Prologue

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During 1978-1979, the Plough, Inc. subsidiary of Schering-Plough Corporation sponsored a course on food and drug law at the University of Mississippi Schools of Law and Pharmacy. Michael J. Pietrangelo, the Associate General Counsel of Schering-Plough, and Gary C. Wilkerson, a staff attorney, both of whom lived in Memphis and were responsible for the legal work for Plough, invited me to teach a two-hour session on food labeling to be held on October 4, 1978 at Oxford, Mississippi. I promptly accepted. When Michael asked me to assign reading materials, I immediately consulted the only casebook available at that time   Cases and Materials on Food and Drug Law by Thomas W. Christopher and William W. Goodrich, published by Commerce Clearing House for the Food and Drug Law Institute. The first edition was published in 1966 and the second edition in 1973. Tom had been a Food Law Fellow at New York University Law School (as I had) and was Dean of the University of Alabama School of Law. Bill had been my teacher when I was a Food Law Fellow and was my predecessor as Chief Counsel for the Food and Drug Administration (FDA). I was surprised to discover that what I had done to change food labeling during my tenure as Chief Counsel at FDA from 1971 to 1975 had made the section on food labeling in the Christopher & Goodrich casebook obsolete. There was nothing that I could reasonably assign to a student.

I telephoned my friend, Richard A. Merrill, who by this time had completed his tenure as Chief Counsel for FDA (1975-1977) and was again teaching food and drug law at the University of Virginia. Dick confirmed that the Christopher & Goodrich text was unusable and explained that he taught from photocopied materials that covered only the food and drug aspects of FDA law. I said that this was an inexcusable situation and that the two of us had to prepare a comprehensive current casebook. Without it, food and drug law would continue to be a backwater of legal scholarship and would be taught only in a few law schools where resident professors had a unique interest or local practitioners taught based on their personal work experience. Dick did not disagree with my comment, but expressed substantial skepticism about a casebook. He did, however, send me the syllabus and the photocopied materials for his entire course.

For reasons that I cannot recall today, I was absolutely insistent on carrying through with the casebook project. Although I (and everyone who has been a Food and Drug Law Fellow in the L.L.M. program at New York University Law School) was taught food and drug law beginning with the statutory definitions, proceeding with the jurisdictional element of interstate commerce, and then continuing through the FDA enforcement powers, I readily agreed to Dick's new approach of beginning the casebook with substantive issues  namely, the regulation of food. Thus, I accepted Dick's structure for the casebook, and virtually all of his materials on food and drugs, but wanted to add additional chapters on areas that his materials did not include  animal feed and drugs, biologics and blood products, medical devices, and cosmetics, as well as the relationship of state law to federal law, FDA enforcement powers, and FDA practice and procedure. Because Dick had already spent considerable time and effort preparing his own photocopied materials for a full term course, I agreed to take it from there and to prepare the first draft of a casebook.

As each chapter was completed, I sent it off to Dick, who undertook the editing and had it typed. By mid-1979, we had the complete typescript for a casebook. These materials were photocopied by the Food and Drug Law Institute (FDLI) and used in the existing food and drug law courses during the academic year 1979-1980.

By now, Dick had been selected as Dean of the University of Virginia School of Law. It was obvious from the beginning of this project that, with his academic stature, he should be the person to negotiate publication. The premier law casebook publisher then, as well as now, was Foundation Press, which produced the well-recognized books with blue covers and gold lettering. With surprising ease, Dick obtained agreement from Harold Eriv, President of Foundation Press, and from his Editorial Board, to publish the book.

What I did not know at the time, but learned later, was that Professor David L. Shapiro of Harvard Law School was the Directing Editor of the Editorial Board for Foundation Press. David had graduated from Harvard Law School in 1957, two years before me. He came directly to Covington & Burling, where he was trained by H. Thomas (Tommy) Austern as a food and drug lawyer. That is the reason why, when I arrived at Covington & Burling in the fall of 1960, there was no room for me in the food and drug law practice. It was only in the spring of 1962, when David decided to leave Covington & Burling, first to be a law clerk for Justice John Harlan and then to teach at Harvard Law School, that I began to work as his successor in food and drug law.

