- Posted October 4, 2013 by
This iReport is part of an assignment:
Shutdown over: What next?
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
Government Shut down and FDA cover-up
2013 The FDA Ombudsman office was to investigate and make a ruling on the testing of experimental heart devices that caused heart attacks in unsuspecting patients during open heart surgery.
THE MYXO FILE PART XI PROVIDES THE 2007 SEC DOCUMENTATION FOR THE LAUNCH OF THE MYXO ETLOGIX DEVICE.
EDWARDS LIFESCIENCES FILED TWO 10K FILINGS FOR 2006 AND 2007 DURING THE 2007 FILING YEAR. BOTH 10K FILINGS STATE THE LAUNCH OF THE MYXO ETLOGIX ANNULPLASTY RING MODEL 5100 WAS LAUNCHED IN JANUARY 2007.
ALL OF THE 10Q QUARTERLY FILINGS ALSO INDICATE THAT THE MYXO ETLOGIX DEVICE WAS LAUNCHED IN JANUARY 2007.
THERE IS NO MENTION OF THE SALES OF THE MYXO ETLOGIX PRIOR TO JANUARY 2007 IN ANY OF THE EDWARDS LIFESCIENCE SEC FILINGS FOR THE COMPANY.
IN SEPTEMBER 2007, TWO MONTHS AFTER MANDATORY REPORTING TO THE NORTHWESTERN MEMORIAL FACULTY FOUNDATION GENERAL COUNSEL, ON BEHALF OF THE UNIVERSITY AND HOSPITAL, THE ATTORNEYS’ RELIED UPON AN EMAIL SENT TO THE GENERAL COUNSEL STATING THE DEVICE WAS ON THE MARKET IN MARCH 2006.
THE DEVICE WAS NOT LEGALLY SOLD ON THE US MARKET BY EDWARDS LIFESCIENCES UNTIL JANUARY 2007, AS PER EDWARDS LIFESCIENCES DISCLOSURES TO THE SEC IN 10K AND 10Q FILINGS.
I HAVE SUBMITTED THIS EVIDENCE TO NORTHWESTERN UNIVERSITY BOARD OF TRUSTEES VIA EMAIL AND HAVE REQUESTED A MEETING TO REVIEW THE EVIDENCE.
THE PATIENTS WERE ENROLLED UNDER GENERAL ANESTHESIA, IN CLINICAL VALDIATION STUDIES
WITHOUT THEIR INFORMED CONSENT.
The government shutdown is delaying the review of the evidence. The FDA and HHS has the legal responsibility under the Neuremberg laws to protect unsuspecting US citizens from human experimentation.
The United Nations and the International Tribunal of the Hague has the oversight responsibility to protect these patients.
The Myxo File PArt XII provides the SEC and FDA evidence.
The Surgical suture video demonstrates the safety issue surrounding the myxo device that was never reported to the FDA compliance committee. Northwestern University and the company had the responsibility to report the data to the FDA.