By Emily Alpert Reyes, LA Times, Jun 23, 2022.

In Rochester, N.Y., Diane Coleman has relied on a machine to help her stay alive, but she worries that it might be slowly undermining her health.

Her ventilator was among millions of breathing devices that Philips Respironics recalled last summer over safety concerns about numerous models of its ventilators, BiPAP and CPAP machines.

The reason: Polyester-based polyurethane foam used to muffle noise in those machines could degrade, giving off chemical gases and bits of black debris that could be swallowed or inhaled.

The possible risks: headaches, dizziness, nausea, irritated eyes and airways, and “toxic or cancer-causing effects,” according to federal regulators. The Food and Drug Administration put the recall in its most serious category, involving “a reasonable probability” that a product “will cause serious adverse health consequences or death.”

Yet a year later, many patients are still awaiting replacements — and some are using the recalled machines despite those possible risks.

Coleman said her machine underwent some initial repairs, but she is seeking a new one after federal regulators sought more safety testing of the replacement foam used for such fixes. The 68-year-old, who is president and chief executive of the disability rights group Not Dead Yet, has a form of muscular dystrophy and uses her ventilator roughly 22 hours each day.

She is nervous about how it could affect her, but “it’s not like I can stop using it.”

Home ventilators are typically provided through an equipment vendor rather than being owned by the patient, complicating the process of changing machines. And even used ones cost thousands of dollars, online listings show. The CPAPs and BiPAPs that help people breathe while they sleep can cost more than $1,000, and insurance companies limit how often they will pay for replacements.

The vast scope of the Philips recall — which covers numerous models manufactured for more than a decade — has sent a flood of people to seek new machines at a time when supply chains are already strained.

As of this spring, Philips said that repairing and replacing devices would take until “approximately the end of 2022” for the majority of users. Philips spokesperson Steve Klink said in a statement that the recall was “a complex undertaking because of the sheer volume of devices to be remediated, and the outreach to every individual patient.” The company said it expects to replace or repair roughly 5.5 million devices globally, the bulk of which are CPAP or BiPAP machines.

“In an average year, we produce and distribute around 1 million sleep devices,” Klink said. Despite challenges with the supply chain, “we have scaled up by more than a factor of three, but inevitably it still takes time to remediate over 5 million devices. While we are working as fast as we can, we acknowledge that this has been worrying for patients.”

The danger of stopping a ventilator that sustains someone’s oxygen flow is obvious. Even switching to a different model can be precarious. Halting recalled CPAP or BiPAP machines can also be “unacceptably risky” for certain patients, physicians warned in the American Journal of Respiratory and Critical Care Medicine.

Sleep apnea is ‘a fatal disease,’ two studies find.

The devices are commonly used to treat sleep apnea, a disorder in which breathing is repeatedly interrupted during sleep, which can increase the risk of heart problems and leave people dangerously drowsy during the day. The FDA has advised patients who use the recalled CPAP or BiPAP machines to talk to their doctors about whether to stop.

Tom Wilson, who administers a Facebook support group for CPAP users affected by the recall, said he has read comments from group members who say they haven’t had any communication with Philips despite registering their devices with the company as much as a year ago. Some have paid out of pocket to get other devices.

“It becomes a choice between continuing to use a potentially cancer causing device or spending $1,000 or more, especially for those with severe obstructive sleep apnea,” Wilson said in an email.

In New Jersey, Chloe Berger said she stopped using her CPAP machine and suffered debilitating migraines and exhaustion. “I couldn’t maintain a job. I was just too tired,” said Berger, 30, a therapist who said she had to give up one job, then another, because she was struggling to stay awake.

Berger said she paid out of pocket for a different machine in April, roughly two months before Philips sent her a replacement. Waiting had taken an emotional and mental toll on her, she said. “You feel like you’re swimming upstream, and nothing is happening.”

The massive recall has already spurred class-action lawsuits from users across the country.

“They’ve botched the whole thing,” said Dena Young, senior counsel at Berger Montague, who said that most of the people represented by her firm had not gotten a replacement or repair. As they wait, “some of them are still using the Philips because they don’t have a choice.”

Federal investigators have also taken interest: In April, Philips said the U.S. Department of Justice had subpoenaed the company in regards to events leading to the recall.

Consumer safety advocates argue that the halting process underscores the shortcomings of the recall system, which relies heavily on private companies to inform consumers and take action.

“It isn’t actually easy for the FDA to take products off the market,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research center that has raised concerns about the safety of medical products. “It should be a lot easier than it is.”

But the actions that the FDA has taken so far in the Philips recall also show that the agency “has more power in recalls than they usually use,” Zuckerman said.

The FDA’s Center for Devices and Radiological Health told Philips last month that it was seeking to order the company to turn in a plan that could include not only repairing and replacing the recalled devices, but also providing refunds. In a November report, an FDA investigator found that Philips had failed to start taking appropriate action years earlier when the company first became aware the foam could be breaking down. Emails showed that the company was aware of “foam degradation issues” as early as October 2015, the FDA investigator found.

Within three years, more emails indicated that Philips had gotten more complaints about crumbling foam in ventilators and said that testing had confirmed that it broke down in high heat and high humidity, but the firm “made the decision not to change the design,” according to the FDA report in November. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as “contaminants, particles, foam, debris, airway, particulate, airpath and black.”

Klink, the Philips spokesperson, said there had been “limited complaints” about foam breakdown in prior years that were assessed on “a case-by-case basis.” He said the 220,000 complaints mentioned by the FDA were identified through “broad word searches” and that a company review found that a much smaller number — about 3% of them — were about alleged foam degradation. The company said that when its executive committee became aware of the issue and its possible significance early last year, it took “adequate actions” that led to the voluntary recall.

This year, the FDA found that Philips’ efforts to alert patients were insufficient, concluding that many patients were probably still unaware of the health risks nine months after the recall had begun. In March, it ordered the company to notify health professionals, device distributors and users of the recalled machines after estimating that only 50% of patients and consumers who had gotten recalled CPAPs and BiPAPs within the last five years had registered with the company for a replacement.

Philips said it had some 2.6 million devices registered for the recall in the U.S. — which it said represented the “vast majority” of affected devices nationwide — but was continuing to try to increase awareness, including by working with durable medical equipment suppliers to reach out to patients.

Craig Lykens, whose 6-year-old son, Gil, uses a recalled ventilator, was dismayed recently to discover that their unit had yet not been registered for replacement. The device is provided through a medical equipment vendor, which hadn’t registered it based on the mistaken belief that Philips was not replacing machines, Lykens said.

