Category Archives: Medtonic Infuse

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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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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Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...

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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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Bronx Teenager Killed in Hit-and-Run, Second Teen Injured

A Port Jefferson Station man was killed on Wednesday in a single-vehicle crash on the Northern State Pkwy in Dix Hills west of Exit 42. He was driving a Nissan Altima.

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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Medtronic Infuse Recipients Receive $8.45 Million in Settlements

Medtronic Infuse Recipients Win $8.45 Million in Settlements

The University of California, Los Angeles has agreed to pay a combined $8.45 million to two patients who received Medtronic’s controversial Infuse bone graft product. These individuals filed lawsuits alleging that the product caused unwanted bone growth. They also claimed … Continue reading

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Medtronic Pays $500 Million Tax Charge To Move $9.8 Billion To United States

Medtronic Pays $500M Tax Charge To Move $9.8B To U.S.

As part of an internal restructuring related to its $49.9 billion merger with Covidien, Medtronic will pay a one-time tax charge of $500 million so that it can bring $9.8 billion in overseas cash to the United States. This move … Continue reading

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European Regulators Review Medtronic’s InductOs in Light of Contamination Issues

European Regulators Review Medtronic’s InductOs

The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the … Continue reading

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Federal Data Shows Medtronic Continues to Pay Doctors in Connection with InFuse Spinal Fusion Device

Federal Data Shows Medtronic Continues to Pay Doctors

Data available through the federal Open Payments database show that device maker Medtronic continues to pay millions of dollars to doctors whose research on the InFuse spinal fusion device has been called into question. Medtronic’s spine division, Medtronic Sofamor Danek, … Continue reading

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Study Reports Decline in Use of Bone Morphogenetic Proteins in Spinal Surgeries

Decline in Use of Bone Morphogenetic Proteins in Surgeries

Bone morphogenetic proteins (BMPs) have been widely used in spinal fusion surgeries since their approval in 2002, a new study published in the journal Spine says BMP use has declined in response to concerns about safety and complications. After BMP … Continue reading

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Lawsuit Involving Medtronic’s InFuse Bone Graft Product Filed in St. Louis

Medtronic’s InFuse Bone Graft Product Filed in St. Louis

A group of law firms has filed a lawsuit in Circuit Court in St. Louis against Medtronic, Inc. on behalf of patients who allege injuries that include catastrophic, unchecked bone growth in the spinal column following surgical procedures with Medtronic’s … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse |

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA Warning for Bone Graft Products in Patients Under 18

The Food and Drug Administration has issued a safety alert to healthcare providers, patients, and parents and guardians that bone graft devices containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18. … Continue reading

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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 |

Lawsuit Filed Against Medtronic for Promoting Off-Label Use of Infuse

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A lawsuit filed this week alleges that Medtronic Inc. deliberately promoted the off-label use of its Infuse bone graft product. The complaint includes the names of 98 plaintiffs who allege that the off-label use of Medtronic caused them to incur … Continue reading

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Medtronic Issued Warning Letter Over Its Diabetes Facility

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Device maker, Medtronic Inc., was just issued a warning letter from the U.S. Food and Drug Administration (FDA) concerning its Northridge, California diabetes facility. The letter was received on September 19 and discussed procedures involving “corrective and preventative action, complaint … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse |

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