The final clues are falling into place in a 12-year-old mystery about how patient protections were bypassed during open heart surgery for hundreds of patients and published in the American Association of Thoracic Surgeons Journal.
CHICAGO, May 6, 2019 /PRNewswire/ -- The final clues are falling into place in a 12-year-old mystery about how patient protections were bypassed during open heart surgery for hundreds of patients and published in the American Association of Thoracic Surgeons Journal. The Society celebrated their 99th anniversary in Toronto, CA this past weekend.
The Model 5100 heart valve ring was implanted into nearly 700 patients without their consent or approval from the Food and Drug Administration.
Documents recently obtained through a Freedom of Information Act request outline how this practice escaped regulatory notice.
On Thursday, one of the Model 5100 patients was in a Chicago courtroom, seeking a new trial in a malpractice lawsuit due to the newly released documents. Her petition alleges fraudulent concealment of critical information, which is now public. The defendants asked for the petition to be dismissed and have a month to file documents explaining why they are not moving forward on the newly discovered FDA FOIA which falls under Northwestern University FWA federal laws. The patient’s attorneys will have 21 days to respond.
“He 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.
Meanwhile, a cardiologist who removed herself from the Model 5100 device study when she realized patients hadn’t given their consent, published a report on Saturday (May 4) to highlight key facts and documents in the case:
- Patients began receiving the controversial heart valve ring in 2006.
- Testing of the device was officially closed by Northwestern University officials as of June 2006, but the final publication of the clinical study published in the American Association of Thoracic Surgery’s premier journal in July 2008 reveals that the study continued without patient consent and without the university approval until November 2007.
- The device was invented by the surgeon implanting it and wasn’t approved by the FDA.
- A press release on Dec. 4, 2008, confirmed the first of many Senate Finance and Senate Judiciary investigations into the Model 5100.
- United States Sen. Charles Grassley (IA) requested evidence as part of the Senate Investigation.
- Over the six-year investigation, the documents, responses and letters were reviewed by Dr. Nalini Rajamannan, the cardiologist who removed herself from the Model 5100 study.
- Initially, the surgeon, device maker and hospital claimed the documents received by the Senate committee were for senators’ eyes only, but during a court hearing attorneys confirmed that any privilege under the Standing Rules of the Senate did not pertain to the documents. Senate Rule XXIX provides privilege only to the Executive Branch under the Constitution of the United States of America for executive sessions as related to matters of national security.
Rajamannan’s report, The Myxo File X and the Myxo Report, offers a comprehensive look at the Senate Finance and Senate Judiciary Investigations from 2008-2014 for the 667 heart valve patients, media, regulators, lawmakers and patients’ rights advocates.
The Myxo File X published Saturday, May 4, 2019 on Amazon.com also provides an in-depth analysis by Dr. Rajamannan, an eye-witness to the human experiments, regarding the release of responses sent to the Senate.
Link to FDA FOIA Documents:
https://www.prnewswire.com/news-releases/foia-documents-cardiac-surgeon-implanted-experimental-devices-without-consent-300836043.html
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.
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SOURCE Dr. Nalini Rajamannan
