LASIK Blog
LASIK Racketeers
December 5th, 2011TLC was once the largest laser eye facility in the United States. Its parent corporation’s stock traded on the New York Stock Exchange, until it recently went bankrupt. However, its bankruptcy did not come soon enough for a large cluster of approximately 60 patients in South Carolina, who developed an avoidable, vision threatening complication, post-LASIK ectasia. In their class action, the patients allege that TLC not only injured them, but also concealed their diagnosis, so that their statutes of limitation would run.
In addition to TLC, the individually named LASIK surgeons include a “who’s who” in the industry, and cover laser centers nationwide, including New York, Chicago, Denver, Atlanta, Boca Raton, Pittsburgh, Cleveland and Madison.
Separate from the medical malpractice claims, the class action alleges that TLC and its doctors engaged in a pattern of racketeering activity by keeping two sets of patient records, and denying patients access to their “true” records, which revealed their diagnosis of vision threatening ectasia.
In a February 2011 decision, the federal court dismissed the racketeering claims because under South Carolina law, patient records are the property of the doctor, and not the patient. In addition, to the extent that some claims were 10 years old, or more, the court ruled that they were barred by the statute of limitation.
Still, the thrust of this shocking lawsuit continues in state and federal court inSouth Carolina. The case is a sad reminder of the worse of the LASIK industry including:
(1) Profits coming ahead of patient care;
(2) Doctor preservation coming ahead of patient vision preservation;
(3) Under reporting and non-reporting of serious vision threatening complications not only to the FDA, but to the patients themselves.
For a copy of the decision, Dickenson v. TLC LASIK Centers, please click here.
If you or a loved one has been injured by a doctor, you should promptly contact an attorney with experience in medical malpractice. The Law Office of Todd J. Krouner has a proven track record of helping patients injured by LASIK (and other forms of medical malpractice) all over the country. To determine if you have a strong case, contact us for a free consultation at (914) 238-5800.
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The Challenges of Medical Malpractice Lawsuits
September 19th, 2011A recent study confirms that 80% per cent of medical malpractice lawsuits are won by doctors. While that news is disappointing to victims of medical negligence, it is neither surprising nor news to seasoned trial lawyers. By contrast, our experience with LASIK eye surgery negligence is quite the opposite. Why the differences?
Medical malpractice cases are difficult for several reasons. First, patients are suing doctors, who generally are trusted, respected and beloved by jurors. Second, patients are required to hire qualified medical experts, who must be willing to testify against their colleagues. Third, the cost of prosecuting malpractice cases is expensive. Fourth, patients typically come to doctors with a disease (cancer for example) or injury which was not the doctors’ fault. Given all of these hurdles, an earlier study revealed that only 3% of patients who had strong claims ever bothered to bring them.
LASIK malpractice is different from other forms of medical malpractice for two important reasons. First, high volume LASIK surgeons, who run LASIK factories and do not even know their patients, are loathed rather than loved by jurors for turning eyes into commodities. “Sale on LASIK! $250/eye this week!”
Second, LASIK malpractice cases differ even from other eye cases, such as where a patient has an underlying disease such as cataracts, glaucoma or a detached retina. Wearing glasses or contact lenses is not a disease. Consequently, when a patient is blinded, or left severely visually disabled by LASIK or PRK surgery, it becomes extremely for difficult for careless eye doctors to defend their actions.
If you or a loved one has been injured by a doctor, you should promptly contact an attorney with experience in medical malpractice. The Law Office of Todd J. Krouner has a proven track record of helping patients injured by LASIK (and other forms of medical malpractice) all over the country. To determine if you have a strong case, contact us for a free consultation at (914) 238-5800.
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The Statute of Limitations is the Doctor’s Friend, Not Yours
June 21st, 2011The statute of limitations is the period by when you are required to start a lawsuit. The statute of limitations varies depending on the type of claim, and even for the same claim, can vary from state to state.
