Chappaqua Personal Injury Blog

According to the Chicago Tribune, the Illinois Department of Financial and Professional Regulation has finally shut down one of its most sued LASIK surgeons, after more than a decade of complaints.

Dr. Nicholas Caro was found guilty of unprofessional conduct and gross negligence earlier this month. However, he has been sued nearly 50 times for medical malpractice since the 1990’s.

While he has been banned from performing any more LASIK surgery, and fined $10,000, that is a small consolation for the dozens of patients who have suffered life altering visual disabilities as a result of his unprofessional conduct and gross negligence.

The fact that Dr. Caro’s colleagues and the Illinois licensing authorities tolerated his misconduct for more than a decade is inexplicable.

If you are a potential patient entering the Wild, Wild West of LASIK, the good surgeons vastly outnumber the bad. However, bad doctors like Nick Caro do not come with warning labels. Consequently, you are on your own.

Coincidentally, the Chicago Tribune story has two ads by Google linked to this story. One is to LASIKPlus, whom I sued in Virginia earlier this month. The second is for “Cornell-Columbia-Harvard trained” Dr. Kevin Niksarli, M.D., against whom I obtained a $5.6 million LASIK malpractice verdict in June 2009.

Sources: Chicago Tribune Article Regarding Dr. Nick Caro - http://www.chicagotribune.com/news/local/ct-met-bad-eye-doctor-20100219,0,2101781.story; Lawsuits Against Dr. Nick Caro - http://www.lifeafterlasik.com/nickcarolawsuits.htm; Niksarli Verdict Press Release - http://www.krounerlaw.com/press-release-061109.html; LASIKPlus Press Release - http://www.krounerlaw.com/press-release-021210.html

As a New York LASIK malpractice attorney, frequently, LASIK patients contact me and complain that they have suffered complications from their surgery. They quickly add that they fear that they signed papers (which they call a “release,” or more accurately, an informed consent form), prior to their surgery, preventing them from pursuing a lawsuit. However, signing an informed consent form does not prevent legal action. The doctor’s pre-operative informed consent form does not protect him from his own negligence.

In New York, the Pattern Jury Instructions, which a judge reads to a jury in a medical malpractice case, provide the following statement of the doctor’s duty of informed consent to his patient:

“Before obtaining a patient’s consent to an operation or invasive diagnostic procedure or the use of medication, a doctor has the duty to provide certain information concerning what the doctor proposes to do, the alternatives to that operation, procedure or medication and the reasonably foreseeable risks of such operation, procedure or medication. It is the doctor’s duty to explain, in words that are understandable to the patient, all the facts that would be explained by a reasonable medical practitioner so that when the patient does, in fact, consent, that consent is given with an awareness of:

1. the patient’s existing physical condition;
2. the purposes and advantages of the operation, procedure or medication;
3. the reasonably foreseeable risks to the patient’s health or life which the operation, procedure or medication may impose;
4. the risks involved to the patient if there is no operation, procedure or use of medication; and
5. the available alternatives and the risks and advantages of those alternatives.” NY PJI 2:250A.

With LASIK surgery, it is customary for a patient to sign a multi-page typed form that purports to instruct the patient of all of the risks of surgery. According to TLC’s form, you may not be a candidate for LASIK surgery if you have:

“inflammation or infection, severely dry eyes, excessive corneal scarring, certain degenerations or dystrophies of the cornea, lazy eye, muscle imbalance, keratoconus or any condition which may affect healing; history of Herpes Simplex eye infections, uncontrolled vascular disease, uncontrolled diabetes, lupus, rheumatoid arthritis; a compromised immune system; a pacemaker or defibrillator; progressive nearsightedness or farsightedness; previous corneal surgery; corneal blood vessel growth; keloid formation; or have taken Accutane, Cordarone or Imitrex.”