David was not just an extraordinarily fine individual, but he had one of the most outstanding academic records in the history of Harvard Law School. David was only the sixth person in the history of the Law School to graduate summa cum laude. Following in his footsteps was therefore a uniquely daunting task.

David later told me that, when the idea of a food and drug law casebook was first discussed with the Editorial Board, he embraced it with an enthusiasm that surprised the Foundation staff. Harold Eriv knew Dick Merrill, of course, but had never heard of me. When David was told that I was one of the two authors, he said that he strongly endorsed my participation. This explains why Harold Eriv reported back to Dick Merrill, with evident surprise, that Dick's co-author was also apparently well-known even though he was not an academician.

I was genuinely excited by the news that Foundation would publish the casebook. In my mind, this was the highest recognition that a casebook can receive. It virtually guaranteed success. All that we had to do now was to produce a superb product.

Dick and I urgently solicited comments from teachers who had used our photocopied manuscript in courses during 1979-1980, but I was disappointed in the response. The materials were so superior to anything else available that we received only general praise and very few helpful suggestions for change. Dick and I worked hard on refining that manuscript, however, and I sent my final suggestions to Dick in mid-summer 1980. Dick did the really difficult work from there, reducing the entire manuscript to the less-than-one-thousand pages demanded by Foundation, sending it for printing, reviewing the page proofs, and sending the corrected versions for final publication. He also took complete responsibility for the Statutory Supplement. The published volume (944 pages) appeared, along with the Statutory Supplement, as if by magic in September 1980, just in time for the fall courses.

It was Dick who suggested the title of the casebook: "Food and Drug Law." From experience, he had learned that casebooks are indexed by the title, not by the subject matter, and it was therefore important for the title to be explicitly descriptive. Thus, although the title was not particularly catchy or provocative, it certainly was functional.

The casebook had exactly the impact that I had hoped it would have. New courses on food and drug law began to appear in law schools throughout the country. People who had never taught the subject before began to consider it, because a comprehensive and current casebook was now available.

Not long after the casebook appeared, friends on the Faculty at Harvard Law School began to suggest that I should consider commuting to Cambridge weekly to teach a food and drug law course during the Fall Term or Spring Term. Professor Christopher F. Edley, Jr. (who had heard me speak on food and drug law issues at the John F. Kennedy School of Government and elsewhere), an expert on administrative law, was the first one to propose this. Professor Elizabeth Bartholet (whom I had helped when she established the Legal Action Center in New York City) urged me to consider it as well. In turn, I attempted to persuade Professor Richard B. Stewart, a Rhodes Scholar who had been trained by Tommy Austern as a food and drug lawyer at Covington & Burling during 1967-1971, to alternate food and drug law with environmental law at Harvard. Dick never took up that suggestion, and later left Harvard Law School in 1989 to serve as the Assistant Attorney General for the Environment and Natural Resources Division in the Department of Justice and then to teach at New York University Law School. Covington & Burling was a training ground for many of Harvard Law School's finest Faculty  Albert M. Sacks (who became Dean), Abram Chayes, and Roger Fisher, as well as David Shapiro and Richard Stewart. Although all were trained by Tommy Austern in food and drug law, none pursued it at Harvard.

It is no secret that I have long had ambivalent feelings about my own three years at Harvard Law School during 1956-1959. I found it to be a cold and impersonal place that did little to foster interest in the practice of law. Most of the professors conducted class with an imperious attitude, pursuing a highly abstract and academic approach to their subject. The professors were remote and intimidating, with the exception of Professor Sacks. It was not easy to get to know much about classmates. I had the feeling when I was there that it was the top law school in the country because of the extraordinary quality of the students, not because of the Faculty, and that the students would excel in later life regardless of where they went to law school. I remember long talks late at night over coffee, with my friend from Kenmore who was at Boston University School of Divinity, John D. Roth, venting my frustration and arguing about how law should really be taught to make it interesting and even exciting. I left Harvard Law School feeling unfulfilled, unsuccessful, and alienated. Nonetheless, these vivid memories did more to entice me to consider teaching food and drug law at Harvard than to discourage me. I was intrigued by the challenge of trying to do it the way I felt it should have been done when I was there.

