Michael Kinch
- Published in print:
- 2016
- Published Online:
- May 2017
- ISBN:
- 9781469630625
- eISBN:
- 9781469630649
- Item type:
- book
- Publisher:
- University of North Carolina Press
- DOI:
- 10.5149/northcarolina/9781469630625.001.0001
- Subject:
- Business and Management, Innovation
The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these ...
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The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes--and indeed because of them--our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy.
To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.Less
The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes--and indeed because of them--our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy.
To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.
Veronica Hope Hailey
- Published in print:
- 1999
- Published Online:
- October 2011
- ISBN:
- 9780198782049
- eISBN:
- 9780191695421
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780198782049.003.0005
- Subject:
- Business and Management, HRM / IR, Strategy
This chapter describes the different approaches taken by two companies (Glaxo Pharmaceuticals UK and Hewlett Packard) to managing culture. Despite the difference in approach, both organizations ...
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This chapter describes the different approaches taken by two companies (Glaxo Pharmaceuticals UK and Hewlett Packard) to managing culture. Despite the difference in approach, both organizations manage culture relatively successfully in terms of the individual contexts in which the approaches are applied and the specific outcomes that each company wants to achieve. The chapter focuses on three main themes: (i) a comparative analysis of values or behaviours as a starting point for instituting cultural change; (ii) a comparative analysis of top-down or imposed cultural change and incremental and emergent cultural change; and (iii) a consideration of cultural management as a form of labour control. The chapter begins by reviewing the current debates under these three headings. Two case studies are then presented, and the chapter concludes with a discussion of the comparisons to be made and the general lessons learnt from the analysis. In particular it draws out the contextual features that are pertinent if companies choose to manage culture and the different outcomes which that management intervention may seek to achieve.Less
This chapter describes the different approaches taken by two companies (Glaxo Pharmaceuticals UK and Hewlett Packard) to managing culture. Despite the difference in approach, both organizations manage culture relatively successfully in terms of the individual contexts in which the approaches are applied and the specific outcomes that each company wants to achieve. The chapter focuses on three main themes: (i) a comparative analysis of values or behaviours as a starting point for instituting cultural change; (ii) a comparative analysis of top-down or imposed cultural change and incremental and emergent cultural change; and (iii) a consideration of cultural management as a form of labour control. The chapter begins by reviewing the current debates under these three headings. Two case studies are then presented, and the chapter concludes with a discussion of the comparisons to be made and the general lessons learnt from the analysis. In particular it draws out the contextual features that are pertinent if companies choose to manage culture and the different outcomes which that management intervention may seek to achieve.
Holly Fernandez Lynch and I. Glenn Cohen (eds)
- Published in print:
- 2015
- Published Online:
- May 2016
- ISBN:
- 9780231171182
- eISBN:
- 9780231540070
- Item type:
- book
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231171182.001.0001
- Subject:
- Law, Medical Law
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations ...
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In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA’s successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.Less
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA’s successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Theodore W. Ruger
- Published in print:
- 2015
- Published Online:
- May 2016
- ISBN:
- 9780231171182
- eISBN:
- 9780231540070
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231171182.003.0006
- Subject:
- Law, Medical Law
The FDA over the past century has achieved high levels of regulatory prestige by enforcing statutory standards of safety and efficacy with relatively little regulation of the end-stage use, or the ...
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The FDA over the past century has achieved high levels of regulatory prestige by enforcing statutory standards of safety and efficacy with relatively little regulation of the end-stage use, or the ultimate price, of food and drugs. This traditional regulatory model is under strain in the twenty-first century as new resource constraints and concerns over consumer and physician behavior increase, and the FDA will need to adapt its regulatory focus to remain relevant.Less
The FDA over the past century has achieved high levels of regulatory prestige by enforcing statutory standards of safety and efficacy with relatively little regulation of the end-stage use, or the ultimate price, of food and drugs. This traditional regulatory model is under strain in the twenty-first century as new resource constraints and concerns over consumer and physician behavior increase, and the FDA will need to adapt its regulatory focus to remain relevant.
