The Elizabeth Birt Center for Autism Law and Advocacy (EBCALA)

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The Elizabeth Birt Center for Autism Law and Advocacy (EBCALA) The mission of the Elizabeth Birt Center for Autism Law and Advocacy is to address the immediate and ongoing legal and advocacy needs of the autism community. The Center seeks to provide: • Legal education on autism issues • Resources for legal practitioners and advocates • A “think tank” to strategize about the legal and advocacy needs of the autism community Autism affects children, parents and their communities with medical, legal, social and educational challenges. Serious unmet needs often begin before a formal diagnosis and extend throughout the lives of the affected individuals, families and communities. Government leaders and agencies have failed to explore and identify autism’s causes, at-risk populations, and impact. Using legal and advocacy tools, the Center seeks to identify and address these systemic failures and to achieve greater justice for the injured and their communities. Specifically, the Center seeks to educate lawyers, parent advocates and others in state-of-the-art legal and medical aspects of autism. Leading attorneys, scientists and advocates will review the most current and critical issues affecting the autism community at periodic conferences. The Center also seeks to make resources available to assist lawyers and advocates in their work on autism. Over time, we expect to offer a referral service and facilitate pro bono legal services for the autism community. The think tank will work to map new legal and advocacy strategies to meet the challenges of autism. It will identify and promote practical tools and techniques, develop original legal approaches, partner with existing organizations, produce legal guides, cultivate broader participation, and work to improve the Center.
Purposes of EBCALA (summary): To create an impact litigation organization (1) to realize the rights of people with autism and neurological disorders; (2) to recognize the internationally recognized right to informed consent in medical decision making, including vaccination; and [(3) to hold accountable actors who may have knowingly or recklessly contributed to the autism epidemic]
To create a legal defense organization for individuals and parents coping with autism and similar neurological disorders o These needs include: Referrals to lawyers for cases dealing with • child protective services and child removal; • special education; • vaccination exemptions;

vaccination injury.
To provide legal education on autism issues, including an annual conference for lawyers and advocates on “autism law and advocacy” and a “think tank” for strategic planning
Recent Achievements: Launched two-day continuing legal education (CLE) conference in May 2009 at the AutismOne event; had cutting edge legal and advocacy speakers; hosted approximately 100 attendees from all over the US Initiated “Vaccine Court Transparency Project” with Pace University Law School Drafted an amicus brief to the U.S. Supreme Court for 11 organizations and 3 parent advocates in Bruesewitz v. Wyeth on whether individuals have the right to bring vaccine design defect claims to civil court Currently drafting an amicus brief to the Federal Circuit in Cedillo v. HHS Board members spoke at the National Vaccine Information Center conference in October 2009 in Washington, D.C. on law and advocacy Board members published articles and blogs, held rallies, spoke on television and radio on vaccination choice and autism law Board members gave testimony to the New York State Assembly in response to the New York State Health Commissioner’s regulation to force all healthcare workers to annually receive the seasonal flu and H1N1 vaccines
Coming: • Articles on informed consent and vaccination of children and op-eds • Description of some previous educational and advocacy work; alerts on autism • EBCALA Legal Training 2010 Resources (links coming):
Elizabeth Birt (1956 - 2005) was one of the earlier advocates who helped shape what would become a community of parent activists committed to finding truth and securing justice for their children. Liz was an attorney, a co-founder of SafeMinds, a founding member of the National Autism Association, a co-founder of A-CHAMP, and a principal author of Mercury in Medicine, the 2003 report by the House Government Reform Committee that found mercury in vaccines was toxic. Liz was a mom. In 1996 Liz’s son, Matthew, then 15-months old, was diagnosed with autism. Liz spent the rest of her life helping her son and other affected children and families. Read more about how Liz’s life here. The Birt Center is founded in her honor to continue her work.
Robert Krakow, Esq.
is an attorney in private practice in New York. Bob started his legal career with the New York Public Interest Research Group, a consumer advocacy organization. For nine years in the 1980s Bob was a prosecutor with the New York County (Manhattan) District Attorney's office, serving as Bureau Chief of the special narcotics prosecution division. He founded his law firm in 1989, focusing on the trial of civil and criminal cases, and specializing in the representation of individuals injured by exposure to vaccines. Bob represents families of children with autism in a variety of venues, including insurance coverage disputes, vaccine exemption issues, IDEA education disputes with school districts, and claims of educational and medical neglect.
