Healthcare Law: Can you do this by end of Day Friday 6th?

Canadian Health Law and policy, 4th edition/question 1.docx

Consent is a fundamental aspect of health care and health law in Canada. It is a central part of the principle of autonomy that policy-makers, the public, and health care professionals hold so dearly. Consent is also, however, a complex concept. As mentioned at the beginning of this unit, consent is a process, not a form or document: it depends on each situation and circumstance; and although it requires many elements to make it viable, just one gesture can nullify it. While consent forms can be useful to prove that consent was given, they do not prove consent on their own. Consent can be written or oral, and either form is equally effective in law.

Ciarlariello v. Schacter, the case study detailed above, was eventually decided by the Supreme Court of Canada. It illustrates all of the key principles of consent law that need to be understood. Use the background you have acquired during your reading to follow the analysis below.

1. The person consenting must have the legal capacity to do so.

Capacity is the ability of the patient to understand and appreciate the nature and purpose of the treatment. Patients are presumed to have capacity, but if the health care provider suspects otherwise, he or she should assess the patient thoroughly, and involve other professionals where appropriate. The capacity must be in relation to the treatment in question, not capacity of the person in general. If capacity is found lacking, then the next step is to seek consent from a substitute decision-maker, via either an advance directive or a court-appointed guardian.

2. Consent must be voluntary.

This means that consent must be obtained without fraud, misrepresentation, or coercion (including through family members). Indicators that consent has been given under pressure or threat, or through misrepresentation or undue influence should raise “red flags” about the voluntariness of the consent.

3. Consent must be “meaningful.”

This means that the consent must be specific enough to refer to both the treatment and the treatment provider. It is common to see consent forms on admission to hospitals cast in very general terms. There is no particular legal problem with this, but the legal effect of general consent forms can be questioned because they do not contain specific enough references to treatment and treatment provider. It is very common, and legally required, for specific treatment to be preceded by a specific consent to that treatment. As you will learn later, the mere existence of a consent form is not enough to prove that consent was given, but might be valuable as evidence that this happened. This element is commonly called “reliable consent.”

4. Consent must be informed.

Entire volumes have been written about the ingredients of informed consent, so this explanation will be brief and general. The ‘informed’ part of the test for legally valid consent focuses strongly on the patient’s right to know and to choose. This right puts a responsibility upon the health care provider to ensure that the patient is properly informed of the risks involved in the treatment. In 1980, in a landmark case, the Supreme Court of Canada said that the physician obtaining the consent must consider not what a reasonable physician would think necessary to tell the patient but, rather, what a reasonable person in the patient’s shoes would want to know. Part of this process is a duty on the part of the care provider to be reasonably knowledgeable about the patient’s personal history—lifestyle, tolerances, sensitivities, etc.—to assess what a reasonable person in this patient’s position would want to know.

Informed consent means that all of the patient’s questions must be answered, and the patient must be told about the nature of the proposed treatment, the alternatives to the proposed treatment, and the risks associated with the proposed treatment.

Legal disputes about consent often revolve around the discussion of risks. This is predictable because lawsuits normally follow treatments in which complications occur, and the patient and care provider disagree about what the patient knew of the risk before it materialized. Both frequently occurring risks, as well as rarely occurring ones with serious consequences, must be disclosed.

5. Consent can be expressed or implied.

Express consent occurs when the treatment was explained and the patient expressly agrees to undergo the procedure.

Where there is no evidence of express consent, and conflicting views about whether consent was implied or implicitly given, confusion about the legality of the consent inevitably follows. The lesson to be drawn from this is that, in all but the most obvious circumstances, asking for express consent is the safer option.

There are two types of implied consent: (a) subsumed consent, and (b) consent by inference. Subsumed consent means that consent to treatment B was implied by the consent to treatment A. The case of O’Bonsawin v. Paradis illustrates subsumed consent. In that case, the physician obtained explicit written consent for surgery of a Gore-Tex graft in order to provide access to the arm for dialysis. The graft was more complicated than the alternative procedure, an arteriovenous fistula, and once the graft was performed, the fistula could not be done.

