Science and Law
15th July 2014

Are you Forcing your Opposition to Review the Science Systematically?

Whatever the details of your toxic tort, pharmaceutical, medical device, or environmental case, odds are that you will confront multiple scientific studies, sometimes referred to by plaintiffs as “lines of evidence.” Plaintiff counsel will then assert that this evidence, “taken as a whole,” supports their case. Synthesizing these scientific studies into a coherent assessment is ultimately what the legal controversy is all about.

Are you Forcing your Opposition to Review the Science Systematically?

Whatever the details of your toxic tort, pharmaceutical, medical device, or environmental case, odds are that you will confront multiple scientific studies, sometimes referred to by plaintiffs as “lines of evidence.” Plaintiff counsel will then assert that this evidence, “taken as a whole,” supports their case. Synthesizing these scientific studies into a coherent assessment is ultimately what the legal controversy is all about. Therefore, the methodology for performing this assessment is a critical component of your case.

We all agree that an expert should not be permitted to cherry pick the studies he believes supports his opinion and ignore studies that fail to support his position. He is not allowed to whimsically decide which studies go into the analysis based on some guru-like sixth sense that he alone possesses. Rather, the expert must follow a clear, reproducible, well-articulated process. The good news is that the scientific community agrees upon a specific methodology for reliably assessing the totality of the scientific evidence. 

The process is called a Systematic Review.

As Daubert challenges have become more popular over the last 20 years, lawyers have become familiar with the view that the reliability of an expert’s methods must stand up to scrutiny. But the systematic review process is a “method of a method.” It is a set of rules that governs how a scientist is allowed to approach and synthesize a body of literature on a particular topic. And it is a very valuable tool that should not be overlooked by Defense lawyers. 

In a recent article, five scientists from the Office of Health Assessment and Translation (OHAT) from the Division of the National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) have published such a roadmap. In their paper, they summarize the 5 steps that must be taken in a Systematic Review and provide a description as to how to conduct these steps reliably:

  • Step 1: Problem formulation and protocol development
  • Step 2: Search for and Select Studies for Inclusion
  • Step 3: Data Extraction
  • Step 4: Assess Quality and Risk of Bias
  • Step 5: Rate the Confidence in the Body of Evidence
  • Step 6: Translate the Confidence Rating into Level of Evidence for Health Effect
  • Step 7: Integrate the Evidence to Develop Hazard Identification Conclusion

At the end of the assessment (in Step 7), the evidence is assessed to determine the “hazard identification conclusion.” The five hazard identification conclusions outlined by OHAT are as follows:

  1. Known to be a hazard to humans
  2. Presumed to be a hazard to humans
  3. Suspected to be a hazard to humans
  4. Not classifiable as a hazard to humans
  5. Not identified to be a hazard to humans

Of course any exposure should meet the highest two hazard identification conclusions (“known” or “presumed” to be a hazard to humans) to meet the burden of proof for a civil action (i.e., preponderance of the evidence). 

The value of this approach is that it provides a well established, well defined methodology and the rules are set forth independent of any specific controversy or topic. This helps prevent the type of cherry picking of data that we see too often in mass tort litigation where an expert reverse engineers the assessment of the evidence based on his or her conclusions.

The OHAT document provides a firm basis upon which to challenge opposing experts in their assessment of the evidence. It should provide defense lawyers with an excellent authoritative source to confront an opposing expert who is using poorly characterized or inappropriate methods for reviewing the totality of the data on a subject and impeach the credibility of the analysis.

Of course, the OHAT framework is not the first authoritative source to clearly set forth the basic methodology for synthesizing the scientific evidence related to human health effects. Applying systematic reviews in the context of non-randomized studies (i.e., observational studies) has been the subject of various workshops and consensus statements (for example, see here and here). AHRQ has provided a clear guidance for Systematic Review processes for human clinical trial data and the elements of a well-developed systematic review are set forth in the PRISMA guidelines (again with a focus on human clinical trials).

 

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