Why don't people ever sue for insufficient informed consent?

[YGB]

Federal trade commission regulations specify that when LASIK MD's advertise a medical procedure they must also list possible complications and side effects. Yet the LASIK MD's ignore this rule because nobody is enforcing it.

My question is ... why isn't anybody enforcing it? In this day in age when you hear about McDonald's being sued for not listing that the contents of a coffee cup can be hot, how can something so wrong be happening in an MD's office no less who is supposed to be upholding the Hippocratic Oath?

The only time I was presented with the the long informed consent form listing the risks of LASIK was just minutes before my LASIK procedure was to be done. The nurse literally had the valium in one hand and the consent form in the other. I was to review the consent form, take the valium, and have the procedure done within minutes. I cannot say specifically what was on the consent form since it was given to me as a formality to initial so that the procedure could be done.

I'm sure we all agree (and a layman/juror would likely also agree) that a form listing the risks of LASIK (like any other medical procedure) should be given at the time of screening or scheduling so that the patient can have time to read about the risks of LASIK and make an informed decision after consulting with the physician or technician who should review the risks with the patient. I, as I'm sure most of you, was led to believe that there were very few risks with LASIK based on what was presented to me at the pre-screeing. Then a big long form is given to me minutes prior to the procedure to "review".

I am sure all of us have wanted to sue for the wrong that has been done. I would think that would be the only way that changes can be made in the current, crazy process. However, it seems like suing for lack of informed consent is rare (although I did see one case) and I am shocked since the physical damage caused by LASIK can be so permanent. Any thoughts or experiences on pursuing a case for lack of informed consent that people can share? I have discussed my case with some big attorneys who seem like they just want the easy case of and MD messing up the slicing or equipment malfunction. I need Alan Shore from Boston Legal to represent me (for you Boston Legal fans out there). Where are these types of lawyers? Are these lawyers just on TV and the real lawyers are complete in the box people who see no grey in the law that should be challenged (obviously LASIK MD's live just fine in the grey space of their law). I expected that most lawyers would feel a shock of their conscience like most people feel when they hear of the current informed consent process. However, so far I have been rejected twice. I plan on continuing my search for an attorney with some fire in his belly even though I view this as a longer term battle.

I feel like I have entered total bizarro land since getting severe dry eye post-LASIK. It's like being at the Mad Hatter Tea Party, but not nearly as pleasant.

P.S. This is the fighter side of me talking.

Matt

[kitty]

This is the medical malpractice claims adjuster side of me talking. While I understand your frustration, I must make a point. If anyone has any question about the information contained on the form they are about to sign, or if they need more time to review it and discuss it with the physician, then don't sign the darn form! Reschedule the surgery! Signing the form means that you read and understand the information contained therein, and choose to proceed with undergoing the procedure fully knowing the potential risks as well as the anticipated benefits and alternative treatments as well. More often than not, people are given the form in advance of the surgery date, and/or are informed of the potential risks as well as benefits during the appointment when the decision is made to proceed with surgery. If not, demand it! People, don't let the excitement and apprehension associated with any procedure get in the way of some common sense! Do your research before your surgery date. Make a list of questions and make an appointment with your surgeon to have them answered. Surgery is about more than signing a form and getting some drugs, and waking up with it all done. Giving informed consent means that you are an informed consumer, taking responsibility for what happens to your own body. Think about the preparation you go through when taking out a loan, buying a new car or a new home. Do you read and understand the contract before you sign? You should. Do you think any less of your body than you do your bank account?

[YGB]

Counter-point

In my life, when I have seen an MD, I have come to expect a higher standard of care and trust than when I see a car salesman to buy a car or if I am shopping various banks for the best interest rate on a home. I do not think I am unique in that regard. I understand your point of buyer beware, but I guess I never associated that so much to the MD profession. I thought that had more to do with buying cars and things like that.

Do I wish I that I listened to my flight instinct minutes before surgery when I was handed a long consent form with complications? ABSOLUTELY! I'm even on medication because I have obsessively pondered that scenario in my head to the point that it is mentally unhealthy. Do I feel that it was unethical to hand me an informed consent form to sign minutes before surgery. ABSOLUTELY! Did I sign it? Yes. I suppose to a medical claims adjuster or lawyer, that is somehow okay since I could have walked out. I guess that 's where I get into feeling like I have entered into a Mad Hatter Tea Party discussion. If your in the legal box, yes I signed it. If your in the ethical box, it was not right to withold the consent until minutes prior to the procedure. Why wait? Hmmmmm.

