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Tag Archives: Drug Administration

Some Previously Approved Medical Devices are Skirting Past FDA Evaluation

Published May 8, 2012 on TMD A loophole in federal law requires the FDA to approve some previously-recalled medical devices. Now, the agency says it wants to see that changed. Defective hip implant devices and transvaginal mesh devices went to market despite significant concerns over the safety of earlier models. In addition, thousands of Americans  Full Article…

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Abbott to Pay $1.6B to Settle Depakote Claims

Published May 7, 2012 by Chicago Tribune Abbott Laboratories said Monday it will pay $1.6 billion to settle federal and state claims that it illegally marketed the anti-seizure medication Depakote for uses not approved by the Food and Drug Administration. As part of the settlement agreement, North Chicago-based Abbott said it would pay $800 million  Full Article…

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Avandia Sales Slumped on Heart Risks: Adverse Event

Published May 3, 2012 on PR Web San Diego, CA (PRWEB) May 03, 2012 The media spotlight is often a double-edged sword. No one knows this better than people who suffer from Avandia severe adverse events and have filed Avandia Lawsuits. And yet, gossip and rumor-mongering aside, the real story here is being overlooked according  Full Article…

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Yaz Lawsuit Settlements Reach $142 Million

Published April 30, 2012 on OpenPR (openPR) – Nadrich & Cohen, LLP reports that Bayer is continuing to offer settlements to plaintiffs involved in federal Yaz side effects litigation. Los Angeles, CA, April 27, 2012 – Nadrich & Cohen, LLP reports that German drug-maker Bayer AG has settled approximately 651 Yaz side effects lawsuits totaling  Full Article…

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Avandia Lawsuit Settlements

Posted April 22, 2012 Rosiglitazone, branded under Avandia and marketed as a drug to help diabetics process insulin by manufacturer GlaxoSmithKline, has been the focus of several lawsuits in the United States and Europe. Due to the reported side effects, Avandia declined in popularity and is now subject to restrictions placed by the Food and  Full Article…

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Transvaginal Mesh Injuries Ruin Lives FDA Slow To React

Posted April 11, 2012 on drugwatch As more women who have been victim to faulty transvaginal mesh devices across the United States come forward, medical device regulators here and in the United Kingdom continue their sluggish investigations into devices that have caused severe injuries and death. In the past months, the U.S. Food and Drug  Full Article…

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Unapproved Transvaginal Mesh Was Used For Years

Posted March 29, 2012 by drugwatch A Johnson & Johnson-brand transvaginal mesh that was used for more than three years before U.S. regulators approved it is now the subject of court claims from women who were injured by it, Bloomberg News reported. The Gynecare Prolift, made by Johnson & Johnson’s Ethicon unit, was introduced to  Full Article…

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St. Louis-based Carey, Danis & Lowe Files Federal Suit in Illinois Against the Maker of Zoloft

Posted March 16, 2012 by Business Wire Suit asserts Pfizer hid risks of birth defects when the antidepressant was taken during pregnancy ST. LOUIS–(BUSINESS WIRE)–St. Louis–based law firm Carey, Danis & Lowe announces the filing of a federal lawsuit against Pfizer (NYSE: PFE) for allegedly causing birth defects in a child after the mother was  Full Article…

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