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1

ALL OPTIONS MUST BE DESCRIBED: You must fully inform the patient of the risks and benefits of each procedure prior to undergoing the procedure. The explanation must be in language that the patient under­ stands and include full information regarding alternative treatments. The patient cannot make an informed choice for one treatment if she does not know of the existence of others.
For example, you inform a patient about the risks and benefits of bone marrow transplantation for chronic myelogenous leukemia. You fully inform the patient about the risk of transplantation, including the possibility of developing graft versus host disease. After the transplantation the patient develops graft versus host disease, which is hard to control. The patient learns that there is an alternative treatment called imitanib (gleevec) which you did not tell them about. Gleevec does not include the risk of graft versus host disease, but will not cure the leuke­ mia. The patient files suit against you. What will be the most likely outcome of the suit?

In this case the patient will probably win the suit because he was not fully informed about the alternatives to the therapies mentioned. The physician has an ethical duty to inform the patient about all the treatment options and then allow the patient to decide among them. Although the physician's preference of procedure or treatment may differ from what the patient chooses, the patient has the option to choose therapy that may not be what the doctor deems is best for him.

2

SPOUSAL ABUSE: The ethics and legalities surrounding spousal abuse are somewhat different from those for child abuse and elder abuse. In the case of spousal abuse, you are dealing with an adult patient that is generally competent consequently you do not have the same authority to report the abuse against the wishes of the victim as you would in a case of child abuse. Many victims experiencing spousal abuse believe they are not in a position to be able to leave the relationship or to report the abuse for fear of worse abuse. Consequently you cannot report the abuse to the police or to anyone else without the express consent of the victim.
For example, a 45-year-old woman comes to the emergency department after hav­ ing had her nose broken by her husband. She has been abused several times in the past. When you tell her you will report the injury to the police she becomes very anxious and insists you tell no one because her husband is a police officer. What should you do?

When the patient will not give consent to have the injury reported, you should answer that you will "encourage the victim to report" or "offer counseling."

3

ALL MAJOR ADVERSE EFFECTS MUST BE DESCRIBED:
Adverse effects and injury from medical care do not necessarily represent a mistake or fail­ ure of therapy. In the case described in the previous example, the error was not that graft versus host disease developed. The patient was fully informed that this could occur and he chose the bone marrow transplantation anyway. The error was not informing the patient of an alternative option in treatment. At the same time, a patient could potentially die as an adverse effect of treatment. This is only an ethical and legal problem if the adverse event happens and the patient was not told that it could have happened. The patient might say, "Doctor, I would never have taken digoxin if you had told me it might cause a rhythm dis­ turbance or visual problem" or "I would never have had surgery if you had told me I might need a blood transfusion:' The main point is to respect autonomy. The patient must be informed of the therapeutic options, the adverse effects of the procedure, and the harm of not undergoing the procedure. If they have the capacity to understand and they choose to do it anyway, they have made an autonomous therapeutic choice, and therefore, the patient bears the burden of any adverse effect, not the physician.
For example, a man undergoes coronary angioplasty. He is informed that the artery may rupture and that there is a small chance he could bleed to death dur­ ing the surgery to repair the damaged vessel. He knows he could have bypass surgery instead. He understands and chooses the angioplasty. He dies from a ruptured blood vessel. The family files suit against you. What will be the most likely outcome?

Although it is unfortunate that the patient died in this case, there is no liability with regard to informed consent or ethical error. The patient was informed of his treatment options and the possible complications, and he chose the treatment.
The patient must understand the risks of a procedure just as a driver must understand the risks before getting behind the wheel of a car. Why can't you sue a car manufacturer if you die in a car accident? Predominantly because you are an adult with the capacity to understand the risks of driving and you chose to drive anyway. The licensing process is an education process that both tries to make you a safe driver, while also properly informing you of the risks of driving. Each time you get in a car, there is implied consent that you are choosing the risk of driving. Even if you get into a car accident and are injured or killed, the manufacturer has no liability, as long as the car is well made, because as a competent adult you chose to put yourself at risk.

4

ALL MAJOR ADVERSE EFFECTS MUST BE DESCRIBED: In addition to understanding the risks of the procedure, you must inform the patient of what could happen if she does not choose therapy that you offer.
For example, a patient comes to the emergency department with appendicitis. He is informed of the risks of surgery, and refuses the procedure both verbally and in writing. The patient dies. What was done wrong here?

The patients must be informed both of the risk of the treatment as well as what will happen if they don't undergo the procedure. In this case the physician is liable in court because he never documented that he informed the patient of the possibility of appendiceal rupture and death if the patient did NOT have the procedure.

5

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CONSENT IS REQUIRED FOR EACH SPECIFIC PROCEDURE
If the patient signs. a consent form for an operation on her left knee, you cannot, in the operating room, decide to operate on her right knee and assume that you have consent. If a patient signs a consent for an appendectomy, but when you open her up you find colon cancer, you cannot just do the colectomy without first informing the patient of the addi­ tional procedure and obtaining her consent. There can be no presumption for consent for anything beyond what the patient specifically said she consented to. Either the patient has to sign consent in advance for the other procedures or she has to regain consciousness and have the additional procedure explained to her.

