Category Archives: St. Jude Defibrillators

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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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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Retailers Accused of Selling Fraudulent Herbal Supplements

Major Retailers Accused of Selling Fraudulent Herbal Supplements

The NYS attorney general’s office has accused four national retailers of selling fraudulent dietary supplements.

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Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed. According to press release issued Jan. 7, a resolution was introduced by Council Member Margaret Chin, Council Speaker Melissa Mark-Viverito and Council Members Paul Vallone and I. ...

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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

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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

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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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