In New York, the statute of limitations for medical malpractice is two and one-half years from the date of surgery. It may be extended for continuous treatment by the same doctor, for the same condition. By contrast, in New Jersey the statute of limitations for medical negligence is two years, but may be extended until the time when the patient discovers his or her injury. The legal definition of “continuous treatment” or “discovery” can be complicated, even to lawyers, and requires careful discussion between you and your attorney.
Too often, I speak to patients with LASIK surgery complications or bad outcomes after their statute of limitations expire. Many could prove negligence or mistakes by their eye doctors. However, their claims, and ability to recover fair compensation for their visual problems, are barred as untimely.
I ask, “Why did you wait so long to call a lawyer?” The answer I get is because the doctor said they would get better with time. Sometimes that may be true. But should the patient wait two years, or longer, on the hope of getting better?
In South Carolina a lawsuit against TLC alleges that its eye surgeons knew patients had ectasia, or other related LASIK malpractice injuries, and did not tell the patients. Instead, the lawsuit alleges that the doctors led the patients along with false hopes and promises of improvements for the purpose of making sure that the patients’ statute of limitations expired.
Certainly not all doctors are that conniving. However, your doctor knows the statute of limitations. So should you. If six months after your surgery you are not getting better, call a medical malpractice attorney in your community to learn the statute of limitations. Making the call should not cost you anything. Making the call will not obligate you to do anything. It’s bad enough to be the victim of a doctor’s negligence. It is even worse to be without any legal remedy. If you know your statute of limitations, then you can make an informed decision whether or not you want to take action. Your rights to be reimbursed for lost income, medical expenses or your pain and suffering should not evaporate without you at least knowing.
If you believe that you or a loved one has been injured as a result of eye surgery negligence, contact the LAW OFFICE OF TODD J. KROUNER for a free initial consultation.
read moreDo I have a LASIK malpractice case?
June 14th, 2011To determine if you have a claim for medical malpractice, including from LASIK surgery, it is not enough that you have a bad result.
First, a qualified medical expert needs to review your medical records, including color copies of color images (such as color cornea topographies or Orbscans), and confirm that your doctor departed from the standard of care.
Second, the expert needs to be able to say that the doctor’s negligence caused your injury, as distinct from a pre-existing disease process.
Finally, you need to demonstrate damages, which can include loss of income, medical expenses, and pain and suffering, including loss of life’s enjoyment.
Often LASIK victims wonder if their claim is worth pursuing. The best way to find out is to consult with an experienced attorney, who has a proven track record of successfully litigating LASIK and related eye injury cases.
For a free initial consultation, please contact the LAW OFFICE OF TODD J. KROUNER at info@krounerlaw.com.
read moreLASIK, Money, and Patient Satisfaction
April 22nd, 2011In The Big Short, in a chapter ironically entitled “In the Land of the Blind,” best-selling author Michael Lewis describes how doctors respond to bad incentives. He explains “The evolution of eye surgery is another great example.” He writes that LASIK was born when Medicare reimbursements for $1,200 cataract procedures were slashed to $450. Quoting a Vanderbilt trained neurologist, Michael Bury, M.D., “the incentive was to maintain their high [seven figure] incomes, and the justification followed.”[1]
In the news, Morris Waxler, Ph.D., calling on the FDA to pull the plug. He worked for the FDA when the lasers were initially approved. In short, Dr. Waxler says if he knew then what he knows now, he never would have recommended that the FDA approve LASIK.
Responding en masse, the LASIK-Industrial Complex is calling on its titans to trumpet the safety of the current generation of LASIK technology in the hands of skillful surgeons.[2][3][4][5] They say LASIK is the safest surgical procedure known, with patient satisfaction rates ranging from 95 to 98 %.
