Law Review
Informed Consent
What you need to know about the process and your own liability.
PAUL PENG, O.D., J.D.

As the scope of optometry continues to expand, more of us are getting involved in the co-management of patients for their surgical needs. Surprisingly, one of the most overlooked aspects of surgical procedures is the informed consent process.

As this issue will pertain to an increasing number of us, let's take a look at the importance of this documentation process and what we need to know about it.

Needed knowledge

As a co-managing optometrist with any surgeon, you should know the answer to the following questions to minimize post-surgical liability.

• Who conducts the informed consent process? Most states' optometry boards allow any member of the surgical managing team (surgeon or staff, co-managing physician or staff, contracted surgical facility, etc.) to conduct the actual informed consent. However, several states specifically require that the surgeon be a part of the actual informed process, so check with your state medical or optometry board to confirm.
• At what point is the patient considered truly informed? Different states have adopted different standards, but in general you'll find, under the professional and fiduciary responsibilities of a healthcare provider, the patient, if a lucid adult, must receive information covering the following areas:
  • a description of the present illness or the group of abnormalities that might explain the person's complaints or symptoms
  • the nature of further diagnostic or treatment proposals
  • the provider's suggestions as to further diagnostic workup or treatment, along with any alternative(s)
  • the risks inherent in the proposed method(s) and in those that the provider opposes
  • the projected success rate of the proposed method, along with any reasonable alternatives
  • the risks of not doing anything.

When the court's involved

If the informed consent to surgery process is challenged, the court will often apply a subjective standard in determining its validity. It will then examine the actions of whomever performed the informed consent.

To reach a decision, the court often asks the following questions.

• Did the doctor who conducted the informed consent consider the patient's individual condition(s)? The court will look at whether the same risks were emphasized to different patients.
  For example, in a case involving laser-assisted in situ keratomileusis (LASIK), did the doctor explain the chance of an improper flap resulting the same way to a patient with a very steep corneal curvature as to a patient with a normal curvature?
  There's a growing trend within the legal arena where the courts aren't just looking at what was conveyed, but also how it was conveyed.
• Did the doctor act in good faith in trying to convey all relevant issues to the patient preoperatively? The court examines communication between all parties involved in the surgical process to establish good faith. Did the surgeon demonstrate good communication with the co-managing doctor? Are all parties aware of the content of the informed consent? Did all doctors accept the way the consent was obtained? Did the patient have any unaddressed concerns?

Hitting it home

Finally, consider the following:

• The refractive surgery patient. Because refractive surgery is considered elective, the standard of the informed consent process is raised. Therefore, the informed consent may become the central issue during a court challenge.
  Currently, most unhappy refractive surgery patients complain that potential side effects, such as decreased night vision, halos or ghost images, weren't mentioned or were down-played by their doctors. These patients often report that if the outcome they experienced had been disclosed, they would not have chosen to proceed with the surgery.
• The cataract patient. Here's a typical scenario: After detecting the presence of a cataract, you refer your patient to a cataract surgeon who performs surgery. The patient returns to you for post-op management.
  Normally, the informed consent process occurs in the surgeon's office, so you probably wouldn't know the content of the informed consent. But if both patients and the government recognize optometry as an entity that's part of surgical management, then you should play a greater role in the informed consent procedure.

Raise your awareness

Although we're not the actual surgeons, in the eyes of our patients, we are an important aspect of the managing team. Although the surgeon may have performed a flawless procedure, he remains responsible for the wrongful actions of the co-managing doctor (you) after the surgery.

The same relationship is also true for the co-managing doctor. In many states, the co-managing O.D. is held to the same liability as the surgeon. If an unfavorable outcome results from surgery, the patient may seek compensation from both the surgeon and you. So you could be held equally liable for the patient's outcome as the attending surgeon.

Dr. Peng is in private practice in Castro Valley, Calif. He's an assistant clinical professor at the University of California, Berkeley, School of Optometry and is also coordinator of ocular telemedicine and the director of the China Optometric Resource Development Program. He's the director of education at the Pacific Laser Eye Center at U.C. Berkeley as well. In addition, he's also a consultant in various aspects of law involving optometry.