Graphic credit The Daily Cardinal and the artist, Zoe Bendoff

NEWS PROVIDED BY
S. Albert Edwards, PharmD, LTD
Oct. 19, 2021

MADISON, Wis., Oct. 19, 2021 /Standard Newswire/ --

Open Letter to Chancellor Rebecca Blank
University of Wisconsin Chancellor
163 Bascom Hall
500 Lincoln Drive
Madison, WI 53706
chancellor@wisc.edu
608-262-9946

October 19, 2021

Dear Chancellor Blank,

On October 14, 2021, Mackenzie Moore wrote an article entitled, Bucky Catches Chancellor Becky Blank with Willie the Wildcat, asks for amicable separation.

We realize this was a satirical article, but it also may, very well, be prophetic since you, Chancellor Blank, will assume and be confronted with, as future President for the Northwestern University, an issue of federal non-compliance which injured numerous patients without their consent, at Northwestern Memorial Hospital, the hospital for Northwestern University's Medical School.

This issue goes back to 2006 and involves cardiac surgeon Patrick McCarthy and device maker Edwards Lifesciences. Heart rings, lacking the required FDA device clearance, were implanted in patient's hearts without their consent.

The issue has now morphed into a legal matter with a motion pending before the Illinois Supreme Court. The motion, in brief, requires the attorneys for Northwestern to tell the truth, that, in fact, the implanted heart rings were investigational and not cleared [approved] by the FDA, at this time of the implants. Under the Illinois Rules of Professional Conduct 8.3 and 8.4, the Supreme Court Judges, the Illinois State Bar, and the Attorneys licensed in the State of Illinois, are responsible for the truth. The Northwestern attorneys are on record, alleging these devices, the heart rings, were FDA cleared [approved]; this is not true.

We are three patients from over 1000 + patients who had heart rings implanted, without our prior informed consent. We underwent illegal human surgical experiments, i.e., the heart ring implants, which damaged our hearts. This was done without our consent, and without FDA authorization.

FDA authorization for medical devices is a federal requirement, legally in place since the early 1990s, for use in patients across this country. Northwestern University delayed reporting to the FDA the fact that Northwestern University began the secret human clinical trials to test patent pending inventions, once the new chief of Cardiac Surgery, Dr. Patrick McCarthy, arrived from the Cleveland Clinic after a similar failure to report unapproved uses of a device used on patients to correct their atrial fibrillation. In 2010, the Department of Justice settled an indictment of the Ohio-based business promoting the unapproved atrial fibrillation treatment tied to the Cleveland Clinic and McCarthy for $3.7+M due to Medicare fraud.

The Vice President for Research Ann Adams who is charged with protecting patients, and the Chief General Counsel for Northwestern University Stephanie Graham have delayed reporting the evidence that non-approved heart devices were tested in over 1000 patients' hearts. Again, the FDA never authorized the testing in the patients; moreover, FDA only learned of this issue when the results were published in The Journal of Thoracic and Cardiovascular Surgery in 2008, and again in 2020. We were never informed that this surgeon was testing his experimental devices and protocols on us.

The Motion is now pending in the Illinois Supreme Court to help get the information to patients who were tested from 2006-2020, confirming that the University has had knowledge that the devices tested in our hearts were classified as investigational since 2009 and are responsible to inform all of the test subjects, according to the Dr. Shuren the head of the FDA's device branch, once the FDA learned that the human experiments were ongoing at Northwestern University since 2004.

To this date, the patients have not been informed, confirming the University's Federal Wide Assurance as non-compliant.

Doctor Nalini Rajamannan a Mayo Clinic Trained Cardiologist and a visiting scientist at the Mayo Clinic, who now practices in Wisconsin and Illinois, has been advocating for over 14 years after witnessing the experimental surgeries at Northwestern University's medical school, Feinberg School of Medicine. She has continued to report the federal violations while informing the General Counsel for Northwestern University, two presidents at Northwestern University, the United States Senate, Elected officials across the Midwest, and Northwestern University's Board of Trustees and chairman, J. Landis Martin.

The Supreme Court Motion summary and evidence were posted on a published press release on September 21, 2021. More than 1,000 patients who underwent experimental heart surgeries without their consent and without FDA authorization finally may get justice. The Daily Northwestern newspaper reported on one patient's death in 2018. Other publications have reported over the years on other patients' complications, while Northwestern has denied any responsibility in informing the victims of the human experiments.

In reviewing his own health records in 2018, Dr. S. Albert Edwards, found that a heart attack had occurred 11 years earlier, February, 2007, at the conclusion of his heart ring implant, and he had not been told. "I requested more information from the university office of human subject protections and I received the following letter stating, 'we consider this matter closed.'"

Instead of reporting the human surgical experiments to the patients, Northwestern Hospital's president and CEO Dean Harrison in January 2009 sent a letter to us and other patients who had received the heart ring. It stated that "we do not consider this device to be experimental."

As of today, the patients have not been informed. We learned of the experiments from Dr. Rajamannan, in her practice in Sheboygan, WI, as the previous valve director at Northwestern and eye-witness. Northwestern University's Federal Wide Assurance attached to 900 Million Federal Research Tax payor dollars is currently not in compliance and has jurisdiction over this process. The response should be immediate to help the over 1000 victims of the unauthorized human test experiments. Chancellor Blank, we ask that you intervene to proffer the truth as the incoming leader to help the over 1000 victims of this 14 year health care fraud and cover-up perpetuated by Northwestern University.

S. Albert Edwards*
Maureen Obermeier
Antonitsa Vlahoulis

*dba, S. Albert Edwards, PharmD, LTD

cc: Michael Chin, J.D. General Counsel for Compliance of the Federal Wide Assurance 00001549, for Northwestern University

Ann Adams, J.D. Vice President for Research, Signatory Official for Northwestern University

Stephanie Graham, J.D. Chief General Counsel

J. Landis Martin, Chairman of the Board of Trustees, Northwestern University

SOURCE S. Albert Edwards, PharmD, LTD

CONTACT: Dr. S. Albert Edwards, fdaexpert@gmail.com