For the LASIK consumer, the challenge is to find the right surgeon and the right technology. As recently as 2007, Alcon’s LADARVision 6000 surgical laser was quietly recalled by the FDA after hundreds of patients were injured by the product defect. Problems with creating surgical flaps have been reduced by Intralase lasers, which have replaced the prior generation microkerotomes, or miniature meat slicers. Yet, doctors still use microkerotomes. And, while the LASIK industry says the current generation of technology is terrific, where were the warnings for those unwitting “guinea pig” patients who were injured by the prior technology?
In selecting a surgeon, competence and experience help. But what matters more is the surgeon’s business model. Even terrific LASIK surgeons have failed their patients in high volume LASIK factories.
In short, I have three impressions about the current debate between Morris Waxler and the LASIK industry:
1. I do not support Dr. Waxlerr’s petition to cease LASIK. I know too many honest, intelligent LASIK surgeons, “who eat their own cooking,” to say the surgery is inherently flawed.
2. Knowing the true risks and consequences of this elective surgery, I choose to stick with my glasses and contact lenses.
3. For LASIK surgery customers to make their own truly informed decision about the risks, benefits and alternatives to this popular surgery they deserve an independent patient satisfaction study that is free of the influence of the LASIK Industrial Complex.
[1] Michael Lewis, The Big Short (2010), pp. 43-44.
[2] http://www.youtube.com/watch?v=RfpV89JZNYY
[3] Doyle Stulting article
[4] http://www.cnn.com/video/#/video/health/2010/09/28/nr.lasik.safety.cnn?iref=allsearch
[5] http://www.osnsupersite.com/view.aspx?rid=81833
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Public Health Advisory on CNN Released about Dangers of LASIK
April 12th, 2011CNN recently featured an interview with former Food and Drug Administration (FDA) Chief, Dr. Morris Waxler, who participated in approving LASIK (Laser-Assisted In Situ Keratomileusis) surgery in the 1990s. LASIK is a serious procedure that permanently alters the shape of the cornea (the clear outer layer of the front of the eye) using an excimer laser.
In the interview, Dr. Morris emphasizes the potential risks involved with LASIK surgery and stated that the procedure and its dangers have not been sufficiently studied. Dr. Morris also stated that the failure rate of LASIK is over about 50% and that only about 60% of patients who have the surgery are able to see without glasses or contacts. Moreover, Dr. Morris claims that 18% or more patients suffer glare, halo, dry eyes, and other similar problems and that less than 1% have suffered the consequences of having a cornea that is too thin.
Previously, Dr. Waxler has stated that if he knew then what he knew today, he would not have recommended approving LASIK surgery medical devices.
The Food and Drug Administration announced the beginnings of a collaborative study with the National Eye Institute and the Department of Defense in 2009 to evaluate the potential effects on patients’ quality of life from LASIK. The LASIK Quality of Life Collaboration Project is hoping to determine the percentage of patients with substantial quality of life problems after having LASIK surgery and hone in on predictors of these issues. In addition, the FDA issued warning letters to 17 LASIK ambulatory surgical centers after inadequate adverse event reporting systems were discovered at the centers.
Dr. Steven Slade presented the counter-point that LASIK is among the safest surgeries performed.
Please view the video below for more on the interview regarding the dangers of LASIK:
read moreLASIK Surgery Rates Increased in 2010
November 11th, 2010Recently, the International Society of Refractive Surgery (ISRS) announced the results of its yearly survey of refractive surgery among its United States members.
The survey showed an increase in the volume of LASIK surgeries for the first time since 2001.
The survey found that the volume of LASIK surgeries was up 7 percent from two years ago. However, the number of surgeons who identify themselves as high-volume LASIK surgeons (defined as performing 75 surgeries a month) continues to decrease; 27 percent identified themselves as such in 2001 and only 12 percent did this year.
There were also increases in the number of surgeons and their family members who underwent LASIK. In 2010, 28 percent had LASIK surgery and 11 percent reported having surface ablation. By contrast, rates in 2009 for the same procedures were 18 percent and 4 percent, respectively. The survey also showed that nearly one third of the respondents’ spouses, as well as at least one child, underwent surgery for vision correction. Additionally, nearly two-thirds of respondents had at least one sibling who underwent LASIK.
