What Is Junk Science?
Total Page：16
File Type：pdf, Size：1020Kb
Second Edition SCIENTIFIC CONSULTANTS to INDUSTRY and COUNSEL www.innovativescience.net ● 973.889.1600 The Litigator’s Guide to Combating Junk Science Table of Contents Table of Contents ........................................................................................................................ 2 Introduction ................................................................................................................................. 3 What Is Junk Science? ................................................................................................................ 6 Limitations of the Peer-Review Process ............................................................................... 12 Teaching Science To Jurors ...................................................................................................... 15 An Example: Explaining Complex Science/Statistics Using Trial Graphics ................. 18 Anti-Junk Science Websites .................................................................................................... 25 How to Evaluate Scientific Sources Online ......................................................................... 29 Anti-Junk Science Books ......................................................................................................... 31 Resources for Regulatory Guidance ...................................................................................... 37 Resources for Scientific Standards ........................................................................................ 43 Placebo and Nocebo Effects .................................................................................................... 46 Preparing An Expert To Testify .............................................................................................. 48 More Preparation For Your Expert ......................................................................................... 56 It’s Not Just Science That Can be “Junk”: Trial Graphics Can Be, Too ......................... 58 About Us ..................................................................................................................................... 63 © 2015 Innovative Science Solutions / A2L Consulting 2 The Litigator’s Guide to Combating Junk Science Introduction In many legal cases, science plays a critical role in the courtroom. Access to scientific research and an understanding of scientific principles, as well as the ability to convey this information to jurors and the court in an effective way, enable the litigator to build a powerful case if these tools are properly used. The team’s expert witnesses must effectively communicate to the judge and jury technical concepts that support the central arguments of the case and show how they fit within the relevant law, but first they must be able to sort the sound science from the junk science. Examples of legal cases that often rely heavily on scientific information and testimony: ■ Personal Injury: Scientific evidence can be important to any personal injury case, but it is almost always critical in mass torts litigation involving allegations of personal injury from a product, an environmental exposure, or a chemical exposure. In these cases, plaintiffs typically rely on scientific studies to demonstrate a link between the exposure and the injury, while the defense typically presents scientific research to cast doubt on the purported causal relationship between the exposure and the injury. ■ Consumer Fraud: In these cases, a plaintiff’s claim that a product failed to achieve the results promised, the defense typically argues that its marketing claims were supported by reliable scientific evidence. The plaintiff typically then reply with evidence that questions or counters the defense’s data. ■ Medical Malpractice: To counter a plaintiff’s claim that a healthcare provider’s error resulted in harm, the defense will typically present scientific studies to demonstrate that 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 typically presents scientific evidence to demonstrate that the information relayed to shareholders was reasonable and reliable. ■ Patent Challenges: These types of case generally focus on science in the form of technology. In such cases, often the plaintiff’s challenge is to establish that the © 2015 Innovative Science Solutions / A2L Consulting 3 The Litigator’s Guide to Combating Junk Science defendant’s actions infringe the plaintiff’s patent and in doing so may rely on scientific evidence relating to how that technology is implemented in the real world. Moreover, the defendant will have their own scientific evidence to counter the plaintiff’s, as well as potentially adding scientific evidence relating to the state of the prior art with respect to the asserted patent in an effort to invalidate its claims as a defense to infringement. There are certainly many other examples of the importance of science to litigation, but those set forth above are common. The parties involved in any legal dispute will typically engage in a debate about the validity of the scientific evidence presented. Even the experts often disagree when interpreting sound scientific data. However, dubious or biased scientific information is occasionally presented in court cases and unfairly influences outcomes. 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, for better or worse. When a case relies on misinformation, unsubstantiated claims, and misleading data, opposing counsel can successfully counterattack by using and providing access to the right resources. In the following pages, we provide you with tools and resources you need to combat junk science in the courtroom. The remainder of this Guide is structured as follows: ■ What Is Junk Science identifies examples of junk science. How can you combat junk science if you cannot identify it. This section provides information and resources to do just that. ■ How to Evaluate Scientific Sources Online. Further to the previous section, here we provide you with a checklist for identifying credible scientific sources. If you can identify the “good” then you can spot the “junk.” ■ Limitations on the Peer-Review Process. Peer review is one of the foundations of good science, but the concept is also abused to push junk science. How do you tell the difference? This section sheds some light on the issue. ■ Anti-Junk Science Websites provides access to resources dedicated to exposing junk science. You are not alone in the battle against junk science. In this section we provide a plethora of resources developed by your allies in this endeavor. © 2015 Innovative Science Solutions / A2L Consulting 4 The Litigator’s Guide to Combating Junk Science ■ Anti-Junk Science Books lists publications focused on illuminating the issue of junk science. The fight against junk science in the courtroom has raged for many years. This section identifies some terrific resources for continuing this fight. ■ 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 cases, and pharmaceutical-related cases in particular. © 2015 Innovative Science Solutions / A2L Consulting 5 The Litigator’s Guide to Combating Junk Science 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, in some controversies, one or both sides rely on faulty data—or junk science—rather than data generated using rigorous scientific methodologies. The term “Junk Science” refers to scientific research that fails to meet the basic standards of a rigorous scientific investigation, such as falsifiable hypotheses, replication, peer-review and publication, general acceptance, neutrality, objectivity, and adherence to the scientific method. Another layer of complexity has also emerged with the revolution in electronic scholarly publishing, which has spawned predatory open-access publishers and journal. Purveyors of junk science typically have an agenda, and their research and results are driven by non-scientific motives that may be political, financial or ideological. Junk science is different from science that is merely imperfect or incomplete. Junk science studies do not adhere to the core scientific principles described above, although they present themselves as doing so. However, the scientific process is not perfect and our understanding of © 2015 Innovative Science Solutions / A2L Consulting 6 The Litigator’s Guide to Combating Junk Science certain topics may change as new data emerge. The following are some qualities of solid scientific research: ■ Peer reviewed ■ Large sample sizes, when possible ■ Control for independent variables ■ Use blinding, randomization, and appropriate control groups ■ Objective and unbiased Junk science fails one or more (or all) of these tests. For instance, a case report or case series