Risk Management

Liability Risks Associated with PRK and the Excimer Laser

By Jean Hausheer Ellis, MD, Richard L. Abbott, MD, Dean C. Brick, MD, and Paul Weber, JD

Digest, Fall, 1996

When the FDA approved the excimer laser for photorefractive keratectomy (PRK) in fall 1995, it opened the door to new liability risks for ophthalmology. Given the elective nature of PRK, the high expectations of patients, and the general public’s misconceptions about refractive surgery, there is significant potential for malpractice claims, particularly as more ophthalmologists incorporate this new technology into their practice. This article discusses some of the “patient-centered” risk management issues that arise with PRK and provides guidelines to help ophthalmologists reduce the likelihood of a claim and better defend claims when they do arise.

Informed Consent and Documentation

Informed consent has evolved into a complex process for the ophthalmologist and patient considering PRK. The ophthalmologist and office staff must counsel and answer prospective patients’ questions. Patients must review patient education booklets and videos, decide between alternative refractive procedures and, if choosing to have PRK, review a long informed consent document. Time spent educating patients and discussing the procedure is well worth the effort, however, as patients who are educated before surgery will be less anxious about the procedure and more likely to have appropriate expectations.

FDA approval of the excimer laser came with a number of conditions concerning patient education and the informed consent process. Under the FDA mandate, as soon as a prospective patient expresses an interest in myopic PRK and prior to undergoing surgery, the patient must first read a patient information booklet. Summit and VISX, the two companies approved to manufacture the excimer laser, explicitly state or infer in their patient education booklets that the patient “should discuss the contents of the booklet with their doctor.” The fact that the prospective patient received this booklet should be documented in the patient’s chart. After the patient has read the booklet, the physician should record any discussion or questions regarding the booklet that the patient had. These booklets cannot be altered or misrepresented in any way and should be used as tools to begin the consent process. Although, the Summit and VISX booklets contain similar information regarding PRK, the patient must be given the correct booklet for the “brand” of excimer laser that will be used. Since PRK patients typically are dilated in the ophthalmologist’s office, it is best to suggest that they take home the required patient information booklet and informed consent documents to read when their eyes are undilated.

The FDA also mandates that, prior to undergoing surgery, prospective patients be informed of the alternatives for correcting their myopia, including eyeglasses, contact lenses, and other refractive surgeries such as radial keratotomy. Although not mandated by the FDA, it is prudent to discuss LASIK and other alternative refractive procedures (“next generation” lasers, “corneal ring,” etc.) with patients who may be appropriate candidates for these emerging procedures. Failure to discuss the alternatives to PRK may be viewed as a breach of the ophthalmologist’s duty to properly inform the patient prior to performing a procedure.

OMIC strongly suggests a separate consent document for PRK. However, informed consent for PRK is not simply the signing of a legal document; it is an ongoing process of information sharing and decision making between the surgeon and patient throughout the treatment process. It involves the surgeon discussing with the patient the key risks of the procedure. These include the fact that the long-term risks of PRK beyond three years are unknown; the procedure is irreversible; and there is the possibility of undercorrection, overcorrection, haze, glare, and astigmatism or inducement of it, as well as loss of best corrected vision and the remote chance of partial or complete loss of vision.

Undercorrection in the range of 20/40 and overcorrection should be demonstrated to the patient with an accompanying note in the record verifying the patient’s willingness to accept an outcome of less than 20/20.

Issues surrounding presbyopia should be explained and demonstrated to patients in the office prior to surgery. This may include the option of monovision. Some experienced PRK surgeons may elect to operate on the dominant eye first as a means of allowing the patient a “trial” period of monovision for a month. Monovision can be simulated prior to surgery by having the patient experiment with disposable contact lenses with monovision power options. The ophthalmologist should document that monovision was demonstrated and discussed with the patient.

Other side effects may be transient but still should be discussed with the patient. These include the possibility of some pain or mild discomfort 24 to 48 hours postoperatively and anisometropia, which can either be induced by PRK or become a temporary problem during the recommended interval between eyes. Surgeons may want to reassure patients that a temporary refractive contact lens in the unoperated eye can help during the potentially awkward time between surgeries.

Ideally, it is suggested that the physician make a brief contemporaneous note indicating that the informed consent discussion took place and that the patient appeared to understand. However, a preprinted statement to this effect in the informed consent document that the physician signs also will suffice. In all cases, it is important that the following be set forth in the informed consent document:

• The recommended procedure, risks, alternatives, and complications were discussed with the patient.
• The patient’s questions were answered and the patient seemed to have a clear understanding of what was discussed.
• No guarantee as to outcome was suggested to the patient.

You can receive a copy of OMIC’s sample Confirmation of Informed Consent for Photo- refractive Keratectomy by faxing your request to 415-771-1810.

Marketing and Advertising Issues

Marketing and advertising of PRK are monitored and regulated by the Federal Trade Commission (FTC). Aside from spawning regulatory investigations by the FTC, improper advertising can adversely impact the informed consent process and create indefensible malpractice claims against surgeons and referring optometrists in comanagement situations. The FDA-mandated guidelines on marketing and advertising of PRK are described to surgeons in PRK certification courses; however, the FTC and FDA continue to update their regulations on PRK and “off-label” issues. These changes occur frequently and are often quite specific and detailed.