Marie Boyd
- Published in print:
- 2015
- Published Online:
- May 2016
- ISBN:
- 9780231171182
- eISBN:
- 9780231540070
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231171182.003.0027
- Subject:
- Law, Medical Law
Recent U.S. Supreme Court holdings suggest that while the manufacturer of a brand-name drug is always responsible for its label’s content, this is not the case for generic drugs. In addition, these ...
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Recent U.S. Supreme Court holdings suggest that while the manufacturer of a brand-name drug is always responsible for its label’s content, this is not the case for generic drugs. In addition, these rulings have removed the protections and compensation that state tort law can provide consumers of generic drugs and exposed a gap in the regulation of generic drugs in which no manufacturer is responsible for updating the labeling. This Chapter argues that to remedy these issues, the Food and Drug Administration (FDA) should use negotiated rulemaking to work with drug manufacturers, consumer representatives, healthcare providers, and other interests to create new drug regulations.Less
Recent U.S. Supreme Court holdings suggest that while the manufacturer of a brand-name drug is always responsible for its label’s content, this is not the case for generic drugs. In addition, these rulings have removed the protections and compensation that state tort law can provide consumers of generic drugs and exposed a gap in the regulation of generic drugs in which no manufacturer is responsible for updating the labeling. This Chapter argues that to remedy these issues, the Food and Drug Administration (FDA) should use negotiated rulemaking to work with drug manufacturers, consumer representatives, healthcare providers, and other interests to create new drug regulations.
John M. Kirk
- Published in print:
- 2015
- Published Online:
- May 2016
- ISBN:
- 9780813061054
- eISBN:
- 9780813051338
- Item type:
- chapter
- Publisher:
- University Press of Florida
- DOI:
- 10.5744/florida/9780813061054.003.0007
- Subject:
- Society and Culture, Latin American Studies
Cuba produces the majority of its own medicines, and exports pharmaceuticals around the world—mainly to developing countries. This chapter examines the origins of Cuban biotechnology, its basic ...
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Cuba produces the majority of its own medicines, and exports pharmaceuticals around the world—mainly to developing countries. This chapter examines the origins of Cuban biotechnology, its basic philosophy, and the kind of research it undertakes. Reference is made to a number of joint ventures, scientific research projects, and healthcare initiatives with which Cuba is involved in Africa and Asia.Less
Cuba produces the majority of its own medicines, and exports pharmaceuticals around the world—mainly to developing countries. This chapter examines the origins of Cuban biotechnology, its basic philosophy, and the kind of research it undertakes. Reference is made to a number of joint ventures, scientific research projects, and healthcare initiatives with which Cuba is involved in Africa and Asia.
Michael Kinch
- Published in print:
- 2016
- Published Online:
- May 2017
- ISBN:
- 9781469630625
- eISBN:
- 9781469630649
- Item type:
- chapter
- Publisher:
- University of North Carolina Press
- DOI:
- 10.5149/northcarolina/9781469630625.003.0011
- Subject:
- Business and Management, Innovation
The title of the chapter is a Greek term that literally translates into “eating oneself” and is representative of a trend of mergers and acquisitions that has subsumed the drug development enterprise ...
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The title of the chapter is a Greek term that literally translates into “eating oneself” and is representative of a trend of mergers and acquisitions that has subsumed the drug development enterprise over the past three decades and now fundamentally threatens our ability to develop new medicines. We begin with two examples of acquisitions by Eli Lilly & Company. One product resulted from an unexpected discovery by Pfizer scientists of a drug meant to treat angina that had the unexpected but not undesired effect of treating erectile dysfunction. The second acquisition, of New York-based Imclone, was the final step in a high profile controversy that led the jailing of its CEO and the celebrity Martha Stewart for insider trading. Despite these two acquisitions, Eli Lilly largely did not participate in the merger mania of the past few decades and we relate how this most innovative company fell through the rankings to become a middling contender. This waning resulted from the meteoric rise of Pfizer as one of the most aggressive purveyors of pharmaceutical industry consolidation and the unlikely rise of Valeant Pharmaceuticals, a company with a checkered history and ongoing woes.Less
The title of the chapter is a Greek term that literally translates into “eating oneself” and is representative of a trend of mergers and acquisitions that has subsumed the drug development enterprise over the past three decades and now fundamentally threatens our ability to develop new medicines. We begin with two examples of acquisitions by Eli Lilly & Company. One product resulted from an unexpected discovery by Pfizer scientists of a drug meant to treat angina that had the unexpected but not undesired effect of treating erectile dysfunction. The second acquisition, of New York-based Imclone, was the final step in a high profile controversy that led the jailing of its CEO and the celebrity Martha Stewart for insider trading. Despite these two acquisitions, Eli Lilly largely did not participate in the merger mania of the past few decades and we relate how this most innovative company fell through the rankings to become a middling contender. This waning resulted from the meteoric rise of Pfizer as one of the most aggressive purveyors of pharmaceutical industry consolidation and the unlikely rise of Valeant Pharmaceuticals, a company with a checkered history and ongoing woes.
