St. Jude Riata Settlement Reached for $64M over Recalled Defibrillator Leads

St. Jude Medical has agreed to pay $64.3 million to settle lawsuits filed by consumers and shareholders over problems with Riata defibrillator leads, which were recalled amid reports that the insulation may fail. 

In a recent press release, the manufacturer indicated that it has reached agreements to settle about 950 St. Jude Riata injury lawsuits for about $14.75 million, leaving only a handful of claims unresolved.

In addition, a class action lawsuit brought on behalf of shareholders over the company’s third-quarter 2009 results is settling for $50 million, resolving claims that St. Jude provided false information by failing to reveal that it knew the Riata leads had problems.

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St. Jude Riata leads are small wires used to connect implantable cardiac defibrillators (ICDs) to the heart. They are designed to monitor the heart rhythms and deliver electric shocks if needed to restore normal heart beats.

About 227,000 of the lead wires were sold worldwide before the manufacturer acknowledged that the insulation surrounding the wire may be prone to decay and erode, leaving exposed wires inside patients. This has caused many users to experience unnecessary shocks, or for the defibrillator to fail.

In late 2010, St. Jude removed the leads from the market amid reports of insulation failure, and a warning letter was sent to doctors about the risk of problems in late 2011, which the FDA classified as a St. Jude Riata recall. However, it is estimated that nearly 80,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is risky and doctors often recommend keeping the defective lead in place unless there is evidence that it has failed.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

Nearly 1,000 patients who received the recalled wires pursued St. Judge Riata lawsuits, alleging that the manufacturer sold a defective and dangerous medical device and failed to disclose the risk of early failure.

Unlike many mass litigation cases involving medical devices or drugs, the St. Jude cases have not been consolidated as part of an MDL, or multidistrict litigation. This has led to conflicting rulings regarding preemption, with some courts finding that the cases are barred, because the device was approved by the FDA.

9 Comments

  • SamuelApril 28, 2022 at 9:13 pm

    My husband got the reata lead put in 2006. But now is having a lot of problems now after 16 yes. He’s gradually started with muscle spasms and gotten to the point where it’s gotten worse. Took him to specialists and no one can figure it out. He has CHF and fills up with to much water. Need to know if it’s the lead.

  • cassJanuary 12, 2022 at 9:43 am

    My mother had a st Jude icd places in her about 4 years ago due to low heart rate from chf she just passed away nov 20 th it was as tho the icd was no longer keeping her heart rate up they eventually shut her kidneys down trying to keep her heart rate up with medications so now the big question in my mind even tho the hospital said her icd was firing was it working right or is it to blame for her [Show More]My mother had a st Jude icd places in her about 4 years ago due to low heart rate from chf she just passed away nov 20 th it was as tho the icd was no longer keeping her heart rate up they eventually shut her kidneys down trying to keep her heart rate up with medications so now the big question in my mind even tho the hospital said her icd was firing was it working right or is it to blame for her being gone ?

  • JoyceOctober 23, 2021 at 7:20 pm

    I also had the st Jude pacemaker after 2 yrs I was told the leads had frailed.had it removed and replaced with a Medtronic pacermaker.

  • DaleJuly 29, 2018 at 9:20 pm

    I received a St Jude's pacemaker October 2012. Found out Friday lead to upper chamber insulation is bad. Having to have another surgery this week because of a known faulty wire issue. Was installed anyway never was even told there was a problem with them . Till researched this past Friday after coming home from Dr. Was taken last Monday by ambulance from MD 360 to hospital with heart issues

  • GarrettJune 10, 2017 at 7:17 pm

    ive had two metronic pacemakers with st jude leads both were recalled. nothing but trouble over a 10 year period, had infection for months, leads broke shocked me 21x before stopping, had all removed with laser surgery an unreal experience that nearly took me out.

  • HomerFebruary 17, 2017 at 7:21 pm

    I had a St. Jude Difribulater removed after years of complications...

  • LindaOctober 13, 2016 at 2:39 am

    My father had the same unit installed in the year 2014 he died of cardiac arrest I believe could've been avoided due to the Saint Jude failure

  • thomasDecember 23, 2015 at 9:42 pm

    The Reata st lead caused me and acute Excaliburation of pancreatitis a rare form of pancreatitis cystic fibrosis and stage 4 pancreatic cancer which are all terminal diseases that are fatal cancer is in remission since January 26th 2012 and I would like you to contact me my leave was personally bear when it was put in manufacture that way

  • DonnieDecember 21, 2015 at 3:14 pm

    My husband had surgery November 6, 2015 to remove the St. Judes Lead removed, the lead was badly frayed. I seen where St Jude Riata class action Lawsuit .

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