BMC Ophthalmol. 2006 Apr 28;6(1):19 

Dada T, Pangtey MS, Sharma N, Vajpayee RB, Jhanji V, Sethi HS. 

ABSTRACT: 

BACKGROUND: Diffuse lamellar keratitis (DLK) is a relatively new syndrome that is increasingly being reported after LASIK. We have observed that a hyperopic shift may be associated with the occurrence of this diffuse lamellar keratitis. 

CASE PRESENTATION: A 26 year old man developed bilateral diffuse lamellar keratitis (DLK) following myopic LASIK. The residual refractive error was +0.5D OD and +0.25D OS at the end of the first week. The sterile infiltrates resolved over a period of 4-6 weeks on topical steroid therapy. A progressive hyperopic shift was noted in the right eye with an error +4.25Dsph/+0.25Dcyl 20 at the final follow up 6 months post surgery. 

CONCLUSION: Diffuse lamellar keratitis after LASIK may be associated with a significant hyperopic shift.

Dr. William Trattler asks that patients lobby against contact lenses

http://asklasikdocs.com/forum/other/106.html

 "LASIK question" Posted by William B. Trattler, MD

Excerpt: "My last comment is to inform some of the LASIK bashers that one of the alternatives to LASIK - contact lenses - can also be a serious health risk to the eye. As a cornea specialist, I take care of contact lens-associated corneal infections on a daily basis. Many patients in the United States go blind every day from the use of contact lenses (especially when patients sleep in them). So please also lobby against the use of contact lenses if you want to reduce the risk of eye injury in the U.S.".

Bill Trattler, MD

Miami,FL

For the latest news on contacts:

http://www.lasiksucks4u.com/index.php?option=com_content&task=blogcategory&id=37&Itemid=60

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15604873&query_hl=13

Cornea. 2005 Jan;24(1):92-102. Related Articles, Links

Pathologic findings in postmortem corneas after successful laser in situ keratomileusis.

Kramer TR, Chuckpaiwong V, Dawson DG, L'Hernault N, Grossniklaus HE, Edelhauser HF.

Emory Eye Center, Emory University, Atlanta, GA 30322, USA. Theresa_Kramer@emoryhealthcare.orgTheresa_Kramer@emoryhealthcare.org

PURPOSE: To examine the histologic and ultrastructural features of human corneas after successful laser in situ keratomileusis (LASIK).

METHODS: Corneas from 48 eyes of 25 postmortem patients were processed for histology and transmission electron microscopy (TEM). The 25 patients had LASIK between 3 months and 7 years prior to death. Evaluation of all 5 layers of the cornea and the LASIK flap interface region was done using routine histology, periodic acid-Schiff (PAS)-stained specimens, toluidine blue-stained thick sections, and TEM.

RESULTS: In patients for whom visual acuity was known, the first postoperative day uncorrected visual acuity was 20/15 to 20/30. In patients for whom clinical records were available, the postoperative corneal topography was normal and clinical examination showed a semicircular ring of haze at the wound margin of the LASIK flap. Histologically, the LASIK flap measured, on average, 142.7 microm (range, 100-200). A spectrum of abnormal histopathologic and ultrastructural findings was present in all corneas. Findings at the flap surface included elongated basal epithelial cells, epithelial hyperplasia, thickening and undulations of the epithelial basement membrane (EBM), and undulations of Bowman's layer. Findings in or adjacent to the wound included collagen lamellar disarray; activated keratocytes; quiescent keratocytes with small vacuoles; epithelial ingrowth; eosinophilic deposits; PAS-positive, electron-dense granular material interspersed with randomly ordered collagen fibrils; increased spacing between collagen fibrils; and widely spaced banded collagen. There was no observable correlation between postoperative intervals and the severity or type of pathologic change except for the accumulation the electron-dense granular material.

CONCLUSIONS: Permanent pathologic changes were present in all post-LASIK corneas. These changes were most prevalent in the lamellar interface wound. These changes along with other pathologic alterations in post-LASIK corneas may change the functionality of the cornea after LASIK.

DR. BILL TRATTLER THINKS SO!

We now know that corneal nerve damage from refractive surgery causes dry eye, and that this nerve damage was found to increase between years 2-3 post LASIK to over 40% loss of corneal nerve density, according to a recent study at the Mayo Clinic:

Dr. Trattler is aware of these findings, but claims that certain palliatives can treat “even the worst dry eye patients after LASIK”:

“We have also shown (in a study I collaborated with Dr. Tseng on) that warm compresses along with other therapies can treat even the worst dry eye patients after LASIK. We took patients from other centers that had failed therapy, and were able to dramatically improve their dry eye state. The study ended 18 months ago, and these patients have done great even since the study end. Part of that is because dry eye is s cycle - so breaking the cycle (with Restasis pre-surgery or other therapies after surgery) can significantly help dry eye after LASIK, and can allow patients to get off Restasis after a number of months.”

Bill Trattler, MD - Miami, FL

Perhaps Dr. Trattler needs to hear from some folks on disability and/or in goggles from their LASIK dry eye.

The asklasikdocs forum is free to join if you care to comment

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15502488&dopt=Abstract

PURPOSE: To report a patient with a past history of LASIK who had decreased vision and induced corneal steepening after lower eyelid ptosis. Surgical correction of lower eyelid ptosis decreased the corneal steepening and improved visual acuity.

METHODS: Interventional case report. RESULTS: A 37-year-old woman had a history of bilateral LASIK, childhood strabismus surgery, and multiple surgeries to release scarring and improve motility in her left eye. Last surgery to release scar tissue resulted in reverse ptosis (lower eyelid ptosis) and decreased visual acuity from induced corneal steepening. Correction of lower eyelid ptosis by reinsertion of the retractor complex resulted in decreasing corneal steepening, improved visual acuity, and good anatomic position of the lower eyelid.

CONCLUSION: Lower eyelid ptosis may induce corneal steepening and decreased vision after LASIK.

Surgical correction of ptosis can decrease the extent of steepening and improve visual acuity.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16129288&query_hl=26

J Cataract Refract Surg. 2005 Aug;31(:1537-43.

Garamendi E, Pesudovs K, Elliott DB.

Department of Optometry, University of Bradford, Richmond Road, Bradford, West Yorkshire, United Kingdom. e.garamendi2@bradford.ac.uk

PURPOSE: To measure quality of life (QoL) outcome in prepresbyopic myopic patients having laser in situ keratomileusis (LASIK) refractive surgery using the Quality of Life Impact of Refractive Correction (QIRC) questionnaire and to compare the QoL of preoperative patients with a sample of spectacle and contact lens wearers not considering refractive surgery.

SETTING: Department of Optometry, University of Bradford, Bradford, and Ultralase, Leeds, West Yorkshire, United Kingdom.

METHODS: The validated QIRC questionnaire was prospectively completed by 66 patients before and 3 months after LASIK. Patients had myopia greater than 0.50 diopters (D) (range --0.75 to --10.50 D) and were aged 16 to 39 years. Patients were also directly asked to evaluate their QoL after surgery.

RESULTS: Overall QIRC scores improved after LASIK from a mean of 40.07+/- 4.30 (SD) to 53.09+/- 5.25 (F(1,130)=172.65, P<.001). Greater improvements occurred in women (53.83+/- 5.46) than in men (49.39+/- 5.94; F(1,64)=9.37, P<.005). Overall, 15 of the 20 questions (especially convenience, health concerns, and well-being questions) showed significantly improved scores (P<.05). Patients who "strongly agreed" (53.96+/- 4.91, n=33) or "agreed" (51.78+/- 6.19, n=23) had improved QoL and had significantly higher QIRC scores than those who "neither agreed nor disagreed" (44.36+/- 4.97, n=5) or "strongly disagreed" (42.82, n=1) (F(1,60)=11.24, P<.001). The matched group not contemplating LASIK scored 42.41 +/- 3.89 on QIRC overall.

CONCLUSIONS: Large improvements in QIRC QoL scores were found after LASIK for myopia in the majority of patients, with greater improvements in women. A small number of patients (4.5%) had decreased QIRC QoL scores, and these were associated with complications. People presenting for LASIK scored measurably poorer than matched patients not contemplating refractive surgery.

REFRACTIVE SURGERY UNTIL IT’S TOO LATE TO DECLINE

The importance of pupil size measurement, and anterior chamber depth…

“What good is making pupil size measurement a part of the standard of care if it is never utilized (by the doctor, or to communicate to the patient the risks it implies about the surgery they are considering)?

