Posts Tagged ‘ learned intermediary ’

Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

Aug 9th, 2012 | By
Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

August 8, 2012 ~ An appeals court ruling in Mississippi has upheld a lower court dismissal of a $10 million vaginal mesh case against Johnson & Johnson’s Ethicon division. The United States Court of Appeals Fifth Circuit filed the decision August 2, 2012 in the case against Ethicon by Deborah and Michael Smith. Deborah Smith
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Court: Drugmakers Do Not Have To Warn Patients About Drug Risks

Jul 17th, 2012 | By
Court: Drugmakers Do Not Have To Warn Patients About Drug Risks

July 17, 2012 ~ In a bizarre twist that puts one more advantage in the corporate side, the Supreme Court of Texas has ruled that manufacturers of pharmaceuticals do not have a responsibility to warn patients about the risks associated with using their products, even as they advertise directly to the public. A lower court
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American Medical Systems Files its Position Statement Laying Out its Strategy in Court in Defective Mesh Lawsuits

Apr 9th, 2012 | By
American Medical Systems Files its Position Statement Laying Out its Strategy in Court in Defective Mesh Lawsuits

April 9, 2012 ~ On Friday, April 6, American Medical Systems Inc. (AMS) of Minnetonka, Minnesota filed its Position Statement with federal court in the Southern District of West Virginia laying out its strategy in its defense of its synthetic surgical mesh used to treat female conditions of pelvic organ prolapse (POP) and stress urinary
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.