Category Archives: St. Jude Defibrillators

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Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.

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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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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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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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Pennsylvania Health System Proposes Comprehensive Fracking Study

A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.

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Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.

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DeflateGate’s Effects Impact Legal Gambling & the Economy

DeflateGate’s-Effects-Impact-Legal-Gambling-and-the-Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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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

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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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