It’s a (kind of sick) joke.

Couple that w/the size of the correction AND with VERY deep anterior chambers (think about the notion of an ‘exit pupil’ taught in most classical physics classics as it pertains to optics – it is obvious that the farther away the ablation from the point of lens focus, the larger that ablation need be). Forget about it – I was guaranteed to have a miserable outcome.”

Patient , age 23, with smeared vision and debilitating dry eye as a result of Custom Vue LASIK on the VISX S4

Acta Ophthalmol Scand. 2003 Oct;81(5):530-2.

LASIK complication: loss of electricity to the microkeratome during the forward pass.

Tuominen IS, Tervo TM. Department of Ophthalmology, Helsinki University Hospital, PO Box 220, HUS, SF-00029 Helsinki, Finland. ilpo.tuominen@hus.fi

CONTEXT: A 32-year-old woman was scheduled for myopic laser in situ keratomileusis (LASIK) because of myopia and anisometropia caused by retinal detachment surgery.

CASE REPORT: During surgery, a sudden malfunction of the microkeratome during the forward pass was experienced. It was not possible to reverse the blade manually along the suction ring. Moreover, disconnecting the suction from the control unit did not help at first, because the suction ring was firmly attached to the ocular surface. However, detaching the suction line from the control unit aborted the vacuum and allowed the surgeon to turn the whole microkeratome backwards, mimicking the normal blade movement. Finally, an almost normal flap was observed, and the operation was successfully completed. Afterwards, the wire to the electromotor of the microkeratome was found to be broken and subsequently replaced.

CONCLUSION: This type of unforeseen microkeratome malfunction may result in serious flap or other complications.

FDA Warning Letters to LaserSight Technologies (pdf format)

http://www.fda.gov/foi/warning_letters/m4234n.pdf

http://www.fda.gov/foi/warning_letters/m3669n.pdf

JOURNAL OF REFRACTIVE SURGERY 2007; 23(3):309

By Prashant Garg, MS; Savitri Sharma, MD; Geeta K. Vemuganti, MD; Balasubramanya Ramamurthy, MD

PURPOSE: To report a cluster of Nocardia asteroides keratitis cases after LASIK.

METHODS: Retrospective review of the history and examination of three patients (four eyes) operated on the same day at a single center who developed postoperative keratitis. All patients underwent lifting of the superficial flap for microbiologic evaluation of the corneal scrapings. The operating surgeon was contacted to identify the possible source of contamination.

RESULTS: Two patients underwent simultaneous bilateral LASIK; however, only one developed postoperative keratitis in both eyes. One patient had unilateral surgery and developed keratitis in the operated eye. Microscopic examination of smears from all eyes revealed thin, branching, acid-fast, filamentous bacteria that were identified as Nocardia asteroides after culture. The infiltrates resolved with topical administration of amikacin sulphate (2.5%) and topical and oral trimethoprim-sulfamethoxazole. Final visual acuity ranged between 20/25 and 20/80. The operating surgeon had used the same blade and microkeratome in all patients.

CONCLUSIONS: Nocardia, a relatively unusual organism, can cause an epidemic of infection after LASIK. [J Refract Surg. 2007;23:309-312.]

Journal of Refractive Surgery Vol. 22 No. 2 February 2006  

Ching-Liang Kuo, MD; Hsiu-Fen Lin, MD; Po-Chiung Fang, MD; Hsi-Kung Kuo, MD; David Hui-Kang Ma, MD, PhD  

PURPOSE: To report a case of late onset lamellar keratitis and epithelial ingrowth associated with orbital cellulitis 1 month after LASIK surgery.  

METHODS: A 19-year-old patient presented with pain and subsequent blurry vision in the right eye. One month prior to presentation, he had undergone LASIK in both eyes. Orbital cellulitis was suspected.  

RESULTS: Under aggressive treatment, the patient recovered from orbital cellulitis and lamellar keratitis and he also regained his vision with topical steroid treatment.  

CONCLUSIONS: Lamellar keratitis does not always occur early following LASIK and may be associated with orbital cellulitis.  

[J Refract Surg. 2006;22:202-204.]  

Here is a link to a description of orbital cellulitis:  

http://www.eyemdlink.com/Condition.asp?ConditionID=477

 Here is an excerpt and link to a comment posted by Optometrist Dr. Greg Gemoules who specializes in the treatment of patients damaged by refractive surgery by fitting them with rigid gas permeable contact lenses.

http://www.asklasikdocs.com/forum/main/3821.html

DrG: The trend now is to ablate more tissue in the periphery in an attempt to reduce spherical aberration that is typically induced by refractive surgery and is responsible for a portion of the night vision disturbances and loss of visual quality experience by refractive surgery patients. We're just now seeing the long term effects of RK. One would expect that other corneal refractive surgical procedures, all of which compromise corneal strength and integrity, will have similar long term effects.

Researchers study the relation between the two.

J Refract Surg. 2006 Nov;22(9):884-9.

Landau D, Levy J, Solomon A, Lifshitz T, Orucov F, Strassman E, Frucht-Pery J.

Cornea and Refractive Surgery Unit, Dept of Ophthalmology, Hadassah University Hospital, P.O.B. 12000, Jerusalem 91120, Israel. dvl_eyes@netvision.net.il

PURPOSE: To report our experience treating eye trauma after LASIK refractive surgery.

METHODS: Nine eyes of eight patients (one woman and seven men) were treated for ocular trauma: blunt trauma (n=5), sharp instrument trauma (n=2,) and trauma from inflation of automobile air bags during a traffic accident (n=2). The time from LASIK varied between 3 months and 6 years. All patients were hospitalized as a result of severe decrease in visual acuity and pain.

RESULTS: Seven of nine LASIK flaps had some degree of dislocation and were lifted, irrigated, and repositioned. Two flaps were edematous without dislocation. Intensive topical steroids and antibiotics were used in all patients up to 3 weeks after trauma. Three months after trauma, five eyes regained their pre-trauma visual acuity (between 20/20 and 20/40), and three eyes lost one line of best spectacle-corrected visual acuity.

CONCLUSIONS: Trauma occurring several months or years after LASIK may cause flap injury. Adequate and prompt treatment usually is successful.

M.S. Sridhar, Christopher J. Rapuano, and Elisabeth J. Cohen;  Cornea Service, Wills Eye Hospital, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA; *Inquiries to Christopher J. Rapuano, MD, Cornea Service, Wills Eye Hospital, 900 Walnut St, Philadelphia, PA 19107; fax: (215) 928-3854
Manuscript accepted 24 May 2001;

PURPOSE: To report a rare complication in which the patient accidentally removed the laser in situ keratomileusis corneal flap.

METHODS: Interventional case report. A 35-year-old woman underwent uncomplicated laser in situ keratomileusis surgery. Ten days after surgery, she inserted a soft contact lens into the right eye to improve her vision. She tried to remove the contact lens, but had pain and bleeding. She was referred 10 days later with a diagnosis of loss of flap.

RESULTS: On examination, she had a best-corrected visual acuity of 20/70 in the right eye. The right eye examination revealed no corneal flap, mild corneal edema, and significant haze. A central epithelial defect was found.

CONCLUSION: Accidental corneal flap removal can rarely follow laser in situ keratomileusis surgery. This complication provides insight into the weak adhesion of the flap onto the stromal bed after laser in situ keratomileusis surgery and, hence, the inherent risk of traumatic flap dislocation or amputation, which needs to be explained to the patient.

Laser eye surgery is remarkable. Never before in American medical history have 3 million people each year responded to massive advertising by paying for an innovative, elective surgery. Never before have surgeons competed so vigorously on price; and never has a surgery been so skillfully isolated from liability lawsuits. If LASIK eye surgery becomes the Mass Tort of 2025, will Americans regret accepting it as the benign 20/20 solution of today?

...PROFESSOR JAMES O'REILLY

I wish to acknowledge with much appreciation for contributing with permission to post on this site by Professor James O'Reilly the following study on Lasik liability exceptions:

E-Text Version of article published in 71 Univ. Cincinnati Law Review 541 (2003), copyright Univ. Cincinnati 2003  AN EYE FOR AN EYE:

FORESIGHT ON REMEDIES FOR

LASIK SURGERY’S PROBLEMS  Prof. James O'Reilly1

I. INTRODUCTION

Laser eye surgery is remarkable. Never before in American medical history have 3 million people each year responded to massive advertising by paying for an innovative, elective surgery. Never before have surgeons competed so vigorously on price; and never has a surgery been so skillfully isolated from liability lawsuits. If LASIK eye surgery becomes the Mass Tort of 2025, will Americans regret accepting it as the benign 20/20 solution of today?

