Category Archives: St. Jude Defibrillators

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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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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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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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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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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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