- Posted October 7, 2013 by
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 2: McDermott, Will and Emery, Covers-up Illegal Human Experimentation in Senate Investigation
David S. Rosenbloom
Attorney at Law
October 30, 2009
VIA E-MAIL AND FED-EX
The Honorable Charles Grassley, Ranking Member Committee on Finance
135 Hart Senate Office Washington DC 20510
ATTN: Mr. Brian Downey Brian.Downey@finance-rep.senate.gov
Re: Letter of September 30, 2009 to Northwestern Memorial Healthcare Dear Senator Grassley:
I am writing again on behalf of Northwestern Memorial Hospital ("NMH") to summarize the efforts of NMH and the Northwestern Medical Faculty Foundation ("NMFF") to identify information and documents responsive to the additional questions raised in your letter of September 30, 2009. We understand that Northwestem University, the other recipient of your letter, will be providing a separate response.
As we have previously noted, we are producing our responses pursuant to Senate Rule XXIX and request that you treat this information as Committee Confidential under that Senate Rule. Because we are providing information pursuant to a Congressional demand letter, we understand that we waive no otherwise applicable privileges that exist under state or federal law.
Because your letter raises various questions about the FDA regulatory approval process for a medical device that was implanted in patients at NMH, we thought it important to reiterate at the outset the differing roles and responsibilities that health care providers and device manufacturers play in providing patients access to safe and effective medical devices that treat serious medical conditions. As you would expect, health care providers, such as the physicians who serve on the
staff of NMH, take seriously their responsibility to be knowledgeable in the latest diagnostic and treatment techniques, and to be aware of the vast spectrum of drugs and devices that are commercially available to provide beneficial therapies to patients. What health care providers cannot reasonably do, however, is to second guess the decisions of manufacturers to distribute products as approved medical devices, or the decisions of the regulators to allow such distribution. To the contrary, health care providers necessarily rely on medical device, equipment, and product manufacturers, pharmaceutical companies, and the government agencies that regulate those entities, to ensure that manufacturers provide safe and compliant products to patients. Neither hospitals nor physicians have the technological ability or regulatory expertise to address whether a medical device has been properly cleared for market pursuant to the FDA' s regulatory processes. Moreover, neither the FDA nor any other regulatory body has ever placed a separate obligation on the user of a medical device to verify that proper step were taken to clear a device for market.
Manufacturers, on the other hand, necessarily develop extensive expertise in the regulations and guidance issued by the FDA relating to the clearing of medical devices for marketing. This repository of expertise at the manufacturer level reflects the reality that all constituencies, including both the FDA and the health care provider community, look to manufacturers to ensure that all regulatory hurdles are cleared before drugs or medical devices are brought to market. Thus, the practical reality is that the commercial distribution of a medical device to physicians and hospitals is a representation by the manufacturer that the device is being legally marketed under applicable laws and regulations, and that the device is safe for use in patient care.
In contrast to the commercial marketing of a cleared device, there are well established, and carefully controlled, regulatory pathways by which manufacturers can distribute devices that are not yet cleared. For example, if a device is not yet cleared for sale, the manufacturer must infonn the hospitals and physicians to whom it offers to make the devices available that the device is investigational. The manufacturer and the provider can then discuss whether the provider would like to participate in a clinical trial or some other investigation of the device. If the provider is interested in investigational use of the device, the provider will then make arrangements with an institutional review board (IRB) before using the device in a clinical trial or in an investigational setting.
The common denominator between the approved commercial distribution of a device and the investigational distribution of a device, is that the device manufacturer is necessarily the source of all information regarding any restrictions on the use of the device. In both scenarios, the health care provider relies on the manufacturer to provide timely and accurate information regarding the regulatory status of the device.
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?
Responses on part II of this story can be found on the CNN ireport