All entries by this author

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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Boston Scientific Wins First Pelvic Mesh Trial

Jul 29th, 2014 | By

After a two week trial, Boston Scientific won its first product liability trial over transvaginal mesh. The jurors returned the verdict around 5 pm Tuesday, July 29. On March 9, 2010, Diane Albright received the implant made by Boston Scientific – the Pinnacle Pelvic Floor Repair Kit.  According to her complaint, Albright suffered mesh complications
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Speak to the FDA Now!

Jul 28th, 2014 | By
Speak to the FDA Now!

  Midnight Wednesday July 30, the opportunity ends to weigh into the FDA concerning the reclassification of POP mesh to class III or a high-risk device which it certainly is. Mesh will never survive that scrutiny. Mesh News Desk and Corporate Action Network, a consumer group, are asking you to share the link below with
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Albright v. Boston Scientific Pelvic Mesh Trial Wraps Monday

Jul 25th, 2014 | By
Albright v. Boston Scientific Pelvic Mesh Trial Wraps Monday

The two week trial of Diane Albright v. Boston Scientific d/b/a Mansfield Scientific, Inc. and Microvasive, Inc. is expected to go to the jury Monday, July 28, 2014 after closing arguments. The product liability lawsuit was filed in Middlesex Co in Massachusetts, Superior Court Action 12-0909. Boston Scientific is headquartered in Middlesex County, MA. On
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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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Is a C.R. Bard Pelvic Mesh Settlement Near?

Jul 22nd, 2014 | By
Is a C.R. Bard Pelvic Mesh Settlement Near?

A company that produces transvaginal mesh for a major manufacturer is setting aside $180 million for transvaginal mesh cases. As of this writing,  pelvic mesh maker C.R. Bard is facing 9,234 product liability cases filed in federal court in Charleston, West Virginia. Multidistrict litigation involving transvaginal mesh filed in the federal West Virginia court also
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NJ Judge Upholds $11 Million Linda Gross Award- Ethicon Announces Another Appeal

Jul 17th, 2014 | By
NJ Judge Upholds $11 Million Linda Gross Award- Ethicon Announces Another Appeal

Congratulations Linda and Jeff Gross! It was a year ago February that Linda and Jeff Gross of  Watertown, South Dakota were awarded $11.1 million following their four-week defective pelvic mesh trial against Ethicon, a subsidiary of Johnson & Johnson. Wednesday the verdict was upheld in the product liability case. Atlantic County Superior Court Judge Carol
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New York Times on Mesh Injuries and Texas Torts

Jul 13th, 2014 | By
New York Times on Mesh Injuries and Texas Torts

Texas has had an inquiry into mesh manufacturers, specifically Johnson & Johnson, for two years and nine other states have joined in.  The New York Times, in its Texas edition reports that Aaron Horton and her Mesh Warrior Foundation for the Injured is helping women to recognize their injuries and providing them with information and
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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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Boston Scientific Opening Arguments in Mass. Court

Jul 9th, 2014 | By
Boston Scientific Opening Arguments in Mass. Court

Today was Day One for opening arguments in the trial of Diane Albright v. Boston Scientific being heard in Middlesex Co. Superior Court in Woburn, Massachusetts.  It appears to be the first product liability trial against Boston Scientific, maker of transvaginal mesh.  The case is being heard before Judge Diane M. Kottmyer and could take
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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.