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A nonprofit was formed this year to run the innovation district. It's designed to help develop resources for a company looking to grow into a world-class venture.

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The post Biden meets with leaders of tribal nations, signs order easing access to federal funds appeared first on Missouri Independent.

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by Isabelle Taft, Mississippi Today, and Mollie Simon, ProPublica

This article contains depictions of self-harm and discussion of mental illness.

This article was produced for ProPublica’s Local Reporting Network in partnership with Mississippi Today. Sign up for Dispatches to get stories like this one as soon as they are published.

Butch Scipper is haunted by the deaths of three men.

As chancery clerk of Quitman County in the Mississippi Delta, he coordinates a legal process in which people are ordered into treatment for serious mental illness or substance abuse — a common way for Mississippians, especially poor people without insurance, to access inpatient care.

Dozens of times a year, people ask Scipper for help because they are afraid sick family members will hurt themselves or others. Up until a few years ago, he sent many of those family members to jail as they waited to be evaluated and treated.

Jailing people with no criminal charges during the civil commitment process is common in Mississippi because many county officials see no other option when publicly funded mental health facilities are unavailable. In jail, Scipper figured, people going through the commitment process would be prevented from harming themselves or others.

Yet three men — Tyrone Compton, Brandon Raymond and Brian Sneed — killed themselves in the Quitman County jail. Compton and Raymond died the same way, in the same cell, just seven months apart in 2006 and 2007. Sneed died in 2019.

“These three guys run back and forth across my head,” Scipper said. Sending them to jail, he now believes, “was not the right thing to do.”

Since 2006, at least 14 Mississippians have died after being placed in jail during the civil commitment process, purportedly for their own safety. Nine of them, including those three men, died by suicide. Twelve had not been charged with a crime.

It’s not easy to know what goes on inside Mississippi jails — unlike in many states, they’re not subject to mandatory health and safety standards — but lawsuits and Mississippi Bureau of Investigation reports provide some visibility.

Mississippi Today and ProPublica read sworn testimony by family members, jail staffers, administrators, sheriffs and other inmates regarding deaths in jail during the commitment process. We reviewed medical and jail records. We compared suicide prevention policies to nationally recognized guidelines. And we shared key facts about these cases or the policies in effect at the time with a dozen experts in correctional health care, including psychiatrists and other physicians.

Before 11 of the deaths, the medical care and suicide prevention measures fell short of national standards, sometimes shockingly so, according to experts and a review of those standards. (The care provided before the other three deaths, including the most recent one in August, is unclear.)

Before most of the nine suicides, staff didn’t take some basic steps to prevent people from killing themselves, according to those experts and nationally accepted guidelines. And when people going through the commitment process exhibited serious medical issues, jail staff didn’t get them the help they needed, experts said after reviewing the circumstances of those deaths drawn from a Mississippi Bureau of Investigation report, depositions and records filed in court. Staff didn’t review medical histories. They interpreted signs of medical distress as manifestations of mental illness or the influence of drugs or alcohol. They failed to act.

Nakema Fox died in 2007 after being held in the DeSoto County jail, leaving behind her high school sweetheart and husband, Terry Fox (right), her daughter, Faith Fox (middle), her son Janauris Blanch (left) and two other children. Nakema Fox had been diagnosed with schizophrenia and was awaiting transportation to a state psychiatric hospital when she died. Over 11 days in jail, she barely ate, according to a Mississippi Bureau of Investigation report. Fox died of a pulmonary embolism soon after a jail employee noticed her coughing and called a nurse. DeSoto County officials declined to comment on Fox’s death, though a sheriff’s department official said staff keep track of when inmates refuse meals and have medical staff evaluate them. (Eric Shelton/Mississippi Today)

When you see somebody that ain’t eating, you can’t just let them sit there and do that. ... They’re still somebody. They’re still a human being.

—Terry Fox, husband of Nakema Fox, who died of a pulmonary embolism in jail

Local officials in Mississippi say they sometimes need to jail people during the commitment process to keep them safe. But according to the experts we interviewed, jails not only fail to guarantee safety for people with serious mental illness, they can be particularly dangerous for them.

“There’s a whole lot more to safety than just bars and shackles,” said Dr. Robert Greifinger, the former chief medical officer for the New York state prison system.

That point has long been made by sheriffs and jail administrators in Mississippi, too. In 1999, for instance, a 43-year-old man killed himself in the Union County jail as he waited to be taken to Mississippi State Hospital near Jackson for psychiatric treatment.

"He was under watch, but you can't watch him every minute," Joe Bryant, then sheriff of the north Mississippi county, said at the time. "It just brings to light a problem that county jails face: There should be some means besides a county jail to house mental patients. A jail is not equipped for this."

Nearly a quarter-century later, the problem persists. A law passed in 2009 requiring jails to meet state standards if they hold people awaiting psychiatric treatment has resulted in just one jail that’s certified among the 71 that detained about 800 such people in the year ending in June 2023.

When someone dies in jail awaiting treatment, litigation is the primary way families can try to hold officials accountable. Yet none of the nine lawsuits filed over deaths since 2006 have resulted in a court ruling that held county or jail officials responsible. Four were settled. One is ongoing. The rest were dismissed or lost at trial.

Legal experts say such suits rarely succeed, in part because it’s so hard to prove that jail medical care was so bad that it violated someone’s constitutional rights.

But the failure to meet a legal standard doesn’t mean there isn’t a problem. Correctional health care experts said Mississippi’s practice of jailing people solely because they’re mentally ill or addicted to drugs or alcohol has caused deaths that could have been prevented.

"It’s taking people with a suspected health problem and putting them in a place that is likely going to increase their risk of dying from that health problem. The health risks of jail are well established, and they include suicide,” said Dr. Homer Venters, former chief medical officer of New York City jails.

“It’s a terrifying practice."