Mary Holland, Esq.
is Director of the Graduate Legal Skills Program at New York University School of Law. Educated at Harvard and Columbia Universities, Mary has been an advocate in the public and private sectors. Prior to joining NYU, she worked for six years at major U.S. law firms, with three years based in Moscow, Russia. Before that, she directed the European Program of the Lawyers Committee for Human Rights (now Human Rights First). After graduating law school, she clerked for a federal district court judge in New York City. She researches and writes on legal issues related to autism and vaccines and consults to the Aspen Institute Justice and Society Program.
Jennifer Keefe, Esq.
is a trial lawyer for a major national law firm who has been nominated by her peers four years in a row as one of Texas' Rising Stars in Texas Monthly Magazine (2006, 2007, 2008 & 2009). She assists clients in a wide range of business litigation, including patent infringement-related suits, financial institution disputes, and traditional oil and gas problems. Ms. Keefe has received several awards for her pro bono activities which have ranged from defending asylum cases before the U.S. Immigration courts for Human Rights Initiative of North Texas to advising on the steering committee for both BRAINS for Autism at the University of Texas Southwestern and the Elizabeth Birt Center for Autism Law and Advocacy. She received her undergraduate degree from Vanderbilt University and law degree from Southern Methodist University Dedman School of Law.
Jim Moody, Esq.
practices public interest law in Washington, specializing in whistleblowers, constitutional law, deregulatory reform and policy, national security, and the promotion of government policies designed to promote liberty and accountability. Born in Kansas City, he is a graduate of the Massachusetts Institute of Technology (artificial intelligence and management) and Georgetown Law School. He is a Director of SafeMinds and the National Autism Association, was one of the coordinators for the Combating Autism Act, supports the Petitioners’ Steering Committee for cases in the U.S. Court of Federal Claims, and is committed to the goals of justice for vaccine-injured children, research to find the cause, prevention, and treatment for autism, accountability, and institutional reform.
Ed Arranga
is the father of two beautiful boys, Jarad and Ian. He co-founded AutismOne in 2002 to help facilitate greater awareness and education about the potential causes of autism and the most promising treatments. Ed is a decade-long delayed graduate of Texas A&M University, taking time off to serve in the Coast Guard and study philosophy. He has taught at UCLA and Cal State
University, Long Beach schools of continuing education. He is the author of a book and numerous articles on software. While pursuing a graduate degree at SMU in software engineering his son was diagnosed with autism. Inspired by Dr. Rimland and others, Ed works to advance their message of hope and recovery.
TRAINING 2009 Program
The Elizabeth Birt Center for Autism Law & Advocacy Training Program at AutismOne 2009 (2010 program coming soon). Thursday, May 21, 2009 1:30 - 1:45 : Introduction - Robert Krakow, Esq. / Jim Moody, Esq. 1:45 - 2:45 : The Science of Autism - Martha Herbert, MD, PhD 3:00 - 4:00 : Vaccine Court: An Opaque Present, A Questionable Future - Renee Gentry, Esq. 4:15 - 5:15 : Autism Omnibus Proceedings - Tom Powers, Esq. 5:30 - 6:30 : Law and the Court of Public Opinion - Andrew Wakefield, MD & William Long, PhD Friday, May 22, 2009 9:00 - 10:00 : Parents' Rights in the Autism Epidemic - Mary Holland, Esq. 10:15 - 11:15 : Special Education Law - Tim Adams, Esq. & Lynne Arnold 11:30 - 12:30 : Legislation, Advocacy and Action in Autism - Barbara Loe Fisher & Rick Rollens 12:30 - 1:30 : Lunch 1:30 - 2:30 : Perfecting Private Insurance Coverage for Autism - Chris Angelo, Esq. 2:45 - 3:45 : Dangerous Profession: Practicing Alternative Medicine in the 21st Century - Michael Ruggio, Esq. 4:00 - 4:30 : Vaccineography 101: The Evolution & Ethical Considerations in the U.S. Vaccine Approval Process , Jennifer Keefe, Esq. 4:45 - 5:45 : Panel discussion
Sunday, May 24, 2009 9:00 - 10:00 : Autism and Vaccines in the US Omnibus Hearings: Legal and Gastrointestinal Perspectives of the Michelle Cedillo Case, Arthur Krigsman, MD & Sylvia Chin-Caplan, Esq.