I do not understand how any person would not agree that it is unethical to provide a consent form AND perhaps I am asking too much, but I would expect the MD or technician would review it with the patient at pre-screening so that an INFORMED decision could be made. To not require this is to basically say that deception and working around the legal grey area is okay for the sake of the almighty $ since a signature is in hand and the patient could have walked minutes prior to surgery or done his own research after he left the MD's office.

Did I make a mistake in assuming that the MD and his staff were not acting like a bad car salesman during my pre-exam by not informing me of the risks of LASIK? YES! Why else would they not provide me a full list of risks at that time? Instead at pre-screening, I was told that I am a great candidate, all the patients love the new technology and everyone is coming out with 20/15 vision, its a "bladeless procedure", you'll do great.

Do I take some responsibility for not doing my own research? YES! In the end, the lesson learned is TRUST NOBODY including the former hallowed profession of MD's. The LASIK MD's have sullied the reputation of good MD's and should be placed in the category of bad used car salesman. I suppose the lesson learned is buyer beware even when you see your hallowed MD's who take a Hippocratic Oath to not do harm to a patient.

[neil0502]

Long answer made short, YGB --- I'm on rented 'net time in Spain.

I used to agree with you, BUT ... it's time for a paradigm shift in this land. We DO deify these docs, and ... even with the BEST of them ... it's mostly art, backed by science.

We have to stop looking at lab coats as Papal Robes and do our homework.

As I've said repeatedly on this board ... the minute I let go the reigns ... I got hurt ... badly (long term use of BAK-containing eyedrops), but I should NOT have let the reigns go ... even momentarily.

Of course, I feel horribly for people for whom all of this Latin is just Greek (Sorry, Rebecca!). Anybody whose looked into this stuff knows that the most important research for us is borderline unintelligible.

But ... even most DOCS will tell you that the BEST patients are well prepared, well read, well thought, and ask many GOOD questions. THESE are the patients with reasonable expectations. Those who walk in yelling "FIX ME!" are more difficult for docs and--totally guessing here--have inferior outcomes.

We need to be partners in our medical care WITH the docs. If a doc doesn't want to read a REAL medical article that you offer ... I don´t know If I'd stay with that doc.

I'm very sorry for your complications ... truly I am. I understand your situation only too well. As a society, however, maybe it's time we stopped yelling "Just give me a pill and make me better" at our doctors and took on more responsibility for managing our health care than we, as a society, probably do now.

Neil
Married to Nurse Practitioner
Stack of ICD-9 codes relating to eyes

[YGB]

Neil - I understand your point and it was my very bad move for trusting that the procedure was safe (or at least that complications could be fixed later). However, why is everybody so willing to let the LASIK MD's off the hook.

It would be like me knowing something really bad might happen to you, but I am not going to tell you unless you ask. If something bad then happens to you, then don't even think about blaming me because I whispered to you that something might happen just moments before you got seriously hurt. If you didn't hear me, then that's your fault and not mine since you could have known if you put forth more effort even before my whisper.

I suppose in the day of the web, the MD's have been able to claim that they do not need to inform patients of the risks at pre-screening since the patient can look it up himself. This is the price we pay for living in the information age. MD's who are more interested in making money rather than providing quality patient care are given a free pass because of responses such as the the ones I have received to date. In essence, MD's have been given a "right" to be negligent in how they present a procedure to a patient (obviously this is my opinion and I am shocked that thus far I have had 2 responses and both have been, in essence, supportive of the current LASIK informed process).

Do you think the LASIK MD would handle their son or daughter the same way in a pre-screening? Should we not expect that the quality of care and information provided a patient be similar to what would be provided to a family member? According to your responses, the answer in this day in age is no. The MD can withhold information if the patient is naiive or not savvy enough to ask. That is wrong and trying to justify the current practice (even if hidden behind a legal cloak) is wrong.

I suppose that I must find a way to deal with this continuous Mad Hatter Tea Party world that I have fallen into and try to resume some of the normalcy that has been lost since LASIK.