Unwatched and Unprotected

(Vanessa Saba, special to ProPublica. Source image obtained by Mississippi Today and ProPublica.)

After Scipper took office as Quitman County chancery clerk in 1992, he started handling up to 100 civil commitments a year. He instructed family members on how to file the paperwork, waited for judges to order people into treatment and, if families didn’t want them at home, figured out where to hold them in the meantime. “We used to just automatically put them in the jailhouse,” he said.

In 2006, a man came to Scipper’s office to file commitment papers after his son attacked him. The father was concerned the young man, Tyrone Compton, would hurt himself. Later that day, Compton hanged himself from a set of bars mounted in front of a window in his cell.

Seven months later, Brandon Raymond hanged himself from the same bars as he waited to be taken to a state hospital for drug rehab. It wasn’t until after his death that a piece of metal was welded onto the bars, even though the jail administrator had warned county officials about the danger after the first suicide, according to a deposition in a lawsuit filed over Raymond’s death.

It was an obvious shortcoming. For years, suicide was the leading cause of death in U.S. jails, primarily from hanging. Long-accepted standards direct jail staff to keep people who are at risk of suicide away from bars or protrusions.

A review of court filings and investigations related to the suicides points to shortcomings in how people going through the commitment process were screened for suicide risk, where they were held and how they were monitored.

Suicide prevention policies that address these issues have long been recognized as an essential element of jail medical care. But the former Quitman County jail administrator testified that he didn’t know about any policies whatsoever at the time of Compton and Raymond’s deaths.

David Fathi, an attorney who has worked on litigation over jail and prison conditions for more than 25 years and now serves as director of the ACLU’s National Prison Project, reviewed suicide prevention policies that were in effect at five Mississippi jails where several people died by suicide. Some, he said, were “among the worst policies I’ve ever seen.” One policy said staff could turn off water in a cell to reduce the risk of self-harm — a practice Fathi said has resulted in deaths by dehydration of people with mental illness.

“To send people to jail because they have mental illness, and to send them to a jail that has either flagrantly inadequate suicide policies or no suicide policy at all, is a recipe for disaster,” Fathi said.

If you or someone you know needs help:

• Call the National Suicide Prevention Lifeline: 988
• Text the Crisis Text Line from anywhere in the U.S. to reach a crisis counselor: 741741

Screening inmates for suicide risk is a key part of such policies, and it’s a standard part of the booking process at jails across the country. Staff should ask inmates multiple questions, ranging from explicit ones about whether they have considered suicide to less direct ones like “Have you ever wished you were dead or wished you could go to sleep and not wake up?”

At least six of the nine people who killed themselves, including Compton and Raymond, weren’t screened at all or underwent screenings that didn’t meet national standards, according to depositions and jail records.

For nearly three years after Raymond died without being screened, staff still did not conduct screenings for medical or psychiatric issues, according to depositions. Jail policy had required such screenings for years, but employees, including the former jail administrator, didn’t know that, according to depositions.

Quitman County’s current medical questionnaire does ask staff to determine whether the inmate is “so disoriented or mentally confused as to suggest the risk of suicide,” but leaders in correctional health care told Mississippi Today and ProPublica that’s not sufficient.

Brandon Raymond’s sister, Stacy Raymond, has few pictures of her brother; she got this one from a Facebook memorial post. She said if she had known he would die so young, she would’ve taken more photos. She described him as big-hearted, always happy and a devoted father to his son. (Photo courtesy Stacy Raymond)

I can still see Brandon in my yard. I can still see Brandon coming in my front door. I’ve lost my daddy, and I’ve lost my mama, but it’s nothing like my baby.

—Sandra Pruitt, mother of Brandon Raymond, in a deposition

Compton’s father and Raymond’s mother filed lawsuits against Quitman County, the sheriff and sheriff’s department staff. In response to the Compton lawsuit, the defendants argued they were shielded by qualified immunity, a doctrine that protects government officials from liability for violations of constitutional rights that are not clearly established. They also argued that Compton’s death was the result of his own conduct and that even if his rights had been violated, it wouldn’t have been due to a county policy.

In response to the Raymond lawsuit, defendants argued that qualified immunity applied, jail staff had no reason to believe Raymond was at risk of suicide, and no county policy led to a violation of his rights.

Quitman County settled both lawsuits for undisclosed sums. The sheriff and county officials other than Scipper did not respond to requests for comment for this story.

Once people are booked into jail, there are nationally accepted guidelines on what staff should do to prevent people from killing themselves.

People who are seriously mentally ill are “naturally at higher risk for suicide,” said Dr. Brent Gibson, former chief health officer at the National Commission on Correctional Health Care and founder of the health care consulting company Avocet Enterprises. “All of these people should be directly observed in some kind of way.”

Staff should check on people at risk of suicide at irregular intervals of no more than 15 minutes, according to standards developed by the National Commission on Correctional Health Care. People who are trying to hurt themselves or say they plan to do so should be watched constantly. At-risk inmates should be housed in cells that are “suicide-resistant.” If necessary, their clothes and bedding should be replaced with smocks and blankets made of thick, sturdy material.

Before all nine suicides in Mississippi jails, those things didn’t happen — in part because at least two inmates were never screened in the first place — according to depositions, Mississippi Bureau of Investigation reports and jail records. Just one person was put on suicide watch and housed in a suicide-resistant cell. At least eight weren’t monitored as frequently as guidelines say. At least seven of the eight who hanged themselves weren’t provided with special clothing or blankets. At one jail, the policy was to put someone on suicide watch only if they had attempted suicide there.

Quitman County Sheriff Oliver Parker said in a deposition that his staff did not keep an especially close eye on Raymond because his commitment did not stem from a suicide attempt.

In 2019, 12 years after Raymond died, Brian Sneed was booked into the Quitman County jail without criminal charges as he awaited a drug rehab bed. When the 52-year-old welder was discovered dead from suicide, it had been more than an hour since jail staff had checked on him, according to a Mississippi Bureau of Investigation report.

