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PHYSICIANS: KEEP YOUR PATIENTS INFORMED

Lack of informed consent is a common claim in medical malpractice cases arising out of alleged negligence during a medical procedure or surgery. In many instances, a patient claims that the physician failed to fully explain the risks associated with a medical procedure before the patient agreed to undergo it. When there is a bad outcome, a plaintiff will often claim that had they been fully informed of the risks of the procedure, they would not have proceeded with the treatment or surgery. This article will briefly discuss the evolution of the informed consent doctrine, the requirements under Ohio law for establishing an informed consent claim and what it means for physicians and medical providers.

The doctrine of informed consent emerged in common law in the context of the tort for battery because the courts equated the failure of a physician to obtain a patient's consent prior to a procedure with a layperson causing physical harm to another person's body without their permission. However, courts began to recognize that obtaining informed consent was really an issue of a physician's professional conduct and so negligence has now become the basis for liability in cases in which a plaintiff contends that they were not fully informed of the risks of a medical procedure.

Recently, the Ohio Supreme Court further delineated the doctrine of informed consent in its holding in White v. Leimbach. In White, the Court held that a plaintiff must offer expert testimony to define the material risks and dangers inherently and potentially involved with a given medical procedure and that an undisclosed risk or danger actually materialized and proximately caused injury to the patient. However, a plaintiff is not required to offer expert testimony on whether a patient would have gone through with the medical procedure had the material risks and dangers been properly disclosed to patient before undergoing the medical procedure.

In order for a plaintiff-patient to prevail on a claim for the lack of informed consent, the patient must establish the following: 1) the physician failed to disclose and discuss with the patient the material risks and dangers inherently and potentially involved with respect to the proposed therapy, if any; 2) the unrevealed risks and dangers which should have been disclosed by the physician actually materialize and are the proximate cause of the injury to the patient; and 3) a reasonable person in the position of the patient would have decided against the therapy had the material risks and dangers inherent and incidental to treatment been disclosed prior to the therapy. Expert testimony is required for the first two prongs of the claim because identifying material risks and whether those risks materialized and caused harm to the patient is beyond the expert knowledge of a layperson. However, what a patient would have done with the information is considered to be within the comprehension of a jury and therefore, there is no need for expert testimony.

While the White case clearly sets forth a heightened burden for plaintiffs to establish a claim for lack of informed consent, it is a reminder to physicians and medical providers of the need to fully explain all material risks to their patients before proceeding with any medical procedure. More importantly, physicians must make sure that their disclosure of material risks is clearly documented in the patient's medical chart.

It is surprising how often attorneys are asked to defend a case where the physician either did not document his discussion regarding the material risks with his patient or the physician relied upon a standardized informed consent form. The problem with a standardized informed consent form is that all too often the form does not contain all of the risks associated with a particular procedure. This practice allows for a broad interpretation by an expert supporting an informed consent claim.

If a physician prefers to use a standardized consent form then all of the material risks should be clearly identifiable and there should be a place on the form to add additional risks particular to a given procedure. The form should be carefully reviewed during the physician's consultation with his patient and the patient should sign the document in the presence of a witness.

A better method of accomplishing this objective is to have the patient write down the material risks as the physician reviews them. The patient should then sign the document to demonstrate his or her understanding of the potential risks and dangers that were discussed. While obtaining such documentation may take little more time and perhaps seem a bit tedious, it could go a long way towards eliminating a lack of informed consent claim should one of those risks arise during the procedure. If the patient writes down the risks and signs the document, an expert for a plaintiff will have a difficult time meeting the requirements set forth by the Ohio Supreme Court.