The grieving parents of a 5-year-old boy who tragically lost his life in a fire inside a hyperbaric chamber last month in Michigan are “completely heartbroken,” having faced a loss that “no parent should ever endure,” according to their attorney, James Harrington, the managing partner at Fieger Law in Southfield, Michigan.

Thomas Cooper’s parents had taken him to the Oxford Center, located in Troy—a suburb of Detroit—to undergo hyperbaric oxygen therapy sessions aimed at treating his sleep apnea and attention-deficit/hyperactivity disorder. The alternative therapy center claims to manage over 100 medical conditions, including autism and cancer, although the FDA has not approved hyperbaric oxygen treatment for these ailments.

The incident, which resulted in Thomas’ death on January 31, was characterized by police and fire officials in Troy as a fiery explosion within the chamber. Harrington shared that in a desperate attempt to rescue her son from the flames, Thomas’ mother, Annie Cooper, sustained serious burns on her arm.

“She has significant burns from her effort to save her child from the inferno,” he told NBC News. “Despite her relentless attempts, she was unable to reach him.”

“The visible burns are distressing, but the profound emotional trauma she will face is even harder to bear,” he continued.

The Oxford Center, which operates two locations in Michigan, has not responded to multiple inquiries about the circumstances leading to Thomas’ tragic death. Following the incident, the center issued a statement emphasizing their commitment to safety, asserting that such an event had never occurred in their 15 years of service. They pledged cooperation with all investigations related to the incident.

As authorities continue their inquiry into the deadly fire, the Troy location of the center remains temporarily closed. A spokesperson from the Troy police department indicated they had no new information to offer about the investigation, and no charges have been filed thus far.

Hyperbaric oxygen therapy, a process where patients inhale pure oxygen in a pressurized chamber, is FDA-approved for specific conditions like carbon monoxide poisoning and decompression sickness in divers. The FDA oversees certain hyperbaric chambers defined as Class II medical devices, intended for disease diagnosis and treatment.

In recent times, various spas and wellness centers have begun promoting hyperbaric oxygen therapy for an array of health issues, despite the FDA warning that some claims regarding its efficacy remain unverified. Sleep apnea and ADHD are not among the approved uses for this therapy, although some anecdotal claims suggest potential benefits.

Describing Thomas as a sweet child who adored his little brother, Harrington said Thomas’ parents were optimistic that the hyperbaric oxygen therapy at the Oxford Center would help address their son’s conditions.

“This was not an urgent lifesaving intervention; it was a loving mother seeking to help her son with his troubles, believing in the promises made by the treatment provider,” Harrington explained. “Annie acted out of love for her child, as any devoted parent would.”

The Cooper family, residing in Royal Oak, Michigan, intends to file a lawsuit aimed at preventing similar tragedies and ensuring that other families do not suffer as they have.

Hyperbaric oxygen therapy facilitates the breathing of 100% oxygen under increased pressure, which enhances oxygen delivery to the lungs. In contrast, regular air contains only 21% oxygen.

Experts emphasize that administering this therapy requires skilled professionals proficient in handling the specialized equipment. Tom Workman, the former director of quality assurance and regulatory affairs for the Undersea & Hyperbaric Medical Society, underscored the necessity for stricter regulation of facilities providing this type of therapy.

“The wellness community promotes these therapies, declaring them non-medical, but this approach raises serious safety concerns,” he stated.

In an email response to NBC News, the FDA indicated that various agencies, including state medical licensing boards, oversee medical practices. Neither the Centers for Medicare & Medicaid Services nor the Joint Commission had provided comments by Friday regarding the matter.

The FDA clarified that upon awareness of a device malfunction, it undertakes a thorough review to evaluate appropriate actions, which could include recalls or safety communications.

Furthermore, the FDA warns on its website that hyperbaric oxygen therapy does not have scientifically proven benefits for conditions such as cancer, Lyme disease, autism, or Alzheimer’s disease—urging patients to consult their healthcare providers to assess if this therapy is suitable for them.

Patients interested in hyperbaric oxygen therapy are encouraged to seek treatment at facilities accredited by the Undersea & Hyperbaric Medical Society, which maintains a list of such institutions; the Oxford Center is not included on that list.

Following Thomas’ passing, the Troy Fire Department noted that while the combination of high oxygen levels and pressure can encourage combustion, “preliminary investigations indicate that such incidents are rare.”

However, history has shown that these events can occur; in 2009, a significant fire in a hyperbaric chamber at an unlicensed clinic in Florida claimed the lives of a 4-year-old boy and his grandmother during treatment for cerebral palsy. The aftermath saw two staff members facing charges, including a physician who ultimately lost his medical license despite not serving jail time.

Harrington explained that the forthcoming lawsuit from the Coopers will focus on any potential negligence that may have contributed to their son’s tragic death.

“Operator error or equipment failure—this should never take place under any circumstances,” he remarked.