The family, who live outside Washington, D.C., could have tried to switch to another kind of ventilator, but Lykens said that probably would involve Gil staying overnight at a hospital so doctors could monitor how he fared with a different machine — something the family was reluctant to do amid COVID-19, which is especially risky for kids with his genetic condition.

Some kids do better on certain models of ventilators, Lykens said. Fearing their child might fare poorly on the wrong one, when faced with the possible risks from foam particles, “we stay and face the long-term threat.”

In Philadelphia, Meghann Luczkowski likewise worried about what would happen if Miles, her 8-year-old son, were switched to a different ventilator. Miles has a rare form of dwarfism that causes a “floppy airway” that needs to be reopened with mechanical ventilation. He had briefly been put on a different ventilator in the past but couldn’t maintain safe levels of oxygen and suffered “blue spells” in which his skin changed color.

His Philips machine has been “his lifeline,” allowing him to live at home with his family. But Luczkowski said they had begun noticing black buildup when they changed a filter in the machine.

“It’s a very scary thing to hear that the machine that keeps your child alive could suddenly be the thing that’s harming them,” Luczkowski said.

Dr. Alon Y. Avidan, director of the UCLA Sleep Disorders Center, estimated that roughly a fifth of his patients have been affected by the recall, which has caused a significant imbalance between supply and demand “that is affecting our patients’ ability to receive treatment from CPAP in a timely and efficient manner.”

He urged patients to talk to their doctors to weigh the risks and benefits of continuing to use a recalled device. Some patients “do not have good alternatives except to stop the therapy,” he said, which “is not a good situation by any means.”

In December, Philips said that its testing of one set of CPAP and BiPAP devices included in the recall found that the level of chemical emissions “is not typically anticipated to result in long-term health consequences for patients.” That testing did not explore the health risks from ingesting bits of foam, however, nor did it look at other devices covered by the recall. The Center for Devices and Radiological Health said in May that it was not convinced that such testing was enough to downgrade the estimated harm from the tested machines.

Philips has also pointed to two analyses that did not find a higher incidence of cancer among patients who used Philips devices rather than those of other manufacturers. Another study from Sweden found signs of an increased incidence of lung cancer, but said the findings were inconclusive and might be related to regional differences in cancer risks.

Concerns have continued to mount. From April 2021 through April 2022, federal regulators have gotten more than 21,000 reports about medical issues potentially tied to the recalled devices — or malfunctions likely to cause injuries if they recurred — including 124 reports linking them to deaths. Cancer has been a stated concern: Since 2020, more than 1,100 such reports about Philips CPAP or BiPAP machines have included the words “cancer,” “tumor” or “tumour,” said Madris Kinard, chief executive of Device Events, which gathers data to track problems with medical devices.

Those medical device reports, which can be submitted by health professionals and patients as well as manufacturers, do not require verification that the device caused the injury or death; Philips stressed that submitting such reports “is not evidence that the device caused or contributed to the adverse outcome or event.”

However, Zuckerman said “it’s assumed that a lot of deaths and other serious injuries don’t get reported at all.”

In La Quinta, Matthew P. Stone counts himself as relatively lucky. The 61-year-old, who had been using a Philips CPAP machine for sleep apnea, had been able to fall back on an old device from another manufacturer.

But Stone, like others, has been galled by the way the recall has played out. At one point, Stone said, he tried to lodge a complaint with federal regulators and was referred to a Southern California number that kept cutting out before he could leave a message.

“I am so incredibly disappointed,” he said, “at the lack of advocacy by anybody involved.”

Article link

By Neil Bedi, ProPublica, Jan 07, 2022.

In 2014, when the Food and Drug Administration found serious problems with a life-sustaining heart pump, its warning letter to the manufacturer threatened to notify other federal health agencies about the inspection’s findings.

But for years, no such alert ever went out. Instead, the agency added the warning letter to an online database alongside thousands of others, following its typical procedures, an FDA spokesperson said.

Agencies such as the Centers for Medicare & Medicaid Services and the U.S. Department of Veterans Affairs went on paying to implant the HeartWare Ventricular Assist Device, or HVAD, in new patients even though federal inspectors had found problems with the device linked to patient deaths and injuries.

Taxpayer dollars continued to flow to the original device maker, HeartWare, and then to the company that acquired it in 2016, Medtronic, for seven years while the issues raised in the warning letter remained unresolved.

If crucial safety information in FDA warning letters doesn’t make it to other arms of the government responsible for deciding which medical devices to pay for, experts said patients are the ones put at risk.

“It’s clearly a breakdown of communication,” said Dr. Rita Redberg, a cardiologist at the University of California San Francisco who researches medical device safety and regulation. “It’s not just the money, obviously. It’s people’s lives.”

The FDA acknowledged that it doesn’t directly notify other agencies when it issues warning letters, pointing instead to its online database, which is accessible to both government officials and the public. “The FDA’s decisions are intended to be patient-centric with the health and safety of device users as our highest priority,” the agency spokesperson said in an email.

The HeartWare letter was removed from the public database about two years ago, even though the problems remained unresolved and patients were still receiving implants. The database clears out letters that are more than five years old.

CMS, which oversees the Medicare and Medicaid programs, would not say why it continued paying for a device that didn’t meet government standards. It directed questions about the HeartWare warning letter to the FDA. “CMS does not have oversight of the manufacturing and related safety assessments of a medical device manufacturer,” a spokesperson said in an email.

The spokesperson noted that CMS requires heart pump patients to have specialized medical teams managing their care, which should monitor FDA communications regarding safety of devices.

CMS doesn’t track data on devices by manufacturer, so it’s essentially impossible to calculate its total spending on HVADs. One 2018 medical journal study found that Medicare and Medicaid paid for more than half the cost of all heart pump implants from 2009 to 2014. If that rate of spending continued, CMS may have spent more than $400 million on implanting HVADs since 2014.

A spokesperson for the VA said his agency was never notified about the HeartWare warning letter. The VA paid HeartWare and Medtronic more than $3 million after the FDA issued the letter in 2014. It offered this explanation for why: “It’s important to note that FDA Warning Letters are notifications issued to manufacturers found to be in significant violation of federal regulations. They are not product recalls.”

In the case of the HVAD, the FDA’s failure to make sure its warning reached beyond the manufacturer may have had life-and-death consequences.

In August, ProPublica reported that federal inspectors continued finding problems at the HVAD’s manufacturing plant for years. Meanwhile, the FDA received thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer.

