Rethinking informed consent: Tell your patients of all the treatment choices available to them

Duty to disclose material information is not limited by the fact that the proposed treatment or therapy is, or is not, surgical or physically invasive in nature.

Lawrence H. Brenner

B. Sonny Bal

The editors gratefully acknowledge the contribution of Jeffrey A. Shane, MD, JD, in the preparation of this article.

The doctrine of informed consent continues to stir debate among physicians, ethicists, and courts. The origins of informed consent derive from the common law tort of battery, which is defined as the intentional harmful or offensive contact to another. Valid consent of the plaintiff negates an allegation of battery. Thus, absent a signed informed consent, a patient could sue a surgeon for battery even if the operation were properly indicated and expertly performed. Over the last century, this traditional understanding of informed consent and how it applies in the medical field has continued to evolve.

In this column we examine two recent legal decisions related to informed consent. The first was issued in Wisconsin and addresses the duty of a physician to inform patients of available options and alternatives to a proposed treatment. The second, from Maryland, illustrates how the concept of informed consent attaches to the continuing communication between a patient and physician during treatment. Both touch the boundaries of the doctrine of informed consent in the context of a health care provider’s treatment of a patient.

Bubb v. Brusky

In 2001, Marjorie and Richard Bubb were dining together when Richard experienced difficulty ingesting his food and fell out of his chair. He was transported to the emergency department of a local hospital and was seen by Dr. Brusky, an emergency room (ER) physician who ordered several tests, including a CT scan, EKG, and various blood tests. Based on this workup, and considering the rapid improvement in the patient, the diagnosis of a transient ischemic attack (TIA) was made. The patient felt well enough that he wanted to go home.

Before discharging the patient, Brusky called a neurologist who reviewed Bubb’s condition over the telephone. The neurologist, Dr. Gu, agreed to see Bubb in follow-up. Accordingly, the patient was sent home on oral aspirin and with care directions specific for patients diagnosed with a TIA. He was also instructed to call Gu the next morning for further care. The next morning, Bubb made an appointment to see Gu about 12 days later.

The next morning, Marjorie returned from work to find Richard on the bedroom floor, pleading for help. An evaluation in the ER found a large-scale stroke affecting the right side of his brain. Further work-up showed a 90% stenosis of the right carotid artery. The stroke left Bubb without use of his left arm and unable to walk without a cane.

Negligence

In their lawsuit, the Bubbs alleged that Brusky negligently failed to diagnose and treat Richard’s condition during the first ER visit, before it escalated into a full-blown stroke. The Bubbs presented expert testimony that Brusky should have informed Bubb that an alternative to discharge from the ER was admission to the hospital for further diagnostic testing to find the cause of the TIA. One testifying expert held that it was the standard of care to perform a Doppler ultrasound of the carotids in TIA patients, so the treating physician can know if further, immediate treatment is necessary.

During testimony, Brusky agreed that admitting Bubb for further workup was a reasonable alternative to discharge with instructions to follow-up with a neurologist. Expert testimony on behalf of Brusky explained that there is considerable debate and variation in practices concerning the management of TIA episodes after the initial evaluation; some institutions admit all patients to the hospital, while others discharge the patient with subsequent follow-up care by a specialist. Experts for the defendant opined that both are reasonable treatment options.

At issue were the jury instructions pertaining to the standard of care described in a Wisconsin state statute that created a standard of care for doctors to inform patients about the availability of “all alternative viable modes of treatment” and their risks and benefits. The plaintiffs urged the court to apply this statute to the facts of the case and find the defendants negligent on the grounds of insufficient informed consent. The trial judge decided otherwise and, as a result, the case went to the jury without any instructions on the informed consent issue raised by the plaintiffs. The jurors found Brusky and Gu not negligent.

Appeals

The Bubbs appealed, arguing that they had presented sufficient evidence to establish the availability of alternative courses of action in treating Richard’s condition, therefore Brusky owed them a duty to inform about the availability of those alternatives.

The defendants maintained that this case concerned the standard of care, and had nothing to do with informed consent, and that the jury was properly instructed on the former legal theory. The appellate court agreed with Brusky, affirming the jury verdict in favor of the defendants.

The case was then appealed to the Wisconsin Supreme Court, which reversed the earlier decisions holding that Brusky had an affirmative duty to discuss the option of hospital admission and further workup with Bubb as a viable alternative to outpatient treatment. The court rejected Brusky’s argument that he had properly discharged his duties as an ER physician, and that the ruling would force other ER physicians to provide patients with knowledge outside their field.

