Posts Tagged ‘ substantial equivalent ’

$8.3 Million Verdict Against J&J’s DePuy Unit Over ASR Metal Hip

Mar 8th, 2013 | By

March 8, 2013 ~ Johnson & Johnson must pay the plaintiff who brought the first DePuy metal hip implant device to trial $8.3 million in damages, a Los Angeles jury decided this afternoon. This is the first of 10,750 product liability lawsuits against J&J’s DePuy unit which makes the ASR XL hip replacement device. The
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Teresa Hughes: Demanding Answers and Raising the Profile of Vaginal Mesh Injuries in the UK

Nov 5th, 2012 | By
Teresa Hughes: Demanding Answers and Raising the Profile of Vaginal Mesh Injuries in the UK

Teresa Hughes, 61, a resident of Liverpool, England, and mother of two, has made so much noise about defective vaginal mesh that last year she was profiled in the UK paper, The Daily Mail. It started: “Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems
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FDA Closer to Funding Goals – Where is Patient Safety?

May 14th, 2012 | By
FDA Closer to Funding Goals – Where is Patient Safety?

On May Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. Food and Drug Administration’s oversight of medical devices for the next five years. However, the House voted 46-0 without approving legislation that would protect Americans from defective medical devices
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FDA: Medical Device Complications Growing Faster than Industry

Nov 8th, 2011 | By
FDA: Medical Device Complications Growing Faster than Industry

Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, defective medical devices that are
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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.