The documents detailed one horrifying device failure after another. A father of four died after his device suddenly failed and his teenage daughter couldn’t resuscitate him. Another patient’s heart tissue was charred after a pump short-circuited and overheated. A teenager died after vomiting blood as his mother struggled to restart a defective pump.

In June, Medtronic ended sales and implants of the device, citing new data that showed patients with HVADs had a higher rate of deaths and strokes than those with a competing heart pump.

Medtronic declined to comment for this story. It has previously said it believed that after the 2014 warning letter the benefits of the HVAD still outweighed the risks for patients with severe heart failure.

Experts said the lack of communication between federal agencies when serious device problems are found is baffling but not surprising. It fits a broader trend of device regulators focusing more on evaluating new products than monitoring the ones already on the market.

“The priority is to get more medical devices out there, paid for and getting used,” said Dr. Joseph Ross, a professor of medicine and public health at Yale University who studies medical device regulation.

Other U.S. health care regulators move more forcefully when providers and suppliers don’t meet the government’s minimum safety requirements for an extended period, putting patients at risk.

Take hospitals. When inspectors find a facility is not meeting safety standards, CMS can issue an immediate jeopardy citation and, if problems aren’t fixed, move to withhold federal payments, which make up substantial portions of most hospitals’ revenues. In the rare cases when hospitals don’t take sufficient action, CMS follows through and revokes funding.

Redberg, the UCSF cardiologist, said the lack of similar action for medical devices offers a clear “opportunity for improvement.” At minimum, the FDA could establish processes to directly inform other agencies when it issues warning letters and finds serious problems with devices being sold in the United States.

“If the agency’s mission is to protect public health, they would want to do these things and move quickly,” she said.

Article link

Federal health officials are warning against the use of ozone gas or ultraviolet (UV) light to clean continuous positive airway pressure (CPAP) devices or accessories, indicating these cleaning methods have not been approved and could result in adverse health consequences.

In a safety communication issued on February 27, 2020, the FDA indicates that patients and healthcare professionals should refrain from using illegally marketed ozone gas or ultraviolet (UV) light cleaning products to disinfect or sanitize CPAP devices. The warning comes after nearly a dozen reports involving patients suffering respiratory complications after trying one of these cleaning methods.

CPAP devices provide steady air pressure through a mask or nose piece, granting continuous positive airway pressure to prevent the user’s airway from collapsing, thus preventing constant broken sleep.

The devices are often used by those diagnosed with obstructive sleep apnea, which is a condition that causes a person’s airway to collapse during sleep, resulting in short periods of time where the individual stops breathing. Individuals suffering from sleep apnea have a greater risk of experiencing adverse health and heart problems. Typically, these individuals have a higher risk of suffering hypertension, stroke, heart disease and daytime sleepiness.

The FDA indicates it has received at least 11 reports of CPAP cleaning problems involving use of ozone or UV light products from 2017 through 2019, involving individuals who experienced coughing, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing problems after using the unapproved products.

Although ozone gas is used to kill harmful bacteria for certain products, for the process to be effective in killing harmful bacteria it must be present at high concentrations that far exceed safe levels of exposure to humans. Consequently, patients could be exposed to unsafe levels of ozone gas which may result in a variety of adverse health consequences to an individual’s respiratory system.

Exposure to UV light poses a number of potential health risks for patients, including burns, eye damage or increasing the risk of skin cancer due to overexposure. The FDA indicates that it has not become aware of any injuries directly related to patients who cleaned their CPAP devices with a UV light, however, the agency warns the UV light may not be able to penetrate all components of CPAP devices and accessories, such as the plastic tubing, masks and connectors. The inadequate cleaning of these accessories could result in unsafe conditions for reuse.

The FDA has never approved the use of ozone gas-or UV light based products to clean CPAP machines and is instructing patients and healthcare professionals to stop using these cleaning methods immediately.

The FDA has identified several manufacturers who are illegally marketing ozone gas or UV light-based products for CPAP cleaning. The agency has requested they submit  data demonstrating the safety and effectiveness of their products, indicating they need clearance and approval to keep marketing those items.

The FDA urges patients to follow the CPAP machine cleaning instructions provided by the manufacturers, which indicate users should only use soap and water to thoroughly rinse, cleanse and disinfect the devices.

Patients and healthcare professionals are encouraged to report any adverse events related to the products through the FDA’s MedWatch Adverse Event Reporting System.

By Fred Schulte and Elizabeth Lucas, KHN, Jun 17, 2021.

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.

Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, according to government officials.

Yet SpineFrontier’s success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through “sham consulting fees” that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.

Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up health care spending and put patients at risk of serious harm, a KHN investigation has found. These payments come in various forms, from royalties for helping to design implants to speakers’ fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.

Health policy experts and regulators have focused for decades on pharmaceutical companies’ payments to doctors — which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.

Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.

“It is simply so much money that it is staggering,” said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and critic of the medical device industry’s influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.

Device makers say the long-established practice leads to higher-quality, safer products. “Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients’ lives,” said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry’s trade group.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Retton, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

The case of Chin’s company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers — from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.

The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Court filings named 35 spine surgeons who used SpineFrontier’s surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has pleaded guilty to criminal charges. It’s illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don’t face criminal prosecution.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

“There is a court date [for the DOJ case] as ordered by a judge,” Chin said via email. “If we get to that point the facts of the case will be litigated.”

Back Surgeries Under Scrutiny

The nation’s outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry report.

Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.

In one common spinal procedure, surgeons may replace damaged discs with an implant and screws and metal rods that hold it in place. The demand for surgery to replace worn-out knees and hips also has mushroomed as aging boomers and others seek relief from joint pain that restricts their movement.

Perhaps not surprisingly, the competition for sales of orthopedic devices is fierce: Some 250 companies proffer a dizzying array of products. Industry critics blame the Food and Drug Administration, which allows manufacturers to roll out new hardware that is substantially equivalent to what already is sold — though it often is marketed as more durable, or otherwise better for patients.

“The money is just phenomenal for this medical hardware,” said Dr. James Rickert, a spine surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group. He said most of the products are “essentially the same,” adding: “These are not technical instruments; [it’s often] just a screw.”

Hospitals can end up charging patients $20,000 or more for the materials, though they pay much less for them. Spine surgeons — who make upward of $500,000 a year — bill separately and may charge $8,000 to $20,000 for major procedures.

Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.

