⒈ Informed Consent Case Summary

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Informed Consent Case Summary



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What is INFORMED CONSENT? What does INFORMED CONSENT mean? INFORMED CONSENT meaning

The Court of Appeal has held, " 'The standard of skill, knowledge and care prevailing in a medical community is ordinarily a matter within the knowledge of experts. Permanente Medical Group, Inc. Whether the standard of care in the community has been breached presents the basic issue in a malpractice action and can only be proved by opinion testimony unless the medical question is within the common knowledge of laypersons. Landeros v. Flood 17 Cal. Grant 8 Cal. Plaintiff's absence of opinion evidence on this issue was fatal to his cause of action. Willard v. Hagemeister Cal. Accordingly, the issue of defendant's negligence in the care and treatment of plaintiff was properly resolved when the summary judgment motion was granted.

As noted previously, the only evidence he suffered from diabetes was plaintiff's objected-to declaration. Grant, supra, 8 Cal. That right can be effectively exercised only if the patient possesses adequate information to enable an intelligent choice. The scope of the physician's communications to the patient, then, must be measured by the patient's need, and that need is whatever information is material to the decision. Thus the test for determining whether a potential peril must be divulged is its materiality to the patient's decision.

In short, a physician has a legal duty to disclose to the patient all material information. Arato v. Avedon 5 Cal. Thomas 27 Cal. When a given procedure inherently involves a known risk of death or serious bodily injury, at a minimum, a doctor has a duty to disclose the potential risks of harm and to explain in lay terms the complications that might occur. Cobbs v. The doctor is also required to reveal any additional information as a skilled practitioner in good standing would provide under similar circumstances.

If a physician does not make the minimal disclosure, he or she is liable for all injuries sustained by the patient during the treatment whether it was negligent or not. Hagemeister, supra, Cal. Plaintiff claims the following facts from his declaration were sufficient to defeat the summary judgment because they created triable issues of material fact concerning whether he was fully informed before consenting to surgery. Plaintiff was told he had diabetes. Of consequence, plaintiff never claimed defendant made a diabetes diagnosis. Rather, plaintiff's declaration vaguely stated: "I have been advised that I suffer from a medical condition known as diabetes. I have been advised such a condition impairs the circulation of blood in my body and compromises the ability of my body to heal wounds inflicted on it.

Plaintiff advised defendant he had diabetes. Defendant failed to note in plaintiff's medical records that plaintiff was diabetic. Defendant did not advise plaintiff that the [25 Cal. If plaintiff had been advised of the facts, he would not have consented to the procedure. Plaintiff contends a question of fact remains as to whether defendant gave him "sufficient information" as to the possible risks and complications associated with surgery on a diabetic so that he could intelligently decide whether to proceed with that mode of treatment. Defendant counters, as he did in the trial court, the trial court properly determined there was no merit to plaintiff's action because the evidence established as a matter of law that no duty was breached and an informed consent to the surgery was in fact given.

Defendant further argues he had no duty to disclose any risks associated with the surgery concerning diabetes because Dr. Klein's declaration shows the absence of any evidence in plaintiff's medical records of a diabetic condition. We agree with defendant that Dr. Klein's declaration established there was no merit to plaintiff's claim he was not fully informed on the hazards of surgery on a diabetic because there is no competent evidence that he in fact had diabetes. As noted previously, at the time the summary judgment was entered, section c, former subdivision n 2 provided in part: "A defendant Once the defendant Plaintiff relies primarily upon Arato v. Avedon, supra, 5 Cal.

In Arato, the survivors of a patient brought a claim against his physicians for failure to inform the decedent fully about the low statistical life expectancy of persons diagnosed with pancreatic cancer. The family claimed at trial that had the decedent been fully informed he would have foregone treatment and tended to various financial affairs. After a defense verdict, the plaintiffs contended that the trial court should not have allowed opinion testimony concerning the standard of medical practice cautioning against disclosing to persons suffering from pancreatic cancer specific life expectancy data, unless the patient specifically requested the information.

The plaintiffs offered their own opinion testimony countering the defendants' evidence. Our Supreme Court considered the roles of opinion witnesses on the issue of the duty to disclose. The court concluded the trier of fact has a paramount role in informed consent cases and held, "[Q]uestions such as whether the danger posed by a failure to disclose a particular risk is remote, whether the risk was or was not commonly known, and whether circumstances unique to a given case support[ ] a duty of disclosure [are] matters for the jury to decide. With respect to opinion evidence in informed consent cases, Arato reiterated the Supreme Court's prior holding in Cobbs that such testimony in informed consent cases is limited.

