People's Law Guide
Paul M. Silva, MD JD
Introduction Refractive surgery was invented in the early 1970s by Vyataslov Fyodorov, a Russian Ophthalmologist. He discovered that the vision improved in a patient who had his cornea accidentally cut. Since then, there has been a tremendous revolution in the delivery of refractive eye care in the United States. This phenomenon has occurred as a result of increased patient demand for better alternatives to vision correction. It is also fueled by the need for eye doctors to maintain their income levels in the face of declining reimbursements and dominance of managed care. After the FDA (Federal Drug Administration) approved PRK (Photorefractive Keratotomy) in 1995, corporations were formed to own expensive lasers, ophthalmologists forged relationships with Optometry referral networks, and optometrists began managing refractive patients after surgery.
History of Refractive Surgery
Refractive surgery has evolved since its inception. First, RK (Refractive Keratotomy) was introduced in the 1980's with mixed results.1 The surgery anatomically weakened the cornea, the results regressed, and there were problems with predictability, scarring, infection, and surgeon acceptance. Then, PRK was approved by the FDA in 1995. This surgery involved scraping off the outer layer of the cornea and applying laser treatment to the underlying tissue.2 The surgery was limited by patient discomfort and risks of scarring, but it is much more predictable and stable than RK.3 PRK was rapidly followed by LASIK because LASIK allows for a less painful and quicker postoperative recovery. Essentially, LASIK involves creating a flap of tissue off the top of the cornea with a blade, placing the laser treatment in the corneal bed, and finally replacing the flap to its original position4. This is a technically demanding surgery. The surgeon must master creating the flap and placing the laser treatment in the appropriate area. Otherwise, a myriad of complications can occur.
Marketing of Refractive Surgery
Unfortunately, as is often the case with a new procedure in medicine, eye surgeons can be "certifed" to perform the procedure at a weekend course. For example, the majority of eye surgeons receive their PRK certification by paying 0 and attending a few hours of lectures on a Saturday and by lasering a few pig's eyes in a wet lab on Sunday. This is the typical experience. Some surgeons do specialize in refractive surgery and follow a more experienced surgeon for a certain amount of time to gain more experience, but this is the exception. Similarly, to become "certified" in LASIK, most surgeons take a weekend course for approximately 00. On Saturday, a few hours of lectures on the technicalities of the procedure are given and on Sunday the surgeon cuts a few pig's eyes with the microkeratome, which is the blade used to make the cap before the laser is applied. When eye surgeons combine inadequate training with the financial pressure to succeed, standards of quality and sterility are compromised. The results are an unhappy patient.
The marketing programs eye practices use can be very aggressive. The laser companies that are national and owned by investors tend to have more cash available for aggressive marketing. It is not uncommon for a marketing program to consist of free screenings, "live surgery" observation, videotapes, brochures, radio advertising, television advertising, and print advertising. These are very expensive, which can result in certain companies and doctors downplaying any potential complications.
The normal reimbursement for LASIK is about ,000 per eye. If the surgeon co-manages the patient with an optometrist, the co-management fee can vary from 0 to 0 per eye. Add to that Pillar Point royalties of 0 per eye on each procedure which are paid to the laser manufacturers. In addition, add a few hundred dollars per eye for marketing costs and it becomes evident why surgeons have to do a high volume of cases to make the endeavor worthwhile.
Hence, there is an economic incentive to cut costs to increase profit margins. There have been reports of laser centers reusing the blades for the microkeratome because each blade is to be used only once and costs around a piece. Other activities which are unethical include high volume surgeons who will meet the patient for the first time on the operating room table, co-management of patients with optometrists for postoperative care, and co-management with optometrists or ophthalmologists who do not do surgery for preoperative care. The last issue is the most worrisome. The laser is dependent on a very careful and precise measurement of the desired correction. If this procedure is done carelessly, then the data fed into the laser results in a sub optimal result. Trash in, trash out.