6

BENEFICENCE IS NOT SUFFICIENT TO ELIMINATE THE NEED FOR CONSENT
Trying to be sincere and to do good is very important and takes primacy; however, the patient's right to control what happens with his own body is more important.
For example, a 40-year-old man is undergoing a nasal polypectomy. In the operat­ ing room you see a lesion on the nasal turbinate that the frozen section determines to be a cancer. You have found the cancer early but will need to resect the nasal turbinate to cure it. What should you do?

You cannot remove the cancerous lesion without the patient's approval. This is true even if the physician is sincere, talented, accurate, and helpful. This is true even if the procedure will save the patient's life, unless the ilnl ess is an emergency in an unconscious patient. Beneficence does not eliminate the need for informed consent. If you live in a very messy apartment your neighbor cannot break into your apartment to clean it even if he doesn't steal anything. You must consent to the cleaning. His good intentions are not as important as your right to do what you want with your own property.

7

DECISIONS MADE WHEN COMPETENT ARE VALID WHEN CAPACITY IS LOST
We must respect the last known wishes of a patient if she loses the capacity to communicate and state those wishes. Although it is preferable to have the patient's last known wishes documented in writing, following verbally expressed wishes is perfectly valid. Oral consent is valid for any level of procedure if the oral consent can be proven. The basis for validity of oral or written consent is not whether the procedure is large or small. In other words, it is not the case that oral consent is valid for a sigmoidoscopy but a brain biopsy requires writ­ ten consent. A patient can give oral consent for a heart transplant if the patient is unable to write. The only difficulty is that if challenged, orally expressed wishes for treatment are more difficult to prove than written ones.
For example, a 42-year-old man with leukemia repeatedly refuses chemotherapy. He loses consciousness and his mother tells you to give the chemotherapy. What should you tell her?

You must respect the last known wishes of the patient. If the patient does not want a treat­ ment, you cannot just wait for him to lose consciousness and then perform the treatment. If this were permissible, then no one could have an estate will. The ultimate form of loss of decision-making capacity is death. We make out a will so that when we lose the capacity to speak for ourselves, our wishes for what to do with our property are respected after death.
For example, a 64-year-old woman accompanied by her husband comes to the emergency room seeking treatment for chest pain. The patient clearly tells you that she wants to have her aorta repaired and she signs consent for the procedure. She later becomes hypotensive and loses consciousness. Her husband is now the decision maker and says, "Let her die." What do you tell him?
A patient's family member cannot wait for her to lose consciousness and then go against the patient's previously expressed wishes regarding treatments and procedures. In the case above, because the patient expressed that she would like to have her aorta repaired her hus­ band cannot go against this after she loses consciousness. The same reasoning holds true if a patient refuses a procedure or treatment and then loses consciousness.

8

CONSENT IS IMPLIED IN AN EMERGENCY
For example, a 50-year-old construction worker arrives at the emergency room by ambulance after an accident lacerating his arm. He has lost so much blood he is unconscious. There is no family member available to sign consent. What should you do?


The management of an emergency is different. Consent is implied in an emergency for a patient without the capacity to speak for himself. This would not apply to a terminally ill patient with a pre-existing DNR order. Neither a court order, nor a hospital administrator, nor the ethics committee is required to give permission before the doctor can administer therapy in an emergency.

9

Justice Cardozo in the case of
Schloendorff v. Society of New York
Hospital in 1914

 "Every human being of adult years and a sound mind
has the right to determine what shall
 be done with his own body and a surgeon who
performs an operation without his patient's
 consent commits an assault, for which he is liable in
damages, except in cases of emergency
 where the patient is unconscious and where it is
necessary to operate before consent can
 be obtained."

10

The Salgo case I. (1957)
55 years old patient with intermittent claudicating
The physician suggests translumbal aortography as a diagnostic procedure
The patient consented and got paralyzed
for both of his legs
The patient brought a lawsuit against his physician

Experts testified that the complication was an inherent risk of the diagnostic intervention
The court however, held the physician culpable since he did not inform the patient about the risk.

The court required "informed consent"

11

The „cortisone” decisions in Germany I.

In the first such case a cortisone injection was
administered into the cavity of the knee
the patient, whose other leg was missing as a result of amputation.
The joint became infected, and the patient was not informed about this possibility before the procedure
The court held, that although the risk was extremely low (1:100000), it should have been told, because it would have had great relevance for the amputated patient

12

The „cortisone” decisions in Germany II.

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In the second case the cortisone injection
was given into the cavity of the shoulder joint
A general sepsis developed and the patient died
-

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Although the risk of death was as small as 1:10000, it should have been told according to the court decision

13

A Hungarian Case I.

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A therapeutic coronary catheterization was needed and the patient was told about its risk:
the rupture of the coronary (1
of which immediate surgical intervention is needed
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The patient consented to the intervention, the
2%) in the case
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coronary ruptured, but the operating theatre of the hospital was not available.
An ambulance car tried to take the patient to
another hospital, but the patient died in the car

The court held that there was no medical negligence since a free operating theatre every time when a coronary catheterization is made would mean more death because of the many operations undone

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The patient however, should have been informed about the fact that in case of rupture, it would not be certain that a free operating theatre would be available