[Guest]

Like you YGB I was given a form that outlines all of the possible failures and complications of RS, but fortunately I was given mine at least 2 days before and I still went ahead with it even armed with my list of questions that were answered to my satisfaction.

I never for a moment considered that I could be in the 1% that get this or the 5% that get that, I like everyone else that goes into this thinks that they will be in the positive category, after all I am and have always been positive and optomistic in life.

The problem is that the 1% and 5% start turning into significant numbers when you start to see the number of procedures being performed. My clinic is like a sausage factory for eyes, there is a constant stream of people going in with glasses (and big smiles) and coming out with eye patches and a rather somber looks on their faces.

Some days I just want to picket the clinic - a one man demonstation.

Fortunately/unfortunately (however you want to interpret this) there seems to be countless people who are happy with their procedure - "best thing I ever did", "should have done it years ago", I think we all believe we will be the same, it is only when something doesn't go to plan that we start wondering what if and question or informed consent and legal options.

I honestly don't believe I and countless other people have any grounds for a case. The consent form lists everything from the common cold (only joking) to blindness as a complication so I think we are pretty well stitched up.

In any case, would it make any difference if I did have a case and I got some compensation, my vision is still crap, my eyes feel dry and horrible and I have to live with this for the rest of my life (well I am working on this one). In my opinion, no amount of compensation could ever rectify this and I quite frankly am not prepared to invest more heartache into battling a battle that I have absolutely no chance of winning.

I want to reserve my energy for getting my life back on track, for learning to deal with this the best way that I can and for putting a foolish decision behind me.

I would like to see balanced advertisement on television for RS instead of misleading statements like "after a few minutes my sight was brilliant", I have been waiting 13 months now for "my brilliant sight", Lucy has been waiting about 7 years, many here have stories to tell that would chill your blood.

I am astounded that laser eye surgery has become a high street business in the UK.

Sure I would like to see these Laser Clinics become far more accountable but I feel the numbers are against you (the positive seem to outweight the negative - real or imagined - I don't know).

The funny thing is that if I was presented with the same consent form today listing "possible dry eye", I would probably go ahead with it again, but after living the last 12 months of my life and discovering what "dry eye" actually is, there is no way on god's green earth that I would ever do this again. I had absolutely no idea what "dry eyes" were before my surgery - never had a problem with my eyes.

I have made it my personal mission to inform people considering RS to frequent this BB for a few days and read back over some of the posts here to see if they are really prepared to live a life with possible dry eyes.

One thing that I never noticed before my procedure is that nearly all the DR's in the practice wear glasses, I guess that says it all. Why would they need or want to practice on their own (they know the risks) when countless volunteers come to your door with cash in hand and are willing to pay considerably for some expermental surgery with somtimes dubious, questionable and unforseeable outcomes.

These are just my thoughts.

Ian

[YGB]

Thanks Ian

[QUOTE=IanPratt]Sure I would like to see these Laser Clinics become far more accountable but I feel the numbers are against you (the positive seem to outweight the negative - real or imagined - I don't know).

Ian - you always provide interesting insight and I wish I had read your posts and others like it before I had LASIK. You make excellent points, but I have to respectfully disagree on a common theme that I have heard from you and others.

You ultimately blame the patient for "taking the chance" and having LASIK done knowing that there were risks. Does the patient who is an optimist like you and I and sees the good in people/MD's and life deserve this? To some degree yes because we took a risk without fully understanding what was at risk. BUT, I view this issue not as a yes, blame the patient or no, blame the MD question. It is instead a spectrum and while the patient has to take some blame, the MD also should have to take AT LEAST an equal share of the blame if he/she does not adequately inform the patient of the various risks (including explaining to patients that risks such as dry eye can become severe AND you can get severe dry eyes even if you did not have it before LASIK AND THERE IS NO CURE for severe dry eyes). Who the heck would know the potential devastating effects of sever dry eyes if it wasn't explained to them? That's right, I should have researched it on my own or asked about it further (yes that part is truly my fault). However, I am certain that if an MD explained the risk of dry eye to me like he should have with the knowledge in his possession and not mine at the time, I would certainly have done my homework on the subject. I thought that's the way it worked with MD's. I viewed it as a profession that didn't hold cards behind its back. Some might say that's why I as the patient deserve the blame and I have no case. I am guilty of trusting my MD. Yes the patient shares some blame for not finding their way to this site pre-LASIK, but the MD with glasses on shares even more of the blame because he, unlike the patient, is not ignorant at that time to major risks like severe dry eye, glare, halos, etc. and the fact that he chooses to not clearly state these risks unless the patient asks is flat out wrong. Also, the MD should not be downplaying these risks if the patient asks. I know this sounds too idealistic to many folks, but I still believe that most MD's do practice this way. In fact, our society practices this way in virtually everything that is done with medicine. Drug companies must state the risks of the drug on EVERY commercial and advertisement. It is practices like this that give patients like me comfort that I am not risking my eyes future when I go to my MD for a pre-screening and he tells me that the biggest risk is corneal infection, but there is a good plan of preventing it by using drops after surgery for about a week. I then asked why he wore glasses and he said that it was because his corneas were too thin (I would love to see medical documentation that this is actually true). He also said that "20% of patients screened are rejected because they are not good candidates". Great answer that gives the patient yet more assurance that proper steps are taken to avoid problems.

