Hello everyone my name is Keith and I’m new here.

I have been reading your personal experiences that you have had with the VNS device and my wife has had a devastating experience with the VNS device also.

First off I have to tell you that my wife suffers from TRD, and she has gone through a gamete of medicine, the longest that any one medicine has worked for her have maybe been 6 months, then she has to change to another type of medicine, soon they are going to run out of meds. for her to try.

Well in 2003 I saw a small news clip of Charles Donavan who had the VNS implanted and said that it had changed his life for the better, and boy I was on that like a hot potato to the FDA to approve this device so that my wife could get it so it could help her TRD. After the FDA had approved the VNS my wife had it implanted. The following is a brief time line of what has happen since it was implanted.

November 21, 2005 – VNS implanted.
March 17, 2006 - VNS device stopped working.
April 28, 2006 - Surgery to try to fix VNS device, device started to work again.
July 20, 2006 - VNS stopped working again.
VNS turned off, dead in the water!

And now folks we are $50,000.00 in debt thanks to Cyberonics and they won’t talk to us! How do you like those apples?

Well my wife and I decided to sue Cyberonics, we had a class action law suite going against them and we moving write along until the (United States Supreme Court has ruled that a medical device that went on the market through the FDA Pre-Market Approval (PMA) process may not be the subject of lawsuits claiming negligence, breach of warranty, or product liability, as a collateral attack upon products’ design, manufacture, marketing, safety or effectiveness, as they would run counter to Congress’ intent that such manufacturers be free of litigation founded upon state-based tort claims.) February 20, 2008. With this decision you can not sue any company as long as they have gone through this approval, even if you or a loved one dies from a medical device failure.
If you want to fine this document go to the Supreme Court web site and look for recent rulings and look for No. 06-179 (2008 U.S. LEXIS 2013).

I talked to are Lawyer and he said that the best way to try to get this ruling changed is to go to are Congressman or even try to have a Congressional hearing, that is a great idea but I need some help. I need help from you the people that have been hurt by the VNS device, weather you thought that it helped but later know that it has not and the ones that have suffered physical and emotional and pain. My wife and I feel that the Supreme Court does not have the write to take away are write to sue a company that manufactures a device that does not work or hurts someone.

All that we were asking for in are law suite was to have all of my wife’s medical bills taken care of and to pay for are Lawyers fee.

My wife is having more physical medical problems because of the VNS; it is affecting her vocal cords and her swallowing.

As I said before I cannot do this alone and as my dad once told me there is power in numbers.

I don’t know if I can list my personal email address but if I can and you would like to join me in trying to get this Supreme Court ruling changed please let me know and I will post it.

Thanks for listening

Keith, I'd like to Welcome you and to Thank you for joining the site and sharing your experiance.

You have given us a very valuable tool and I want to be the first one to say I will help you in any way possible. Please check your pm's

If you would please be so kind as to give supporing links. it would be much appreciated.

first off i would lie to welcome you :Welcome: there are a few of us on here that have had a BAD experience with the vns my son inculded... i'm so sorry to hear about your wife! it's terriable to watch our loved ones go thru awful things while we feel so helpless..please know there are many people here to talk to anytime

i will help you in ANYWAY I CAN!! my poor boy suffered with this thing and it was terraible how the dr's ,and the nurses ,surgeons,and CYberonics PLAIN out LIE!!!!!! :Really Mad: please keep up what you are doing Because you are right there is power in numbers

Dear Keith, Hello & :Welcome:

I am glad you found this website. And totally support you in what you said. This ruling is totally unfair and needs to be changed. And Cyberonics should flip the bill. I'm sorry about your wife, and how is she doing now? It is wrong to protect Cyberonics if something negative has happened.

I will write a letter for you for the Congressional hearing if that will help. Is it possible to sue the FDA, since Cyberonics is being protected? There should be loop hole somewhere you can use. I would put the pressure on the FDA if that can be done. This law needs to go.

Even though I have a VNS and am having no problems with it, these negative events the company should be liable or at least pay for hospital bills. Is it possible to attack both the FDA & Cyberonics? As far as I'm concerned both of these agencies should have pressure put on them. :yes2: Will the doctor that put in the VNS be supportive? Just an idea. It would carry weight if the doctor who implanted the VNS is also on your side.

If you can give links, I would be happy to write a letter for your wife's behalf. Would your insurance company help with this? I'm just trying to think of more people etc. that would give you support in this fight. There has to be a way, you just need to find out how. What about the State Commissioner, would he help if you told him this?

Keep in touch, and let us know what we can do. I support you in this fight.

Sincerely,
Bonnie
:bigarmhug:

Hi Keith and Welcome to the forum!

I totally agree with what you are saying and am more than willing to help you with this endeavor. I am so sorry to hear what your wife has been through, and if the Supreme Court were to hear from people who's lives were devistated by this device, I think they would reconsider this decision. After all, FDA approves medications but we can still sue the pharmaceuticals, so what is the difference when it comes to medical care and treatment?

Please put up any links you would like us to help with and also feel free to pm me for my contact information.

Cyberonics is not the only "implantation device" manufacturer out there, have you checked to see if other manufacturers have had similar cases? Were they in favor of the patient? If so, this too could be used as "precedence".

My prayers are with you and your wife and I hope your lawyer can find a good way to get around this recent ruling. And yes, there is power in numbers!!!!!

:im_033:

Hasn't the FDA reversed approval for drugs before when safety concerns surfaced in the consumer market that weren't apparent from the studies used to gain approval? Were there lawsuits involved there (either against the pharmaceutical companies or the FDA itself)?

I'm thinking of Vioxx, but I didn't pay close attention to the developments on that issue.

:Welcome: to the site.

Yes I will help. I don't know how much help it will be but I will help. In higher numbers the VNS makes me mentally unstable, to include panic attacks and strange things like that, and I have problems eating. The bigger problems is I never know what the numbers are. I finally had to theraten my doctor that I would duct tape my magnet on to shut it down or find my old doctor to sign a release to have it removed if he didn't move it back to stable numbers. If it will be any I'll even get them to try and release my medical records that I believe the nurse has indicated has some of this information in it.
mike1352

Hi, I will help you in any way I can. My story is
on here. I just posted more a few days ago.

I had to have a cat scan today due to not being able to have an MRI. My Dr. is considering having mine taken out.

They knew about all of my medical problems and went
right ahead and put it in.

I am having more breathing problems from having
it on and they are bad with it off now also. My problems started
right away with breathing.

I don't want to write all of my story here but if you want to email me
you can at[edited]*.

I have fought for a lot through the Gov. and
Senators of Co. and got things done. I am willing to
help do this now.

Ada

By the way, how do you get rid of these faces so I can see what
I am writing on here. Put them at the bottom or
top like other forums are.


*sorry, posting email address is not allowed

You can contact another member here through the PM system or the email button at the bottom of their posts (if it is enabled). Members should get an email notification when they receive a PM.

I adjusted the number of columns on the smilies... Is it better now?