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This iReport is part of an assignment:
Shutdown over: What next?
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- 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
Part 3: McDermott, Will and Emery, Covers-up Illegal Human Experimentation in Senate Investigation
PART II OF RESPONSES TO THE SENATE FINANCE COMMITTEE
With this general background in mind, we proceed to address the specific questions of your September 30 letter:
1. Did Dr. McCarthy, Northwestern and/or the Hospital request confirmation from the company that the Myxo ETlogix 5100 Ring was cleared by the FDA before Dr. McCarthy first implanted the device? If so, on what date was the request(s) made, by whom, to whom at Edwards, and on what date was the assurance(s) received?
Northwestern Memorial Hospital did not request additional confinnation from the manufacturer that the Myxo Ring was cleared by the FDA before Dr. Patrick McCarthy first implanted it. Dr. McCarthy and NMH rely upon manufacturers to comply with all applicable regulatory requirements. Edwards Lifesciences LLC ("Edwards,,) is a well established manufacturer of heart valves and related products. As such, Edwards has a non-delegable duty of ensuring regulatory compliance for all its products. Edwards provided the Myxo ETlogix 5100 Ring (the "Myxo Ring") to NMH in commercial packaging, with a commercial label, as is the case with any other lawful device approved by the FDA or cleared for market through the FDA's process. When the Myxo Ring was first used at NMH, we understood that Edwards had fully complied with any and all FDA regulations that would allow the marketing of the product, and at no time did Edwards suggest that the device was investigational.
In order to respond completely to your inquiry, we have inquired of Dr. McCarthy about his communications with Edwards, both in his capacity as a clinician practicing at NMH and in his consulting role to Edwards. Dr. McCarthy again confirmed that he did not participate in the regulatory decision-making process at Edwards related to clearing the Myxo Ring for market. To the contrary, Dr. McCarthy has assured us that at no time did Edwards directly or indirectly inform him that the Myxo Ring would be considered an experimental or investigational device. In fact, Edwards assured Dr. McCarthy that it was taking the steps necessary to obtain FDA approval. For example, in October 2005, over five months before Dr. McCarthy first used the Myxo Ring, one of Edwards' engineers infom1ed Dr. McCarthy that Edwards was in the process of ordering rings needed to complete its in-house testing, which was required for FDA approval. (A copy of the email dated October 21, 2005, is enclosed herewith.) While Dr. McCarthy had no
knowledge of what particular testing was required by the FDA, or to which test this email referred, this type of communication confirmed his understanding that Edwards was
doing whatever was necessary to comply with applicable FDA guidelines, whatever those might be.
Heart valve surgery, in particular valve repair, is one of Dr. McCarthy's areas of expertise, and he is a leader in the field of heart valve repair. Given his level of expertise and depth of experience, it is not surprising that Dr. McCarthy has invented several concepts used in the heart valve repair field, including the technology that resulted in the Myxo Ring, which was the third heart valve repair ring he created and assisted in developing for Edwards. As described above, it is our understanding that Dr. McCarthy's relationship with Edwards is based entirely on Dr. McCarthy's nationally recognized clinical expertise, and not at all on any notion that Dr. McCarthy had or has any regulatory expertise. Consistent with this purely clinical focus, during the time Dr. McCarthy worked with Edwards in developing and finalizing the design for the Myxo Ring, his communications with Edwards dealt almost exclusively with the ring's design, engineering and other scientific aspects. The only exception to these purely clinical communications that Dr. McCarthy reports was that Edwards also occasionally sought Dr. McCarthy's input concerning marketing materials for the Myxo Ring, which again reflects Edwards interest in Dr. McCarthy's clinical understandings of the circumstances in which the ring would be considered for use by other clinical providers. Such marketing communications do not suggest any role for Dr. McCarthy in the regulatory approval process.
2. Please provide the Committee with a copy of emails, letters, memoranda, or any other documentation of Edwards' assurance to Dr. McCarthy, Northwestern, and the Hospital that the Myxo ETlogix 5100 Ring was cleared by the FDA prior to use in the cardiac surgery outcomes registry. This request covers the period of
August 1, 2005 through April 30, 2006.
Other than the previously referenced commercial packaging and labeling and for the time period specified above, there are no emails, letters, memoranda or documentation of Edwards' assurances to NMH that the Myxo Ring was cleared by the FDA. Edwards did, however, send an email in October of2005 to Dr. McCarthy, confinning that Edwards was conducting in-house testing pursuant to the FDA process for device clearance.
Please see answer to Question One regarding the 2005 email and the process established by the FDA. Pursuant to tliat process, the device manufacturer is vested with the responsibility to clear a device for market.
When a question was raised as to proper clearance, Edwards supplied confirmation emails on August 28, 2007 and September 10, 2007, and these were produced in our correspondence to Senator Grassley dated January 16, 2009.
3. Ifwritten assurance or confirmation was not requested and/or ptovided, please explain why not and on what basis Dr. McCarthy, the Hospital and/or Northwestern that the device had been cleared for use.
In 2006, when Edwards first marketed the Myxo Ring, NMH and Dr. McCarthy considered the distribution of the device with commercial packaging and labeling as a representation by Edwards that the ring was safe and compliant with all FDA regulations. With no information to the contrary, neither NMH nor Dr. McCarthy sought additional assurances. Indeed, it was not an industry standard for physicians, hospitals or other purchasing entities to conduct a review of the regulatory compliance of medical devices being marketed by medical device manufacturers for commercial use. In fact, as discussed above, it is our understanding that the regulations established by the FDA vest the device manufacturer with the responsibility to ensure that a device is safe and properly cleared for market. Further answering, please refer to answers to Questions One and Two.
4. The Hospital stated, "At no time did any surgeon at the Hospital believe themselves to be implanting an investigational or experimental device." Other than Dr. McCarthy, how many other surgeons at the Hospital implanted the device during the period between March 1, 2006 and August 30, 2007? Did any of these surgeons inquire about the approval status of the device before they first used the device? If not, on what basis did they determine that they were implanting a cleared device?
Because of his national prominence and expertise in the specialized area of myxomatous valve repair, Dr. McCarthy performed the great majority of the myxomatous valve repair surgeries at NMH. One other attending surgeon at NMH implanted the Myxo Ring between March 1, 2006 and August 30, 2007. That surgeon implanted the device with the understanding described above, that the act of labeling and selling the product commercially, was a representation by Edwards that the product was marketed in compliance with all applicable FDA regulations. The surgeon did not inquire further about the approval status of the device. Further answering, please see answers to Questions One, Two, and Three.
5. What policies and protocols do Northwestern and the Hospital have in place to ensure that the appropriate assurances are obtained regarding the status of a device before it is first used by a faculty member and/or Hospital physician?
the Senate Finance Committee website: