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LASIK Eye Surgery: Litigation Challenges and Issues
Todd J. Krouner
LASIK eye surgery is one of the most common forms of surgery in the United
States. The overwhelming majority of patients are satisfied. However, for those
who suffer complications, the resulting visual disability can be life altering.
This article examines the common bases of liability in LASIK litigation.
Plaintiff verdicts from around the country confirm that the pain and
suffering associated with poor quality vision, such as blurring, halos, double
vision and impaired night vision have substantial seven-figure value. The hope
among plaintiff lawyers is that such verdicts will influence high-volume LASIK
surgeons to be less aggressive when dealing with borderline candidates for this
The surgical complication rate is disputed and underreported. The industry
suggests this rate is below 1 percent. However, a recent article asserts that
the rate of complications following LASIK surgery, such as halos, glares, dry
eyes, and impaired night vision, is approximately 20 percent.1 The
disparity occurs because LASIK surgeons do not count dry eyes and poor night
vision, as well as other light phenomena, as "complications," but rather as
known and accepted risks of LASIK surgery.
One of the most serious complications from LASIK surgery is
post-LASIK ectasia. Ectasia
is the bulging of the cornea, which can result in the excessive thinning of the
cornea and compromise its structural integrity. It can occur naturally, and when
it does, it is referred to as keratoconus.2 The term post-LASIK
ectasia is used to refer to ectasia that was laser induced. Ectasia is
progressive in nature, and usually will continue to worsen over time. In most
cases, the ectasia will manifest within the first year following LASIK surgery.
However, a leading article by J. Bradley Randleman, M.D., and others, from Emory
University (the Randleman Study), teaches that post-LASIK ectasia may not
develop until 45 months after the initial LASIK surgery.3 For claims
arising in New Jersey, this is not a problem because the statute of limitations
runs from discovery of the injury. By contrast, New York has no such discovery
rule. Consequently, the delayed onset of symptoms can be fatal to a case, absent
continuous treatment with the LASIK surgeon.
Keratoconus, and its early or sub-clinical predecessor, forme fruste
keratoncus (FFK), are contraindications to LASIK surgery. The Randleman Study
concluded that post-LASIK ectasia is most often caused by the clinician's
failure in screening signs of keratoconus or FFK, or by surgical error in
cutting the patients' cornea too thin, and breaching the structural integrity of
the cornea. Recent studies suggest that 95 percent of the time ectasia occurs
for known reasons, such as the surgeon missing pre-operative warning signs, or
cutting the cornea too. Consequently, ectasia cases should be treated as
evidence of presumptive malpractice.
In addition to cases involving contraindications and surgical negligence,
some LASIK lawsuits arise with patients whose pupil size is larger than the
optical zone of the surgery. In Post v. University Physicians, Inc.,
2002 WL 32832041 (Ariz. Super. 2002), the plaintiff, who was a pilot, was
awarded a $3.4 million verdict when the surgeon failed to recognize the
plaintiff's large pupil size.
Other LASIK litigation involves lifting and creating the flap;
maladministration of postoperative steroid drops giving rise to glaucoma;
varying auto-immune disorders, thin corneas, corneal dystrophy, and central
islands (discussed below) due to poor laser maintenance or product defect.
With today's laser technology,
are another injury, like ectasia, that rarely just happen for no known reason.
The term is used to describe elevations in the central treatment zone of the
cornea that can occur if the laser does not remove enough tissue in this area.
The 'island' consists of a small mound of corneal tissue that can interfere with
vision. Initially, central islands were an unfortunate complication of the early
technology that resulted from the uneven application of the laser's energy. In
recent years, this complication was thought to have been eradicated due to
advances in laser technology. Today, if central islands occur, they can be
assumed to be either a result of a product defect, or of the poor maintenance
and cleaning of the laser itself. In September 2007, Alcon Laboratories recalled
its LADAR 6000 surgical laser, because of reports that its laser created central
Even though the Supreme Court has preempted product liability claims for
medical devices in Riegel v. Medtronic, Inc., 128 S. Ct. 999
(2008), claims against product manufacturers can succeed under at least three
theories. These include failure to manufacture the product in accordance with
the specifications submitted to and approved by the Food and Drug Administration
(FDA), failure to follow FDA protocols, and violations of parallel state law
consumer fraud statutes. In March 2009, the Medical Device Safety Act was
introduced to overturn Riegel, and reinstate injured patients' rights
to recover for faulty medical devices.
