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The Pro Se Brief Submitted to Cook County to Retrieve Waiver 1532-004
"pro se, and petitions this Honorable Court for leave to intervene as of right in this cause, pursuant to 735 ILCS 5/2-408(a)(2) or, in the alternative, for leave to intervene by permission, pursuant to 735 ILCS 5/2-408(b)(2). In support of said motion, petitioner states as follows:
Plaintiff filed this lawsuit to recover from defendants for injuries she received as a result of alleged medical malpractice perpetrated by one of the defendants, Dr. Patrick McCarthy, M.D. (“McCarthy”), a cardiothoracic surgeon employed by the Northwestern Medical Faculty Foundation, and with faculties at Defendant Northwestern Memorial Hospital (“NMH”), when McCarthy surgically implanted an experimental and investigational annuloplasty ring, the Myxo Ring, into plaintiff’s heart. The Myxo Ring device, at that time, had not been approved by the Food and Drug Administration (‘FDA”), and had not even been submitted to the FDA for review or approval, pursuant to CFR 21.
Pursuant to plaintiff’s discovery requests, NMH produced a document to plaintiff that was constituted as a waiver (1532-004) and an echo research protocol, whereby the Northwestern Institutional Review Board (“IRB”) waived the requirement that McCarthy obtain his patients’ consent to gather their information and data for a non-approved clinical trial of the Myxo Ring as outlined in the research protocol.
In order to obtain the waiver from the IRB, McCarthy misrepresented to the IRB that the Myxo Ring was not experimental and had been approved by the Food and Drug Administration (“FDA”), and thereby misrepresented that the data being gathered was not for a clinical trial of an experimental device or for a medical study. He misrepresented that, as such, he did not need to obtain a consent from patients to obtain and use their data for his clinical trial of the Myxo Ring. One of the elements of the waiver was that McCarthy was supposed to remove patients’ names from the database, but he did not do so. Patient names remain on the list of patients whose data McCarthy used without their consent.
Dr. Nalini Rajamannan, M.D. (“Petitioner”) agreed to co-author the echo protocol with McCarthy and others from Northwestern University, NMH and Northwestern Memorial Faculty Foundation, based on McCarthy’s misrepresentation that he had obtained approval from the IRB to permit him and Petitioner and others to gather data from patients implanted with annuloplasty rings, including the Myxo Ring, for inclusion in the echocardiographic database. McCarthy misrepresented to Petitioner that he was using an IRB-approved consent form to obtain signed, written, informed consent from these patients for the release of their data to Petitioner for the echo database, and Petitioner’s IRB-approved study to test their surgical tissues obtained from surgery. In fact, however, as set forth above, McCarthy, had not obtained IRB approval for a clinical trial of an experimental device. Instead, as set forth above, he had misrepresented to the Northwestern IRB that he was merely gathering data from surgical implantation of an FDA-approved device. Contrary to what McCarthy misrepresented to Petitioner, he had not, in fact, obtained an IRB-approved patient consent form. Instead, he had obtained a waiver (based on his misrepresentation to the IRB) so that he could avoid the requirement that he had to obtain patient consent. In the early days of the Myxo Ring clinical trial, Petitioner and co-authors obtained and used data from patients in whom McCarthy implanted Myxo Rings, for a scientific abstract publication (AATS 2007), because he had also misrepresented to her and many other people and to the institution, including NMH, Northwestern University and Northwestern Memorial Faculty Foundation, that his Myxo Ring device was FDA-approved and that it was not experimental. In fact, in the early days of McCarthy’s clinical trial of the Myxo Ring, he misrepresented to Petitioner and others that he had IRB approval for his clinical trial of the Myxo Ring.
Petitioner is a world-renowned cardiologist and medical researcher in her field of cardiology. Over several years and in numerous scholarly medical publications and in countless presentations throughout the world, Petitioner has used the data she has legitimately obtained through signed, written patient consent, as part of various clinical trials and studies, including the data she obtained and used with signed, written, informed consent from patients implanted with the Myxo Ring. Petitioner’s reputation and integrity as a cardiologist and medical researcher is dependent upon the integrity of the data she obtains and the legitimate and lawful use of that data in a manner consistent with the purposes agreed to by patients with their written, signed, informed consent.
In fact, however, McCarthy illegitimately obtained patient data, without informed consent and with the waiver (1532-004) and the echo protocol co-authored by the Petitioner, and he used it for his own illegitimate purposes in his unapproved clinical trial of the experimental Myxo Ring. McCarthy used Petitioner’s legitimately-gathered data and research endeavors to gather data for his unapproved clinical trial of an unapproved and experimental Myxo Ring device. On information and belieft, McCarthy was thereby able to test the experimental device without disclosing to NMH, the Northwestern IRB, Petitioner, the FDA, patients and others that the Myxo Ring was an unapproved and experimental device that had never been submitted to the FDA for review. As a result, unbeknownst to Petitioner for several years, medical data she legitimately obtained with patients’ consent for inclusion in the echo database was used by McCarthy as data in his unapproved clinical trials without patients’ consent.
Petitioner only learned on November 19, 2013 that the Northwestern IRB and McCarthy had entered into the waiver (#1532-004) so that McCarthy could obtain data of patients in whom he implanted his inventions the Myxo Ring and the IMR ring without obtaining their consent. Petitioner immediately informed Northwestern University’s IRB and Clinical Trials Unit, as mandated of investigators in FDA regulated research (CFR21).
On December 6, 2013, this Honorable Court heard a motion filed by NMH whereby NMH moved that the waiver be protected from disclosure pursuant to the Illinois Medical Studies Act (“IMSA”). This court granted NMH’s motion and the waiver document thus is currently prevented from disclosure to third parties.
Because of this court’s ruling on December 6, 2013, Petitioner and others are unable to obtain the waiver for investigatory purposes and for purposes of demonstrating that Petitioner was not aware of nor did she agree to the illegitimate and unconsented use of patient data in an unapproved clinical trial of a non-FDA approved and investigational medical device.
Petitioner has been implicated by association in McCarthy’s illegitimate use of patient data in an unapproved clinical trial of a non-approved medical device. Petitioner legitimately obtained patient data through signed, written, informed patient consent for inclusion in an IRB-approved surgical tissue database for use in an IRB-approved study. Patients did not consent to McCarthy’s illegitimate use of their data in his unapproved clinical trial. Petitioner was unaware that her patients’ data would be used for purposes that they never agreed to, data which Petitioner obtained in the echo database. As such, Petitioner’s reputation and integrity as a world-renowned cardiologist and medical researcher has been impugned and the integrity of her medical research has been impugned. McCarthy and NMH, through the waiver, betrayed the trust of patients under their care. McCarthy, through misrepresentations to NMH, abused the clinical trial process and abused patient data ..."