Academic journal article Washington and Lee Law Review

The Usage and Meaning of "Clinical Significance" in Drug-Related Litigation

Academic journal article Washington and Lee Law Review

The Usage and Meaning of "Clinical Significance" in Drug-Related Litigation

Article excerpt

I. Introduction

Drugs and other pharmaceutical products are of such great importance, both to public health and to the national economy, that the issues surrounding their development, approval, use, and effects have spawned a considerable volume of litigation. Drug and pharmaceutical litigation can be broken down into three important categories based on distinct stages at which litigation is likely to arise. These include (1) suits for and against Food and Drug Administration (FDA) approval of new or reformulated drugs, which occur both before and after the drug is available on the market, (2) false advertising and patent infringement suits that develop as a result of the marketing of the drug, and (3) products liability suits that develop as a result of consumers' use of the drug.'

At each of these potential stages of litigation, parties are likely to encounter the concept of (or at least the use of the phrase) "clinical significance." This Note will demonstrate an absence of definition and an unevenness of understanding and application of that phrase in all of these drug-related contexts.2

It is not necessarily the case that the phrase itself is innately flawed (although "significance" is certainly a word that can present difficulties in interpretation).3 When the words "clinical" and "significant" have specific

definitions, either alone or in concert, for a given context, the potential problems are minimized, if not obviated entirely.' Such definitions may come from statutes or from precedents in case laws The definitions may be, and

indeed may have to be, only for very narrowly limited contexts.6 When these definitions appear, there is clarity and uniformity sufficient to make the terms useful in their given context.

However, despite this apparent capacity for precision of meaning and relative uniformity of understanding when the terms are defined and used separately, confusion and ambiguity are much more typical where the phrase "clinical significance" is concerned. The contrast between the majority and the dissenting opinions in a Sixth Circuit case, Glaser v. Thompson Medical Co.,' exemplifies the confusion.' Although the majority in Glaser uses the phrase "clinical significance" several times throughout its opinion, nowhere does it provide any definition or explication. The best indication of the majority's understanding is its apparent reliance on one expert's statement that the averages necessarily involved in finding "statistical significance" actually hide the real variations that are "clinically significant" for individual patients.9 This suggests a vague idea of clinical significance as something that can be determined by an individual physician by observation of an individual patient, in spite of statistics suggesting that the observation, and more importantly, the causal relationship posited, is untrustworthy. …

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