Backlund v. University of Washington (975 P.2d 950) 1999

We are asked to apply Washington's informed consent law for health care patients, RCW 7.70.050, in a case where the Backlunds allege Dr. Craig Jackson committed malpractice while he was employed by the University of Washington (University). They contend he was negligent in continuing to treat Ashley Backlund's jaundice at birth with phototherapy. They argue he should have abandoned phototherapy, a more conservative form of treatment for jaundice, or applied it in conjunction with a transfusion of Ashley's blood, a riskier procedure. A jury, however, exonerated Dr. Jackson and the University from any negligence in the decision to continue phototherapy instead of transfusing the baby. Now, the Backlunds complain Dr. Jackson and the University failed to provide them sufficient information upon which to make an informed health care choice, thus violating RCW 7.70.050, subjecting Dr. Jackson and the University to liability despite their exoneration from liability for negligence.

The University argues a cause of action for failure to obtain informed consent is unavailable to the Backlunds as a matter of law where the jury exonerated Dr. Jackson and the University from negligence. We disagree with the University's contention.

But because the Backlunds did not prove the elements of a prima facie case of breach of informed consent, in particular "that a reasonably prudent patient under similar circumstances would not have consented to the treatment if informed of such material fact or facts" as required by RCW 7.70.050(1)(c), we affirm the trial court's judgment dismissing the Backlunds' complaint….

The Backlunds' daughter, Ashley, was born a week prematurely on December 31, 1987. She weighed six pounds, four ounces at birth. Ashley was transported to Children's Hospital Medical Center the next day when she began showing signs of respiratory distress. She was treated there by Dr. Craig Jackson, a neonatologist employed by the University of Washington.

Ashley suffered from hyperbilirubinemia, or jaundice, caused by elevated levels of bilirubin, a substance released into the bloodstream when red blood cells break down. Such jaundice is not uncommon among infants as approximately a third or more of all newborns at the intensive care unit at Children's Hospital have jaundice. Greatly elevated bilirubin levels, however, can result in permanent brain damage. When Ashley was admitted to Children's Hospital, her serum bilirubin level was 4.2 micrograms per deciliter. It gradually increased to as high as 22.0 mcg/dl on January 7, 1988, then decreased to 5.7 mcg/dl on January 18, 1988.

The type of jaundice Ashley experienced is generally treated with phototherapy, the exposure of the infant's skin to special lights. More serious cases are treated with a transfusion of all the blood in the infant's body, a treatment entailing greater risks including cardiac arrhythmia, bleeding, bacterial infection, and the development of air bubbles in the circulatory system. Dr. Jackson prescribed phototherapy for Ashley, but did not discuss transfusion with the Backlunds. The phototherapy proved unsuccessful, and Ashley suffered brain damage. The Backlunds allegedly were not informed of the risks associated with high bilirubin levels. They did not know Ashley's subsequent developmental problems were caused by the high bilirubin levels she suffered while at Children's Hospital until almost two years after her treatment there….

The initial question we must address is the University's contention the Backlunds had no cause of action for failure to obtain informed consent under RCW 7.70.050 as a matter of law where the jury exonerated Dr. Jackson and the University from liability for negligence. The University asks us to dismiss the Backlunds' complaint based on Dr. Jackson's failure to secure informed consent where Ashley's injury was not caused by Dr. Jackson's actual treatment. In effect, the University contends that because Dr. Jackson was exonerated from negligence by the jury for his alleged misdiagnosis of Ashley's condition (i.e., his decision that her condition was not so serious as to require transfusion instead of phototherapy), his failure to obtain informed consent did not proximately result in Ashley's harm and he could not be liable under RCW 7.70.050. We disagree with the University's argument on these facts.

We note the trial court here made reference to the conduct of Dr. Jackson being in compliance with the standard of care as a factor in its decision on informed consent. The trial court's emphasis on the patient's likely following of the non-negligent recommendation of a physician goes too far in confusing negligence and informed consent claims. Negligence and informed consent are alternative methods of imposing liability on a health care practitioner. Informed consent allows a patient to recover damages from a physician even though the medical diagnosis or treatment was not negligent….The Court of Appeals in Holt aptly explained that if a doctor breaches the duty to obtain an informed consent from the patient before proceeding with treatment, the patient has a cause of action for damages against the doctor even if the doctor has performed the treatment properly within the standard of care of the profession. Thus, the cause of action can arise against a doctor for failing to obtain the patient's knowledgeable permission to the treatment even though the doctor's actions have not been negligent and would not give rise to a cause of action in any other way….

