- 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
Madoff Meet PENN state in Federal cover-up: Institutional Responsibility to Innocent Victims
FDA, Edwards Lifesciences and Northwestern University at the center of cover-up of illlegal human experimentation of innocent patients receiving black market devices that were never FDA approved in their hearts during open surgery.
Government shut down provides further delays in FDA rulings for the testing of illegal devices in patients hearts without informed consent.
What should have been a 5-minute conversation turned into a 6-year conversation that I will continue until the truth is revealed. The veil of the surgeon-patient relationship covers the truth. The final outcome is still pending, but hope is not pending, it is real, and it is the reason why we as human beings wake up in the morning and fall on our knees thanking God for another day.
I continue to update the ongoing chronology of the Myxo Files. I still have one deposition pending from the patient’s malpractice case (Obermeier v. Edwards, et al., File No. 590.11478). I have now been promoted from a 213(f)2) treating physician witness to a 213(f)(3) witness for disclosure purposes. The defense attorneys filed the motion to promote once I revealed in 17 hours of depositions of my ongoing efforts to help my patients. I know the truth, I have presented the truth to the officials who can protect these patients and who can turn around this atrocity, but to this date, no relief is in site for the innocent victims. The University has not responded to my requests for a meeting.
While I continue to advocate for my patients by contacting the FDA, Northwestern University and HHS, the evidence continues to point towards the fact that the McCarthy Annuloplasty ring was not only investigational (as per FDA designation July 16, 2009, The Myxo File Part I and Part II), but the ring was part of a validation study during the life-cycle of the newly invented patent pending medical device (The Myxo File Part VII: The Design History File The Smoking Gun).
In December 2009, the Wall Street Journal published an article entitled: Doctor’s Spat Exposes FDA Loophole. The authors of the publication wrote about the study, the FDA oversight review of the device, and the patient’s struggle. Dr. McCarthy was quoted as saying that it is common for surgeons to “try out tweaks to devices” and that when asked if needed an investigational review board, he said: “not even remotely.”
The Myxo File Part XII, will provide evidence that continues to demonstrate that the device was not sold on the US market until January 2007. The device which was tested in the patients from March 2006 to January 2007 as part of a validation study for in vivo testing of the device in the patients.
“Dr. McCarthy says it is common for surgeons to try out tweaks to devices without going through the whole clinical-trial process. Asked whether he thought he should have asked for a review board, he said: "Not even remotely."”1
Mundy and Flavole, Wall Street Journal, December 2009