Quitman County Chancery Clerk Butch Scipper at the courthouse in Marks, Mississippi (Eric J. Shelton/Mississippi Today)

They may die out on the street — I can’t say they don’t. But in a jail cell is just not a good spot for them.

—Quitman County Chancery Clerk Butch Scipper

After Sneed’s death, Scipper concluded he couldn’t guarantee people waiting for treatment would be safe in jail. “I said right then, they may die out on the street — I can’t say they don’t,” he said in an interview. “But in a jail cell is just not a good spot for them.”

Now, he tells people to wait at home until a publicly funded treatment bed is available. Nothing in state law prohibits that, though the state Department of Mental Health says people who are well enough to wait at home may not actually need to be committed.

When the Doctor’s Waiting Room Is a Jail Cell

(Vanessa Saba, special to ProPublica. Source images obtained by Mississippi Today and ProPublica.)

The bare-bones medical care in many Mississippi jails can be dangerous for people who are mentally ill even if they aren’t suicidal.

Over the three days that Princess Anderson was held in the Marshall County jail awaiting a commitment hearing in February 2011, her physical condition declined precipitously. Jail staff did little to inquire about her medical history, according to depositions in a lawsuit later filed over her death. And staff failed to call for help as she exhibited signs of medical distress.

By the time Anderson arrived at a hospital, “she may very well have been one of the sickest patients I’ve ever seen,” her attending physician in the intensive care unit testified in that lawsuit.

Anderson’s journey through the commitment process had started four days before, when she went to a hospital near Memphis and learned she might be suffering from an ectopic pregnancy, a painful and possibly fatal condition. She was released but later that day went to Baptist Memorial Hospital-DeSoto, where she reported that she had ingested cough syrup and marijuana and complained of nausea and anxiety. After she shoved nurses and screamed that she was going to die, a mental health assessor working on behalf of the hospital filed paperwork to have her involuntarily committed.

Anderson was taken in shackles from the hospital to the jail in neighboring Marshall County, where she lived, to await a psychiatric evaluation. On one jail document, her “most serious charge” was recorded as “LUNACY.”

Booking officer Adella Anderson, who is not related to Princess Anderson, handled the medical screening. Princess Anderson didn’t respond to her questions, so the booking officer later testified that she filled out the screening form with the limited information in the commitment paperwork.

Experts said the booking officer should not have simply stopped her inquiries because Anderson didn’t respond; she should have asked a mental health professional to gather more information.

The booking officer testified that she knew Anderson had been brought from a hospital but didn’t find out why. She said she didn’t open an envelope containing Anderson’s medical records because she thought that was illegal. (The law allows correctional staff to review medical records if necessary, but experts said such staff should be trained in doing so, and she was not.) If she had opened the envelope, she might have seen hospital paperwork about the ectopic pregnancy.

Gibson said he has seen “numerous deaths” occur after a jail staffer gave up on a medical screening because an inmate didn’t provide information. “If someone is literally not responsive, they probably shouldn’t be in the jail at all — they should be in the hospital,” he said.

Efforts to reach Adella Anderson by email, phone and mail were unsuccessful.

The next day, an employee of Communicare, the local community mental health center, tried to evaluate Princess Anderson. Again, she was “unresponsive,” according to the form that therapist Debra Shelton filled out. Shelton used paperwork from the hospital to complete the form, concluding that Anderson had tried to harm herself after learning she was pregnant. “Recommend immediate transfer to hospital” for psychosis, Shelton wrote. (Efforts to reach her for this story were unsuccessful.)

Instead of being hospitalized, Anderson was left alone in her cell with inconsistent monitoring until she could be evaluated further as part of the commitment process.

Angela Anderson wrote in a text message that her daughter Princess Anderson, at left with unidentified people, had a “Beautiful Spirit that she carried everywhere.” Angela Anderson testified that hospital staff wouldn’t let her take her daughter home because commitment proceedings were underway. She was surprised to learn that meant Princess would wait in jail for psychiatric treatment. (Photo courtesy Angela Anderson)

I would never ever thought in my life that anything like this would ever go on, you know, what happened to my child. … They’re supposed to be protecting you. They supposed to be caring for you.

—Angela Anderson, mother of Princess Anderson

If she had been in a state psychiatric hospital, medical professionals would have routinely checked her vital signs. That’s important because people with mental illness may not recognize signs of physical illness and ask for help, correctional health care experts said. In jail, however, none of the staff were required to have any medical training aside from CPR.

Over the next two days, Anderson’s condition became increasingly concerning to those around her — but not to jail staff, according to depositions.

She removed her clothes and, according to an inmate’s testimony, lay on the floor in a pool of water for hours at a time. “There wasn’t nothing abnormal for her to get on the floor,” the booking officer later testified. “Most lunacies do that.”

Anderson got sicker. She barely spoke. Her fingers bled from scratching the walls. When she foamed at the mouth, inmates beat on a cell block door for help and told jailers they thought she was having a seizure. Two inmates called 911. Even “the church people” who regularly came to the jail tried to get staff to call an ambulance, one inmate testified.

The booking officer later testified that she didn’t take those calls for help seriously. Inmates “do that with everybody,” she said.

Greifinger, the former chief medical officer for the New York state prison system, said that kind of thinking is common among correctional staff around the country. Even when they see an inmate vomiting or know someone hasn’t eaten for days, he said, “there’s a tremendous culture of disbelief that’s rampant.”

Meanwhile, Anderson’s mother, Angela Anderson, found hospital paperwork saying her daughter might have an ectopic pregnancy. Angela Anderson went to the courthouse to ask if she could take her daughter to a hospital for an ultrasound.

Sarah Liddy, the special master presiding over Princess Anderson’s commitment proceedings, allowed the young woman to leave the jail only after her mother signed a document promising to pay for her medical care. Liddy didn’t respond to a request for comment for this article.