And it doesn’t stop there. Whistleblower cases filed under the federal False Claims Act allege a startling array of schemes to influence surgeons, including compensating them for joining a medical society created and financed by a device company. In other cases, companies bought billboard space or other advertising to promote medical practitioners, hired surgeons’ relatives, paid for hunting trips — even mailed checks to their homes.

Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.

These gigs are legal so long as they involve professional work done at fair market value. But they have drawn fire as far back as 2007, when four manufacturers that dominated the hip and knee implant market, including a J&J division, agreed to pay $311 million to settle charges of violating anti-kickback laws through their consulting deals.

KHN found at least 20 whistleblower suits, some settled, others pending, that have since accused device makers of camouflaging kickbacks as consulting work, including paying doctors to sit on suspect “advisory boards” or other activities that entailed little work to justify the fees.

In November 2019, device maker Life Spine and two of its executives admitted to paying consulting fees to induce dozens of surgeons to use Life Spine’s implants in the operating room. In all, 21 of the top 30 Life Spine adopters were paid and they accounted for about half its total device sales, according to the Justice Department. Life Spine and the executives paid a total of $6 million in penalties. The company did not respond to requests for comment.

Similarly, SpineFrontier received “the vast majority” of its sales, more than $100 million worth, from surgeons who were compensated, the Justice Department alleges. Often, they were paid by way of a “sham” company run by Chin’s wife, Vanessa, from a mail drop in Fort Lauderdale, according to the Justice Department. Vanessa Dudley Chin, a defendant in the DOJ civil case, had no comment.

Kingsley Chin told KHN via email that he takes no salary from SpineFrontier, based in Malden, Massachusetts. In 2013, Chin received $4.3 million in income from the company, according to court filings in a divorce case in Philadelphia from an earlier marriage. In 2018, SpineFrontier valued Chin’s interest in the company at $75 million, according to government records, though its current worth is unclear.

SpineFrontier’s management thought paying doctors was “the only reliable way to steadily increase its market share and stave off competition,” Charles Birchall, a former business associate of Chin’s, alleged in a whistleblower complaint. The case is one of two whistleblower suits filed against SpineFrontier that the DOJ has joined and consolidated. Chin has yet to file a response in court.

From March 2013 through December 2018, the company offered some surgeons $500 or more an hour for “consulting,” which could include the time they spent operating on patients — even though they already were being paid by Medicare or other health insurers. Other surgeons were paid repeatedly to “evaluate” the same products, though their feedback was “often minimal or nonexistent,” according to the DOJ complaint.

Patient Injuries Pile Up

While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.

Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered “phony” consulting deals to surgeons who had complained about alarming defects in one of its knee implants.

Their findings should have been forwarded to the FDA to protect the public, Fuentes and two former Exactech sales reps alleged in their suit. Instead, the company paid the surgeons “to retain their business and secure their silence” about patients needlessly undergoing a second operation to address the defects implanted in the first, according to the suit. Lawyer Thomas Beimers, who represents Exactech in the case, said the company “emphatically denies the allegations and looks forward to presenting the real facts to the court.” In a court filing, the company said the suit was “full of conclusory, vague and immaterial facts” and said it should be dismissed.

In Maryland, spine surgeon Dr. Randy F. Davis faces a lawsuit filed in early 2020 by 14 former patients who claim he implanted counterfeit hardware from a device distributor that had paid him hundreds of thousands of dollars in consulting fees and other compensation.

Davis used the hardware, which had not been FDA-approved, on about 250 patients at the University of Maryland Baltimore Washington Medical Center in Glen Burnie, Maryland, according to the suit. Several patients say screws or other implants failed and they sustained permanent injuries as a result. One woman said she was left with little feeling in her right foot and needs a cane or walker to get around. Others claim “extreme mental anguish” for fear the hardware inside them will fail, according to the suit.

The patients allege that Davis improperly disposed of defective screws and other hardware he removed rather than send the items for analysis or report the failures to authorities. Instead, the University of Maryland hospital sent “hush” letters to patients that falsely told them that no defects had been found, according to the suit. A spokesperson for the hospital, which also is a defendant in the suit, denied the allegations, noting: “We will vigorously defend this lawsuit and at its conclusion are quite confident we will prevail.” Davis and his lawyer didn’t respond to repeated requests for comment. The lawsuit is pending in Anne Arundel County state court.

Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.

That happened when three patients filed lawsuits in 2018 against Arthrex, a Florida device company. The patients argued they were forced to undergo repeat operations to replace defective Arthrex knee devices implanted by Pennsylvania orthopedic surgeon Dr. Thomas Meade.

Meade was not a defendant in the cases. But the patients accused him of misleading them about the product’s safety and a recall. One noted that Meade had served as a prominent consultant to Arthrex and had “participated in the design, testing, marketing, promotion and sales” of the knee implant. The patient alleged that Arthrex had paid Meade more than $250,000 for work that included “promotional speaking, travel, lodging, and consulting.”

In court filings, Arthrex admitted making payments to Meade for “consulting and royalties” but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.

Chin’s dual roles as SpineFrontier’s CEO and user of its hardware was called a “huge” conflict of interest by a judge in a pending malpractice case filed against him and the company in South Florida.

In that case, Miami resident Patrick Chapoteau alleges Chin performed back surgery in 2014 using SpineFrontier hardware even though it had little chance of success. According to the suit, a Chin-designed screw implanted to stabilize Chapoteau’s spine broke in half, causing him pain and disabling injuries.

In a legal brief, Chin’s lawyers argued that he regularly operates on people with disabling back problems, noting: “The surgery is sophisticated and challenging. On a few rare occasions, his patients have not obtained the relief they expected or experienced unanticipated complications that required additional care.”

Joseph Wooten, a former Chin patient and Florida power company employee, alleged in a 2014 lawsuit in Broward County Circuit Court that Chin had 15 previous malpractice claims that had ended in more than $8 million in settlements, an assertion Chin’s lawyers disputed.

“He never told me of his bad record injuring people,” Wooten, 64, wrote in a court filing. He and his wife, Kim, said the surgery caused “debilitating and life-altering injuries.” The case has since been settled. Chin acknowledged no wrongdoing and the terms are confidential.

KHN reviewed court pleadings in nine settled malpractice cases in Philadelphia, where Chin served on the faculty of the University of Pennsylvania Medical School from 2003 to 2007, and six in South Florida filed since 2012. Details of the settlements are confidential. Five of the six South Florida cases are pending, including one filed in December by the widow of a man who died shortly after spine surgery. In all the cases and settlements, Chin has denied negligence.