My response to Chris Edley and Betsy Bartholet, however, was that I simply could not teach once a week, commuting to Cambridge each time. Although my former partner, Michael Boudin, did that for a decade before being elevated first to the District Court in the District of Columbia and then to the First Circuit in Boston, my type of practice seemed incompatible with that schedule. We therefore dropped the matter, although it did continue to come up from time to time.

By 1987, Dick Merrill was pushing me to consider a second edition to the casebook. We had talked about a supplement, but that did not appeal to me. I felt that, if we were going to do anything, we should prepare a comprehensive second edition.

Dick had been Dean for some eight years, during most of which he had not taught food and drug law. My partners at Covington & Burling, Richard Kingham and Ellen Flannery, had stepped in to teach it for him. He was therefore not very current on the most recent developments. I promised to undertake the first draft based on the existing text, as I did previously, if he would again undertake all the editing and publication responsibilities as well as the Statutory Supplement.

To me, this has always represented the perfect partnership. I would never have undertaken the casebook to begin with, or agreed to produce a second edition, without Dick's participation. I have respected and enjoyed him immensely since we first met. His intellectual capacity is enormous, as reflected in his academic credentials  Phi Beta Kappa at Columbia, a Rhodes Scholarship, Editor in Chief of the Columbia Law Review, and a clerkship for Judge Carl McGowan on the United States Court of Appeals for the District of Columbia Circuit. We worked closely together when he was at Covington & Burling during 1965-1969, prior to his leaving for the University of Virginia. I have been genuinely excited to have him return to Covington & Burling in an Of Counsel capacity for the past two years. More important, he is one of the nicest, kindest, most thoughtful persons I have known. It has never occurred to me to work on the casebook with anyone else.

In actuality, I finished a draft of the second edition one year later than I had originally intended. Private law practice is, after all, demanding, and even with working rather extraordinary hours I could not adequately revise the casebook in the two years that I initially projected.

There were several reasons for this. First, I wanted to include in the casebook more "informal" (other than case law) materials, which illustrate the real life development of administrative law in general and food and drug law in particular. Second, I wanted to add two additional chapters, one relating to regulation of carcinogens and the other on the impact of biotechnology on food and drug law. Third, I felt it essential to improve a number of areas that had been included in the first edition, but which I thought could be better presented and analyzed. This meant substantially more work than I had intended, but the ultimate product was worth it. The second edition was unquestionably a major improvement over the first edition. Dick kept up his end of the bargain admirably, and the final book (1,325 pages) and Statutory Supplement were available for the fall of 1991.

At the same time that the second edition of the casebook was being prepared, further consideration was being given within Harvard Law School to the inclusion of some type of food and drug law course. Chris Edley suggested doing the course during Winter Term, rather than in the Fall or Spring Terms. Winter Term did not exist when I was at Harvard. It was created during 1978-1979 to allow second and third year students to take their fall exams just before the Christmas holidays. This left open the entire month of January, before the spring courses began in early February. The Law School decided to offer a variety of courses (e.g., practical clinical practice and negotiation courses) that otherwise would not readily fit into the customary academic schedule, but also to have some regular courses compacted into a one month period. Second and third year students took only one course, attending class each day for three weeks, with the usual examination at the end. When informed about this, I told Chris that it was the type of schedule I could readily fit into my calendar. I was accustomed to blocking out four to six weeks for a vacation during the summer, and there was no reason why I could not also do it during January.

