The Litigator’s Guide to

Combating Junk Science

The Litigator’s Guide to Combating Junk Science

© 2013 Innovative Science Solutions 2

The Litigator’s Guide to Combating Junk Science

Table of Contents

Introduction .................................................................................................................................................... 3

What Is Junk Science? ................................................................................................................................ 5

Anti-Junk Science Websites ..................................................................................................................... 7

Anti-Junk Science Books ......................................................................................................................... 11

Resources for Regulatory Guidance ................................................................................................... 13

Resources for Scientific Standards ..................................................................................................... 16

Placebo and Nocebo Effects ................................................................................................................. 20

About Innovative Science Solutions .................................................................................................. 21

The Litigator’s Guide to Combating Junk Science

© 2013 Innovative Science Solutions 3

Introduction

Science plays a critical role in the courtroom. Access to scientific research and an

understanding of scientific principles enable the litigator to build a powerful case.

The team’s expert witnesses can effectively communicate to the judge and jury

technical concepts that support the central arguments of the case.

Five types of legal cases often rely on scientific information:

• Personal Injury: Scientific evidence is typically presented in mass torts

involving allegations of personal injury from a product, an environmental

exposure, or a chemical exposure. In these cases, plaintiffs rely on scientific

studies to demonstrate a link between the exposure and the injury. The

defense presents scientific research to cast doubt on the purported causal

relationship between the exposure and the injury.

• Consumer Fraud: To counter the plaintiff’s claim that a product failed to

achieve the results promised, the defense argues that its marketing claims are

supported by reliable scientific evidence. Plaintiffs will present evidence that

questions or counters the defense’s data.

• Medical Malpractice: To counter the plaintiff’s claim that a healthcare

provider’s error resulted in harm, the defense will present scientific studies to

demonstrate the provider adhered to the generally accepted standard-of-care.

• Securities and Shareholders Lawsuits: In securities and shareholder lawsuits

involving medical devices or pharmaceutical products, the defense presents

scientific evidence to demonstrate that the information relayed to

shareholders was reasonable and reliable.

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• Patent Challenges: Opposing parties in patent infringement cases will most

likely agree on the fundamental science. But the plaintiff will present specific

scientific evidence to support the claim that the patent does not meet the

necessary requirements.

The parties involved in any legal dispute will typically engage in a legitimate debate

about the validity of the scientific evidence presented. Even the experts often

disagree when interpreting scientific data.

However, dubious or bias scientific information is occasionally presented in court

cases, influencing the outcome. Judges and juries who lack the background and

knowledge to properly evaluate the validity of scientific data tend to accept the

information placed before them.

When a case relies on misinformation, unsubstantiated claims, and misleading data,

opposing counsel can successfully counterattack with access to the right resources.

In the following pages, we provide you with the tools and resources you need to

combat junk science in the courtroom.

• What Is Junk Science identifies examples of junk science.

• Anti-Junk Science Websites provides access to resources dedicated to

exposing junk science.

• Anti-Junk Science Books lists publications focused on illuminating the issue of

junk science.

• Resources for Regulatory Guidance provides access to government resources

that will allow you to counter misinformation with scientifically sound

principles.

• Resources for Scientific Standards provides access to reputable online

resources that present generally accepted scientific methods.

• Placebo and Nocebo Effects provides the latest research on this medical

phenomenon, which is central to many pharmaceutical cases.

The Litigator’s Guide to Combating Junk Science

© 2013 Innovative Science Solutions 5

What Is Junk Science?

Legitimate controversies erupt daily in political arenas, the news media, the

courtroom, and the court of public opinion. In these debates, valid evidence usually

emerges to support both sides. However, we have observed a number of

controversies in which one side relies on faulty data – or junk science – rather than

rigorous scientific methodologies.

Junk science refers to scientific research that fails to meet the criteria characteristic

of a rigorous scientific investigation, such as falsifiable hypotheses, replication, peer-

review and publication, general acceptance, neutrality, objectivity, and adherence to

the scientific method. Purveyors of junk science typically have an agenda, and

research and results are driven by non-scientific motives that are often political,

financial or ideological.