The patient had expressed disappointment when the physician examined her arm and found it to be unsuitable for the fistula. However, once the patient was anaesthetized, the surgeon found the vein to be suitable for the fistula, and therefore decided to perform that procedure. There was some pain and numbness in the wrist after surgery, and the patient sued the doctor. In this situation, the onus was on the physician to prove that consent to the one procedure was included in the scope of the other. The court in the O’Bonsawincase found that, because both procedures had been explored by doctor and patient, and the preference for the simpler, less risky procedure had been expressed by the patient, the fistula did not go beyond the consent given. The doctor had reasonably inferred that consent to the fistula had been given.

6. Consent can sometimes be inferred.

Consent by inference is illustrated by the case of Mitchell v. McDonald. That case involved a woman who received a cortisone shot in her rhomboid muscle that, freakishly, pierced a lung (specifically, a blister on the lung from smoking), and resulted in pneumothorax (collapsed lung). The woman sued the doctor. She had had several cortisone shots in the past, and knew she was getting a couple of cortisone shots on this visit. In fact, the one to the rhomboid muscle was the second of two that day. The court found that the patient had given implied consent to the procedure.

A different decision about inferring consent was reached in the case of Toews (Guardian ad litem of) v. Weisner, [2001] B.C.J. No. 30 (B.C.S.C.). In this case, an eleven-year-old girl was vaccinated against hepatitis B as part of a school program. In this program, the procedure of the public health nurse was to send home consent forms, then phone those parents who had not signed the forms to get their oral consent. In the case of the eleven-year-old girl, the nurse honestly believed she had spoken with the girl’s mother on the phone. On the day of the vaccination, the girl told the nurse that her parents did not want her to be vaccinated; the nurse told the girl that her parents had told her it was okay and vaccinated the girl. The court found that it was not reasonable for the nurse to infer consent on the day of the vaccination, and given the vehemence of the parents in their objections against vaccination, it was a matter of fact that the parents did not consent. The court warned that people may give consent and then withdraw it, and in this case, the “child’s statement should not have been disregarded” (para. 24).

7. Consent can be withdrawn.

Since consent is closely linked to choice, it is not surprising that the law strongly supports a person’s right to withdraw consent after it has been given. This is subject to certain limitations based on how the withdrawal has been communicated, and the clinical circumstances at the time the withdrawal is communicated. Traditionally, courts have been cautious about punishing care providers faced with patients who get “cold feet” in the middle of treatment procedures.

The Mitchell case, described above, illustrates this point. During the second cortisone shot, the woman cried out something like: “for God’s sake, stop,” which could have been construed as a withdrawal of consent. However, the court decided that this was an expression of pain, as in “stop the pain,” rather than a withdrawal of consent, as in “stop the procedure.” Also, the court found that the damage to the lung had been done before she cried out. As a result, the doctor was not found to have been negligent.

Another case, with a different result, that illustrates the threshold of withdrawal of consent is Nightingale v. Kaplovitch. A man consented to a sigmoidoscopic examination to determine the cause of rectal bleeding. As the examination progressed, the man was in incredible pain, and demanded that the doctor stop. The doctor said that he was almost finished, and continued to insert the instrument to its full length, but the patient could tolerate the pain no longer and released his position. It turned out that the man’s bowel had been perforated. The resulting case differed from Mitchell because the withdrawal of consent was determined to be a true withdrawal and, more significantly, because the damage to the bowel occurred after the patient indicated withdrawal of consent.

8. Consent can be resumed.

After consent has been withdrawn and a treatment has been stopped, the treatment cannot be continued without a resumption of the consent. However, re-consenting does not require repeating the entire consent process.

Situation B

An involuntary psychiatric patient suffering from schizophrenia refuses to take neuroleptic drugs as treatment. The drugs are to control symptoms of schizophrenia but do not work for all, and are sometimes accompanied by possibly serious side effects. The patient now lacks the capacity to consent or refuse consent, but when he was competent, he had expressed his wish not to take such drugs

Commentary

The most difficult legal issues around consent arise when the patient lacks the ability to exercise decision-making autonomy. Adults might be intellectually or judgmentally impaired or disabled. Children might be intellectually precocious but have questionable emotional maturity. Parents, guardians, agents, relatives, or friends might be aggressive advocates or influential interveners in the decision-making process.

Some jurisdictions in Canada use legislation to assist in the resolution of disputes about consent in these situations. In Ontario, for example, the  Ontario Health Care Consent Act, 1996 S.O. 1996 c. 2, provides comprehensive rules and establishes an administrative review board to interpret the  Act to resolve disputes. Some provinces have legislation that addresses very specific issues, like guardianship of adults who cannot make their own decisions, or children who are wards of the government. All provinces have legislation with variable degrees of coverage and otherwise rely on the courts to hear and resolve disputes, and in the process, make law that governs future situations.