The first decisions in a series of liability suits against LASIK surgeons have been reported, with one plaintiff receiving a $4 million verdict.2 Yet the procedure is too new for a body of reported appellate precedent, so this review must be a forward-looking prediction of future judicial behaviors. This article examines the conundrum that an injured eye patient, whose vision deteriorates several years after the surgery, may be unable to find a viable defendant, thus leaving the LASIK customer without an effective remedy.

II. UNDERSTANDING THE CONTEXT

What is LASIK Surgery?

Open your eyes, read a newspaper, watch a television, see a billboard, and elective surgery advertising hits your eye. From thousands of dollars down to hundreds, the competition to sell this mass volume elective surgical procedures has driven down prices. The specific service that was to be provided to an estimated 3,135,000 patients in 2002 is LASIK.3 LASIK is the acronym for "laser in-situ keratomileusis", a form of computer software-guided cutting of the cornea in the eye using laser light beams. LASIK and other eye surgery procedures4 flatten the central curvature of the cornea of the eye, with a flap of skin peeled back in order to effectively alter the ability of the eye to see without external spectacles or contact lenses. A Pennsylvania court summarized the mechanics of the LASIK process in a succinct summary:

“During the LASIK procedure, after the surface of the eye has been anesthetized by eyedrops, a microkeratome is used to create a flap in the outer layer of the cornea which is folded back to allow an excimer laser access to the exposed corneal surface. Computer-controlled laser beams then remove thin layers of corneal tissue to reshape the curvature of the cornea so that visual images will focus directly onto the retina, thereby improving visual acuity. The corneal flap is returned to its original position without utilizing sutures, and a protective "bandage" contact lens is applied to prevent the eyelid from rubbing against the eye surface as the outer layer of cells regrow and the flap re-adheres”.5

Measurement of the eye and setting the correct parameters into the computer-controlled laser equipment appear to be the principal determinants of surgical success. An experienced surgeon can perform many surgeries in the same day by using the staff of an outpatient surgery facility to prepare the patient. Though the equipment is constantly being improved, the computer controls depend on the accuracy of the data being fed into the system by a skilled surgeon during the pre-surgical evaluation of the patient.

The reader may choose to read more of the technical details of the surgery elsewhere6. This paper will deal with LASIK but some of the issues are relevant to other processes. Relative to older forms of such refractive surgery, LASIK does not appear to produce greater glare or halo effects during the early stages after surgery.7 We just do not know its longer term consequences.

Is LASIK Surgery Safe?

As with any surgery penetrating through body tissue, cells are affected by the cutting of corneal tissue. The eye cells heal differently with different patients whose personal health and other characteristics will affect recovery. In the event that slowly-developing cellular changes in the cornea may cloud the vision of LASIK patients in future years, we simply do not know how a LASIK procedure’s longer term effects will manifest themselves. An experience base of five or more years may be needed to follow the progress of patients whose corneal cellular changes are manifest by slow blurring of the vision or the appearance of nighttime glare effects which hinder their ability to drive. This poses the same causation challenge that lawyers experience in other medical delayed-effects situations: the manifestation of eye deterioration attributable to the cutting of cells may be hard to differentiate from deterioration attributable to the effects of normal aging or of unrelated eye problems. For the short term, LASIK appears to be safe, with a small number of adverse effects, as discussed later in this article.

Why Is LASIK Different from Other Surgical Procedures?

Surgery is typically a drastic interventional response to a medical emergency or to the failure of an organ or bone system. Any surgery carries risks, especially the in-patient surgery that carries risks of hospital-related infections. The development of skilled surgical techniques involving micro-surgical interventions have made American surgical capabilities well respected around the world.

But not all surgical interventions respond to health necessities. Persons who find contact lenses annoying or spectacles inconvenient are being pressed to “try the safe and affordable alternative: LASIK”.8 Americans are willing pay for various types of elective surgery for anatomical flaws and cosmetic defects. Because the word "cosmetic surgery" draws angry rebukes from eye surgeons, the LASIK processes can at best be called "improvements on nature", rather than the classic use of surgery for a needed remediation of injuries. The wave of 3,300,000 annual LASIK procedures in the United States may be the greatest volume of surgical procedures ever voluntarily undertaken by consumers in the history of medicine.

The sales target for expanding LASIK is 35% of the 180 million Americans who may need vision care.9 Of course, such a goal is ambitious, and it amplifies the concern that even a small percentage of damaged eyes might mean that tens of thousands lose their optimal eyesight as a result of flawed surgery. The market’s size is great and the potential downside for a fraction of that population could produce substantial damages. One symptom of the fluid nature of change in this marketplace is the way in which the manufacturers earn their profits: New eye lasers, once approved, are leased to surgeons in return for a per-surgery fee, with new equipment emerging continually in a hot competitive climate.

III. THE REGULATORY CONTEXT

FDA’s 12-Month Norm

A traditional question arises again: how much of a safety data base of experience should society demand, before a new technology is “safe enough” for use on humans? The Food and Drug Administration has statutory jurisdiction over medical devices10. FDA has used this authority to specifically approve numerous laser devices for surgical use on the eye. 11 So it would seem that the consumer expects to be fully protected by prior government approval before the LASIK device enters the competitive marketplace.

But the human clinical studies of comparative surgical results, needed for FDA approval of a new laser eye device, are only required to study patients in the small test sample for 12 months post-surgery. Some studies go to 24 months, continuing after the approval of the new device12. The laser device maker must supply extensive information about the machine from which FDA can evaluate the safety and efficacy of the design, and these “premarket approval applications” can be voluminous.13 But the experience base is relatively short and cannot be expected to catch the longer term deterioration effects on the eye, if such effects occur. This does not mean LASIK is going to be found to have a higher risk than we now expect – we just don’t know, and if ill effects do not arise among the 3 million customers per year then a definitive risk conclusion can be made at some future date.

A review of the FDA website's summaries of product safety for the approval of new laser devices14 consistently shows that manufacturers submit, and FDA grants approval based upon, 12 months' experience with the new laser devices. FDA examines both the adverse events reported during the 12 month post-surgery followup and the complications from surgery reported by the surgeons. FDA’s Office of Device Evaluation in the Center for Devices & Radiological Health then makes a decision about the product’s acceptability.15

So the protection of LASIK surgery patients by the regulatory intermediary, the FDA Office of Device Evaluation, is premised on experiences of up to 12 months post-surgery. By its own public admission, the post-approval examination of medical devices “is not working well”.16 FDA requires device sponsors to report the numbers of patients who seek a second LASIK procedure to improve vision after the first surgical results were inadequate, but “no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery.”17 It is possible that vision effects may be manifested after a longer period, as reports slowly arrive that demonstrate evolving patterns of experience with clouding of vision as cells change. Such might be noticeable after several years have passed, for example when a patient changes eye doctors and complains about the results promised by an earlier eye surgeon who sold a LASIK procedure as the ideal solution for that person’s desires.

Here the time of reported effects becomes significant in a liability claims context. Corneal surgery of various types has a longer history than the very recent LASIK mode. But the laser/computer interface combined with mass marketing is a relatively recent novelty. A few warning flags are visible in the medical literature, discussed below in Part V, but there is no one who can reliably predict the percentage of 10-year or 20-year post-surgical experiences that will be adverse for LASIK patients. It may be that LASIK produces no adverse long term effects. Or it may be that LASIK might cause a cellular degeneration more rapid and serious than other causes. The nexus of uncertainties regarding cellular change, rates of deterioration, the value of a 12-month pre-approval study as a predictor, and patient intolerance of vision problems, make for an intriguing challenge to the would-be tort plaintiff.

How Are The Surgeons Regulated?

The Food and Drug Administration has no jurisdiction over physicians such as the surgeons who use the laser equipment.18 FDA requires adequate labeling for proper use by physicians19 but cannot police the physicians. Surgeons' performance is left to the state medical boards20 and to the private malpractice system.

