Risk Management



Informed Consent Revisited

By Paul Weber, JD
OMIC’s vice-president of risk management

Digest, Summer, 2001

Poor informed consent continues to be a frequent and serious allegation in claims and lawsuits against ophthalmologists. Despite the availability of procedure-specific informed consent documents from OMIC, an alarming number of insureds still do not use them and simply rely on the hospital or surgicenter’s consent form to cover their exposure. Unfortunately, these generic documents focus on the risks of anesthesia and rarely address ophthalmic-specific risks. Informed consent documentation is so critical to the successful defense of a malpractice claim that it bears revisiting.

Q  What is the risk of not obtaining informed consent from a patient?
A  The courts in most states have decided that if a physician performs a procedure or provides care without first informing the patient of the risks, complications, and alternatives and the patient has a known complication or side effect, the doctor must pay damages. (In some states, this decision has been codified into a statute.) This legal doctrine provides another avenue for patients to sue their physician and is often used in conjunction with claims of improper performance. The law in most states provides that: (1) In providing medical services, a physician must get informed consent; (2) Informed consent occurs after disclosure by the physician of factors a “reasonably well qualified” physician would disclose under similar circumstances; (3) Failure to obtain informed consent is negligence; (4) Expert testimony is needed to prove the sufficiency of disclosed risks/alternatives.

Q  What must the plaintiff prove to prevail in an allegation of informed consent?
A  The plaintiff must prove that: (1) The physician failed to inform the patient of the risks/alternatives another physician would have disclosed; (2) If these risks/alternatives were disclosed, a reasonable person would not have submitted to the procedure; (3) The patient was injured; (4) Failure to disclose these risks/alternatives was cause of injury.

Q  What steps can I take to ensure that the patient is properly informed?
A  The process of informed consent begins when the patient is first seen and given information to read and/or a video to view about his or her condition and its treatment. For risk management purposes, it is important to document that the patient received this information and/or viewed a video to help refute a claim of lack of informed consent.

Q  When does informed consent “happen”?
A  Some experts suggest that informed consent is an ongoing process rather than a seminal event. However, for medicolegal purposes, it is essential the ophthalmologist have a personal discussion with the patient about the risks, benefits, and alternatives to treatment and personally answer the patient’s questions. Only after this discussion can the patient give his or her informed consent. It is this discussion and subsequent patient agreement that constitutes “informed consent.” What comes next is the documentation or memorializing of the patient agreement.

Q  Why is a procedure-specific informed consent document so important? Why isn’t a simple note in the chart sufficient?
A  Without a document signed by the patient listing the risks specific to the procedure, the jury will be confronted with two entirely different versions of what was discussed. Unfortunately, it is quite rare that handwritten chart notes are as comprehensive as a procedure-specific informed consent document. However, such a note in the patient’s chart coupled with a procedure-specific informed consent document presents a formidable defense. Also document whenever the ophthalmologist spends a significant amount of time with a patient discussing a procedure, including how much time was spent. This helps refute claims that the physician was “in and out” of the room and did not seriously address the patient’s concerns.

Q  What are some strategies surrounding the actual signing of the informed consent document?
The patient should sign the document after having the discussion with the ophthalmologist. Many of these documents state that “the doctor has answered my questions.” This assumes that a discussion has taken place so if the patient signs the document before the discussion, it is inaccurate and may diminish the document’s effectiveness. Ask the patient to initial each page of a multi-page document or even specific paragraphs to avoid allegations that the patient was shown only the last page to sign and not given a chance to review the document in its entirety. Encourage the patient to take the document home prior to signing to digest the information and review it with a family member if necessary. The patient also may be given a copy of the document to keep.

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