Authors Guild, Inc. v. Hathitrust

Filing 163

AMICUS BRIEF, on behalf of Amicus Curiae Medical Historians, FILED. Service date 06/04/2013 by CM/ECF. [955897] [12-4547]--[Edited 06/05/2013 by JW]

12-4547-CV
United States Court of Appeals
for the

Second Circuit
THE AUTHORS GUILD, INC., THE AUSTRALIAN SOCIETY OF AUTHORS
LIMITED, UNION DES ECRIVAINES ET DES ECRIVAINS QUEBECOIS,
ANGELO LOUKAKIS, ROXANA ROBINSON, ANDRE ROY, JAMES
SHAPIRO, DANIELE SIMPSON, T.J. STILES, FAY WELDON,
THE AUTHORS LEAGUE FUND, INC., AUTHORS’ LICENSING AND
COLLECTING SOCIETY, SVERIGES FORFATTARFORBUND, NORSK
FAGLITTERAER FORFATTERO OG OVERSETTERFORENING,
THE WRITERS’ UNION OF CANADA, PAT CUMMINGS, ERIK
GRUNDSTROM, HELGE RONNING, JACK R. SALAMANCA,
Plaintiffs-Appellants,
(For Continuation of Caption See Inside Cover)
ON APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK

BRIEF OF AMICUS CURIAE MEDICAL HISTORIANS IN SUPPORT
OF DEFENDANTS-APPELLEES AND URGING AFFIRMANCE

ERIC J. GRANNIS
THE LAW OFFICES OF ERIC J. GRANNIS
18 East 48th Street, 19th Floor
New York, NY 10017
Counsel for Amicus Curiae

v.
HATHITRUST, CORNELL UNIVERSITY, MARY SUE COLEMAN, President,
University of Michigan, MARK G. YUDOF, President, The University of
California, KEVIN REILLY, President, The University of Wisconsin System,
MICHAEL MCROBBIE, President, Indiana University,
Defendants-Appellees,
NATIONAL FEDERATION OF THE BLIND, GEORGINA KLEEGE, BLAIR
SEIDLITZ, COURTNEY WHEELER,
Intervenor Defendants-Appellees.

TABLE OF CONTENTS

TABLE OF AUTHORITIES..............................................................................................ii
INTEREST OF AMICUS CURIAE.....................................................................................1
SUMMARY OF THE ARGUMENT..................................................................................2
ARGUMENT.......................................................................................................................2
CONCLUSION..................................................................................................................10

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TABLE OF AUTHORITIES
CASES
James Glanz, Cues of Asthma Study Risks May Have Been Overlooked,
N.Y. Times, July 27, 2001 .................................................................................... 5
Influenza Pandemic in the United States, 125 Public Health Reports (2010) .......... 6
Wallace Park and FJ Cockersole, ‘Hexamethonium Lung’: Report of
a Case Associated With Pregnancy,” 63(5) British J. of Obstetrics and
Gynecology 728 (1956) ......................................................................................... 8

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INTEREST OF AMICUS CURIAE
Amici are specialists in the history of medicine who hold teaching and
research positions at prestigious research universities in the United States.1 They
respectfully submit this brief of amicus curiae in support of Appellees. Amici’s
intent in writing the brief is not to address the legal issues involved in the case but
rather to provide the Court with information about how a large group of people,
namely scholars who use libraries to conduct their research, will be profoundly
affected by the outcome of this appeal. Amici’s institutional affiliations are
provided for identification purposes only, and imply no endorsement of the views
expressed herein: Nancy Tomes, Ph.D. (Professor of History at Stony Brook
University, President of the American Association for the History of Medicine);
Rima D. Apple, Ph.D. (Professor Emerita at the University of WisconsinMadison); David Barnes, Ph.D. (Associate Professor of History and Sociology of
Science and Director of the Health and Societies Program at the University of
Pennsylvania); Jeremy Greene, M.D., Ph.D. (Elizabeth Treide and A. McGehee
Harvey Chair in the History of Medicine at the Johns Hopkins University School
of Medicine); David Jones, M.D., Ph.D. (A. Bernard Ackerman Professor of the
Pursuant to Fed. R. App. P. 29(c)(5) and Local Rule 29.1(b) of the United States
Court of Appeals for the Second Circuit, Amici hereby certify that no party’s
counsel authored this brief in whole or in part; no party or party’s counsel
contributed money intended to fund preparing or submitting the brief; and no
person other than Amici contributed money intended to fund preparing or
submitting the brief.