FDA tracks post-approval rates of injury under its Medwatch program of voluntary adverse effect reports on medical devices, 21 as explained on FDA's Center for Devices website. 22 The surgeon who finds a LASIK device malfunctioned could file a report on line with the Medwatch system but is not required to do so. Congress responded to complaints by manufacturers and hospitals and severely restricted the FDA’s medical device user reporting authority23 in 1997 amendments to the device statutes.24

IV. THE LIABILITY CONTEXT

Identifying Causes of Action

At the rate at which LASIK surgery is being sold to new patients, even a small percentage of vision loss claims, as a fraction of the millions of cases, could produce a significant volume of potential tort suits. This is a statistical certainty, since the smaller occurrence of adverse eye effects would become manifest slowly, as the multiple millions of LASIK recipients ages during the years since their eyes were cut by the surgery25.

The classic tort negligence test requires a showing of foreseeability of the injury, and fault by the responsible product manufacturer or physician. Modern strict liability imposes a compensation obligation on the manufacturer of a defective product regardless of fault26 and leaves malpractice law to remediate the problems caused by the professional user of the device. Strict liability shifts the costs of injury to the designer and marketer of the product that caused the injury, without a need to show fault or even proof of foreseeability of the injury27.

But strict liability is a policy that carries an important exception; it does not apply if the product offers a special societal benefit like a rabies vaccine or an important pharmaceutical to cure cancer28. These latter products were deemed by the creators of modern strict liability to be “unavoidably unsafe”, and thus subject only to negligence law norms, in order to prevent the advance of medical progress from being retarded by the costs of strict liability. 29

The Third Restatement Shield

One of the controversial aspects of the 1997 adoption of the Restatement of Products Liability 3rd was the virtually complete shielding from strict liability for prescription drugs and devices which have any beneficial effect for any class of patients.30 The concept is that if there is a class of patients who could benefit, then the device can be sold for all other classes as well, and will be immune from the strict liability analysis. 31 For example, leprosy is rarely encountered among U.S. residents, but a drug that was beneficial to leprosy patients would not be vulnerable to challenges against its marketing for some other medical indication, such as cancer. The express predicate for this exclusion from strict liability was that FDA “adequately review(s) new prescription drugs and devices, keeping unreasonably dangerous designs off the market.” 32If one believes FDA achieves this goal, the Third Restatement makes sense.

Eye laser devices benefit from the protective shield that the Third Restatement seeks to apply to prescription-only products. It can be argued that the availability of laser surgical devices benefit some patients whose eyes are medically impaired and for whom the corneal surgery has a therapeutic purpose. But a contrary argument can be offered, that 3 million annual uses of a surgical tool for appearance and aesthetics far outweigh the smaller numbers of uses of these devices for cases of real medical necessity.

The Case of the Disappearing Defendants

In the event that even a small fraction of LASIK buyers experience eye difficulties later, a small fraction out of three million customers each year is still a substantial population of potential plaintiffs. A significant concern for these plaintiffs is that tort law lags far behind laser technology. Lasers are improved each year but liability systems lag behind, so no compensation for injury may be available to the LASIK customer at the time when a belated manifestation of injury to the eye is diagnosed. If vision clouding problems appear, there may be no financially responsible defendant available against whom to obtain sufficient recovery. This is a particular problem when the longer term cellular effects of today’s LASIK eye surgery manifest themselves years after the surgeon has been paid.

In part, this tort liability phenomenon of “no viable defendant to sue” reflects business practices that emphasize the very short term orientation of the coverage of malpractice insurance for ophthalmic surgeons. The malpractice insurance industry seems well protected by its preference for “claims-made” policy coverage, the dominant form of new coverage. Such coverage pays claims made during the year for which the insurance was in force. The coverage would not shield the individual surgeon when a claim about delayed corneal blurring effects is made long after the brief LASIK operation is over. This makes a difference for the plaintiff, because the absence of an insurance carrier diminishes the prospects that the plaintiff will get paid damages.

V. THE MEDICAL CONTEXT

What Long-Term Issues Exist After LASIK Surgery?

LASIK is widely performed worldwide "despite the absence of thorough data on the healing response and long-term complications at the tissue level. Clinically visible complications…are relatively well known, but the underlying cell biology of these phenomena is less well understood." 33 Loss of cells in a layer of the eye, beginning at 6 months after surgery, was found in one study, but its reasons are unknown and require further research.34 Corneal haze of several types "may degrade the retinal image" and more research is needed about its clinical impact.35 These concerns are more long-term; issues concerning the flap of corneal tissue cut in the eye are among the near-term concerns of eye surgeons, as illustrated in American Academy of Opthalmology publications.36

A frequently cited challenge for surgeons is "irregular astigmatism"; when the same eye has been subjected to laser multiple surgeries to improve on conditions initially reported by the patient after surgery, "corneal stability in the long term is still a worrying factor", and in those with a major degree of irregular astigmatism, loss of visual acuity is permanent and symptomatic.37 Not all irregular astigmatism can be corrected; careful patient selection is often recommended.38 The LASIK technique is too new for surgeons to understand the natural history of future effects of "central islands" on the cornea, which cause numerous detrimental effects.39 For the estimated165,000 PRK procedures done annually, "visually debilitating corneal haze may persist in approximately 5% of all PRK patients."40 Enhanced cellular reflections from high numbers of wound healing keratocytes are an important contributor to haze and drugs may be useful to aid clarity of vision after PRK.41 Night vision deficiencies are "one of the main challenges" to improving laser eye surgery.42 Corneal scarring and keratectasia, dilation of the eye, were a particular issue with patients who had multiple LASIK surgeries, with cautions for surgeons about third and fourth retreatments of the same eye. 43 A Utah researcher/surgeon noted the "paucity of peer review literature" to substantiate LASIK's safety and efficacy and expected in a 1998 article that better computer software would reduce the 30% of patients who required retreatment.44 We simply don't yet know enough.

VI. THE LITIGATION CONTEXT

Are Long-Term Effects Actionable?

If a patient is dissatisfied with the resulting vision after LASIK, a second surgical procedure may be offered, but the literature cautions about more serious consequences with each successive cutting of the eye tissue.45 Corneal perforation is rare but there can be ingrowth of the epithelial layer, infection, severing of the flap of skin cut in the cornea, wrinkling of the flap and corneal astigmatism. 46 The longer term effect of the surgery on cellular changes in the complex tissues of the eye is being studied, but time will tell whether the current favorable view of the surgery is altered by future studies showing a longer term degradation in vision in a LASIK population compared to an uncut-cornea “control group”. We just do not yet know. The cases that have reached litigation have involved a variety of vision impairments, some disabling for persons who need excellent night vision such as pilots.47

Whether the individual’s impaired vision effects are worth litigating is a matter of judgment for the patient and counsel. The contingent fee system makes the plaintiff’s counsel somewhat reluctant to challenge multiple defendants on a cause of action that does not yet have substantial case law illuminating the duty and liability of the manufacturer and surgeon. The population of persons paying for this elective surgery tend to be somewhat more affluent than average patients, and for some of them, perhaps a later experience of complications will stimulate the search for legal relief on a fee-paid hourly basis. Counseling such a client to initiate damages litigation involves a number of considerations including the unavailability of insurance carriers for claims that are made several years after the surgery.

The causes of action would include defects in LASIK equipment design, defects in the knife-like microkeratome used to slice the cornea, failure to adequately communicate risks to the patient, failure to adequately warn of the longer term effects observed in the LASIK medical literature, and perhaps claims of breach of express warranty that the procedure is “safe” for the eye of the patient. The bold and attractive promises being made in LASIK advertising by eye surgery marketing corporations, some of whom are publicly traded entities48, may give rise to express warranty claims49 as well as to claims against the individual surgeon or the surgeon’s corporate entity as conventional malpractice claims. Safety advances in the design of machines for laser eye surgery may have reduced the adverse effects that would have been seen with the earliest LASIK equipment, though an insufficient time has passed to form reliable statistical projections. An elaborate publicity campaign against criticism of LASIK has been launched by a trade group, funded by manufacturers using a national public relations firm.50

Plaintiffs confront numerous barriers, including the Daubert standard51 which will allow equipment makers and surgeons to exclude the testimony of a critic of the LASIK device’s use if that critic had not passed the scrutiny of the Daubert pre-trial screenings. A climate for product design liability regarding inadequacy of pre-market testing of the machines may exist when future claims are brought. The makers of the expensive laser equipment are rapidly altering and upgrading their machines and software as the marketplace demands rapid responses to competitors' innovations.

What Barriers to Recovery Exist?