To illuminate the issue, we provide below examples of controversial claims based on

junk science, and links to resources refuting these questionable claims.

Controversial Claim #1: Electromagnetic radiation causes adverse health effects.

Junkscience.com - EMFs and Cell Phones

National Institute of Environmental Health Sciences - Electric and Magnetic Fields

Controversial Claim #2: Endocrine disruptors disturb human hormone balances.

SafeChemicalPolicy.org - Endocrine Disruptors

Sciencebasedmedicine.org - Endocrine disruptors—the one true cause?

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Controversial Claim # 3: Hydraulic fracturing leads to adverse health effects for

nearby residents.

Junkscience.com - Penn pilot study: Group of Bradford Co, Pa. residents concerned

about health effects of hydrofracking

K&L Gates Law Firm - Junk Science Meets Hydraulic Fracturing: Unfounded

Environmental Scare Threatens Energy Development

Controversial Claim #4: Multiple chemical sensitivity causes a host of adverse health

effects.

Junkscience.com - Multiple Chemical Sensitivity Testimony Inadmissible Under

Daubert, Court Says

Skepdic.com - multiple chemical sensitivity (MCS) from Skeptic’s dictionary

Controversial Claim #5: Vaccines lead to autism.

Junkscience.com - The risk of autism is not increased by ‘too many vaccines

too soon’

Nature - A case of junk science, conflict and hype

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Anti-Junk Science Websites

The following online resources are dedicated to exposing junk science. They offer a

wealth of information that counters assertions based on unreliable data.

Bad Science

Dr. Ben Goldacre, author of the bestseller Bad Science, continues his campaign

against junk science in his witty and insightful blog of the same name. In his book

and blog, he exposes the tenuous scientific claims of newspapers, doctors,

government reports and drug companies.

Bjorn Lomborg

Bjorn Lomborg, an adjunct professor at Copenhagen Business School, a bestselling

author, and a frequent media commentator, challenges mainstream concerns about

the environment. In news articles and social media posts, he strives to focus

attention on effective solutions to environmental issues.

Debunked & Exposed

Maintained by JunkScience.com, Debunked & Exposed offers Debunkosaurus™, a

Wiki-based tool for researching health scares and scams.

Gary Taubes

Gary Taubes is a science writer and the author of Nobel Dreams (1987), Bad Science:

The Short Life and Weird Times of Cold Fusion (1993), and Good Calories, Bad

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Calories (2007). He has won the Science in Society Award of the National Association

of Science Writers three times and was awarded an MIT Knight Science Journalism

Fellowship for 1996-97. Taubes’ books deal with controversies in the field of science.

Nobel Dreams takes a critical look at the politics and experimental techniques

behind the Nobel Prize-winning work of physicist Carlo Rubbia. Bad Science

chronicles the short-lived media frenzy surrounding the Pons-Fleischmann cold

fusion experiments of 1989.

JunkScience

“All the Junk That’s Fit to Debunk.” As its motto indicates, JunkScience.com’s mission

is to reveal the facts behind junk science in the media and the courtroom.

JunkScience takes on Global Warming theorists, the EPA, the American Heart

Association and others.

Not Even Wrong

William H. Kinney, associate professor in the University at Buffalo Physics

Department, named his website after the Wolfgang Pauli quote “It is not even

wrong.” The website is described as “A page dedicated to the ample evidence that

we need better science education.” Topics include vaccines and autism, EMFs, plastic

softeners, silicone breast implants, and more.

QuackWatch

QuackWatch is an international network of advocates who are concerned about

health-related frauds, myths and misconduct. Activities include investigating

questionable claims, debunking pseudoscientific claims, and distributing reliable

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publications, among others. Visitors can search the website’s vast database of

questionable products, services and theories by topic.

Science-Based Medicine

Science-based medicine evaluates medical treatments and products in a scientific

context. “Good science is the best and only way to determine which treatments and

products are truly safe and effective,” according to the website. Recent articles have

analyzed placebo prescribing, cancer screening tests, and SPECT scans.

