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FDA in Massive Cover-Up of Defective Heart Valves by Failure to Sanction Northwestern University and Edwards Lifesciences for Refusing to Inform Patients
Contact: Oscar Delgado, 773-573-6890
SHEBOYGAN, Wisc., June 6, 2017 /Christian Newswire/ -- FDA continues the 10-year cover-up and collusion surrounding the testing of a heart valve invention, the McCarthy annuloplasty ring, manufactured by Edwards Lifesciences, (Irvine, CA). Newly discovered Senate Finance Committee Documents, confirms the research, design and testing in patients.
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Senator Charles Grassley (IA) investigated on behalf of the Finance Committee and Senate Judiciary Committee, over potential misuse of Medicare and Medicaid funds and FDA fraud, from 2008 -- 2014. During the entire investigation, the device manufacturer and Northwestern University reported to the Senator that the device was for sale on the US market as of March 2006, and denied any human testing to the Senate Committees.
The ten-year saga of unraveling the cover-up for the testing, began when Antonitsa Vlahoulis required a second heart operation due to complications after receiving the McCarthy valve in April 2006. In 2007, Vlahoulis confirmed to the Valve Director for Northwestern University at the time of the study, Dr. Nalini Rajamannan a native Minnesotan, that Vlahoulis never gave consent to receive the McCarthy valve in April 2006. Once Rajamannan learned that the patients were not given informed consent, the Notre Dame Graduate and Mayo Clinic Trained Physician which began in 1985 at Mayo Medical School to the completion of her cardiology training in 2000, removed herself from participation in the clinical study to test McCarthy's invention. Rajamannan began reporting to the Northwestern University, the FDA, HHS, Federal Authorities, and the US Senate and House Committees.
2009, 3 years after the experimental testing, the FDA's response was to approve the model 5100 with a third name, the DEtlogix valve. The FDA cited the scientific publication from Northwestern University published in 2008, as the evidence for safety and efficacy to approve the device in a letter to Senator Richard Lugar (IN). Even though the publication was missing several adverse events including deaths and heart attacks. The FDA's compliance division confirmed that the device was not a minor modification, and that it was illegal to sell the model 5100 on the US market as the Myxo ETlogix on or after January 24, 2007. Instead of enforcing the federal laws, which protect the patients, the FDA approved the device by allowing the company to change the name to DEtlogix and to change the indication for use. The FDA wrote one patient Vlahoulis on July 16, 2009, stating the Myxo ETlogix required an IDE, and promised her a call from Senator Richard Lugar.
Over the next 10 years, Dr. Rajamannan, Valve Director in Sheboygan WI, and currently a visiting physician scientist at the Mayo Clinic, Rochester, MN, since 2000, followed the procedures and federal laws for reporting to the FDA and HHS. Dr. Rajamannan is the chairman of the working group on valve disease for the NIH, author of over 75 scientific publications, editor and author of several textbooks in valvular heart disease, and has received several NIH grants and ARRA Awards. She believed that someday the evidence would emerge confirming her eye-witness account of the testing of the invention at Northwestern Memorial Hospital under the FWA for Northwestern University, Chicago IL, but she never thought it would take ten years.
On March 25, 2017, the FDA reviewed the newly discovered Senate Documents. The memo dated October 13, 2005, confirms evidence that the McCarthy valve was developed during a dinner meeting at a Tommy Bahamas restaurant in New Port Beach, CA. The company presented several options for the future heart valve, to the inventor, Dr. Patrick McCarthy. McCarthy chose a "closed ring design" and placed a suture through the sample heart valve during the meeting at the Tommy Bahamas Restaurant. McCarthy confirmed that once he performs the first ten surgeries for the new design, he would expand the testing to other surgeons. Edwards Lifesciences engineers confirmed that the first round of sample valves would arrive by the end of February 2006. 
After the dinner meeting in October 2005, Northwestern Memorial Hospital, Chicago Il, began to receive the first version of the valve, the McCarthy valve Model 5100, by March 2006. The inventor, Dr. McCarthy, completed the first round of human test surgeries on the McCarthy valve, from March 2006 to November 2006. Concurrently, Edwards Lifesciences completed engineering testing and design development of the new invention, which ran from October 13, 2005 to November 20, 2006. 
