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Defective Defibrillator Implants Lead to Federal Charges Against Guidant

Federal law enforcement officials have leveled criminal charges against Guidant LLC, a medical device manufacturer that Justice Department officials say knowingly sold defective defibrillator implants to consumers and then tried to cover up attempts to correct the defect.

Department of Justice (DOJ) investigators filed charges against Guidant on February 25 in federal court in St. Paul, Minnesota, after a four-year investigation into several models of the company’s implantable cardioverter defibrillators (ICDs). The charges allege that Guidant hid information from the FDA regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs which in some cases resulted in death.

Guidant LLC is a subsidiary of Boston Scientific, which announced last November that it intends to pay $296 million in connection with the charges against Guidant. A DOJ press release announcing the charges indicates that Boston Scientific is likely to enter a guilty plea in connection with the charges.

ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. The DOJ charges claim that Guidant was aware as early as 2002 that the Ventak Prizm 2 DR had the potential to suffer an electric arc, which could short-circuit the device, making it unable to provide life-saving heart rhythm corrections when the patient needed it.

The DOJ accuses the company of changing the design to fix the problem, and then lying to the FDA about the design changes to cover up the fact that there was a problem. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

The FDA determined that the warnings constituted Class 1 medical device recalls, the most serious category of recalls, which indicate that a product has the probability of causing serious injury or death.

“The government charges that Guidant committed serious crimes by undermining the FDA’s role to guard the American public against potentially dangerous medical devices,” said Assistant Attorney General Tony West in the DOJ statement. “Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law.”

The DOJ has put up a website for those who have been implanted with Guidant ICDs. The site contains case-related information, and notices of court events and hearings. The website is http://www.justice.gov/civil/ocl/Cases/Guidant/index.htm.

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12 comments

  1. william Reply

    i have had 3 pace makers and difibulators put in my chest the defibulator
    has went off 8 times one time 5 times in 15 minutes i was told by my lawyer and zimmerman and reed in minnisota by 4 different people that it wasnt a class action suit i would have not gone through the class action if i knew what it was i would have found someone else and sued on my own, in the process of have the 2nd and 3rd one replaced there was a guidant representative in the opereatin room to take the one comming out if my chest back to guidant the 3rd one under my protest in the operating room he still took it to guidant they gave me a machine to monitor my pace maker and difibulato from home but that doesnt work every time i have it checked they say irs fine and i know my body and when it will go off they said to me at 165 beats per minute it wiill go off having ot gone off before i have been there and it hasnt worked. wen suing guidant my lawyer said we did not get the threshhold of people to get our full amount of money i called the judges chambers and they said the threshhold was met and there is still some money met, they gave us a choice to opt out of te law suite but quoted some decision the court had just made stating you couldnt sue for mdical a company on default poducts and scared the people into going with the law suit. if a lady can get over 10x the money for burning herself at mcdonalds how much should a life threatning machine put in your chest for your heart to work right and still doesnt get???? with the settlement everyone ws robbed and the attorneys got the money and we are still owed on it, let them walk around with this non working machine in there chest!!!!!!!!!!!!!!

  2. Leo Reply

    I was implanted with a Ventak Prism 2 DR 1861 and had it removed when I became aware of the risk and had another Guidant Defifibillator my question is ” will people like myself receive any monies from the fine and forfeiture of $296 million Guidant will pay once they plead guilty and a court judge approves at a court hearing ??

  3. Joe Reply

    THE COMMENT ABOUT THE PEOPLE OTHER THAN DOCTORS IN AN OPERATING ROOM IS absurd, and illegal, AND ANYONE WHO DOES allow this is a co-conspirator, [ including the Hospitals and MD’s and nurses as well ]. THIS IS A CRIMINAL; yet, as in WWII, when the Germans put people in gas chambers, ovens, etc., killed millions as the WORLD stood by and watched, and the criminals acting as Soldiers, or involved citizens, said “I WAS ONLY DOING MY JOB” and we have the same thing here, with the Company Reps taking faulty heart products, w/o your permission, and they are not prosecuted?? WHY? ALL the lawyers who told people that they had run the statue of limitations are also Incompetents, as well as criminals, they all should be removed from the BAR, this has happened to me in other situations, for other legal problems, Many / a majority of Lawyers simply want easy cases, quick settlements, and they go for high legal fees. Some judges are no better. That is why they LIKE Class actions. Most “laws” are based on “Precedent,” rather than the Common Law, or the Constitutional aspects of Liberty, Property, and most of all LIFE. Our country is going to the toilet, and no one will change it, especially the Federal / State Representatives, THE LAW MAKERS, much less the federal judges, or agencies that become ROGUES, making up their own rules as they go along, in many cases, also are indifferent!. SAD.

