Posts Tagged ‘ Food and Drug Administration ’

Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh

Jul 29th, 2013 | By
Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh

The case of Donna Cisson v. C.R. Bard began for a second time in a federal court in Charleston, West Virginia today. Cisson, 55, was implanted with a Bard Avaulta Plus Posterior mesh on May 8, 2009 in Toccoa, Georgia. The initial product liability trial began July 8, but two days later, a statement by
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Mistrial Declared in First Federal Transvaginal Mesh Trial

Jul 10th, 2013 | By
Mistrial Declared in First Federal Transvaginal Mesh Trial

July 10, 2013~  Saying it was the first time in his 20 years on the bench he had declared a mistrial, federal Judge Joseph R. Goodwin ended the first federal trial involving one of six transvaginal mesh manufacturers, C.R. Bard, after just two days of testimony. More than 25,000 cases have been consolidated in the
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Op-Ed: Dr. Shezad Malik on Doctors and Transvaginal Mesh

Jul 2nd, 2013 | By
Op-Ed: Dr. Shezad Malik on Doctors and Transvaginal Mesh

Op-Ed: Dr Shezad Malik Law Firm http://www.shezadmalik.com/ Dr. Malik is a cardiologist and now an attorney in Dallas who heads his own law firm. He is board certified in internal medicine and was a practicing cardiologist for 10 years. In 2003 he decided to go to law school and has been practicing personal injury law
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Happy Anniversary Food and Drug Administration – Now What?

Jul 2nd, 2013 | By
Happy Anniversary Food and Drug Administration – Now What?

July 2, 2013 ~ Many of you may be aware that the entire pursuit of lawsuits against mesh manufacturers began two years ago this month with the issuance of a safety warning from the U.S. Food and Drug Administration concerning transvaginal mesh. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical
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MDND: Welcome July 2013

Jul 2nd, 2013 | By
MDND: Welcome July 2013

July 2, 2013 ~ Welcome.  I’m Jane Akre, the Editor of MDND. There is a lot of stuff brewing this month. C.R. Bard, a mesh maker, will face off against Donna and Don Cisson in a federal court in West Virginia. This is the first of four bellwether cases, as they are called, in this
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Bard Docs: Company Knew Hernia, Transvaginal Mesh Not Fit for Human Implants

Jun 26th, 2013 | By
Bard Docs: Company Knew Hernia, Transvaginal Mesh Not Fit for Human Implants

June 26, 2013 ~ Bloomberg is reporting on court documents revealed in advance of the July 8, C.R. Bard trial that the company had been warned the plastic used in its hernia and transvaginal mesh was unfit for human implantation. Read the story here. Unsealed court records shows that the Bard Davol unit received a
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Pap Smears: A Technican Speaks Out About Problems and Profits

Jun 20th, 2013 | By
Pap Smears: A Technican Speaks Out About Problems and Profits

June 20, 2013 ~Mark K. is a laboratory technician whose job it is to read PAP smears, the annual test recommended to screen for cervical cancer for most women. In a rare insider opinion, he shares with readers of MDND what he feels is not working. It is a rare look at what many rank
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FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA Asks Consumers to Report Product Failures

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements.
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UK Meshies United Group Asks for Govt. Review for Failure of Duty

Apr 30th, 2013 | By
UK Meshies United Group Asks for Govt. Review for Failure of Duty

April 30, 2013 ~ One year ago, Teresa Hughes made history by turning in a petition on behalf of a number of women suffering mesh complications in the United Kingdom (UK) to 10 Downing Street, the home of the Prime Minister. Hughes founded The Meshies United Group in the UK.  See back story here.  She
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FDA Workshop on Health of Women

Apr 9th, 2013 | By

April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW).  The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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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.