The first barrier to recovery will be time; if the now-reasonable balance of risk data and effectiveness were to shift against LASIK after 5 to 10 more years of experience, the patient with blurred eyes must establish a causal connection to his or her present condition. The complexity of medical proof of causation would be formidable, because many post-surgery events might have triggered the harm.

Time also affects the viability of a damages case, by the statute of limitations impacting the ability of a plaintiff to sue for an effect that became evident long after the laser surgery was completed. The cause of action arose either when the surgery was done or when the plaintiff discovered the connection between the surgery and the plaintiff’s presently deficient vision. Plaintiffs could claim that they sued within a reasonable period after discovering that a tort had been committed. It is this "discovery rule" in torts that would halt the tolling of the statute of limitations52. But the degree to which any belated discovery of blurred vision can be tied in to knowledge of the surgery-injury connection will be very fact-specific. This is not an easy issue for the plaintiff to reopen, several years after surgery. State medical malpractice procedures form an additional barrier against the potential plaintiff’s recovery. 53

Effects of the Malpractice Crisis

The second barrier will be a very likely absence of malpractice insurance as a force for settlement. An immediately observable injury tied to malpractice can produce a sizeable claim and a large settlement, as occurred in a recent Colorado case.54 But LASIK’s cellular effect on the eye if it occurs in a patient will take time to develop.

 Timing is everything when insurance coverage is at stake, and here it will be central to the plaintiff’s attorney selecting the right contingent fee case to accept. There has been a significant rise in the use of "claims-made" malpractice policy forms, under which most medical malpractice carriers decline to pay claims that have not been presented to the insurer during the contract term or within a short "tail" thereafter55. This type of surgical malpractice policy contrasts with the “occurrence” policy which covers the acts of the surgeon during the entire policy period, even if the claim is made after expiration of the policy years.

The severe lack of profitability is driving some insurance carriers out of the medical malpractice insurance market. Aggregate 2001 industry statistics56 show that about $10 billion was spent on health care malpractice insurance mechanisms in 2001, of which $5,586,584,000 was in insurance premiums. Loss ratios rose to 74.4% in 2000 from 54.3% in 1997. It is estimated that the malpractice insurance carriers’ combined ratios of loss and expense exceeded 133% of the insurance carrier’s income from premiums at the same time that income from investments was diminished by stock market declines. St. Paul Insurance Co. quit the medical malpractice insurance market when its losses became too severe; in 2001 that major malpractice carrier lost $940,000,000 on medical malpractice coverage and halted all future policy renewals or new policies.57

If an adverse eye effect is only manifested some years after the surgery, the physician's carrier will decline coverage because the eye patient’s vision deterioration claim was not presented to the carrier during the contract period of the “claims made” policy. The plaintiff is able to continue the suit against the corporate or individual entity that performed the service, but the likelihood of a major settlement payment diminishes without the presence of an insurance carrier at the negotiating table.

Once the plaintiff’s lawyer learns that no insurance coverage exists for the belated claim, the corporate structure of the eye surgeon becomes very important to the plaintiff’s recovery efforts.58 The corporate structures used to protect the surgeons' own assets in an LLC or professional corporation may have been dissolved by the year when litigation begins. The surgeon is quite likely to have imprinted the corporation’s name on the documents to protect the surgeon’s personal assets. Propensity of the LASIK surgeon’s competitors to cut prices and to reduce overheads leaves less residual cash for an insurance or loss reserve within the surgeon’s limited liability corporation. In short, there may be no viable defendant left by the time the plaintiff determines that LASIK caused the vision problems.

Effects of Consent

Consent forms present the third barrier to the plaintiff. The attractive models in the LASIK advertisement and the terrific price claims for throwing away one’s glasses will inevitably receive more visible space in advertisements for LASIK than the comparable visuals receive in prescription drug advertisements. That is because the surgical consent forms that contain the warnings only need to be presented at the time the buyer pays for the service. FDA requires warnings be stated for prescription drug ads made to consumers, but it does not require the same communication about risks in LASIK advertising. FDA has jurisdiction over the advertisements for a prescription medical device59.

The drafting of a surgical consent form is an art, at which defense counsel should excel. Surgeons have listened carefully to their defense counsel. If a LASIK surgeon is sued, the defense will argue that an ironclad consent form was executed by the plaintiff. The consent forms for laser eye surgery may be an extreme readability test for people who have selected one among several competing vendors for cheaper, faster and more efficient service for their eyes. The savvy surgical staff always have "one more form" to hand the patient to be signed. The person who has elected to get the surgery has probably signed the credit card receipt before signing all the other forms, including the surgical consent forms. The buyer of high volume elective surgery may be unaware that among the routine paperwork, the customer is signing away future rights by failing to focus on the consent forms. Breaking through this barrier to attack the failure to adequately warn will be a major inhibition upon the willingness of the plaintiff’s bar to take these cases on a contingent fee basis.

Effects of Preemption Defenses

The reader may expect that, even if the surgeon escapes liability, the device manufacturer is still an available defendant for a compensation claim. Alas, preemption of state tort recoveries by federal statutes is the fourth barrier to be faced by an injured customer. The Constitution permits Congress to govern interstate commerce.60 Congress responded to a concern about medical device safety by regulating interstate sale of medical devices.61 At the time the specific authority to approve new medical devices was delegated to FDA, Congress answered the device manufacturers’ pleas by prohibiting the states from adopting "requirements" for medical devices that differed from federal “requirements”.62 In the 1976 Medical Device Amendments, Congress preempted states from imposing medical device requirements that are in addition to or different from federal medical device approval requirements63.

In two cases, the Supreme Court has interpreted the device legislation to shield virtually all manufacturers of innovative medical devices. The LASIK-injured patient’s compensation claim against a LASIK device maker is likely to be barred by the Supreme Court’s interpretation of the Food Drug & Cosmetic Act64 to prevent state verdicts asserting design defect claims against FDA-approved medical devices65. The plaintiff in a LASIK case against a manufacturer must overcome the legacy of the device industry’s landmark victory in the Supreme Court Lohr 66 decision in 1996, when combined with the industry's successful effort to win 1997 amendments to the FDA law67 and the 2001 Supreme Court victory in Buckman68 . These efforts have collectively slammed the door on most causes of action for defective design of a medical device69. Suing the LASIK equipment supplier will be very unlikely to succeed if the claim is related to design; claims of inadequate warning might also blocked both by the FDA’s specific product labeling approval70 and by the patient consent forms, considering the breadth of wording in the pre-surgery consent documents that are routinely signed by LASIK patients.

Effects of Market Volatility

Finally, the medical device market is both global and volatile. Rapid changes in technology are altering the competitive landscape. And the manufacturers of LASIK devices are entering and leaving the market more rapidly than manufacturers in more conventional medical fields71. The marketplace of laser makers is rapidly evolving, with some of the makers of today's machines unlikely to be found in business if cases arise several years hence, and others consolidating and merging assets, perhaps without retaining liabilities for past users of the equipment.

It may be that the maker of the machine used in a 2001 surgery has disappeared entirely or is not doing business in the U.S. by the time in 2011, when the LASIK customer learns that the person’s 2011 serious vision problem was triggered by cellular changes in the aftermath of the 2001 surgery. Piercing the corporate veil is a rarity72 and the device makers presumably acted within the law in their merger or dissolution of the corporate structures.

Likewise, the physician who performs LASIK surgery as the agent of a corporation will seek to be shielded by the corporate form under state corporate laws, as occurred in a Pennsylvania LASIK negligence case.73 The surgeon may have structured the corporate shell as thinly as possible, so that the corporation or limited liability company will be terminated after a few years or will be insufficiently capitalized to pay those later judgments that arise from later-detected harms.

The result of this litany of disappearing defendants is that the eye surgery purchaser of 2003 may be unable to gain compensation in 2013, if and when serious eye problems can be diagnostically attributed to the 2003 surgery. The maker of the device is shielded; the surgeon is shielded or the surgeon’s corporation is dissolved; and the malpractice carrier is excluded by a claims-made policy format. One does not have to be clairvoyant to recognize that LASIK’s future problems would bring calls for a legislative solution to the absence of compensation or remedy.