When Angela Anderson arrived at the jail, she found a horrifying scene, according to her testimony. Her daughter was lying on the floor, in two inches of water, feces and vomit. Her fingernails were broken off and there was blood on the walls. Princess was unconscious, only able to groan. Angela begged jail staff to call 911, testifying later that she felt “like a fool” for calling for help from inside a jail.

Princess Anderson was admitted to an ICU with a diagnosis of psychosis, acute renal failure, a metabolic disorder and sepsis. She died a month later at the same hospital where staff had started the legal process that landed her in jail.

According to her autopsy report, Anderson may have experienced a miscarriage in jail. Based on the autopsy and the available information, a medical examiner concluded that she died from multisystem organ failure of an unknown cause.

Dr. Marc F. Stern, a professor at the University of Washington and former medical director for the Washington State Department of Corrections, reviewed key facts of Anderson’s case. He said the behavior that caused hospital staff to initiate commitment proceedings may have been caused by an underlying medical issue.

What happened to Anderson, he said, shows that Mississippi’s practice of jailing people who need medical care is “dangerous, unconscionable, and inhumane.”

“Ignoble, Sordid, Upsetting, and Tragic.” But Not Unconstitutional.

(Vanessa Saba, special to ProPublica. Source image obtained by Mississippi Today and ProPublica.)

When Anderson died, her mother sued Marshall County and Sheriff Kenny Dickerson, as well as Baptist Memorial Hospital-DeSoto. Hers was one of at least nine lawsuits filed by families seeking to hold accountable the people who had detained their loved ones.

Outside of criminal charges, such lawsuits are typically the only option relatives have. Eight of those suits have run their course; none have resulted in court rulings holding anyone liable.

Unlike the vast majority of Americans, incarcerated people have a constitutional right to health care, thanks to a 1976 Supreme Court decision. But in order to prove that insufficient medical care violated an inmate’s constitutional rights, a plaintiff must demonstrate “deliberate indifference” — that staff knew an inmate needed medical attention or was at risk of suicide, but did little or nothing in response.

“That’s a super hard standard to meet,” said Michele Deitch, an expert on jail oversight and director of the Prison and Jail Innovation Lab at the Lyndon B. Johnson School of Public Affairs at the University of Texas at Austin. “You have to get into the head of the person who caused harm,” she said. “They had to know there was a risk of serious harm, and then they did this thing anyway, not caring.”

Princess Anderson’s mother couldn’t meet that standard.

Her suit alleged the sheriff’s office was deliberately indifferent to Princess Anderson’s medical needs. Attorneys representing the sheriff and the county argued the sheriff was entitled to qualified immunity and that jail staff had taken measures to care for Anderson, pointing out that hospital staff had medically cleared her to be taken to jail. The sheriff and other county officials didn’t respond to inquiries for this article.

The suit also alleged that the hospital failed to diagnose the cause of Princess Anderson’s altered mental state and stabilize her and that it handed her over to deputies without proper instructions. In response, the hospital argued that it was protected by a provision of Mississippi law that says anyone “acting in good faith” during the civil commitment process can’t be held liable.

A federal judge dismissed the case against the sheriff based on qualified immunity. The county was later dismissed as a defendant because jail policies were not the “moving force” behind Anderson’s death and jail staff had “periodically” monitored her.

“Officers observed Anderson’s pattern of taking off her clothes and lying on the floor, but they found this conduct to be consistent with other mentally ill inmates at the jail,” U.S. District Judge Debra M. Brown wrote in her December 2014 opinion.

Angela Anderson appealed that decision to the 5th Circuit Court of Appeals. In their ruling, circuit judges called Princess Anderson’s death “ignoble, sordid, upsetting, and tragic.” But they agreed that Anderson’s mother had not proven that officials had acted with deliberate indifference.

All of the lawsuits filed over these deaths alleged the care provided in jail demonstrated deliberate indifference. In the three cases in which judges issued rulings, none found those arguments persuasive.

Anderson’s suit against the hospital eventually went to trial in state court. A jury sided with the hospital.

In an email, Baptist Memorial Health Care’s director of public relations, Kim Alexander, wrote of Princess Anderson, “I am confident our medical team did everything they could to help her and provide compassionate treatment while she was in our care.”

“We are saddened by outcomes like Ms. Anderson’s,” Alexander wrote, “and fully support efforts by our state and mental health professionals to refine our mental health system.”

Eight of the nine counties where people died as they went through the commitment process, including Marshall County, still jail those people. Quitman, where Scipper works, no longer does.

Do you have a story to share about someone who went through the civil commitment process in Mississippi? Contact Isabelle Taft at itaft@mississippitoday.org or call her at (601) 691-4756.

Aerosmith’s “Dream On” may have been released 50 years ago, but fans still love listening to it.  The classic tune just reached over one billion streams on Spotify, so the…

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by Debbie Cenziper, ProPublica, and Michael D. Sallah and Michael Korsh, Pittsburgh Post-Gazette

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

In 2021, after Philips Respironics sold millions of defective medical devices to those who struggle to breathe, the federal agency charged with protecting the health of the American public swept in.

The Food and Drug Administration accused the global powerhouse of a succession of mistakes — casting aside test results and health risks — long after the company discovered an industrial foam embedded in its breathing machines could break down and send tiny particles and fumes into the lungs of patients.

The FDA maintains that it acted as soon as it learned of the safety concerns in April 2021, just weeks before Philips launched one of the largest recalls of its kind.

But a ProPublica and Pittsburgh Post-Gazette investigation found that in the years leading to the recall, the FDA repeatedly failed one of its most critical missions: alerting the public about devices that can inflict serious harm. Over the course of a decade, the agency missed a pattern of warnings from health care workers, patients and others that something was very wrong with the company’s popular sleep apnea devices and ventilators.