In addition to
defective surgical laser, patients have developed central islands where a
well-designed laser was not maintained properly. The laser needs to be tested
and calibrated periodically. If this is not done, saline-like fluid has been
known to splash on the laser optics and impair the even flow of the laser
energy, and has also resulted in central islands. Central islands are one
example of a corneal injury that, if severe enough, has no present cure or
Effects on Individuals
Vision has two components, acuity (quantity) and quality. Post-LASIK
complications can distort the patient's vision, may impair visual acuity and
will affect visual quality. Even if the patient can read the letters on the
Snellen eye chart, often it is accompanied with double vision, blurring,
ghosting, halos and various light phenomena including photosensitivity,
difficulty with night vision, and starbursting.4
In addition, there are a small, but alarming, number of patients who have
committed suicide allegedly due to LASIK complications. Although the industry
asserts that suicide is a multi-factoral issue, and that no such association
between LASIK and suicide can be demonstrated, there exists a clear correlation
between visual impairment and depression.5 As other surgeons are
required to assess a patient's mental health before surgery, at minimum, it
would be prudent for LASIK surgeons to do the same.
Treatment is difficult for patients of
Glasses do not help. Contact lens therapy is thwarted by dry eyes. Intacs offer
another hope in stabilizing vision. Intacs are artificial lenses implanted into
the cornea in an attempt to reshape the cornea. In the worse case, a corneal
transplant surgery is necessary. Recently, the FDA has approved an experimental
protocol to arrest, but not cure, post-LASIK ectasia. It involves riboflavin
drops and ultraviolet (UV) light. The hope is that the combination of riboflavin
and UV light will, on a microscopic level, increase the levels of collagen in
the cornea to strengthen the cornea and prevent further deterioration.
Jury Verdict Data
Juries in New York, and around the country, are recognizing the substantial
value associated with loss or impairment of vision. At the same time, it is
difficult to explain to a jury how problems with visual quality can ruin a
patient's life, when the patient retains a reasonable visual acuity. Pictures of
these qualitative complaints, from the patient's eye doctor, or from the
patient's environment can be quite helpful.
In July 2005, a Manhattan jury awarded an investment banker $7.25 million in
Schiffer v. Speaker, where the author represented the plaintiff. The
doctor was found negligent in screening the patient, who had pre-operative FFK.
The pain and suffering award alone was $3 million. The award was affirmed in
Schiffer v. Speaker, 36 A.D.3d 520 (1st Dept 2007). Last month, in a
case where the author represented the plaintiff, a Manhattan jury returned a
verdict of approximately $5.6 million in another ectasia case. The pain and
suffering component in that case was also $3 million. Devadas v.
Index No. 107637/07 (N.Y. Sup. Ct.) The post-trial process is at an early stage.
In 2006, a jury in Nassau County returned a pain and suffering award of $3
million (which was reduced to $2.1 million post-trial). Gropack v.
Donnenfeld, Index No. 8476/02 (Sup. Ct. Nassau Co. 2007) (J. Mahon). No
meaningful claim for loss of income was reflected in that verdict.
Prior to the Schiffer case, a pilot was awarded $3.4 million for
post-LASIK visual complaints. Post v. University Physicians, Inc., 2002
WL 32832041 (Ariz. Super. 2002). Last year, a $2.1 million settlement was
reported in a LASIK malpractice case in New Jersey, against Dr. Joseph Dello
Russo. Russell Ben-Ali, "Lasik patient received $2.1M: Eye surgeon settles suit,
does not admit fault," The Star Ledger, 07/08/08.
