I'm writing as a person who has had some problems with my VNS and I am trying to keep my eye on what's going on with Cyberonics and any legal action taking place. I am NOT a lawyer or an expert of any kind. I am concerned that some of the info being posted here MAY be causing some confusion.
The case Keith cited that is causing concern, Riegel v. Medtronic, Inc., may have been interpreted incorrectly. The fact that a device has PMA (pre-market approval) by the FDA does not prevent a person from seeking legal recourse if their specific unit/device was defective and caused injury. It does not prevent a consumer from seeking legal recourse if the doctor who implanted it was negligent and caused injury.
Riegel v. Medtronic had to do with the consumer trying to use state law to over ride the criteria established by the FDA. The FDA established PMA in part, because some states did not have adequate laws to help the consumer. To obtain PMA a device has to go thru a "rigorous process" that is "focused on safety". That doesn't mean there aren't many individual cases that for many different reasons cause injury to the patient. AND YOU CAN SEEK LEGAL RECOURSE. You can't have a lawyer try to use state laws that are different from or in addition to the FDA criteria which relates to the safety or effectiveness of the device.
In one of the links (I can't find it now) I read on this forum, the doctor who inserted the catheter in Mr. Riegel ignored packaging directions and 1) used the catheter in a manner it was not designed for and 2) inflated the device far above the instructed level. From the info provided in everything I've read so far...Medtronics was not to blame...the doctor was. I haven't seen anything posted about whether they sued the doctor???
So...in my opinion, the Riegels may have hired an attorney who may have been fighting the wrong battle. Consumer law, especially in the area of medicine, is very specialized. Even an attorney who handles personal injury and medical malpractice may still not have the expertise to work thru this area of the law.
You will see that I have a lot of MAYs in this post. We don't have all the facts. As you consider taking action by contacting Congressmen/women or news agencies...I want each of us to take accurate information so that we don't look misguided by providing data that may not be correct.
I obviously don't have the answers...I do know that what has been posted so far is incomplete and may be incorrect.
I'm continuing to do research and hope you all do too.
Anne
Thanks Anne I appreciate any and ALL input into this area. I know NOTHING about the law or how things are determined.
That particular case, was the reason given to Keith on thier lawsuit, I never got the details so I am taking people at their word.
If there are any corrections of information, please inclued a source so I may edit the board.
Good job!
Thank you for your information. I was not told when the VNS was implanted, that the leads couldn't be removed. The leads are causing me pain!!! I have talked to 2 surgeons about removing them, they both said no. I am not giving up!! But I don't really know what to do next?????
Jennie
how long have you had the VNS??? my son had his for 9 months and it was just removed the 20th of march.. ALL of it the leads and all!! the coils and EVERYTHING!! :D sometimes if it's in there for just a short period of time it might be easier seeing as the scar tissue is minimal.. : g :
we had it done at the cleveland clinic.. in ohio..
the dr there was GREAT!!!