In 1987, Donna Feeley experienced a normal pregnancy without prenatal problems, her fourth pregnancy. When her water broke two days after her due date, she was admitted to Beth Israel Hospital in Boston, although she was not in labor.  Her physicians chose a course of treatment known as "expectant management," believing that after the membranes rupture, a pregnancy should proceed naturally to spontaneous labor, when possible.  In this treatment mode, surgical intervention or medication to induce labor would not be offered to the patient unless there were some indication that either the mother or the child would be jeopardized by the natural delivery.

 

Eric Feeley was born two days later by spontaneous vaginal delivery.  Because of the time lapse, the care team was considering delivering the child by Cesarean section, if necessary.  The infant, however, developed a streptococcus pneumonia and died five days later.  Donna Feeley sued the physicians, alleging medical malpractice and lack of informed consent.  The informed consent claim essentially stated that, if she had been informed about the risk of infection to the infant, she would not have proceeded in the natural delivery mode.

 

During trial, the judge ruled the plaintiff's evidence was not sufficient to establish a cause of action for lack of informed consent.  He noted that both sides agreed a risk of infection existed after Ms. Feeley's membranes ruptured, but Feeley's expert did not establish that there was more than a negligible risk of serious harm if an infection occurred.  The jury found in favor of the defendant doctors on the other issues of malpractice.

 

The plaintiff appealed the dismissal of the informed consent claim. The Massachusetts Court of Appeals overturned the dismissal and sent the case back for a new trial, just on the issue of informed consent.

 

This time the doctors appealed. The Supreme Judicial Court reviewed the case and upheld the original decision, finding that the trial court had been correct in dismissing the informed consent claim. The Court ruled that, while there may be risks of harm from a particular procedure, the risks only need to be explained if there are potential serious consequences should they materialize.  In this case, the Court said, risk of serious harm materializing from an infection was negligible.

 

There has been significant debate about what risks need to be explained to a patient.  Case law in Massachusetts and other states makes it clear that the likelihood of the risk occurring must be more than negligible to expect a physician to discuss it with a patient.  Obviously, "negligible" is an extremely subjective term, and courts have been reluctant to specifically define it.  For example, some courts have mentioned likelihood of risk in terms of percentages.  Other courts have cautioned against defining risk by a specific mathematical formula. 

 

More often, courts consider both the likelihood of a risk and the severity of the harm to the patient if the risk occurs.  It would be more likely for a court to require disclosure of a small possibility of death, as opposed to a larger risk of a transient or easily-treatable side effect.  Courts have said the plaintiff must present fairly specific testimony about the foreseeability of the risk of the particular injury being complained of in the lawsuit.  If the risk of that injury was not foreseeable, the physician will not be held to a standard that requires informing the patient of that risk.

 

This decision reaffirms the doctrine of informed consent and how it will apply in medical malpractice cases.  For the most part, informed consent has not been a major basis of liability in medical negligence actions.  However, it is clearly established that patients need to be involved in their treatment.  They need to be informed of the significant risks and benefits of treatments involving issues ranging from the prescribing of certain medications, to invasive surgical procedures,  to end of life of decisions.   Physicians are best guided by what an individual patient would consider significant information in a given situation,  to adequately participate in the decision-making process.  Documenting those discussions provides some protection for physicians if an adverse event occurs as a result of the decisions made by patients and their physicians.


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Procedures Requiring Informed Consent

by Attorney Frank E. Reardon

July 1997