Posts Tagged ‘ FDA ’

ARICEPT 23: How an Unusual Dose Generated More Revenue for Big Pharma

Oct 14th, 2014 | By
ARICEPT 23:  How an Unusual Dose Generated More Revenue for Big Pharma

By Dan C. Bolton Keller, Fishback & Jackson LLP With the clock about to run out on patent protection for their blockbuster drug Aricept, prescribed to treat symptoms of Alzheimer’s Disease (AD), two pharmaceutical giants, Pfizer, Inc. and Eisai Inc., came up with a brazen idea to dodge patent expiration and continue to reap profits.
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Mesh Survivors UK- Contact Your GP, MP – Challenge the Information!

Oct 10th, 2014 | By
Mesh Survivors UK- Contact Your GP, MP – Challenge the Information!

A mesh survivor from the UK suggests survivors contact their GP and MP with their mesh survivor stories.  (GP is general practitioner and MP is Member of Parliament. The reason – no one ever gets a letter to confirm it has been reported. Finally, this writer got a report to confirm. It said:  this event
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FDA Must Reclassify Synthetic Mesh Now!

Oct 1st, 2014 | By

October 2, 2014   Margaret A. Hamburg, M.D. Commissioner, Food and Drug Administration Department of Health and Human Services   Jeffrey E. Shuren, M.D., J.D. Director, Center for Devices and Radiologic Health Food and Drug Administration Department of Health and Human Services   Dear Drs. Hamburg and Shuren, We, the supporters and members of the
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Scottish Medical Officer Says Docs Can Continue to Implant Mesh Despite Mesh Suspension

Sep 28th, 2014 | By
Scottish Medical Officer Says Docs Can Continue to Implant Mesh Despite Mesh Suspension

Marion Scott, the reporter who has passionately reported on the pelvic mesh issue for the Daily Record and Sunday Mail newspaper in Scotland, reports a top medical adviser to the Scottish government suggests doctors may continue to perform mesh implants even though the Health Secretary has advised use of pelvic mesh be suspended. Dr. Frances
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Report Finds Doctors Still Using Power Morcellator Despite the Risks

Sep 22nd, 2014 | By
Report Finds Doctors Still Using Power Morcellator Despite the Risks

Months after the U.S. Food and Drug Administration (FDA) warned a medical device could spread deadly uterine cancer, many doctors and hospitals are still using it. The power morcellator made by Johnson & Johnson (J&J) was removed from the market after the FDA warned it could spread undetected uterine cancers. A report in the Wall
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Dallas Trial, Salazar v Boston Scientific Covered by Dallas Observer

Sep 3rd, 2014 | By
Dallas Trial, Salazar v Boston Scientific Covered by Dallas Observer

The Dallas Observer and reporter Amy Silverstein offer this coverage of the Martha Salazar v. Boston Scientific trial underway in Dallas. She wrote  a May feature story, about the Batiste trial. She was awarded $1.2 million by a jury in her defective mesh case against Johnson & Johnson.  Jurors also found her TVT-O was defectively
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POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

Aug 15th, 2014 | By
POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

By Dan Bolton, Keller, Fishback & Jackson LLP An estimated 50,000 women a year in the United States undergo a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) with the use of a medical device known as a power morcellator. Power morcellators typically use a rapidly rotating blade to cut (or “morcellate”)
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Thank You All for Telling the FDA to Reclassify!!

Jul 31st, 2014 | By
Thank You All for Telling the FDA to Reclassify!!

Thank you,,, thank you…. thank you! I talked to the FDA today  and they say that it could take many months for individuals within the FDA to read all of the comments made to a Petition to reclassify pelvic mesh as High Risk!    Some of you may have posted that you wanted to be private
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Huskey V. Ethicon- Case Survives Summary Judgment

Jul 24th, 2014 | By
Huskey V. Ethicon- Case Survives Summary Judgment

Jury selection August 22. Pelvic mesh trial to start August 25. The case of Huskey v. Ethicon (Johnson & Johnson) has survived a summary judgment motion and will continue to federal court in Charleston, West Virginia. Jo Huskey is a 54-year-old woman who was implanted with a TVT-O pelvic mesh device in February, 2011 to
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ProteGen Mesh ~ The Grandmother of them All

Jul 13th, 2014 | By
ProteGen Mesh  ~ The Grandmother of them All

Fantastic researcher and friend, Suzanne McClain has always been the most competent person in digging through the U.S. Food and Drug Administration records (FDA), tedious work which involves a lot of patience. Here she has prepared a spreadsheet that shows the Johnson & Johnson meshes, and predicate devices used in order to clear them through
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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.