St. Jude Medical To Pay $16M to End Defibrillator Kickback Probe

U.S. prosecutors say that St. Jude Medical paid doctors as much as $2,000 per patient to convince them to have the company’s pacemakers and defibrillators implanted, and the company has agreed to pay $16 million to settle the illegal kickback allegations. 

The U.S. Department of Justice (DOJ) announced the St. Jude settlement agreement on January 20.

According to the DOJ’s claims, St. Jude used three post-market studies and a medical device registry as cover for payments to doctors to entice them to implant their heart devices in patients. The company solicited physicians to participate in the studies to get them to stop using competitor products and to continue to implant their patients with St. Jude-manufactured devices, including pacemakers and implantable cardioverter defibrillators (ICDs), the DOJ alleged.

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In a press release issued the same day the settlement was announced, St. Jude claimed that the post-market studies and registries were legitimate clinical studies used to gather important scientific data. The company said that the settlement is not an admission of guilt and that it agreed to the terms to avoid the cost of lengthy and expensive litigation.

The probe came as the result of a whistleblower lawsuit filed by Charles Donigian, who will receive a $2.64 million share of the settlement.

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

The St. Jude whistleblower settlement is the second settlement this month involving an implantable defibrillator medical device manufacturer. Last week, a federal judge accepted a guilty plea and $296 million settlement from Guidant over claims that it tried to cover up problems with defective ICDs. The company also agreed to a three-year probation sentence which will come with increased regulatory scrutiny into its devices and practices.

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4 Comments

  • LATONYADecember 12, 2011 at 11:56 pm

    HAVE ANY ONE HEARD ABOUT THE ST.JUDE DEFIBATTOR IMPLANT LAWSUIT AOR IS IT LOST FORVER...

  • MauriceJuly 29, 2011 at 11:48 pm

    I had a St. Jude Pacemaker implanted on 7/31/09 at Ohio Valley Heart Care, in Evansville, Indiana, by Dr. Crevey. How do I find out if he accepted a kickback ? When I went in for a device check, the technician told me that the doctors implant different devices into different people. (I ignorantly assumed that the hospital used only St. Jude.) The technician informed me that the doctors use the [Show More]I had a St. Jude Pacemaker implanted on 7/31/09 at Ohio Valley Heart Care, in Evansville, Indiana, by Dr. Crevey. How do I find out if he accepted a kickback ? When I went in for a device check, the technician told me that the doctors implant different devices into different people. (I ignorantly assumed that the hospital used only St. Jude.) The technician informed me that the doctors use the devices of the companies which gives them the best sales pitch. That statement bothered me. It sounded as though the doctors are on the take; that they go to the highest bidder; which ever company greases their palms the best. What a damn racket ! Doctors, literally, gambling with our health; which we lay in their hands. Not only are there needed heavier fines and penalities on the companies, but the doctors need to be punished, perhaps, through the loss of the medical licenses.

  • JarrodMarch 29, 2011 at 4:02 pm

    This is one crazy story, doctors being paid by St. Jude Medical to implant defribrillators to install their device. Its all about money with these doctors and medical companies. I had a St. Jude device implanted in my chest of October 2006, and the date was the 13th. It fired of one day while I was showering. That was the beginning of 2010. Back in Feburary of this year, 2011. I had to have CPR do[Show More]This is one crazy story, doctors being paid by St. Jude Medical to implant defribrillators to install their device. Its all about money with these doctors and medical companies. I had a St. Jude device implanted in my chest of October 2006, and the date was the 13th. It fired of one day while I was showering. That was the beginning of 2010. Back in Feburary of this year, 2011. I had to have CPR done three different times to bring me back to life, simply cause the defribrillator didn't work as it should have. No lawyer I contact won't even take my case. When I heard of this lawsuit, I figure I need to get invovled in this, since I almost lost my life three times, cause the St. Jude device didn't fire like its suppossed to. I thank God that He was there to save me, when a man made device, St. Jude, failed to fire off when I needed it most.

  • LatonyaMarch 2, 2011 at 3:42 pm

    I truly don't understand about this whole situation. I for had a St.Jude defbrillator that caused me damages.The ICD pokes whole in my heart,delivered unwanted shocks ,blood poison and staff infection I had to have opened heart surgery for the removal of the generator the riata lead is still embedded in my heart without possible removal. the lead came detached from the generertor.I mad as the devi[Show More]I truly don't understand about this whole situation. I for had a St.Jude defbrillator that caused me damages.The ICD pokes whole in my heart,delivered unwanted shocks ,blood poison and staff infection I had to have opened heart surgery for the removal of the generator the riata lead is still embedded in my heart without possible removal. the lead came detached from the generertor.I mad as the devil because I can't get any help I'm 27 years old and have two kids that I scared evenutally i going to die what am I to do .

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