An example of why doctors and patients all have valid concerns with advancements

[DSOB]

The link below is to a Chicago Sun-Times article dealing with a newly developed ring on an Edwards valve. As a civil defense attorney I have lots and lots of questions about the lawsuit, some of which might be seen as judgmental towards the doctor, others towards the patient, but none of which I have sufficient knowledge to even pose legitimately. I will therefore keep my mouth (or typing fingers acting as mouth) shut and be thought a fool rather than open my mouth and remove all doubt.

I would note that in Illinois a medical malpractice case cannot be filed until (in this case) a cardiac surgeon signs an affidavit saying the sued physician's patient care fell below reasonable medical standards. In this case not getting informed consent might be enough to get such an affidavit, even if there is insufficient evidence that this patient's result would have been better if a non-experimental valve/ring had been used. In other words, there may or may not be evidence that the valve/ring caused her subsequent medical problem, that isn't clear in this article.

I guess this stands for the proposition that as patients we should make sure we understand what doctors are telling us and opt for the treatment of our choice, not the physician's. Sure it takes a few minutes to explain the pros and cons of mechanical vs. biological valves, but I don't know of any surgeon who doesn't spend a couple of minutes doing that and making their recommendation if the patient hasn't already decided which to get. I doubt it would take much more time to point out the valve you are using is in a trial phase, and to explain why the physician feels it would be better for the patient to use the new valve.

Having said that, once the mechanical vs. decision has been made, how many first time OHS patients has debated model numbers and manufacturers with the surgeon? I certainly didn't know anything about models, though i knew what type of valve I didn't want because of my lifestyle prior to our having the discussion.

http://www.dailyherald.com/story/?id=242828&src=143

 

[Eva]

Hi Dennis,

Thanks for starting this wonderful thread which will be an eye opener for many members

Personaly, before my surgery, I had the luxury to interview three surgeons. I asked them about pros and cons of the mechanical, about their different manufacturers, and about the tissue valves. They all explained in details and left the decision to me. I knew there were different models, but when I made up my mind about my surgeon, I did not ask which model as by then I had deep faith in him. His passion to his profession and care for his patients filled me with confidence that he would use what was the best for me. I think I was lucky. Not many may have the luxury to see different surgeons and do much research. I had lots of time to think about this. And here is where I commend you for starting a great thread which will be helpful to too many members

 

[Nancy]

Unfortunately there are several members on this site who have had or their family members have had very serious complications and even death from trial devices. I don't think anyone here has had a surgeon surreptitiously implant an experimental device.

That goes beyond the pale of hubris and unethical behaviour.

Look at the harm it has caused to this poor person.

Sometimes, all I can do is just shake my head. What was this person thinking?? And how can he look at himself in the mirror.

 

[escargome]

Working for a medical device manufacturer (not heart related), I can only say that sometimes doctor's/surgeons forget that they are human and not God. I am truly saddened that this person put their faith in a doctor who then abused his privilege. And giving his conflict of interest money to charity certainly does not make the situation right.

 

[lance]

Informed consent

Informed consent

I've always been concerned about the "Informed Consent" forms. Patients receive information that is interpreted by them as all the information they should be aware of without omissions. The information they are presented with might be only a small percentage of the information they should have been given. This is certainly the case referred to in the article and probably most patients as well. Patients lack a medical education and can't possibly know when they have been truly informed. They need the procedure and will sign anything asked of them to save their lives.

This surgeon thought the device he was implanting was superior to others for whatever reason and it's surprising he didn't do a bit of bragging about what he had discovered and how lucky the patient was to be the recipient of this modification. Apparently he didn't implying there was something to hide. It matters not the money was given to charity. The patient is his first responsibility. Were his actions unethical? I think so.

In a perfect world, surgeons would discuss make, model, attributes of approved devices and no doubt some do. Hopefully their number will increase.

 

[Ross]

Doctors and Surgeons automatically think that their patients are not smart enough to understand differences and usually don't say boo about anything other then the manufacturer of the valve. Model and number never enter the picture until after implantation and the card is sent by the manufacturer. I've even heard that some of only said tissue or mechanical without mention of manufacturer.

Dr McCarthy saved my life when my aneurysm ruptured in 1995. I would vouch for the mans integrity to anyone. He is the guru of heart surgeons with various device designs, some tried and tested, some only on paper and a dream. There is no way on earth he would voluntarily subject another human to unknown risk without previously discussing it with the person involved. That is simply how the man is. The McCarthy/Edwards ring or Myxo ETlogix ring as it's now known, was tested extensively and I assume FDA approved.

I think this person is on a witch hunt wanting to take down a world reknowned surgeon for the sole purpose of personal gain.

Unfortunately, the media is all we have to rely on for information surrounding this case. It would be great to have and see the legal documentation of the case. I think I'd be doing an extensive background check on the patient. I have a feeling that ties can be found to other cases.

 

[kfay]

I have a very close friend who is a Dr, as well as her husband. It is shocking to me how often people try and bring up lawsuits. I told her I didn't know how she could lay her head down at night to go to sleep, I would be so worried that I had missed something during the day. She said that is part of the reason for our high medical costs because Dr.'s alot of times order every test possible just to cover their butts. Her husband is an ER Dr. and has had one case actually go to trial...he won. Since then, he literally orders every possible test so that no one can say he didn't do everything he could.

On a side note, I was not given a consent form to sign for either my cath or OHS...I was very surprised by that.

Kim

 

[Lisa in Katy]

I'm going to take Ross's word for it that this doctor is a great person, committed to his profession. Most of them are.

kfay - Are you sure you didn't sign a consent form in the 500 things you signed at the hospital? I signed two. One at the doctor's office and one when I registered at the hospital.

I worked for a plastic surgeon for a while, and the number of frivolous suits was amazing. One patient sued him and every other doctor she saw in a 3 month period because they didn't diagnose her pregnancy, which could have caused harm because she drank alcohol during that time. She came to him for a consultation for breast reduction. They met in the office for maybe 10 minutes, on opposite sides of the desk, and then she left, stating that she didn't have the money and wasn't sure if insurance would cover it. When he was served, I pulled her chart and on the patient information sheet where it asked if there was a possibility that she was pregnant, she had written "I am a virgin." Needless to say he was dropped from the suit, but he still had to pay a lawyer to take care of it.

 

[Duff Man]

I've met the surgeon. Great guy.