In her lawsuit pending against Chin in South Florida, Nancy Lazo of Hialeah Gardens, Florida, said she slipped and tumbled down the stairs outside her Miami office, landing on her back and arm. When the pain would not go away, she turned to Chin and had two operations, in 2014 and 2015. Her lawyers allege that a SpineFrontier screw Chin implanted in her spine in the second procedure caused nerve damage. Lazo, 51, a former billing clerk with two adult sons, said she can no longer work and remains in “constant” pain. “Based on what my doctors have told me,” she said, “I will never get back to normal.” Chin denied any negligence and the case is pending.

Government Struggles to Keep Pace

Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional hearings, in media exposés and in federal investigations. The recurring scandals led Congress to require that device makers and pharmaceutical companies report the payments, starting in August 2013, to a government-run website called Open Payments. That website shows that payments to all doctors have risen from $8.6 billion in 2014 to just over $10 billion last year. A recent study found payments by device makers exceeded those of pharmaceutical companies by a wide margin.

Both the North American Spine Society and the American Academy of Orthopaedic Surgeons told KHN that close ties with the industry, while seeming to generate huge payouts to some surgeons, lead to the design of safer and better implants. “These interactions are really essential for good outcomes in patient care and that needs to be preserved,” said Dr. Joshua J. Jacobs, who chairs the orthopedic surgery department at Rush University Medical Center in Chicago and the AAOS’ ethics committee.

Although more than 600,000 American doctors lap up industry largesse, most do so through small payments that cover the cost of food, drinks and travel to industry-sponsored events. When it comes to big money, however, orthopedists and neurosurgeons dominate, collecting 25% of the total — even though they represent only 5% of the doctors accepting payments, according to the KHN analysis of Open Payments data.

Dr. Charles Rosen, a spine surgeon and co-founder of the advocacy group Association for Medical Ethics, said he was once offered $2,000 just to show up and watch an industry-sponsored panel. “It was quite unbelievable,” he said.

Rosen said while he believes a “relatively small number” of surgeons cash whopping industry checks, many who do so are influential figures who can “help direct medical care.”

Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.

Federal officials recently signaled their displeasure with the hefty fees paid to doctors who promote their products to peers, especially at restaurants, entertainment or sports venues that feature free food and booze but little educational content. In November, the inspector general at the Department of Health and Human Services issued a special fraud alert that such gestures could violate anti-kickback laws.

Companies that ignore the reporting law can be fined up to $1 million, though no fines were levied from 2014 through spring 2020, according to a CMS report. That changed in October, when device giant Medtronic agreed to pay the government $9.2 million to settle allegations that it paid kickbacks to Sioux Falls, South Dakota, neurosurgeon Dr. Wilson Asfora to promote its goods. Officials said the company sponsored more than 100 events at a Brazilian restaurant owned by the surgeon to clinch the sales. Just over $1 million of the fine was assessed for failing to report the transactions. A Medtronic spokesperson said the company fired or took other disciplinary action against the sales employees involved and “remains committed to maintaining the highest standards of ethical conduct.”

KHN identified four spinal device makers — including SpineFrontier — that have been accused in whistleblower cases of scheming to hide consulting payments from the government.

Responding to written questions, a CMS spokesperson said the agency “has multiple formal compliance actions pending which it is unable to discuss further at this time.”

But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.

“Some people would say if you penalize companies enough, they won’t be making these offers,” said Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine. She said small fines may be chalked up to the “cost of doing business.”

The Federation of State Medical Boards does not keep data on how often its members discipline doctors for civil kickback offenses, according to spokesperson Joe Knickrehm. The federation has “long advocated for stronger reporting requirements,” Knickrehm said.

Justice Department officials would not discuss whether they are seeking fines from more surgeons. But in a statement in April 2020, then-U.S. Attorney for the District of Massachusetts Andrew E. Lelling noted that the government will investigate any doctor “who accepts money from a device manufacturer simply for using that company’s products.”

Update: This story was revised at 10:30 a.m. ET to correct the spelling of former gymnast Mary Lou Retton’s name.

Article link

By Maia Anderson, Becker’s Hospital Review, Jun 21, 2021.

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are five reported to the FDA since the end of May:

1. Philips recalls 3.5M CPAP and BiPAP devices, cites potential cancer risk

Philips has recalled roughly 3.5 million ventilation devices after finding a defect that could cause cancer. The ventilators use polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects.

      2. Viona Pharmaceuticals recalls metformin due to carcinogen

Viona Pharmaceuticals, a generic drugmaker in Cranford, N.J., has recalled two lots of metformin tablets after finding they contain levels of Nitroso dimethylamine, or NDMA, above acceptable daily limits.

       3. Innova Medical Group recalls unauthorized COVID-19 test

Innova Medical Group has recalled at least 77,339 of its COVID-19 antigen tests after the FDA discovered the company was selling the test without its approval and that it carries the risk of false positive and false negative results.

       4. Lepu Medical Technology recalls COVID-19 antigen test

Lepu Medical Technology has recalled its COVID-19 rapid antigen test after finding it’s likely to produce false results. The test wasn’t authorized, cleared or approved for marketing or distribution in the U.S.

       5. Step-Har Medical recalls infusion pump

Step-Har Medical, a biomedical repair company in Fountain Valley, Calif., has recalled the Alaris infusion pump after finding a component of the device may crack or separate, leading to an inaccurate delivery of fluids to patients. The pump is used to deliver medications, nutrients, blood and other therapies into a person’s body in controlled amounts.

By Phil Galewitz, KHN, Mar 16, 2021.

In the nation’s battle against the diabetes epidemic, the go-to weapon being aggressively promoted to patients is as small as a quarter and worn on the belly or arm.

A continuous glucose monitor holds a tiny sensor that’s inserted just under the skin, alleviating the need for patients to prick their fingers every day to check blood sugar. The monitor tracks glucose levels all the time, sends readings to patients’ cellphone and doctor, and alerts patients when readings are headed too high or too low.

Nearly 2 million people with diabetes wear the monitors today, twice the number in 2019, according to the investment firm Baird.

There’s little evidence continuous glucose monitoring (CGM) leads to better outcomes for most people with diabetes — the estimated 25 million U.S. patients with Type 2 disease who don’t inject insulin to regulate their blood sugar, health experts say. Still, manufacturers, as well as some physicians and insurers, say the devices help patients control their diabetes by providing near-instant feedback to change diet and exercise compared with once-a-day fingerstick tests. And they say that can reduce costly complications of the disease, such as heart attacks and strokes.

