Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, February 6, 2013

Howard Sadwin: Video of Medical and Legal Purgatory

Howard Sadwin, too late, sees clearly the trap that he entered when he got his second failed hip.  He has researched the ecosystem of toxic lies & misinformation that are told by medical device sales reps, hospital administrators, FDA regulators and even elected officials.  He traveled to Washington DC June 27 and 28, 2012 to testify and share this information with the public.



 According to Howard, no journalist has yet to go beyond hip trial or personal stories.  It is time to tell the full story to protect our nations' healthcare funding.  Allowing failed devices to compete directly with functioning devices exposes patients to devastating harm.

Pre-emption laws are not events mentioned nor understood.  The media can help expose this flaw.
The FDA was created for our safety and well being yet the pre-emption laws protect PMA approved devices.  The pre-emption laws were to prevent patients from suing manufacturers for every little issue.  They were not created to harbour a manufacturer from prosecution when their device malfunctions, hurting thousands.   (Such as Smith&Nephew’s Birmingham Hip Resurfacing device (Bhr). ) The 5th amendment gives us the right to Due Process, part of the Bill of Rights protets against abuse of government authority in legal procedure.  

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