Purendra Prasad and Amar Jesani (eds)
- Published in print:
- 2018
- Published Online:
- July 2019
- ISBN:
- 9780199482160
- eISBN:
- 9780199097746
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/oso/9780199482160.001.0001
- Subject:
- Sociology, Health, Illness, and Medicine, Social Stratification, Inequality, and Mobility
Equity and Access attempts to unravel the complex narrative of why inequities in the health sector are growing and access to basic health care is worsening, and the underlying forces that contribute ...
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Equity and Access attempts to unravel the complex narrative of why inequities in the health sector are growing and access to basic health care is worsening, and the underlying forces that contribute to this situation. It draws attention to the way globalization has influenced India’s development trajectory as health care issues have assumed significant socio-economic and political significance in contemporary India. The volume explains how state and market forces have progressively heightened the iniquitous health care system and the process through which substantial burden of meeting health care needs has fallen on the individual households. Twenty-eight scholars comprising social scientists, medical experts, public health experts, policy makers, health activists, legal experts, and gender specialists have delved into the politics of access for different classes, castes, gender, and other categories to contribute to a new field of ‘health care studies’ in this volume. Adopting an interdisciplinary approach within a broader political-economy framework, the volume is useful for understanding power relations within social groups and complex organizational systems.Less
Equity and Access attempts to unravel the complex narrative of why inequities in the health sector are growing and access to basic health care is worsening, and the underlying forces that contribute to this situation. It draws attention to the way globalization has influenced India’s development trajectory as health care issues have assumed significant socio-economic and political significance in contemporary India. The volume explains how state and market forces have progressively heightened the iniquitous health care system and the process through which substantial burden of meeting health care needs has fallen on the individual households. Twenty-eight scholars comprising social scientists, medical experts, public health experts, policy makers, health activists, legal experts, and gender specialists have delved into the politics of access for different classes, castes, gender, and other categories to contribute to a new field of ‘health care studies’ in this volume. Adopting an interdisciplinary approach within a broader political-economy framework, the volume is useful for understanding power relations within social groups and complex organizational systems.
Robert I. Field
- Published in print:
- 2013
- Published Online:
- January 2014
- ISBN:
- 9780199746750
- eISBN:
- 9780199354528
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199746750.003.0002
- Subject:
- Public Health and Epidemiology, Public Health
The American health care system, which appears on its surface as a predominantly private endeavour, actually rests on a foundation of government support. Itreflects a huge public-private partnership ...
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The American health care system, which appears on its surface as a predominantly private endeavour, actually rests on a foundation of government support. Itreflects a huge public-private partnership that drives one-sixth of the economy. Four key sectors poignantly demonstrate this dynamic. Pharmaceutical manufacturing depends on the National Institutes of Health for research funding and on the Food and Drug Administration for public reassurance of safety. The hospital industry depends on Medicare for a large share of its revenue. The medical profession garnered public trust from regulatory oversight that it developed in collaboration with state governments, and many specialties rely heavily on Medicare for reimbursement. And private insurance companies depend on a huge tax subsidy for employment-based policies and on opportunities to administer coverage under Medicare and Medicaid. The public-private relationship is complex with industry segments routinely capturing their regulators, yet it represents the system’s defining economic paradigm.Less
The American health care system, which appears on its surface as a predominantly private endeavour, actually rests on a foundation of government support. Itreflects a huge public-private partnership that drives one-sixth of the economy. Four key sectors poignantly demonstrate this dynamic. Pharmaceutical manufacturing depends on the National Institutes of Health for research funding and on the Food and Drug Administration for public reassurance of safety. The hospital industry depends on Medicare for a large share of its revenue. The medical profession garnered public trust from regulatory oversight that it developed in collaboration with state governments, and many specialties rely heavily on Medicare for reimbursement. And private insurance companies depend on a huge tax subsidy for employment-based policies and on opportunities to administer coverage under Medicare and Medicaid. The public-private relationship is complex with industry segments routinely capturing their regulators, yet it represents the system’s defining economic paradigm.