Pressure for a food and drug law course at Harvard was also coming from another source. George M. Burditt, a private practitioner who specialized in food and drug law in his own firm in Chicago, had graduated from Harvard Law School in 1948. During 1988-1990, George was President of the Harvard Law School Association. He used that position to urge Dean Robert C. Clark to consider a food and drug law course and recommended that I teach it. George casually mentioned this to me on a few occasions, but in January 1992, after the second edition of the casebook was published, George wrote me to say that the course was now a real possibility and that the matter was coming down to financial considerations.

George told me that the Law School thought that the cost of a food and drug law course would be about $30,000. I wrote George in February 1992 to say that I was "mystified about your reference to a cost of about $30,000," explaining that I would be willing to consider only a course during Winter Term and that the cost would be minimal, if anything, because I had previously said that I was quite willing to forgo compensation. Armed with that, George pursued the cost issue. In April 1992, the Law School sent him, and he forwarded to me, a justification for the $30,000 figure. I responded in May that the analysis proceeded on "a series of false premises," and stated that I would need "no discretionary allowance, no secretarial support, and no lecturer stipend." All that I would need would be one office for three weeks. George forwarded my letter directly to the Law School, and out of the blue I received a telephone call in early June from Professor Daniel J. Meltzer, the Associate Dean, who offered me the position of Lecturer on Law during Winter Term 1994. I accepted on the spot, and promptly wrote to George Burditt that "miracles never cease."

For the next eighteen months, my contact with Harvard Law School was entirely through Sue Robinson, the Registrar. Sue grew up in my home town of Kenmore, New York (a suburb of Buffalo), and went to school there a year behind me. I cannot begin to describe how helpful she was. She periodically sent me the formal written Harvard Law School Faculty materials, and then waited for my predictable telephone call to give me the informal oral explanation.

By January 1993, I had to begin to make choices. Michael Boudin and Dick Merrill urged me to teach only a two credit (two hours each day) course, but that seemed too short and I therefore decided that I would go for a full three credits (three hours each day). I was accustomed to long working days, and three hours would be quite modest in comparison with my usual schedule. As Sue Robinson explained, moreover, the actual teaching time would be two and a half hours because an "hour" during Winter Term is really only fifty minutes. She also recommended a fifteen minute break approximately half way through the morning. To Sue's delight, I agreed to an "early" course, beginning at 8:30 (which certainly was not early for me). Sue told me this hour was considered hardship duty by both the Faculty and the students. I did take the advice of everyone and agree to a three day take home examination.

When Sue Robinson asked me what classroom I would like to use, however, I simply could not respond. First, many of the classrooms were in new buildings that did not exist when I was there (Griswold Hall and Pound Hall), and thus I had no way of knowing what they were like. Second, I had no way to predict how many students would choose to take food and drug law. Sue and I ultimately agreed to wait until the students handed in their preliminary registration in May, showing at least a preliminary head count for the course.

Then I had to prepare both a course description and a short biographical statement. On these, I consulted with my son and daughter who had recently graduated from Stanford and Duke law schools, Peter and Sarah, and my son who had recently graduated from Yale College, Everett. I kept both of these statements decidedly neutral in tone, but recognizing that food and drug law had never before been taught at Harvard Law School and that the students would know nothing about me, I included in the course description the following sentence that hopefully would appeal to even the most jaded second and third year law student:

"The course covers such contemporary issues as controlling carcinogens, expediting approval of AIDS and cancer drugs, balancing the benefits and risks of breast implants, compassionate use of experimental products, control of such biotechnology techniques as gene therapy, requiring adequate consumer and professional labeling, and the relationship among international, federal, and state regulatory requirements."

If that did not entice a few students, I would be surprised.

I declined to set a limit on the number of students who could take the course. It did not seem likely that a new course with an unknown teacher would attract an unwieldy number of students. In the back of my mind, I imagined about twenty to twenty-five students, but I also thought I could accommodate a few more. I decided to say that administrative law would be desirable but not a prerequisite, because I intended to address large issues rather than technical details. With all that settled, all I could do is await the student response.