BIOS & ABSTRACTS Timothy A. Adams, Esq. received his Bachelor’s degree from the University of California, Irvine and his Juris Doctorate degree from Pepperdine University School of Law. He has served as an adjunct professor and Associate Director of the Special Education Advocacy Clinic, Pepperdine University School of Law. He is actively involved in educating parents through presentations to disability rights organizations and parent support groups including speaker at Autism One (2005-2008), the National Autism Association (2005 and 2007-2008) and the National Epilepsy Foundation Annual Conference (2001). He has been interviewed and quoted in publications including the Daily Journal (2001), the Orange County Register and the nationally published magazine Parenting (March 2003). He is Chief Executive Officer of Adams & Associates. Lynne Arnold is the chapter director for Talk About Curing Autism (TACA) of Visalia, CA and an Autism One parent mentor. Through conference presentations and mentoring, she helps parents to understand their child's rights to appropriate interventions and education. Lynne is the editor of Autism: Asserting Your Child's Rights to a Special Education by David A. Sherman. She has presented at Autism One (2005-2008), National Autism Association Conference (2005 and 2007-2008), Families for Effective Autism Treatment (FEAT), Autism Society of America and for other autism groups. Special Education Law, Tim Adams, Esq. & Lynne Arnold is a unique and complex area of the law. Attorneys and advocates who are new to special education law are often confounded by the lack of specificity in the Individuals with Disabilities Education Act (IDEA). California attorney Tim Adams, and TACA parent and volunteer advocate Lynne Arnold will discuss how to overcome obstacles presented by gray areas in the law by focusing on a strategic approach to addressing the IEP process. This training session is designed to sharpen the advocacy skills of those who are already familiar with the basics of IDEA. Christopher E. Angelo, Esq.
Christopher E. Angelo is a consumer contingency fee trial attorney representing those catastrophically injured by insurance companies, defective product manufacturers, defectively constructed buildings and other corporate malfeasance. Mr. Angelo has prosecuted and established pro-consumer legal precedents that have received national attention in areas affecting healthcare, biotechnology, environmental clean-up and insurance. He is also the proud father of an 18-year-old son with autism. After his son was diagnosed in 1994, Mr. Angelo proposed a mental health parity state mandate to overrule all “mental and nervous disorder” exclusions in California health plans. With the help of UCLA, this state mandate ultimately became known as AB88 and is now the most progressive autism state mandate in the nation. Mr. Angelo has spoken throughout California and other states on how parents and professionals can perfect medically necessary major medical coverage for autism under their private healthcare plans. Perfecting Private Insurance Coverage for Autism Christopher E. Angelo will speak about how parents and professionals can use insurance laws common throughout the nation in perfecting major medical coverages for autism. He will also speak on the benefits of state autism mandates and how other states can use California’s Mental Health Parity State Statute as a template for grass roots movements. Lastly, he will speak about how parents can use state law to overcome negative anti-consumer federal law. Barbara Loe Fisher is co-founder & president of the National Vaccine Information Center (, a nonprofit founded in 1982 by parents of vaccine injured children. She is the co-author of the seminal 1985 book "DPT: A Shot in the Dark" and author of the 1998 book "Vaccines, Autism & Chronic Inflammation: The New Epidemic." She is a blogger and editor of the NVIC E-newsletter. She has served on the National Vaccine Advisory Committee; Institute of Medicine Vaccine Safety Forum; FDA Vaccines & Related Biological Products Advisory Committee; Vaccine Policy Analysis Collaborative and Consumers United for Evidence-Based Healthcare - Cochrane Collaboration (US). The mother of three, including a son who suffered a brain inflammation after his fourth DPT shot in 1980 and was left with multiple learning disabilities, she has defined the grassroots vaccine safety and informed consent movement for the past quarter century in the media, in state legislatures, Congress and in many other public forums. Rick Rollens is a co-founder of the M.I.N.D. Institute (Medical Investigation of Neurodevelopmental Disorders) at UC Davis Health System, a Sacramento lobbyist and former secretary of the California Senate who is devoted to improving the lives of children