Risk Management

Informed Consent and Elective Procedures

By Paul Weber, JD, OMIC Risk Manager [Digest, Fall 2001]

The majority of ophthalmologists at a recent OMIC risk management seminar (73%) agreed that elective surgery patients are more likely to sue their surgeon than other patients. Of the more than 300 ophthalmologists in attendance, 64% agreed that physicians have legal duty to determine if an elective surgery patient has “realistic expectations” of what surgery can accomplish. Why do patients who undergo elective surgery seem to present a greater liability risk than other patients? What steps can be taken during the informed consent process to better understand these patients’ expectations?

Q  What characteristics of elective surgery patients impact the informed consent process?

A  Elective surgery patients rarely have a vision threatening condition or compelling clinical reason to undergo the procedure. If things go wrong, it is not unusual for them to claim that the ophthalmologist persuaded or cajoled them into having surgery. Ask elective surgery patients to write on the informed consent document or in the chart itself their own personal reasons for having surgery. This helps them acknowledge their primary role in the decision-making process and makes it difficult for them to later claim that the only reason they went forward with the surgery was because of the “undue influence” of the ophthalmologist and staff. Another factor that distinguishes elective surgery patients is that most elective procedures are not covered by health insurance so patients pay out of pocket. This can become problematic if the patient needs an enhancement or revision after the initial surgery. The informed consent process document should specifically state the possibility of future procedures (enhancements/revisions) to get the desired result or to deal with the complications. The fact that there will be additional costs associated with further treatment should be addressed and documented before embarking upon any elective surgery.

Q What impact does advertising have on informed consent?

A Your own advertising and marketing materials will be brought into court if a lawsuit arises. If a statement in your ad conflicts with your informed consent document, that conflict will be raised as evidence that the patient was not properly informed. OMIC considers refractive surgery advertising such a potentially problematic issue that as part of being underwritten for refractive procedures, insureds must submit their advertising and marketing materials to OMIC for review prior to publication. Insureds who have questions about the appropriateness of their advertising should contact the Risk Management Department at (800) 562-6642, ext. 652.

Q How can I determine if a patient has unrealistic expectations?

A There is no substitute for spending time with a patient to find out what he or she expects from surgery. One busy refractive surgeon makes it a point to ask each patient, “What is the most important thing about your vision?” This helps him to determine if he can deliver what the patient wants. During one pre-LASIK interview of a seemingly perfect candidate, a 58-year old -6.00 D, he discovered that the patient’s favorite hobby was tying flies and that he had won championships in it. To tie them, he had to take off his glasses and work about eight inches in front of his face. When asked what he considered especially important about his vision, the patient replied, “I really like how good my vision is right here.” Had they not had this discussion, this important fact would not have been revealed and the surgeon could have been exposed to a claim of failure to provide informed consent if the patient lost his vision after LASIK.

Q Is there a duty to inform the patient about how postoperative care will be handled?

A Postoperative co-management issues often arise in the context of refractive surgery. If it is known in advance that some portion of the postoperative care will be handled by another provider, this should be communicated to the patient. Many times, a patient chooses to have an elective procedure performed by a particular surgeon and has the reasonable expectation that the surgeon will handle the postoperative care. When this is not the case, the patient may be disappointed and upset, especially if there is a complication or concern about the result. Prior to surgery, the patient should understand and consent to the handling of postoperative care by health care providers other than the surgeon.

Q How should informed consent be handled for off-label procedures?

A It is not uncommon for refractive and cosmetic surgeons to use a drug or device in a manner that has not been approved by the FDA. In such cases, the patient should be informed of the nature of the technique, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Other options should be discussed, and the patient should be encouraged to seek a second opinion before proceeding.