Mike Fortun
- Published in print:
- 2008
- Published Online:
- March 2012
- ISBN:
- 9780520247505
- eISBN:
- 9780520942615
- Item type:
- chapter
- Publisher:
- University of California Press
- DOI:
- 10.1525/california/9780520247505.003.0003
- Subject:
- Biology, Evolutionary Biology / Genetics
This chapter discusses how speed genomics spurred a complex political economy in Iceland, focusing on the experiences of three of the earliest genomics-based companies: Human Genome Sciences Inc., ...
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This chapter discusses how speed genomics spurred a complex political economy in Iceland, focusing on the experiences of three of the earliest genomics-based companies: Human Genome Sciences Inc., Incyte Pharmaceuticals (now Incyte Genomics), and Millennium Pharmaceuticals. Each company adopted different dance steps with their outsize partners in the pharmaceutical industry, but each participated in a kind of futures market for genomic information that would intensify over the remainder of the 1990s as more genomic companies, including eventually deCODE Genetics, stepped onto the dance floor. What can we learn from these three examples about the speed transforms of genomics? The first things that changed in the field were the size, type, and connectability of biodatabases. The disease targets transformed as well. The genetics approach that had yielded the single genes (and their variants) implicated in “simple disorders” such as Huntington's and cystic fibrosis had become a genomic approach addressed to “complex conditions” such as those targeted by Millennium: heart disease, asthma, and obesity.Less
This chapter discusses how speed genomics spurred a complex political economy in Iceland, focusing on the experiences of three of the earliest genomics-based companies: Human Genome Sciences Inc., Incyte Pharmaceuticals (now Incyte Genomics), and Millennium Pharmaceuticals. Each company adopted different dance steps with their outsize partners in the pharmaceutical industry, but each participated in a kind of futures market for genomic information that would intensify over the remainder of the 1990s as more genomic companies, including eventually deCODE Genetics, stepped onto the dance floor. What can we learn from these three examples about the speed transforms of genomics? The first things that changed in the field were the size, type, and connectability of biodatabases. The disease targets transformed as well. The genetics approach that had yielded the single genes (and their variants) implicated in “simple disorders” such as Huntington's and cystic fibrosis had become a genomic approach addressed to “complex conditions” such as those targeted by Millennium: heart disease, asthma, and obesity.
Abena Dove Osseo-Asare
- Published in print:
- 2014
- Published Online:
- May 2014
- ISBN:
- 9780226085524
- eISBN:
- 9780226086163
- Item type:
- book
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226086163.001.0001
- Subject:
- History, History of Science, Technology, and Medicine
Bitter Roots is a history of drug discovery from plants across different African countries. It reconsiders the history of pharmaceutical patents, biopiracy, and bioprospecting to show that African ...
