Explains the Senate Documents and the FDA FOIA documents.

Press Conference in Sheboygan WI on May 29, 2019 at 11:00 central

SHEBOYGAN, WISCONSIN, UNITED STATES, May 28, 2019 /EINPresswire.com/ — Sheboygan, WI., May 29, 2019 Northwestern University and its chief cardiac surgeon confirms no Institutional approval prior to implanting experimental heart valve rings during open heart surgery, according to an article published Thursday in The Daily Northwestern.

The Doctor who has spoken on behalf of the patients is holding a press conference to discuss the new evidence at Most Sacred Heart of Jesus Cardiology and Valvular Institute, Sheboygan WI. The newly elected Mayor in Chicago IL, Mayo Lori Lightfoot is invited to the press conference.

The newspaper cited documents recently obtained recently under a Freedom of Information Act request. Among the documented issues with the heart valve ring, implanted in 667 patients in 2006-07:

• The device was not approved by the Food and Drug Administration, but should have required that approval.
• The experimental device, invented and patented by the Northwestern surgeon, was implanted without patients’ consent.
• The surgeon continued implanting his invention and studying outcomes even after he told the ethics board at Northwestern University that he had terminated the study.
• The 667 patients who received the valve ring before it was recalled never have been told of the recall or of the associated risks, even though several patients have had issues ranging from heart attacks to death as written in a letter by the FDA to Senator Charles Grassley, Chairman of the Senate Finance Committee and Senator Richard Lugar.

The case has been investigated by the US Senate Finance Committee, Senator Charles Grassley, the House Government Oversight Committee, Congressman Glenn Grothman, Congressman Danny Davis of IL, and The US Senate Committee on Homeland Security, Senator Ron Johnson and President Barack Obama former Senator of IL. In the past, it was largely dismissed as a series of innocent mistakes. Documents obtained under the FOIA request, however, paint a darker picture – one of fraudulent concealment of evidence and human experimentation without consent as alleged in the 1401 petition filed in the case of Obermeier versus Northwestern etc 08-L-012426.

https://dailynorthwestern.com/2019/05/23/top-stories/in-focus-years-after-surgery-new-documents-renew-patients-malpractice-claims-against-northwestern-memorial-doctor/

One of the nation’s most respected college newspapers, The Daily Northwestern has won dozens of national and regional awards. The Daily has won the Pacemaker — long regarded as the Pulitzer Prize of college journalism — nine times since 2000.

Dr. Nalini Rajamannan, a former cardiologist at Northwestern, praised The Daily Northwestern for its journalistic investigation into the decade-plus-old case.

She encouraged the 667 patients, lawmakers, regulators, reporters and patients’ rights advocates to read the FOIA documents themselves to decide whether they believe patients’ rights were protected.

“The response should be immediate under the federal laws which protect US citizens,” Rajamannan said. “These patients should be informed of their unknowing participation in the prospective clinical trial. They should receive a full review of their medical history. And they should receive proper medical care moving forward.”

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Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She has been researching heart valve disease for 31 years. 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. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine. Currently, she practices consultative medicine specializing in Cardiac Valvular Heart Disease at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.

Nalini Rajamannan
Most Sacred Heart of Jesus Cardiology and Valvular Institute
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NBC26 Interviews Heart valve patients say they still feel a prototype's effects a decade later

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