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, April 17, 2013

Not a final win for metal on metal hip defense.


Never confuse a single defeat with a final defeat.
~ F. Scott Fitzgerald

Re-examine all you have been told.  Dismiss what insults your soul.  Walt Whitman

Laws, like the spider’s web, catch the fly and let the hawk go free.
Spanish Proverb

By BARRY MEIER  April 16, 2013   The New York Times  FiDA highlight
A jury in Chicago rejected claims on Tuesday that the orthopedics unit of Johnson & Johnson inappropriately marketed an artificial hip, which the company recalled in 2010.

The verdict came in the second trial of some 10,000 pending lawsuits involving the all-metal device, which was known as the Articular Surface Replacement, or A.S.R. In March, a jury in Los Angeles awarded $8.3 million in the first trial of an A.S.R.-related case.
The DePuy Orthopaedics unit of Johnson & Johnson said in a statement that all its actions related to the sale, marketing and recall of the device had been appropriate.
Internal DePuy documents introduced at the trials indicated that company officials knew that the design of the A.S.R. was flawed long before they recalled the device and even considered redesigning the implant. They never shared that information with doctors and patients, those documents show.
It was not immediately clear why the two juries returned such differing verdicts.
Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve. Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.
The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.
It was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use in the United States in standard hip replacements that used the same cup component as the resurfacing device.

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