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On Martin Luther King Day, Illinois and Minnesota Attorney Generals and Chicago City Mayor Lori Lightfoot Receive FDA Testimonies on Non-Exempt Medical Device as FDA Delays to Not Inform the Patients as Confirmed by Dr. Rajamannan

Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens
Press Release – updated: Jan 20, 2020 05:00 EST

SHEBOYGAN, Wis., January 20, 2020 (Newswire.com) – Most Sacred Heart of Jesus Cardiology and Valvular Institute Medical Director Dr. Nalini Rajamannan has sent an FDA Affidavit outlining Illinois and Minnesota testimonies to the Illinois and Minnesota Attorney General’s offices regarding Patient’s rights under HHS Federal Codes for human subject research. Chicago City Mayor Lori Lightfoot’s office and the Attorney General’s office have civic oversight to protect citizens in their city and states from receiving non-exempt FDA medical devices without informed consent.
The events follow recent reporting by Kaiser Health News that the FDA has lifted their exemption laws.​​ Dr. Nalini Rajamannan, a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, confirms FDA statements after a decade of requesting answers from the FDA from her location in Downtown Sheboygan. Dr. Rajamannan revealed the confirmation FDA letter to Congressman Glenn Grothman that the Food and Drug Deputy Commissioner on policy for the FDA will not inform the patients regarding the status of a heart device implanted in 667 patients across the United States of America.
Former Board of Trustee for the University and now Governor of Illinois, Gov. Pritzker receives the FDA affidavit after years of delays by the FDA in reporting to the patients. The surgical placement for these devices began in 2006. In 2007, the device manufacturer confirmed the “exempt status” in a two-line email to the hospital. The saga related to the heart device is outlined by Dr. Elisabeth Rosenthal’s new book “An American Sickness”, which highlights the issues related to exempt medical devices in the chapter, “How to get into a Patient’s Heart? Follow the Money.” The chapter outlines the events summarized by eye-witness Dr. Nalini M. Rajamannan in the series “The Myxo Files a XXIV: A Tale of Three Rings” as published by Kindle Publishing on Amazon.com. Dr. Rajamannan reviewed the FDA letter to the Senate Finance Committee’s Chairman Grassley after several years of investigations, classifying the device as not exempt from reporting the device to the FDA, and that the device manufacturer needs to submit a new approval application. (See Linked PDF of the FDA Congressional Letter.)
Summation points from the recent press conference at the Institute after a decade of FDA investigations:
1)    FDA report to Senate Finance Committee confirms the Myxo ETlogix Device is not exempt and needed an approval from the FDA.
2)    FDA letter to Senator Lugar confirms 667+ patients received the non-exempt device which needed an approval.
3)    FDA report to the House Committee on Government Oversight confirms that the FDA does not plan to inform the patients.
4)    Congressman Grothman is still waiting for a response as to why the FDA is not planning to inform the patients.
5)    HHS Inspector General Daniel Levinson is not planning to inform the patients of the non-exempt status of the heart device after requests for information by Senator Ron Johnson.
6)    Dr. Rajamannan Presented documents and affidavit to Senator Amy Klobuchar’s staff in Minneapolis. Senator Klobuchar has met with Dr. Rajamannan since 2014 in Washington DC, after the Senate Judiciary Committee began their investigation.
The information will help the 667+ patients to finally may get answers about whether medical devices placed in their bodies are tested and safe, as the Food and Drug Administration begins to allow access to volumes of previously shielded data from consumers as written to then-Senator Richard Lugar (IN) and Congressman Glenn Grothman (WI). The Senate Finance committee is involved in these investigations on behalf of Medicare and Medicaid because government dollars fund the use of medical devices in patients’ health. More importantly, the new changes to the FDA reporting laws as outlined by Kaiser Health News will help patients know more about medical devices implanted into their bodies.
Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. 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 and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.
​Press ContactOscar Delgado​​Press Officer for Most Sacred Heart of Jesus Cardiology and Valvular InstituteFormer NBC Bureau Chief Latin America773-573-6890oidwinds@gmail.com
Source: Most Sacred Heart of Jesus Cardiology and Valvular Institute