TLC’s form also states that vision threatening complications include:

“excimer laser malfunction, causing permanent irregularity of the cornea leading to uncorrectable loss of vision; microkeratome or Pulsion-FS laser malfunction, causing an abnormal corneal flap leading to uncorrectable loss of vision;  decentered treatment causing permanent irregularity of the cornea, leading to uncorrectable loss of vision; irregular corneal healing which causes distortion, ghost images and scarring; epithelial healing defects, resulting in delayed healing, pain, light sensitivity, or infection; wrinkled, displaced or lost corneal flap; corneal infection; corneal inflammation; intractable glare and inability to function in a dark environment; retinal detachment, venous or arterial blockage of the retina, hemorrhage of the retina, cataract formation, total blindness or loss of the eye; and complications due to anesthetic drops or other medications used in conjunction with LASIK.”

Given the comprehensive nature of such forms, the patient wonders how he can sue when this fine print regrettably applies to him. First, the consent form does not protect the doctor from his own negligence. For example, if the patient initially was not a good candidate for surgery, if the doctor was negligent in performing the surgery, or if the laser malfunctioned, the informed consent form will not protect the doctor.

So, when might the informed consent form matter? A recent article in Cornea reports that 20% of LASIK patients suffer varying degrees of dry eye after LASIK surgery.  As a general rule, the complication or side effect of dry eyes is not due to any error or mistake by the doctor. It is generally considered to be a known and accepted risk of the surgery. The doctor tells you this so that you are not surprised if it happens to you. Dry eyes generally are not a sign of malpractice.  However, failing to inform a patient of this common side effect would constitute a breach of the duty of informed consent. (Bailey M.D., Zadnik K. “Outcomes of LASIK for myopia with FDA-approved lasers,” Cornea. 2007 Apr; 26(3):246-54.)

Informed consent is a process. It is not a piece of paper. The pre-printed informed consent form is prepared for the vast majority of refractive laser surgery patients. But if the patient is at higher risk because he has a pre-existing corneal condition or disease, such as keratoconus, is suspicion for ectasia, or has a thin cornea, the doctor has a duty to inform his patient.

Ideally, it would be appropriate for the doctor to give the patient the written form in advance of the day of the surgery, such as when the initial screening is performed. Then, the patient might actually be able to read and understand the form, and have a chance to ask the surgeon follow up questions. However, in some high volume LASIK surgery centers, patients have been given such forms after their eyes have been dilated, when they cannot read, or after they have given Valium as a sedative for the surgery, after which they may not fully comprehend what they are reading.

If you have had LASIK surgery and suffered a complication, you should contact a lawyer to investigate whether you have a malpractice claim. Your having signed an informed consent form does not prevent you from pursuing a valid claim of surgical negligence.

If you have not yet had surgery, you should insist on speaking to the surgeon, and not your optometrist, or “technician.” You should ask your eye surgeon to describe to you in terms that you can understand the risks, benefits and alternatives to surgery. The fact that LASIK surgery is customarily scheduled by the doctor in 15 minute increments, and takes just seconds to perform, does not mean that the doctor cannot give you 5 minutes of his time to talk to you, especially after having paid thousands of dollars for the surgery. Most importantly, you should acknowledge that you have read, or would like a chance to read, the written informed consent form, BUT you would like to know if there is any reason, particular to you, why the surgery may carry increased risks that do not apply to the general population. Given the elective nature of the surgery, if so, you may want to think long and hard about going forward with such surgery, and hope that you have surgeon who thinks the same way.

In a recent article, New York Times reporter Abby Ellin writes that Army doctor Erik J. Rupard, refers to LASIK as “the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that the few of us who speak ill of it are dismissed as cranks and/or loonies.”  Dr. Rupard’s assessment is based on the volume of dry eye complaints he witnessed in soldiers serving in Iraq.

More alarming still, is the admission of Morris Waxler, who as former branch chief of the FDA’s Center for Devices and Radiological Health Office of Service and Technology, was responsible for the FDA’s approval of the first lasers in 1998.  Mr. Waxler says: “We screwed up…We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials.”