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Culture of Medicine at Harvard University); Arleen Marcia Tuchman, Ph.D.
(Professor of History and affiliated faculty member of the Center for Medicine,
Health and Society and the Center for Biomedical Ethics and Society at Vanderbilt
University.)
SUMMARY OF THE ARGUMENT
The ability to freely and easily identify and locate diverse research materials
and existing medical research is essential not only to the integrity of medical
historiography but to the medical and public health communities as a whole. An
inability to access text-searchable databases whose scope reaches back decades,
such as HathiTrust, would diminish researchers’ ability to learn from and build
upon past research, and would have a crippling effect on the medical community’s
capacity to adequately address the many challenges still unsolved in the modern
medical world.
ARGUMENT
Historical researchers depend upon research libraries to do their work and
thus have a vested interest in preserving the tradition of fair use that has long
guided their use. Restrictions on research libraries’ abilities to use new digital
technologies to preserve sources and make them key word searchable would have a
very negative impact on scholarship in the United States. In the case of the history
of medicine, the kind of enhanced access to library collections provided by the

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HathiTrust will facilitate researchers’ ability to provide useful information and
strategic advice about health issues of great importance. Thus the Amici write in
support of the HathiTrust’s appeal.
The Court may be surprised to learn how useful historical research is in the
field of health research. As health policy experts are the first to admit, many
important health problems have not yet yielded quickly or easily to the power of
modern biomedicine. In some cases, the problem lies with unequal distribution of
resources; new medical technologies and pharmaceutical discoveries are too
expensive for widespread use, especially in developing nations. In other cases,
available knowledge about the disease is hampered by ethical questions or social
issues that limit its application. And last but not least, in a great many cases science
has yet to develop a “magic bullet” capable of curing a specific disease.
For all these reasons, understanding how diseases and their management
have evolved over time is a very important tool for health policy makers. By
delving deeply into the original sources of the past, including newspapers,
government reports, scientific journals and monographs, historians provide a
wealth of insights into the political, social, and economic factors that shape both
the expression and treatment of illness. Over the past decade, the growing
availability of digitized sources and keyword searching has added new depth to the
quality of this work. Agencies as diverse as the Centers for Disease Control, the

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Department of Defense, the National Academy of Medicine, the National Institutes
of Health, and the World Health Organization have all used information provided
by historians to inform their strategies regarding major health problems as diverse
as child and maternal health, disability policy, infectious disease management,
industrial health and safety, and environmental risk management. Major health
science journals such as the Journal of the American Medical Association, The
New England Journal of Medicine, and the American Journal of Public Health
regularly feature historical articles on these and other topics. Two examples that
illustrate the utility of historical research are the management of pandemic
infectious diseases and the evaluation of drug safety.
Public health authorities around the world today are concerned about how
well they can manage pandemics involving viral diseases, either novel strains of
existing diseases or completely new agents. As scientific understanding of viruses
has grown since the 1980s, global health experts have come to better understand
the likelihood of such threats. Viruses replicate so often that their chances of
mutating into new and potentially more dangerous variants are very high. Viruses
also have the capacity to swap genetic material with their counterparts that affect
other species, such as birds and swine, creating even more unpredictable and
possibly deadly new strains of disease. Outbreaks of SARS in 2002 and a novel
strain of the H1NI influenza virus in 2009 caused worldwide concern. Just last

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week came news of a death from SARS in France. There are no effective cures for
these viral diseases; all health professionals can do is to provide supportive therapy
to the ill and try to limit the disease’s spread to others. Their best case scenario is
to slow down the novel strain’s spread long enough for scientists to develop an
effective vaccine. The methods of slowing disease transmission in 2013 remain
much as they were in 1918: isolation of the ill and other social distancing
measures.
These facts help explain the intense interest among public health authorities
in the history of the last great pandemic of the H1N1 influenza, which occurred in
1918-1919. Estimates of the world wide death rate range from 40 million to 100
million. (Poor record keeping makes the exact count unavailable.) In the United
States alone, an estimated 675,000 people died, many of them young and healthy
adults. The chaos of wartime, along with new forms of transportation and mass
media, combined to make the influenza pandemic both very lethal and widely
feared. Although much has changed since 1919, the ways in which modern media,
easier transportation, and urban lifestyles contributed to the disease’s spread have
clear parallels to conditions today. Moreover, there remains no “cure” for
influenza. Hence contemporary public health agencies have been interested in
learning more about the impact of the 1918-1919 pandemic in the United States as
part of strategic planning about how to manage a similar disease event in the early