with autism. He is a devoted father of Russell, who was diagnosed with autism at 20 months of age. Rollens assisted in raising over $70 million dollars to fund research efforts aimed at finding the causes and treatments for autism spectrum disorders, was instrumental in the founding of Families for Early Autism Treatment (FEAT) and is also a former board member of the Autism Society of America. Legislation, Advocacy and Action in Autism, Barbara Loe Fisher & Rick Rollens Rick Rollens and Barbara Loe Fisher, who have worked together since the 1990's to educate the public and legislators about vaccine associated autism, will put the last decade of autism and vaccine safety advocacy into historical perspective. Rick, a father with a vaccine injured son with autism and Barbara, a mother whose son was left with learning disabilities after a neurological reaction to his fourth DPT shot, talk about their experiences working in Congress and state legislatures, with the media and with families to raise awareness about vaccine risks and protect the legal right for all to make informed, voluntary vaccine choices. Renée J. Gentry, Esq. joined Shoemaker & Associates in October 2001. She received her Juris Doctorate from Washington University Law School in 1995, and a Bachelor of Arts in Political Science/History from Drake University in 1992. She is licensed to practice law in the District of Columbia, and is admitted to the Federal Claims Court Bar. At Shoemaker & Associates she specializes in damages and appellate work in the National Vaccine Injury Compensation Program. Vaccine Court: An Opaque Present, A Questionable Future, Renée J. Gentry, Esq. Ms. Gentry will present an overview of the evolution of the National Vaccine Injury Compensation Program (NVICP), from its origins to the present including a statistical breakout of the Program so far. The overview will include a review of the statutory and administrative changes to the Program, specifically the changes to the Vaccine Injury Table, which vaccines and injuries are covered. The changing burden of proof will also be reviewed. Finally, Renée will give an overview of the life of a case filed in the Vaccine Court from beginning to end.
Martha Herbert, MD, PhD is an assistant professor of neurology at Harvard Medical School, a pediatric neurologist at the Massachusetts General Hospital in Boston, a member of the MGH Center for Morphometric Analysis, and an affiliate of the Harvard-MIT-MGH Martinos Center for Biomedical Imaging. She is director of the TRANSCEND Research Program (Treatment Research and Neuroscience Evaluation of Neurodevelopmental Disorders), which utilizes multimodal imaging techniques including MRI, EEG and MEG and is particularly aimed toward using imaging in coordination with clinical observation, metabolic biomarkers and animal studies in shedding light on the physiological level of changes in autism and other neurodevelopmental disorders, and on potential domains of plasticity and targets for intervention. Dr. Herbert earned her medical degree at the Columbia University College of Physicians and Surgeons. Prior to her medical training she obtained a doctoral degree at the University of California, Santa Cruz, studying evolution and development of learning processes in biology and culture in the History of Consciousness program. She then did postdoctoral work in the philosophy and history of science. She trained in pediatrics at Cornell University Medical Center and in neurology and child neurology at the Massachusetts General Hospital. Dr. Herbert received the first Cure Autism Now Innovator Award. She is the co-chair of the Environmental Health Advisory Board of the Autism Society of America and directs their Treatment Guided Research Initiative, is on the Scientific Advisory Committee of Autism Speaks and is a co-PI of the ATN site at the Massachusetts General Hospital. Her research program includes studying what makes some autistic brains unusually large, how the parts of the brain are connected and coordinated with each other, and how we can develop measures sensitive to changes in brain function that could result from treatment interventions. She is also pursuing multisystem prospective at-risk infant sibling research to monitor medical and physiological development in parallel with behavioral development. The Science of Autism: Martha Herbert, MD, PhD The diagnostic entity “autism” is currently formally defined by set of behavioral criteria determined by a committee of specialists and published in DSM-IV, Diagnostic and Statistical Manual, by the American Psychiatric Association. The behavioral definition of autism has been turned into a model of the biology of autism which presumes that there are alterations in brain modules that govern behavioral domains altered in