According to the U.S. Food and Drug Administration (FDA), LASIK is a surgical procedure that helps reduce a patient’s dependency on contact lenses or glasses by permanently reshaping the cornea by using a laser.
The majority of patients who have this popular elective surgery are satisfied. However, for some, compilations of LASIK surgery can reduce their visual acuity or visual quality to the point where they have a difficult time working, driving, or pursuing the very activities for which they sought LASIK surgery. Complaints can include dry eye, blurring, and difficulty with light, such as sensitivity, ghosting, glare and halos. In patients with ectasia, or a thinning of the cornea caused by LASIK surgery, cornea transplants may be required.
When performing high-risk surgeries such as LASIK, it is expected that medical professionals will act with the utmost care. Most LASIK lawsuits involve the failure of high volume surgeons to adequately pre-screen patients before surgery.
If you or someone you love has undergone LASIK surgery and suffered permanent visual disability, the nationally recognized LASIK malpractice attorneys at the Law Office of Todd J. Krouner will represent you in court. You may be able to recover compensation for medical expenses, pain and suffering, loss of life’s enjoyment, loss of income, and more. Our attorneys have obtained the two largest verdicts in the history of LASIK malpractice and will work hard to ensure you are compensated justly. For more information, please contact our office today by calling 914-238-5800 or by emailing Mr. Krouner at info@krounerlaw.com.
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The Wild, Wild West Of LASIK
February 25th, 2010February 25, 2010
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
read moreInformed Consent
February 8th, 2010February 8, 2010
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:
- the patient’s existing physical condition;
- the purposes and advantages of the operation, procedure or medication;
- the reasonably foreseeable risks to the patient’s health or life which the operation, procedure or medication may impose;
- the risks involved to the patient if there is no operation, procedure or use of medication; and
- 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.
read moreHow Safe is LASIK? The Tiger Woods of Medical Procedures?
February 1st, 2010February 1, 2010
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.
read moreTHE STATUTE OF LIMITATIONS AND TIME BOMB OF POST LASIK ECTASIA
December 29th, 2009The 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.
[1] Randleman, J.B., et al.“Risk Factors and Prognosis for Corneal Ectasia after LASIK.” Ophthalmology 2003; 110:267-275.
read moreFDA To Study LASIK Patient Satisfaction
October 30th, 2009What 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.”
read moreLetter to the New York Times Regarding Doctor Medical Malpractice Exemption
June 16th, 2009June 15, 2009
Letters to the Editor
The New York Times
620 Eighth Avenue
New York, NY 10018
Re: Obama Open To Reining In Medical Suits: Bargaining Chip Seen in Health Overhaul, Sheryl Gay Stolberg and Robert Pear, A1, June 15, 2009
Dear Madam or Sir:
In the June 15, 2009 edition of The New York Times, President Obama reportedly seeks to immunize doctors from medical malpractice lawsuits if they adhere to standard guidelines. From the perspective of a LASIK malpractice lawyer, it is a dumb idea.
First, who will draft the guidelines? Following a $7.25 Million LASIK malpractice verdict in 2005, seven LASIK surgeons drafted a White Paper to promulgate such guidelines for LASIK surgery, to ensure that no such verdict would be duplicated. In the process, they obliterated a decade of medical knowledge and claimed there were no standards. They did not do so in the interest of medicine, but explicitly to dampen the “considerable anxiety” among their fellow refractive surgeons following the verdict.
Second, who will serve as the administrative referees? In a case last week, one seemingly qualified eye doctor actually admitted that his version of the Hippocratic Oath actually meant, in part, “First, harm no ophthalmologist.”
Third, if the profession is incapable of throwing out serial offenders now, who will address this issue later? In President Obama’s hometown of Chicago, Dr. Nicholas Caro has been sued more than 40 times. Still, he performs LASIK surgery.
