Tuesday, July 22, 2008
Advanced Bionics Settlement and ...ZEN
There is just no time to breathe with the million projects I'm trying to get organized before leaving for Dublin with six crazed teenagers. A special friend suggested that I read up on my ZEN to find some equilibrium in this crazed period I'm living...so, I've been doing just that! Here are some little pearls, I've been contemplating...
1. I dreamed a thousand new paths, I woke up and resumed mine.
*I'm gonna throw up, the neighborhood kids are blasting High School Musical 2 tunes*
2. To be happy requires incredible courage: that of being oneself. (And, uh, who exactly am I???)
3. Those who are happy to be nothing in particular are noble persons. Don't fight. Be ordinary. (See, now this one goes against everything I am...I'm screwed)
4. Do not search for yourself in others. Look at yourself within yourself. (kind of like this one)
5. (This one is kind of cute...) Buddha says that our sufferance is derived from the fact that we do not see the true nature of things. Begin to see things for what they are...and not as you would like them to be.
6. Then, there was a book by Josh Swiller THE UNHEARD...kind of the entire book was ZEN for me, and the last chapter, entitled THE RAIN...touched me enormously.
There's something so sensual, sad, invigorating, beautiful, etc. about rain...kind of depends on your mood...where you are in your life and thoughts at the moment it comes pouring down.
Onto the Advanced Bionics settlement comment left by Kimberly whose passion and experience in regard to this matter has led me to continue blogging about the situation.
Kimberly...thank you for your comments, I hope leaving them is cathartic for you and others in such a way as only writing your thoughts can be...:
It's me...Kimberly. I posted about my AB experience a few months ago. Obviously, I've been following the AB/FDA lawsuit and resulting settlement. My take?
Well, I'm hesitant to really voice my honest opinions. Sometimes it's more prudent to keep them to oneself, so I will keep the majority of my thoughts to myself. I believe everyone should form their own opinion by doing the research and not allowing themselves to be blinded one way or another. Let me give you an example:
It's like buying a car. I may have owned XXX brand for years, with no problems. However, it's time for an upgrade, too many miles on the old car and I want to upgrade. However, while I'm doing the research for a new XXX I read in the leading consumer magazine that the 2008 model has many manfacturing recalls. In fact the issues are so severe that they have led to an unacceptable amount of driver injuries, so many in fact that the National Auto Safety Board is suing the automaker for not following Federally mandated safety guidlines. Well, I never believe what I hear from just one source, so I do more research on the internet and find more and more negative information about the problem from numerous sources. My research shows that it's been an ongoing problem for several years. I begin to feel pretty lucky that I haven't had the problem with my previous model. However, as a smart consumer, I'm passing not only on the 2008 model, but I'm now shopping for brand X. I'm not going to let owner "loyality" jeopardize my safety of my loved ones. Even if I've never had a problem with my previous model. Especially when I hear that automaker "XXX" settled the lawsuit with the National Auto Safety Board instead of fighting it and proving to me, the consumer that it DID follow all the Federally Mandated safety laws.
What I will say, and this is just my opinion based on how I would react if I were being sued wrongfully. IF I HAD done everything I was supposed to do according to the FDA guidelines. I would have fought turning any monies over tooth and nail. I would have provided all the documentation to prove I followed all the mandated guidlines I was supposed to follow. I would have provided copies of all the documentation I gave to the FDA notifying them of the change of the manufaturer I was using and cleared myself of the allegations, Then countersued for my costs. I would have fought it openly, posted all my supporting documentation and proof that I followed all the guidelines on my web sites and kept the fight as open and public as possible. In other words, I would have done eveything possible to "clear my good name". Especially if I had the financial reserve to fight. (AB received a pretty substancial amount of money from Boston Scientific last year. The amount was disclosed on the web in the buy/sell agreement). However, I'm a fighter, and when I'm falsely accused, I'm going to fight to clear myself, my name and my reputation. But, that's just me.
As far as the response of AB "In the best interested of our consumers"...again prudence tells me to keep my opinion to myself. The one thing I will say....when a device fails (and I'm not even going to begin to address the failure related to the moisture issue. I have VERY strong feelings about that and I AM going to keep my lips zipped on that one. Sometimes being "prudent" is tough). ANY failure is a HUGE problem, but when it's related to a BASIC issue, that would have been detected had the device simply been tested PRIOR to leaving the manufacturer....it would have been caught. Period.
(I'm talking about the basics. Like a car company not starting an engine to see if it runs before sending it to a customer who special ordered the vehicle).
I know I keep going back to the car as an example. I do so for a reason. We are a pretty safety minded society. We wouldn't get behind the wheel of a 6000 pound machine if we knew if was unsafe. We count on the auto companies to build a car that is safe for those driving, being transported and traveling along side it. If we are that careful as a society about the safety of our transportation we should be even MORE vigilent about the saftey of our medical devices.
I'll close on one final thought:
Medical devices of ANY kind, not just class III, are designed to improve, safeguard, enhance or even restore life....and HOPE for millions of people everyday. The vast majority of them do just that. Millions of people are alive because of these wonderful devices. People hear, see, eat and breathe because of them. Whether it be a heart lung machine that keeps someone alive during open heart surgery, or a simple IV catheter that infuses life sustaining fluid and medication into a premature baby fighting to stay alive, or a cochlear implant that has given a deaf person the ability to perceive sound.
However, that being said, the companies that manufacture these products have a RESPONSIBILITY to do everything in their power to ensure their products are safe and DO NO HARM. Every now and then, something unforseen and unpreventable happens. It's tragic, and an ACCIDENT. However, when these companies decide NOT to follow the safety guidelines, the Federal Laws and something happens then they SHOULD be held accountable.
Who obligates you to follow the highways of thought, traced by philosophers or by great psychoanalysts?
Sometimes, on the smaller streets, simple and real people can speak of their own truth.