You are defending a client in a case involving exposure to an alleged toxic substance (drug, device, chemical, consumer product), and you’re buried under scientific health outcome data.
You are defending a client in a case involving exposure to an alleged toxic substance (drug, device, chemical, consumer product), and you’re buried under scientific health outcome data. You’re confronted with case report evidence, surveys, animal studies, and some controlled human studies purporting to link your client’s product to adverse health effects, including the event at the heart of your case. Your expert, or more likely one of your partners, suggests that you apply the “Bradford Hill Criteria” to cast doubt on this evidence and bolster your case.
Presented by Sir Austin Bradford Hill in 1965, the Bradford Hill Criteria are widely used by scientists to evaluate a possible link between an agent and an illness. The Bradford Hill Criteria have garnered a great deal of attention in scientific literature (see, for example, this recent review) and the legal academic press (see, for example, this article).
Below are five reasons you should consider using the Bradford Hill Criteria in your next case involving personal injury from a drug, medical device, supplement, chemical exposure, or consumer product.
1. It’s the Right Way To Evaluate Causation
It’s a mistake to draw definitive conclusions about health risks from the results of a single epidemiological study. Scientists have recognized for decades that a set of criteria is required to properly evaluate a body of scientific evidence and determine if that body of evidence supports causation. One of the earliest sets of causal criteria is referred to as the Henle-Koch postulates and dates back to the 1800s. These criteria were designed to provide guidelines for the assessment of acute infections. The next major advance in the development of causal criteria was the 1964 Report on Smoking and Health, developed by the Surgeon General of the United States. Two years later, Sir Austin Bradford Hill made his presentation to the Royal Society of Medicine in which he set forth nine criteria to establish causation.
Since the publication of Hill’s criteria, they have been used to assess a plethora of causation pathways, including the following:
The Bradford Hill Criteria represent the most effective and common approach to evaluating causation in the scientific community.
2. It’s the Best Way to Combat Anecdotal Evidence
In our experience, the plaintiff’s team thrives on chaos and confusion. They like to inundate judges and juries with copious data points, some of which appear to link the exposure of interest to the adverse health event. They tend to dismiss important factors like methodology and rigor. Most of their information is typically based on anecdotal evidence, not scientific methodologies.
Your job is to insist on a systematic, structured approach to reviewing the data. And the Hill criteria are tailor-made for such an approach. They provide you with a well-documented, authoritative, and reliable methodology for determining whether the data fail to demonstrate causation.
3. Your Adversary Doesn’t Want You To
The Hill Criteria will not only weaken your opponent’s case, but also throw them off balance. As noted earlier, counsel for the plaintiff doesn’t like a systematic and rigorous approach to evaluating data. They rely on anecdotal evidence to make their case. Forcing your adversary to apply the Bradford Hill Criteria will diffuse their strategy.
4. It Puts Epidemiology Into the Appropriate Narrative Structure
Epidemiological studies are dry and sometimes complex. It is difficult to develop a clear direct examination using them as a basis and even more difficult to cross examine an opposing expert. The testimony can have an arbitrary feel to it as you pivot from one study to the next without a clear narrative structure.
The Hill criteria provide you with that narrative structure. Instead of addressing individual studies in a vacuum, you can use them to show how they fail to meet each criterion that Hill sets forth. Hill’s criteria serve as a litmus test, invalidating the data presented by the plaintiff.
5. It Works
Litigators have applied the Hill criteria in a multitude of personal injury lawsuits over the years to put the epidemiology into the appropriate context. Most notably, the Hill criteria were used by the Science Panel convened in the silicone breast implant litigation as an organizing principle to conclude that silicone breast implants failed to cause systemic autoimmune disease. The criteria have been used to effectively defend against claims linking ephedra to cardiovascular disease, phentermine to pulmonary hypertension, and welding rod fumes to neurodegenerative diseases. The Bradford Hill Criteria is a time-tested, proven approach to evaluating data in the laboratory and the courtroom.
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