VII. SOLUTIONS

Suggesting a Pooled Reserve Solution

A certain portion of those who claim a LASIK-induced eye deterioration will be correct in attributing their harm to the surgery. For some injuries there is no compensation because an act of God or force of nature caused the harm; LASIK surgery is the kind of expensive service for which, if an unexpected harm occurs, the injured person will expect to be compensated. The adverse eye conditions will diminish occupational abilities for persons like airline pilots and will diminish the quality of life for all who depend on clear vision. Such harm would merit some form of compensation under tort law principles if the surgeon acted negligently or the device the surgeon utilized was negligently designed, or if the plaintiff received inadequate warnings. But the legal system has the exceptions noted above, so tort law will deny compensation in most cases.

Nature abhors a vacuum -- and modern media and politics seems to abhor a remediless injured person. Federal compensation for mass injury situations is requested by victims and their advocates in numerous situations. But the actual passage of federal relief legislation is very rare. Agent Orange compensation to military personnel who had served in Vietnam74, and swine flu vaccine for persons who developed a rare adverse effect, are among the rare few. Relief by federal cash assistance to persons who had elective surgery is quite unlikely in this instance.

The states can respond to future calls for compensation by requiring the insurance carriers who write surgical malpractice coverage to establish a sufficient reserve to be available for future claims. Perhaps in hindsight, such a reserve compensation pool should have been done for asbestos and other chronic illness with belated onset, once the medical signs of future problems appeared for those products, but the opportunity passed and the later claims system has borne the higher transaction costs of that inactivity. A state insurance department that imposed a surcharge on surgical malpractice policies could create the pool of funding, and then claims on the pool in future years could be adjudicated through the tort system, as it operates in the future. Claims for which a viable defendant or carrier exists, must be brought first against those viable parties.

What Loss-Reserve Structure Could Work?

In light of the probable unavailability of viable defendants for the compensation of longer term LASIK injuries, as discussed above, this paper advocates the creation of a state-level statutory “risk reserve pool” to pay claims for which no other resources are available. The fund is to be used as a limited compensation vehicle with a cap on individual benefits payable upon proof of the elements warranting compensation. Funding for the risk reserve would come from a required surcharge or supplemental coverage payment for the issuance of malpractice insurance covering physicians who perform elective, non-emergency eye surgery. The payments into the risk reserve pool would be made by the surgeons or their corporate structure, perhaps in the form of a state surcharge of $50 per non-therapeutically indicated75 eye surgical operation performed. The pool would be held by the state insurance department in escrow as a funding source for any future claims for compensation. If the funds were not the subject of claims for ten years, which seems unlikely given the size of the patient population receiving LASIK surgery, then the fund would dissolve and return the surcharges to those physicians who “contributed”.

In the event of a LASIK patient’s post-operative eye problems that are persistent or that appear at a point in time set in state legislation, claims would be made against the pool only if normal channels of compensation are foreclosed and only if the surgical event had proximately caused the harm to the eye. The longer term negative consequences of these elective eye surgeries might manifest themselves after the plaintiff has found that conventional compensation routes, against malpractice coverage of the surgeon or against the device maker, are no longer available. The insurance excise charge would produce the “insurer of last resort” in the state insurance fund.

Why a State Remedy?

Since these surgeries are elective purchases of a medical service76, they have no federal Medicare cost consequence. These elective surgeries are not paid for with federal funds, and not usually provided as an employee benefit, so the federal roles that lead to ERISA preemption of state remedies are not likely to inhibit state legislators. At least one court has held that such surgery is not medically necessary but is elective.77 The state primacy over such surgical activities will be manifested by state oversight of malpractice insurance terms and reserves78, and by the medical licensure roles of the states79. The states that recognize a LASIK compensation issue would be free to employ their authority over insurance carrier policy conditions and loss reserves, as well as the state medical licensing powers over physicians practicing in this area of surgery.

How the proposed LASIK injury compensation system will work is yet to be determined, of course. State legislators first will have to hear from a constituency supporting compensation, in numbers that can outweigh the power of the medical lobby and the LASIK machine manufacturers’ probable defensive alliances. If the experience with HMO legislation in Congress is any indication, many legislators will undoubtedly approach the task of drafting remedial legislation with a pro-patient approach.

The compromise legislation that ultimately passes may set a standard for recovery from the fund that requires exhaustion of other remedies before making a claim to the state fund. Simplified administrative hearings before an administrative agency physician or panel of physician, attorney and administrator might be convened. The hearing could be similar to a disability benefits hearing, without the transaction costs of adversarial litigation. Causation of the eye condition will be the major fact issue for the adjudicator or panel; a delayed effect of damage to the eye could be causally attributed to the LASIK surgery, only after close attention to the eye’s present condition by an expert ophthalmologist employed as advisor to the panel.. The plaintiff’s expert would be expected to meet informal norms of qualification, less stringent than the constraints on expert testimony under the Daubert80 test or other state-law test of expert witness testimony. Causation proof could be somewhat relaxed in claims against the fund, perhaps with a set of presumptions concerning the vision deterioration effects of eye surgery and of aging as causal factors, when the legislation establishing the compensation scheme is created.

The hearing could determine the current amount of eye impairment compared to an age-appropriate eye functions grid; then fix the percentage of such current eye condition attributed to the LASIK surgery; and then determine whether another source existed from which benefits would be accessible to the claimant. Payments from the state fund would not be available unless the administrative official in the state department of insurance found sufficient credible evidence from competent medical evaluators that the vision conditions in patient’s eye had been adversely affected by the results of the elective LASIK eye surgery, and that the impairment of vision as of the time of a benefits application was causally attributable to the surgery. Awards could be set up to a maximum amount of compensation, perhaps $50,000. If there were a viable civil tort case to be brought, the compensation would not be pursued or might be deferred by the panel.

Certainly, proponents of the relief legislation will argue for statutory presumptions that eye surgery caused the compensable deterioration; opponents of the statute. including eye surgeons and their malpractice carriers, will argue that the person who bought the elective surgery should be left with the consequences. The degree of relaxation of such proof of causation would likely draw intense debate in the state legislatures. The factual issue of causation based on competing expert testimony regarding the source of the eye deterioration will pose a tough question for the civil jury. If a claimant’s normal aging of the eye tissue exacerbated the adverse effects of the laser slicing of the eye, the expert will need to opine about relative percentages of causation attributable to the effects of the surgery. The standard of proof in a case involving an older adult with other health problems may be especially difficult for the plaintiff.

VIII. CONCLUSION

New issues suggest new solutions. While laser eye surgery seems today to have few near-term problems, the massive numbers in the target population and the vagaries of human optical problems will pose trial lawyer concerns. Barriers to recovery when and if problems are found will be a challenge to the remedial system of the future. State legislative action and insurance regulatory decisions to establish a risk-pool surcharge may be the optimal means to assure that future claims can be compensated. Plaintiffs' trial counsel have a role in the creation of this future mechanism for relief, which will entail a focused and intelligent effort for governmental assurance of remedies.

#####

1 Visiting Professor of Law, University of Cincinnati College of Law; B.A. cum laude, Boston College, J.D. University of Virginia. The author appreciates the research assistance of Alison Elk, R.N., J.D. 2003.

2 “$4M Award Over Laser-Eye Surgery Breaks New Ground”, Lawyers Weekly USA at 24 (May 27, 2002).

3 The author thanks Spectrum Consulting and the media department of the American Academy of Opthalmology for providing their January 2001 estimates.

4 In addition to the LASIK procedures there will be approximately 165,000 others who will purchase photorefractive keratectomy (PRK) another form of eye surgery designed to improve vision.

5 Oven v. Pascucci, 46 Pa. D. & C.4th 506, 2000 Westlaw 1876811 (Pa.Com.Pl. 2000).

6 A useful reference is the FDA LASIK website providing information about LASIK safety, see http://www.fda.gov/cdrh/LASIK/

3Peter Hersh et al., Photorefractive Keratectomy versus Laser In Situ Keratomileusis, 107 Opthalmology 925, 932 (May 2000).

8 Of course, the wording of the advertisements vary with the particular sales approach offered. The emphasis remains on cosmetic appearance benefits, the easier alternatives to glasses and the affordability of the surgery.

9 Spectrum Consulting Estimates, January 2001.

10 21 U.S.C. 321(h).

