Former Northwestern University Cardiologist Releases New Information Regarding Heart Valve Device and Seeks Answers for the Patients
A dozen years after 667 patients received a new heart valve ring at Northwestern University, a former university cardiologist is working to get them newly released information about their procedures and devices as published in a new report on Amazon.com.
Dr. Nalini Rajamannan filed a Freedom of Information Act request for information related to the Myxo ETlogix heart valve ring, Model 5100. Recently, she obtained a hefty collection of documents and is making them public.
She is encouraging patients, lawmakers, regulators, reporters and patient rights advocates to carefully scour the FOIA documents.
“These documents shed a bright light on the circumstances surrounding those surgeries,” she said. “I would encourage interested parties to read these files and make their own informed decisions about whether patients’ rights were protected.”
Rajamannan, former valve director for the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital, originally was involved with the Myxo ring surgeries at Northwestern. But she removed herself after one of her patients said she hadn’t given consent for the surgeon to implant a non-FDA approved valve he invented into her heart.
The cardiologist reported the situation to University officials and others and eventually was terminated. She now works in a private practice in Wisconsin.
Another of the valve ring patients, Maureen Obermeier, filed a malpractice lawsuit against the surgeon, the university, the device maker and others. The case, (08-L-012426 Circuit Court of Cook County), was dismissed in 2016. But Obermeier has filed a petition for a new trial, in light of the new FOIA documents.
Northwestern’s defense attorney from the law firm Anderson Rasor stated in Hon. Judge Gomolinski’s Chicago courtroom on Dec. 6, 2013 that the federal protocol 1532-004 had nothing to do with a published study on the heart valve.
But the new FOIA documents confirm that after the Federal FDA Inspection, 1532-004 was the study to test the Myxo Ring. The documents also confirm that there was no documentation provided to the Universityconfirming the FDA approval status of the device during the testing.
Obermeier is claiming that the surgeon, university, device manufacturer and others fraudulently concealed information critical to her case. A ruling is expected in June as to whether the case will be re-opened.
"He (the surgeon) was putting it into patients, seeing how it worked, and not telling them," Obermeier's attorney, Adrwin Boyer, said during opening statements of the 2016 court trial in Cook County, according to Fox 32 in Chicago.
Rajamannan has compiled dozens of documents related to the Myxo ring surgeries into two reports: The Myxo File X and the Myxo Report. This pair of reports offers a comprehensive look at the Senate Finance and Senate Judiciary investigations into the situation from 2008-2014.
The Myxo File X, published on Amazon.com, also provides an in-depth analysis by Dr. Rajamannan, an eye-witness to the surgeries.
Public Statement from Dr. Nalini Rajamannan, former medical director and valve director at the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital:
“I have been fighting for more than a decade to obtain these critical documents. They confirm what I knew to be true—that patient protections were bypassed during open heart surgery for hundreds of patients.”
“These documents reveal systematic failures that allowed a surgeon to implant an experimental device he invented into patients without their consent. Among the documented issues:
- 1) Patients began receiving the controversial heart valve ring in 2006 until November 2007.
- 2) New Court Filing in Circuit Court of Cook County 08-L-012426.
- 3) A press release on Dec. 4, 2008, confirmed the first of many Senate Finance and Senate Judiciary investigations into the Model 5100.
- 4) United States Sen. Charles Grassley (IA) requested evidence as part of the Senate Investigation.
- 5) The device was not approved by the Food and Drug Administration, but should have required that approval.
- 6) The experimental device was implanted without patients’ consent.
- 7) The surgeon continued implanting his invention and studying outcomes even after he told the ethics board at Northwestern 8) University that he had terminated the study.
- 9) The surgeon later published selected results in the American Association of Thoracic Surgeons Journal. He omitted adverse outcomes from the journal article as listed in the FDA database.
- 10) 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.”
“For 12 years, I have been reporting to federal HHS officials, FDA, NIH, Northwestern University leadership, and US Senate and Congressional representatives that I am an eye-witness to the human experimentation testing a new invention in patients for the first time in human use.”
“The FDA FOIA provides the evidence to confirm my public statements that the study was a prospective (forward-looking) study, and that all of the patients needed to provide informed consent. The FOIA documents clearly show that the University signed an official termination contract with the investigator, Dr. Patrick McCarthy. No future experimentation, no future publications.”
“But McCarthy continued the study without authorization. The FDA relied upon the study to eventually approve the device without full understanding of the medical injuries reported to Sens. Charles Grassley and Richard Lugar. Hundreds of unknowing patients received the device without their consent.”
“The FDA and Maureen Obermeier never knew she sustained a heart attack for several years, since they heart attack was concealed in her medical records as confirmed in the 2011 response to the Third Amended complaint Obermeier versus Northwestern 08-L-012426.”
NBC26 Green Bay WI, Interviews the patients
“Northwestern University’s response should be immediate under the federal laws which protect US citizens. 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.”
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.