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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Saturday, December 9, 2017

Why Jury Trials/Verdicts Do Not Stop Medical Device Harm-for-Profit

Listen to this link: J&J defense lawyers attempt to void a $502 federal trial verdict by disassociating the 'parent' company from toxic metal-on-metal DePuy Pinnacle hips

This took place on December 7 at the New Orleans 5th District Federal Court of Appeals.


  1. It is good to remember that only some devices are "approved" by the FDA. Others are "cleared", which is a less rigorous process. People including doctors and patients should understand the difference.

  2. The PMA (Pre-Market Approval) by the FDA is not a reliable marker for safety or effectiveness for patients. Often the research is provided by the manufacturer and the protocols are not followed or the markers are selected to promote the approval of the device. If a patient is harmed, the Supreme Court in the recent verdict of Riegel v Medtronic, made the patient go to Federal court to gain compensation and stop further harm. FDA rarely recalls products. The manufacturer calculates how much they can afford in verdicts and settlements and loss of sales and then pulls the product from the market without fanfare.