Tag Archives: implantable cardioverter defibrillators

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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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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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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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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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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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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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Trial over Ethicon Transvaginal Mesh Begins in California

Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries.

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed. According to press release issued Jan. 7, a resolution was introduced by Council Member Margaret Chin, Council Speaker Melissa Mark-Viverito and Council Members Paul Vallone and I. ...

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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St. Jude Medical Recalls Defibrillator Leads Due to Damaged Insulation

defibrillator-implant

On January 22, 2016, device maker St. Jude Medical announced that a voluntary global field safety action related for the company’s Optisure Dual Coil Defibrillation Leads has now been designated a Class 1 advisory by the Food and Drug Administration … Continue reading

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