Arato stated: "We underline the limited and essentially subsidiary role of expert testimony in informed consent litigation. As we cautioned in Cobbs v. In such instances, expert testimony will usually be appropriate. In Cobbs, the Supreme Court stated the physician's function in terms of disclosure consists of informing the patient of: the risks inherent in the procedure; the risks of a decision not to undergo treatment; and the probability of successful outcome of the treatment. The court reasoned there was no expert skill required to weigh these risks against individual subjective fears and hopes of the patient because such an evaluation and the ensuing "decision [was] a nonmedical [25 Cal.

In determining the reasonableness of disclosure, the doctor's duty was not bound to the customs of physicians practicing in the community because in the court's words, "[u]nlimited discretion in the physician is irreconcilable with the basic right of the patient to make the ultimate informed decision regarding the course of treatment to which he [or she] knowledgeably consents to be subjected. This court concluded the absence of declarations on the issue precluded the plaintiff's negligence claim. However, this court further held that the absence of a declaration by a physician or other qualified witness was not fatal to the lack of informed consent claim as to whether the plaintiff was given sufficient information as to the nature of a root canal and crowning.

The problem with plaintiff's reliance on Arato, Cobbs, and Willard is none of those decisions involved an issue of whether the plaintiff in fact had a particular medical condition which required disclosure concerning the particular range of effects of a proposed procedure on the patient. Moreover, no decision supports plaintiff's implicit argument that in informed consent cases, a lay witness may render a medical opinion as to whether a patient has a condition which requires particular advice be given as to risks of a surgery.

Williams 3 Cal. There is an exception to this rule for witnesses offering opinions Evid. The Court of Appeal held: "In every case the court must be guided by the general rules governing the use of expert testimony. If the fact sought to be proved is one within the general knowledge of laymen, expert testimony is not required; otherwise the fact can be proved only by the opinions of experts. Vargas Cal.

Plaintiff has produced no evidence that he has any medical knowledge or expertise that would permit him to diagnose a diabetic condition and the risks of surgery on a patient suffering from diabetes. Moreover, he produced no medical records or any other scientific information which established he was in fact suffering from diabetes. The only medical evidence concerning the condition was produced by defendant and showed the absence of any evidence of diabetes and multiple normal blood sugars. A physician has no duty to disclose and explain risks that are not medically indicated. Vandi v. Kaiser Permanente Medical Group, Inc. Because there was competent opinion evidence by medical professionals that plaintiff did not have diabetes and no admissible evidence to the contrary, the trial court properly made the determination plaintiff could not rely on his lay opinion to create a triable issue of material fact on this particular issue.

Further, even if he had diabetes, plaintiff should have produced properly qualified opinion evidence that his condition created risks other than those identified by defendant prior to the surgery. The foregoing constitutes the limited role opinion testimony plays in informed consent cases. In Arato v. The entire factual predicate of plaintiff's theory is that he suffered from diabetes to such a degree defendant had a "duty of reasonable disclosure of the available choices with respect to proposed therapy and of the dangers inherently and potentially in each. Defendant's evidence demonstrated no diabetes was present.

Defense counsel specifically objected to plaintiff's lay opinion concerning his diabetic condition. The experienced law and motion judge sustained defendant's objections by noting no "expert" opinion was presented in a counterdeclaration submitted by plaintiff. Therefore, this case involves a second limited situation, other than the one referred to in Arato, where opinion testimony was admissible and pertinent to the resolution of informed consent litigation.

Accordingly, the trial court properly determined defendant was entitled to judgment under the circumstances of this case. To sum up, given defendant's properly qualified opinion evidence filed in support of the summary judgment motion, plaintiff had the responsibility to present evidence on two narrow points in this case. First, he had to submit a declaration by a properly qualified witness that plaintiff suffered from diabetes. Had such evidence been produced, then a triable issue of fact would have been raised which would permit a trier of fact to determine if plaintiff had been given " 'adequate information to enable an intelligent choice,' a peculiarly fact-bound assessment which juries are especially well-suited to make. The judgment is affirmed.