autism, and that these alterations are caused by genes. However, the phenomena and experiences of “autism” go far beyond what is included in the formal “autism” diagnostic criteria. Medically, these include a range of nervous system changes that go beyond the behavioral domain (such as sensory processing alterations, sleep disturbances and seizures), symptoms in other organ systems (prominently gastrointestinal and immune systems) and systemic metabolic alterations (such as in mitochondria/energy metabolism and methylation pathways). As scientific evidence and clinical experience accumulate, it is becoming apparent that autism is not simply a so-called “static encephalopathy” (i.e. fixed state of brain dysfunction) that results from permanent pre-natal brain alterations, but an ongoing and active state of physiological altered regulation. Phenomena such as transient significant improvement during fever and in association with various other physical influences (such as staying off solid foods prior to surgical procedures or taking certain anti-inflammatory medications or antibiotics), as well as loss of diagnosis by some children after intensive interventions, are not totally consistent with autism being nothing more than a permanent, hard-wired brain injury. Reframing autism as a dynamic (not static) encephalopathy that is a consequence of a chronic active set of pathophysiological processes that begin prenatally or early in life is more consistent with emerging understanding. It also opens doors for treatment and for research strategies that will lead to optimized and innovate treatments more quickly. The thinking behind this talk is laid out much more extensively in the following in-press article: Autism: The Centrality of Active Pathophysiology and the Shift from Static to Chronic Dynamic Encephalopathy Martha R. Herbert, MD, PhD To appear in Autism: Oxidative stress, inflammation and immune abnormalities. Chauhan A, Chauhan V, Brown T, eds., in press, 2009, Taylor & Francis/CRC Press. PAPER ABSTRACT The purpose of this chapter is to reflect upon the implications of the identification of active pathophysiological processes in autism spectrum disorders (ASD), and to reflect back upon prior findings and formulations in the light of these recent discoveries. The chapter articulates challenges posed by these discoveries to deeply held assumptions about ASD. These assumptions are embodied in a classical model framing ASD as a problem of genes, brain and behavior – i.e., as a genetically determined developmental disorder of the brain whose main manifestation is behavioral alterations based upon an indelible static encephalopathy; this model would not have predicted the growing documentation of pathophysiological disturbances. The chapter describes an emerging pathophysiology-centered model of autism that can subsume genes, brain and behavior but also includes much more. Prior findings and models are re-evaluated to support the framing of ASD as 1) not only developmental but also a chronic condition based on active pathophysiology, 2) not only behavioral but also having somatic and systemic features that are not secondary but rather intrinsic consequences of underlying mechanisms, 3) not only genetic
but also environmental, 4) not a static encephalopathy but a dynamic, recalcitrant encephalopathy, and 5) not a set of discrete behavioral features neatly mapping to specific genetic mechanisms but a set of emergent properties dynamically arising from pathophysiological systems whose parameters have been dramatically and interactively perturbed. It is argued that a research program based upon this approach will incorporate the strengths of the classical model, will encourage many more routes to investigations with practical and treatment applications, and may be a much more rapid path to providing much needed help to affected individuals and their families. Mary Holland, Esq. is Director of the Graduate Legal Skills Program at New York University School of Law. Educated at Harvard and Columbia Universities, Mary has been an advocate in the public and private sectors. Prior to joining NYU, she worked for six years at major U.S. law firms, with three years based in Moscow, Russia. Before that, she directed the European Program of the Lawyers Committee for Human Rights (now Human Rights First). After graduating law school, she clerked for a federal district court judge in New York City. She researches and writes on legal issues related to autism and vaccines and consults to the Aspen Institute Justice and Society Program. Parents' Rights in the Autism Epidemic, Mary Holland, Esq. This talk will give a broad overview of parents' rights to decide medical, educational, custodial, religious and other issues for their children, and the challenges that the