gap between what the agency says and what it does. O’Malley said 10% has been the default withholding rate in one of the Social Security programs, Supplemental Security Income. But KFF Health News and Cox Media Group have found people whose entire SSI benefit checks were suspended on account of alleged overpayments.

The changes announced won’t apply automatically to people already on a repayment plan or whose monthly benefits are already being docked, O’Malley said outside the hearings. To take advantage of the new terms, beneficiaries would have to contact the agency and request relief, he said. The agency will notify people that they have that option, he added.

O’Malley implored lawmakers to increase funding for the agency. On average, customers trying to reach the agency by phone wait 38 minutes, he said. Most who call the 800 number “hang up in disgust after waiting far too long,” he said in written testimony.

Trouble getting through to anyone at the agency can contribute to overpayments and make it harder for recipients to resolve them.

Sen. Bob Casey (D-Pa.), chair of the Special Committee on Aging, said that unless Congress provides adequate funding for the agency, fixing problems “will be really difficult.”

Sen. Mike Braun of Indiana, the top Republican on that committee, called for looking at how the agency is run “before we throw more money at it.” He suggested focusing on what can be done to prevent overpayments “rather than forgiving them once they occur” or trying to claw them back, “which is insult on top of injury.”

O’Malley noted that the Social Security Administration recently sought public comment on a long-delayed plan to reduce overpayments by automatically obtaining monthly wage and employment data on beneficiaries.

Finance Committee Chairman Ron Wyden (D-Ore.) praised O’Malley for tackling what Wyden called “the scourge of overpayments.”

“I think you’re really off to a strong start in terms of righting wrongs,” Wyden said.

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White House officials, senior military and other national security leaders, retired military officers, and family members have all benefited. The Washington elite could jump the line when filling prescriptions, book appointments through special call centers, and receive choice parking spots and escorts at military hospitals and other facilities, including Walter Reed National Military Medical Center in Bethesda, Maryland, according to the Pentagon’s inspector general.

Through a unit at the White House, government personnel were routinely allowed to receive treatment under aliases, providing no home address or insurance information. For some of them, the care was free, as Walter Reed had no way to bill for it or waived charges.

The so-called executive medicine program was described in a report the Pentagon’s inspector general released in January. The investigation drew extensive media attention for spotlighting a history of loose prescribing practices and poor controls of powerful drugs including opioids in the White House Medical Unit, a military outfit that attends to the president, vice president, and others in the White House compound.

But the White House Medical Unit is just the tip of the broader executive medicine program, intended to provide VIP treatment to senior government and military officials. Though the program is meant largely to accommodate top officials’ busy schedules, the privileges have followed many patients into retirement. According to data from late 2019 and early 2020, the IG’s report said, 80% of the executive medicine population in the national capital region were military retirees and members of their families.

Some facilities “provided access to care for executive medicine patients over active-duty military patients that had acute needs,” according to the report, which added that prioritizing medical care by seniority rather than medical need “increased the risk to the health and safety of non‑executive general patient population.”

Much of the report was written in past tense, leaving unclear whether all the practices it described continue. Before the report was made public, a draft was under review by the White House Medical Unit for more than three years — from May 2020, when Donald Trump was in office, to last July. The delay isn’t explained in the report, and White House spokespeople didn’t respond to questions for this article.

A spokesperson for the inspector general’s office, Deputy Assistant Inspector General Reishia Kelsey, declined to elaborate on the report. A spokesperson for the Pentagon, James P. Adams, also declined to comment.

In a response included in the inspector general’s report, a Pentagon official said there were “new procedures already put in place by the White House Medical Unit.” The report didn’t detail those changes.

At Walter Reed, the program is available to Cabinet members; members of Congress; Supreme Court justices; active-duty and retired generals and flag officers and their beneficiaries; members of the Senior Executive Service who retired from the military; secretaries, deputy secretaries, and assistant secretaries of the Department of Defense and military departments; certain foreign military officers; and Medal of Honor recipients.

Walter Reed’s executive medicine program caters to the “time, privacy, and security demands” of leaders’ jobs, the hospital says on its website. The IG report makes clear that the program has, at times, provided extraordinary privileges to the government’s most elite officials.

For example, one unnamed executive medicine patient asked to have a prescription for an unspecified “controlled medication” refilled two weeks early — and complained when pharmacy staff at Fort Belvoir Community Hospital said that wasn’t allowed.

Hospital leaders told hospital staff to fill the prescription as requested. According to the report, the staff said the task required an estimated 30 hours of extra work.

Controlled medications are subject to abuse, and some, such as opioids, can be addictive. Defense Department health policy calls for minimizing the use of opioids and prescribing them only when indicated.

A spokesperson for the Fort Belvoir hospital, now known as Alexander T. Augusta Military Medical Center, said every patient is seen through the same lens and treated with the care they deserve.

The spokesperson, Reese Brown, said the facility shows military deference to top officers on account of their rank. For example, they don’t have to sit with the general population of patients.

The facility’s website mentions an “Executive Medicine Health & Wellness Clinic” for authorized patients, including eligible family members.

Brown said he was unaware of the inspector general’s account of the prescription refill and had no information about it.

The report said that at one unidentified pharmacy site, “all pharmacy staff members expressed frustration about the prioritization and filling of executive medicine prescriptions. This prioritization of executive medicine prescriptions diverted the pharmacist from filling prescriptions for patients diagnosed with conditions that are more urgent.”