Continuous glucose monitors are not cost-effective for Type 2 diabetes patients who do not use insulin, said Dr. Silvio Inzucchi, director of the Yale Diabetes Center.

Sure, it’s easier to pop a device onto the arm once every two weeks than do multiple finger sticks, which cost less than a $1 a day, he said. But “the price point for these devices is not justifiable for routine use for the average person with Type 2 diabetes.”

Without insurance, the annual cost of using a continuous glucose monitor ranges from nearly $1,000 to $3,000.

Lower Prices Help Propel Use

People with Type I diabetes — who make no insulin — need the frequent data from the monitors in order to inject the proper dose of a synthetic version of the hormone, via a pump or syringe. Because insulin injections can cause life-threatening drops in their blood sugar, the devices also provide a warning to patients when this is happening, particularly helpful while sleeping.

People with Type 2 diabetes, a different disease, do make insulin to control the upswings after eating, but their bodies don’t respond as vigorously as people without the disease. About 20% of Type 2 patients still inject insulin because their bodies don’t make enough, and oral medications can’t control their diabetes.

Doctors often recommend that diabetes patients test their glucose at home to track whether they are reaching treatment goals and learn how medications, diet, exercise and stress affect blood sugar levels.

The crucial blood test doctors use, however, to monitor diabetes for people with Type 2 disease is called hemoglobin A1c, which measures average blood glucose levels over long periods of time. Neither finger-prick tests nor glucose monitors look at A1c. They can’t since this test involves a larger amount of blood and must be done in a lab.

The continuous glucose monitors also don’t assess blood glucose. Instead, they measure the interstitial glucose level, which is the sugar level found in the fluid between the cells.

Companies seem determined to sell the monitors to people with Type 2 diabetes — those who inject insulin and those who don’t — because it’s a market of more than 30 million people. In contrast, about 1.6 million people have Type 1 diabetes.

Helping to fuel the uptake in demand for the monitors has been a drop in prices. The Abbott FreeStyle Libre, one of the leading and lowest-priced brands, costs $70 for the device and about $75 a month for sensors, which must be replaced every two weeks.

Another factor has been the expansion in insurance coverage.

Nearly all insurers cover continuous glucose monitors for people with Type 1 diabetes, for whom it’s a proven lifesaver. Today, nearly half of people with Type 1 diabetes use a monitor, according to Baird.

A small but growing number of insurers are beginning to cover the device for some Type 2 patients who don’t use insulin, including UnitedHealthcare and Maryland-based CareFirst BlueCross BlueShield. These insurers say they have seen initial success among members using the monitors along with health coaches to help keep their diabetes under control.

The few studies — mostly small and paid for by device-makers — examining the impact of the monitors on patient’s health show conflicting results in lowering hemoglobin A1c.

Still, Inzucchi said, the monitors have helped some of his patients who don’t require insulin — and don’t like to prick their fingers — change their diets and lower their glucose levels. Doctors said they’ve seen no proof that the readings get patients to make lasting changes in their diet and exercise routines. They said many patients who don’t use insulin may be better off taking a diabetes education class, joining a gym or seeing a nutritionist.

“I don’t see the extra value with CGM in this population with current evidence we have,” said Dr. Katrina Donahue, director of research at the University of North Carolina Department of Family Medicine. “I’m not sure if more technology is the right answer for most patients.”

Donahue was co-author of a landmark 2017 study in JAMA Internal Medicine that showed no benefit to lowering hemoglobin A1c after one year regularly checking glucose levels through finger-stick testing for people with Type 2 diabetes.

She presumes the measurements did little to change patients’ eating and exercise habits over the long term — which is probably also true of continuous glucose monitors.

“We need to be judicious how we use CGM,” said Veronica Brady, a certified diabetes educator at the University of Texas Health Science Center and spokesperson for the Association of Diabetes Care & Education Specialists. The monitors make sense if used for a few weeks when people are changing medications that can affect their blood sugar levels, she said, or for people who don’t have the dexterity to do finger-stick tests.

Yet, some patients like Trevis Hall credit the monitors for helping them get their disease under control.

Last year, Hall’s health plan, UnitedHealthcare, gave him a monitor at no cost as part of a program to help control his diabetes. He said it doesn’t hurt when he attaches the monitor to his belly twice a month.

The data showed Hall, 53, of Fort Washington, Maryland, that his glucose was reaching dangerous levels several times a day. “It was alarming at first,” he said of the alerts the device would send to his phone.

Over months, the readings helped him change his diet and exercise routine to avert those spikes and bring the disease under control. These days, that means taking a brisk walk after a meal or having a vegetable with dinner.

“It’s made a big difference in my health,” said Hall.

This Market ‘Is Going to Explode’

Makers of the devices increasingly promote them as a way to motivate healthier eating and exercise.

The manufacturers spend millions of dollars pushing doctors to prescribe continuous glucose monitors, and they’re advertising directly to patients on the internet and in TV ads, including a spot starring singer Nick Jonas during this year’s Super Bowl.

Kevin Sayer, CEO of Dexcom, one of the leading makers of the monitors, told analysts last year that the noninsulin Type 2 market is the future. “I’m frequently told by our team that, when this market goes, it is going to explode. It’s not going to be small, and it’s not going to be slow,” he said.

“I believe, personally, at the right price with the right solution, patients will use it all the time,” he added.

Article link: https://khn.org/news/article/continuous-glucose-monitoring-blood-sugar-little-evidence-beneficial-type-2-diabetes-patients/

By Maia Anderson, Becker’s Hospital Review, Apr 30, 2021.

Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are six reported to the FDA since mid-April:

Editor’s note: The recalls are listed from most to least recent. 

1. Pacific Medical Group recalls infusion pump

Pacific Medical Group is recalling the Alaris infusion pump module model 8100, used to deliver fluids such as medications, nutrients and blood into a person’s body in controlled amounts. The recall is because a component of the device may crack or separate, leading to inaccurate delivery of fluids to patients. There have been 62 complaints reported about the issue, and one death may have been related to the recall.

      2. Cordis recalls carotid artery device

Cordis has recalled its Precise PRO Rx US Carotid System, a device used to treat patients with narrowed carotid arteries. The recall is due to a risk of separation in the delivery system, which could cause a stroke. There have been seven complaints about this issue, including five reported injuries. No deaths have been reported.

