Patients who received an experimental heart valve without their consent according to an article published Thursday in The Daily Northwestern.
EVANSTON, ILLINOIS, UNITED STATES OF AMERICA, May 24, 2019 /EINPresswire.com/ — Patients who received an experimental heart valve without their consent have renewed hope that the hospital and surgeon will be held accountable, according to an article published Thursday in The Daily Northwestern.
The newspaper cited documents recently obtained recently under a Freedom of Information Act request to confirm Northwestern University’s chief cardiac surgeon didn’t have the university or patient approval to implant a heart valve ring he invented during open heart surgery.
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 Northwestern’s Dr. Patrick McCarthy, was implanted without patients’ consent.
• The surgeon continued implanting his invention and studying outcomes even after he told Northwestern’s ethics board that he had terminated the study.
• The surgeon later published selected results in the American Association of Thoracic Surgeons Journal. He omitted several adverse outcomes from the journal article.
• 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 Sen. Charles Grassley, Chairman of the Senate Finance Committee.
The case has been investigated by the US Senate Finance Committee, Sen. Charles Grassley, the House Government Oversight Committee, Congressman Glenn Grothman, Congressman Danny Davis of IL, and The US Senate Committee on Homeland Security, Sen. Ron Johnson.
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.
One of the patients, Maureen Obermeier, has filed a 1401 petition to ask for a new trial in Obermeier versus Northwestern etc 08-L-012426 in Cook County Circuit Court.
An excerpt from The Daily Northwestern article:
The outcome of the new lawsuit is still to be determined, but Obermeier said she is hopeful that the FOIA documents are a turning point that will finally “end the cycle of horrible behavior.”
But even if the lawsuit is settled in her favor, Obermeier has to deal with the ramifications of her 2006 surgery for the rest of her life. She will continue to rely on a number of medications and have to live a restricted lifestyle.
“My life is completely different now,” Obermeier said. “My cardiologist told me, ‘You’re alive probably only because you’ve worked so hard at staying alive.’”
A link to full The Daily Northwestern article: 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 receive proper medical care moving forward.”
Link to FOIA documents: https://www.scribd.com/user/383243128/Nalini-Rajamannan
Link to public court documents: https://www.scribd.com/document/401704498/PlantiffPetition1401-02222019
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.
NBC26 Interviews the Patients
Source: EIN Presswire