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Counterclaim Defendant, Case No UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION NESTLÉ PURINA PETCARE COMPANY, Plaintiff/ Counterclaim Defendant, Case No. 4:14-cv-859-RWS v. BLUE BUFFALO COMPANY LTD., Defendant/ Counterclaim Plaintiff. DECLARATION OF VINAYAK P. DRAVID, PH.D. I have been retained by Blue Buffalo Company Ltd. (“Blue Buffalo”) and have been asked to provide a preliminary opinion about the scientific adequacy and reliability of the conclusions set forth in the Expert Report of James V. Makowski dated July 23, 2014 (PUR_000207-52), (“Makowski Report”). In his Report, Dr. Makowski, purports to reach definitive quantitative conclusions about the compositions of various Blue Buffalo products based solely on visual observations of the products using rudimentary optical microscopy. Briefly, Dr. Makowski obtained various product samples directly from Nestlé Purina. Dr. Makowski then examined the processed samples under a low-power light microscope, with very limited capabilities. Dr. Makowski purported to identify ingredients based solely on a subjective, visual comparison of what he observed to “a reference library of known ingredients” – though his Report fails to identify the reference library and validate its utility. Dr. Makowski made no effort to document what features he saw that led to a particular identification (save for four low quality, scale-less photographs, three of which were from a single sample). In other words, he apparently made these identifications based on 7271442v.1 gut feeling. Similarly, Dr. Makowski purported to quantify the amount of ingredients he identified through a “visual estimate,” though his Report and supporting laboratory notebook fail to set forth any methodology for arriving at such numbers. Furthermore, for some particles – he does not say which – Dr. Makowski apparently required a higher-powered microscope to make the identification, though again he did not document any of the characteristics or features that led to any particular identification. Thus, the Makowski Report reflects the use of an inadequate apparatus, an inappropriate methodology and insufficient sampling of the heterogeneous (i.e. comprised of different kinds of parts) and complex mixture in pet foods to arrive at unbelievably definitive and quantitative assertions of their composition, at a level of accuracy and precision that is inconsistent with the scientific approach. In sum, and as set forth in more detail below, Dr. Makowski’s methods raise serious questions about the accuracy, reliability, and overall validity of his conclusions. Furthermore, because his Report lacks critical supporting information, it fails to provide the basis for his conclusions. I. BACKGROUND AND QUALIFICATIONS 1. I am currently the Abraham Harris Chaired Professor in the Department of Materials Science and Engineering in the McCormick School of Engineering and Applied Science at Northwestern University. I am also the founding Director of the NUANCE (Northwestern University Atomic-and-Nanoscale Characterization Experimental) Center (since 2001), the founding Director of the Global McCormick Initiative (since 2012), and the founding Director of the Electron Probe Instrumentation Center (since 1995). 2. I received my Bachelor’s degree in Metallurgical Engineering in 1984 from the Indian Institute of Technology in Bombay, India. I performed my doctoral research work in 2 7271442v.1 Materials Science and Engineering at Lehigh University, receiving my Ph.D. in 1990. I began my career at Northwestern in 1990 as an Assistant Professor, was promoted to Associate Professor in 1995, and was promoted to full Professor in 2000. 3. I maintain an active research program investigating nanoscale phenomena in materials. As such, I have extensive experience spanning about 25 years in the development and application of microscopic and spectroscopic techniques to the identification and characterization of a wide range of materials and associated phenomena. My research encompasses the use of microscopy and analytical tools and techniques applied to hard materials (e.g., metals, ceramics, and semiconductors), soft materials (e.g., biological, polymeric, and food-related products), and soft-hard interfaces (where hard structures and soft materials are in intimate contact). 4. In my career hitherto, I have published over 380 papers in peer-reviewed academic journals, I am a named inventor on 21 issued or pending patents, and I have given nearly 300 talks or presentations about my research, primarily related to microscopy and analysis. My publications have been cited over 12,000 times and my so-called H (Hirsch) index is more than 50, which is considered to be exceptionally noteworthy, indicating that my scholarly activities and contributions are considered world-class and peer accepted for a sustained duration. 