Fourth, why would doctors want to trade in their judgment to follow guidelines like robots? The best defense of any medical malpractice claim is the doctor’s exercise of his sound professional judgment.
If the SEC could not protect us from Bernie Madoff, why should the public be comfortable having a similar bureaucracy created to dispense “justice” to victims of medical malpractice?
Respectfully submitted,
Todd J. Krouner
For more information regarding LASIK surgery and LASIK medical malpractice, please visit http://www.krounerlaw.com/ or call 914-238-5800.
read moreDR. WILSON HORSLEY SUED FOR LASIK MALPRACTICE – PRESS RELEASE
March 18th, 2009PRESS RELEASE – FOR IMMEDIATE RELEASE
Nathaniel Chapman and Princess “Shelli” Chapman vs.
Wilson Horsley, M.D., HorsleyEyeCenter, P.C., and Clear Vision Eye Center, Inc.
United State District Court, District of Massachusetts
Case # 1:09-cv-10325-JGD
DR. WILSON HORSLEY SUED FOR LASIK MALPRACTICE – On March 4, 2009, plaintiff, Nathaniel Chapman, filed suit against Wilson Horsley, M.D., Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc., in the United State District Court, District of Massachusetts, for performing LASIK surgery on Mr. Chapman. Mr. Chapman is a 36-year-old army trained respiratory therapist, who resides in New Braunfels, Texas. On March 22, 2002, Mr. Chapman came under the care and treatment of Dr. Horsley for the purpose of having LASIK surgery on both eyes at the Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc. Despite signs of Mr. Chapman’s pre-existing corneal condition, Dr. Horsley performed LASIK surgery. To compound Dr. Horsley’s error, on April 14, 2006, Dr. Horsley performed a second corrective LASIK procedure, euphemistically referred to as an Aenhancement@, on Mr. both of Mr. Chapman’s eyes at Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc. As a result, Mr. Chapman developed post-LASIK ectasia. Consequently, Mr. Chapman’s vision has suffered severely, and he faces a possible corneal transplant.
The complaint alleges, among other things, that Dr. Horsley was negligent in failing to determine that Mr. Chapman was not a suitable candidate for LASIK eye surgery and in performing LASIK eye surgery on Mr. Chapman when said procedure was contraindicated.
The plaintiffs are represented by Todd J. Krouner, from Chappaqua, New York, and Jeffrey N. Catalano of Todd & Weld, LLP, from Boston, Massachusetts. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Catalano has extensive experience in litigating medical malpractice actions.
A copy of plaintiffs’ complaint is available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Jeffrey N. Catalano, Esq., at (617) 720-2626.
View Complaint: Nathaniel Chapman vs. Wilson Horsley, M.D.
read moreSelecting A LASIK Surgeon
August 14th, 2008If you think the benefits of LASIK surgery outweighs the risks, you should consider the following factors in selecting a LASIK surgeon:
- fellowship training in cornea
- significant academic credentials
- affiliation with a university teaching hospital
- 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:
- there are lawsuits
- 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
read moreNew York – Not So Tough on Doctors?
July 20th, 2008A new report by the New York Office of Professional Medical Conduct suggests what New York medical malpractice attorneys have known for year – that New York is punishing fewer doctors than ever, though complaints against doctors have been on the rise for years. Now known as one of the nation’s most pro-doctor physician disciplinary systems, New York’s system has actually punished 20 percent fewer doctors in the last few years – even as complaints rose nearly 43 percent, its highest-ever number.
Though New York leads the nation in doctor monitoring agreements, it does not necessarily suspend or revoke the licenses of these doctors. This move has been criticized as a veritable slap on the wrist that does nothing to protect New York patients from incompetent or malicious doctors…and the prospects facing a patient safety bill in New York’s legislature remain unclear.
What does this report mean for New York patients? Unfortunately, not much. With little incentive to clean up their acts, it is likely that New York doctors will continue to endanger the lives of their patients with irresponsible actions that are passed off as “care.” The result: injury, trauma, even death.