Science-ish

Science-ish, a blog on the Maclean’s magazine website, checks health-related news

against the evidence to hold politicians, opinion leaders, and journalists accountable

for the information they disseminate.

Skeptoid

Skeptoid is a weekly podcast dedicated to debunking the widespread

“pseudosciences.” According to the website, “Skeptoid attempts to expose the folly

of belief in non-evidence based phenomena, and more importantly, explains the

factual scientific reality.” Topics include hydraulic fracturing, high-fructose corn syrup,

DDT, vaccine ingredients, cell phone radiation, and more.

STATS

Are you interested in the latest research questioning the purported connection

between cell phone use and brain cancer? Do you want to know why a leading

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expert condemned the crusade against BPA? Do you question the supposed link

between sugary beverages and obesity? You can find information on these topics

and more on the STATS website, an affiliate of George Mason University that aims to

correct scientific misinformation in the media and public policy. STATS offers

analyses of the latest research on key issues and links to revealing articles.

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Anti-Junk Science Books

The following books offer insight into the insidious nature of junk science and how

we can guard against it.

Junk Science Judo: Self-Defense against Health Scares and Scams

Steven J. Milloy

Cato Institute, 2001

218 pages

Book Description: This book is a simple, easy-to-read guide to debunking health

scares and scams before you get hurt.

Galileo's Revenge: Junk Science In The Courtroom

Peter Huber

Basic Books, 1993

288 pages

Book Description: A scathing indictment of the growing role of junk science in our

courtrooms. Peter W. Huber shows how time and again lawyers have used—and the

courts have accepted – spurious claims by so-called expert witnesses to win

astronomical judgments that have bankrupted companies, driven doctors out of

practice, and deprived us all of superior technologies and effective, life-saving

therapies.

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Voodoo Science: The Road from Foolishness to Fraud

Robert Park

Oxford University Press, 2001

240 pages

Book Description: In a time of dazzling scientific progress, how can we separate

genuine breakthroughs from the noisy gaggle of false claims? From Deepak

Chopra's "quantum alternative to growing old" to unwarranted hype surrounding the

International Space Station, Robert Park leads us down the back alleys of fringe

science, through the gleaming corridors of Washington power and even into our

evolutionary past to search out the origins of voodoo science. Along the way, he

offers simple and engaging science lessons, proving that you don't have to be a

scientist to spot the fraudulent science that swirls around us. While remaining highly

humorous, this hard-hitting account also tallies the cost: the billions spent on

worthless therapies, the tax dollars squandered on government projects that are

doomed to fail, the investors bilked by schemes that violate the most fundamental

laws of nature. But the greatest cost is human: fear of imaginary dangers, reliance

on magical cures, and above all, a mistaken view of how the world works. To expose

the forces that sustain voodoo science, Park examines the role of the media, the

courts, bureaucrats and politicians, as well as the scientific community. Scientists

argue that the cure is to raise general scientific literacy. But what exactly should a

scientifically literate society know? Park argues that the public does not need a

specific knowledge of science so much as a scientific world view – an understanding

that we live in an orderly universe governed by natural laws that cannot be

circumvented.

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Resources for Regulatory Guidance

The following government websites contain a plethora of valuable resources that can

be tapped when confronting junk science. Available information includes research

studies, databases, publications, news, regulatory guidelines, and a host of other

materials.

Food and Drug Administration (FDA)

The FDA is responsible for protecting public health by ensuring that foods are safe,

wholesome, sanitary and properly labeled (except for meat from livestock, poultry

and some egg products, which are regulated by the U.S. Department of Agriculture).

The FDA is also charged with ensuring that human and veterinary drugs, vaccines

and other biological products and medical devices intended for human use are safe

and effective. In addition, the FDA is responsible for protecting the public from

electronic product radiation, ensuring that cosmetics and dietary supplements are

safe and properly labeled, regulating tobacco products, and advancing public health

by promoting product innovations.

