Category Archives: Medtronic Infuse

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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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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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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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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Medtronic Uses Preemption in Medtronic Infuse Case, Again

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , , , , |

European Medicines Agency Seeks Market Suspension of Medtronic InductOs

Euro Medicines Agency Seeks Suspension of Medtronic InductOs

The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , , , |

Medtronic Claims InFuse Injury Suits Preempted by Federal Law

Medtronic Claims InFuse Injury Suits Preempted by Federal Law

In an effort to avert lawsuits filed over injuries attributed to its InFuse bone growth device, device maker, Medtronic Inc., has tried to convince courts that the federal preemption clause of the federal Food, Drug and Cosmetic Act preempts the … Continue reading

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Class Action Lawsuit over Infuse Could Complicate Medtronic Acquisition of Covidien

A class action lawsuit over Medtronic’s bone growth product Infuse could complicate the company’s planned acquisition of Dublin-based device maker Covidien. U.S. District Judge John Tunheim will allow lawyers for Medtronic investors to explore an alleged coverup of Infuse’s side … Continue reading

Posted in Class Action Lawsuits, Defective Medical Devices, Legal News, Medtronic Infuse |

Medtronic Fourth-Quarter Reported Profits Drop 54 Percent, InFuse Litigation Cited

Medtronic, Inc. just announced a massive drop in its net earnings for fourth-quarter ended April 25th. The announced drop of 54 percent involved fourth-quarter net earnings of $448 million—$.44 per share—over the prior year’s $969 million and $.95 per share. … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Medtronic Could Pay Up to $140 Million in Lawsuits Over Infuse Bone-Growth Product

Medical device maker Medtronic Inc. announced on Tuesday that it would include in its fourth-quarter results a charge between $120 and $140 million to settle hundreds of lawsuits over its InFuse bone-growth product. The charge will account for 1,200 claims … Continue reading

Posted in Defective Medical Devices, Health Concerns, Legal News, Medtronic Infuse |

Five Infuse Patients Bring Lawsuit Over Bone Graft Injuries

Infuse-patients-bring-lawsuits-over-bone-graft

Five Infuse patients have brought a lawsuit against Medtronic Inc. over its controversial bone graft product. The recent litigation was recently filed in California Superior Court. Allegations all involve that the patients were implanted with Infuse off-label and have, as … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Medtronic Denied Preemption in Another Device Injury Lawsuit

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An Indiana appeals court just ruled that Medtronic cannot use so-called “preemption” to get out of a negligence lawsuit filed over a failed Transvene defibrillator lead. Preemption is legal concept that a number of medical device makers have used in … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Defibrillators, Medtronic Infuse |

Merck Cutting Staff Over Research Unit Re-Structure Plans

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Drug giant, Merck, has announced plans to cut 8,500 employees as part of a restructuring meant to increase marketplace competitiveness. Over the next two years, in addition to the massive layoffs, Merck also announced that it would be implementing significant … Continue reading

Posted in Defective Medical Devices, Fosamax, Medtronic Infuse, Pharmaceuticals |

Stryker, Medtronic Lose Preemption Bid in Lawsuit Involving Alleged Off-Label Bone Product Use

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A preemption bid made by device makers Medtronic and Stryker to dismiss a lawsuit filed over their bone protein products has been rejected. A California state court ruled that federal law does not preempt the case from proceeding, according to … Continue reading

Posted in Defective Medical Devices, Defective Products, Medtronic Infuse |

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