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Category: Product Defect

Drug and Medical Device Corporations — Are They Above the Law

08/24/2011
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Not a week goes by without a headline reporting on yet another settlement between a multi-national pharmaceutical company and state or federal prosecutors. Medical device manufacturers are often also frequently subject to similar prosecutions.  While it is laudable that governmental authorities are finally taking action against chronic wrongdoers, the frequency […]

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FDA: Continuing Concerns Relating to Transvaginal Mesh

08/17/2011
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On September 8 and 9, 2011, the Food & Drug Administration will convene a panel of experts to provide advice to the Agency with regard its regulation of gynecological medical devices.  The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the safety and […]

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Zimmer NexGen Knee Implant Update

08/11/2011
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On August 8, 2011, the Judicial Panel on Multi-District Litigation (JPML) announced a new MDL would be created for all of the Zimmer NexGen high-flex knee implant cases that have been filed in the federal court system.  At the time the petition was filed with the JPML requesting that multi-district […]

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Pregnancy and Birth Defect Warning: Diflucan (fluconazole)

08/4/2011
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Yesterday, the FDA warned that the drug Diflucan (fluconazole) can result in rare and distinctive birth defects if taken during the first trimester of pregnancy. The FDA Safety Information and Adverse Event Reporting Program issued this safety alert to obstetricians, gynecologists, pharmacists, and infectious disease physicians, as well as the […]

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Entire Class of Diabetes Drugs Under Fire

08/3/2011
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Two very popular and enormously successful diabetes drugs have come under intense regulatory scrutiny over the past year. Avandia and Actos were developed and prescribed to treat type 2 diabetes. In people with type 2 diabetes the body does not make enough insulin, and the insulin that the body produces […]

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Johnson & Johnson: Management Without Fault?

08/2/2011
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Johnson & Johnson claims that its numerous product recalls last year can be attributed to poor management, staffing cuts, and integrating the consumer unit it purchased from Pfizer Inc., the company said in court papers. The report makes clear, however, that top executives are not to blame.  This poses an […]

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