Deep flaws in FDA oversight of medical devices, and patient harm, exposed in lawsuits and records

Published

1 year ago

December 21, 2023

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Dec 21 2023 KFF Health News

Living with diabetes, Carlton "PeeWee" Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

"There's a big hole left where he was," said Gautney's daughter, Carla Wiggins, who is suing the manufacturer. "A big part of me is missing."

The wrongful-death lawsuit alleges the pump was "defective and unreasonably dangerous." Medtronic has denied the pump caused Gautney's death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could "lead to an over or under delivery of insulin," which could "be life threatening or may result in death."

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including: Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely. Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery. Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths. And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have "substantial equivalence" to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

"Patients believe they are getting an implant that's been proven safe," said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. "No, it hasn't," Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it "has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices." 'Too little, too late'

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, lauded the device as a "first-of-its-kind technology" that would give patients "greater freedom to live their lives" and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with "no serious adverse events," the release said. Shuren declined to be interviewed.

The FDA's enthusiasm didn't last. In November 2019, Medtronic, citing the ring problem, launched an "urgent medical device recall" of the pumps, which it expanded in late 2021.

During an inspection at Medtronic's plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren't investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an "insulin-induced coma" that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man's home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. "Simply too little, too late," the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones "redesigned to reduce the risk of damage" and "fulfilled all pump replacement requests at no cost to customers."

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system. Shortcut to market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has "substantial equivalence" to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was "not intended to evaluate the safety and effectiveness of medical devices" and said "a move away from the 510(k) clearance process should occur as soon as reasonably possible."

More than a decade later, that hasn't happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don't realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

"Doctors are shocked to learn this," she said. "Patients aren't going to know it when their doctors don't."

In response to written questions from KFF Health News, the FDA said it "continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices." The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as "predicate" devices.

"We can't get detailed data," said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. "It's very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems."

Rothenberg cited the history of "metal-on-metal" artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices. Alarm bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.

According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic's subsidiary company Covidien made its claim even though the device has completely different "guts" and operates using software and other "substantially different" mechanisms, according to the whistleblowers' suit.

In response, Medtronic said it "believes the allegations are without merit and has moved to dismiss the case." The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that "the wheels for the ventilator cart may actually fall off the ventilator during transport," according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a "manufacturing assembly error" that the company said may cause the ventilator to become "inoperable."

Medtronic said in an email that the ventilator "has helped thousands of patients around the world," including playing a "critical role in the global response to the COVID-19 pandemic." Late warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody's guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a "commonsense step we can take up front to mitigate risk, improve certainty and save money later." Related StoriesStem cell therapy trial shows promise for regenerative treatment of heart failureFetal hormone GDF15 linked to nausea and vomiting in pregnancyIncreased internet use linked to higher anxiety in teens, research shows

The FDA said it is working to "strike the right balance between assuring safety and fostering device innovation and patient access." Yet it noted: "Additional resources are required to establish a fully functioning active surveillance system for medical devices." For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA's own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump's retainer rings were reported to the agency. The FDA said the complaints "were part of the information that led to the compliance actions." The agency said it "approved design and manufacturing changes to the retainer ring to correct this issue" and "has reviewed information confirming the effectiveness of the modification."

"What is the threshold for the FDA to step in and do something?" said Mara Schwartz, who is a nurse, diabetes educator, and pump user. "How many deaths or adverse events does there have to be?"

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private eyes

Some countries don't trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That's not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what's already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country's health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had "worked closely" with the Australian group to resolve the problems. "We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions," Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it's not available to them. 'Exciting features'

While the FDA clears thousands of devices for use based on the "substantial equivalence" premise, manufacturers often tout "new and exciting features" in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has "limited resources to actively monitor the volume of direct-to-consumer advertising," according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report. Legal barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn't have agreed to the procedure.

He lost when the judge cited a legal doctrine called "learned intermediary." The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device's risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. "They never gave me any warning about what could happen down the road," he said in an interview. "I never had a chance to have my day in court."

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: "It's fine right now," court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

"It should never be put on the patient to determine if there is a problem," Wiggins said.