      3. BD recalls ChloraPrep applicator

Becton, Dickinson and Co. is recalling its ChloraPrep applicator, found defective. In some lots, the applicator end cap was improperly secured because of a manufacturing error, which can result in broken glass and solution dropping out of the applicator once activated.

      4. Medtronic recalls blood-pumping console

Medtronic is recalling a blood-pumping console after reports of electrical failure causing the device to stop. The device is used to pump and return blood to someone during cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery. There have been nine complaints about this issue and three injuries. No deaths have been reported.

      5. CareFusion recalls Alaris pump module

CareFusion is recalling the Alaris pump module — an infusion pump and vital signs monitor — because of a risk of the keypad lifting up when fluid enters, which could lead to keys becoming unresponsive or stuck. This could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected devices.

      6. Medtronic recalls heart pump

Medtronic has recalled its HeartWare Ventricular Assist Device, used to help the heart continue to pump blood into the rest of the body, because of the risk of wear and tear to the connector plug, which could damage the controller port metal pins. Damaged controller ports may prevent the power and data cables from being connected to the controller and lead to a full or partial stop of the pump. There have been 12 deaths and eight injuries related to the recall.

Surgical stapler lawsuits aimed at medical device manufacturers claim that these defective surgical staplers have caused serious injuries—for many years: The majority of complications were concealed from the public by the FDA in a “hidden database” and have just recently been made public.

DEFECTIVE SURGICAL STAPLERS

Surgical staplers, also known as sutures for minimally invasive surgeries, are used to save time during surgery and supposedly reduce the risk of anesthesia complications. Their purpose is to both cut tissue and vessels and then quickly seal them. But serious complications can occur by firing defective staples into organs or other tissue. Surgical stapler injury can also occur by not firing all the staples necessary to seal an incision, which can cause bleeding and other complications. Defective surgical stapler reports include staplers that have created holes in the tissues without leaving staples behind, or staplers that have failed to close the implanted staples.

If the surgical stapler is defective, the repair it is supposed to secure could break loose and cause the contents of an organ that is undergoing repair to be released into the surrounding body.

The ECRI Institute, an independent non-profit health safety group, identified misuse of surgical staplers as a top health technology concern. In its “Top 10 Technology Hazards Report” surgical stapler misuse and malfunction ranks Number 1.

“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” said Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”

SURGICAL STAPLER RISKS AND COMPLICATIONS

Patients have been seriously injured when staplers have failed to fire or seal tissue, causing internal bleeding, organ damage and/ or infections or death when used during surgeries.  Reported complications include severe infections, cardiac problems, and the need for corrective surgeries. One patient required several additional surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his bowel. Another patient reported that her intestines were punctured when a Medtronic EEA surgical stapler allegedly misfired during her surgery.

SURGICAL STAPLERS AND FDA “SECRET” DATABASE

It took a Kaiser Health News report in 2019 for the FDA to release its hidden database and tighten regulations around surgical staplers. The agency admitted in a letter to doctors (March 2019) that it received more than 56,000 surgical stapler malfunction reports from 2011 through 2018 but chose not to inform doctors, hospitals or the public.

In April 2019 the FDA toughened regulations and proposed reclassifying surgical staplers from low-risk to moderate-risk devices, which meant a stricter approval process. (Surgical staplers were in the same category as simple devices like tongue depressors and bandages.) At the same time, labeling changes included proper use and safety hazards. The agency then asked for expert input on its analysis of all reported injuries and less than two months after toughening regulations, it warned to doctors and hospitals of the high number of deaths and injuries related to staplers.

Of the 41,000 malfunctions reported to the MAUDE public database, at least 366 deaths and more than 9,000 serious injuries were related to surgical staplers over eight years—from 2011 until early 2019.  But the FDA posted less than 100 stapler-related injury reports to the public MAUDE database in 2016.

The FDA in May 2019 published an analysis of 109,997 stapler incidents since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. According to MAUDE, deaths were associated with Ethicon and Covidien (a division of Medtronic) products.

Medtronic and Johnson & Johnson’s Ethicon are the two biggest surgical stapler makers. Medtronic said the FDA granted it exemptions for stapler-related malfunctions, but J&J said it had not.

SURGICAL STAPLER LAWSUITS

In lawsuits filed against Medtronic and Covidien, plaintiffs blame the manufacturers for serious health complications, claiming that the staplers were defectively designed and manufactured. Medtronic has been blamed for failure to warn doctors and patients of the potential dangers.

At least three lawsuits filed in late 2017 against Medtronic involve patients who underwent gastrointestinal surgeries that required staples to be precisely placed in organs after surgery. The Medtronic staplers allegedly malfunctioned by creating holes without leaving behind staples or not properly closing implanted staples.

One of those lawsuits filed against Medtronic states that “A reasonable and prudent manufacturer is or should be aware of the risk that if its product is defective, the [surgical] repair it is intended to secure could break loose, causing the contents of an organ undergoing repair to be released into the surrounding area of the body.”

Another patient sued Medtronic after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his small bowel, leading to several infections, more surgical treatments a serious complication called an anastomotic leak.

THE FDA AND MEDTRONIC ASR REPORTS

The FDA hid from the public 10,000 reports as so-called “alternative summary” reports according to Kaiser Health News.

The above plaintiffs all say Medtronic intentionally used a secret loophole in federal adverse-event reporting laws that allowed it to conceal the true risks from the device by burying injury reports in nonpublic files known as alternative summary reports (ASRs). “By doing so, [Medtronic) intentionally concealed from public view the many injuries caused by the use of its Endo GIA staplers,” one lawsuit says.

Federal law requires med-tech companies like Medtronic and Covidien, the staplers’ maker before Medtronic acquired the company in 2015 — to file a public report with the FDA anytime anyone at the company learns that “any of their devices may have caused or contributed to a death or serious injury,” says the FDA. “Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”

However, until 2019 the FDA’s ASR program allowed manufacturers to secretly file spreadsheets summarizing large numbers of adverse events with little to no supporting detail, in cases in which the FDA agreed with the manufacturer that the adverse events were “well-known and well-established risks associated with a particular device,” reported the Star Tribune.  Back in 2016, the Tribune reported that Medtronic was a prolific user of the virtually unknown ASR system, but the following year—once this information was made public– the number of ASR reports filed with the FDA declined steeply, FDA filings show. Following critical reports in other media outlets, the agency eliminated the program in 2019.