Defendant, Joseph Borden, shall recover his costs on appeal from plaintiff, Harry Jambazian. The complaint named Northridge Hospital Medical Center as a defendant. Plaintiff filed a written request to dismiss Northridge Hospital from the action on September 29, The summary judgment was entered on April 15, The Legislature had amended section c effective January 1, Based on a review of a number of plaintiff's medical records from various sources including those of defendant, Dr. Evidence Code section provides: " a Subject to Section , the testimony of a witness concerning a particular matter is inadmissible unless he has personal knowledge of the matter. Against the objection of a party, such personal knowledge must be shown before the witness may testify concerning the matter.

We do not imply that the sole evidence that an informed consent plaintiff must present in every case is a declaration containing the opinion of a properly qualified physician or other professional health care provider. For example, if there was evidence defendant had stated plaintiff had diabetes, then such an admission plus the evidence of the physician's qualifications would have been sufficient to prove the existence of a diabetic condition. In the present case, this would have sustained plaintiff's burden of responding to defendant's evidence concerning the existence of a diabetic condition created by section c, subdivision n as it was in effect in Respect for an individuals right to autonomy has been an established human right continuing from the time of ancient Greek civilisation which has continued to influence contemporary medical ethics and law.

Respect for autonomy was articulated in early 20th Century caselaw e. Every human being of adult years and sound mind has a right to determine what shall be done with his own body. A competent adult patient has the right to refuse treatment. Thus informed consent is an important legal and ethical mechanism to ensure respect for patient autonomy in medical treatment. He stated:. Any attempt to substitute a rule of law or even a rule of thumb or practice for the individual Judgment of a qualified doctor, doing what he considers best for the particular patient would be disastrous….

I cannot admit any abstract duty to tell patients what is the matter with them…. All depends on the circumstances — the character of the patient, her health, her social position, her intelligence, the nature of the tissue in which the needle is embedded, the possibility of subsequent infection, the arrangement made for future observation and care and numerable other considerations. In the present case the patient was passing through a post partum period in which the possibility of nervous or mental disturbance is notorious….

A second case of Bolton v Blackrock Clinic concerned laryngeal nerve damage warnings prior to sleeve resection surgery of the broncos. Both of these cases emphasised the need to obtain from the patient informed consent to treatment. In both of these cases the question of valid consent, including whether consent was indeed properly informed was to be assessed by the professional standard test of negligence pursuant to the seminal Supreme Court Judgment in Dunne v National Maternity Hospital In other words the Courts held that the patient must prove that the doctor was guilty of such failure in the consent process as no medical practitioner of similar skill and specialisation would be guilty of if acting with ordinary care.

Thus the doctor only was obliged to disclose a risk to his patient that a reasonable doctor would deem necessary to disclose. In assessing what risks should be disclosed to the patient so as to ensure a valid consent to treatment is obtained. The notable exception is the UK which still persists with this approach. In Geoghegan v Harris the Plaintiff claimed that had he known of the risk of chronic neuropathic pain during dental treatment he would have foregone the treatment. Kearns J held that a medical defendant was obliged to give a warning to the Plaintiff of any material risk according to what a reasonable patient would want disclosed and which is a known or foreseeable complication of an operation. It was held that the consent process was negligent as the aforesaid risk was a known complication.

A warning of the risk was required. This was a radical change of approach for the Irish Courts. The Plaintiff however failed in his action as he could not prove that but for the negligent consent process he would not have had the treatment. In short it was held that even had a proper warning been given he would still have undergone the procedure. No-one, not even the Supreme Court were happy to question to professional judgment of a doctor at that time.

In Fitzpatrick v White the Supreme Court reinforced the objective reasonable patient test and applied it to elective treatment. The patient contended that the High Court erred in Law in holding that a proper warning had been given prior to cosmetic eye surgery of the risk of post operative double vision. The patient argued that the lateness of the warning, which was only given in the operating theatre rendered the consent null and void. The Supreme Court acknowledged that it was undesirable to give such a late warning as the patient may clearly be unable to make a rational decision due to nerves etc. In the event the appellant offered no evidence to show that he was unduly stressed.

Therefore the Court found that in fact there was no negligence in the consent process. A Plaintiff will find it hard to succeed in an informed consent action if the clinician can refer to written evidence documenting the consent process. A doctor might be exposed to a successful medical negligence action centering on the issue of informed consent if the following three criteria are established by the dis-satisfied patient:. The right of patient autonomy is embraced in the constitution and the States duty to protect the person is embraced in Article The right is also a dimension of the uninumerated right to bodily integrity recognised by our constitution Ryan v Attorney General IR It follows that a competent adult with full capacity has an absolute right to decline medical treatment.