Medtronic has denied the pump failed and caused Gautney's death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are "really wonderful" devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump's hazards.

"The risks get minimized and the benefits exaggerated," he said.

This article was reprinted from khn.org, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism. Source:

KFF Health News

Entertainment

P Diddy: Everything you need to know about the Sean Combs trial

Published

7 mins ago

May 5, 2025

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P Diddy: Everything you need to know about the Sean Combs trial

Seven months after his high-profile arrest, the trial of hip-hop mogul Sean “Diddy” Combs is set to get under way today.

A three-time Grammy winner and one of the most influential hip-hop producers of the past 30 years – also known variously as Puff Daddy, P Diddy and “Love” in the years since he rose to fame in the 1990s – the rapper and founder of Bad Boy Records is now facing serious criminal charges in the US, as well as several civil lawsuits.

He has pleaded not guilty to criminal charges, said his sexual relationships were consensual, and strenuously denied all allegations of wrongdoing.

Combs, 55, was arrested and charged in September 2024, six months after raids by federal agents on two of his properties in Los Angeles and Miami. He has been held in detention in New York since his arrest, having been refused bail as he awaits trial.

Jury selection is set to begin this morning and will potentially take several days. Opening statements by lawyers and the start of the testimony are expected to begin next week.

Here is everything you need to know.

What is Combs on trial for?

Combs is facing five felony charges:

• Racketeering conspiracy
• Two counts of sex trafficking by force, fraud or coercion
• Two counts of transportation to engage in prostitution

The rapper was initially charged with three offences – racketeering, sex trafficking, and transportation to engage in prostitution. Two extra counts – one each of sex trafficking and transportation to engage in prostitution – were added earlier in April.

Combs has pleaded not guilty to all charges.

Racketeering broadly means engaging in an illegal scheme or enterprise, and the charge falls under the Racketeering Influenced and Corrupt Organisations Act (RICO) in the US.

According to the US justice department’s definition of RICO statute, it is also illegal to “conspire to violate” the laws.

The indictment against Combs alleges that between 2008 and 2024, he “led a racketeering conspiracy that engaged in sex trafficking, forced labour, kidnapping, arson, bribery, and obstruction of justice, among other crimes”, the US attorney’s office for the Southern District of New York said following his arrest in September.

Who are the accusers?

Prosecutors expect four accusers to testify against Combs during the criminal trial.

Three have requested their identities not be revealed to the press or the public and that they instead be referred to using only pseudonyms.

One accuser, who is referred to as Victim 1 in court documents, is prepared to testify under her own name, prosecutors have said.

When did allegations begin?

In November 2023, Combs’ former girlfriend, R’n’B star Cassie – full name Casandra Ventura – filed a civil lawsuit alleging she was trafficked, raped, plied with drugs and viciously beaten by the rapper on many occasions over the course of 10 years.

The lawsuit was settled the following day. Terms of the agreement were not made public but there was no admission of wrongdoing from Combs, and he issued a statement saying he “vehemently” denied the “offensive and outrageous” allegations.

Six months later, footage recorded at a hotel in Los Angeles in 2016 emerged, allegedly showing Combs hitting and kicking Cassie in a hallway.

Shortly afterwards, he released a video apology, saying his behaviour in the video was at a time when he had “hit rock bottom” but nonetheless was “inexcusable” and that he was “disgusted” with himself.

The rapper’s lawyers argue the footage was nothing more than a “glimpse into a complex but decade-long consensual relationship”.

Details of ‘freak offs’

The charges include details of alleged “freak offs” – described as “elaborate and produced sex performances that Combs arranged, directed, masturbated during, and often electronically recorded”.

He allegedly induced female victims and male sex workers into drug-fuelled sexual performances, according to the indictment.

Prosecutors allege victims were given controlled substances during the sometimes days-long events to keep them “obedient and compliant” and Combs subjected them to “physical, emotional, and verbal abuse” to get them to engage.

The indictment also alleges Combs “engaged in acts of violence, threats of violence, threats of financial and reputational harm, and verbal abuse” including kidnapping and arson when witnesses of his alleged abuse threatened his authority or reputation.

What happens first?

