Category Archives: St. Jude Defibrillators

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Death in Those Taking Bactrim with ACE Inhibitors or ARBs

Sudden Death in Those Taking Bactrim Along with ACE Inhibitors or ARBs

Association between sudden death in those given Bactrim while already taking renin-angiotensin system blockers angiotensin receptor blockers (ARBs), heart medications.

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Fracking Should be Kept 600m From Aquifers, Study Says

New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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Riata Lawsuits Challenge Liability Protection for Device Makers

Lawsuits are being filed against St Jude Medical Inc., the device maker that manufactures the controversial Riata defibrillator leads. The cardiac devices have been associated with numerous reports of deaths and injuries. The Riata was removed from the market in … Continue reading

Posted in Defective Medical Devices, St. Jude Defibrillators |

St. Jude Medical Strongly Warned by Federal Regulators Over Durata Lead

The U.S. Food & Drug Administration just issued another, stronger warning to St. Jude Medical about its Durata electrical heart lead. The warning letter discussed either imposing a fine or other, serious, actions against the medical provider for not responding … Continue reading

Posted in Defective Medical Devices, St. Jude Defibrillators |

Report Raises Concerns Over St. Jude Heart Device

A just-released federal inspection report on Sylmar, California’s  St. Jude Medical facility is raising concerns. The report, released by the U.S Food & Drug Administration (FDA), revealed serious flaws in St. Jude’s testing and its oversight of what The New … Continue reading

Posted in Defective Medical Devices, Legal News, St. Jude Defibrillators |

St. Jude likely to receive FDA warning letter following inspection of California manufacturing facility

St. Jude Medical Inc. believes it is likely to face a regulatory warning letter on the heels of a recent Food and Drug Administration inspection of a California manufacturing facility that makes some of its troublesome cardiac defibrillator leads. According … Continue reading

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St. Jude Riata Lead Defects Have One Family Living in Fear

The mother of a little girl who has already been through one painful ordeal because of a defective defibrillator lead wire now lives in fear that the St. Jude Riata defibrillator lead her daughter received as a replacement could go … Continue reading

Posted in Defective Medical Devices, St. Jude Defibrillators |

St. Jude Riata Lead Patients Face Rising Medical Bills

Patients who have been implanted with St. Jude Medical’s now-recalled Riata defibrillator leads will likely face some hefty medical bills.  According to a report from The Wall Street Journal, doctors are increasingly removing St. Jude Riata leads, a procedure that … Continue reading

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New Study of St. Jude Durata Defibrillator Lead Wires Raises Red Flags

A new study conducted by a prominent cardiologist is raising concerns about St. Jude Medical’s line of Durata defibrillator lead wires.  According to Dr. Robert Hauser, a new type of coating  that is used on the Durata lead may not … Continue reading

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Heart Device Patients with St. Jude Riata Leads Need X-Rays to Check Insulation, FDA Warns

Federal health regulators are warning that patients with implantable cardiac defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices that are connected to their hearts via St. Jude Medical’s Riata or Riata ST lead wires need to undergo x-rays or other … Continue reading

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St. Jude Says Analysis Shows Durata Lead Failure Not Related to Riata Flaws

St. Jude Medical has acknowledged that one of its Durata defibrillator lead wires suffered from “externalized abrasion,” but denies that the model suffers from the same type of critical flaw that forced it to pull its Riata lead wires from … Continue reading

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Top Doctor Says St. Jude Durata Lead Failure Report is Credible

A top cardiologist is of the opionion that a Durata lead failure report is, in fact, credible. We recently wrote that the U.S. Food & Drug Administration (FDA) received a report of a St. Jude Durata cardiac defibrillator lead wire … Continue reading

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