11 21 U.S.C. 360e(c), 21 C.F.R. 814.20

12 FDA, Checklist of Information Usually Submitted in an Investigational Device Exemption for Refractive Surgical Lasers, Oct. 10, 1996, see http://www.fda.gov/cdrh/ode/2093.html

13 See FDA Checklist for Premarket Approval Application submitters, at http://www.fda.gov/cdrh/ode/checklist/pma.html

14 See e.g. Approval of Bausch & Lomb Technolas® Excimer Laser System, FDA Approval, May 17, 2002, Premarket Approval P990027/S2, Summary of Safety & Effectiveness, available from www.fda.gov/cdrh

15 FDA, Checklist of Information Usually Submitted in an Investigational Device Exemption for Refractive Surgical Lasers, Oct. 10, 1996, see section 3.2.6

16 FDA, GPRA Annual Report 2003, available at http://www.fda.gov/ope/fy03plan/part2_med.html

17 FDA, “LASIK Eye Surgery: What should I expect before, during and after surgery?”, on the web at www.fda.gov/cdrh/lasik/expect.htm

18 Sigma-Tau Pharmaceuticals Inc. v Schwetz, 288 F.3d 141, 145 (4th Cir., 2002).

19 21 U.S.C. 352(f)

20 Colorado State Bd. of Medical Examiners v. Roberts, 42 P.3d 70 (Colo.App.,2001).

21 21 C.F.R. Part 803.

22 http://www.fda.gov/medwatch/articles.htm

23 21 U.S.C. 360i(b)

24 The device user reporting section was partially repealed by Pub. L. 105-115, Title II, sec. 213(a)(1)(E), 111 Stat. 2347 (1999).

25 The rapid increases in volume of LASIK surgeries "adds to the importance of identifying even small risks associated with these elective procedures." David Mazur et al., Retinal Detachment in Myopic Eyes After Laser In Situ Keratomileusis, 129 Am. J. Opthalmology 823 (June 2000).

26 Restatement of Product Liability 3rd §2 (1997).

27 A product that is defective and unreasonably dangerous will be addressed with strict liability even if the designer was not negligent. Restatement of Torts 2d §402A (1965); Restatement of Products Liability §2 (1997).

28 Restatement of Torts 2d §402A comment k (1965).

29 Comment k, id.

30 Restatement of Product Liability 3rd §6(c) (1997): “A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug for any class of patients.”

31 Id. at comment (b).

32 Id. at comment (b).

4 Minna Vesaluoma et al., Corneal Stromal Changes Induced by Myopic LASIK, 41 Investigative Opthalmology & Visual Science 369, 373 (Feb. 2000).

5 Id. at 375.

6 Hersh, supra n. 1 at 932.

36 See e.g., “My LASIK flap management technique”, Eye World (2002), posted at http://www.eyeworld.org/aug02/0802p43.html

37 Jorge Alio et al., Selective Zonal Ablations with Excimer Laser for Correction of Irregular Astigmatism Induced By Refractive Surgery, 107 Opthalmology 662, 670 (April 2000).

38 Id. at 670.

39 Yi-Yu Tsai and Jane-Ming Lin, Natural history of central islands after Laser In Situ Keratomileusis, 26 J. Cataract & Refractive Surgery 853 (June 2000).

40 Torben Moller-Pedersen et al., Stromal Wound Healing Explains Refractive Instability and Haza development After Photorefractive Keratectomy, 107 Opthalmology 1235, 1236 (July 2000).

41 Id. at 1243.

42 Mihai Pop and Yves Payette, Photorefractive Keratectomy Versus Laser In Situ Keratomileusis, 107 Opthalmology 251, 256 (February 2000).

43 Simon Holland, Avoiding Serious Corneal Complications of laser Assisted In Situ Keratomileusis and Photorefractive Keratectomy, 107 Opthalmology 640 (April 2000).

44 Thomas Clinch, Discussion, commenting on Howard Gimbel et al., Incidence and Management of Intraoperative and Early Postoperative Complications in 1000 Consecutive Laser In Situ Keratomileusis Cases, 105 Opthalmology 1839 (Oct. 1998).

45 Clinch, id.

46 Yuichi Hori et al., Medical Treatment of Operative Corneal Perforation Caused by Laser In Situ Keratomileusis, 117 Archives of Opthalmology 1422 (Oct. 1999).

47 “$4M Award Over Laser-Eye Surgery Breaks New Ground”, Lawyers Weekly USA at 24 (May 27, 2002).

48 Attractive websites offering “safe” surgery include http://www.sightsolutions.com/index-dhtml.htm (no claim is made that this site or others creates an express warranty; it is used for illustrative purposes only).

49 Conceptually, eye surgery is a service rather than “goods”, so the conventional treatment of express warranties under Uniform Commercial Code section 2-313 is available only by analogy.

50 Funding comes from Alcon, Bausch & Lomb, Visx, TLC Vision Corp., IntraLase, Nidek, Moria, Vision Fee Plan, Refractec, and Katena Products. “New campaign aims to tell the truth about laser surgery “, reported in the trade journal Eye World at http://www.eyeworld.org/june02/0602p13.html

51 Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). This doctrine is followed in 17 states, see Joseph Eaton, “Survival of the Fryest”, 30 Prod. Safety & Liab. Rptr. (BNA) 333 (Apr. 15, 2002).

52 See e.g. Kubrick v United States, 444 U.S. 111 (1979)(courts apply rules requiring actions to be initiated within a reasonable time after discovery of the malpractice).

53 These statutes place procedural restrictions upon the malpractice plaintiff and reduce the potential damage awards.

54 Colorado State Bd. of Medical Examiners v. Roberts, 42 P.3d 70 (Colo.App.,2001).

55 A major professional liability insurer explains the distinction: A "claims made" policy protects the policyholder against claims or incidents that are reported while the policy is in force, or during an "extended reporting period". The negligent act, error or omission must have also occurred during the specific time frame set by the policy.” AIG Group, Frequently Asked Questions, available at http://www.aigdirect.com/small_business/customer_service/faq_index.cfm?PageID=fq020#top

56 The statistics are taken from A.M. Best reports and other sources, and were presented to the 2002 Annual Meeting of the American Bar Association by malpractice insurance experts. (Copy on file, University of Cincinnati Law Review offices).

59 21 U.S.C. 352(r) literally covers advertising for “restricted” devices, but in practice the broader class of prescription devices have been within FDA’s advertising controls. 21 C.F.R. 801.109.

60 U.S. Const. Art. I sec. 8 cl. 3.

61 21 U.S.C. 321(h). The LASIK machinery is classified as a medical device under federal regulations, 21 C.F.R. 886.4390.

62 21 U.S.C. 360k(a)(1).

63 21 U.S.C. 360k(a)(1).

64 21 U.S.C. 360k.

65 Lohr v Medtronic Inc., 470 U.S. 518 (1996).

66 Lohr v Medtronic Inc., 470 U.S. 518 (1996)(preemptive effect of 21 U.S.C. 360k(a) upheld against certain state tort claims).

67 Pub.L. 105-115, 111 Stat. 2295 (1997).

68 Buckman Co. v Plaintiff's Legal Committee, 531 U.S. 341 (2001).

69 See e.g. Baker v Medtronic Inc., 2002 Westlaw 485013 (S.D. Ohio 2002)(preemption precludes virtually all state tort claims against medical device manufacturers).

70 The issue remains debatable for medical devices like LASIK equipment. Several courts have held that FDA clearance of a label does not preempt state tort cases for failure to adequately warn. Webster v. Pacesetter, Inc., 171 F.Supp.2d 1 (D.D.C.,2001)(medical device); Eve v Sandoz Pharamaceutical Corp., 2002 WL 181972 (S.D. Ind. 2002)(drug).

71 Devices for laser eye surgery incur large development costs, making some companies vulnerable, with corporate survival consequences if the equipment does not achieve the desired results. S.E.C. v Schiffer, 2001 Westlaw 504860 (S.D.N.Y. 2001); In Re VISX Securities Litigation, 2001 Westlaw 210481 (N.D. Cal. 2001)

72 This piercing would mean that parent or related corporations and successors might be held liable for injuries alleged to have been the result of a prior dissolved corporation’s actions.

73 Oven v. Pascucci, 46 Pa. D. & C.4th 506, 2000 Westlaw 1876811 (Pa.Com.Pl. 2000).

74 38 U.S.C. 1116(a)(1).

75 A norm such as that used by Medicare for “medically necessary” surgical procedures would separate the aesthetic or convenience self-paid surgeries from those where eye surgery had been performed to respond to a medical need. “Under the Medicare Act, a physician's certification that the ambulance services provided are medically necessary is required before Medicare reimbursement is available.” Howard Medical Inc. v Temple Univ. Hospital, 2002 Westlaw 169380 (E.D. Pa. 2002, citing 42 U.S.C. § 1395n(a)(2).) Since this is not provided as an employee benefit, ERISA preemption is not likely to inhibit state responses.