Attorney John Q. Kelly Featured on ABC’s 20/20 Discussing the Natalee Holloway Disappearance

Attorney John Q. Kelly

“ … it was shrouded in mystery on a small island far away from home”

GREENWICH, Conn. (PRWEB) January 17, 2020
“She had no idea what happened to her daughter; it was shrouded in mystery on a small island far away from home,” Kelly commented.
In 2010, Joran van der Sloot contacted John Q. Kelly by email, claiming that in exchange for $250,000, he would reveal the location of Natalee Holloway’s remains to Kelly.
On 20/20, Kelly described how he contacted the FBI and orchestrated a sting operation that resulted in federal wire fraud and extortion charges against van der Sloot.
After 15 years, Natalee’s disappearance remains unsolved, but Beth still believes Joran is responsible for her daughter’s demise. Joran is currently serving a 28-year prison sentence for the murder of Stephany Flores Ramírez in Lima, Peru in 2010. Once that sentence is completed, he will be extradited to the United States on federal extortion and wire fraud charges.
About Ivey, Barnum, & O’Mara, LLCIvey, Barnum & O’Mara, LLC, is the largest Greenwich, CT-based law firm, with additional offices in New Canaan, CT and New York City.Established for more than 65 years, Ivey, Barnum & O’Mara, LLC’s team of accomplished and dedicated attorneys represent clients in a wide range of individual and corporate legal issues, including: Personal Injury/Wrongful Death, Litigation, Residential and Commercial Real Estate, Land Use/Zoning, Trusts and Estates Planning, Corporate Law, Franchise, Employment Law.To learn more about Ivey, Barnum & O’Mara, LLC, visit https://www.ibolaw.com/ or call 203-661-6000.

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Attorney Dmitry Gorin Discusses Controversial Child Pornography Law on National Public Radio

Dmitry Gorin

LOS ANGELES (PRWEB) January 11, 2020
Dmitry Gorin, a former sex crime prosecutor with the Los Angeles County District Attorney’s Office and now a criminal defense lawyer discussed how if a therapist fails to report patients who view child porn, it could lead to a criminal fine or harsher punishments against them.Listen to interview here.
In late December 2019, the California Supreme Court revived the long-running debate when it reinstated a lawsuit over whether therapists must advise authorities when their patients report they are attracted to child pornography.
The lower courts had dismissed a lawsuit by therapists who made the argument that California’s mandatory reporting law violated patient confidentiality and discouraged their patients from revealing they downloaded or viewed child pornography images or videos.
The Supreme Court was split 4-3 in favor of reinstating the case and sending it back to Superior Court, where the burden falls to the offices of the state Attorney General and Los Angeles County District Attorney to show that mandatory reporting protects children.
The majority noted the therapists argued their patients in the case don’t present a serious risk of sexual contact with children. However, they decided that patient privacy rights only apply to disclosures during voluntary therapy sessions, not to actual possession or viewing child pornography, which remains illegal and reportable.
The issue at hand is a 2014 law that modernized California’s 40-year-old mandatory reporting requirement that included downloading, streaming and electronically accessing child porn.
For years, California law has required therapists to report patients admitting to developing, duplicating, printing or exchanging material that depicts an obscene act involving a child. They accepted the law and regarded it as an obligation to report anyone who distributes child pornography.
Dmitry Gorin is a partner at Eisner Gorin LLP, a Los Angeles-based law firm with an AV-Preeminent Rating (Top 5% U.S. Law Firm) specializing in criminal defense.
He is annually selected to Best U.S. Lawyers and aggressively represents clients against sex crimes, theft crimes, domestic violence, drug crimes, white collar crimes, and federal offenses.
For more information, visit us online at https://www.egattorneys.com.

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