Lasik and the Patients Right to Know

Bruce Bierhans
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Posted by Bruce BierhansApril 26, 2008 11:30 AM
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In the summer of 2001, I tried a landmark case in Worcester, Massachusetts. I represented the family of a young man with hemophilia that died from receiving clotting concentrate infected with the HIV in the early 1980s. The tragedy of the 10,000 hemophiliacs that died unnecessarily has , to this day, still not been adequately reported.

In any event, we tried the case on a theory that sounds simple, but was aggressively  opposed by the defendants and the medical community. We argued that, even though research regarding AIDS was not completed, that the medical community still had a responsibility to inform the families of children receiving clotting concentrate of the potential risk of AIDS. Although we could not prove what lot of concentrate killed our client, the jury found one defendant physician negligent  for failing to adequately disclose known risks. I would certainly feel honored if this case, on which I worked for 6 years, turned out to be my legacy.

However, today we now read that the FDA is beginning to look into the "risks" associated with Lasik surgery. This, after a decade of patients/victims suffering from life altering side effects, including worse vision, dry eye, pain, glare and others. One law school student, Colin Dorrian, committed suicide last year after suffering from a deep depression associated with his eye pain.

Does anyone think, or believe, that these conditions and risks were not known ten years ago. Of course they were. Interestingly, a well known oncologist that I recently worked with on a cancer diagnosis case told me he wouldn't have Lasik surgery if they did it for free.  He also would not allow anyone in his family to have the surgery. Unfortunately, the FDA investigation comes years too late for many patients that have suffered permanent damage.

Someday, the medical community and the FDA will learn that patients have the right to know. It is the patients right to have the information required to make an "informed decision" about whether or not to take a medication or have a procedure. In the 1980s it was AIDS. Today you can pick a medication. Did the patient know about all the risks before a medication was prescribed or a procedure was recommended? Did the FDA have all the information that should have been provided by the manufacturer? Simple but essential questions.

In 2001, my jury in Worcester said the patient had a right to know. Hopefully, juries will continue to make this important statement.

 

 

 

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Dean Andrew Kantis
Posted by Dean Andrew Kantis
April 26, 2008 12:19 PM

FDA PANEL DISCUSSION POINTS- April 25th, 2008
By Dean Andrew Kantis 2nd Guest Speaker

Good morning FDA Panel, Honored Guests, and Fellow Victims of the Flawed & Unpredictable LASIK Eye Surgical Procedure. My name is Dean Andrew Kantis, founder of LifeAfterLasik.com. For the past 9 years, I have spent $30,000 seeking restoration of my ruined vision only to find out there is NO CURE. Through my website, hundreds of victims have contacted me expressing their suicidal thoughts. Some have already committed suicide. It’s always the same story. I WAS LIED TO…The name says it all…LA...SICK!

When I began to speak out against LASIK years ago, I encountered a severe backlash. My own doctor, Nick Caro of Saint George in Chicago, tried to sue me for $2 million dollars for exposing his 40+ LAWSUITS. He then caused my family to get a divorce last year by harassing my wife attempting to get her fired from her nursing profession. My family has been harassed, has had death threats, and was lied to by this doctor, yet no one has punished him for his actions…Where was the FDA?

How is it that a doctor in this country can have 40+ lawsuits with NO KNOWN DISCIPLINARY ACTION? I feel that my “second opinion” doctors also lied to me, and I know they are the problem. How is a patient ever able to find out they have a problem if all of the “follow up” doctors lie to protect the original doctor?

After submitting complaints on these same doctors to the Department of Regulation, backed by solid evidence, I soon found all were DENIED. They all went up to “Probable Cause,” and there at the top sits a Medical Doctor in order to “cover a fellow doctor.” I feel like I have been RAPED…Where is the FDA?

Because of the Lies, I was unable to sue my doctor before the Statute of Limitations ran out. I guess that is why they all kept telling me that it would take 3, 4 maybe 5 years to fully heal. Sound familiar? I had to go online to find out the truth. I am now out of pocket for all medical costs, lost wages and for daily suffering.

I don’t know of any other procedure where hundreds of patients have created websites, warning the public about the unpredictability and corruption of LASIK surgery. I have outlined (5) KEY Emergency Points which should be thoroughly answered by this Panel, to ensure that the LASIK industry does not continue to DUPE the misinformed public.

Number One: What is the truth about the FLAP and Pupil Size? I was told that the flap created heals like a cut on your hand. But the truth is the flap NEVER heals, is unpredictable, and leaves the patient with a permanently scarred cornea. My pupils were measured off the charts at 9mm, yet my doctor told me “I was the perfect patient candidate for LASIK.” Just remember: Today’s happy 20/20 LASIK patient may regress and be tomorrow’s LASIK casualty driving a school bus picking up YOUR children. Oh yes, it effects every single one of you here today…

Number Two: What is “True Informed Consent”? I have submitted a complete pamphlet to this panel that gives the patient “True Informed Consent” with full color pictures illustrating the known side effects. Please consider mandating this pamphlet for yours is antiquated. Then educate the consumer on the Statute of Limitations so they know the “timeframe to sue their doctor” starts from the date of the procedure NOT the date of discovery. The Lying LASIK Doctors all know this…

Number Three: What constitutes a LASIK “Success?” I see double vision, halos, starbursts, fluctuating vision, and dry eye syndrome…Yet, I was told that I was a “Success.” Can you believe that? In order to believe the LASIK Industry’s reported satisfaction rate of 95%, you must accept these complications to be “acceptable normal outcomes.” That's the question... Do you believe a patient who has these problems to be a “Success” because the LASIK industry does! Shouldn’t “Patient Success” be decided by each individual patient however THEY define “Success?” How does this Panel define Success?

Number Four: What is a “Breach of the Standard of Care” for LASIK Doctors? The FDA has stated over and over that it is NOT their job to discipline doctors. Then who’s job is it because nobody seems to be doing it? I am out of a life that I once enjoyed because MONEY came first and my Well Being came last! I ask this Panel to hold the FDA responsible for reviewing the Ambulatory Code: 21 CFR 803.17 requiring all LASIK facilities since 1997 to report ALL adverse patient outcomes. I feel every LASIK facility in this country is in violation of this mandatory requirement, which should prompt a Class Action Lawsuit. If the CDRH has not even bothered to check the LASIK Centers in their own neighborhood, why did they all of a sudden set up “Sight Net” as a new initiative for their own incompetence? I do hope the media here today will investigate this.

Lastly, Number Five: What are the unforeseen Emotional Consequences of LASIK that Effects Every LASIK Doctor, Their Family Members, and Patients? I come today, at my own expense, to inform this Panel that you have a serious problem on your hands of very desperate, suicidal and angered patients that know their LASIK doctors lied to them and blame their doctors for ruining their precious lives. I ask this panel to set up an Emergency Hurt LASIK Patient Fund, in order to help patients with suicidal preventative therapy, ongoing medical expenses, legal representation, and lost wages. Please take immediate action to protect the end consumer who is paying you to protect them.

Thank you.

USAEyes
Posted by USAEyes
April 27, 2008 10:14 PM

Don't be fooled by Glenn Hagele and his surgeon certification group known as USAEYES / CRSQA. USAEYES is a referral service for substandard surgeons and patient harassment organization. Learn the truth at More ...

john
Posted by john
April 27, 2008 10:23 PM

Many people dont take the time to learn the risks or learn about their doctors. There are plenty of bad doctors who don't really guide you are really determine if you will be a good lasik candidate. Learn more at More ...

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