For years Northwestern University has operated in non-compliance with Federalwide Assurance 1549
The evidence demonstrates for the first time, the conflicting statements regarding the FDA status at the time of the “surprise FDA study” between the FDA, the hospital/University and the device Manufacturer Edwards Lifesciences:
- Device Manufacturer states that the device is “FDA approved” as of September 2007 in a 2 line email, and the hospital/University confirms this status in statements to the Illinois Supreme Court as of December 2019.
- FDA states to Senate Committee that the device is not “FDA approved” as of March 2009 and is on recall.
- FDA confirms to Congress that there are no plans to inform any of the 667 patients that the device was not approved during the surprise FDA study.
- Senator Grassley’s Senate Finance Committee has oversight over use of Medicare and Medicaid Funding, and has maintained follow up of the new evidence brought forth to the Senate this week for the failure to investigate pre-authorization from Medicare for the FDA study to test the device.
- Northwestern University never reverses their position from the 2007 email claiming “FDA approval” despite receiving the status of the FDA decision not to approve the device as of July 16, 2009.
Over 667 United States Citizens who received the device prior to December 2008 FDA recall, as disclosed to Senator Richard Lugar have not been informed as of today. Hundreds of US Citizens still have not been informed of the status of the device prior to the recall. In fact, Congressman Glenn Grothman received a letter from the FDA in 2017 confirming the fact that the FDA was not planning to inform patients, as the FDA “did not believe that notification would provide a benefit to patients and instead could unnecessarily alarm patients and raise unwarranted concerns. Therefore, FDA did not mandate the company notify all patients who received the device prior to its April 2009 clearance.” – FDA Letter in 2017 to Congressman Glenn Grothman.
In May 2019, the Daily Northwestern interviewed the victims and their families and published their stories and injuries in anticipation of the Obermeier Case, highlighting a patient’s death, Mr. William Knotts, in November 2018 as a result of the FDA protocol.
The December 2019 evidence presented to Senator Grassley on 2-10-2010 confirms that the company and the University are still claiming that the FDA approved the device as of 2006, claims which are contrary to the official FDA decision proving that the device was not approved prior to 2009 for use in humans.
The statements are now in the hands of the Senate Finance Committee and the Secretary of HHS, to help the hundreds of US citizens who have the device implanted in their heart without consent and without FDA oversight to help them and their physicians understand any future complications as outlined in the Daily Northwestern publication in 2019.
Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She earned her undergraduate science pre-professional degree from the University of Notre Dame, her Medical Doctorate from Mayo Medical School and her post-graduate training in Internal Medicine and Cardiology at the Mayo Clinic and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and as an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.
Press Contact Oscar Delgado Press Officer for Most Sacred Heart of Jesus Cardiology and Valvular Institute, Former NBC Bureau Chief Latin America, 773-573-6890 heartvalves@sacredcardiology.
SOURCE Most Sacred Heart of Jesus Cardiology and Valvular Institute