autism epidemic presents for parents and other guardians. It will first look at the history of parents' rights in this country and then at how the courts have both protected, and assaulted, these rights. We will examine the parental decisions most at issue in autism - decisions on vaccination, traditional and non-traditional medical treatments, educational interventions and custody - and discuss how to advocate most effectively for parents' rights. Jennifer Keefe, Esq. is a trial lawyer for a major national law firm who has been nominated by her peers four years in a row as one of Texas' Rising Stars in Texas Monthly Magazine (2006, 2007, 2008 & 2009). She assists clients in a wide range of business litigation, including patent infringement-related suits, financial institution disputes, and traditional oil and gas problems. Ms. Keefe has received several awards for her pro bono activities which have ranged from defending asylum cases before the U.S. Immigration courts for Human Rights Initiative of North Texas to advising on the steering committee for both BRAINS for Autism at the University of Texas Southwestern and the Elizabeth Birt Center for Autism Law and Advocacy. She received her undergraduate degree from Vanderbilt University and law degree from Southern Methodist University Dedman School of Law. Vaccineography 101: The Evolution & Ethical Considerations in the U.S. Vaccine Approval Process, Jennifer Keefe, Esq. The presentation will cover the history of vaccine approvals in the U.S. government and the conflicts of interest that exist in the process. The presentation will begin with the controversial cowpox vaccine that was developed in 1799 and the ethical red flags that were immediately raised with the doctor who developed the vaccine. This historic example will be contrasted with the modern day rotovirus vaccine to demonstrate that the same ethical dilemmas surround the vaccine approval process today as did in the early 19th century. The presentation will also include a semi-coherent mapping of the framework of various agencies and committees (CDC, NIH, IOM, FDA, HHS, DOJ, ACIP), along with the relevant statutory provisions, related to decision-making on new vaccines. Finally, the presentation will include the ethical considerations for a collective immunization program. Arthur Krigsman, MD is a pediatrician and board certified pediatric gastroenterologist and is an assistant professor of pediatrics at New York University School of Medicine in New York. He is the director of gastrointestinal services at Thoughtful House Center for Chidren in Austin, Texas, where his time is divided between clinical care of autistic gastrointestinal disease and clinical research exploring the nature of this gastrointestinal pathology in autistic children. A New York based satellite practice, located in Lawrence, New York, services an identical group of affected children living in the Northeast. Dr. Krigsman has evaluated and treated over 600 children suffering from autism and a variety of gastrointestinal problems and has presented his findings at scientific meetings in the United States and abroad. He has testified at a Congressional hearing dealing with autism and its possible causes, and, more recently, testified regarding the gastrointestinal disease of plaintiff Michelle Cedillo in the U.S. Omnibus Autism Proceeding. Sylvia Chin-Caplan, Esq is a 1984 graduate of Boston College Law School and has an undergraduate degree from Northeastern University's College of Nursing in Boston. Sylvia is admitted to the Supreme Judicial Court for the Commonwealth of Massachusetts, the U.S. District Court for the District of Massachusetts, U.S. Court of Appeals for the First Circuit and the U.S. Court of Federal Claims. Autism and Vaccines in the US Omnibus Hearings: Legal and Gastrointestinal Perspectives of the Michelle Cedillo Case,
Arthur Krigsman, MD & Sylvia Chin-Caplan, Esq. In this two-part discussion, Sylvia Chin-Caplan Esq. will review the legal process surrounding claims of vaccine induced injury in the US court system. Topics to be addressed include the role of vaccine court in the US justice system, class action vs. filing outside the class, burden of proof, and examples of previous awards and the appeal process. Specific legal arguments presented to the court in the Michelle Cedillo case will be presented along with a review of the decision. Following this, Arthur Krigsman MD will discuss the medical facts considered by the court in determining whether Michelle Cedillo suffered from symptoms of bowel inflammation, highlighting critical items omitted by the court in its decision. Tom Powers, Esq. is a partner in the Portland, Oregon law firm Williams Love O'Leary & Powers. He represents people seriously injured by dangerously defective