Our Boston brain injury attorneys know that trauma to the head occurs in many different situations, including slip and fall accidents and car wrecks. When a brain injury occurs, immediate treatment is often required in order to prevent life-threatening or life-changing complications from arising. A failure to get prompt treatment to relieve pressure on the brain and to restore the flow of oxygen can result in permanent cognitive impairment. 

Unfortunately, when many brain injury victims are taken to the hospital after car accidents or other incidents, these victims are unconscious and unable to give informed consent to medical treatment. Getting in touch with family members or pursuing other avenues to obtain consent to treat can be time consuming and delays can adversely impact the ability of patients to recover. To avoid these delays and allow for more prompt treatment, a group of Boston doctors is now trying to join a study allowing brain injury victims to be treated without first obtaining informed consent.

Boston Doctors Address Treatment of Brain Injury Victims

According to the Boston Globe, a group of Boston doctors is proposing joining a national trial designed to determine the impact of the hormone progesterone on a brain injury patient. The study team, which is made up of doctors from Massachusetts General Hospital and from the Boston Medical Center, want to be able to provide these progesterone injections to the patient in the hours immediately after trauma occurs that affects the brain.

Typically, patients must give informed consent before receiving any type of treatment. If a patient is unconscious or unable to give consent, then family members are usually asked to make the decision on the victim’s behalf. Trauma victims brought in after accidents, however, often come in alone with no one to give consent or speak for them.

While doctors try to get permission to provide treatment, swelling, metabolic changes and fluid build-up in the brain cause a “secondary cascade” of brain injury after the initial trauma to the head. During this “secondary cascade,” cells in the brain continue to die. This causes more and more neurological and cognitive impairment and can result in devastating lifelong disability.

There is no cure once the cells have died and the brain has been permanently damaged, but administering progesterone can help to stop this secondary cascade and can result in a reduction in severe brain injury complications and fewer deaths after a head trauma.

While it may seem obvious that doctors should be able to give patients progesterone to stop cell death, federal law and medical ethics both impose general rules that patients should be able to refuse enrollment before participating in a study and should give informed consent to do so.

The very definition of this study, however, would involve doctors giving patients treatments when they cannot consent. This raises concerns, especially if the progesterone treatment turns out to cause complications or be dangerous. The person harmed by it or the family members could potentially argue that the doctor committed medical malpractice for the failure to obtain informed consent.

If the doctors do join the national clinical trials, this will be the first exception since 1996 to the informed consent rules requiring a patient have a chance to refuse participation in a study before it begins.  However, the exception could end up being worth it if fewer people suffer severe traumatic brain injury due to accidents.

If you’ve been hurt, call 1-800-WIN-WIN-1 for a free consultation with a personal injury lawyer at the Law Offices of Mark E. Salomone.