Informed Consent in Eye Surgery Expert Witness

Consent claims travel with nearly every surgical malpractice case, and they are often the claim that survives when the surgery itself was performed properly. They are also frequently pleaded and thinly supported. An expert is useful on both sides of that problem.

Consent is a process, and the form is evidence of it

The Code of Ethics of the American Academy of Ophthalmology describes informed consent as "the process of shared decision-making between the ophthalmologist and the patient" that "must precede the performance of medical or surgical procedures." The American Medical Association’s Code of Medical Ethics directs the physician to assess the patient’s ability to understand, to present the diagnosis, the nature and purpose of the recommended intervention, and the burdens, risks and expected benefits of all options including forgoing treatment, and to document the conversation.

The signed form is therefore one piece of evidence about a conversation. A detailed, procedure-specific form signed days before surgery supports the defense. A generic form signed in the preoperative area minutes before the operation supports it far less. The absence of a form does not prove the conversation never took place, and a signature does not prove it was adequate.

Two legal standards, one set of medical facts

States take two broad approaches to how much must be disclosed. Some measure disclosure by what a reasonable physician would tell the patient. Others, following Canterbury v. Spence and, in California, Cobbs v. Grant, measure it by what a reasonable patient would consider material to the decision. In Cobbs the California Supreme Court stated that "the test for determining whether a potential peril must be divulged is its materiality to the patient’s decision."

Which standard governs is a legal question for counsel. Under either one, the medical facts come from the expert:

• the recognized risks of the procedure, how often they occur and how severe they are;
• the reasonable alternatives, including no surgery, and what each would have meant for this patient;
• what ophthalmologists customarily disclose for this procedure;
• whether the patient’s own eye carried added risk that should have changed the discussion; and
• whether the complication that occurred is the risk that was allegedly withheld.

Recurring consent disputes in ophthalmology

• Cataract surgery. An elective operation with a small risk of serious vision loss and a real chance of needing glasses afterward. Disputes involve patients with known added risk, such as a weak lens support system or a prior eye injury, whose consent discussion did not reflect it. See Cataract Surgery Expert Witness.
• Premium lenses. Whether halos, glare and reduced contrast were explained, and whether a conventional lens was presented as a real alternative. See Premium Intraocular Lenses.
• Laser-assisted cataract surgery. What benefit was represented for the added fee. See Laser-Assisted Cataract Surgery.
• LASIK and other refractive surgery. Surgery on a healthy eye, where dry eye, night vision symptoms and corneal weakening are the risks patients say they were not told about. See LASIK Expert Witness.
• Off-label drugs. Bevacizumab injected into the eye and mitomycin C applied during pterygium or glaucoma surgery are accepted off-label uses. Whether the off-label status was mentioned is a common allegation. See Intravitreal Injections and Pterygium Surgery.
• Who operated and who followed the patient. Participation of a resident or fellow, and postoperative care transferred to another provider. The Academy’s Code of Ethics treats postoperative care until recovery as integral to patient management.
• Language, capacity and timing. Whether an interpreter was used and documented, whether the patient had the cognitive ability to decide, and whether the form was signed after sedation had been given.

The evidence of what was said

Beyond the form, the chart may contain a note of the consent discussion, a record that an educational video or brochure was provided, interpreter documentation, and the surgical scheduling notes that show how much time separated the recommendation from the operation. Practice marketing material is relevant when the claim is that the patient was promised a result. Procedure-specific consent forms published by the Ophthalmic Mutual Insurance Company are a useful reference for the risks ophthalmologists commonly disclose. They are a liability carrier’s samples and do not define the standard of care by themselves.

How Dr. Shomer approaches a consent claim

He first identifies the complication that actually occurred and asks whether it is a recognized risk of the procedure. He then compares the consent documents and chart notes with what a careful ophthalmologist discloses for that procedure and that eye, including any patient-specific risk the preoperative examination revealed. Finally he sets out the medical necessity of the procedure and the realistic alternatives, so that the question of what a prudent patient would have decided can be answered on facts. He does not offer an opinion on what a particular patient was told when the record is silent and the testimony conflicts; that is a question of credibility for the trier of fact.

Frequently Asked Questions

Authorities Cited

Primary sources referenced on this page. Links open the source on the publisher’s or agency’s site.

• Cobbs v. Grant, 8 Cal.3d 229 (Supreme Court of California, 1972)
• Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972)
• American Medical Association, Code of Medical Ethics Opinion 2.1.1, Informed Consent
• American Academy of Ophthalmology, Code of Ethics (Rule 2, Informed Consent; Rule 8, Postoperative Care)
• Ophthalmic Mutual Insurance Company, procedure-specific consent forms