The following links to FDA guidances provide authoritative information related to

dietary supplements, food health claims, and radiation-emitting products:

Dietary Supplements - Draft Guidance for Industry

Food Health Claims - Guidance for Industry

Radiation-Emitting Products

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National Institute for Occupational Safety and Health (NIOSH)

The NIOSH is responsible for conducting research and making recommendations to

prevent work-related injury and illness. The mission of NIOSH is to generate new

knowledge in the field of occupational safety and health and to put that knowledge

into practice to benefit workers. To accomplish this mission, NIOSH conducts

scientific research, develops guidance and authoritative recommendations,

disseminates information, and responds to requests for workplace health hazard

evaluations. NIOSH is part of the Centers for Disease Control and Prevention (CDC)

within the U.S. Department of Health and Human Services.

United States Environmental Protection Agency (EPA)

The EPA’s mission is to reduce environmental risks based on the best available

scientific information. The agency is charged with protecting human health and the

environment by developing and enforcing regulations based on laws passed by

Congress.

United States Geological Survey (USGS)

The USGS provides impartial information on the health of the Earth’s ecosystems

and environment, the natural hazards that threaten humans, the natural resources

we rely on, the impacts of climate and land-use change, and the core science

systems that help us provide timely, relevant, and useable information. The USGS

provides reliable scientific information to describe and understand the Earth;

minimize loss of life and property from natural disasters; manage water, biological,

energy, and mineral resources; and enhance and protect our quality of life.

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United States Department of Agriculture (USDA)

The USDA is responsible for developing and executing U.S. federal government

policy on farming, agriculture, forestry and food. The agency provides leadership on

food, agriculture, natural resources, rural development, nutrition, and related issues

based on sound public policy, the best available science, and efficient management.

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Resources for Scientific Standards

The following independent organizations provide information on generally accepted

scientific standards and practices. Specific knowledge of scientific principles will

enable you to formulate an argument discrediting junk science.

The Cochrane Collaboration

From the Cochrane website:

“Cochrane Reviews are systematic reviews of primary research in human health care

and health policy. Cochrane Reviews are internationally recognized as the highest

standard in evidence-based health care. They investigate the effects of interventions

for prevention, treatment and rehabilitation. They also assess the accuracy of a

diagnostic test for a given condition in a specific patient group and setting. They are

published online in The Cochrane Library.

Each systematic review addresses a clearly formulated question; for example: Can

antibiotics help in alleviating the symptoms of a sore throat? All the existing primary

research on a topic that meets certain criteria is searched for and collated, and then

assessed using stringent guidelines, to establish whether or not there is conclusive

evidence about a specific treatment. The reviews are updated regularly, ensuring

that treatment decisions can be based on the most up-to-date and reliable

evidence.

Cochrane Reviews are designed to facilitate the choices that practitioners,

consumers, policy-makers and others face in health care.”

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Consolidated Standards of Reporting Trials (CONSORT)

From the CONSORT website:

“The main product of CONSORT is the CONSORT Statement, which is an evidence-

based, minimum set of recommendations for reporting RCTs. It offers a standard

way for authors to prepare reports of trial findings, facilitating their complete and

transparent reporting, and aiding their critical appraisal and interpretation.

The CONSORT Statement comprises a 25-item checklist and a flow diagram, along

with some brief descriptive text. The checklist items focus on reporting how the trial

was designed, analyzed, and interpreted; the flow diagram displays the progress of

all participants through the trial.”

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

From the PRISMA website:

PRISMA “is an evidence-based minimum set of items for reporting in systematic

reviews and meta-analyses.

The aim of the PRISMA Statement is to help authors improve the reporting of

systematic reviews and meta-analyses. We have focused on randomized trials, but

PRISMA can also be used as a basis for reporting systematic reviews of other types

of research, particularly evaluations of interventions. PRISMA may also be useful for

critical appraisal of published systematic reviews, although it is not a quality

assessment instrument to gauge the quality of a systematic review.

The PRISMA Statement consists of a 27-item checklist and a four-phase flow

diagram. It is an evolving document that is subject to change periodically as new

evidence emerges. In fact, the PRISMA Statement is an update and expansion of the

now-out dated QUOROM Statement. This website contains the current definitive

version of the PRISMA Statement.”