Interestingly, the Supreme Court acknowledged that the trial court jury had found Brusky not negligent in his standard of care for failing to employ the alternative of admission while treating Bubb. But, this did not relieve him of his duty to inform the Bubbs “about the availability of all alternate, viable medical modes of treatment” as required by the relevant state statute.

McQuitty v. Spangler

Plaintiff Peggy McQuitty sued her obstetrician Dr. Donald Spangler after giving birth to a child with severe cerebral palsy in 1995. McQuitty was admitted to the hospital, 28-weeks pregnant, with vaginal bleeding. Ultrasound showed partial placenta abruption. The mother had an earlier child by Cesarean section. Based on the facts known to him, Spangler admitted McQuitty to the hospital for monitoring, and further testing, with the goal of delaying delivery as long as it was feasible.

Immediate delivery by Cesarean section risked fetal morbidity and prematurity, while any delay risked further abruption of the placenta; these risks were discussed with the patient.

While the patient was being monitored, the pregnancy was complicated by further abruption, oligohydramnios and intrauterine growth restriction. Spangler continued observation until delivery could no longer be delayed. The child, delivered by Caesarean section, was born with severe cerebral palsy.

Informed consent

In addition to a medical negligence claim, the mother also alleged that the doctor had breached his duty to obtain her informed consent to treatment, when he failed to inform her, after she consented to hospitalization and treatment for a partial placental abruption, of the risks and available alternative treatments related to material changes in her pregnancy. In other words, the obstetrician should have kept her informed of ongoing changes in her pregnancy, so that she could have chosen an immediate, riskier delivery, over further delay.

The doctor maintained that he had already obtained her consent to the treatment that consisted of prolonging the pregnancy with its attendant risks, and that absent any actual or proposed affirmative invasion of her physical integrity, he had no duty to obtain further informed consent.

After a trial in 2004, a jury returned a verdict in favor of the defendant physician on the medical malpractice issue, but could not reach a verdict on the informed consent claim.

A second trial in 2006 addressed only the informed consent issue and the jury awarded McQuitty more than $13 million in damages.

Upon a motion for a “judgment notwithstanding the verdict,” the trial judge agreed with Spangler that Maryland law had held that the doctrine of informed consent pertains only to affirmative violations of the patient’s integrity. Lacking such, the jury verdict for damages was overturned by the judge on technical grounds.

Upon appeal, the court of appeals agreed with Spangler and affirmed the trial judge’s ruling. In other words, while the jury had awarded damages, in special cases, as here, the judge can still enter judgment that is contrary to the jury verdict.

Absence of battery

Plaintiffs, deprived of their damages award, appealed for review by the Supreme Court, seeking an interpretation of Maryland law. Specifically, did an informed consent claim exist under Maryland law in the absence of damages caused by a battery committed by the physician?

Also, is an informed consent issue triggered under Maryland law where a doctor withholds material information from his patient about changes in his or her medical status, which might have negated her earlier consent to a delay in operative treatment, causing harm?

The Supreme Court sided with the plaintiffs and rejected the basis for the trial judge granting the motion notwithstanding the verdict. It held that an informed consent claim can be asserted by a patient in the absence of a battery, or in the absence of an affirmative violation of the patient’s physical integrity. In so doing, the court distinguished an informed consent claim, from a claim for medical malpractice.

Medical malpractice claims borrow from the concept of battery: The requirement of an affirmative invasion of the physical integrity of the patient was specified in Maryland law, at least until this ruling. The court stated that the obstetrician had a duty to tell the mother of ongoing material changes in her condition or that of her baby, even after obtaining consent to observation, treatment, and delay in delivering the baby. Those changes in the mother’s condition or that of the baby were material to McQuitty’s decision-making regarding whether to continue a pre-established course of treatment, or abandon it in favor of a risky, immediate delivery of the child by Cesarean section.

Comments

As these cases illustrate, the doctrine of informed consent goes well beyond the well-recognized duty to disclose to the patient the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. In both of these cases, jurors found that the defendant doctor was found not negligent of medical malpractice. Even so, the respective courts permitted the plaintiffs to move forward with their claims on the theory of insufficient informed consent.

These cases do not suggest that all possible risks have to be divulged while obtaining informed consent. As the Maryland court explained, the scope of the duty to inform is measured by the materiality of the information to the decision of the patient. That said, a physician’s duty to disclose material information is not limited by the fact that the proposed treatment or therapy is, or is not surgical, or physically invasive in nature.

Informed consent is a difficult and complex topic; one that we will continue to tackle in future columns, by using illustrative case examples. As always, your perspectives are welcome; selected articles will be printed in this forum.

For more information:

• B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
• Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.