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21st century. To give but one example of this rich literature, Public Health Reports
in 2010 dedicated a special issue to historical works on the influenza pandemic
exploring the lessons to be learned from its successes and failures. 2
The field of pharmaceutical research likewise illustrates the urgency for
digitizing past medical periodicals and printed publications in text-searchable
format. In the first years of the 21st century, researchers at Johns Hopkins
University School of Medicine began to test a promising new inhaled medication
for the treatment of asthma. The medication, hexamethonium, was an acetylcholine
receptor ganglionic blocker initially used systemically for the treatment of high
blood pressure, which had fallen out of favor in clinical use by the early 1970s.
The Johns Hopkins team theorized, however, that an inhaled version of the drug
might actually be useful for relaxing airway constriction in the treatment of
asthma. To the best of their knowledge, hexamethonium had never been used as an
inhaled agent and showed great promise. A few scattered papers in the medical
literature from the 1970s suggested no evidence that inhaled hexamethonium was
harmful. They initiated clinical trials in healthy human volunteers in the spring of
2001.
One of the healthy volunteers enrolled for this trial, Ellen Roche, received
her first dose of inhaled hexamethonium on May 4, 2001. The next day she

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Influenza Pandemic in the United States, 125 Public Health Reports (2010).
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developed a cough, and soon developed a fever as well. A CT scan conducted on
May 12 showed extensive ground-glass opacities in both lungs, and two days later
she required mechanical ventilation in an intensive care unit. Before the month was
out she was dead.
It should be added that Ellen Roche did not have asthma and therefore did
not stand to benefit materially in any way from her participation in the study. As
her shocked family, colleagues, and journalists began to ask why a perfectly
healthy volunteer had died from the administration of an experimental drug, more
attention was paid to the back history of hexamethonium itself. Journalists from
The New York Times turned up physical copies of undigitized medical articles
published in the 1950s that clearly indicated hexamethonium was associated with
lung toxicity. As the New York Times reported, “when [the lead researcher] applied
to the Hopkins review board for approval to perform the experiment, his literature
search apparently failed to turn up those papers.” 3 Why? In part because they were
not indexed as part of the most commonly-used online database of the clinical
literature, PubMed, which has only systematically indexed articles from 1966
onwards.
The digitized collections of the HathiTrust, however, contain text-searchable
clinical journals and texts which include nearly 20,000 digitally text-searchable
James Glanz, Cues of Asthma Study Risks May Have Been Overlooked, N.Y.
Times, July 27, 2001.
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entries regarding hexamethonium prior to 1966. A simple Boolean search pairing
“hexamethonium” with “toxicity” and “lung” produces multiple references to
prominent papers from the 1950s—including more than 100 explicit references to a
condition known as “hexamethonium lung.” The condition was first described in
1954, and had already, by 1956, been widely discussed by pharmacologists,
pulmonologists, and cardiologists as a cautionary tale in experimental
pharmacotherapeutics. These reports were in prominent medical journals. “In
recent years the use of hypotensive drugs has attracted increasing attention,” wrote
two physicians in a review of “Hexamethonium Lung” in 1956. “The present case
is reported to show that such therapy may not always be free of danger…and to
draw attention to an unusual fibrosis occurring in the lungs of some cases under
treatment with drugs of the hexamethonium series.” 4 In short, the hazards of
hexamethonium had been well-documented in the modern medical literature, just
not in the medical literature indexed by conventional digital databases such as
PubMed. Had the fulltext-searchable database of digitized historical documents of
the Hathi trust been available to Johns Hopkins University medical researchers in
2001, the flawed study would quite likely never have taken place and Ellen Roche
may very well not have died a senseless death.

