Tag Archives: Premarket

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New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability

A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.

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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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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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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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Premarket Approval for Essure Birth Control Device Was Fraudulent, Patients Say

premarket-approval-Essure

Patients involved in the clinical trials conducted in connection with the premarket approval application (PMA) for the Essure birth control device say that patient records were altered to show favorable results despite patient reports of problems. The Food and Drug … Continue reading

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