The hearing is set to begin with jury selection at the US District Court for the Southern District of New York in Lower Manhattan.

After the two additional charges were added, Combs’ legal team requested a delay of two months, saying they needed more time to prepare his defence. However, Judge Arun Subramanian, who will hear the trial, denied the request, saying it had been made too close to the start date.

So, the trial will go ahead as planned, starting with jury selection. This is currently scheduled to take a week, but as a high-profile case, this process may be complicated and take some time.

If jury selection goes to plan, the opening statements from the prosecution and defence are set to begin on Monday 12 May.

Lawyers for Combs have requested for potential jurors to be asked about their views regarding sex, drugs, alcohol, and violence in a questionnaire.

In a letter submitted to the judge, the rapper’s legal team said: “Because this trial involves content that is sensitive and private in nature, many individuals are uncomfortable speaking about these issues in front of others and would be more candid writing about them in a questionnaire.”

Examples of areas “requiring inquiry” are potential connections to “drug or alcohol abuse… domestic violence, their willingness to watch videos with physical assault and videos that are sexually explicit, and their views towards people with multiple sexual partners”, they said.

They also want potential jurors to say if they have watched documentaries released about Combs since the charges were announced.

Prosecutors criticised the defence’s proposed questionnaire – with 72 questions – as too long and touching on subjects that would be better asked in person by the judge, if at all.

What has Combs said?

The rapper has strongly denied all the allegations against him.

Following his initial court appearance in September, one of his lawyers, Marc Agnifilo, said the rapper would “fight this to the end,” that he was “not afraid” of the charges, and was “looking forward to clearing his name”.

“Eventually he’s going to be shown to be innocent,” Mr Agnifilo said.

In a document submitted in February, Combs’ legal team argued for the transportation charge to be dismissed, saying he had been subject to a “racist” prosecution “for conduct that regularly goes unpunished”, and that he was being “singled out” as “a powerful black man” over the use of escorts.

They argued that “no white person” had ever “been the target of a remotely similar prosecution” and said that while the rapper had “complicated relationships with significant others as well as with alcohol and drugs… that doesn’t make him a racketeer, or a sex trafficker”.

Are the criminal charges separate to the lawsuits?

Yes. Combs has also been hit with dozens of civil claims – a few filed before the criminal charges were announced, but the majority afterwards.

These include accusations of sexual abuse by men and women, from alleged victims who were as young as 10 at the time of the alleged incidents.

Many of these have been filed by Texas lawyer Tony Buzbee, whom Combs’ team have accused of seeking publicity.

One particularly high-profile lawsuit, involving rapper Jay-Z as well as Combs, was voluntarily dropped with prejudice, meaning it cannot be brought again, by the accuser in February.

Another lawsuit accuses Combs of raping a woman as alleged payback for her saying she believed he was involved in the murder of rapper Tupac Shakur. Combs is suing the lawyer involved in this case for defamation, over other allegations that have been made against him.

What sentence does Combs face?

The US attorney’s office for the Southern District of New York announced details of potential sentences when Combs was charged, but said the decision would ultimately be determined by the judge.

Racketeering conspiracy carries a maximum sentence of life in prison, the attorney’s office said, as does sex trafficking by force, fraud, or coercion – which also carries a mandatory minimum sentence of 15 years in prison.

The charge of transportation for purposes of prostitution carries a maximum sentence of 10 years in prison.

Sports

This time at UCF, Scott Frost won’t need to catch lightning in a bottle

Published

7 mins ago

May 5, 2025

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This time at UCF, Scott Frost won't need to catch lightning in a bottle

Andrea AdelsonMay 3, 2025, 09:58 AM ET
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- ACC reporter.
- Joined ESPN.com in 2010.
- Graduate of the University of Florida.

ORLANDO, Fla. — Scott Frost walks into the UCF football building and into his office, the one he used the last time he had this job, eight years ago. The shades are drawn, just like they used to be. There are drawings from his three kids tacked to the walls. There are still trophies sitting on a shelf.

He still parks in the same spot before he walks into that same building and sits at the same desk. The only thing that has changed is that the desk is positioned in a different part of the room.