In the appropriate case, treatment choice may fall within the classic professional negligence situation requiring the patient to prove the physician breached the standard of care….

Informed consent focuses on the patient's right to know his bodily condition and to decide what should be done. RCW 7.70.050. Whenever a physician becomes aware of a condition which indicates risk to the patient's health, he has a duty to disclose it.

In response to Dr. Graham's liability, Thomas T. Reiley, M.D., an expert called on behalf of the Burnets, stated Dr. Graham was unaware of the risk of brain herniation and subsequent injury. The trial court determined that the issues presented were confined to negligence and misdiagnosis rather than a violation of the informed consent law. We agree; informed consent is an alternative method to impose liability. Thus, a high risk method of treatment rendered in a nonnegligent manner, but without an informed consent of the patient, may result in liability. That is not the situation here. It is undisputed Dr. Graham was unaware of Tristen's condition which implicated risk to her, so he had no duty to disclose. The Burnets' claim relates solely to issues of failure to meet the standard of care and diagnosis. Burnet, 54 Wash. App. at 168-69 (citations and footnote omitted). In Bays, noting the patient's attempt to disguise a negligence issue as a failure to obtain an informed consent issue, the court stated: A failure to diagnose a condition . . . is a matter of medical negligence. We decline to create a second or alternate cause of action on informed nonconsent to a diagnostic procedure predicated on the same facts necessary to establish a claim of medical negligence. Bays, 63 Wash. App. at 883. See also Thomas, 65 Wash. App. at 261 (where physician (correctly) diagnosed asthma rather than Malathion poisoning, he did not breach duty to inform by failing to relate information regarding Malathion poisoning treatment because failure to diagnose a condition is a matter of medical negligence, not a violation of the duty to inform a patient).

A physician who misdiagnoses the patient's condition, and is therefore unaware of an appropriate category of treatments or treatment alternatives, may properly be subject to a negligence action where such misdiagnosis breaches the standard of care, but may not be subject to an action based on failure to secure informed consent. We have no facts in this case, however, suggesting Dr. Jackson was unaware of the transfusion alternative. Rather, in his professional judgment, he did not believe Ashley required a transfusion because her bilirubin levels were not serious enough to warrant such treatment. The jury upheld his professional judgment on that issue, but a trier of fact might still have found he did not sufficiently inform the patient of risks and alternatives in accordance with RCW 7.70.050. The University's contention, that an informed consent action is not present here as a matter of law because the patient's injury was not caused by the practitioner's actual treatment, fails.

Washington's informed consent statute is generally based on the policy judgment that patients have the right to make decisions about their own medical treatment….

This concept of patient decisionmaking regarding treatment has sometimes been described as "patient sovereignty": A patient has the sovereign choice of whether he will submit to surgery in the course of the diagnosis and treatment, and in order to make this choice meaningful and realistic the doctor is under a legal duty to disclose to a patient any serious risks involved in the contemplated surgery, and the alternatives available to him, including the risks from declining surgery….

A patient must be given sufficient information to make an informed health care decision. Shannon, 100 Wash. 2d at 29. Accordingly, "it is for the patient to evaluate the risks of treatment and that the only role to be played by the physician is to provide the patient with information as to what those risks are." Id. at 30. RCW 7.70.050 indicates a patient must be advised of those "material facts" relating to the treatment; RCW 7.70.050(1) provides: The following shall be necessary elements of proof that injury resulted from health care in a civil negligence case or arbitration involving the issue of the alleged breach of the duty to secure an informed consent by a patient or his representatives against a health care provider:

A fact is deemed material for purposes of informed consent "if a reasonably prudent person in the position of the patient or his representative would attach significance to it deciding whether or not to submit to the proposed treatment." RCW 7.70.050(2). Material facts which must be established by expert testimony include:

RCW 7.70.050(3). In a claim for lack of informed consent, the concept of patient sovereignty is bounded by the objective elements of proof for material facts required under RCW 7.70.050.... In an informed consent case arising from a physician's failure to discuss alternatives to generalanesthesia with a patient undergoing exploratory surgery, the trial court granted a directed verdict to the hospital on the ground that the plaintiff "failed to testify that he would have chosen an alternative treatment had he been apprised of the risks of general anesthesia and the available alternatives…."The Court of Appeals reversed, reasoning "the test is not whether Mr. Brown himself would have chosen a different course of treatment, but whether a reasonably prudent patient in Mr. Brown's position would have chosen a different course of treatment." The Court of Appeals appropriately emphasized the importance of the objective approach in Washington's informed consent law….