I will now discuss the various remedies to combat overly aggressive and unethical marketing in the realm of refractive surgery. They are limited to a discussion of Florida law. However, the reader is likely to discover an analogous statute in his or her state. The Florida Statutes, Chapter 456.062, requires that a health care practitioner who advertises a free or discounted service, treatment, or examination post the following statement in capital letters clearly distinguishable from the rest of the text: THE PATIENT AND ANY OTHER PERSON RESPONSIBLE FOR PAYMENT HAS A RIGHT TO REFUSE TO PAY, CANCEL PAYMENT, OR BE REIMBURSED FOR PAYMENT FOR ANY OTHER SERVICE, EXAMINATION, OR TREATMENT THAT IS PERFORMED AS A RESULT OF AND WITHIN 72 HOURS OF RESPONDING TO THE ADVERTISEMENT FOR THE FREE, DISCOUNTED FEE, OR REDUCED FEE SERVICE, EXAMINATION, OR TREATMENT.5 Failure to do so may result in a disciplinary investigation by the Board of Medicine. In addition, the Agency for Healthcare Administration who oversees the Board of Medicine in Florida states under Florida Statutes Chapter 458.331(d) that false, deceptive, or misleading advertising is grounds for disciplinary action by the Board of Medicine6. Florida Statutes Chapter 458.331(w) also provides for disciplinary actions for delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or had reason to know that such person is not qualified by training, experience, or licensure to perform them7. In Florida, Chapter 725 addresses unenforceable contracts and specifically, Florida Statute 725.01, states that "no action shall be brought whereby to charge the defendant to answer for a debt whereby to charge any health care provider upon any guarantee, warranty, or assurance as to the results of any medical, surgical, or diagnostic procedure performed by any physician, unless the agreement or promise upon which such action shall be brought, or some note or memorandum thereof shall be in writing and signed by the party to be charged therewith or by some other person by her or him there unto lawfully authorized"8. So there is no cause of action against a health care provider unless the physician or an employee signs a memo, consent form, or any promotional material. So, a consent form that guarantees a result, which is signed by the surgeon or employee can be used as evidence of a guaranteed result. The complications that can arise from refractive surgery range from the most negligible to loss of the eye9. These patients are generally young or middle aged and gainfully employed. Informed consent is the cornerstone of an educated patient. That is, a patient who has a reasonable understanding of the types of complications and the likelihood of a complication. However, optometrists or patient representatives and not the surgeon commonly provide informed consent to the patient. In Florida, under Florida Statutes Chapter 766.103(4)(a), "a consent which is evidenced in writing and meets the requirements that a reasonable individual, under the circumstances would have a general understanding of the procedure, the medically acceptable alternatives and procedures, and the substantial risks and hazards inherent in the proposed treatment or procedures which are recognized by other physicians, or the patient would have undergone the procedure anyway if advised by the physician, if validly signed by the patient or another authorized person, raise a rebuttable presumption of a valid consent10". There is a case in Florida that indirectly discusses informed consent and warranties by health care practitioners. In PUBLIC HEALTH TRUST OF DADE COUNTY v. VALCIN, 507 So.2d 596, (Fla.1987), the patient and her husband brought an action against a public hospital after she suffered a ruptured ectopic pregnancy one and one half years after the hospital staff performed a tubal ligation on her11. Valcin sued petitioner on the grounds that its agents had 1)breached an alleged warranty as to the effectiveness of the operation, 2) failed to obtain a truly informed consent, and 3) negligently performed the operation. With regards to the allegation of an oral warranty that the procedure would result in sterility, The Supreme Court of Florida decided that even though Valcin signed a Consent form and a "Consent for Authorization for Sterilization"13, the forms did not expressly discuss risks of an ectopic pregnancy. The Valcin Court held that a consent which is evidenced in writing and meets the requirements of subsection (3) of Section 768.46, which has been modified and renamed Chapter 766.103-Florida Medical Consent Law, shall, if validly signed by the patient or another authorized person, raise a rebuttable presumption of a valid