76 Steven Z. v Kimberley Z,. 2000 Westlaw 1658620 (Del. Fam. Ct. 2000).

77 Stasack v. Capital Dist. Physicians' Health Plan Inc., 736 N.Y.S.2d 764 (A.D. 3 Dept.,2002).

78 Federal ERISA recognized the primacy of states in regulating insurance within the states, and these malpractice insurance reserve issues are properly within the realm of state insurance departments. 29 U.S.C. 1144(b)(2)(A), UNUM Life Ins. Co. v Ward, 526 U.S. 358 (1999).

79 See e.g. Colorado State Bd. of Medical Examiners v. Roberts, 42 P.3d 70 (Colo.App.,2001)(LASIK surgical malpractice led to state medical board disciplinary action)..

80 Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).

J Cataract Refract Surg. 2005 Dec;31(12):2356-62. 

Brown SM, Freedman KA.  Cabarrus Eye Center, Concord, North Carolina 28025, USA. sbrownmd@carolina.rr.com  

PURPOSE: To determine whether the currently accepted method of selecting a minimum optical zone diameter for laser refractive surgery that is equal to or slightly greater than the dark-adapted pupil diameter provides a sufficient diameter of corneal surface to focus light arising from objects in the paracentral and peripheral visual field.  

SETTING: Department of Ophthalmology and Visual Sciences, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.  

METHODS: An optical model of the anterior segment was developed to calculate the effective corneal refractive diameter (ECRD), which is the diameter of the area of cornea that refracts all incident light rays arising from an object through the physical pupil (PP). This model incorporates the patient variables of central anterior chamber depth (ACD), central corneal curvature (K(c)), and the diameter of the apparent entrance pupil (EP). The model was expanded to incorporate distant objects off the line of sight (LOS), described by their angular displacement from the fixation object in visual space (the object tangent angle delta(ob)). Results were calculated for the 360 meridian degree visual field (ie, for all objects in visual space perceptually displaced from the fixation object by angle delta(ob)). The effect of the prolate nature of the cornea was also investigated.  

RESULTS: The ECRD expanded rapidly as a function of PP and delta(ob) but was minimally influenced by K(c). Beyond a critical object tangent angle delta(c), light rays striking the corneal vertex were not refracted through the PP, and the ECRD became an annular surface centered on the corneal vertex. The delta(c) was not a function of K, but increased as the PP increased and decreased as the ACD increased. The prolate nature of the cornea had little influence on the ECRD, even for very peripheral light rays.  

CONCLUSIONS: The ECRD expands rapidly when considering distant objects only slightly displaced from the LOS. A patient treated with an optical zone equal to or slightly greater than the dark-adapted pupil diameter may experience vision quality loss for paracentral and midperipheral objects even under conditions of ambient indoor lighting.

LADARVision for RUINING HER VISION

LasikCasualty.com at http://www.lasikcasualty.com/

The LADARVision® Tragedy: One Victim’s Story

As an ophthalmologist, Dr. Sandra Brown is acutely aware of what can go wrong when a surgical laser is applied to someone’s eyes. She waited a long time before consenting to laser eye surgery to correct her own flawed vision.

Her caution was well-placed. Few people realize that as many as 10% of all laser eye surgery patients are less than satisfied with the results. Many patients are scarred and left with permanent vision problems.

“It’s why I waited for the technology and the surgical procedures to improve,” says Dr. Brown. When a Fort Worth, Texas based company called Alcon, one of the giants in the multi-billion dollar eye care industry, announced the development of an “innovative laser radar tracking technology” called LADARVision®, Dr. Brown decided to take the plunge. She’s regretted her decision ever since.

A surgeon performed LASIK surgery on Dr. Brown in April 2001, using the LADARVision® Excimer Laser System. During the surgery, the laser performed erratically and removed too little tissue in an asymmetrical pattern from Dr. Brown’s eyes. As a result, she has sustained permanent damage to her eyes resulting in limited vision. The harm can’t be reversed by medical or surgical interventions. She has filed a lawsuit against Alcon.

"I specifically waited for the LADARVision® laser machine before having my surgery. For me, the wait cost me my vision,” says Dr. Brown. I will now have to live with the consequences because of a serious defect in Alcon's laser. When I started looking into my problem, I realized that I was not alone and many other people have likewise been hurt by this same problem," says Dr. Brown.

While horror stories associated with laser vision correction are not new, recent disturbing news about the Alcon LADARVision® laser may cause victims to consider whether harm to their eyes was caused by the laser and not doctors and medical staff.

“In the past, poor surgeries were usually blamed on the surgeon,” says Joel Fineberg, one of the attorneys for Dr. Brown. “There is now mounting evidence that the Alcon LADARVision® laser is at the heart of many of these problems.” Surgeons throughout the country are questioning the effectiveness of the laser.

In addition, an article authored by an Alcon consultant in the April 2003 issue of Opthalmology, reveals that patients treated with the LADARVision laser are twice as likely to need follow-up surgery. According to an investigative report in the London Times the rate of required retreatment might be even higher.

“Patients go in expecting to come out with clearer vision, and many times they come out with permanent damage,” says Mr. Fineberg. “What we have here is a company that has decided to ignore serious concerns raised by physicians about an obviously flawed product.”

Health News - Lasers or surgeons: What’s really the cause of high retreatment rates? - Published Saturday, January 1, 2005

Satisfied users of Alcon Inc.’s LADARVision excimer laser abound, but other surgeons are convinced retreatments were too frequent after they used the system.

READ MORE AT THE WEBSITE

The Promise of Refractive Surgery: A Promise Not Kept

An Insiders Journal on the Evolution and Misinformation of Refractive Surgery

Dedicated to:

And the thousands of others whose quality of life has suffered greatly as a result of

believing the professionally communicated promise of refractive surgery

From website:

http://www.birkacre.freeserve.co.uk/spherical_aberration.htm

Spherical aberration is one of the most important problems that can occur after laser eye surgery, in particular with high myopic corrections.

For lenses made with spherical surfaces, rays which are parallel to the optic axis but at different distances from the optic axis fail to converge to the same point. The peripheral light rays are bent more than the central ones as in the following diagram:

A spherical surface has a "Q value" of 0. A surface which is a parabola has the peripheral part of the lens relatively flatter than the centre and so bends the peripheral light rays less, eliminating this spherical aberration. Such a cornea has a negative Q value and has a prolate shape A parabola has a Q value of -0.5. The human eye of a young person has a Q value of -0.5, which is made up of the cornea (Q= -0.25) and the lens of the eye (Q= -0.25) added up together. The over 40y age group has a rounding out of the lens, so its Q value becomes near O. Hence older people have more natural spherical aberration as their Q value is only that of the cornea i.e. -0.25.

Informed Consent 

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith.

AND MORE...

Cleaner LASIK: Is it Possible?

This from a doctor who was fined $1.1 Million from the FDA for damaging 125 patients...

IOL calculations after refractive surgery need extra care

http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.jsp?id=302330

Excerpt:  The topic of  IOL implantation after refractive surgery and power calculations arose a few years ago. However, Dr. O'Brien noted that now this situation is arising on a daily basis in practices as the number of refractive procedures increases each year and as the population ages.  "There has been a question of whether laser refractive surgery is accelerating the development of cataract. This is controversial, but I see it more and more often in my practice," he said. Dr. O'Brien is professor of ophthalmology and director of the Refractive Surgery Service, Bascom Palmer Eye Institute, Miami.  The problem, he pointed out, is that the patients who have undergone refractive surgery and then develop cataract are different in mindset from the traditional patient with cataract in that they have extraordinarily high expectations; they want immediate results; and they want no surgical discomfort, sutures, or downtime after the procedure.

"These patients who develop cataract after refractive surgery want a perfect outcome. They are potentially frustrated and angry because their quality of vision has suffered as the result of the refractive surgery, and the results may be unpredictable. Interestingly, incorrect power is the most common reason for IOL explantation. This is the result of our not being able to determine the power as accurately as we would like," he stated and advised exercising extra care with these patients.

"Successful LASIK" is an oxymoron

Found on LasikFlap bulletin board: http://www.lasikflap.com/forum

The flap never heals. It cannot heal. All it can do is form a scar at the margin of the flap