That right of autonomy is not however without its limits. Medical treatment may not be given to an adult person of full capacity without his or her consent. There are a few rare exceptions to this e. The consent which is given by an adult of full capacity is a matter of choice. It is not necessarily a decision based on medical consideration. Thus, medical treatment may be refused for other than medical reason, or reasons most citizens would regard as rational, but the person of full age and capacity may make the decision for their own reasons. If the patient is a minor the consent may be given on their behalf by parents or guardians. If the patient is incapacitated by reason other than age then the issue of capacity to consent arises. Later in the context of discussing Article The right to life is the pre-eminent personal right.

The State has guaranteed in its laws to respect this right. This respect is absolute. The right refers to all lives — all lives are respected for the benefit of the individual and for the common good. The States respect for the life of the individual encompasses the right of the individual to, for example, refuse a blood transfusion for religious reasons. In the recognition of the individuals autonomy, life is respected. In that case as I am sure the delegates will appreciate a Jehovah Witness, who suffered a massive post partum haemorrhage after the safe birth of her child refused to accept a blood transfusion.

In the event, fearing for her life, the hospital successfully applied ex-parte for injunctive relief to give a blood transfusion. Subsequently, these actions were challenged by the mother and a 35 day plenary hearing took place to consider the issues. The first core legal issue to be decided in the case was whether the mother had given a legally valid refusal of treatment. For a refusal of treatment to be valid it must be based on appropriate treatment information, be made by a person with the necessary capacity and be voluntary.

In effect that particular case turned on whether the mother had capacity to make a decision to refuse at the time she articulated the refusal. Laffoy J carried out a detailed analysis of the relevant law relating to capacity. She concluded:. It seems to me that the relevant principles applicable to the determination of the capacity question are as follows:. Denham J in the course her Judgment in Fitzpatrick v K states:. The duty of the clinician caring for a patient in the circumstances which prevailed in relation to Ms K on the morning of 21 September is to advise the patient of, and afford him or her, the opportunity to receive appropriate medical treatment. If as a competent adult the patient refuses to accept the treatment and no issue arises as to the capacity of the patient to make that decision, the clinicians duty to provide such treatment is discharged.

However, if an issue arises as to the capacity of the patient to refuse treatment the duty of the clinician to advise on and provide the appropriate treatment remains. As a matter of law and common sense the duty of care which the clinician owes the patient in those circumstances is no different from what it would be if there was no refusal or if the patient was unconscious.

What is required of the clinician is to take the steps to have the capacity issue resolved with the assistance of the Court if necessary. In this case the responsibility of the Master and the other clinicians treating Ms K was to give her the information that the appropriate treatment for her was a blood transfusion, as counsel for Ms K acknowledged. Laffoy J was satisfied on the evidence that a blood transfusion was necessary and was appropriate treatment for the mother. She was satisfied that the Master and the other treating clinicians gave the mother the necessary information to enable her to make an informed decision whether to accept or refuse a blood transfusion.

However, the evidence in the case from the Master was to the effect that when he first decided to seek the authority of the Court to transfuse her that he had not come to a conclusion whether she lacked capacity to make a decision of such gravity as to refuse life saving treatment on religious grounds, nor had he come to a conclusion that she had such a capacity. Irrespective of that finding on the evidence adduced … the capacity question falls to be determined by reference to the evidence which was available to the hospital personnel and the court on the 21 September In obstetric medicine respect for autonomy may conflict with the right to life.

Primacy must be afforded to the right to life maternal and foetal. The issue of balancing the potentially competing rights of a competent mother to autonomy and the rights of the unborn child was not dealt with in Fitzpatrick v K. As Laffoy J stated:. There was consensus that the balancing of rights question would only arise in the event that the Court were to find that Ms K had full capacity to make a decision to refuse a blood transfusion.

On the basis of the finding that Ms K did not have capacity to make that decision the balancing of rights question does not arise. For the Court to express a view on it would in effect amount to an advisory Judgment on an issue which has been rendered moot by the decision on the capacity question. The State acknowledges the right to life of the unborn and with due regard to the equal right to life of the mother, guarantees in its laws to respect, and as far as practicable, by its laws to defend and vindicate that right.

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