Victims File Complaint Today Confirming Patient Safety Issues Related to Doctors' Training at Northwestern Memorial Hospital, After NBC Exposes FDA Cover-up of Testing
Press Conference Today at noon, ACGME office, street level front doors: 401 N Michigan, Chicago IL, 60611 a copy of the complaint will be available to any members of the press who attend the conference.
Contact: Nalini M. Rajamannan, 312-498-9496
CHICAGO, Nov. 27, 2017 /Christian Newswire/ -- Northwestern University and Northwestern Memorial Medicine Residency training program exposed physicians in training to unauthorized testing of heart valve devices in hundreds of unknowing patients from 2004 to the present.
From 2004 to the present, hundreds of patients were enrolled in secret clinical experimental surgical trials without consent and without FDA approval. Delays in submitting this report, were due to the fact that until September 2017, the FDA never admitted in public the fact that human experiments were ongoing to test the unauthorized heart devices model 4100 and model 5100.
ACGME, Accreditation Council for Graduate Medical Education, procedures requirements as of July 2017 emphasize patient safety. Moreover, the ACGME require that all complaints undergo submission, only after all available reporting agencies, Local and National have evaluated the complaint.
After submitting several complaints to Northwestern University and Hospital, from the office of human subjects to the Board of Trustees, and local investigative agencies, no effort has been made to to stop the testing without consent and to inform the citizens of Chicago and across the United States regarding the illegal sales of these unregistered devices in interstate commerce without FDA approval, prior to 2008. The head of the General Counsel earlier in 2017, denied Dr. Rajamannan a meeting to discuss the patient safety issues related to the clinical trial performed at Northwestern University and hospital without consent and without FDA authorization.
In 2017, the most recent investigations began in the State of WI, where the eye witness, Dr. Nalini Rajamannan, a former Cardiologist at Northwestern University Fienberg School of Medicine, VA Lakeside, and currently a Cardiologist at Most Sacred Heart of Jesus Cardiology, Sheboygan WI, CorVita, Chicago IL, Global Heart Valves, and Visiting Scientist at the Mayo Clinic, Rochester MN, contacted Sheboygan's Congressman Glenn Grothman, who immediately sent letters to the FDA, followed by questions from Senator Ron Johnson of WI, Chairman of the Homeland Security Committee to the Office of the Inspector General, for delays in reviewing allegations submitted since 2014, as reported by WHBL Radio Sheboygan, WI.
According to the NBC investigation in September 2017, the FDA in 2009 reportedly asked NMH CEO to inform the patients of the testing of the model 5100 and the model 4100 after both devices were placed on a voluntary recall due to the unauthorized sales in the USA from 2003-2008, according to NBC26 reporter Max Grossfeld.
However, according to the NBC news report the letters written by the CEO for Northwestern Memorial Healthcare, did not reveal the fact that the device was experimental at the time of the test surgeries and that the model 4100 and the model 5100 were under a voluntary recall as of January 2009 when the CEO sent the patient letters.
After a series of interviews on local radio, NBC, and ABC, the Office of Inspector General for Health and Human Services confirmed in early October 2017, that they are investigating the sales of the devices across state lines using Medicare and Medicaid dollars for the price of the test surgeries as reported by ABC Milwaukee in October 2017.
Since 2008, the Senate Finance and Judiciary Committees under Senator Grassley, investigated the testing of the non-approved devices in patients during open heart surgery without informed consent. However, key documents surrounding the patients' testing were withheld from the Senate Committee, the FDA, and the patients, which required further investigations by the Senate Judiciary Committee.
Today, as of November 27, 2017, after the FDA confirmation of the experimental testing and the OIG investigation of the unauthorized use of Medicare and Medicaid funds for the sales of the unauthorized devices, Dr. Rajamannan and three patients who learned of their experimental heart surgeries after the fact, are filing a complaint with the ACGME, in order to get immediate help for the other 664 victims, and to inform the ACGME of the dangerous conditions for the training of young physicians during their residency program at Northwestern University, Northwestern Fienberg School of Medicine and the various hospitals associated with these entities.