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Northwestern Hospital Faces Round Two of HIPPA Security Violations as Revealed in Cook County Court Filings
NEWS PROVIDED BY
Oscar Delgado
March 13, 2019
CHICAGO, March 13, 2019 /Standard Newswire/ -- Northwestern Memorial Hospital and Northwestern University are facing more HIPPA legal issues after the Jussie Smollet electronic medical records made waves last week. Cook County Court records confirm concealed Food and Drug Administration evidence related to one hundred patients in a clinical trial.
Court Documents and FDA Freedom of Information Act records reveal that Dr. McCarthy, Northwestern's Chief of Cardiac surgery, received a one-time expedited HIPPA waiver from Northwestern University in June 2006 to publish the initial test results of his new invention. The evidence confirms that no consent was given. For years, Northwestern University attorneys have informed the US Senate Finance and Judiciary Committee under the leadership of Senator Grassley (IA), and the Cook County Court System that the HIPPA protocol 1532-004 had nothing to do with the research study. Northwestern claimed that implantation of the experimental device and publication of the study was performed according to the federal laws and there was no need for any patient consent.
However, a recent Cook County Court petition 08-L-012426 reveals newly released 2008 FDA inspection records of Northwestern University Federal office for human subject protections, confirms that Northwestern University knew all along that Dr. McCarthy was experimenting and tried to stop the surgeon. After being told that he needed approval for a "prospective" study (clinical trial) in June 2006 by Northwestern University's IRB coordinator, Osafo, McCarthy told Osafo in July 2007 that he had agreed to terminate and signed the federal termination contract. The most recent Cook County petition states that this meant that he violated the termination agreement he signed with Northwestern's Office for Protections of Human Research Subjects, because he had continued to use the ring in procedures after June 2006 until at least November 2007, without patients' consent.
Senator Charles Grassley(IA) press officer stated that "we are reviewing the new evidence filed in the Cook County Court Case regarding the allegations as it relates to the Senate Investigations of the FDA, Northwestern University and Hospital, and Edwards Lifesciences, (Irvine, CA)." The FDA press officer Deborah Kotz in a statement for this story stated, "We do not comment on pending litigation." Northwestern University learned of the FOIA in December 2018 and continues to refuse to contact the patients who received the experimental protocol without their knowledge. Northwestern University and Hospital failed to return emails or answer calls for comment.
SOURCE Oscar Delgado
CONTACT: Oscar Delgado, 773-573-6890
Oscar Delgado
March 13, 2019
CHICAGO, March 13, 2019 /Standard Newswire/ -- Northwestern Memorial Hospital and Northwestern University are facing more HIPPA legal issues after the Jussie Smollet electronic medical records made waves last week. Cook County Court records confirm concealed Food and Drug Administration evidence related to one hundred patients in a clinical trial.
Court Documents and FDA Freedom of Information Act records reveal that Dr. McCarthy, Northwestern's Chief of Cardiac surgery, received a one-time expedited HIPPA waiver from Northwestern University in June 2006 to publish the initial test results of his new invention. The evidence confirms that no consent was given. For years, Northwestern University attorneys have informed the US Senate Finance and Judiciary Committee under the leadership of Senator Grassley (IA), and the Cook County Court System that the HIPPA protocol 1532-004 had nothing to do with the research study. Northwestern claimed that implantation of the experimental device and publication of the study was performed according to the federal laws and there was no need for any patient consent.
However, a recent Cook County Court petition 08-L-012426 reveals newly released 2008 FDA inspection records of Northwestern University Federal office for human subject protections, confirms that Northwestern University knew all along that Dr. McCarthy was experimenting and tried to stop the surgeon. After being told that he needed approval for a "prospective" study (clinical trial) in June 2006 by Northwestern University's IRB coordinator, Osafo, McCarthy told Osafo in July 2007 that he had agreed to terminate and signed the federal termination contract. The most recent Cook County petition states that this meant that he violated the termination agreement he signed with Northwestern's Office for Protections of Human Research Subjects, because he had continued to use the ring in procedures after June 2006 until at least November 2007, without patients' consent.
Senator Charles Grassley(IA) press officer stated that "we are reviewing the new evidence filed in the Cook County Court Case regarding the allegations as it relates to the Senate Investigations of the FDA, Northwestern University and Hospital, and Edwards Lifesciences, (Irvine, CA)." The FDA press officer Deborah Kotz in a statement for this story stated, "We do not comment on pending litigation." Northwestern University learned of the FOIA in December 2018 and continues to refuse to contact the patients who received the experimental protocol without their knowledge. Northwestern University and Hospital failed to return emails or answer calls for comment.
SOURCE Oscar Delgado
CONTACT: Oscar Delgado, 773-573-6890
