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US doctor accused of killing 14 patients – experts cite ‘flawed’ hospital system

A US doctor, due in court for the murder of 14 patients, and who was described as hard-working and popular with nurses and hospital staff, not only had a criminal record no one knew about, but had also been fatally overdosing critically ill patients for four years, reports Medscape.

However, federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that have been exposed by the cases, with one medical expert saying there was no record of anyone supervising or monitoring the care of the doctor involved in the wrongful death lawsuits

On 5 December 2017, Danny Mollette, 74, was taken to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mollette, who had diabetes, had previously had been hospitalised for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, the sole physician on duty in the ICU during the overnight shift.

At about 9pm, Husel discussed Molletteʼs “grim prognosis” with the man’s family at the patientʼs bedside. He advised them that Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Annʼs in Ohio, from 2014 to 2018 — all under Huselʼs care.

Like Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl — often combined with a dose of one or more other painkillers or sedatives like hydromorphone — and being withdrawn from the ventilator. These deaths all occurred after palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Husel in December 2018 after an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort”. His Ohio medical license was suspended. He is scheduled to go on trial this month (February,) in Columbus on 14 counts of murder.

Hanging over the murder case against Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over four years, and why numerous registered nurses and hospital pharmacists went along with Huselʼs actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.

The Franklin County (Ohio) Prosecuting Attorneyʼs Office faces two big challenges in trying Husel for murder. The prosecutors must prove that the drugs Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Major flaws in the hospital patient safety systems have been highlighted since the Husel cases came to light, with an outside medical expert, Dr Robert Powers, a professor of emergency medicine at the University of Virginia, testifiying in one of the dozens of wrongful death lawsuits against Mount Carmel and Husel that there was no record of anyone supervising Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Huselʼs criminal record as a young man before hiring and accrediting him, even though the Ohio Medical Board had obtained that record.

As a student in West Virginia in 1994, Husel and a friend allegedly stole car stereos, and after a classmate reported their behaviour, they built a pipe bomb they planned to plant under the classmateʼs car, according to court records.

Husel pleaded guilty in 1996 to a federal misdemeanour for “improperly storing explosive materials”, and he received a 6-month sentence followed by supervision.

He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, said attorneys representing the families of his deceased patients.

A Mount Carmel spokeswoman said the hospital only checks a physician applicantʼs background record for the previous 10 years, according to Medscape.

“I think [the credentialing process] should have been more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You donʼt hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Huselʼs palliative extubation practices until a staffer reported Huselʼs high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Huselʼs patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

In January 2019, Mount Carmelʼs then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Huselʼs care could have been treated and survived. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Husel ordered — 500 to 2000 micrograms — were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients, except those with high opioid tolerance, by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmelʼs 2016 guidelines for IV administration of fentanyl specified a dosage range of 50 to 100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25 to 50 micrograms.

Mount Carmel West hired Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. He was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Husel was chosen by his hospital colleagues as physician of the year, and again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Dr Larry Swanner, Mount Carmelʼs former vice president of medical affairs, who was fired in 2019.

Huselʼs criminal defence attorney, Jose Baez, said Huselʼs treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. Butt medical and pharmacy experts disagree.

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Huselʼs and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney whoʼs representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, in the low-income, inner-city neighbourhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Huselʼs care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmelʼs patient safety system.

First, there was no evidence in the record that Mollette was in pain or lacked the ability to breathe on his own before Huselʼs palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mollette and two other ICU patients who died. Deemer said Husel told him the patient had to be in pain, given his condition.

After consulting with Molletteʼs family at the bedside, Husel ordered Deemer to administer 1000 micrograms of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist pre-approval system. He said Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mollette and other Husel patients were fully informed about their relativesʼ conditions before agreeing to the palliative extubation. Molletteʼs son, Brian, said in July 2019 that Husel “said my fatherʼs organs were shutting down and he was brain damaged.”

“In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, thereʼs the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patientsʼ deaths — as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and thatʼs illegal in the US.

“There is no evidence that medication played any part in the death of any of these patients,” said Landy, who is representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids after extubation extend life, not shorten it.”

Medscape reports that Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare and Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy havenʼt accepted that defence. Instead, they have cited Mount Carmel, Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Huselʼs drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard non-emergency process of getting pre-approval from the duty pharmacist. Instead, they used the override function on Mount Carmelʼs automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospitalʼs correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, writes Medscape, pharmacists must immediately report concerns about drug prescribing safety up the hospital pharmacy chain of command.

Huselʼs high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely, if ever, questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Husel. Under the Zero Harm patient safety programme Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasised those responsibilities in his 30 November 2020 report on nurse Deemerʼs actions regarding three patients who died under Huselʼs care in 2017 and 2018. At Deckerʼs recommendation, Deemerʼs license was suspended for three years. Decker wrote that the ICU nurses had a professional responsibility to question Husel and, if necessary, refuse to carry out the doctorʼs order and report their concerns to managers.

“Challenging a physicianʼs order is a difficult step even under ideal circumstances,” wrote Decker, calling Mount Carmel Westʼs ICU a “dysfunctional” environment.

“But,” he noted, “when Mr Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate….Clearly, Mr Deemer trusted Dr Husel. But Dr Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many US hospitals.

 

Medscape article – Doc Accused of Killing 14 Patients in the ICU: Upcoming Trial Notes Patient Safety Lapses (Open access)

 

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