  4. Grace Reply

    I had my defib put in Oct. 2003 2 years later while visiting my neice in Washington State, I ended in the Hospital they had to reset it, as it was set for 170 when I needed 150. To make a long story short , I was in the Hospital for several days to have many tests done .

    also was told by Dr Vosler I needed to have one of my ground children fly out to Seattle to be with me when I flew home to Rochester, N.Y.

  5. Ada Reply

    I am the daughter to Jerry that was a victim of the Model l861 and it was defective. I would of preferred having my father. How would you like some one just took your life the same way you all felt that fatten your pockets were so important verses a human being.
    I feel that criminal charges should be given to you for what you have done to other people.

  6. Joy Reply

    I am 34 years old and on my 3rd defibrillator. It was 2004 when i got my first one. The first one was suppose to shock me, but didnt. That happened in 2006, Model #V-196. Then the secound one, it woke me up shocking me 36 times before anyone could turn it off. And it wasnt suppose to shock me. This was in 2008 and model #V-158. The pain/feeling a person gets from being shocked, is just not right. It’s like a big BOOM comin from within your body. So this third one is stil the same model number, V-158. It was recalled in August of 2008 by the FDA. One month after they replaced it. For some reason, you look up to see if its still recalled, and well, i can’t find it.. I did make a print out of it though for my own records. I have never once been told about any recals on any of my Difibrillators. And if you pay $30,000 to $40,000 each time they replace a product that is suppose to last 5-7 years and only lasts 2. Why should i have to keep paying for something that dont work and only ingures me at the same time?

  7. Juan Reply

    I just recently had a Boston Scientific defibrillator implanted, 7-9-2009, this is freaking me out reading about this, it was implanted through Kaiser, I no longer have Kaiser, they are having a ICD support group meeting soon, ive called to try and set up to see if i can go to there meeting since it was implanted there but no succes, anyone know if my model is safe!!!! Boston Scientific model/ serial number E110/120024

  8. Carol Reply

    My mother died from having a CONTAK RENEWAL TYPE DDDR MODEL NUMBER IS H135 SN 773213 implanted in her chest. I have her Guidant Defibrillator pacemaker here at my home. Before she was cremated it was taken out of her chest. They said if if stayed in her chest while she was cremated it would blow up the creamatorium. They said they donate them to animal clients for animals. I didn’t want it used on another person or animal. I asked them for it and they gave it to me.

  9. Tricia Reply

    Mine went bad Boston Scieritic model, because mine die with in a year I got it on 12-17-2009 and I just had it replaced on 12-01-2010 with a St. Judes device (my model number was E110/129082

  10. Barbara Reply

    This is the first I have heard of this recall. I just heard it on The Greta Show on Fox. There were several attorneys and prosecuters outraged on the settlement of this. I again I had no idea of this. My brother died on June 7,2008, 3 monthss after he had a defribullator placed. He had congestive heart failure. The day before he died, he kept complaining that the defib. was shocking him all day. He drove himself to his cardiologist, and he wasn’t there. He went home and we found hiim the next morning dead. My brother was 49 years old. I don’t knowi f this was the mfg., but I would love it if anyone can share with me how to proceed with an investigation. My brother was my best friend and we were attached at the hip. I miss him very much and if thisis true, my family would want justice.

  11. Juliana Reply

    I had my Guidant ICD unit implanted in 2005. It was recalled in or around 2006 but my records had an incorrect serial number so I was never notified. Although it beeps periodically I have had no luch finding anyone to represent me in a case against Guidant. And Guidant will do nothing in regards to removing or replacing it. Many of us do not have the money to simply have the operation needed so we are at the mercy of these people. If anyone has an idea I would appreciate your advice.

  12. Connie Reply

    I had one that failed. It was September 14 I was on a friends deck with about 5 other friends. I went into arrhythmia, it was very obvious to my friends yet my Ventak Prizm 2 DR 1861.did nothing!!! Days later my friends seen on TV that there was a recall on Guidant 1861 model you can imagine my surprise. Still in disbelief I made the call to Guidant sure enough another surgery. I’m still surprised no one contacted me. Once I started making calls everyone already new, all EXCEPT me. I also requested to take my OLD defibrillator with me. They refused me saying they could give me a demo, but mine needed to go to there lab. That was the last time anyone seen it because Guidant lost it. Now I new nothing about this action that started??? Signed non trusting victim!!!

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