FDA sues Advanced Bionics Cochlear Implant maker for 2.2 million in fines for manufac

rick48 said:
Parents, not mere "people", are making the decision to implant their children. Parents are also making the decision NOT to implant their children. Why do you not have a concern for those children for whom the decision not to provide them with a cochlear implant is being made without their knowledge and consent?

Interesting that you have no qualms about your making the cochlear implant decision for your child but you express "concern" over my child and our cochlear implant decision.


Rick


BTW R2D2 great post!
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The biggest difference is, those who have chosen not to implant their children leave their children with a choice....to be or not to be implanted at a later time. Those who implant at the age of 6 months, 2 years, 3 years, etc., have made an irreversible decision. To choose to have the implant removed requires additional surgery.
 
faire_jour said:
Have you ever considered that I am not talking about YOU!

I know personally probably a dozen parents who went into implanting their children with very little information and had no idea about the other options avaiable to them. The doctors told them to do it, so they did. Some worked out for the best others did not. I hope that someday ALL information will be given to parents and not just one side.

As, I have said before I have a huge concern with the entire idea of a parent consenting to ANY surgery for a young child (of course life threatening injuries and illnesses aside). I have the view that we are steward of our children, not owners. I believe that our society has a very warped view of children, in general not about deafness or ci's or anything, and I believe that affects how I view childhood implantation.


As for my daughter...I will continue to do what I feel will be of greatest benefit to her, and right now that does not include an implant. As I have said before, I have no problem with the technology, I have a problem with the philosophy and perspective that generally go along with it.
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Well said! Wonderful post!

BTW, I wonder how many of those "fully informed" parents and/or patients were aware of the fact that AB was touting the wonders of CI while using defective components that placed the implantees at additional risk? So much for their concern for the patient. Looks to me like the almighty dollar is the bottom line. Perhaps parents should be made explicity aware of the financial incentives for the manufacturer and the physician prior to implantation.
 
jillio said:
The biggest difference is, those who have chosen not to implant their children leave their children with a choice....to be or not to be implanted at a later time. Those who implant at the age of 6 months, 2 years, 3 years, etc., have made an irreversible decision. To choose to have the implant removed requires additional surgery.
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I think that later implantations should come with extensive counselling so that the young person understand that their results on the whole, will not be the same as that for their younger implanted friends and education required to show that for those whose hearing hasn't been well stimulated in childhood the outcomes are generally poor. I think this is probably what happens anyway. Some programs will not implant or are reluctant to implant young adults who fall into that category.

So in a sense there are irreversible consequences with both choices.
 
R2D2 said:
I think that later implantations should come with extensive counselling so that the young person understand that their results on the whole, will not be the same as that for their younger implanted friends and education required to show that for those whose hearing hasn't been well stimulated in childhood the outcomes are generally poor. I think this is probably what happens anyway. Some programs will not implant or are reluctant to implant young adults who fall into that category.

So in a sense there are irreversible consequences with both choices.
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All decisions involve consequences. I personally believe that ALL implantation should require extensive counseling. In the case of extremely early implantation, it is the parents that should undergo counseling to insure that their expectations are in proportion to the variance of degree in benefit.

I personally have 2 students who were implanted at a later age...one at the age of 9 and one at the age of 12. Both do well with their implants, although they continue to require accommodation in the form of terps and notetakers. However, there are also those who were implanted at younger ages who continue to require such accommodation.

Perhaps if we concentrated a bit more on language acquisition for the young deaf child, even the later implantees would show more success.
 
Jillio.

No disagreement from me about the need for counselling for all, since as you say, while there are many good outcomes results can vary quite a lot. However, late implantees with minimal auditory stimulation from childhood get consistently poorer results than other groups and would require greater commitment to auditory therapy than other groups as a whole. Since such people are often motivated by the results of more successful implantee peers, it's important for this group that they understand the greater limitations of CIs in their case.

Yes I agree that many "successful" early implantees still need accommodations in an education setting, even if they do fine on one on one and small group conversations. Educational setting by nature involves large groups, which many HOH people struggle with. However, this is somewhat different to a situation where wearing a CI becomes unbearable because you experience severe headaches or you cannot separate background noise from say speech. My friend who never wore a device and who was implanted in adulthood said that all he heard was a constant buzzing. Interestingly, I've recently heard that he wants to give CIs another go...
 
R2D2 said:
Jillio.