In considering the elements set forth in RCW 7.70.050(1) for a prima facie case of failure to secure informed consent, the Backlunds proved three of the four statutory elements to the satisfaction of the trial court. The real question here is whether the Backlunds proved the third element of informed consent: whether a reasonable patient under similar circumstances would not have consented to the treatment if informed of the material fact or facts associated with such treatment.

The Backlunds ask us to redefine the third element of the cause of action so that RCW 7.70.050(1)(c) is satisfied if either of the following can be established by a preponderance of the evidence: (1) that "some patients, exercising reasonable prudence, might have opted for the recognized alternative treatment if informed of the material facts of which the doctor failed to inform the plaintiffs(s)," or (2) if "the recognized alternative treatment would have been among the range of reasonably prudent responses that patients could make upon being informed of the material facts of which the doctor failed to inform the plaintiff(s)." Pet. for Review at 14-15.

We decline the Backlunds' invitation to rewrite RCW 7.70.050(1)(c). The Backlunds' test for the third statutory element essentially eliminates its objective feature. Their test would allow proof that some patients, exercising reasonable prudence, might have opted for the recognized alternative treatment if informed of the facts. Alternatively, the test is met if the recognized alternative treatment is among the range of reasonably prudent responses by patients had they been informed of the material facts. These alternatives would greatly diminish the proof necessary to establish an informed consent claim. The Legislature, however, clearly intended an objective test be employed with respect to this element of a prima facie case when it said the test involved a "reasonably prudent" patient.

The Legislature has clearly stated what is required: the plaintiff must establish that "a reasonably prudent patient under similar circumstances would not have consented to the treatment if informed of such material fact or facts…." RCW 7.70.050(1)(c). Thus, the trier of fact must determine from the evidence taken as a whole whether a reasonably prudent person in the patient's position would have chosen a different treatment than received….

When determining whether a reasonably prudent patient would have declined treatment if informed of material facts regarding his or her treatment a trial court looks to the situation of the patient, i.e., his or her medical condition, age, risk factors, etc., and then the court makes findings of fact regarding the risks of the treatment and any material risks regarding treatment alternatives. Based on these findings along with any other relevant evidence, the trier of fact will ordinarily determine whether a reasonably prudent patient in the plaintiff's situation would have chosen a different treatment option. See Hutchinson v. United States (1990) (where trial court's findings indicated patient's asthma was responding favorably to low-risk conservative drug treatment, which was discontinued in favor of another drug carrying substantial risk of crippling side effects, to which patient succumbed, reviewing court found such trial court findings showed a reasonable person in plaintiff's shoes would have continued the low-risk conservative drug treatment option had he been informed of the commensurate/concomitant risks of the alternative treatments); Canterbury v. Spence (1972) (the plaintiff may prevail in an informed consent cause of action "if adequate disclosure could reasonably be expected to have caused that person to decline the treatment because of the revelation of the kind of risk or danger that resulted in harm").

Under the statutory test, the trial court correctly ruled the Backlunds failed to establish the third element of the prima facie case of informed consent. This is essentially a case of failure of proof. A reasonably prudent patient would not have opted for the transfusion, even if the reasonably prudent patient had been informed of all the pertinent risks of no treatment, phototherapy, and the alternative treatment of double transfusion. We seriously doubt the Backlunds would have chosen no treatment for Ashley. The record below indicates there was a 1 in 10,000 chance the phototherapy treatment course employed by Dr. Jackson would result in the kind of permanent brain damage Ashley Backlund suffered. On the other hand, evidence also indicated there was a 1 in 300 to 1 in 100 chance of death if Ashley Backlund had been treated with a double transfusion of her blood. Under these circumstances, in the absence of proof from the Backlunds to the contrary, no reasonably prudent patient/representative would prefer a treatment with a 1 in 100 chance of death of their baby to the more conservative course of treatment within the standard of care that bears a 1 in 10,000 chance of permanent brain damage. The record indicates the Backlunds simply did not bear their burden of proof with respect to the reasonableness of a patient's consideration of the treatment alternatives. On this basis, the trial court's judgment dismissing the Backlund's informed consent claim is affirmed.

Under the facts of this case, the Backlunds simply did not sustain their burden of proof with respect to a prima facie case of failure to obtain informed consent under RCW 7.70.050. We affirm the trial court's judgment dismissing the Backlunds' complaint.