First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s 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 Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.
After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. 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. Mr. 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 Mr. Mollette and two subsequent Husel patients.
Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s 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 Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. 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, there’s 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 patients’ 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 that’s illegal in the United States.
“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”
Dr. 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 & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. 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 Dr. Husel’s 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 nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s 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 hospital’s 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, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.
“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”
Dr. Husel’s 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 Dr. Husel.
Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.
“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s 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 U.S. hospitals.
“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”
A version of this article first appeared on Medscape.com.
Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice.
This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.