CONTACT LENS LAW

Contact Lens Law: Informed Consent and Extended Wear

Taking the time to obtain informed consent is in the best interest of both your patients and your practice.

By Michael G. Harris, OD, JD, MS, & Robert E. Dister, OD, JD, MS

Dr. Harris is associate dean emeritus, clinical professor emeritus and past-chief of the Contact Lens Clinic at the University of California at Berkeley School of Optometry.

Dr. Dister is an associate clinical professor at the University of California at Berkeley School of Optometry

"It is the patient's right to refuse or consent to a proposed medical procedure and the doctor's duty to provide sufficient information so that the patient can make the decision in an intelligent, knowledgeable manner." This doctrine, known as informed consent, applies to all aspects of patient care and to contact lens practice in particular.

Contact lens practitioners should take the time to obtain informed consent for three reasons. First, patients will be better educated and are less likely to be displeased with the course of treatment because of unrealistic expectations. Second, you will be complying with state law requiring that patients receive the information necessary for an informed consent. Third, you will be better able to mount a legal defense to malpractice charges, if necessary.

State Laws

You can find the law governing informed consent for a particular state either in the court opinions or statutes of that state. Some states have enacted statutes that deal specifically with informed consent, while other states' laws are parts of larger, comprehensive malpractice reform acts or state medical practice acts. In states lacking specific regulations, some general rules have evolved. The courts at various times have determined that a healthcare practitioner must discuss the following items before a patient can give a valid informed consent:

1. Diagnosis.
2. Nature, purpose and benefits of treatment.
3. Risks, consequences and side effects of treatment.
4. Feasible alternative treatments.
5. Probability of success.
6. Prognosis in the absence of treatment.

The relative importance of these items depends upon the procedure involved. For a non-therapeutic contact lens fitting, discussing the diagnosis, nature of treatment, probability of success and prognosis in absence of treatment is a relatively straightforward affair, and none of these items is a likely source of informed consent liability. However, the risk, consequences and side effects are of major concern. Discussing feasible alternatives is often important, especially when fitting extended wear contact lenses because daily wear lenses are a less risky alternative.

No set rule exists as to which risks must be disclosed, but it's often beneficial to look at the seriousness of a risk and the probability of its occurrence. You should disclose an important risk with serious consequences (such as the risk of Acanthamoeba keratitis to a patient making homemade saline). You should also disclose less common risks, both to minimize the possibility of lawsuits and to ensure that patients have realistic expectations about the eventual course of treatment. Patients who suffer a temporary red eye condition due to initial overwear of a contact lens may not sue, but they will not likely return or refer new patients.

The informed consent rule followed in most states is the "patient-based" or "objective" standard, under which the practitioner must disclose enough information for a "reasonable patient" to decide whether to undergo a procedure. This rule is based on the belief that "respect for the patient's right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves." This rule helps a litigating patient because it means that expert testimony isn't necessary to establish the prevailing community standard of care or to show that the patient would not have undergone treatment had an adequate disclosure been made.

With limited exceptions, only an adult who is competent to understand the proposed treatment and its risks and benefits can give a valid informed consent. If the patient is a minor (usually defined by state law as someone less than 18 years of age), a parent or the minor's court-appointed guardian normally must give the informed consent.

Injury to Persons Other Than the Patient

A practitioner may be liable to persons with whom he has no special relationship and whom he has never met. For example, a pedestrian who is injured by an inadequately informed monovision contact lens wearer who is driving with compromised vision may sue the contact lens practitioner. If the patient has no liability insurance, the practitioner and malpractice carrier offer a convenient "deep-pocket" target for the injured party.

Disclosure of Practitioner-specific Information

Recent court cases in some states have found it a duty to disclose practitioner-specific information as part of informed consent. For example, the Supreme Court of the State of Wisconsin found that a practitioner's own experience level in performing a particular procedure, as well as success rates when the procedure was performed by practitioners who have more experience, were relevant to an adequate informed consent agreement. The Louisiana Court of Appeals held that a doctor's failure to disclose his history of alcoholism negated a patient's consent to a medical procedure. The California Supreme Court ruled that an informed consent cause of action was created by a doctor's failure to inform his patient of research and economic interests that could affect his medical judgment.

These cases indicate that in some states, it may be necessary for a practitioner to disclose information such as his own medical history, lack of experience in the procedure or possible financial benefit from a patient's willingness to undergo the procedure. However, courts in other jurisdictions have held that there is no duty or only a very limited duty to disclose such information. Because the law in this area of informed consent is unsettled, practitioners should consult an attorney familiar with the laws of their particular state.

Informed Consent and Malpractice

We'd like to emphasize that although an action for negligent nondisclosure under the informed consent doctrine is similar to one for malpractice, the two are actually different and will usually be pleaded as separate counts within a single complaint. In some circumstances, a practitioner might be liable for failure to disclose but not liable for malpractice. A properly fitted and instructed contact lens patient who loses vision because of a corneal ulcer might lose a malpractice action but prevail on a negligent nondisclosure action under the theory that he wouldn't have opted for contact lenses if informed of the risk of ulcers.

Informed Consent Documentation

Although there's no legal requirement that an informed consent be written or videotaped, it's in your best interest to have a permanent record of the consent. Otherwise, a patient's word will be weighed against your word, and juries are often inclined to favor a sympathetic, injured patient over a seemingly wealthy doctor and his insurance company.

A written or videotaped record also serves to emphasize the importance of your warnings to the patient. Studies have shown that patients often remember only a small part of what practitioners tell them. Likewise, a practitioner's recall of what was said may also be faulty. A written or videotaped record prevents this difficulty.