Abby Ellin, who previously wrote of her own poignant LASIK regrets, reports that the LASIK industry disagrees with Dr. Rupard, and maintains that LASIK is among the safest elective procedures ever devised.  Millions of satisfied patients may agree.  And, some soldiers may claim that LASIK literally saved their lives, notwithstanding their dry eyes.

Still, for most of us civilians, the decision to have LASIK surgery is rarely a matter of life or death.  Hopefully, the recently announced FDA and Department of Defense proposed joint study will give LASIK consumers reliable information about LASIK complications and quality of life issues so that they can make an informed decision whether to have this surgery.

The statute of limitations refers to the period within which you must start a lawsuit.  If you fail to act in timely fashion, a court will dismiss your lawsuit, no matter how strong your claim may have been.  Consequently, tardy victims can be left without any legal remedy.  The statutes of limitations for medical malpractice vary from state to state in duration (and exceptions).  For instance, the statute of  limitations in New York is two and one half years, and may be extended, or “tolled”, if you continued treatment with the same physician for the same condition;  in New Jersey, the statute of limitations is two years, but may be extended until you discover your injury;  in California, the statute of limitations is three years, or one year from discovery of your injury, but in no event can you sue more than three years after the last act of the defendant doctor.

For victims of LASIK eye surgery malpractice, the statute of limitations poses extra perils.  Recently, I was contacted by doctor who had LASIK eye surgery at TLC in 2003, when he was living in California.  In 2004, he moved to New York, where his subsequent treating ophthalmologist diagnosed him with post-LASIK corneal ectasia in 2009.  Ectasia is a progressive thinning of the cornea, which can cause poor visual acuity and poor visual quality.  Complaints such as double vision, halos, glare, ghosting, star bursts, blurring, and photosensitivity are common.  In this case, the new eye doctor informed his patient that the original TLC surgeon was negligent because the patient was never a suitable candidate for LASIK due to the preoperative condition of his eyes, which included thin corneas and substantial astigmatism.  On average, ectasia can take 16 months to develop after LASIK surgery[1].   In this case, unfortunately for the patient, the time bomb of ectasia had a particularly long fuse, and took almost five years to develop, by which time it was too late for the patient to sue his LASIK surgeon, under his unique circumstances.

In short, lawsuits are not like fine wine.  Generally, legal claims do not improve with time.  Memories fade; witnesses disappear; evidence is lost.  If you think you may be the victim of medical negligence, you should seek prompt legal advice.  Many potential clients explain that they need to take care of their medical crises before they can even think about a lawsuit.  That priority makes sense and is understandable.  But it is equally important to at least learn and understand the statute of limitations that applies to your case, so that it does not expire inadvertently.

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[1] Randleman, J.B., et al.“Risk Factors and Prognosis for Corneal Ectasia after LASIK.” Ophthalmology 2003; 110:267-275.

What is the true complication rate for LASIK surgery? Who knows?  Last summer, in the New York Law Journal, I reported that depending on the source it varies from 1% to 20%.  There are two explanations for this large discrepancy.

First, most LASIK doctors do not report complications.  Hundreds of patients were injured by Alcon’s defective LADAR 6000 surgical laser, which had to be recalled.  Yet, only a minority of surgeons reported on injuries caused by the defective laser.  Ectasia is a rare complication of LASIK surgery.  Hyperopic ectasia, in farsighted patients, is rarer still. In the medical literature there is only one reported case of hyperopic ectasia.  In my law office, I have two. In neither case did the LASIK surgeon report the complication.  In one case, the ectasia followed 10 operations on one eye.  In the other case, the ectasia followed four operations on one eye.  Obviously, it would help the LASIK community, to say nothing of their patients, if doctors saw fit to report that repeated surgical procedures might be associated with LASIK complications, including hyperopic ectasia. The discrepancy turns on the definition of a complication.  Complications have been recognized to include sensitivity to light, difficulty in night driving, difficulty in reading, double vision, fluctuation in vision, glare, halos, starbursts, dryness, pain and foreign body.