In Crawford v. City of New York, 198 A.D.2d 48 (1st Dept. 1993), the
plaintiff was awarded $1 million for pain and suffering for an injury to only
one eye. In Cofsky v. Goosey, 2002 WL 32119471 (Texas Dist. 2002), the
plaintiff received a settlement of $1.75 million. In Johnson v. LCA Vision,
Inc., 285 A.D.2d 971 (1st Dept. 2001), the New York Appellate Division held
that a $1 million award for future pain and suffering for post-LASIK visual
impairment in only one eye was reasonable.
Multimillion-dollar verdicts have made LASIK surgeons less aggressive in
operating on patients whose screening is suspicious for FFK. In 2005, in
response to the Schiffer v. Speaker verdict, several ophthalmologists
wrote and published an article in an attempt to reset the standard of care.
Binder, P, Lindstrom, R, et al., "Keratoconus and Corneal Ectasia After LASIK,"
Journal of Refractive Surgery, Nov/Dec 2005, p. 749.
Finding a LASIK surgeon who is willing to testify on behalf of an injured
patient is almost impossible. Yet, without a reputable LASIK surgeon, the case
cannot proceed. One of the most significant impediments to retaining a LASIK
expert to testify is retaliation. In Post, supra, TLC's founder,
Jeffrey Machat, M.D., testified in favor of the patient.6 As a
result, his refractive surgeon colleagues retaliated against him, cursed him,
verbally assaulted him, and he was forced to resign from TLC's advisory board.
In other cases, experts have had invitations to present at professional
conferences revoked and been threatened with baseless ethics complaints.
Consequently, extraordinary efforts must be made to protect the identity of
the few well-credentialed experts who are willing to testify on behalf of
plaintiffs. Protective orders should be considered to insulate experts from
FDA Advisory Panel Hearings
In April 2008, the FDA convened hearings in response to patient requests for
a review of the safety and effectiveness of LASIK surgery. As there have been
increasing complaints of dissatisfaction and suicide in connection with LASIK
surgery, the FDA assembled members for the Ophthalmic Device Panel to hear from
various constituents. In response, the FDA has commissioned a LASIK Study Task
Force to evaluate quality of life after LASIK. To date, there has been no
report. Incidentally, all of the ophthalmologists on the Advisory Panel wore
Contrary to the Supreme Court's view in Riegel, supra, the FDA is
LADAR 6000 surgical laser was approved without input from its Ophthalmic
Device Panel. State licensing agencies are indifferent to complaints of serial
wrongdoers. A LASIK surgeon in Chicago has been sued 43 times, and the Illinois
Medical Disciplinary Board has seen no merit to patient complaints. Governmental
oversight is myopic.
Todd J. Krouner is a principal at the Law Office of Todd
J. Krouner, in Pleasantville, N. Y. He represented the plaintiffs in 'Schiffer
v. Speaker' and 'Devadas v.
Niksarli' which are discussed in this article. Leigh Ryan,
a law clerk at the firm, assisted in the preparation of this article.
- Bailey M.D., Zadnik K. "Outcomes of LASIK for myopia with FDA-approved
lasers," Cornea. 2007 Apr; 26(3):246-54.
- For the purposes of this article, the terms "keratoconus" and "post-LASIK
ectasia" will be referred to by the term "ectasia."
- Randleman JB, et. al. "Risk Factors and Prognosis for Corneal Ectasia
after LASIK," Ophthalmology. 2003;110:267-275 at 269.
- See, e.g., Abby Ellin, "L.ASIK Surgery: When the Fine Print Applies to
You," N.Y. Times, March 13, 2008.
- Ingrid U. Scott, M.D. et al., "Quality of Life in Low Vision Patients and
the Impact of Low Vision Services," 128 American Journal of Ophthalmology 1
- TLC is a national provider of laser facilities. It is a public company
whose shares trade on the NASDAQ. Tiger Woods is one of their celebrity
spokesmen. TLC was also a codefendant in the Schiffer case.
This article is republished with permission from the
July 15, 2009, issue of the New York Law Journal,