From 2011 to 2021, Philips sent hundreds of complaints about the machines to the FDA, none of which resulted in alerts to doctors or patients. One report described a “black powder substance” inside a ventilator. Another noted foam that was “loose and tangled.”

Scores specifically cited “contamination,” a red flag that experts say should have prompted an immediate inquiry because the machines send air directly into the noses and mouths of users, including infants and the elderly. It is unclear who, if anyone, read the reports at the agency.

After the recall, the FDA said that Philips had held back thousands of additional complaints, compromising a public warning system meant to inform consumers about life-threatening device failures. The FDA allowed the company to submit reports years later, so far without penalty.

The FDA also permitted Philips to submit follow-up reports about those late complaints and update the dates that the company first received them. Then the agency concealed the original dates from the public, obscuring how long Philips had the warnings in hand before turning them over to the government.

“That’s regulatory failure,” said Paul Pelletier, a former federal prosecutor who once led health care probes for the Justice Department. “There is no other way to say it. They dropped the ball.”

ProPublica and the Post-Gazette spent more than a year investigating the Philips CPAP recall and the FDA’s response, analyzing 17 million reports in a complaint-tracking system open to the public that has long served as the backbone of the government’s oversight of medical devices.

Created about three decades ago to detect repeated breakdowns, the system relies on companies whose profits are tied to the success of their products to quickly disclose problems and on the FDA to review the warnings, respond to them and hold device makers accountable when they delay reporting on time or fail to do so at all.

Federal law has long required manufacturers to disclose malfunctions, patient injuries and deaths within 30 days. But since 2010, Philips and other subsidiaries of Dutch parent Royal Philips have been late in submitting at least 60,000 complaints to the FDA — often by years, government records show.

That includes more than 3,700 complaints about the recalled continuous positive airway pressure, or CPAP, machines and ventilators, which a ProPublica and Post-Gazette story reported in September. The delays came as patients using the machines suffered from inexplicable respiratory infections, cancers, liver and kidney problems, and other illnesses — ailments that some medical experts fear are tied to the crumbling foam.

Philips said early on the devices could send potentially “toxic and carcinogenic” material into the masks of patients, and the FDA classified the recall as the most serious, for defects capable of causing severe injury or death.

Philips has a history of withholding complaints about medical devices it manufactures. The FDA’s own inspectors have previously cited the company for failing to turn over reports about safety breakdowns involving widely used CT scanners and defibrillators, public records show. Though the agency can pursue criminal charges for the delays, Philips has never faced such penalties.

The lapses in enforcement have not been limited to Philips.

In analyzing complaints in the government’s tracking system, the news organizations found that other leading device makers have submitted hundreds of thousands of late reports to the FDA, in some cases waiting years before disclosing the information. Last year alone, 1 in 8 reports — more than 232,000 complaints — were submitted past the 30-day deadline, leaving regulators and the public without badly needed safety information.

The FDA has sent warning letters to errant companies, but criminal charges are rare.

The analysis also exposed the troubling use of the FDA directive instructing manufacturers to update the dates they became aware of potential defects when providing follow-up reports to the agency.

A review of more than 100,000 complaints submitted since 2013 by two dozen large medical device makers showed that dates were changed on 1 in 5 reports, including those about flawed pacemakers, prosthetics, dialysis machines, and even screws and plates for bones.

The news organizations found the discrepancies in the dates after obtaining the original reports from a private company that stores FDA data and comparing them to the reports as they appear in the agency’s public database.

Medical experts and lawyers who rely on an accurate timeline of breakdowns say that permitting companies to submit late reports or change dates undercuts the nation’s primary system for tracking the safety of medical devices.

“I never imagined that this would be allowed,” said Madris Kinard, a former FDA analyst who was brought in to fix the system in 2010 and quit four years later. “It boggles the mind.”

In a statement, the agency acknowledged that device makers are directed to replace original dates when updating reports in the system but said copies of earlier versions — not available in the public tracking system — are kept separately at the agency.

The FDA did not respond to questions about why such a policy is in place but said that the tracking system is “just one source of information” about faulty medical devices.

The Food and Drug Administration in Silver Spring, Maryland (Aaron M. Sprecher via AP)

The agency defended its handling of the Philips recall, saying officials continue to “take steps to protect the health and safety of individuals using these devices.”

The FDA said it received complaints about “general contamination issues” before the recall but that the debris could have been caused by external sources unrelated to degrading foam. Complaints that specifically described problems with the foam did not indicate that any patients had been harmed, the agency said. The FDA said all complaints are read but did not specify when it reviewed them.

More than two years after the recall, Philips maintains that patient safety is a top priority and its machines are unlikely to cause “appreciable harm.”

In a statement, the company said that it turned over the late complaints about its breathing machines to the FDA “out of an abundance of caution” and that it did not initially believe the complaints needed to be reported to the government. The company did not say why so many other complaints were reported late. It said the date changes were “consistent with regulatory guidelines.”

Philips and Philips Respironics, the company said, “share the same objectives as the FDA.”

Philips has disclosed that it is in discussions with the agency about a consent decree that could compel the company to make significant improvements. The FDA said it could not comment on potential enforcement action.

Criticism of the agency’s oversight of the industry is not new.

Over the years, the FDA has promised to overhaul the way it detects dangerous medical devices by relying more on real-time data in medical registries, electronic health records, insurance claims and other sources. Under Jeff Shuren, a neurologist and attorney who has long led the FDA unit that regulates devices, the agency has directed millions of dollars to that effort.

But to carry out the plan, the FDA in 2016 turned to an organization whose members include major device makers, such as Philips. The group paid for conferences, consultants, travel and pay for its executives, public records show.

Jeff Shuren, at center-left in 2010, is the country’s top regulator of medical devices. (Daniel Rosenbaum/The New York Times)

Years later, the promised system is still not in place.