Second, LASIK surgeons do not count dry eyes as a complication of LASIK surgery.  Rather, it is a mere side effect.  However, for patients with severe dry eye, it can be a visually disabling.

In April 2008, the FDA held hearings on LASIK complications.  To date, no report has resulted.  However, last week, the LA Times reported that, at last, the FDA has decided to examine patient satisfaction with LASIK surgery.  With the assistance of the Department of Defense and National Eye Institute, a multi-phase, multi-year, study is planned.

We will have to wait a while to learn whether the real complication for LASIK surgery is closer to 1% or 20%, and we will have to see how narrowly, or broadly, the FDA defines a “complication.”

If you think the benefits of LASIK surgery outweighs the risks, you should consider the following factors in selecting a LASIK surgeon:

1. fellowship training in cornea
2. significant academic credentials
3. affiliation with a university teaching hospital
4. a conservative approach to surgery, especially here, where LASIK surgery is entirely an elective procedure.

If one doctor has expressed reservations about performing LASIK surgery, or has indicated you may not be a suitable candidate, why look for a more aggressive surgeon who will do it? Using a more aggressive doctor may lead to a serious LASIK malpractice case. This is not cancer treatment. I have had two cases where one doctor said “no”, and the second doctor said “yes”, with predictably bad outcomes each time for the patient.

Finally, I would not select a doctor, no matter how good his or her credentials are, where:

1. there are lawsuits
2. the doctor works at a high volume national LASIK center, like TLC, or the local equivalent.

Lawsuits are like cockroaches. Where there is one, there are likely to be several. You do not want to be perceived by your doctor as merely a potential cost of doing business.

Good doctors make bad mistakes at high volume LASIK mills by being inattentive, over-delegating responsibility for your screening, care and post-operative treatment, or simply by running the LASIK patient conveyor belt too fast. You are paying for, and deserve, individualized medical care. Make sure your LASIK surgeon accepts responsibility for all facets of your care and always consult a New York LASIK malpractice attorney if there are complications or disagreements about said responsibility

Data support LASIK benefits, safety

Negative opinions and LASIK complication horror stories were not the only component to the public testimony at the meeting. Several speakers presented a large body of scientific evidence that showed the benefits of LASIK and high patient satisfaction rates.

OSN Refractive Surgery Section Member Kerry D. Solomon, MD, spoke about the worldwide retrospective literature review of LASIK that found a 95.4% patient satisfaction rate from post-LASIK patients. Dr. Solomon and OSN Chief Medical Editor Richard L. Lindstrom, MD, who was not present at the panel meeting, are co-chairs of the ASCRS task force on LASIK.

OSN Cornea/External Disease Section Editor Eric D. Donnenfeld, MD, presented for the first time a separate worldwide retrospective review that the task force conducted analyzing dry eye after LASIK.

In a meta-analysis of more than 1,000 articles, the task force found reviewable data from 46 peer-review articles published in 13 journals from 15 countries and covering more than 32,000 eyes. Dr. Donnenfeld and colleagues found that although dry eye is common after LASIK (35% of patients), 32% of those same patients had pre-existing dry eye before surgery.

“The great majority of patients had complete resolution of their dry eye symptoms over a 2- to 4-week period following surgery,” Dr. Donnenfeld said. “Severe dry eye following LASIK is extremely rare.”

The military experience

Some of the strongest evidence and testimony in support of LASIK came from reports from the U.S. military’s experience with LASIK.

Previously trained in the Special Forces before becoming an eye surgeon, Lt. Col. Scott Barnes, MD, from Fort Bragg, N.C., described how commanders in the Special Forces asked him to evaluate LASIK specifically for those Special Forces soldiers.