At its roots, obtaining a legally valid consent involves making a series of judgments about the individual patient, and then, if necessary, moving on to make a series of judgments about the individual or individuals who have been given or are requesting the power to consent (or refuse consent) on behalf of the patient.

In analysing specific consent problems, typically you will need to identify and analyse the following issues.

· Is the patient intellectually capable and emotionally mature enough to understand the consequences of consent (or refusal or withdrawal of consent)?

· If a patient lacks intellectual capacity or emotional maturity, who is legally authorized to consent on the patient’s behalf? Closeness of relationship gives way to legal status in this assessment.

· How serious is the situation? If it is a clinical emergency, it is possible to give treatment without consent. If the treatment is lifesaving, it might be possible for the government to consent to treatment of a child in the face of the objections of parents. If the treatment is less than an emergency but is medically necessary, it might be possible for clinicians to treat an unconscious patient without waiting for a substitute consent.

· How clear are the patient’s wishes, whether the patient has expressed them directly, on paper, or through a representative(s)?

· Who or what is available to resolve disputes about consent? As noted above, dispute resolution varies from province to province, and might include administrative bodies or courts, dispute resolution structures inside organizations, as well as time-honoured dialogue between the health care provider, the patient, and the patient’s family.

There are, inevitably, difficult cases, in which a patient’s capacity to consent is uncertain, there is no one with formal legal authority to substitute consent, or clinical judgment conflicts with patient decision-making autonomy or the wishes of the family of an incapacitated patient with life-threatening consequences. In these hard cases, practical considerations, such as the following, must be weighed.

· What is in the patient’s best interests?

· Has the patient ever expressly refused what would be in his or her best interests?

· Is the family in agreement or split on the decision?

· What is the risk that the decision will later be challenged as not consistent with what the patient would have wanted?

1. In Situation B, even though the patient is involuntary, what are the limits on the treatment that can be provided to him without his consent? Who can legally provide consent for the patient? Of what relevance is his prior expressed non-consent? Under what circumstances can the medication be given without any consent?

ANS; In Situation B, even though the patient is involuntary, the limits on the treatment that can be provided to him without his consent rest on the fact in law that medication cannot be given to a competent patient without the patient’s consent. In Canadian law, the question of competence and the capacity of a person to make decisions must be determined in each specific situation – while a person might be deemed incompetent in one situation, that person might be competent in another. An incompetent patient who provided advance directions (while competent) to not receive a neuroleptic drug might not be given the drug. Before the medication can be administered without his or her consent, the patient must be declared incompetent.

Situation B reflects the facts of Fleming v. Reid, [1991] O.J. No. 1083 (Ont. C.A.), where a prior capable refusal of neuroleptic drugs was upheld even though the patient was incapable and involuntarily committed. The central issue of the case was whether or not the state could administer neuroleptic drugs to involuntary incompetent psychiatric patients who previously, while competent, had expressed the desire not to be treated with these drugs. The patient had been diagnosed with schizophrenia, and a Review Board previously decided that the patient should receive a neuroleptic drug as part of his treatment, based on a clause in “the Mental Health Act that obliged the Board to make a treatment decision based on the patient’s best interests, not on his or her interests” (Carver, 2011, p.358).

The judge spent considerable time analyzing the reasoning of the Review Board in this case, and unauthorized the section of the Mental Health Act that allowed the review board to override the refusal of consent specified by the patient’s substitute decision maker. The substitute decision-maker (the Public Trustee) for the now incompetent person refused to consent, based upon the patients’ prior directive (while competent) to not receive neuroleptic drugs. In discussing situations in which the patient provided an advance directive to refuse a certain treatment before becoming incompetent, the judge reasoned that the patient’s wishes not to receive the treatment must still be honoured.

In his reasoning, the judge quoted applicable sections of The Mental Health Act. Section 35(2) of the Act states that psychiatric/medical treatment should not be given to a patient who is mentally competent without that patient’s consent. When the patient is not mentally competent, the consent of an authorized substitute decision maker is needed; or a review board must prepare an order authorizing the treatment; or a doctor can consent for the patient in the case of immediate danger to the patient’s life, limb, or vital organ.