Executive medicine services are also provided at the DiLorenzo Tricare Health Clinic at the Pentagon, Fort McNair Army Health Clinic, and Andrew Rader U.S. Army Health Clinic, the report said.

The inspector general recommended the Department of Defense take steps such as establishing controls for billing nonmilitary senior officials for outpatient services. The assistant secretary of defense for health affairs agreed but said the department would consider “the historical practices of the White House Medical Unit, the DoD’s health care support for non‑military U.S. Government senior officials, and the need for strict security protocols to protect the health and safety of White House principals.”

Chaseedaw Giles, KFF Health News’ digital strategy & audience engagement editor, contributed to this report.

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“I want to apologize for any confusion or misunderstanding during the October hearing,” acting Commissioner Kilolo Kijakazi wrote in a letter dated Dec. 11.

Kijakazi sent the letter days after KFF Health News and Cox Media Group reported that the agency has been demanding money back from more than 2 million people a year — more than twice as many as Kijakazi disclosed to a House panel at an Oct. 18 hearing.

The report was based on a Social Security document the news organizations obtained through a records request under the Freedom of Information Act.

“In my effort to be responsive to Committee questions on overpayment numbers, I provided a preliminary, unvetted and partial answer,” Kijakazi said in her apology letter.

“My goal — and SSA’s goal — is always to provide Congress with the most complete, accurate, and responsive information possible,” Kijakazi said. “We did not do that in this case and will use this experience to improve our communications with Congress going forward.”

In an interview before she sent the apology, Rep. Greg Steube (R-Fla.) said Kijakazi “wasn’t being completely upfront” at the hearing, and he wondered whether the agency had “intentionally deflated the numbers.”

Meanwhile, in a Dec. 12 interview, the chairman of the Senate Finance Committee, Ron Wyden (D-Ore.), said the agency had damaged its credibility by “not telling the truth.”

The hearing of the House Ways and Means Committee’s Subcommittee on Social Security focused on the agency’s record of sending out billions of dollars of benefit payments that it later concludes it never should have paid — and then, sometimes years later, demanding the recipients pay the money back.

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The unexpected bills, which can total tens of thousands of dollars or more, can be devastating for the recipients. Many are disabled and struggling to get by on minimal incomes.

Until the hearing, the agency had not disclosed the number of people affected, making it harder for policymakers to assess the seriousness of the problem and what to do about it.

At the hearing, Rep. Mike Carey (R-Ohio) asked how many people a year are receiving overpayment notices.

Reading from a piece of paper, Kijakazi gave two precise numbers: 1,028,389 for the 2022 fiscal year and 986,912 for the 2023 fiscal year.

Under further questioning, she repeated the numbers.

She also said they were “under Social Security” and “for Social Security.”

After the hearing, KFF Health News and Cox Media Group sent the Social Security press office several emails over a period of weeks asking for clarification: Did the numbers Kijakazi gave at the hearing represent all programs administered by the Social Security Administration, or just a subset?

SSA spokesperson Nicole Tiggemann did not give a direct answer.

The news organizations filed the FOIA request for a copy of the document from which Kijakazi read the numbers at the hearing.

The document showed that Kijakazi did not tell House members the whole story.

She read numbers that included two benefit programs, but she repeatedly omitted numbers for a third program her agency administers under the Social Security Act. The numbers she omitted were bigger than the numbers she disclosed, and, on the piece of paper, they appeared directly below the numbers she disclosed.

She left out more than a million people a year.

More than seven weeks passed before she sent Congress the apology.

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“We should have followed up with additional context following the hearing,” she said in her letter. “I take seriously the commitment that all Federal officials make to provide the Congress with accurate information and I very much regret not contacting you with more information right away.”

KFF Health News and Cox Media Group obtained a copy of the letter addressed to Rep. Drew Ferguson (R-Ga.), chair of the Ways and Means’ Subcommittee on Social Security, and a copy sent to a Democratic member of the committee.

Asked which members of Congress were sent the letter, Tiggemann said in an email, “The correspondence was between Acting Commissioner Kijakazi and members of the committee.”

Tiggemann did not respond to a request for an interview with Kijakazi.

In her letter, Kijakazi essentially disavowed the numbers she gave the committee. She said the agency is trying to make sure it has “the right data to make meaningful improvements.”

“We are committed to sharing this data with the Committee and the public,” she wrote, “as soon as it is fully vetted.”

Addressing overpayment problems — and communicating with Congress about them — will soon be someone else’s responsibility.

The evening of Dec. 18, the Senate voted 50 to 11 to confirm former Maryland Gov. Martin O’Malley (D) as commissioner of Social Security.

At his confirmation hearing in November, O’Malley said he would “absolutely prioritize” reducing overpayments and overhauling the appeals process for people asked to repay money.

“It’s been heartbreaking reading some of these stories” of people who face government collection efforts “through no fault of their own” and “without regard” for their circumstances, O’Malley said.

“We have to do a better job of recognizing the justice at stake in each of these individual cases,” O’Malley, a former presidential candidate, said at the hearing.

O’Malley said he would emphasize improving customer service, measuring results, and disclosing data.

Instead of hoarding information, he said, “you need to share information openly and transparently.”

Do you have an experience with Social Security overpayments you’d like to share? Click here to contact our reporting team.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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