No disagreement from me about the need for counselling for all, since as you say, while there are many good outcomes results can vary quite a lot. However, late implantees with minimal auditory stimulation from childhood get consistently poorer results than other groups and would require greater commitment to auditory therapy than other groups as a whole. Since such people are often motivated by the results of more successful implantee peers, it's important for this group that they understand the greater limitations of CIs in their case.

Yes I agree that many "successful" early implantees still need accommodations in an education setting, even if they do fine on one on one and small group conversations. Educational setting by nature involves large groups, which many HOH people struggle with. However, this is somewhat different to a situation where wearing a CI becomes unbearable because you experience severe headaches or you cannot separate background noise from say speech. My friend who never wore a device and who was implanted in adulthood said that all he heard was a constant buzzing. Interestingly, I've recently heard that he wants to give CIs another go...
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**nodding agreement** I wish your friend the best of luck.
 
Advanced Bionics' FDA Settlement

Advanced Bionics' FDA Settlement


FDA%20Settlement%202008.pdf
 
jillio said:
Oh, yeah...they agreed to pay out 1.1 million in company funds, and a personal settlement from the CEO of 75 thousand dollars, and don't believe they did anything wrong! Right.:roll:
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That is one of the few times I ever heard about a CEO volunteered to pay anything toward a fine.
 
john57 said:
That is one of the few times I ever heard about a CEO volunteered to pay anything toward a fine.
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Agreed. The details of his involvement have not been released, but if I were to venture a guess, I'd say that evidence has shown that he knew the parts were not to standard, and continued to outsource them anyway.
 
john57 said:
That is one of the few times I ever heard about a CEO volunteered to pay anything toward a fine.
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John,

I tend to doubt that he "volunteered" to pay the $75k. Don't know for sure, but most likely he was named individually in the matter. He could also very well be indemnified by AB so ultimately they will eat the $75k. Parties settle matters for various reasons and for corporations, costs, expenses, legal fees and reputational risk along with prolonged negative public relations associated with any lawsuit/regulatory action (even those they win) all factor into the mix especially their liability, if any.

I have never read the allegations against AB nor their response thereto, so to comment further would just be speculation on my part as to the merits, or lack thereof, of the allegations against AB.
Rick
 
He agreed to pay the $75,000 as a result of his culpability in the situation. Had the lawsuit followed the full course of action, rather than a large settlement agreed to by AB, the chances are very great that the amount would have been in excess of $75,000. Same with the 2.2 million.
 
rick48 said:
John,

I tend to doubt that he "volunteered" to pay the $75k. Don't know for sure, but most likely he was named individually in the matter. He could also very well be indemnified by AB so ultimately they will eat the $75k. Parties settle matters for various reasons and for corporations, costs, expenses, legal fees and reputational risk along with prolonged negative public relations associated with any lawsuit/regulatory action (even those they win) all factor into the mix especially their liability, if any.

I have never read the allegations against AB nor their response thereto, so to comment further would just be speculation on my part as to the merits, or lack thereof, of the allegations against AB.
Rick
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AB never responded till just now . Talk about a slow response !!!
 
AB paid the fine probably because they knew they were guilty as sin.. If they had handled this differently, I might had chosen AB. Instead, they decided to sweep it under the rug for a few years hoping it would "disappear". As a consumer and as a parent, yes I would had been concerned if something like this happened to me or my kids.

I chose the MedEl for the advanced technology and being upfront. Also the remote control will also come in handy. Two AB users told me they saw the new MedEl Opus 2 at the HLAA convention and really like the remote control idea too.

My hat is off to MedEl...Keep up the good work MedEl. I am sure enjoying my inplant of almost 90 days. woo hooo

Anyone can contact me privately if they want to discuss CI...
So
 
That's good for you. You can go check it out at my other thread "I'm curious about all CI user" You can answer my question if you want to.

SouthFella said:
AB paid the fine probably because they knew they were guilty as sin.. If they had handled this differently, I might had chosen AB. Instead, they decided to sweep it under the rug for a few years hoping it would "disappear". As a consumer and as a parent, yes I would had been concerned if something like this happened to me or my kids.

I chose the MedEl for the advanced technology and being upfront. Also the remote control will also come in handy. Two AB users told me they saw the new MedEl Opus 2 at the HLAA convention and really like the remote control idea too.

My hat is off to MedEl...Keep up the good work MedEl. I am sure enjoying my inplant of almost 90 days. woo hooo

Anyone can contact me privately if they want to discuss CI...
So
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SouthFella said:
AB never responded till just now . Talk about a slow response !!!
Click to expand...

