This article explains the use of p-values as part of statistical analyses to support several types of pharmaceutical litigation, focusing on how lawyers can best present relevant studies to benefit their clients “when the math matters” and indeed critically affects the outcome of the dispute. The article begins with a conceptual discussion of p-values as utilized in the scientific community and continues by describing the substantial concerns many scientists have voiced about the use of p-values to show much of anything. The article then explains use by lawyers and judges of p-values in litigation, particularly three aspects of pharmaceutical litigation, where concerns about p-values sometimes are identified, but the discussion is typically relatively superficial and the broader concerns of the scientific community about p-values are neither generally understood nor discussed. In this section, the article dives deeper into three exemplar cases, showing how p-values were used and perhaps mis-used in those contexts. The article concludes by discussing principles of scientific communication that may help lawyers to break down the discussion and better explain “the math” in similar cases.
GW Paper Series
48 Vermont L. Rev. ___ (2023 or 2024).