CEO Northwestern Memorial Ignores FDA Request to Inform Patients

In 2018, William Knotts of St. Charles, IL, died at Northwestern Memorial Hospital. His death followed a difficult, and prolonged hospital stay to try to restore his heart function after a failed experimental heart surgery in 2014, as reported by the student newspaper, The Daily Northwestern in 2019.

The experiments began in March 2006. I was an eye-witness, but I removed my participation from the experimental human clinical trial in 2007, once I learned that the patients were not receiving proper consent forms. I informed the University, and I informed the FDA.

Instead of informing the patients, The Hospital and the University relied upon an email from the company claiming they believed it was similar to previous devices. Edwards Lifesciences, the company claimed that they did not need to seek approval from the Food and Drug Administration as of recently.

In 2007, Edwards Lifesciences reported to investors the fact that the company was selling the device, in annual Security Exchange Filings, but never reported to the FDA the existence of the device until 2008 when the FDA began their investigations.

The company reported to the Chicago Tribune in May 2011,

"Edwards followed FDA's guidance relative to our (Myxo) annuloplasty ring and Edwards addressed the requests from FDA and resolved them more than two years ago."

Edwards Lifesciences also reported to Cook County Court, Illinois Appellate Court, Illinois Supreme Court in IL, and the Senate Finance and Judiciary Committee investigations under the direction of Senator Charles Grassley(IA), claiming to the Court and the United States Senate, that the FDA never found the company to be non-compliant, after the FDA began their own investigation in 2008.

How was it possible for the company to test, sell and market the device without registering the device with the FDA?

The Illinois appellate record from 2019 confirms that Edwards Lifesciences had self certified the device using a "justification to file:"

Paragraph 25-28 of the Appeal confirms testimony by Senior Director of Regulatory affairs Ms. Susan Gamble:

Paragraph 25:" Susan Gamble, senior director of regulatory affairs for the heart valve therapy division at Edwards, also testified at trial. She explained how the “Justification to File” (JTF) pathway to market a product works."

Paragraph 27:" Ms. Gamble testified that, with regard to the Myxo ring, Edwards complied with the guidance document and completed the JTF process on February 27, 2006. The JTF remains in the records of a device manufacturer so it is available for inspection by the FDA."

Paragraph 28:" It was Ms. Gamble who made the decision regarding the regulatory pathway of the Myxo ring, with the agreement of her senior management. Edwards never considered the Myxo ring to be an investigational product, and it never was an investigational product."

Missing from her testimony was the second justification to file dated November 20, 2006, necessary to modify the device for safety reasons prior to the marketing, evidence provided to the US Senate by Edwards Lifesciences. See attached figure, the second version of the Myxo ETlogix Ring Model 5100, with the additional marker added to point the front from the back of the ring prior to placement in the heart of the patients. The marker is missing from the first version of the McCarthy ring.

After the Appellate Court completed the case, the attorneys for Edwards Lifesciences posted their outcome:

"Edwards obtained summary judgment on the basis that proper FDA clearance was to be decided solely by the FDA, which had never found the myxo ring to be non-compliant with its procedural requirements." Eichhcorn and Eichhcorn, David C. Jensen and Kirk D. Bagrowski

The official FDA decision:

In March 2009 and again in July 2009, the FDA officially classified the Myxo device as investigational.

The FDA required the company to recall the Myxo Etlogix device, and then subsequently submit a new application to use the device in patients.

The new application required a new name for the device, calling it the DETLOGIX ring, a new indication for use, and never approving the experimental version of the device, the Myxo ring. Photo of the different rings manufactured by Edwards Lifesciences are attached in this article.

After an inspection of the company's headquarters in Irvine CA, the Company received an FDA warning letter in 2010, for misbranding of the Model 5100, and failure to submit several adverse events to the FDA database.

A recent search by CEO and founder of Device Events, Madris Kinard, discovered over 10,000 adverse events over the lifetime of these annuloplasty rings manufactured by Edwards Lifesciences. Madris Kinard has worked tirelessly to identify patient safety and health outcomes which are impacted by the inaccessible information on adverse events caused by medical devices. The FDA's warning letter to the company to report the events after the inspection in 2009, caused a significant uptick in reporting events in the FDA's database.

After several investigations, the FDA concluded that Edwards Lifesciences was not in compliance, and this was confirmed again by the FDA to the Chicago Tribune in an interview, and also to the Senate Finance Committee during their investigation.

The director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) Dr. Jeffrey Shuren confirmed these facts to the Chicago Tribune in May 2011:

"Yet according to the FDA, between the time the Myxo ring first was being implanted and the time it was cleared, about three years, it was an investigational device."

"If a device is supposed to get cleared by the agency first before you're marketing it, we consider that investigational," Dr. Jeffrey Shuren, head of the FDA's medical device branch, told the Tribune.

Northwestern Memorial Hospital and Northwestern University's response

In 2009, Dean Harrison wrote the patients:

"In January 2009, Northwestern hospital's president and CEO, Dean Harrison, sent a letter to Vlahoulis and other patients who had received the Myxo ring. It stated that "we do not consider this device to be experimental."

