Suit claims companies failed to perform adequate testing of harmful pelvic mesh product

Posted on August 17th, 2012 No Comments

Connie C. Pinkerton of Ohio has filed a product liability complaint against Pennsylvania-based Endo Pharmaceuticals and Minnesota-based American Medical Systems. Her attorney, James D. Barger, filed the civil action August 6, 2012. Pinkerton, after having had the Elevate Prolapse Repair System implanted in her body during a surgery, has since experienced physical and mental pain […]

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Are there shortcuts to FDA approval for medical devices?

Posted on August 16th, 2012 No Comments

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. It includes the Medical Device User Fee Amendments of 2012 (MDUFA III), which increase user fees in exchange for speeding up the approval process. For some, this hastening of the approval process raises concerns, particularly for those […]

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