consent14. Finally, the Valcin Court held that upon remand to the trial court, Valcin "will be required to establish through expert testimony the information which should have been conveyed to her under the circumstances"15. In summary, the Florida Medical Consent Law states that a health practitioner is not liable for invalid informed consent if: 1) consent is in accordance with the accepted standard of medical practice among members of the medical community with similar training and experience, and 2) a reasonable individual from the information provided by the physician would have a general understanding of the procedure, alternatives, and substantial risks and hazards inherent in the procedure which are recognized by physicians in the in similar communities who perform similar procedures, or 3) the patient would reasonably, under all the surrounding circumstances, have undergone the procedure16. Therefore, each informed consent should be carefully examined. Did the surgeon sign the form? When did the patient sign the form? Did the patient have all of her questions answered? Were all the foreseeable complications discussed? Was the patient made aware of all "substantial risks"? This would include complications that have more recently been seen in the medical literature. These include corneal wrinkling with irregular astigmatism, star-bursting and halos around lights at night from a large pupil in dark light, corneal ectasia secondary to a corneal bed with is too thin to name a few17. Generally, corneal wrinkling can occur if the corneal flap is not checking regularly after the procedure18. All patients should have their pupil size measured in dim light19. If the pupil is greater than 7mm in size, only part of the seeing part of the cornea will be treated by the laser, resulting in severe blurring of lights and moving objects at night20. Finally, corneal ectasia is a severe complication, which can necessitate a corneal transplant21. This results from making the flap too thick in a cornea that is not very thick, resulting in a forward bowing of the cornea and poor vision. Certainly, general negligence is the most effective remedy for these unethical behaviors when they fall below the standard of care that a similar health care provider would render under the circumstances. In addition to disciplinary actions, the health care provider may be liable for medical malpractice if his care of the patient falls below the generally accepted standard of care and those actions cause damages. This brings us to another important point. Although, surgical results are measured by visual acuity, this is an arcane form of measuring visual potential. Visual acuity is measured in the controlled environment of dark examination room with black letters on a white surface. Real world conditions such as sunlight, glare, shade, reflections, motion affect vision and are not accounted for in a visual acuity measurement. Therefore, a patient may have 20/20 vision in the office and be considered a perfect result, but have difficulty driving a night from glare or halos around light. Vision is a subjective measurement and it is difficult to convey to another individual the experienced symptoms. This presents a major challenge in quantifying damages in a LASIK case. However, there are new methods being developed which simulate postoperative vision for different complications. In addition, corneal topography machines, which map the surface of the cornea, are very effective at illustrating irregularities in shape and contour of the cornea. Finally, overly aggressive and misleading marketing can be used in the litigation of a LASIK case, which meets the requirements of negligence, causation, and damages, to imply that the surgeon acted below the standard of care in the recruiting, screening, and treatment of the LASIK patient.
End Notes 1 .F.A. L'ESPERANCE, OPHTHALMIC LASERS (3rd ed. 1989). 2 .HAROLD L. STEIN, ET AL, THE EXCIMER, FUNDAMENTALS AND CLINICAL USE, 64-66 (Slack Incorporated 1994). 3 .Id. at 75-78. 4 .Id. at 151. 5 .FLA.STAT.ch.456.062(2000) 6 .FLA.STAT.ch.458.331(d)(2000) 7 .FLA.STAT.ch.458.331(w)(2000) 8 .FLA.STAT.ch.725.01(2000) 9 .J.S. PANNU, Incidence ant Treatment of Wrinkled Corneal Flap Following LASIK, 23 J. CATARACT AND REFRACTIVE SURGERY 695 (1997). 10 .FLA.STAT.ch.733.103(4)(a) 11 .PUBLIC HEALTH TRUST OF DADE COUNTY v. VALCIN, 507 So.2d 596, (Fla.1987) 12 .Id. at 597. 13 .Citing Thomas v. Berrios, 348 So.2d 905 (Fla.2d DCA 1977) 14 .PUBLIC HEALTH TRUST OF DADE COUNTY v. VALCIN at 599. 15 .Id. at 598. 16 .FLA.STAT.ch.766.103(2000) 17 .John R. Wright, DO, LASIK Myths, Ocular Surgery News, 29-30, 30(August 1, 2000) 18 .Id. 19 .Id. 20 .Id. 21 .Id.