“It’s very disappointing that we continue to see delays in public notifications of serious device safety issues from the FDA,” said Dr. Rita Redberg, a cardiologist and expert on medical device safety. “We learn about [problems] after years and years and lots of preventable injuries and deaths. It’s such an avoidable disaster.”

“I Was Just Horrified”

In late 2012, hospitals in three U.S. cities scrambled to contain a disturbing pattern of infections among patients who had undergone exams for digestive illnesses.

Eventually, investigators found the connection: a hollow, lighted tube made primarily by medical device maker Olympus that doctors snake down the throat and stomach to peer at the small intestine.

By the time the maker of the duodenoscope launched a recall about three years later, the FDA had received dozens of reports about deaths, infections and injuries to the bowels and other organs, the ProPublica and the Post-Gazette analysis found.

A Senate investigation in 2016 faulted the FDA and its “outmoded” complaint-tracking system for allowing the crisis to continue well after the devices started sickening patients with virulent infections.

“Preventable tragedies,” a Senate report called the crisis after doctors around the world raced to treat patients. “A vivid example of the failure of FDA’s current system for tracking and monitoring the safety of medical devices on the market.”

The congressional probe came six years after an inspector general’s report found the FDA had allowed warnings about medical devices to sit untouched for weeks or longer.

At the time, about 20 people were assigned to read the complaints, which were kept in an electronic tracking system from the 1990s that couldn’t easily retrieve large numbers of related records or run comprehensive searches for key information. Reviewers often jotted down details about the most alarming cases on Post-it notes and tacked them to their computers.

“A huge number of reports weren’t read,” said Kinard, the former FDA analyst. “I was just horrified.”

Madris Kinard, a former FDA analyst, said the agency’s system to track medical device malfunctions, patient injuries and deaths is inadequate. (Benjamin B. Braun/Pittsburgh Post-Gazette)

As the complaints languished, thousands more came in. The increase was driven partly by the sheer number of products on the market, the vast majority approved through an expedited review process created in the 1970s and championed for years by the industry.

Last year, the FDA received 3 million reports about potentially defective devices — nearly 30 times more than in 2005, government records show. Nearly one-third described injuries and deaths.

The FDA, which regulates more than 200,000 types of medical devices, did not say how many people are currently assigned to screening the reports.

Reports About Medical Device Defects Skyrocketed in Recent Years

Manufacturers are required under federal law to turn over to the FDA reports of patient deaths, injuries and malfunctions that have the potential to cause harm.

Source: Pittsburgh Post-Gazette and ProPublica analysis of data from Device Events, which extracted data from the FDA’s Manufacturer and User Facility Device Experience system.

Amid concerns about the agency’s response time, the inspector general in 2009 faulted the FDA for not cracking down on companies that submitted late reports. In response, the agency pledged to offer “educational assistance” to manufacturers and conduct inspections for chronic offenders.

But years later, device makers have continued to turn over complaints months or years after they came in, ProPublica and the Post-Gazette found.

The FDA has significant power to address defective products or companies that ignore its rules by seeking criminal charges, fines and injunctions.

Olympus pleaded guilty and agreed to pay tens of millions of dollars in 2018 for holding back reports that would have exposed the scale of the problem with its duodenoscopes. Late last year, the company was warned again by the FDA about failing to disclose complaints on time.

Olympus acknowledged that it filed some complaints about duodenoscopes late but said the “disclosure failures” were not tied to patient injuries. The company said it is launching a new global complaints system to address the FDA’s more recent concerns.

“Olympus takes the FDA findings and feedback very seriously,” Olympus said in a statement.

Other companies have escaped penalty.

Device maker Becton, Dickinson and Company did not submit 25,000 reports dating back to 2010 about its defective infusion pumps until the devices were recalled nine years later, government records show. The pumps, linked to scores of injuries and at least one death, were malfunctioning while delivering medication and blood to critically ill patients.

In a statement, the company said that it turned over the late reports after the FDA carried out an inspection in 2020 and that none of the cases involved patient injuries or deaths. The FDA said it took steps to provide information to the public and work with the company.

Public health advocates and patients who have been harmed by defective devices, however, say the FDA too often fails to hold companies accountable.

Tess Schulman, a paralegal in North Carolina, struggled with rashes that her doctor said were caused by Essure, a contraceptive device manufactured by Bayer that was blamed for lost pregnancies and deaths and later pulled from the market.

“Why are we still allowing this to happen?” she asked. “Everybody thinks they are there to protect the public and they would not allow companies to sell something that wasn’t safe. We have a false sense of security.”

In a statement, Bayer said it continues to “stand behind Essure’s safety.”

Beyond the late filings, Olympus updated the dates on follow-up reports submitted to the FDA — more than 2,000 times in the case of its troubled duodenoscope, government records show. In each case, the change made it appear in the FDA’s tracking system as if the company had more recently received warnings when they had actually come in months or years earlier.

Like Philips, the company said it was following instructions from the FDA.

The directive has created vast inconsistencies in a system meant to inform and protect the public. ProPublica and the Post-Gazette found that other companies have often left the original dates intact, despite the FDA’s guidance.

The agency said it has the capability to root out “systemic” reporting problems, but experts say they fear the date changes serve companies seeking to conceal potential violations of the law.

“The risk is obvious,” said Michael Gonzalez, an Ohio lawyer who advises companies on health care compliance. “You don’t take what might be evidence in a case — and even your own culpability — and then alter or change it.”

Kinard, the former FDA analyst, said she discovered about a year ago that the agency had created a pathway for manufacturers to make the changes.

“It is an error on the FDA’s side that is being exploited by manufacturers,” said Kinard, who added that she had no idea the changes were so extensive. “I want to know … who has been taking advantage?”

An Unfolding Crisis

The steady series of reports about contaminated CPAPs and ventilators streaming into the FDA in the years before the Philips recall should have come as no surprise to the government.