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Bitter Roots is a history of drug discovery from plants across different African countries. It reconsiders the history of pharmaceutical patents, biopiracy, and bioprospecting to show that African medicine inspired new phytochemicals and probes the responsibilities of multiple innovators to compensate rural communities through benefit-sharing agreements. It traces the geography of economic , chemical, and botanical exchanges of rosy periwinkle (Catharanthus roseus), pennywort (Centella asiatica ), grains of paradise (Aframomum melegueta), arrow poison plant (Strophanthus hispidus), Ghana quinine (Cryptolepis sanguinolenta), and Hoodia or (Hoodia gordonii ). Scientists at universities and research institutes in Ghana, Cameroon, Republic of Congo, Madagascar, Nigeria, and South Africa competed with traditional healers and herbalists. African plant experts also competed with biologists, botanists, and chemists in Canada, England (United Kingdom), France, India, Jamaica, the Philippines, and the United States of America including researchers at the firms Bristol-Meyer Squibb, Eli Lilly, Pfizer, La Roche-Posay, and Unilever. The book maps the distribution of plant specimens during the Early Modern, Atlantic Slave Trade, Pre-colonial, Colonial, and National (Independence) Periods. New plants entered pharmacopeia and materia medica from the late nineteenth century when colonial wars in Africa coincided with the rise of the pharmaceutical industry. During the twentieth century, research into cures for cancer, diabetes, erectile dysfunction, HIV/AIDS, impotence, leprosy, leukemia, malaria, and obesity led researchers to re-examine ethnobotanical evidence in areas with high levels of biodiversity. The book concludes that African scientists direct chemical prospecting and proposes the concept of bioprosperity to express a more equitable sharing of profits.Less
Bitter Roots is a history of drug discovery from plants across different African countries. It reconsiders the history of pharmaceutical patents, biopiracy, and bioprospecting to show that African medicine inspired new phytochemicals and probes the responsibilities of multiple innovators to compensate rural communities through benefit-sharing agreements. It traces the geography of economic , chemical, and botanical exchanges of rosy periwinkle (Catharanthus roseus), pennywort (Centella asiatica ), grains of paradise (Aframomum melegueta), arrow poison plant (Strophanthus hispidus), Ghana quinine (Cryptolepis sanguinolenta), and Hoodia or (Hoodia gordonii ). Scientists at universities and research institutes in Ghana, Cameroon, Republic of Congo, Madagascar, Nigeria, and South Africa competed with traditional healers and herbalists. African plant experts also competed with biologists, botanists, and chemists in Canada, England (United Kingdom), France, India, Jamaica, the Philippines, and the United States of America including researchers at the firms Bristol-Meyer Squibb, Eli Lilly, Pfizer, La Roche-Posay, and Unilever. The book maps the distribution of plant specimens during the Early Modern, Atlantic Slave Trade, Pre-colonial, Colonial, and National (Independence) Periods. New plants entered pharmacopeia and materia medica from the late nineteenth century when colonial wars in Africa coincided with the rise of the pharmaceutical industry. During the twentieth century, research into cures for cancer, diabetes, erectile dysfunction, HIV/AIDS, impotence, leprosy, leukemia, malaria, and obesity led researchers to re-examine ethnobotanical evidence in areas with high levels of biodiversity. The book concludes that African scientists direct chemical prospecting and proposes the concept of bioprosperity to express a more equitable sharing of profits.
- Published in print:
- 2009
- Published Online:
- March 2013
- ISBN:
- 9780226498065
- eISBN:
- 9780226498089
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226498089.003.0004
- Subject:
- History, History of Science, Technology, and Medicine
This chapter summarizes key U.S. federal legal decisions about the admissibility of expert evidence. It analyzes the Supreme Court cases Daubert v. Merrell Dow Pharmaceuticals, Kumho Tire v. ...
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This chapter summarizes key U.S. federal legal decisions about the admissibility of expert evidence. It analyzes the Supreme Court cases Daubert v. Merrell Dow Pharmaceuticals, Kumho Tire v. Carmichael, and Frye v. United States. The chapter suggests that the Frye case established a rule for determining the admissibility of expert testimony while the Daubert and Kumho decisions provided trial judges with grounds for restricting the admissibility of scientific evidence in civil cases, thus relieving the burdens imposed on civil defendants in “toxic torts.”Less
This chapter summarizes key U.S. federal legal decisions about the admissibility of expert evidence. It analyzes the Supreme Court cases Daubert v. Merrell Dow Pharmaceuticals, Kumho Tire v. Carmichael, and Frye v. United States. The chapter suggests that the Frye case established a rule for determining the admissibility of expert testimony while the Daubert and Kumho decisions provided trial judges with grounds for restricting the admissibility of scientific evidence in civil cases, thus relieving the burdens imposed on civil defendants in “toxic torts.”