But the man doing all the same things at the University of Central Florida is a different Scott Frost than the one who left following that undefeated 2017 season to take the head coach job at Nebraska.

UCF might look the same, but the school is different now, too. The Knights are now in a Power 4 conference, and there is now a 12-team College Football Playoff that affords them the opportunity to play for national championships — as opposed to self-declaring them. Just outside his office, construction is underway to upgrade the football stadium. The same, but different.

“I know I’m a wiser person and smarter football coach,” Frost said during a sit-down interview with ESPN. “When you’re young, you think you have it all figured out. I don’t think you really get better as a person unless you go through really good things, and really bad things. I just know I’m where I’m supposed to be.”

Out on the practice field, Frost feels the most at home — he feels comfort in going back to the place that has defined nearly every day of his life. As a young boy, he learned the game from his mom and dad, both football coaches, then thrived as a college and NFL player before going into coaching.

He coaches up his players with a straightforwardness that quarterbacks coach McKenzie Milton remembers fondly from their previous time together at UCF. Milton started at quarterback on the 2017 undefeated team, and the two remained close after Frost left.

“I see the same version of him from when I was here as a player,” Milton said. “Even though the dynamic in college football has changed dramatically with the portal and NIL, I think Coach Frost is one of the few coaches that can still bring a group of guys together and turn them into a team, just with who he is and what he’s done and what he’s been through in his life. He knows what it looks like to succeed, both as a coach and a player.”

Since his return, Frost has had to adjust to those changes to college football, but he said, “I love coming into work every day. We’ve got the right kids who love football. We’re working them hard. They want to be pushed. They want to be challenged. We get to practice with palm trees and sunshine and, we’re playing big-time football. But it’s also just not the constant stress meat grinder of some other places.”

Meat grinder of some other places.

Might he mean a place such as Nebraska?

“You can think what you want,” Frost said. “One thing I told myself — I’m never going to talk about that. It just doesn’t feel good to talk about. I’ll get asked 100 questions. This is about UCF. I just don’t have anything to say.”

Frost says he has no regrets about leaving UCF, even though he didn’t get the results he had hoped for at his alma mater. When Nebraska decided to part ways with coach Mike Riley in 2017, Frost seemed the best, most obvious candidate to replace him. He had been the starting quarterback on the 1997 team, the last Nebraska team to win a national title.

He now had the coaching résumé to match. Frost had done the unthinkable at UCF — taking a program that was winless the season before he arrived, to undefeated and the talk of the college football world just two years later.

But he could not ignore the pull of Nebraska and the opportunities that came along with power conference football.

“I was so happy here,” Frost said. “We went undefeated and didn’t get a chance to win a championship, at least on the field. You are always striving to reach higher goals. I had always told myself I wasn’t going to leave here unless there was a place that you can legitimately go and win a national championship. It was a tough decision because I didn’t want to leave regardless of which place it was.”

Indeed, Frost maintains he was always happy at UCF. But he also knew returning to Nebraska would make others happy, too.

“I think I kind of knew that wasn’t best for me,” he said. “It was what some other people wanted me to do to some degree.”

In four-plus seasons with the Cornhuskers, Frost went 16-31 — including 5-22 in one-score games. He was fired three games into the 2022 season after a home loss to Georgia Southern.

After Frost was fired, he moved to Scottsdale, Arizona, where his wife has family. He reflected on what happened during his tenure with the Cornhuskers but also about what he wanted to do with the rest of his career. He tried to stay connected to the game, coaching in the U.S. Army Bowl, a high school all-star game in Frisco, Texas, in December 2022. Milton coached alongside him, and distinctly remembers a conversation they had.

“He said, ‘It’s my goal to get back to UCF one day,'” Milton said. “At that time, I was like, ‘I pray to God that happens.'”

If that was the ultimate goal, Frost needed to figure out how to position himself to get back there. While he contemplated his future, he coached his son’s flag football team to a championship. Frost found the 5- and 6-year-olds he coached “listen better than 19-year-olds sometimes.”

Ultimately, he decided on a career reboot in the NFL. Frost had visited the Rams during their offseason program, and when a job came open in summer 2024, Rams coach Sean McVay immediately reached out.