“I said, ‘Well the Army has decided it’s a good thing.’ They said, ‘We don’t care what the Army says. We want to know from one of our guys who used to be out there doing the sorts of things that we’re doing: jumping out of planes, diving and flying helicopters. We need to know is this safe for us,’” Dr. Barnes said.

Since that time, Dr. Barnes said, the Special Forces troops have come to rely on LASIK to help them on the battlefield.

“It’s a significant issue for these guys,” he said. “They’re not talking about cosmetic needs. They’re saying, ‘I can’t do my job as well in glasses or contacts as I can after refractive surgery.’”

Cmdr. David Tanzer, MD, of the Navy, who was invited to speak by the FDA panel, cited a number of studies such as the flap stability study that found no flap dislocations occurred in either halo jumps, which are freefall parachute jumps from airplanes at high altitude, or forced ejections of pilots from airplanes, which occur with great force.

“There have been 45 studies performed to date by the Department of Defense,” he said. “Our goal is the constant, independent evaluation of the safety and efficacy of laser vision correction.”

Quoting a study published last year in Archives of Ophthalmology, Dr. Tanzer said the risk of infection from contact lens wear was 0.18%, whereas infection from LASIK was 0.05%.

To date, there has only been one medical disability retirement due to complications related to laser vision correction, which would equate with a 0.0009% incidence in the military, Dr. Tanzer said.

Panel reacts

The FDA panel commented on the diversity of opinions represented at the forum.

“I think we have heard here today there are two different animals here,” Dr. Weiss said. “We have those patients who come in the next day who are filled with elation … and they are very happy patients, and then we have those people who have been reported to us today, who have visually disabling starbursts and halos. I think we need to start, if we are not already, distinguishing between the side effects that disappear and the complications.”

According to Dr. Weiss, there were a number of disturbing issues raised during the meeting that fell outside of the purview of the FDA that should be addressed in other forums, including overly aggressive marketing, use of LASIK as a commodity, the lack of informed consent in some cases and inadequate patient screening procedures.

Recommended labeling changes

The panel made a number of recommendations for changes to patient labeling as well as for the FDA Web site page on LASIK.

The panel agreed that post-LASIK patients who go on to have cataract surgery should have IOP monitoring. There should also be an indication that LASIK affects IOL implant measurements. Several photos should be used to distinguish how vision appears when affected by halos, starbursts or glare. The panel also recommended, if not present already, there be sufficiently strongly worded caution for patients with keratoconus and other ecstatic disorders.

The panel also advocated distinguishing between those with collagen vascular disease vs. those with collagen vascular disease with dry eye. Dr. Weiss said some wording should be included to point out possible psychological implications of adverse LASIK outcomes.

Surgeons recognize warning

Drs. Solomon and Donnenfeld discussed with Ocular Surgery News what they took away from this meeting and how it would impact refractive practices.

“I think it’s important that we make absolutely certain we have a good discussion about the motivations and expectations a particular patient has in terms of why they want to be less dependent on their glasses and contacts,” Dr. Solomon said. “I think it’s incredibly important because in my own experience, assuming that the eye is healthy and a good exam has been done, if someone’s goals, expectations and motivations are in line with what these procedures can provide, and I have had a good informed consent discussion with them, the vast majority of patients do incredibly well.

“If that rare occasional thing should occur where someone is dissatisfied, we as physicians need to spend the time with that patient to make them understand we are in this together. … What I did hear [at the panel] was that some of these patients felt like they were abandoned.”

Dr. Donnenfeld also stressed the need to care for dissatisfied patients.

“While LASIK is the safest elective procedure ever, we as ophthalmologists cannot rest until every patient has as good a result as possible and every complication is eliminated,” he said.

“We also have to be sensitive to the needs of unhappy patients,” he said. “These patients require more time and empathy, and we really have to go out of our way to make sure they achieve the best results they can possibly achieve.”