The FDA also has stated that discussion of the safety or efficacy of the laser in promotional materials must include sufficient information about the risks and limitations of the procedure. Furthermore, if “material information” is omitted in promotional materials, the ophthalmologist may be subject to scrutiny by the FDA. Common improper promotional statements include the following:

• Claims that cannot be substantiated. “Over 300,000 patients have successfully undergone PRK.” No one knows how many patients have had PRK and certainly no one knows the “success” of these thousands of surgeries.
• Claims that the procedure is “safe and effective.” This is basically guaranteeing that there will be no side effects or complications and that the patient will be corrected to 20/20 every time.
• Claims that patients can throw away their glasses or contacts after the procedure. Patients may need reading glasses and/or spectacles to correct small amounts of over- or undercorrection postoperatively.

Some aggressive marketing consultants are persuading ophthalmologists to use such claims in their advertising to get prospective patients to call the office or come in for an appointment. Even if the patient is given the correct information about the procedure during the appointment, a lawsuit can nonetheless arise. Jurors evaluate the credibility of the ophthalmologist and will take into account that the physician may have made misleading statements in advertising and marketing to get the patient in the door.

Comanagement Issues

Advertising and marketing within comanagement networks may lead to situations where one comanaging partner will be held accountable for improper promotion by the other. For example, a comanaging optometrist may state that all the ophthalmologists he refers to are “board certified refractive surgeons.” This is misleading since there is no board certification for refractive surgery, and in fact, some of the ophthalmologists referred to may not even have taken or passed their boards in ophthalmology. In such cases, it is imperative that the ophthalmologist confront the comanaging partner or entity about such statements. The public perceives the comanaging team as a partnership since everyone shares in the profits arising from the refractive surgery and all are involved in caring for the patient. Naturally, the public also will assume that the ophthalmologist benefits from the marketing efforts of other members of the comanagement team and is therefore responsible if there are misleading statements in their ads.

Good communication is essential to proper comanagement. Optometric comanagement in refractive surgery is a constantly evolving process requiring a commitment to regular and timely communication, orally and in writing, among all members of the professional eye care team. Fax or telephone communication is acceptable but, in either case, it must be documented that such communication took place. It is important that all members of the team agree upon and adhere to standardized guidelines and protocols concerning the preoperative, operative, and postoperative care and management of patients undergoing excimer laser surgery.

The ophthalmologist must personally verify and document that the comanaging optometrist has the requisite education, training, and skill to follow postoperative refractive patients and that such care is within the optometric scope of practice. Otherwise, the ophthalmologist may be exposed to claims of negligent referral if the optometrist is later shown not to have the skills to follow these postoperative patients.

The outcome of the PRK procedure is permanently and profoundly affected by the postoperative pharmacologic care of the patient. Referring optometrists must be able to describe and quantify haze in a meaningful and standardized manner when conferring back with the ophthalmologist so changes in medication can be implemented in a timely fashion. Online computerized technology and computerized corneal topographical mapping should serve to enhance communication in this area between comanaging doctors.

Finally, since optometry is sharing enhanced potential liability in the delegation of postoperative management of PRK patients, the ophthalmologist should be certain that comanaging optometrists carry appropriate malpractice coverage with sufficient limits so the ophthalmologist does not become the “deep pocket” when a claim arises.

Off-Label Use of the Excimer Laser

Off-label use of the excimer laser is becoming more common. Some of the more prevalent off-label uses of the excimer laser include:

• Fewer than three months interval between surgery on each eye.
• Use of a bandage contact lens postoperatively to enhance patient comfort.
• Treatment alternatives for astigmatism and myopia greater than the FDA-approved amounts.
• Bilateral simultaneous PRK.
• Laser assisted in-situ keratomileusis (LASIK).

There are many technological and pharmacological applications for PRK that have not completed U.S. clinical trial studies, but which make good sense clinically and scientifically and are accepted as the standard of care in the community. The patient who could benefit by off-label use of the excimer laser should be educated to understand that the off-label procedure is used by surgeons to improve patient comfort, visual recovery, and satisfactory results following surgery. If the necessary steps are taken to properly inform the patient about the nature of the changes to the underlying PRK procedure, many off-label procedures can be done without fear of substantially increasing liability exposure.

In addition to general PRK patient information materials, the nature and extent of the information given to the patient regarding the off-label procedure depends upon what is to be done. If you are using a bandage contact lens in the postoperative period, a note in the record that you discussed the risks, benefits, and alternatives of using the contact lens should be sufficient. However, if you are planning to perform LASIK, a much more thorough, in-depth discussion, education, and documentation process is necessary so the patient is properly informed that this is an excimer laser procedure that has not been approved by the FDA. This information can be presented in a non-threatening manner; however, it is essential that the patient understand the difference between FDA-approved PRK procedures and off-label procedures that are considered “practice of medicine.”

For an off-label procedure such as LASIK, a separate informed consent document should be created tailored to the risks and benefits of this procedure. Other variations on FDA-approved PRK may warrant only an addendum to the standard PRK document to confirm that the patient understands that some aspect of the procedure and treatment course has not been approved by the FDA. OMIC has developed a number of suggested clauses that can be inserted into a standard informed consent document to address certain off-label uses of the excimer laser. Please fax your request for these suggestions to the Risk Management Department at 415-771-1095.

Finally, before performing an off-label use such as LASIK or bilateral simultaneous PRK, contact your professional liability insurance carrier to ascertain if your policy will cover off-label refractive procedures and what restrictions your carrier may place on your performance of these procedures.

Conclusion

PRK surgery and other uses of the excimer laser can be successfully defended in court provided the surgeon approaches the procedure responsibly and with concern for the patient’s best interests. To help ensure that claims are defensible, guidelines and protocols for refractive procedures and care of the patient should incorporate risk management principles as discussed in this article. OMIC insureds who are considering performing PRK surgery are encouraged to contact the Underwriting Department for further information on PRK coverage.