Frost was hired as a senior analyst, primarily helping with special teams but also working with offense and defense.

“It was more just getting another great leader in the building, someone who has been a head coach, that has wisdom and a wealth of experience to be able to learn from,” McVay told ESPN. “His ability to be able to communicate to our players from a great coaching perspective, but also have the empathy and the understanding from when he played — all of those things were really valuable.”

McVay said he and Frost had long discussions about handling the challenges that come with falling short as a head coach.

“There’s strength in the vulnerability,” McVay said. “I felt that from him. There’s a real power in the perspective that you have from those different experiences. If you can really look at some of the things that maybe didn’t go down the way you wanted to within the framework of your role and responsibility, real growth can occur. I saw that in him.”

Frost says his time with the Rams rejuvenated him.

“It brought me back,” Frost said. “Sometimes when you’re a head coach or maybe even a coordinator, you forget how fun it is to be around the game when it’s not all on you all the time. What I did was a very small part, and we certainly weren’t going to win or lose based on every move that I made, and I didn’t have to wear the losses and struggle for the victories like you do when you’re a head coach. I’m so grateful to those guys.”

UCF athletics director Terry Mohajir got a call from then-head coach Gus Malzahn last November. Malzahn, on the verge of finishing his fourth season at UCF, was contemplating becoming offensive coordinator at Florida State. Given all the responsibilities on his desk as head coach — from NIL to the transfer portal to roster management — he found the idea of going back to playcalling appealing. Mohajir started preparing a list of candidates and was told Thanksgiving night that Malzahn had planned to step down.

Though Frost previously worked at UCF under athletics director Danny White, he and Mohajir had a preexisting relationship. Mohajir said he reached out to Frost after he was fired at Nebraska to gauge his interest in returning to UCF as offensive coordinator under Malzahn. But Frost was not ready.

This time around, Mohajir learned quickly that Frost had interest in returning as head coach. Mohajir called McVay and Rams general manager Les Snead. They told him Frost did anything that was asked of him, including making copies around the office.

“They said, ‘You would never know he was the head coach at a major college program.” Mohajir also called former Nebraska athletic director Trev Alberts to get a better understanding about what happened with the Cornhuskers.

“Fits are a huge piece, and not everybody fits,” Mohajir said.

After eight conversations, Mohajir decided he wanted to meet Frost in person. They met at an airport hotel in Dallas.

“He was motivated,” Mohajir said. “We went from coast to coast, talked to coordinators, head coaches, pro guys, all kinds of different folks. And at the end of the day, I really believe that Scott wanted the job the most.”

The first day back in Orlando, Dec. 8, was a blur. Frost woke up at 3:45 a.m. in California to be able to make it to Florida in time for his introductory news conference with his family.

When they pulled into the campus, his first time back since he left in 2017, Frost said he was in a fog. It took another 24 hours for him and his wife, Ashley, to take a deep exhale.

“Rather than bouncing around chasing NFL jobs, we thought maybe we would be able to plant some roots here and have our kids be in a stable place for a while at a place that I really enjoyed coaching and that I think it has a chance to evolve into a place that could win a lot of football games,” Frost said. “All that together was just enough to get me to come back.”

The natural question now is whether Frost can do what he did during his first tenure.

That 2017 season stands as the only winning season of his head coaching career, but it carries so much weight with UCF fans because of its significance as both the best season in school history, and one that changed both its own future and college football.

After UCF finished 13-0, White self-declared the Knights national champions. Locked out of the four-team playoff after finishing No. 12 in the final CFP standings, White started lobbying for more attention to be paid to schools outside the power conferences.

That season also positioned UCF to pounce during the next wave of realignment. Sure enough, in 2023, the Knights began play in a Power 4 conference for the first time as Big 12 members. This past season, the CFP expanded to 12 teams. Unlike 2017, UCF now has a defined path to play for a national title and no longer has to go undefeated and then pray for a shot. Win the Big 12 championship, no matter the record, and UCF is in the playoff.

But Frost cautions those who expect the clock to turn back to 2017.

“I don’t think there’s many people out there that silly,” Frost said. “People joke about that with me, that they’re going to expect you go into undefeated in the first year. I think the fans are a little more realistic than that.”