In the end, will I have a case? Likely not. As you pointed out, the LASIK machine has become a fixture in our capitalistic societies. The industry has figured out how to work the grey area of the law like a champ and make the overwhelming public feel that the industry has done its job in following medical and legal due diligence. Like you said, there are plenty of happy stories out there to drown out the misery we are currently suffering with.

I suppose I need to figure out how to keep living in pain for the foreseeable future in my own little world and put the bitter past behind. However, my gut still says to fight since this is the only way that changes will be made. In some respects, for my personality style, I would think that it would be rather therapeutic to my severe dry eye condition to fight rather than accept that I need to just move on with my life and deal with my condition with the hopes that it will someday get better or even better, just go away. I can just see it now, I'll be in the middle of a legal battle and then my severe dry eyes will just clear up and I'll say "wow my strategy of fighting worked ... uhhh, never mind, I'll just let the next damaged person who does not put the full blame on him/herself fight this uphill battle" .

[kitty]

What is expectation and what is the law may not be one in the same.

Informed Consent

"A person may state they understand the implications of some action, as part of their consent, but in fact not have appreciated the possible consequences fully and later deny the validity of their consent for this reason. Understanding needed for informed consent is stated to be present but is in fact (through ignorance) not present."

[kurt]

What is expectation and what is the law may not be one in the same.

True. But being legal and being honest are not always the same thing.

[YGB]

So Kitty, if I am reading your informed consent message correctly (and maybe I'm not ), it sounds like there may be a long-shot case to be had after all. I am sure that the LASIK hit men will start harassing me at some point if they spy on this site. Can your firm represent me ?

[bostonlover]

I pretty much feel the same way Ian does about it. I knew when I decided to have the surgery I was rolling the dice. I, being young (28), and optimistic looked at the fact that my chances were overwhelmingly in my favor and went for it. I had a lot of questions about the dry eye issue more than any other concern because I had done a lot of internet research and I had been contact lense intolerant. I was screened and they said all was fine. They stained my eyes and said I had no signs of dryness. I still addressed concern and the Doc said that if it is a problem they will help me manage it. So I chose at that moment to trust the professionals. At this point in my healing I am 6 months out of the surgery. I still can't say whether or not I made a mistake. I have struggled and am still struggling but I still hold onto hope that I will be better and at that point I will have my 20/15 vision to enjoy. My biggest gripe is my lasik clinic has done nothing to help me manage it. I had to go to an opthomologist referred by my general doctor to get help. I am now trying Restasis and will see how that goes. My biggest thing I stress to those that are thinking about the surgery is I feel the numbers for long term dry eye problems are not accurate. How could they be when the lasik clinics don't care to follow up with their patients? I feel that the odds I thought I was rolling the dice with were still probably in my favor but definitely not as great as I thought.

Anyway, I wish you all the best and hopefully this will be a bad memory for all of us at some point. Just voicing our frustrations in a public forum and to any one we know hopefully helps get it out there that this is more common than one might think.

[YGB]

Bostonlover - you make an excellent point. Who is coming up with the %'s of "success" for LASIK being such a high %. I don't think anybody has rushed out to do a survey on LASIK patients 1 year out to see what kind of problems, if any, they are experiencing? I saw somewhere that showed that only 60% of patients are happy that they had LASIK.

