Zapper Update/July 4, 2005

July 4, 2005

Zap•Update

July 4th 2005

LATEST HEADLINES

~ Updated: July 4, 2005 ~

EXCLUSIVE:

Complete Guidant ICD Recall Coverage

Two Minnesota Doctors Credited With

Making Guidant Flaws Public...

Next Question: Who Pays for Explants?

FDA Reclassifies Guidant Recall...

Assigning it " Highest Priority "

Seeger Weiss Amends Class Action...

& Forms Alliance with ZapLife.org

Medtronic Introduces EnTrust

ICD in U.S.A.

Excellent Profiles of ICD Recipients:

A Toddler, A Senior, & 2 Athletes - Back in the Game...

Union Files Grievance over Punishment of

Whistleblower in Fatal AED case..

GO

TO Zap•News

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Publisher's

Note from

Jon Duffey

Greetings

everyone..

Here's hoping your weekend, the Independence Day holiday in the U.S., is going well for you and your families.

Sadly, it's been a tough month for ICD recipients to go about our daily lives with a sense of freedom and independence... since our focus became so preoccupied with the progression of defective device revelations from Guidant Corporation.

For a decade I have preached how an ICD gives us the freedom to live life like other people. But reports that thousands of implanted medical devices may unexpectedly malfunction is paraylzing a large portion of our ZapFamily with fear..

It almost sounds like a punch line from Letterman or Jay Leno: " In addition to living with the anxiety of getting shocked by 700 volts without warning 24/7, now defibirillator implant recipients must worry that they will NOT get zapped - when their lives depend on it! " But it's not a joke!

It's a serious life and death issue for thousands of ZapLife.org readers. We did a couple (unscientific) polls on the issue via the Zapper •BBS. Results of the first one indicated 55% of our readers have some kind of Guidant ICD inside them. Of those, two-thirds are depending on a potentially defective device - and that survey was done when only the Ventak Prizm Model 1861 problem had been reported. That amounts to one third of the 100,000+ total of our monthly readers!

The latest survey we conducted asked only Guidant recipients to respond to the question: Will you get your next ICD from Guidant or another company? So far, the tally is tied: 49% " YES " responses and 49% " NO " votes. Those with potentially defective units lean slightly (3% margin) toward replacing Guidant devices with those from another manufacturer. Those with a non-suspect devices are leaning slightly (3% margin) toward staying with a Guidant product when it's time to replace their existing implants.

The primary complaint in the flood of emails and phone calls I'm getting from ZapLife.org readers is not about having a defective device. Most of us accept the fact that manufactured products can break, wear out, or have defects. But when a car maker finds an electrical problem or baby crib maker discovers a choking risk, we get recall warnings in a timely manner. Until now, we expected the same safeguards with our medical devices.

This drama indicates that's not the case anymore. Most people contacting me are angry (some livid) that Guidant delayed telling doctors and patients about the life threatening problems - as much as three years. The federal Food and Drug Administration shares much of the blame for the delayed notification because it failed to demand immediate action by Guidant.

When I questioned a Guidant executive about withholding information from ICD recipients even though major investors were briefed about the problems soon after they were discovered, I was incensed when told: " We had a moral obligation to inform people who have millions of dollars in our company - so they could make portfolio adjustments before this became public. " What about the moral obligation to people whose lives depend on their hardware, no moral obligation to tell them so they can make an adjustment that may save their lives? Guidant apparently forgot that we ICD and pacemaker recipients have invested BILLIONS of dollars - as well as our lives in their company.

The revelation that Guidant continued shipping suspect devices for months after the problem was found came next. Not taking those off the shelf immediately was unconscionable. It left me feeling violated - even though I do not have one of the suspect units. (As far as I know - right now - anyway.) My faith in this company and its product line has faded. And like many of you, that loss was compounded as news of more and more device problems trickled out of the Guidant Corporation PR Department.

I found it curious that each of these announcements over the past month came on Fridays. Perhaps the company did this intentionally, hoping the " bad press " would fade over the weekend news cycle - with the biggest story (FDA elevating the recall status to the highest priority) coming on the eve the 4th of July holiday weekend.

Guidant's response to this announcement was nothing short of pathetic. Instead of acknowledging the reasons the government finally put this threat into the proper perspective it deserves, the ICD maker again resorted to mathematics and statistics to make us think the danger is not worth concern or worry.

My eyes glaze over when I hear " low probability " and " a dverse event rates. " When I contacted Guidant after learning of this danger months ago, the one thing I remember most was the rather casual way I was told, " Only one person has died. "

Well now it's " only " two. Stop with the numbers! These were HUMAN BEINGS! " One may have had 80% of his life to live when he fell dead off his bicycle. Just ONE person dead is too many to warrant a cavalier attitude.

Hope faded quickly that the FDA position change would lead to Guidant adopting a policy with as much concern for patients as they do for their profit margin (and risk to the & deal.) Rehashing the company's " statistics rationale " shows dogma still controls decision making at the ICD maker, and little has changed when the Guidant news release (July 1, 2005) contains the following phrases [ which can not go without my thoughts that may reflect yours:]

• Guidant Reiterates its Previous Physician and Patient Recommendations… [ho hum, same old… same old…]

• Guidant recommends that physicians continue with normal follow-up patient visits at three-month intervals…

[nothing special?]

• However the probability of serious adverse health consequences is remote…

[ " remote " threats already killed two.. who will be #3?]

• Neither Guidant nor FDA is making a recommendation as to whether individual patients should have their devices removed.

[And why not… even with a " remote " but documented risk?]

• …risks associated with the surgery to explant the device will outweigh the extremely small risk of device malfunction…

[ " small risk " is still too much! How about " NO risk? " ]

• Guidant believes FDA’s classification will assist in its efforts to ensure that doctors and patients receive the necessary information to determine patient care.