The game, of course, is different. Had the transfer portal and NIL existed when Frost was at UCF during his first tenure, he might not have been able to keep the 2017 team together. The 2018 team, which went undefeated under Josh Heupel before losing to LSU in the Fiesta Bowl, might not have stayed together, either.

This upcoming season, UCF will receive a full share of television revenue from the Big 12, after receiving a half share (estimated $18 million) in each of his first two seasons. While that is more than what it received in the AAC, it is less than what other Big 12 schools received, making it harder to compete immediately. It also struggled with NIL funding. As a result, in its first two years in the conference, UCF went 5-13 in Big 12 play and 10-15 overall.

Assuming the House v. NCAA settlement goes into effect this summer, Mohajir says UCF is aiming to spend the full $20.5 million, including fully funding football.

“It’s like we moved to the fancy neighborhood, and we got a job that’s going to pay us money over time, and we’re going to do well over time, but we’re stretching a little to be there right now, and that requires a lot of effort from a lot of people and a lot of commitment from a lot of people,” Frost said. “So far, the help that we’ve gotten has been impressive.”

Mohajir points out that UCF has had five coaching changes over the past 10 years, dating back to the final season under George O’Leary in 2015, when the Knights went 0-12. Frost says he wants to be in for the long term, and Mohajir hopes consistency at head coach will be an added benefit. Mohajir believes UCF is getting the best of Frost in this moment and scoffs at any questions about whether rehiring him will work again.

“Based on what I’m seeing right now, it will absolutely work,” Mohajir said. “But I don’t really look at it as ‘working again.’ It’s not ‘again.’ It’s, ‘Will it work?’ Because it’s a different era.”

To that end, Frost says success is not recreating 2017 and going undefeated. Rather, Frost said, “If our group now can help us become competitive in the Big 12, and then, from time to time, compete for championships and make us more relevant nationally, I think we’ll have done our job to help catapult UCF again.”

You could say he is looking for the same result. He’s just taking a different route there.

Sports

Ex-Cougar Haulcy, top transfer safety, picks LSU

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7 mins ago

May 5, 2025

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Ex-Cougar Haulcy, top transfer safety, picks LSU

Max OlsonMay 4, 2025, 11:06 PM ET
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- Covers the Big 12
- Joined ESPN in 2012
- Graduate of the University of Nebraska

Houston transfer safety A.J. Haulcy committed to LSU on Sunday, his agency, A&P Sports, told ESPN.

Haulcy, the top player still available and No. 1 safety in ESPN’s spring transfer portal rankings, committed to the Tigers after taking an official visit Sunday. Miami, Ole Miss and SMU were also contenders for his pledge.

The 6-foot, 215-pound senior defensive back has started 32 games over his three college seasons and earned first-team All-Big 12 honors in 2024 after producing 74 tackles, 8 pass breakups and 5 interceptions, which tied for most in the conference.

LSU has assembled one of the top incoming transfer classes in the country this offseason with 18 signees, including six players — wide receivers Barion Brown (Kentucky) and Nic Anderson (Oklahoma), linemen Braelin Moore (Virginia Tech) and Josh Thompson (Northwestern), cornerback Mansoor Delane (Virginia Tech) and defensive end Patrick Payton (LSU) — who ranked among the top 60 in ESPN’s winter transfer rankings.

The Tigers also landed USF transfer Bernard Gooden, one of the most coveted defensive tackles in the spring transfer window.

Haulcy began his career at New Mexico in 2022, earning a starting role as a true freshman and recording 87 tackles, including a career-high 24 against Fresno State, and two interceptions. The Houston native entered the transfer portal at the end of the season and came home to play for the Cougars.

As a sophomore in 2023, Haulcy recorded a team-high 98 tackles and received votes for Big 12 Defensive Newcomer of the Year from the league’s coaches.

Haulcy chose to re-enter the portal April 21 after Houston’s spring game, as did starting cornerback Jeremiah Wilson, who’ll continue his career at Florida State. Wilson and Haulcy were the Nos. 11 and 12 players, respectively, in ESPN’s spring transfer rankings.