The FDA had co-hosted a meeting with the nonprofit Association for the Advancement of Medical Instrumentation about ventilator safety in 2014, raising alarms about how material packed in the devices could contaminate the air quality and send “substances into the patient airway and lungs.”

When Philips finally announced a recall in June 2021, acknowledging the foam fitted in its machines could break down in heat and humidity, the FDA released a series of updates on its website but did not address the warning it had issued years earlier.

The recalled Philips CPAP machines were sold around the world. (Liz Moughon/ProPublica)

The agency also said little about the reports it had been receiving from Philips all along.

One of the first arrived in 2011, describing “black substance in the air path” of a ventilator, records show. Another the next year noted a “significant build up of dust and particulate.” Other reports were more detailed, describing problems with the foam itself. “Foam was found to be deteriorated,” read one report submitted to the FDA in 2020, about seven months before the recall.

It remains unclear whether anyone at the FDA at the time looked at the mounting evidence that something was amiss. The agency has since said that Philips submitted 30 reports between 2011 and April 2021 that specifically described foam degradation.

“We review and take seriously all reports of adverse events associated with medical devices and conduct additional evaluation and analysis when necessary,” the agency said. “We take prompt action and communicate publicly when appropriate.”

There is no evidence, however, that the FDA took any action as a result of the foam complaints or the hundreds of reports that described contamination.

While Philips forwarded some complaints to the government, ProPublica and the Post-Gazette reported that the company withheld thousands of others over a span of 11 years, including reports that described deaths among patients.

It wasn’t the first time Philips held back reports about malfunctioning medical devices.

In 2011, the FDA cited a Philips subsidiary for failing to turn over complaints about faulty imaging scanners, including at least two that reported the machines had caught fire, government records show. That same year, the agency found the company was withholding reports about emergency defibrillators that failed to work when patients with heart problems needed them.

A federal court eventually forced Philips to stop distributing defibrillators in the United States, but the order was lifted in 2020.

All the while, Philips was quietly scrambling to deal with the flurry of complaints about its popular breathing machines. And people were getting sick.

Eleven hundred miles away from Washington, in a trim white house in Baton Rouge, Louisiana, Richard Ieyoub rarely thought about the company behind the CPAP machine he had used for years.

The former attorney general of Louisiana, who helped lead a groundbreaking lawsuit against U.S. tobacco companies that ended in a massive settlement in 1998, was serving out a term as the state’s top oil and gas regulator.

First image: Ieyoub and his wife, Caprice, in 2003. Second image: Caprice Ieyoub wears a necklace with her husband’s fingerprint. (AP Photo/Bill Haber, Liz Moughon/ProPublica)

He was also recovering from a rare form of mouth cancer; doctors had to remove a part of his jaw and then rebuild it during a 17-hour surgery to remove a tumor in 2017. The father of seven spent time in recovery at Jesuit retreats and at a family lake house, sitting by a fire pit and regaling his grandchildren with stories about parents, aunts and uncles who had emigrated from Lebanon and settled in rural Louisiana parishes.

After Philips launched the recall, Ieyoub, like the other CPAP machine users who had grown sick, said he began to question whether the device he had used for hours every night was to blame.

And as the prosecutor who took on the dangerous practices of tobacco companies, he wondered why the federal government did not warn the public years earlier.

“To think that so many people are going to suffer,” he said in an interview last year. “There has to be some kind of accountability.”

Early Warning System

Members of Congress have repeatedly questioned the FDA’s oversight of medical devices, especially in the aftermath of wrenching reports of injuries and deaths. Shuren, the top regulator, has long promised to keep the public safe.

“We will remain vigilant,” he said this year.

But the agency’s use of enforcement tools, including inspections and seizures, has dropped significantly in recent years even as the number of new devices hitting the market reached record levels.

The FDA said gaining entry to manufacturing plants during the COVID-19 pandemic was difficult. But the number of inspections started dropping in 2018, two years before the coronavirus crisis, and continued through last year, FDA data shows.

The number of warning letters, which the FDA considers the “principal means of achieving prompt voluntary compliance,” dwindled to 27 last year, down from 217 in 2012, records show. The use of injunctions and seizures against troubled device makers has also dropped.

The FDA Has Issued Far Fewer Warning Letters to Medical Device Manufacturers

Warning letters are used by the FDA to compel manufacturers to voluntarily comply with federal regulations. The agency has attributed the drop to difficulties gaining access to manufacturing plants during the COVID-19 pandemic.

Source: FDA’s Compliance Dashboard

Shortly after the congressional probe into the Olympus recall in 2016, Shuren and the FDA launched a bold plan.

That year, the agency awarded $3 million in seed money to the nonprofit Medical Device Innovation Consortium to establish a center that would bring together information from electronic medical records, insurance claims and medical registries.

Dubbed NEST, the National Evaluation System for health Technology, the initiative aimed to spur medical device innovation and advance an early warning system that would alert doctors, patients and regulators to device malfunctions actively occurring in medical settings.

Over the course of eight years, the FDA devoted millions of dollars to the effort. The nonprofit paid for travel, consultants, technology and bonuses, and about $400,000 a year in pay for its last executive director, records show. But the group has yet to develop a comprehensive new system.

Patient advocates and others have questioned whether Shuren — one of the most influential voices in the $185-billion-a-year U.S. medical device industry — pushed hard enough to see the plan succeed.

Shuren was the vice chairman of the membership committee at MDIC and has been a board member for years, records show.

One top FDA official said Shuren’s connection to the group, given the deep involvement of industry, has signaled to device makers that they have an ally in the agency responsible for regulating them.

“It smells to high heaven as far as I’m concerned,” said the official, who spoke on the condition of anonymity because he was not authorized to comment publicly.

The FDA said Shuren adheres to all ethics and conflict of interest guidelines. Shuren declined an interview request and to answer written questions.

