Letter to Morton Schapiro, President of Northwestern University and Richard J. Gannotta, President of Northwestern Memorial Hospital - Northwestern Memorial Hospital

Letter

Dear Mr. Schapiro and Mr. Gannotta:

On December 3, 2008, and September 30, 2009, I wrote to you about troubling allegations that the Myxo-ETlogix 5100 Ring (Myxo Ring), an annuloplasty ring used in heart valve repair, had not been cleared for marketing by the Food and Drug Administration (FDA) before it was implanted in patients as part of an outcomes study. However, the Myxo Ring was actually implanted as part of two outcomes studies.

In October 2008, Edwards Lifesciences LLC -- the manufacturer of the Myxo Ring -- discontinued distribution of the device due to safety concerns. Then, in March 2009, FDA found that the Myxo Ring was a "significant risk device" that required FDA approval. Ultimately, in April 2009, the device was cleared with a new name, dETlogix Annuloplasty Ring. In my December 2008 letter, I asked you seven questions, including the following:

Please provide a copy of all internal communications and correspondence regarding the Myxo Ring and the use of the device as part of an outcomes study. This request covers the period of January 2006 through the date of this letter.

The request was not limited to a specific Institutional Review Board (IRB) Project Number. Rather, the request was for "all internal communications and correspondence regarding the Myxo Ring . . . ." However, in response to my December 2008 letter, you produced documents pertaining only to IRB 1532-003. You did not produce any documents pertaining to IRB 1532-004 -- until my recent request by specific project number.

In your March 21, 2014 response to my March 4, 2014 letter, you claimed that my staff limited the scope of my December 3, 2008 request informally during conversations you had with them. However, you provided no documentation of any such agreement and my staff does not recall one. You also indicated in your March 21, 2014 letter as follows:

[W]hen we responded to your [previous] inquiries . . . . and even today, it did not appear that . . . IRB Study 1532-004 was responsive . . . . 1532-004 . . . was terminated in 2007. Thus, the only relevant actual IRB study that was responsive to [your] request was, and remains, 1532-003

As you noted, IRB 1532-004 was terminated in 2007. My December 3, 2008 letter explained that "this request covers the period of January 2006 through the date of this letter." In addition, according to the documents you produced on March 21, 2014, a primary objective of IRB 1532-004 was to "evaluate results of myxomatous mitral valve repair using the Myxo ETlogix Annuloplasty Ring . . . ." My December 3, 2008 letter requested "all internal communications and correspondence regarding the Myxo Ring . . . ." Thus, by both subject-matter and time-frame, the documents pertaining to IRB 1532- 004 fall squarely within the scope of my December 3, 2008 request.

Moreover, the IRB 1532-004 documents which you belatedly disclosed bear directly on the question that precipitated my investigation in 2008 and remains unanswered: did Northwestern implant an unapproved device -- which it knew, or should have known, required approval -- in patients without obtaining their informed consent?

Since September 18, 2008, Northwestern has repeatedly stated that it did not believe that such approval and consent were required because Dr. McCarthy was assured by Edwards in August 2007 that the Myxo Ring was only a "minor modification" of preexisting devices However, the documents produced thus far show that Dr. McCarthy was making statements that directly contradicted Edwards' assurances and that Northwestern would have known of these contradictory statements. Specifically, in a journal article submitted by Dr. McCarthy and ten Northwestern colleagues on behalf of its Bluhm Cardiovascular Institute in June 2007, Dr. McCarthy was promoting the Myxo Ring as "significantly larger than existing commercial remodeling rings." In addition, in a protocol submitted to the University on June 7, 2006, Dr. McCarthy stated as follows:

[R]epair with current ring systems do not address . . . excessive leaflet tissue . . . . The Myxo . . . [R]ing was specifically developed to help eliminate the need for the complex . . . sliding-plasty procedure. The Myxo
ETlogix is the first ring . . . designed to reshape the annulus to accommodate the larger leaflets . . . by reshaping the . . . [annulus] . . . instead of cutting the . . . [leaflets.]

Given Dr. McCarthy's clear expertise in the field of heart-valve repair and his firsthand knowledge of the Myxo Ring and other devices used in that field, there is a genuine question as to how he could have believed that the Myxo Ring was only a "minor modification" of existing devices when he himself designed and promoted the Myxo Ring for a different purpose, with a different shape, and as "significantly" different in size. To determine how Northwestern could have reconciled these contradicting positions, an analysis of all relevant documents was required. To this end, your March 21, 2014 document production was helpful, as the protocol referenced above is from IRB 1532-004 and clearly relevant. However, your response raises new questions and leaves unanswered the central question of this investigation. Accordingly, please respond to the following:

1. Please provide documentation of any agreement to limit the scope of my December 3, 2008 request to IRB Project Number 1532-003. If you have none, please indicate that you have no such documentation.

2. Is it Northwestern's understanding that Dr. McCarthy believed that the Myxo Ring was "significantly larger than existing commercial remodeling rings" or that it was merely a "minor modification" of existing remodeling rings?

3. In light of the protocol referenced above, how did Northwestern reconcile Dr. McCarthy's description of the Myxo Ring as a groundbreaking design with Edwards' assurances that the device was merely a "minor modification?"

I would appreciate a response by May 16, 2014. Should you have any questions, please contact Jay Lim of my Committee staff at (202) 224-5225.

Source