5. In my capacity as director of the NUANCE Center, I conceived of and implemented a center that provides multi-faceted and integrated tools to analyze atomic and nanoscale particles, including electron, ion and photon-based microscopy and scanned probe capabilities. I oversee all aspects of NUANCE, ranging from instrument acquisition to training and education of internal students and researchers as well as external industry and academic users in microscopy and analysis. I am responsible for instrument acquisition, implementation, 3 7271442v.1 development of training and usage protocols, upkeep and sustained high-impact use of various instruments and techniques in NUANCE. I supervise an administrative staff of three and a technical staff of over ten, including eight Ph.D. staff scientists. The NUANCE center has over 700 student and researcher users and over 100 faculty affiliates, spanning diverse technical departments and themes. 6. My teaching and education activities also make use of my expertise and experience in microscopy of materials. I have been teaching classroom and hands-on laboratory- intensive microscopy courses for almost 25 years to undergraduate and graduate students with diverse backgrounds and training. Over 1500 students have undergone training and supervision under my tutelage related to all aspects of microscopy and analysis, ranging from complex specimen preparation to quantitative data analysis. I have conceived, developed and implemented several “short-course” modules for education and training of students and researchers from diverse backgrounds. These include, for example, Nano Bootcamp, a series of lectures and demonstrations offered under the auspices of the American Society of Mechanical Engineers (ASME). I have also delivered lectures, seminars and short-courses related to microscopy and analysis to external agencies and professional societies, such as, among others, National Institutes of Health (NIH) and Federal Drug Administration (FDA). 7. I have consulted and advised industries and both academic and non-profit institutions related to microscopy, analysis and nanotechnology. Some of my consulting work is specifically related to biology/polymers (DNA, proteins, peptides, cells/tissues), natural food (plants/leaves, fruits), processed foods and food products (cheese, wine, ice-creams) and other materials which require use of microscopy and analysis to understand their hierarchical length- scale architecture (microstructure), such as chewing gums and soft-hard drug delivery systems 4 7271442v.1 (drug eluting stents). This work has required sample preparation, microscopy and analysis analogous to feed microscopy. 8. I serve as an Editor of Microscopy & Microanalysis, the flagship journal of the Microscopy Society of America, the oldest professional society for microscopy in the U.S. As an Editor of Microscopy & Microanalysis, I manage the complete peer review process, mediate interactive discourse between anonymous reviewers and authors, as well as employ editorial discretion for over 90 technical manuscripts related to microscopy and analysis submitted to the journal every year. My role was diversified in recent years to cater to correlative and emerging microscopy applications, including the scientific discipline encompassing the microscopy of food, agricultural products and related “soft” matter. Since 1995, I have been a member of the Editorial Board of the Journal of Microscopy, a 175-year old peer-reviewed scientific journal published by the Royal Microscopical Society. Recently, I also joined the Editorial Board of Current Opinion in Solid State & Materials Science, a journal devoted to publishing a series of reviews covering recent and important developments in the field of materials science. In these various roles, I am responsible for reviewing articles submitted for publication, taking into consideration comments from reviewers, and making judgments about the scientific acceptability of the work reported. 9. I have received numerous awards for my research, education and outreach efforts and achievements related to microscopy, analysis and materials science. I was elected Fellow of Microscopy Society of America, in its inception class, for pioneering contributions to applications of microscopy in materials science, and received the Burton Medal from the Microscopy Society of America, given to a researcher under 40 to honor his or her distinguished contributions to the field of microscopy and microanalysis. My other professional society 5 7271442v.1 fellowships (American Ceramic Society, Materials Research Society, and the American Association for the Advancement of Science) represent primarily my research, education
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