[Tell me how!]

We invited Guidant to take part in our Zap•Chat to ease the worry this episode was causing our readers. I was promised company reps would join us. A couple hours before our weekly online support group was schedule to start, I got a short email that Guidant would be a " no show " without explanation.

Ironically, a couple weeks later the company announced intentions to establish an independent panel as suggested by the HRS (Heart Rhythm Society - formerly NASPE) to improve communications between ICD makers and ICD recipients when recalls need to be issued. I sent Guidant a note requesting they put me on that panel, and asked Zapper & Zap •List readers to lobby for my appointment. Honestly, with my strident attitude that the Guidant's actions bordered on criminal behavior, I imagine my chances of being selected have about as much chance of survival as a snowball in Key West.

Still, I hope Guidant executives realize they MUST have someone with an ICD on that panel. If the ICD maker had advisors who really understand what we face, the defective ICD issues would not have been kept secret for so long. And quite possibly, two people who are now dead would still be alive. I do not see the company restoring even a small portion of its former credibility without bringing people on board, at least in advisory capacities, whose lives actually depend on their products.

When I got my ICD nearly eleven years ago, I found neither my doctors nor the maker of my implant was able to help me deal with this thing inside me. They told me what to expect when I needed therapy, what I should do if it zapped me, how to care for the wound, how often I needed to get it checked, and how to fill out the insurance papers. But NOT one person could tell me how to live with an ICD.

I only got that needed advice from a support group sponsored by Morton Plant Hospital in Clearwater , Florida . There I met others dealing with the challenges I faced. All were willing to share their unique insights and help me survive. Perhaps being the youngest guy in the club, they elected me President. Being a sidelined journalist, my first action was to put out a monthly newsletter - including a narrative of what I learned each month.

When I decided others in the world might benefit from that newsletter, I put The Zapper on the internet in early 1995. We expanded ZapLife.org over the years, offering more and more support programs. We discourage the dispensing of medical information - urging people get that from the doctors who best know their medical condition and history. Still, we have been able to provide a forum where people can harvest material to help them live with an ICD… information not available anywhere else. It’s the kind of stuff that can not come from anyone who does not have one of these things inside them.

Paying the bills from my disability check and modest donations, we have provided ALL of those services for FREE to anyone who needs them 24/7. The growth of ZapLife visitors and its success helping people have exceeded my wildest expectations. I believe the most important things we offer people are the tools to eventually not think about their ICD every waking moment of the day. Only when we reach that milepost can we really live life like normal people: Appreciate the medical science that makes this possible, but don't dwell on that box embedded in the body. Independence is the goal.

That is why this Guidant episode bothers me so much: It has robbed us of the feeling that our built-in EMS crew will be there to rescue us when we need it. The loss of faith has thrown us (even if our device is not on a suspect list) into insecurity and constant fear that we may not be protected, like we have been lead to believe. Plus, I feel this saga has damaged my credibility. No one on the planet has been a bigger cheer leader for the Guidant ICD… and how this device really is our Declaration of Independence .

That's why I have stopped urging my readers to find a solution without going to court. Guidant continues to prove over and over again it will NOT act responsibly, and tell us quickly (as we deserve) when problems are found in our medical devices. That college kid who died had a right to know something was wrong with his implant - and should have been given the chance to decide for himself if the risk was too great for him. Guidant deprived him of the chance to make a choice for himself. And I believe the ICD maker would still be keeping the ICD defects and dangers a secret, if not for a few doctors and journalists who forced the issue into the light of public scrutiny.

When I made public my position change, I took a look at many law firms who expressed an interest in pursuing litigation against Guidant - finding a couple that appeared to have both the experience necessary and a genuine concern for those affected. I contacted Seeger Weiss LLP and discussions began with Chaffin, a former federal prosecutor who is now a partner with the New York City law firm. He expressed an interest in working with ZapLife.org to provide patients with information about their rights and the litigation concerning allegedly defective medical devices.

Since we have never accepted sponsorship or advertising, I talked with many people I have gotten to know and respect over the years from their participation in the Zapper BBS, Zap •Chat, and Zap •Lists. All endorsed the idea of working with Seeger Weiss without reservations. So last week, we made the alliance official and the firm issue a news release last Friday. That same day, Seeger Weiss banners went up on ZapLife.org.

We are proud to make it easier for ZapLife.org visitors to find a reputable law firm to provide them with information on how to deal with this situation. We deeply appreciate Seeger Weiss forming an association with us. The big thing this means for us: We no longer need to worry about this web site fading into the TwiByte zone, should I scoot off into the afterlife without warning. That has always been a heavy weight on my mind, knowing how many people depend on this collection of forums and services. Thank you and everyone at Seeger Weiss for making this Independence Day special for us.

If you have a potentially defective Guidant device, or had problems with an implant from another ICD maker, please explore your options and consider making (a no obligation) contact with Seeger Weiss by clicking their banner. Get back your independence so you can really celebrate this holiday in the years ahead.

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There were several other things I wanted to address in the July, 2005 issue of The Zapper Newsletter, but since Subject#1 took up so much space I will just list headlines that we will try to cover more extensively next month:

• Update your Zapper BBS Profile - to include device type, hometown, and instant messaging ID to boost our one-on-one support system…

• Plans to relaunch the Zapper Gallery…

• Revamping Zap•Group listings… email me with dates and times of your local meetings, along with contact person's name and number/email …

• Special " Group Hug " this Wednesday (check for details on BBS)

• Recent concerns in BBS postings: Device migration, infections, and lead reliability….

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Make it a great month and stay well…

Jon Duffey

Publisher

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