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Grading of Recommendations Assessment, Development and Evaluation

(GRADE)

From the GRADE website:

“The Grading of Recommendations Assessment, Development and Evaluation (short

GRADE) Working Group began in the year 2000 as an informal collaboration of

people with an interest in addressing the shortcomings of present grading systems

in health care. The working group has developed a common, sensible and

transparent approach to grading quality of evidence and strength of

recommendations. Many international organizations have provided input into the

development of the approach and have started using it.”

U.S. Preventive Services Task Force (USPSTF)

From the USPSTF website:

“Created in 1984, the U.S. Preventive Services Task Force (USPSTF or Task Force) is

an independent group of national experts in prevention and evidence-based

medicine that works to improve the health of all Americans by making evidence-

based recommendations about clinical preventive services such as screenings,

counseling services, or preventive medications. The USPSTF is made up of 16

volunteer members who come from the fields of preventive medicine and primary

care, including internal medicine, family medicine, pediatrics, behavioral health,

obstetrics/gynecology, and nursing. All members volunteer their time to serve on the

USPSTF, and most are practicing clinicians.”

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The National Research Council (NRC) and National Academy of Sciences (NAS)

From the NRC website:

“The National Research Council, created under the NAS charter in 1916 by executive

order of President Woodrow Wilson, extended the scope of the NAS in its advisory

role. The National Academy of Engineering (NAE) and the Institute of Medicine

(IOM) were founded under the NAS charter in 1964 and 1970, respectively. Together,

the NAS, NRC, NAE and IOM enlist the aid of the nation’s most knowledgeable

scientists, engineers, health professionals, and other experts who volunteer their time

to produce reports that have led to some of the most significant and lasting

improvements in the health, education, and welfare of all the world’s citizens. The

Academy's service to government has become so essential that Congress and the

White House have issued legislation and executive orders over the years that

reaffirm its unique role.”

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Placebo and Nocebo Effects

The placebo effect refers to a positive health outcome that results from a patient’s

belief that a treatment will be effective. The nocebo effect is the antithesis – it refers

to the symptoms patients experience due to their anticipation of those symptoms.

Both are real, physiological phenomena that can be measured using standard

scientific techniques. The placebo effect plays a significant role in lawsuits against

drug companies. Clinical drug trials typically include a placebo control group,

allowing researchers and the Food and Drug Administration to effectively evaluate

the efficacy of any new medication. The nocebo effect is also a factor, as participants

taking the placebo occasionally experience negative side effects.

The following resources provide essential background information on the placebo

and nocebo effects:

Pain Physician Journal - Placebo and Nocebo in Interventional Pain

Management: A Friend or a Foe - Or Simply Foes?

Journal of Biobehavioral Medicine - Drug-Related Information Generates

Placebo and Nocebo Responses That Modify the Drug Response

Badscience.net - Ben Goldacre on the Placebo and Nocebo Effect

Philosophical Transactions B (Biological Sciences) - Harnessing the placebo

effect: the need for translational research

The Psychiatrist - The placebo effect

The New Yorker - The Nocebo Effect: How We Worry Ourselves Sick

Discover - Are Warnings About Drug Side Effects Actually Making Us Sick?

Nocebo Effect - Think Sick and You’ll Be Sick

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About Innovative Science Solutions

Innovative Science Solutions (ISS) is a leading scientific consulting firm for the

worldwide pharmaceutical, biotechnology, and medical device industries. Our expert

team of scientists, regulatory strategists, and consultants provide a wide range of

fully integrated services to industry and counsel.

From strategic insight for FDA Advisory Committee meetings to scientific expertise

for complex litigation, ISS delivers specialized and effective solutions for your legal

and regulatory challenges. Let our proven combination of experience and innovation

work for you.

David H. Schwartz, Ph.D.

Head of Scientific Support to Counsel

A “scientific detective,” Dr. Schwartz excels at analyzing how science and law interact.

