Energy and Commerce Committee Reviews Newly Uncovered Evidence on Citizens Who Received Heart Devices Across the United States From 2006-2008 During Open Heart Surgery

WASHINGTON, Feb. 13, 2020 /PRNewswire/ -- Dr. Rajamannan, Most Sacred Heart of Jesus Cardiology and Valvular Institute Medical Director, continues the effort to inform the patients of the clinical studies using heart valves invented by surgeons across the United States. The Energy and Commerce House Committee has received the new evidence this week regarding statements by Northwestern University made in December 2019 to the Illinois Supreme Court stating that the heart device, the Myxo ETlogix was "FDA approved in 2006," during the clinical study published in the Lead Journal of the American Association of Thoracic Surgeons in July 2008.

The Energy and Commerce Committee held oversight hearings in August 2009 which included Dr. Marcia Crosse from the Government Accountability Office and Dr. William Maisel who at the time of the hearings, was an Associate Professor of Medicine at Harvard Medical School with more than 15 years of clinical experience as a Board‐certified cardiologist. Dr. Maisel is currently the Chief Medical Officer and Director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health. He is responsible for providing leadership in the development, implementation, execution, management and direction of the Center's broad national and international biomedical science programs. Dr. Maisel confirmed to the oversight committee that the device was not approved for use in humans during the study and that the device was placed on recall after the patients received the device without FDA oversight.

Dr. Rajamannan, who has submitted evidence to the Energy and Commerce committee from 2009 to 2020, also presented the FDA Affidavit summarizing the patients' injuries, as published in The Daily Northwestern in May 2019.

The New Evidence Provided to the House Committee on Energy and Commerce include:

• 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.
   
• The Energy and Commerce 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.

The Energy and Commerce Committee health committee which has oversight Jurisdiction includes public health and quarantine; public health insurance (Medicare, Medicaid) and private health insurance; medical malpractice and medical malpractice insurance; the regulation of food, drugs, devices, cosmetics, and tobacco (the Food and Drug Administration); drug abuse; the Department of Health and Human Services; the National Institutes of Health; the Centers for Disease Control; Indian Health Service; and all aspects of the above-referenced jurisdiction related to the Department of Homeland Security.

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 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
[email protected]

Related Files

+Page 5_Testimony_Maisel_Energy_Commerce_2009.pdf

FDAAffidavit_ Investigation MPLS_FDA and Testimony from the Victims_12-19-2018+JMJ.pdf

Related Images

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Dr. Rajamannan presenting evidence to Congress in Washington DC
Presenting evidence to the Energy and Commerce Committee and Senate Finance Committee

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Dr. Rajamannan

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