Print your written consent form in language that is clear and free of optometric terminology and jargon. Limit it to matters pertinent to the proposed treatment. Don't include clauses in which patients appear to waive legal rights, and avoid language and other legal "boilerplate" that appear to relieve you of liability. Such wording has little or no legal effect and may bias a jury against you.

Ask each patient whether he understands everything that was discussed and whether he has any questions. Document this discussion in the patient's permanent record. A written informed consent should be signed by the patient, although it need not be witnessed. Store the signed informed consent form in a safe place until the applicable statute of limitations expires.

Although printed forms are probably the most common means of documenting warnings, they aren't conclusive proof of a valid informed consent because the patient can assert that the warning wasn't explained in a manner that resulted in true understanding. To avoid this potential pitfall, some clinicians and investigators use video presentations and video recording to present information and to document the obtaining of an informed consent. Video documentation is especially advantageous for patients who may have difficulty reading and understanding a printed form due to visual impairment or limited education. Be sure to obtain the patient's permission for videotaping, either in writing or on the video recording itself.

Application to Extended Wear Contact Lenses

In no aspect of eyecare practice is informed consent more important than in fitting extended wear contact lenses. Studies have shown that the possibilities of corneal infections and corneal ulcers are significantly greater in extended wear patients than in daily wear patients. Other corneal complications are also more likely when patients wear lenses on a 24-hour basis, especially if worn for weeks at a time.

During the pre-fitting evaluation, take a thorough case history and discuss with each patient the general risks and benefits of contact lenses. Also discuss the possible alternatives and their likely prognosis. If a patient's likelihood of success is remote, advise him that he can intelligently decide whether to proceed with the contact lens fitting.

You have a legal obligation to advise a patient of pre-fitting borderline findings even before contact lenses are placed on the patient's eyes. If you discover any abnormalities or questionable results, advise the patient of the findings and their possible implications. Also advise the patient of possible additional testing that could rule out or confirm the tentative diagnosis.

Advise patients interested in contact lenses of the relative advantages and disadvantages of soft and GP lenses based on each patient's individual situation. It's prudent to consider the patient's vocation, avocation, refractive error, keratometer readings and ocular health in determining the appropriate lens type. If several lens types seem appropriate for a particular patient, advise him so that you and he can decide which of these options best suits the patient's needs.

If a patient is interested in extended wear contact lenses, thoroughly advise him of the potential risks and benefits of extended wear lenses compared to daily wear lenses prior to the fitting. Also advise patients being fitted with extended wear lenses of the risks and benefits of seven-day versus 30-day wear. Provide a suitable initial wearing schedule to the patient, and advise him that the actual period of wear may be significantly less than the wearing period approved by the Food and Drug Administration for that particular lens.

Advise all patients fitted with any type of contact lens that the lenses must be replaced at the recommended time. Recommending that patients keep lenses for a longer period than what's specified in the packaging instructions could be considered evidence of negligence on your part. Emphasize the importance of proper cleaning and disinfection when patients remove their lenses. Inform all contact lens patients of the necessity of regular follow-up evaluations. Only when patients have this vital information can they give informed consent to be fitted with extended wear contact lenses.

Specialty Lenses

Specialty contact lens fitting represents another area where informed consent can play an important role.

Contact Lenses for Presbyopia Counsel presbyopes seeking a contact lens correction for their refractive condition as to the risks and benefits of the various types of contact lenses suitable for their needs. These include monovision, bifocal/multifocal contact lenses, distance contact lenses with reading glasses, modified monovision correction or bifocal spectacles.

Warn patients fitted with monovision or bifocal/multifocal contact lenses of the potential vision compromises associated with wearing these lenses compared to spectacle bifocal correction. Because correction with monovision and most bifocal and multifocal contact lens designs compromises binocular vision, you must advise patients that depth perception and peripheral vision may be reduced. These types of vision reductions can be especially important when driving or operating industrial equipment during which acute binocular vision is important.

Before dispensing a monovision or bifocal/multifocal contact lens correction to a patient, it's prudent to allow the patient to wear the lenses in the controlled environment of your office to determine how well he responds to this vision correction. Any significant adverse response would indicate that the patient is not an appropriate candidate for that type of contact lens.

Contact Lenses for Astigmatism When fitting toric and bitoric lenses, advise patients of the additional cost and time involved with these types of correction. Patients need to know what alternatives are available so they can help choose the appropriate lens modality.

Tinted Contact Lenses Tinted contact lenses pose another area of concern, especially when the color portion of the lens covers the pupil. These lenses can cause decreased night vision, thus affecting a patient's ability to drive and walk safely. Patients fitted with such lenses need to be advised of this problem so they can choose whether to wear lenses under dark-illumination conditions.

Therapeutic Lenses Patients who have corneal pathologies such as bullous keratopathy and recurrent corneal erosion often attain improved vision and comfort with therapeutic extended wear soft contact lenses. Because patients who have corneal pathology generally have compromised corneas, thoroughly advise them as to the risks and benefits of contact lenses as well as about alternatives to contact lens therapy.

Conclusion

The legal doctrine of informed consent is extremely important in contact lens practice, but unfortunately many practitioners overlook it. Such oversights can be detrimental to both patient and practitioner. The procedures for informed consent are straightforward and relatively simple to apply. When you have your patients' best interest in mind, informed consent is a natural part of contact lens practice. Only by careful attention to the requirements of informed consent can you provide patients with the information they need to make an intelligent decision about wearing contact lenses. Failure to comply with informed consent requirements will undoubtedly be a major source of liability for contact lens practitioners in the future. CLS