Edwards Lifesciences concluded that the McCarthy heart valve, prototype version of the Model 5100, had 122 potential product defects, and several adverse events, including deaths, and heart attacks. These discoveries required the company to modify the device several times to make the device safe prior to the sales on the US market as reported by Edwards in 2007. The second version of the model 5100, the Myxo ETlogix Ring, was sold on the US market according to US Trademark certificate on or after January 24, 2007. Edwards Lifesciences and Northwestern University made no comment last week, regarding the newly discovered design memo submitted to Congress during the Senate Finance Committee Investigation. The FDA press officer refused to comment regarding the evidentiary documents as of May 31, 2017.
Senator Charles Grassley (IA) expressed concern over the inconsistent statements made to the Finance Committee in responses by Northwestern University during his investigations from 2008- 2014. According to comments published in the Chronicle of Higher Education, the spokesperson for the Senator, Jill Gerber, stated he "has done what he can, unless something new comes to light."
Maureen Obermeier confirmed that she also received the McCarthy valve on November 6, 2006. Obermeier learned of the experimental surgery when her physician read a report on the heart.org in 2008. Not only did McCarthy not report the experimental surgery to Obermeier, he also failed to report to her and her referring physician that she had sustained a heart attack in the operating room, while he was placing the McCarthy valve in her heart. Finally, during a heated legal battle in Cook County, Northwestern Memorial hospital admits her heart attack in the operating room after 5 years. Antonitsa Vlahoulis confirmed that the Cleveland Clinic removed the McCarthy Valve from her heart, within one year of the experimental 2006 surgery. She had developed severe complications from the McCarthy valve, Model 5100.
Both patients confirmed that Dr. McCarthy failed to inform them he was testing his invention for the first time in humans. They also expressed concern for other patients who have the device and have no knowledge of the testing, and the 122 potential side effects associated with the experimental McCarthy heart valve. Both patients received a device identifier card, which confirms the prototype heart valve. Senator Durbin has not contacted Ms. Vlahoulis as promised by the FDA congressional office on July 16, 2009.
Dr. Rajamannan is persisting to get the information to the 667 patients with the model 5100, even though the FDA sent several letters to her practice location in Sheboygan, WI, Most Sacred Heart of Cardiology and Valvular Institute, refusing to inform the patients of the testing, safety issues and the recall of the model 5100. The doctor also informed Northwestern University, HHS, the FDA, local members of Congress and Senators that patients have died, suffered heart attacks while undergoing the secretive human experiments without consent to receive the device.
Rajamannan, a visiting physician scientist at the Mayo Clinic since 2000 and a practicing cardiologist in Sheboygan WI, stated that "In the United States the federal laws regarding patient consent are clear, patients have the right to know and decide whether they want to participate in an experimental heart valve surgery prior to FDA approval." Once the evidence emerged that there was no consent and that patients have died, the FDA, HHS and the University's response should have been immediate on behalf of the safety of the citizens of the United States.
Instead, the FDA continues to refuse to inform the patients and meet with Rajamannan. Northwestern University's general counsel, Mr. Phil Harris, in an email to Dr. Rajamannan dated May 3, 2017, "I will respond to any request I receive from the US Senate" as a statement in writing to Dr. Rajamannan's continued requests to meet the University officials to report Harms under Northwestern University's FWA 1549: IRB 1532-003-1532-004, regarding the several heart attacks, deaths, and removal of the Myxo ETlogix valve under a recall as of December 5, 2008.
The testing of unapproved FDA heart devices for purposes of research and development without consent violates the Common Rule, the Belmont Report and laws which date back to WWII under the Nuremberg Code. Patients have been harmed and have the right to know that the first and second version of the model 5100, which is implanted in 667 individuals, is on recall and may have serious side effects, which can affect heart and lung function. The FDA, Northwestern University and hospital, HHS and Edwards Lifesciences have a responsibility to these patients under the Federal Laws to make sure the safety protocols are in place to protect the 667 patients who received the model 5100 and the countless number of patients who received the model 4100 which also went on recall on December 5, 2008, and was also tested at Northwestern, according to Rajamannan.
·         Edward Lifesciences Interoffice Memorandum, Nov. 11, 2005
·         The Myxo ring mix-up, Medscape, Monday, June 5, 2017
·         Grassley seeks answers about the use of a heart device in clinical research, United States Senate Committee on Finance, Dec. 4,2008
·         Northwestern U. Gets Renewed Grilling Over Unauthorized Tests on Patients, The Chronicle of Higher Education, March 6, 2014
·         Doctors Experimenting on Humans: Five Questions with Dr. Nalini Rajamannan, The Project on Government Oversight (POGO) Blog, June 7, 2011

·         Reportable New Information -- Harms, IRB Institutional Review Board, Northwestern University