pharmacuetical products and medical devices, as well as handling individual catastrophic injury and death cases. He has worked on national "mass-tort" litigations including Rezulin, PPA, PPH, hormone therapy, asbestos, and pain-pumps. As a leader of the Petitioners’ Steering Committee pursuing autism and other injury claims in the National Vaccine Injury Compensation Program, Tom coordinates discovery efforts on behalf of nearly 5,000 thimerosal-injured children seeking compensation in the U.S. Court of Federal Claims. Tom participated in two of the 2007 "Theory One" test case trials in the Omnibus Autism Proceeding, involving thimerosal exposure and the MMR vaccine leading to autism. Tom and his partner Mike Williams were lead trial counsel in all three of the "Theory Two" test cases in the OAP heard in 2008, involving thimerosal exposure and autistic regression. He is co-chair of the Legislative Committee of the Oregon Trial Lawyers Association (OTLA), serves on the Executive Committee of the Oregon State Bar's Products Liability Section, and is a member of the American Association for Justice, Trial Lawyers for Public Justice, and the Multnomah Bar Association. He is on the board of directors of the OTLA PAC and the Oregon League of Conservation Voters. Several of Tom's articles have appeared in bar and professional and publications, and he regularly makes presentations at CLE seminars and professional association meetings. Tom is admitted to practice in Oregon, Washington State, the US Court of Federal Claims, and is admitted pro hac vice in state and federal courts around the country. Autism Omnibus Proceedings, Tom Powers, Esq. The "Omnibus Autism Proceeding," or OAP, was created in July 2002 to manage the approximately 5000 autism claims in the Vaccine Court program, and in particular to provide a mechanism for presenting evidence of "general causation" relating these claims to either thimerosal exposure or the MMR vaccine, or a combination of the MMR and thimerosal exposures. This presentation will: 1) review the history of the proceedings, with an emphasis on critical decisions in the discovery process that effected the presentation of the cases; 2) describe the "test case" procedures ordered by the special masters to address issues of general causation; 3) summarize the evidence presented in the two rounds of test case hearings in 2007 and 2008; 3) analyze the decisions of the special masters denying compensation in the first round of thimerosal/MMR combined exposure test cases; 4) provide an update on the status of the thimerosal test cases heard in 2008 and not yet adjudicated; 5) address statute of limitations issues in the OAP; 6) discuss attorney fee and cost petitions in these cases; and 7) talk about where the OAP goes from here. Michael F. Ruggio, Esq. has extensive litigation experience in representation of CAM associations, individual hospitals and physician practices that focus on integrative treatments and products. He has successfully expanded the laws in several states through his vigorous litigation in this area to open medical boards and medical educational institutions to this evolving area of health care. Mr. Ruggio has represented many large and small dietary supplement companies before the Federal Trade Commission and the Food and Drug Administration on many regulatory and litigation matters, including DESHA. One of his cases involved one of the largest FTC actions against dietary supplement producers, U.S. v QVC, Inc. (2001) Garden State Nutritionals, Nutrition 21 and their spokespeople on QVC. Other matters include defense of products against aggressive FDA and FTC actions involving producers and distributors. He has also been involved in numerous pharmaceutical, e-health technology, and bio-health cases concerning average wholesale pricing issues, reimbursement fraud, medical necessity and other related matters. He represents numerous large and mid-size integrative medicine groups and many integrative and health freedom trade associations. He is outside general counsel for the American Association of Health Freedom and Optimal Health, P.C. He was lead trial counsel in the largest Medicare and Medicaid health care carrier case in the U.S., and recovered damages of $144 million for the Federal Insurance Fund and has subsequently used this experience to defend numerous hospitals on Medicare and Medicaid issues. As Special Assistant U.S. Attorney, Mr. Ruggio assisted in the investigation and plea negotiation in one of the largest medical device fraud cases in the state of Virginia. He also has experience in affirmative defense fraud litigation and civil suits. Mr. Ruggio is the recipient of many awards by the Department of Justice, including the Attorney General’s award for outstanding work in the U.S. vs. HCSC case.