SURGICAL STAPLER RECALLS

In May 2019, Medtronic recalled a number of its Ethicon Endo-Surgery Staplers, identifying it as a Class 1 recall, the most serious type. The recall said a missing pin in devices distributed since 2014 could lead to problems, including anastomotic leak. In October 2019, Ethicon recalled the Echelon Flex Powered Plus Endopath 60mm Stapler, due to the potential for malfunction.

An attorney for one of the plaintiffs said in late 2019 that these lawsuits might spur the beginning of litigation against Medtronic regarding the way it sells and reports safety information on its now-recalled staplers.

ONGOING SURGICAL STAPLER LITIGATION

The largest surgical stapler lawsuit verdict was $80 million for a woman who suffered injuries during surgery that nearly killed her. Due to recalls, reclassification, and increased public awareness of these defective devices being hidden from the public, attorneys predict an increase in surgical stapler lawsuits.

The Food and Drug Administration continues to file thousands of reports of patients’ deaths related to medical devices through a reporting system that keeps the safety data out of the public eye.

The system is similar to a vast program exposed earlier this year by KHN that kept device-injury reports effectively hidden within the agency. The FDA shuttered the program after the article about it was published and released millions of records.

The result of this remaining so-called registry exemption program is that key death data about heart devices sits in inaccessible FDA reports that can take up to two years for the public to see under open-records laws. Device-related death reports are typically open, allowing researchers to track and alert their peers about safety concerns.

The FDA carved out the exemption in 2010 and it covers six devices, a spokeswoman said. Doctors tend to report extensive data on patients for certain medical devices that are closely monitored in registries. Private medical societies tend to administer the registries and act as gatekeepers to the data.

The registry leaders, in turn, have reported data to device makers, who sent the FDA spreadsheets detailing what they know about more than 8,000 patient deaths. Those spreadsheets are also inaccessible to the public.

Under standard FDA reporting rules, the device maker is bound to investigate and send the agency a detailed public report about each patient death believed to be device-related.

Device makers say the registries strip key data they need to fully investigate each death, most of them related to heart valves threaded through a catheter and implanted in faulty hearts.

“It’s crazy,” said Diana Zuckerman, president of the National Center for Health Research. “I have to say, there’s not a particular reason I can think of why you put [summary reports] behind some kind of firewall where no one can see it.”

An FDA spokeswoman said the agency just got additional funding from Congress that it plans to use to make “more information readily available and easier to access.”

“We agree that the public should have access to more information about reports of adverse events for medical devices,” the agency said in an email, noting that its current public device database called MAUDE is outdated and “has limited functionalities.”

Earlier this year, the FDA shut down other so-called exemptions to its device-reporting rules that put millions of device harm or malfunction reports out of public reach. Doctors, researchers and even device-safety experts were unaware that for 20 years the FDA accepted 5.7 million reports through its “alternative summary reporting” program.

The FDA released the data ― and the identity of 108 devices that had been quietly “exempted” from public reporting ― in June after KHN reported on the scope of the program.

The FDA also said in December that it is no longer accepting “litigation” summary reports, also highlighted in the KHN report, which makers of pelvic mesh and surgical robots used to file thousands of reports on spreadsheets straight to the agency.

The FDA said it left the registry exemption in place to support the massive datasets being built around certain devices. The registry data helps the agency “act quickly with manufacturers and health care professionals to make more timely, evidence-based decisions to mitigate device problems and keep patients safe,” the statement said.

The FDA accepts hundreds of death reports on spreadsheets kept within the agency from the TVT Registry, which tracks valves threaded through a patient’s vessel in a catheter and implanted in the heart.

The devices have been hailed as lifesaving for patients too fragile for open-heart surgery. They have also been controversial because they have created a need in some patients for an additional device ― a pacemaker ― compounding their risk. Experts have also questioned whether the devices will be durable, particularly as they’re increasingly implanted in younger patients.

Such a heart valve made by Medtronic called CoreValve amassed the most reports, with more than 5,800 death incidents reported since 2014, according to Medtronic. The device was initially approved for patients too sick for open-heart surgery.

The device helped boost survival in fragile, elderly heart patients, with nearly three-quarters still alive and free of major strokes a year after the valve was implanted. It and a competing, similar valve have since been approved for use in younger, healthier patients.

The quarterly summary reports filed with the FDA note hundreds of deaths and thousands of injuries. They say the “anonymized” registry data did not have enough information for Medtronic to determine whether the event was previously reported to the company or the FDA’s public device-injury database called MAUDE. The spreadsheet sent straight to the FDA includes “observations related to patient deaths.”

Medtronic filed far fewer stand-alone public device-death reports, about 900, many summarizing valve-related deaths mentioned in published research. While device companies are required to report patient deaths to the FDA if they have enough information to investigate, doctors are not ― explaining some of the reporting gap.

Medtronic said in a statement that it strives to eliminate malfunctions in all of its devices, but, when they occur, “we make every effort to inform regulators, the healthcare community and the public in a timely … manner.” The company said about 40% of deaths reported from the registry data list no cause, so it’s unclear if they were related to the device.

The maker of the competing device approved in 2011, the Sapien 3 Transcatheter valve, also files death reports under the registry exemption. Edwards Lifesciences filed spreadsheets since 2016 reflecting 2,400 death incidents and individual reports on about 400 deaths.

Edwards’ reports describe possible device-related deaths in patients who had too little or too much calcification in their hearts or whose deaths were attributed to fragility and age. Edwards also notes in its summary filings that “device information is not included in the data received from the registry.”

Edwards spokeswoman Sarah Huoh said that 600,000 patients worldwide have benefited from transcatheter valve surgery. She noted that the Sapien 3 valve used in healthier, younger patients showed a “remarkably low” 1% death or disabling stroke rate a year after surgery. 

Dr. Steven Nissen, chief academic officer at the Cleveland Clinic, said the number of deaths is not alarming, given the frailty of the patients initially undergoing the procedures. But he said the underlying data sent to the FDA should be open.

“To understand safety of devices, we need to have access to all of the data,” he said.

The valve business is brisk and growing, with much of the money coming from the taxpayer-funded Medicare program. Edwards reported $700 million in sales for one quarter of this year for its Sapien valves and predicts a $7 billion market in 2024.

In all, the FDA said it has granted registry exemptions to six devices tracked in three registries. Makers of the MitraClip, which is also threaded in a catheter to clip together flaps in the heart, have filed spreadsheets reflecting more than 500 deaths.

The FDA said it has also given the registry exemption for a cardiac device called the Watchman and to Medtronic’s Valiant Thoracic Stent Graft and a Medtronic catheter used to reopen blocked leg arteries.