Informed consent: Must the risk of death be discussed?

Last week, I wrote about the tragic case of a young girl in California who was declared brain-dead after what most media sources called a tonsillectomy. In fact, the patient had a much more extensive procedure for treatment of obstructive sleep apnea. In addition to having her tonsils removed, she underwent a uvulopalatopharyngoplasty (UPPP) and resection (removal) of her inferior nasal turbinate bones.

As I stated before, I will not speculate on whether the surgery was indicated or why the patient died because none of the facts about those two aspects of the case have been disclosed.

Questions have arisen about the informed consent discussion that may have been held with the patient's mother. We obviously do not know exactly what was said. However, some have wondered whether the possibility of death after this procedure was part of the consent process.

The mortality rates for a simple tonsillectomy range from about 1 in 10,000 to 1 in 35,000. For UPPP, the mortality rate for adults is generally quoted at 0.2% or 1 in 500. I was unable to find any information about the mortality rate for that operation in the pediatric age group.

The issue then is—must a surgeon mention death as a possible outcome after this type of surgery?

According to a medico-legal encyclopedia, the disclosure of risk depends on two general elements.

Would other doctors have disclosed the risk of death and would the patient (or family) have made a different decision if the risk of death had been discussed?

A paper from Duke University states the following: "In fact, there is no dictum that death must be included among the risks of every surgical procedure; when the risk of death is so low as to be unexpected and highly improbable, including it may actually be misleading." What they mean is that patients could be unnecessarily dissuaded from agreeing to a procedure they really needed.

The authors of the Duke paper go on to say that the question of how high of a risk requires disclosure is debatable, "but it may range from any chance of death to about 0.1% risk as a reasonable threshold for inclusion." Keep in mind that this is merely an opinion by three surgeons and a medical oncologist.

An informed consent guideline from Harvard says, "The type and the number of risks to be disclosed should depend on the significance the doctor's patient would attach to such risks in deciding whether to consent to the procedure or treatment. (The court recognizes that such disclosure does not apply to all 'remotely possibly risks of proposed treatment' which may be 'almost without limit.')"

The website of Dr. Erik J. Kezirian, a prominent expert in sleep apnea surgery, has information pertinent to this issue. The surgeon lists a number of complications related to UPPP including bleeding, infection, difficulty swallowing, tooth injury, and continued snoring. Notably absent is any mention of death.

I had always heard that adverse outcomes occurring less than 1% of the time need not be part of an informed consent discussion. Again, this is only an opinion. There is no agreed upon standard.

If a malpractice suit is filed, I doubt it will hinge on informed consent, but it is useful to discuss the topic. 

What do you think about informed consent and the risk of death?

[Disclaimer: I am not a lawyer and this is not legal advice.]

Why do misconceptions about brain death persist?

On December 9, 2013, 13-year-old Jahi McMath underwent a tonsillectomy at a children's hospital in Oakland, California. She suffered postoperative hemorrhage and became comatose. She was declared brain-dead by doctors at that hospital on December 12th. This was later confirmed by a court-appointed outside consultant.

There are many issues surrounding this case. Was the tonsillectomy indicated? Some stories reported that it was done to improve her obstructive sleep apnea. Why wasn't she successfully rescued from her complication of bleeding? I can find no discussion about how she could have bled so much without intervention in any article about the case.

But one of the most distressing aspects of this poor child's demise is that despite many years of experience with brain death, it is still misunderstood by laypeople, the courts, and even some medical providers.

As of December 26th, 14 days after the brain death declaration, the child remains on a mechanical ventilator with apparently stable vital signs.

A lawyer for the family had petitioned the court for the outside expert's consultation and to prevent the hospital from disconnecting the child's life-support.

After all this time, a judge has finally ruled that the hospital may remove the life-support but not until December 30th to give the family time to appeal to a higher court.

What a shame. It is bad enough that this girl has died. But to realize that in 2013, society still cannot deal with the concept that brain death is "death" makes it sadder.

It may be a problem of terminology. When we say "brain-death," it somehow does not sound like real death.

The problem is compounded by other words used in this post such as "life-support" and "vital signs." These terms perpetuate the mistaken notion that life is still present.

The Harvard Criteria for brain death were written in 1968. That is 45 years ago. Why are we still debating this in court?

The answer is, we have failed to properly educate the public about this relatively straightforward fact.

It must be extremely difficult for this child's family to accept that the girl is dead after what many have called "routine" surgery. I feel very bad for them.

Something that has not been mentioned in any report about this case is another issue that society has trouble handling—organ donation. Perhaps the family should consider this. Those who have been in similar situations say that donating organs gives them some comfort in that part of their loved one lives on and that someone else has been helped.

I hope the higher court does the right thing and declines to review the case and that the family can eventually find peace.

UPDATE: December 27, 2013

According to the San Jose Mercury-News, the family says it has found a facility willing to provide long-term care for the girl. They want doctors at the Children's Hospital to perform a tracheostomy and a gastrostomy (semi-permanent feeding tube), which they have declined to do because it is futile.

The child's uncle is quoted, "It looks like we may have found a miracle to keep Jahi alive and to give her another fighting chance to wake up." I'm sorry to say that is not going to happen.

Also, the original surgery was much more than just a tonsillectomy. The girl underwent a full obstructive sleep apnea operation consisting of the following: adenoidectomy, tonsillectomy,  uvulopalatopharyngloplasty (UPPP), and submucous resection of bilateral inferior turbinates of the nose.