Healthy mother-of-three died of freak cardiac arrest after paramedics enrolled her in medical study WITHOUT her consent

Cristina Belmonte was in good health until the day she died taking part in a medical experiment she didn’t know about.

Without her consent, she was enrolled in an emergency medicine study being conducted by the University of Texas Southwestern Hospital in Fort Worth, Texas.

The paramedics that treated her used a different kind of ventilation than the standard method as part of an emergency medicine study, and her husband, Manuel, fears that may have led to her death.

Controversial studies of emergency medical devices and techniques can often only be field tested in situations where neither the patient nor their family is able to express consent.

It wasn’t until seven weeks after her death that Manuel Belmonte received a letter from the University of Texas Southwestern (UTSW) alerting him to his wife’s involvement in the study.

Cristina was 45 years old and her only health concern was diabetes. She had never had any heart problems.

On August 8, she told her co-workers at Planned Parenthood in Fort Worth that her chest was hurting. Her colleagues asked Manuel to pick her up from work. During his 20 minute drive to her office, Cristina took a turn for the worse. The other employees called 911.

By the time Manuel arrived, paramedics already had Cristina behind the ambulance.

‘They wouldn’t let me go back there, they didn’t ask me anything,’ Manuel says. He couldn’t even see what was going on.

Forty minutes later, the paramedics decided to take Cristina to the hospital, ‘but she was already gone,’ Manuel says. Cristina went into cardiac arrest, and never regained consciousness.

The Belmonte family buried Cristina without an autopsy, but Manuel was incredulous of how the paramedics had treated his wife.

‘A lot of stuff just didn’t make sense,’ he says, so he requested her medical records from the University hospital, and began pouring over all the documentation of his wife’s death.

The paramedics performed an laryngeal or ‘King’s’ intubation on Cristina to help her breath when her heart stopped.

Most medical literature suggests that this kind of intubation works as well as the standard endotracheal intubation usually used by paramedics treating patients in cardiac arrest.

But Cristina’s paramedics used the alternative method because they chose to enroll her in a study on which of the two intubations was better, without her consent.

Russell Rian, director of public relations at the hospital told Daily Mail Online via email that ‘both are current standards of care for participating EMS agencies.’

‘Subjects enrolled in the study are not conscious nor breathing properly at the time of treatment by paramedics on scene, and would otherwise receive one of these treatments regardless of the study, unless a valid do not resuscitate order is presented to the paramedics,’ he added.

Manuel showed the paramedic’s detailed report to a friend, who is a nurse in an ER. She pointed out that Cristina was also not given a drug that could have helped her.

According to the paramedics’ report, Cristina had gone into ventricular tachycardia. When her heart stopped, she was given three rounds of epinephrine and three shocks from a defibrillator, just like she should have been.

The report specifically says that she was not given amiodarone, a drug often given to try to help patients with Cristina’s kind of heart arrhythmia. It is unclear if there was any medical reason that she was not given the drug.

On September 27, almost two months after his wife’s death, Manuel received the letter informing him that his wife had been part of a study. It did not disclose which one.

The letter both expressed condolences for the Belmonte family’s loss, while offering the option to ‘withdraw’ Cristina from the study after her death.

Manuel’s sister-in-law, Angie Chavez, called the number included in the letter to try to find out more about what had happened to Cristina. No one would tell her which study her sister had been involved in.

Worryingly, there had been a third trial involving the drug that Cristina was not given. It was meant to determine whether administering lidocaine, amiodarone, or a placebo (saline solution) gave patients like Cristina the best chances of survival. The study concluded in 2015, and resulted in recommendations that either lidocaine or amiodarone be given to patients with ventricular tachycardia.

The letter also claimed that, as part of the study, Cristina was given her experimental treatment ‘in addition’ to standard practices.

‘This was done without your or your family member’s prior consent because they were unconscious and without a pulse at the time and immediate treatment for this was necessary,’ the letter says.

But if the paramedics’ documentation of their treatment is accurate, she was not given the recommended amiodarone or liodocaine.

In order for a study to be exempt from laws and rules governing informed consent in the US, it has to meet rigorous criteria, including that the subject is in a ‘life-threatening situation,’ consent cannot be obtained from the subject due to their medical condition, and that the ‘intervention must be administered before consent can be obtained from the subject’s legally authorized representative.’

The public also must be informed of the ongoing research, via posters, radio announcements and ‘notify the community,’ says Dr Arthur Caplan, a bioethicist at the New York University School of Medicine.

Notification of this kind of study has to include information about a free wrist band that can be ordered and notifies health care professionals not to enroll a person in a trial.

‘But does community consent work very well? No,’ Dr Caplan admits.

He says that studies that are exempt from informed consent typically take place in situations where ‘you have no real practical treatment.’ But he also says that ‘you have to make sure if next of kin is around, you’re supposed to look for them.’

He says that, even though the two intubation methods were not exactly hail Mary strategies to try to save Cristina, the airway trial ‘probably fits’ the FDA’s non-consent requirements.

This falls the description of measures and protocols taken by the hospital that Rian sent to the Daily Mail Online in an email.

‘The only questions I would raise are did they try to notify anyone that they were going to try two different intubation techniques… make sure thy look for next of kin,’ he says.

According to Manuel’s account, Cristina’s paramedics did not look for him and would not let him into the area where they were working to save his wife.

From his conversation with his friend who is an ER nurse, ‘if they would’ve followed protocol as they normally would, she would have had a chance to be alive,’ Manuel says.

Recently, he went to see an attorney who told him he might have a medical malpractice case, but the paramedics’ actions would likely fall under so-called Good Samaritan law, which protects people who go beyond what is medically necessary to save a dying person.

‘From my knowledge, the EMTs take an oath to save people, they have a medical education,’ and should not be protected by the Good Samaritan law, Emanuel says.

He went to see a second lawyer on Friday in hopes that he has a chance to take Cristina’s case to court.

‘I don’t think they should allow them to study on people, especially in a life or death situation,’ Manuel says.

‘I would like for whoever’s responsible for allowing [this] to pay for what they did.’