The first indication I had that this venture could be successful was when Sue Robinson told me in May 1993 that fifty-four students had chosen the food and drug law course in their preliminary registration. This galvanized me into action. I decided that, since I would be teaching for a month, I should immerse myself completely in the academic world while I was there. I promptly wrote my friend from Yale and Harvard Law School, Charles L. Grimes, whose sister, Arline Heimart, had been Co-Master of Eliot House at Harvard for more than twenty years. Within a few weeks, Kevin P. Van Anglen, the Keeper of the Matthiessen Room in Eliot House, wrote to say that he had booked me in the Matthiessen Room, which is Room C-11 in Eliot House, for the month of January 1994. The cost was $35 per night. This not only assured me of accommodations, but also the opportunity for at least some interchange with the undergraduate Faculty and student body.

Throughout the fall of 1993, I attempted to find a time when I would be in Boston and Sue Robinson would have sufficient free time to answer a number of my questions about details relating to the Winter Term. We talked by telephone periodically, but could not seem to find a mutually convenient time to meet. Finally, I was able to meet with her on the afternoon of December 3, 1993, following a Board of Directors meeting for Oculon in Cambridge earlier that day. She could not have been more pleasant and gracious. She showed me my office (Room 309 in Griswold Hall) and the room in which I would teach (Room 110 in Griswold Hall, just two floors below my office). The office was spacious and full of light. The classroom was the typical law school amphitheater with a capacity of seventy-five, just the right size.

The thing that struck me most on that occasion, however, was not the accommodations. Rather, Sue introduced me, and everyone I met immediately greeted me, as "Professor Hutt." I simply had not thought about that, and was quite unprepared for it. The first time, indeed, I was startled, and almost looked around to see to whom the person was speaking. By the end of two hours, however, I will confess that I rather enjoyed it. When I returned to Covington & Burling later that day, I told my secretary, Beth Vida, that she might wish to consider the new title. Beth thought the suggestion was hilarious, and it ended there.

Beginning in the late summer of 1993, I kept telling myself that I should start to prepare for the course. Everyone at Harvard Law School undoubtedly thought that I had taught the course before, but in fact I had never done so. I had lectured on virtually every aspect of food and drug law on more than five hundred occasions, but that is quite different from teaching a full course. I thus needed to outline the course from beginning to end. As the relentless daily work of private practice and outside activities continued, however, it became apparent that this would never occur. I therefore set aside the entire last week of December 1993, and decided to arrive at Harvard a full week before the first class. This would give me time both to move into Eliot House and my Law School office and also to prepare for the first full week of the course.

For Christmas, I flew to Paris the evening of December 23, spent the next two days with Everett (the only member of the family who could not otherwise be with family for Christmas), and flew back to Washington on December 26. Peter and Gretchen were in Puerto Rico, and the rest of the family were with my Mother in Florida.

When I arrived back at National Airport on the afternoon of December 26, I rented a four door Oldsmobile from National Car Rental. I drove immediately to Covington & Burling, where I packed the things I would need for my Harvard Law School office. This included primarily the handwritten notes of all of my talks on food and drug law during the past twenty years and a few basic reference books. Fortunately (as I will relate later), I also included some standard office supplies. I then packed my clothes in Xerox boxes. Everything fit easily into the trunk and back seat of the car.

On Monday, December 27, I worked hard at Covington & Burling to finish all of the projects I could and to delegate to others the ones that remained. By 6:00, I had completed everything that I could do there. I therefore drove the 250 miles to New York City, arriving at 10:00. I spent the night there, rather than trying to drive on to Boston, in order to break up the long drive.

I was up early in the morning, at 7:00, and on my way. Everett had told me to take Interstate Route 91 from New Haven to Hartford, Interstate Route 84 from Hartford to the Massachusetts Turnpike, and then the Massachusetts Turnpike to Cambridge. It proved to be very good advice, and the two hundred mile trip went quickly. I arrived at Eliot House at 10:30. I immediately embarked upon what I hoped would be, and what in fact became, an extremely stimulating and rewarding academic adventure.

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