Information Considered

My opinions are based upon my own personal experience and knowledge of activities developed while at the FDA, my review of FDA's records, my own professional activities, education and experience, and consulting activities after leaving FDA. I am familiar with the FDA's regulation of medical products, including radiological and imaging products, Adverse Event Reporting, health risk assessment, and labeling of FDA-regulated products that are intended to be marketed in the U.S.

I have been responsible for the Agency’s review of biocompatibility and toxicity data including animal and clinical studies.

I was Chief Medical Officer of ODE’s Division that reviewed radiologic products and was involved in the review and evaluation of contrast agents 3 and imaging devices.

I am a Board Certified Anatomic and Clinical Pathologist.

I have reviewed materials regarding Iophendylate, Pantopaque, Lafayette Pharmacal, Eastman Kodak Company, Alcon Laboratories, Inc. that have been provided to me for this litigation.

I have conducted my own review of FDA’s database and the U.S. medical literature through the National Library of Medicine’s database to obtain documents pertaining to the use of iophendylate.

I have reviewed all the Iophendylate, Pantopaque and Lafayette Pharmacal, Inc. and Alcon Laboratories, Inc. documents that were available to me within the public database.

Finally, I have reviewed the March 20, 2002 Expert Witness Report of Charles V. Burton, M.D.

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