Medical malpractice is a growing problem for Americans dealing with a broken health care system, tight finances, and an increasing incidence of chronic disease and obesity. Luckily, victims do have rights – and the right medical malpractice attorney can help address these issues with aggressive and savvy legal action. A thorough investigation, smart legal strategy, and an eye on compensation for the physical and psychological ramifications of medical malpractice can help victims of medical malpractice gain the justice they deserve. However, timeframes and rules for medical malpractice litigation are very strict. That’s why it’s so important to seek the proper legal representation as soon as possible after even the possibility of medical malpractice arises.
Todd J. Krouner has been defending the rights of medical malpractice victims for years. Don’t take chances with your health, your livelihood or your future. Contact Todd Krouner, an experienced personal injury lawyer today for more information and a free phone consultation.
read moreFDA Panel Meeting On LASIK Not All Negative
July 13th, 2008Data 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.”
read moreFDA panel meeting pushes LASIK practices into the limelight
July 7th, 2008Although the panel made no sweeping changes, it offered recommendations for updates to its patient labeling information and Web site.
GAITHERSBURG, Md. – Issues surrounding patient safety, patient satisfaction and even marketing practices associated with LASIK came under intense scrutiny since the U.S. Food and Drug Administration Ophthalmic Devices Panel heard public testimony in April in favor of and sometimes vehemently opposed to the surgery.
Based in part on the testimony and the passage of time since labeling information was last reviewed, the panel made recommendations for updating labeling information as well as its own patient information Web site.
Despite some dramatic testimony at the April 25 meeting, the panel was not a “referendum on LASIK,” according to Jayne S. Weiss, MD, who chairs the FDA Ophthalmic Devices Panel.
“It appears to me from hearing what was said today that this really has been a referendum on the performance of LASIK by some surgeons who should be doing a better job,” Dr. Weiss said.
The Ophthalmic Devices Panel heard a number of impassioned presentations opposing LASIK. The testimony ranged from individuals who had suffered adverse LASIK-related complications, therapists and other specialists who had treated patients for depression after adverse complications, optometrists, ophthalmologists and attorneys representing those patients.
Much of the debate surrounded the proposed quality-of-life study to be conducted in 2009 by the National Eye Institute, the FDA, with support from the American Society of Cataract and Refractive Surgery, and the American Academy of Ophthalmology. The announcement of the survey comes on the heels of syndicated reports in recent months of depression and suicide of patients after LASIK.
Strong calls for change
Todd J. Krouner, JD, argued that the FDA quality-of-life study be carried out independent of the refractive surgery industry, which he sees as embodied in the ASCRS and AAO.
Mr. Krouner, a LASIK malpractice attorney based in Chappaqua, N.Y., said, “Given the self-interest of the LASIK industry and its surgeons, it is respectfully submitted that any review of LASIK safety, satisfaction or study of correlation between bad LASIK outcomes and suicide should not be delegated exclusively to those who have a vested interest in the conclusion.”
Matt Kotsovolos, former chief financial officer of Duke Eye Center in Durham, N.C., went even further, calling upon the FDA to impose a moratorium on LASIK procedures until more is known about the alleged psychological damage inflicted upon those who have experienced debilitating complications.
Mr. Kotsovolos argued that although the LASIK industry quotes complications rates of 1% to 3%, the real numbers are much closer to 20% to 30%, but these complications are disguised as side effects or symptoms.
“I have met plenty of people who are depressed and considering suicide because of complications that are currently buried in the device labeling and are classified as symptoms or side effects,” he said. “Patients do not want to continue to exist as helpless victims with no solutions and no voice. … I urge the FDA advisory panel to recommend placing a moratorium on LASIK until a proper comprehensive study of long-term LASIK complications and symptoms, including clinical depression, is completed.”