He focuses his practice on both health care and civil litigation, with an emphasis on pharmaceutical clinical trials; average wholesale pricing and compounding pharmacies in addition to health freedoms, institutional and physician integrative or complementary and alternative medicine and medicine representation, health care fraud and abuse and white-collar. Dangerous Profession: Practicing Alternative Medicine in the 21st Century - Michael Ruggio, Esq. Based on case studies Mr. Ruggio presents a powerful indictment of a mainstream medicine unresponsive to change and prone to litigation. But, in spite of the intimidation factor, Americans are flocking to complementary, alternative and integrative practices, which provide a variety of interventions for treating autism. Mr. Ruggio discusses many of the most important issues including the increasing evidence of vaccine causation of autism, health freedoms, the bias of the vaccine court, and what the future holds in store. Andrew Wakefield, MB, BS, FRCS, FRCPath is an academic gastroenterologist. He graduated in Medicine from St. Mary's Hospital (part of the University of London) in 1981, pursuing a career in gastrointestinal surgery with a particular interest in inflammatory bowel disease. He qualified as Fellow of the Royal College of Surgeons in 1985, and in 1996 was awarded a Wellcome Trust Traveling Fellowship to study small-intestine transplantation in Toronto, Canada. Discoveries made during his work in Canada led him on return to the UK to pursue the study of inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. In 1998, he and his colleagues at the Royal Free Hospital in London reported a novel inflammatory bowel disease in children with developmental disorders such as autism; the condition later became known as autistic enterocolitis. Dr. Wakefield resisted pressure to stop his research on the possible links between childhood immunizations, intestinal inflammation and autism, leaving the Royal Free School of Medicine in 2001. He is involved in many scientific research collaborations in the U.S and abroad, investigations centering on the immunologic, metabolic, and pathologic changes occurring in inflammatory bowel diseases such as autistic enterocolitis, links between intestinal disease and neurologic injury in children, and the possible relationship of these conditions to environmental causes, such as childhood vaccines. During the course of his work on childhood developmental disorders, Dr. Wakefield was increasingly convinced of the need for a research-oriented, integrated bio-medical and educational approach to these disorders, in order to translate clinical benefits for affected children into measurable developmental progress; this is the driving aim of Thoughtful House. As of the beginning of 2007, Dr. Wakefield has published one hundred thirty-four original scientific articles, book chapters, and invited scientific commentaries. He was awarded the Fellowship of the Royal College of Pathologists in 2001; he is medical advisor to the United Kingdom charity Visceral, and sits on the board of the U.S. charity Medical Interventions for Autism. William R. Long, MDiv, PhD, JD is currently a writer and legal consultant living in Salem Oregon. The three projects that currently occupy him are: (1) foundation consulting--legal status of foundation, goals, mission, learning about grantees, maximazation of foundation efforts-and (2) writing a book on autism and law, focusing especially on biomedical treatments for autism; and (3) leading Oregon's effort to abolish the death penalty. From 2003-2006 he was a Visiting Professor of Law at Willamette University College of Law in Salem, Oregon. Before Willamette he was a litigation attorney with Stoel Rives LLP in Portland, Oregon (2000-2003), a professor of history and government at Sterling College in Kansas (1990-96), interim senior pastor at Westminster Presbyterian Church in Portland (1988-89), and a professor of religion and humanities at Reed College in Portland (1982-88). During a sabbatical from Reed, he was a senior editorial writer for The Oregonian (1985), Oregon's largest circulating daily newspaper. Bill is the author or co-author of eleven books and numerous articles on subjects of law, religion and history. Most of his writing these days is focused on the 4,000+ mini-essays on this web site, primarily on legal subjects, words, history, exposition of classic texts (such as Shakespeare), and reviews of current events or movies. He launched his autism "page" on November 1, 2007 and his page called "Supreme Court Times" on November 27, 2007. To date he has posted the equivalent of more than sixty 200 to 240-page books of mini-essays on this site. Bill holds the B.A. and Ph. D. from Brown University in Providence, R.I., the J.D. from Willamette, the M.Div. from GordonConwell Theological Seminary, South Hamilton, MA and was the recipient of a prestigious DAAD (Deutscher akademischer Austauschdienst) award for research and dissertation writing at the University of Tuebingen, Germany (1980-81). Law and the Court of Public Opinion: Andrew Wakefield, MD & William Long, PhD, JD In January 2009 Dr. William Long, a writer, former law professor, litigation attorney and history professor, met with Dr. Andrew Wakefield for 12 hours of intensive interviews in Austin TX. The purpose of the interviews was to see if there was a "story" beyond what had been previously said and written about Dr. Wakefield, especially regarding the events leading to the publication of and fallout from the crucial Lancet article in Feb. 1998. The result of Dr. Long's interviews and research into hitherto unpublished materials appeared in a recent edition of the AUTISM FILE. In this presentation, Dr. Wakefield will speak briefly about the legal process he has been engaged in over the past few years, how he and Dr. Long met, why he decided to
grant these interviews to Dr. Long, what he thinks the article his accomplished and other comments relating to the way that the "court of public opinion" has handled his "case." Dr. Long will then address why he decided to undertake this project, how he went about his work, what he hoped to accomplish from the article, what his principal conclusions were and how his mind "changed" during the course of the interviews. Both will then respond to each other and provide opportunity for question and answer from the audience.