President Michael Schill 2-130, Rebecca Crown Center 633 Clark Street Evanston, IL 60208 Nu-president@northwestemn.edu Eric Neilson, MD Vice President of Medical Affairs 420 E. Superior Street, 12" Floor Chicago, IL 60611 Phone: 312-503-0340 Email; feinbergdean@northwestern.edu Executive Assistant: Sharon Atas, satas@northwestern.edu Peter Barris Chairman of Northwestern University Board of Trustees 633 Clark Street Evanston, IL 60208 pbarris@nea.com Executive Assistant Ms. Ball jball@nea.com J. Larry Jameson, MD President UPENN, 1 College Hall, Rm 100 ladelphia, PA 19104-6380 president@upenn.edu December 20, 2023 Dear President Schill, VP Neilson, Chairman Barris and President Jameson, ‘THIS IS AN OPEN LETTER. Previously, we contacted you, President Schill, in January 2023, regarding the continuing issues related to Dr. Patrick McCarthy and Edwards Lifesciences Model 5100 annuloplasty heart rings. Also, please note that this letter and previous communications are not intended to be an all- inclusive statement of FDA and human subject violations that may exist in connection with this, matter. Ireceived the 5100 ring on February 14, 2007. I presumed the procedure was the standard of care and that I was not participating in a research project. Upon further review of the situation in 2011, I was able to uncover information and/or was informed by the Northwestern IRB, that:“My implant was, indeed, investigational since there was no 510k clearance on the ring and no IDE in place at the FDA at the time of my surgery, T was never given any informed consent for this investigational procedure, and ‘My data were used by Northwestern researchers to publish their results in a 2008 Journal of Thoracic and Cardiac Surgery article, without my consent. This latter Journal publication was the trigger for FDA’s involvement in this debacle and deception. Neither Edwards Lifesciences nor Dr. McCarthy elected to inform the FDA as per the normal duties of sponsors, aka, manufacturers and clinical investigators. Northwestern claimed to have relied on Edwards, and Edwards relied on their multi-hundred page “JTF”, Justification to File, document. The JTF’s purpose was to claim that the 5100 was so similar to prior marketed heart rings that no regulatory action or notice need be filed. This line of logic or defense fades quite quickly with the Edwards’ 5100 patent filing claiming over 40 characteristics that make the 5100 distinctly different from other rings on the market. Plainly stated, the JTF was false and misleading. Dr. Rajamannan, a former collaborator and Valve Director has published outcomes and injuries as related to the first in human clinical trial of this novel heart ring, performed at Northwestern University Feinberg School of Medicine without consent and without an FDA IDE or any other FDA device clearance procedures. This is an issue dating back to former VP Jameson’s and currently under VP Neilson’s tenure. Dr. Rajamannan’s Case Report includes FDA events reported during the years of the first in human elinical trial: DOI link: https://doi.org/10.54289/JCRMH2300137 Tam also aware that Patients Obermeier [multiple cardiac arrests] and Vlahoulis [5100 ring explant required at the Cleveland Clinic] have suffered different and more extensive medical sequelae following their 5100 implants. I am further aware of a death, Patient Knotts, reported by the Daily Northwestern, and numerous deaths and injuries listed in the FDA MAUDE database. These adverse events are missing and not reported in the final publication, JTCVS 2008. The FDA relied upon the publication to review the subsequent 510k application for its clearance, aka, approval, for the successor ring. There was no FDA approval, aka 510k clearance, for my device and the device implants for Patients Obermeier and Vlahoulis. By December, 2008, all 5100 heart rings were recalled by Edwards Lifesciences at the request of FDA, with the exception of those devices implanted in the hearts of unknowing and unsuspecting patients. These patients remain uninformed roday regarding the exact nature of their treatments, i.e., a presumed standard of care versus the clandestine research treatment that they actually received. https://pubmed.nebi.nlm.nih.gov/18603056/‘The FDA confirmed in a for cause inspection of the Northwestern University IRB, on August 8, 2008, that the IRB could find no FDA approval, aka, no 510k clearance for the Model 5100 heart ring and that the research protocol, enabling this clandestine testing by Dr. Patrick McCarthy, was terminated by Northwestern University IRB, July 17, 2007. The aforementioned JTCVS 2008 publication reports that implants were carried out until November 17, 2007. https://www.scribd.com/document/693838086/R-CHI-Northwestern-IRB-Exh-15-Dtd-8-8-08- Redacted-6 ‘The next steps are yours, and they are fairly obvious, based on Northwestern University’s regulatory compliance federal laws: https://www.feinberg.northwestern.edwompliance/index. html 1) Inform patients and referring physicians. 2) Retract 2008 JTCVS publication listed in this letter. 3) Report within 5 days as required under FWA 00001549. https://irb.northwestern.edu/compliance-education/fda-site-inspections.htm] Dean Harrison issued two letters to McCarthy's patients. Neither letter identified the core issues discussed in this letter. Moreover, patients were never informed about the true prospective nature of the research and that their data would form the basis for a research publication and a subsequent regulatory, aka FDA approval or clearance for the model 5100 heart ring. The deception continues until the patients and their caregivers know the truth about their implants. We expect a response to this open letter within 5 business days. Respectfully, ernse: wd 'S. Albert Edwards ‘Maureen Obermeir “Antonitsa Viahoulis