SouthFella said:
AB paid the fine probably because they knew they were guilty as sin.. If they had handled this differently, I might had chosen AB. Instead, they decided to sweep it under the rug for a few years hoping it would "disappear". As a consumer and as a parent, yes I would had been concerned if something like this happened to me or my kids.

I chose the MedEl for the advanced technology and being upfront. Also the remote control will also come in handy. Two AB users told me they saw the new MedEl Opus 2 at the HLAA convention and really like the remote control idea too.

My hat is off to MedEl...Keep up the good work MedEl. I am sure enjoying my inplant of almost 90 days. woo hooo

Anyone can contact me privately if they want to discuss CI...
So
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Your posts reeks of brand wars... which most of us don't participate in... so knock it off!
 
SouthFella said:
AB paid the fine probably because they knew they were guilty as sin.. If they had handled this differently, I might had chosen AB. Instead, they decided to sweep it under the rug for a few years hoping it would "disappear". As a consumer and as a parent, yes I would had been concerned if something like this happened to me or my kids.

I chose the MedEl for the advanced technology and being upfront. Also the remote control will also come in handy. Two AB users told me they saw the new MedEl Opus 2 at the HLAA convention and really like the remote control idea too.

My hat is off to MedEl...Keep up the good work MedEl. I am sure enjoying my inplant of almost 90 days. woo hooo

Anyone can contact me privately if they want to discuss CI...
So
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I agree with Boult it is not a brand war. I have had Advanced Bionic Hi-Res and Harmony for a year and I do not have a negative word to say about them. I love my CIs, both of them. I also have friends with the other brands and love it too. The brands are a personal choice.

As for this fine, it is over and paid, now time to just enjoy my CIs.
 
jillio said:
Oh, please. Med-El didn't get sued. Keep up the good work, Med-El.
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Med El is not a big player in the US, which is the biggest market in the world for CIs. For a while, I believe they had problems getting FDA approval, I'm not sure of the reason why but anyway that affected their ability to establish there for a while. Their market share is now slowly growing I believe.

Business is business and I'm not convinced that if Med El had a much bigger market share, they wouldn't operate too differently to AB, Cochlear or any of the large hearing aid manufacturers. I'm not excusing the past behaviour but just stating the cynical reality of for profit business in your country. In Europe where Med El has it's biggest market share, socialised medicine is the norm and such markets tend to be well regulated.

Southfella has the right to post his mine-is-more-advanced posts if he wants to but it isn't the culture that we have on this board and it is over the top. We just want every user to be happy, whatever CI choice they make.
Deafdyke often makes the point that she feels some CI users are "gotta have the latest gadget" types. Southfella seems to come close from my perspective.
 
R2D2 said:
Med El is not a big player in the US, which is the biggest market in the world for CIs. For a while, I believe they had problems getting FDA approval, I'm not sure of the reason why but anyway that affected their ability to establish there for a while. Their market share is now slowly growing I believe.

Business is business and I'm not convinced that if Med El had a much bigger market share, they wouldn't operate too differently to AB, Cochlear or any of the large hearing aid manufacturers. I'm not excusing the past behaviour but just stating the cynical reality of for profit business in your country. In Europe where Med El has it's biggest market share, socialised medicine is the norm and such markets tend to be well regulated.

Southfella has the right to post his mine-is-more-advanced posts if he wants to but it isn't the culture that we have on this board and it is over the top. We just want every user to be happy, whatever CI choice they make.
Deafdyke often makes the point that she feels some CI users are "gotta have the latest gadget" types. Southfella seems to come close from my perspective.
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I understand your perspective, and actually agree with it. Business is business, and the sooner that people realize that the CI manufacturers are in business to turn a profit, the better able they will be to make informed decisions. The problems with AB came about because they out sourced the manufacture of the components to a cheaper company in order to increase AB's profit margin for each devise sold. Their primary focus is that of profit. The deaf individual is secondary to that monetary concern. The deaf individual is important only in that they are the population to whom the devise is marketed, and therefore, the population whereby the profits for the company are realized. And their focus is even more narrow than that. They are not concerned with "deaf individuals", but only with "implantable deaf individuals."

Such is the nature of business, and to remove that fact from the equation is to walk around in a dangerous state of naivete. I'm not saying, by any stretch, that CI manufacturers are "evil", as I have been accused of doing. Nor am I saying that the "CI" is evil. I am saying, the manufacture and implantation falls into the business realm, and the motives of business are profit margins, not altruistic deeds. Anyone considering an implant needs to be aware of that and factor it into their decision, and use it when evaluating the claims made by those who promote the devise.
 
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