Malvina Eydelman, MD, senior medical adviser on ophthalmic devices to the FDA, defended the still-undefined survey at another point in the meeting, saying, “I can assure you that every precaution is being taken so there are no potential conflicts of interest and everything will be done consistent with FDA and NEI regulations.”
Painful stories from poor outcomes
Much of the public testimony given to the panel against LASIK concerned personal stories of depression, suicide or suicidal ideation and other psychological problems resulting from adverse LASIK outcomes.
Gerard Dorrian talked about his son Colin, who had LASIK as a law student at the University of Michigan. According to Mr. Dorrian, Colin had become intolerant of contact lenses due to dry eye. Mr. Dorrian said Colin suffered painful chronic dry eye after LASIK and committed suicide 6 years after the procedure. He read from a letter that his son wrote, which read, in part, “I cannot accept the fact I have to live like this. I am rotting from the inside out.”
“A patient satisfaction survey does not really give any information about how people are suffering. It doesn’t address issues faced by patients deformed by LASIK,” Mr. Dorrian said.
The panel also heard a presentation from Edward L. Boshnick, OD, who, according to the EyeFreedom.com Web site, specializes in “restoration of vision and comfort lost as a result of refractive eye surgery, keratoconus, pellucid marginal degeneration, extreme dry eye, corneal dystrophies, corneal trauma and Stevens-Johnson syndrome.”
Dr. Boshnick said he has cared for several hundred post-LASIK patients. Although he cautioned that because of the nature of his practice he does not see “happy post-LASIK” patients, he said he has seen the devastating effects of patients suffering from vision disturbances associated with LASIK.
“I would say that most of my patients are depressed, and many are on anti-depressant medication. From what I have seen and witnessed from many patients, I feel at the present time LASIK presents a significant public health crisis,” Dr. Boshnick said.
read moreFDA Takes on LASIK Safety
June 24th, 2008Spurred on by reports of unsafe and unethical practices surrounding LASIK eye surgery, the FDA recently convened a panel on LASIK safety. While the panel’s chair says the Gathersburg, Maryland meeting was “not a referendum on LASIK,” the panel did hear testimony in opposition to the popular corrective procedure, listening as patients told about complications including depression, suicidal tendencies, and more.
Present at the hearings was Todd J. Krouner, who pled with the panel to consider outside opinions and leave decisions on LASIK out of the hands of those with vested interests in its outcome. The stories shared by victims ranged from suicidal depression to corneal trauma and chronic dry eye.
Also present were U.S. military officials, who praised LASIK for its use on the battlefield in special forces units. Though the military cites a 0.0% retirement rate due to LASIK complications, other issues, such as LASIK’s aggressive marketing campaigns, were raised at the panel.
Ultimately, the panel recommended that IOP monitoring was appropriate in post-LASIK patients who go on to have cataract surgery. Changes in patient labeling were recommended, as was different FDA website wording emphasizing caution for patients with certain conditions.
However historic this panel on LASIK, its results remain to be seen. As long as the adverse effects of LASIK are kept under wraps, hundreds of thousands of Americans remain in danger. The complications of LASIK can range from low-level blurriness to dry eye so severe that suicide seems like the only option. With LASIK complication rates as much as 29 percent higher than reported by the industry, it is all too clear that consumers aren’t getting the real story on LASIK.
If you’ve been injured by a negligent LASIK procedure, don’t suffer alone. Call the Law Office of Todd J. Krouner today for a free, confidential phone consultation.
read moreLASIK Regrets
May 29th, 2008On March 13th, 2008, the New York Times wrote an article by Abby Ellin titled: “LASIK Surgery: When The Fine Print Applies To You.” Click on the title to read this very informative article in full.
This article prompted a response from Attorney Todd J. Krouner, which was sent to the NY Times on March 12, 2008. Mr. Krouner is a plaintiffs’ litigation attorney with over 20 years of experience and is considered an authority in the field of medical malpractice. In July 2005, he obtained a verdict of $7.25 million which is the largest verdict ever for a case involving LASIK malpractice, Schiffer v. Speaker, et al.