The hospital said Harrison's information was based on an email received from Edwards Lifesciences in August 2007, after the devices had been implanted, saying the Myxo "is not an investigational device."

"Yet according to the FDA, between the time the Myxo ring first was being implanted and the time it was cleared, about three years, it was an investigational device."

The Chicago Tribune May 2011, Deborah Shelton and Jason Grotto

In 2019, the student newspaper the Daily Northwestern also published the evidence that Northwestern University's Human Subject Protections Office issued a cease and desist of the study on July 17, 2007. Yet, the remaining investigators continued the study and published the results in 2008 in 100 patients, and again in 2020, in 1044 patients.

What is new?

The recently emerged Food and Drug Administration letter to Northwestern which is part of the Senate Finance Committee investigation. The letter written in 2008, by the FDA official Ms. Doreen Kezer to Dean Harrison the current CEO and Board of Trustee Member for Northwestern University, confirms the truth. See Attached FDA letter, Doreen Kezer.

The FDA mandated Mr. Harrison to inform the patients that their patient data collected in "a registry,” would be used to eventually apply for the approval of the device in April 2009, three years after they had undergone the surgery.

13 years later, the CEO has not fulfilled the FDA's Request.

The patients and their family members recently testified for over three hours to the FDA in Minneapolis MN, regarding their injuries, heart attacks, deaths and reoperations as a result of the experiments. They also answered questions surrounding the forms they signed, from an expert in human subject research protections, again confirming the patients had no knowledge of their experimental surgery.

There was no mention in the paperwork of any devices being tested.

Which elected officials are helping these patients?

From 2008-2015, Senator Charles Grassley requested documentation from the FDA, Northwestern University and hospital and the Company Edwards Lifesciences, Irvine CA.

In 2017, Congressman Glenn Grothman contacted the FDA twice, but as of today, according to the Congressman's staff only one reply was received, awaiting the second response. Finally, in 2017, Senator Ron Johnson contacted the HHS OIG, and the patients finally received the first call in March 2021.

In 2021, Senator Amy Klobuchar contacted the Minneapolis, MN FDA and the director Dr. Michael Dutcher sent one email.

If the CEO of the Hospital had heeded the FDA’s request in 2008, to inform the patients, would the future 1000 patients had been protected, including William Knotts?

I have been reporting to Northwestern University, The President and the Board of Trustees for over a decade, and only in November 2020, was I promised a meeting with the Northwestern University’s office of diversity, Provost and Dean, on November 10, 2020, however, no meeting has been scheduled as of today.

"Greetings, Nalini. Thank you for connecting with us. Please note that I have forwarded your message to the Office of Equity and to general council. Someone from one of those offices should be in contact. In the meantime, please know that we thank you for your care and concern.

Sent from my iPhone"

-Dr. Sekile M. Nzinga, Acting Provost of Diversity Northwestern University 11-10-2020

Northwestern University Board of Trustees Response:

Only two members of Northwestern University's Board of Trustees responded to my request for help for the patients:

In 2013 Philip Harris while he still worked for Jenner and Block before joining the General Counsel at Northwestern University and again leaving the general counsel abruptly in 2018:

Harris, Philip L <PHarris@jenner.com>

Mon, Mar 25, 2013, 11:04 AM to me

I am comfortable with the way this is being addressed and do not believe that me meeting with you is necessary. I know that you have contacted many people about this and believe that there has been appropriate follow-up.

------------------------------------

Philip L. Harris

Jenner & Block LLP

353 N. Clark Street

Chicago, IL 60654-3456

Tel (312) 923-2675

Fax (312) 923-2575

PHarris@jenner.com

www.jenner.com

"Our Commitment to Racial and Social Injustice"

-Jenner and Block Website 4-5-2021

The second response came from another former Northwestern University Board of Trustee Member and Bioethicist, Julia Eihlein an Assistant Adjunct Professor of Bioethics and Medical Humanities and Pediatrics at the Medical College of Wisconsin in Milwaukee, WI:

On Thu, Dec 21, 2017 at 1:16 PM, Uihlein, Julia <JUihlein@mcw.edu<mailto:JUihlein@mcw.edu>> wrote:

Dear Dr. Rajamannan. I have received your e-mail and will take into consideration. I have consulted Morton Shapiro. Julia A. Uihlein

Sent from my iPhone

Thanks to Ms. Kinard of Device Events, the 10,000 adverse events are available and submitted to the FDA Acting Commissioner. The events, missing heart valve ring approvals and failure to follow-up on the FDA letter is currently under investigation by the FDA. The investigation was confirmed by the Acting Commissioner for the Food and Drug Administration Dr. Janet Woodcock has referred the matter on the record, to the large number of adverse events to FDA authorities for investigation, as of March 12, 2021.

“Thank you for writing. I have referred all the information you have send in emails, to the appropriate authorities within FDA. Janet Woodcock M.D.”

Janet Woodcock, MD Acting Commissioner for the FDA Under President Biden 3-12-2021

The FDA letter sent Dean Harrison on 11-26-2008 was sent to the Board of Trustees and the President of the University for Northwestern University for comment, as of today, there is no response.

And, as importantly, shouldn't every one of the patients tested now over 1000 in total, be informed today so they can make sound decisions about their health moving forward?