- Posted October 7, 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
Part ONE: McDermott, Will and Emery, Covers-up Illegal Human Experimentation in Senate Investigation
Innocent patients are being used as experimental victims during open heart surgery at Northwestern Memorial Hospital.
The FDA discovered in 2008 that heart devices were being tested and sold on the US market with FDA regulatory oversight.
In 2008, The FDA placed two heart devices called annuloplasty rings (The IMR and the Myxo ETlogix) on a voluntary recall from October 2008 to April 2009.
The IMR was fully cleared for sales on the US market in April 2009, but prior to this clearance the device was considered to be experimental.
The FDA relied upon the hospital to inform the patients of the voluntary recall.
The hospital wrote the following letter attached in this report to the patients.
Which stated by the CEO of the hospital Mr. Dean Harrison on January 26, 2009:
" Some news stories have reported allegations that the Myxo ET Logix 5100 ring was experimental and not cleared by the FDA for use.
We do not consider this device to be experimental."
The letter published in January 26, 2009 never states the fact that the device was under a voluntary recall and was pulled off the market.
Senator Grassley from 2008-2010 investigated Northwestern Memorial Hospital, Northwestern University, the FDA and Edwards Lifesciences, releasing several Congressional inquiry letters and the responses were posted on the Senate Finance Committee website:
Including the response to the Senate Finance Committee from McDermott, Will and Emery, Chicago IL:
"Despite the affirmative evidence of the ring's safety and efficacy, in light of the publicized issues regarding the ring and to address any patient concern, Northwestern
Memorial Hospital issued two letters to patients who received the ring (a copy of each is enclosed). The first letter explained that Edwards voluntarily took the ring off the market pending the FDA's decision. The second letter explained that the FDA had cleared the ring for market without making a single change to the ring. Both letters reiterated NMH's unequivocal belief that the Myxo Ring was safe and effective. Northwestern Memorial Hospital also set up a phone line to answer any questions that patients had."
The letter sent to the patients on January 9, 2009 does not discuss the device being removed from the US market and placed on a voluntary recall. This letter delayed the proper health care and full disclosure by the hospital, the FDA and the device manufacturer that the device was investigational and under a voluntary recall and still is investigational as of October 7, 2013.