Wallace Park and FJ Cockersole, ‘Hexamethonium Lung’: Report of a Case
Associated With Pregnancy, 63(5) British J. of Obstetrics and Gynecology 728
(1956)

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In response to Ellen Roche’s death, in July of 2001, the United States Office
for Human Research Protections (OHRP) placed the status of almost all federallyfunded human subjects medical research at Johns Hopkins University in indefinite
suspension. This was a heavy price for Hopkins to pay, but not nearly as heavy as
that paid by Ellen Roche and her family. In the field of medical research, online
accessibility of historical records can be a matter of life or death.
These examples could be multiplied many times over. Historians of
medicine are actively involved in many important areas of research: the evolution
of industrial health and safety issues; the control of infectious diseases such as
tuberculosis, malaria, dengue fever, and polio; the changing ethics of human
subject experimentation; the impact of new pharmaceutical agents on the diagnosis
and treatment of disease; the impact of unequal access and discrimination on
specific groups such as women, children, racial and ethnic minorities; the factors
leading to increases and decreases in specific diseases such as lung cancer,
cardiovascular disease, and type 2 diabetes; and the efficacy of public health
measures such as mandatory vaccination and sex education.
In order to do our research, amici rely heavily on the books and journals
available in research universities. While some universities have extensive
collections, others do not. Researchers at newer institutions rely heavily on being
able to borrow, through interlibrary loan, from the collections of older universities,

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including those who are part of the HathiTrust project. By digitizing their holdings
and allowing enhanced keyword searching of their contents, the HathiTrust project
is making it easier for historians of medicine to find sources for their work. The
project does not make the scanned book available to researchers; rather it lets them
know that the book exists and can either be purchased or requested via interlibrary
loan, just as the researcher would do had they located the material using a
conventional subject heading supplied by World Cat or some other online database
of library holdings. These benefits are especially important to scholars with
disabilities whose physical access to libraries may be limited, or who may have
limitations on their sight that make conventional reading practices difficult.
Amici, who as a group have authored twenty books, appreciate the
importance of copyright and the protection of creative property. Although they
profess no expertise on the legal issues involved in this case, what the HathiTrust is
doing does not seem to threaten authors’ rights to protect their work.
CONCLUSION
Libraries are under tremendous pressures right now due to new
technologies, ever rising journal fees, storage difficulties, and the inevitable
deterioration of print sources. As the United States struggles to compete in a global
knowledge economy, it needs to protect the national treasures that its great
research libraries represent so that they will still be available to our children and

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our grandchildren. Historians’ ability to provide useful perspectives on pressing
health issues depends upon the good health of our research libraries. Thus,
speaking on behalf of our fellow historians of medicine, Amici respectfully ask the
court to consider the negative impact that overturning this decision on appeal
would have on the production of useful knowledge.

Respectfully submitted,
LAW OFFICES OF ERIC J. GRANNIS
By:
Eric J. Grannis
Attorneys for Amicus Curiae
18 East 48th Street, 19th Floor
New York, New York 10017
[phone]

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CERTIFICATE OF COMPLIANCE

This amicus brief complies with the type-volume limitations of Fed. R. App.
P. 29(d) & 32(a)(7)(B), because this brief contains 2447 words, excluding the parts
of the brief exempted by Fed. R. App. P. 32(a)(7)(B)(iii). This brief complies with
the typeface requirements of Fed. R. App. P. 32(a)(5) and the type style
requirements of Fed. R. App. P. 32(a)(6) because this brief has been prepared in a
proportionally spaced typeface using Microsoft Word in Times New Roman 14
point font.
Dated: New York, New York
June 4, 2013
LAW OFFICES OF ERIC J. GRANNIS
By:
Eric J. Grannis
Attorneys for Amicus Curiae
18 East 48th Street, 19th Floor
New York, New York 10017
[phone]

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CERTIFICATE OF SERVICE

I hereby certify that on June 4, 2013, I electronically filed the foregoing amicus
brief with the Clerk of the Court for the United States Court of Appeals for the
Second Circuit by using the appellate CM/ECF system. The participants in the case
who are registered CM/ECF users will be served by the appellate CM/ECF system.
Dated: New York, New York
June 4, 2013
LAW OFFICES OF ERIC J. GRANNIS
By:
Eric J. Grannis
Attorneys for Amicus Curiae
18 East 48th Street, 19th Floor
New York, New York 10017
[phone]

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