- Posted October 6, 2013 by
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- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
Statement From Nalini M. Rajamannan, MD on Her Termination From Northwestern University, Chicago, IL on Being a Whistleblower for Exposing Human Experimentation of Investigational FDA Devices
Effective September 30, 2011, I was terminated from Northwestern University as a result, I believe, of my attempts to protect my patients who had investigational devices placed in their heart. This was recently confirmed in an article written by Paul Basken in the Chronicle of Higher Education dated October 11, 2011. In 2007, I began reporting to the proper channels at Northwestern the fact that numerous patients had a non-approved device surgically implanted in their hearts without their informed consent. Most of these patients still do not know this occurred and may be suffering as a result. Northwestern rejected this notion, although it has since been confirmed that the experimental device was not, in fact, approved by the FDA at the time of implantation.
Since my reporting, Northwestern University and its various related entities, including Northwestern Memorial Hospital and Northwestern Medical Faculty Foundation, have subjected me to severe retaliatory conduct not experienced by my peers in the same position enjoyed by me. Logically, this can only be because I followed my ethical responsibility and reported the inappropriate conduct. While Northwestern may have finally terminated my employment in the hopes of silencing me, it is clear that they continue to ignore the effects on the patients who received the non-approved device and who they were charged with protecting. Many of these patients are still suffering after surgery and may have no idea as to the causal connection to their suffering.
Congressional and FDA investigations are ongoing, but the patients are, after 5 years, still unaware. The laws which should protect these human beings are derived from the Nuremberg laws enacted after WWII, called the Common Rule. These laws were meant to protect human beings from being subjected to human experimentation. I believe these laws are not being followed in this instance, and that innocent people are suffering as a result.
SOURCE Nalini Rajamannan, MD