The below is a complete copy of Attorney Todd J. Krouner’s letter to the editor of the NY Times:
March 12, 2008
Editor, New York Times
To the Editor:
LASIK Regrets
I read Abby Ellin’s biographical piece about her own LASIK eye surgery misfortune with keen interest. It was a sad but refreshing counterbalance to the LASIK industry’s infomercials that pass as news in other publications. Ms. Ellin confesses, “I’m not mad at my doctor. I’m mad at myself.” She thinks she succumbed to her vanity. It is a classic victim’s guilt. If she only knew.
Do the math. The application of the surgical laser to the cornea actually takes less than 60 seconds. A corneal or refractive surgeon can schedule ten patients in 15-minute blocks, and at $5,000 per patient, generate $50,000 of revenue in just 2.5 hours. This is a huge business.
I represent patients with bad LASIK outcomes nationwide. The surgery is not complex. Most errors occur in the screening with the doctors who are too busy running the conveyor belt to notice warning signs of unsuitable LASIK candidates. The industry, whose numbers I am inherently skeptical about, claims the incidence of post-LASIK ectasia is less than 1%.
The post-LASIK ectasia is an avoidable, surgically-induced thinning of the cornea, which causes severe problems with visual quality: blurring, double vision, halos, glare, star-bursting, ghosting, photosensitivity and impaired night vision. Its onset can be almost immediate. I had on client’s vision devolve to legally blind, 20/200, in about 2 weeks. Other cases are time bombs with a long fuse, which can take as long as five years to explode (well after New York’s 2.5 year statute of limitation for medical malpractice will likely have expired).
However, when it happens, most often, it is due to the surgeon’s malpractice. The industry makes it difficult to prove these cases of presumptive malpractice by intimidating colleagues from testifying against one another, and by retaliating against those that do. At the same time, I’ve yet to have a case where a doctor who had an obligation to repeat a bad result, or unexpected outcome, ever did. One doctor in the metropolitan New York region has repeatedly spent over $1 million in advertising his LASIK services, been sued and paid upwards of two dozen patients for his alleged malpractice, and continues to practice with seeming impunity from his colleagues and licensing regulators.
Then there is the equipment. If it is not properly calibrated by the laser facility pre-operatively, bad things will happen. If the doctor uses it in a way in which the FDA and manufacturer did not intend it, bad things will happen. If it is not well-manufactured, like the Alcon Ladarvision 4000, and enough bad things happen, it may be recalled by the FDA. But expecting the FDA to police the LASIK industry is like waiting for the Cubs to win the pennant. If it cannot get a staff person to reply to my Freedom of Information Act request concerning the LadarVision recall in seven months, how can we expect it to get an investigator to do something meaningful in timely fashion.
Finally, Ms. Ellin describes the false success of good visual acuity. It is only half of your vision. Visual quality comprises the other half. For an impeccably-credentialled LASIK surgeon to say the surgery was successful because the patient has good visual acuity is dishonest. I hear it often: 1) of the homemaker who took her cat’s medication, while the cat her thyroid medication for three days due to blurred vision; 2) of the surgical assistant who cut the patient instead of the surgical thread due to poor contrast sensitivity and impaired depth perception; and 3) of the executive whose son asks, “Daddy, why don’t you play with me anymore?”, due to photosensitivity and irritation from wind, dust, and sand. The list is limited only by space.
All of my LASIK clients are clinically depressed. One world-class photographer says, “I spent $5,000 to acquire a visual disability.” Another says his visual disability, notwithstanding his fine visual acuity, is worse than cancer. He explains, “During the Super Bowl, a cancer patient can at least watch and forget about his troubles for two hours. I’m reminded of mine every waking minute.”
After LASIK, now about 4 million people wake up and can read their clock without glasses. About 40,000 wake up and cannot, but that’s just the beginning of their daily misery, as a result of an entirely elective procedure which their LASIK surgeons sold them.
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