As head of ISS’s Support to Counsel practice, he helps clients defend and support

pharmaceuticals, industrial chemicals, medical devices, foods, and dietary

supplements in the courts, the regulatory arena, and the market place. With a talent

for communicating complex scientific information, Dr. Schwartz has become a go-to

for lawyers, business professionals, and financial and investment firms. Dr. Schwartz

specializes in providing strategic and tactical support to counsel in legal cases

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involving complex scientific issues. He has played a lead role in winning multi-billion

dollar legal cases for clients. With the sheer weight of the scientific data he’s able to

collect, evaluate, and present as evidence, he’s helped counsel win cases before

going to trial, saving ISS clients time and money.

Dr. Schwartz counts Daubert hearings among his biggest successes. His expertise

guides the ISS team across all disciplines related to the health sciences: toxicology,

epidemiology, environmental health and safety, biostatistics, pharmacology, and

regulatory affairs.

He has pioneered programs to critically review the scientific foundation of an

adversary's case and provided persuasive, evidence-based responses. For 20 years,

he has worked with the legal community evaluating product safety and defending a

host of products and exposures, including the following: welding rods, cellular

phones, ionizing and non-ionizing radiation, hydraulic fracturing and other drilling

technologies, breast implants, wound care products, dietary supplements, general

healthcare products, and a host of over-the-counter and prescription pharmaceutical

agents (including: antidepressants, dermatologics, anti-malarials, anxiolytics,

antipsychotics, and diet drugs).

Prior to founding ISS, Dr. Schwartz served as the Director of Scientific Litigation

Support for the law firm McCarter and English, where he played a principal role in

the safety evaluation of Prozac. Since then, he has guided clients using scientific

principles to defend products before, during and after launch.

Dr. Schwartz received a Ph.D. in Neuroscience from Princeton University and

postdoctoral training in Neuropharmacology and Neurophysiology from the Center

for Molecular and Behavioral Neuroscience at Rutgers University.

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Steven M. Weisman, Ph.D.

Head of Clinical and Regulatory Support

Dr. Weisman knows how to bridge the gap between science and marketing. As head

of ISS's Clinical and Regulatory Support practice, he focuses on the development of

scientific and regulatory approaches that increase a product's market potential. He's

an invaluable resource for scientific litigation support for products in crisis and,

under his guidance, ISS has encouraged firms to proactively monitor the safety and

effectiveness of their products and develop systems that reduce liability claims.

Dr. Weisman has over 20 years of experience in pharmacology, toxicology,

pharmaceutical product development, clinical and regulatory affairs, and marketing

evaluation and communication.

He played a leading role in the pharmaceutical industry's response to the removal of

PPA (phenylpropanolamine) from over-the-counter products. He's worked extensively

on management initiatives for opiate safety, antibiotic drug resistance, and

emergency contraceptives. He's even credited with establishing the safety and

continued marketing of artificial fingernail products.

Dr. Weisman is a leading authority on the switch of prescription-only products to

over-the-counter status and is widely published in these areas. His development and

support work includes shepherding the analgesic, Aleve, from a prescription-only

product to its popular over-the-counter form, and promoting the cardiovascular uses

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of aspirin for heart attack and stroke prevention. He is also recognized for effective

regulatory strategies that maximize the global market potential of regulated

products. His expertise in claim substantiation has helped clients successfully defend

against challenges to their marketing initiatives and saved them millions of dollars.

Prior to founding ISS he ran the Pharmaceutical and Food practices at a major

scientific consulting firm in Washington, DC. Before that, he served as Global

Director of Medical and Clinical Affairs at Bayer, Director of Strategic Research at

Sterling Winthrop, and held similar positions at Hoffman La Roche and Procter &

Gamble. He has organized and presented at numerous symposia, FDA advisory

committee meetings, and other regulatory venues, worldwide. He manages the FDA

advisory committee process for many of the largest pharmaceutical concerns and

represents companies before regulatory authorities in major markets around the

world.

Dr. Weisman received his Ph.D. in Pharmacology from Cornell University Medical

College and completed his postdoctoral training in Immunopharmacology at the

Roche Institute of Molecular Biology.

For more information, please contact us at 973.889.1600 or

info@innovativescience.net.