The FDA noted that representatives from other government agencies are also on the board of MDIC and that a network of hospitals, medical centers, clinics and practitioners is bringing together data about devices. The agency said it requires funding to go directly to building and maintaining the network of partners.

In a statement, MDIC said that NEST, a “sub-group” within the nonprofit, did not receive enough money to build an active surveillance system and that as much as $50 million a year would be needed to do so.

The FDA official, who has long been familiar with the effort, said very little has come out of the project.

“It has been a huge waste of time and money,” the official said. “It was all in the service of industry.”

Public health experts and others said they worry that it’s only a matter of time before another emergency unfolds.

“Everybody at the FDA that I ever worked with — everybody — gets up in the morning and the one thing that they most worry about every day is, ‘Is there something on the market that’s going to hurt anybody?’ Nobody wants that on their heads,” said Larry Kessler, a former FDA official who spent 13 years at the agency before leaving in 2009. “When people’s lives are concerned, you want to take quicker action.”

“Government Is Supposed to Be There”

Ieyoub at his home in Baton Rouge in March, where he spoke to ProPublica and Post-Gazette reporters. He died two weeks later. (Liz Moughon/ProPublica)

Long before his cancer diagnosis, former Louisiana Attorney General Ieyoub often talked to his family about good government. “Government is supposed to be there for people who don’t have a voice,” his son-in-law, Art Murray, recalled Ieyoub saying.

In recent years, the veteran prosecutor compared the Philips case to the battle he fought against tobacco companies in the 1990s. Even then, as the industry used cartoon characters to market cigarettes to children, Ieyoub fretted about the government’s failure to intercede.

“That’s the job of these agencies,” he said.

It’s one of the reasons he grew profoundly distressed after the Philips recall, his family members said.

The Ieyoub family pictured together (Liz Moughon/ProPublica)

Murray said Ieyoub believed the company was determined to keep the problem with its machines secret “and unfortunately a regulatory agency ... fell right into that trap.”

“This is one of those perfect storm situations,” Murray said.

Ieyoub, who had recovered from mouth cancer, died of an aortic aneurysm in April. Known as “Giddie” to his five grandchildren, he was 78.

The FDA’s Flawed Medical Device Tracking System

Since the 1990s, the Food and Drug Administration has been using an electronic system known as MAUDE to track complaints about medical devices. The Manufacturer and User Facility Device Experience is a repository of reports about device malfunctions, patient injuries and deaths. To date, more than 17 million reports have been submitted. Yet the system isn’t working the way it should to warn the public about emerging dangers. Here’s how it’s supposed to work and why the system is failing to live up to its mission.

What the Reporting Requirements Are

Under federal law, device makers are required to submit information about reported malfunctions, injuries and deaths within 30 days. Patients, their family members and others can also voluntarily submit reports. The tracking system is publicly available and includes information such as the type of device involved, the date the manufacturer became aware of the problem, the date the report was submitted to the FDA and a description of any patient symptoms and injuries.

How the System Is Supposed to Work

The FDA is supposed to read the reports and look for patterns — or “emerging signals” — about device breakdowns that can harm the public. Though the FDA uses other sources to pick up on patterns, experts say the MAUDE system remains the cornerstone of the agency’s ability to track dangerous devices, an early warning system meant to save lives. Two-thirds of all recalls and FDA regulatory actions begin with a MAUDE report, according to former FDA analyst Madris Kinard, who spent four years working with MAUDE before leaving the agency. She has since developed a database to better sort and examine the reports.

How the System Actually Works

An investigation by ProPublica and the Pittsburgh Post-Gazette found device makers have repeatedly submitted reports after the 30-day deadline, in some cases waiting months or years before forwarding them to the FDA. Reporters also discovered that the FDA directs device makers to update the dates they first became aware of a defect when submitting follow-up information to the government. The new dates are put into the agency’s public tracking system, overriding original dates and obscuring how long companies had the warnings in hand before turning them over to the government.

How We Uncovered a Hidden Flaw in the FDA’s Medical Device Warning System

To report this story, ProPublica and the Pittsburgh Post-Gazette analyzed a database of more than 17 million complaints about medical device malfunctions, patient injuries and deaths submitted to the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience, or MAUDE, tracking system. Because the FDA system is cumbersome and difficult to navigate, the news organizations paid for a subscription to a proprietary database of MAUDE reports called Device Events, developed by former FDA analyst Madris Kinard.

Reporters used these government records to better understand the reporting practices of Philips Respironics and more than two dozen other large medical device manufacturers. The records showed how often companies, including Philips, submitted timely reports about potentially dangerous devices to the government and how often the reports were late.

During this analysis, reporters discovered that the FDA directs device makers to update the dates they first became aware of a defect when submitting follow-up information to the government. The new dates are put into the agency’s public tracking system, overriding original dates and obscuring how long companies had the warnings in hand before turning them over to the government.

In a first-of-its-kind analysis, reporters compared the dates on file in the government’s public tracking system to the dates on the original reports, which were maintained by Device Events. In all, the news organizations compared the dates on more than 100,000 reports from more than two dozen companies dating back to 2013.

Students at Northwestern University’s Medill Investigative Lab helped read and sort hundreds of the reports.

To better understand the FDA’s ability to monitor its tracking system and respond to problem devices, the reporting team interviewed current and former FDA administrators, quality assurance experts for medical device companies as well as public health practitioners who have studied and written about the agency. Over the course of the investigation, the team also examined years of FDA warning letters, inspections, recall notices and safety alerts along with Department of Justice consent decrees and criminal filings.

Reporting was contributed by Mike Wereschagin and Evan Robinson-Johnson of the Pittsburgh Post-Gazette and Monica Sager, Susanti Sarkar, Madaleine Rubin, Molly Burke, Aidan Johnstone, Kelly Adkins, Haajrah Gilani and Juliann Ventura of the Medill Investigative Lab.

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