The sad thing is that I was unhappy with my decision even before I developed severe dry eye. Aside from the burning sensation from the drops given in the first week, I did not like the not so subtle glare of lights at night or the look of my former virgin eyes where the laser had sliced them open (even though it is fairly subtle).

I would bet that the actual % of long-term LASIK induced dry eye and other complications is higher than what is being represented to the "informed" public. Of course, there is nobody that is going to do a survey except for the LASIK giant itself and based on its track record to date, I'm sure it would find plenty of "grey" answers that fall in the "happy" category (within legal limits of course).

I wish you and everyone else the best in your recoveries.

[kitty]

So Kitty, if I am reading your informed consent message correctly (and maybe I'm not ), it sounds like there may be a long-shot case to be had after all. I am sure that the LASIK hit men will start harassing me at some point if they spy on this site. Can your firm represent me ?

I suggest that you read the rest of the information on the page.

[YGB]

Thank you Kitty. I did not realize that there was a web link at first. After further detailed review, I am still perplexed as to why it has become a "standard of care" for LASIK MD's to practice in such an inappropriate manner and why attorneys will not readily take on insufficient informed consent.

I am a private person who hates confrontation. I am certainly not the type of person who would want to try to sue somebody. However, I will reluctantly take it on if I feel that I have been greatly wronged. My goal in life was to be an active dad who helps raise wonderful children and have a happy family with rewarding work. Since my LASIK complication affects all of these things, obviously I feel like I have been greatly wronged due to the reasons stated in my prior posts.

It is interesting that the web link states ... "In the United States, Australia, and Canada, a more patient-centered approach is taken and this approach is usually what is meant by the phrase "informed consent." Informed consent in these jurisdictions requires that significant risks be disclosed, as well as risks which would be of particular importance to that patient. This approach combines an objective (the reasonable patient) and subjective (this particular patient) approach."

Using this definition, in addition to all of the objective risks that were not explained to me at pre-screening, it could even be argued that there was also a major subjective risk that should have been explained (although admittedly nobody would have the surgery if they told them about it). It was never disclosed that I was potentially risking the ability to perform my work by having this surgery due to potential complications such as severe dry eye (that would be under the "subjective" category using the above definition for this particulary patient (me) since I work on a PC for 8-10 hours per day).

[Guest]

smoke and mirrors!!!

I have absolutely no doubt that there are far more "Lasik Disasters" out there that are undocumented, finding them may be a problem.

I guess I am still grappling to accept responsibility for my decision to have this surgery. I am a firm believer in acceptance being a significant part of forgiveness (of myself) and moving on.

Sure my DR needs to take some responsbility also, but unfortunately, I can only accept responsibility for my own actions and not those of others.

The problem with informed consent is that there is an assumption that by signing the form you fully understand and appreciate the plethora of possible adversities.

I fully agree that if the DR believes there are contraindications for surgery they have a moral and professional obligation to advise you. However, how does it stack up post surgery when you were a "perfect" candidate with no contraindications? Again, it comes down to the patient to accept the risks as stated.

In our instant gratification world we just want to cut to the chase, have the surgery and get the successful outcome that we are promised. Lets be realistic, how many of us even remotely understand the mine field of acronyms and medical jargon the consent form contains.

I did my research, I chose a surgeon that has done 6000+ procedures, I read up the complications and made a list of my concerns (I still have it and the notes I made as the DR answered me), I guess I didn't fully understand what halos, starburts, ghosting, dry eyes and induced astigmatism were until I experienced them soon after RS but you can bet your last dollar that all of them were mentioned on the form.

One thing I learnt from my days as a finance support officer to a goverment minister was that I could be a master magician and load our raw statistics into the "spin machine" add a bit of smoke and mirrors and out would come the perfect set of statistics and charts that could prove/disprove the argument of the day. No doubt today we have similar professionals doing the same thing with RS statistics.

It saddens me that everyday more and more people are ending up on BB's like this one (although pleased that they have found some form of support mechanism) with similar horror stories.

I often wonder how many others out there haven't found "us" yet and are suffering their desperation in silence - what a chilling thought.

I guess we all have our ways of spreading the word that RS may not be all it is cracked up to be, difficult challenge when the statistics machine suggests otherwise.

Interesting discussion
Ian