Posts Tagged ‘ shrinkage ’

Day Five: Lewis v Ethicon: Ticking Time Bomb

Feb 15th, 2014 | By
Day Five: Lewis v Ethicon: Ticking Time Bomb

Lawyers for the plaintiff Carolyn Lewis (C.L.) wrapped up their defective product case against Ethicon (Johnson & Johnson) on Friday, February 14th, Valentine’s Day, capping off the day with C.L. on the stand. Before that there was more testimony via videotape from scientists working with Ethicon to show the company knew it had a problem
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Some Thoughts on Mesh: Product Design & Development

Mar 6th, 2013 | By
Some Thoughts on Mesh: Product Design & Development

~March 1, 2013 I helped Adam Slater as an expert with what became Gross v Ethicon from early in 2009. My job was to help Mr. Slater make sure Ethicon had produced all its relevant documents. I have the qualifications to do that because I am a veteran researcher and have run product development for
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New Hope for Mesh Patients

Feb 19th, 2013 | By
New Hope for Mesh Patients

By David Spellberg, MD As a Urologist, I have read about horrible complications such as bleeding, abdominal pain, perforated organs, and sexual dysfunction associated with certain types of mesh products and some of the terrible suffering of mesh patients. The Food and Drug Administration issued two warnings, one in October of 2008 and another in
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Day 11: Linda Gross v Ethicon: Medical Director Signs off on Prolift

Jan 26th, 2013 | By
Day 11: Linda Gross v Ethicon: Medical Director Signs off on Prolift

January 26, 2013 ~ It was Day 11 in the Linda Gross v. Ethicon trial that brought Dr. Charlotte Owens, Worldwide Medical Affairs Director for Ethicon to the stand via videotaped deposition. Her story was remarkable for the safety and efficacy information that did not make it into the Clinical Expert Report. It was her
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Day 5: Linda Gross v Ethicon: Company Docs Show Doubts Before Prolift Launch

Jan 16th, 2013 | By
Day 5: Linda Gross v Ethicon: Company Docs Show Doubts Before Prolift Launch

January 16, 2013 ~ The worldwide medical director of Ethicon took the stand all day in the trial of Linda Gross v Ethicon in an Atlantic City courtroom. The past president of the Flemish Society of Obstetrics and Gynecology from 2007 to 2008, Piet Hinoul had become the Director of Medical Affairs at Ethicon, a
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Doctor: Plaintiff Lawyers in ‘Attack Mode’ Over Mesh Complications

Sep 25th, 2012 | By
Doctor: Plaintiff Lawyers in ‘Attack Mode’ Over Mesh Complications

Sept 25, 2012 ~ A recent news release from an ObGyn in Minneapolis shows that at least he is on the offensive when it comes to mesh injuries. The doctor doesn’t let the facts get in the way. For some reason the doctor, an Ob/Gyn at Oakdale Obstetrics & Gynecology in the Minneapolis, Minnesota area
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FDA Orders Manufacturers to Study Mesh Complications

Jan 5th, 2012 | By
FDA Orders Manufacturers to Study Mesh Complications

JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration’s division that oversees medical devices has ordered surgical mesh manufacturers to study how often synthetic mesh harms women by causing infection and organ damage. (story is here) The order follows an FDA report last summer of a five-fold jump in the number of
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Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

Dec 1st, 2011 | By
Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

Linda Dodson, a dark-haired, attractive Georgia peach with a long southern drawl to match decided to visit a new gynecologist near her home in Georgia, just south east of Atlanta. After about 30 minutes on the exercise bicycle she would experience a muscle spasm in the urethra area. Not a big deal, she thought. Share
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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.