Science and Law
4th February 2014

Integrating Science Into Early Case Assessment

An effective early case assessment (ECA) allows companies to anticipate and contain litigation costs. But when it comes to drug and device litigation, it’s essential to incorporate an early evaluation of the case’s scientific component.

Integrating Science Into Early Case Assessment

An effective early case assessment (ECA) allows companies to anticipate and contain litigation costs. But when it comes to drug and device litigation, it’s essential to incorporate an early evaluation of the case’s scientific component.

The importance of ECA in drug and device litigation has received a lot of attention in the trade press (see, for example, this interview with PD Villarreal and this piece by Lori Leskin). Villarreal is credited with developing the ECA methodology; he coined the term early dispute resolution system when he was counsel of litigation and legal policy for General Electric. According to Villarreal, with an effective early case assessment, “in 60 days… you will know 80 percent of what you will ever know about a case.”

We agree that ECA plays an important role when preparing a case. However, the critical scientific element is often overlooked when it comes to drug and device litigation. Without a thorough understanding of the case’s scientific aspects, it is impossible to make sound and informed decisions on any other front. To ensure the scientific component receives the attention it warrants, we have developed a new strategy: early scientific case assessment (ESCA). Unlike the issues that are purely legal in nature (e.g., jurisdictional strategy, framing questions for trier of fact, case law, etc.), ESCA focuses on the following questions:

  • What scientific evidence supports the causation arguments?

  • Is there a sound risk-benefit profile?

  • Who are the leading experts who can provide insight into the disease state?

  • Who are the leading practitioners who might be able to provide insight into the drug’s usage patterns?

  • How do company documents relate to questions of causation, warnings, and/or liability?

Components of ESCA

Focus on Causation

Drug and device product liability litigation often revolves around questions of causation. Even a case revolving around warnings typically includes a causation component. It is important to explore and assess the issue of causation early in the case. Significant causation questions include the following:

  • Can a valid case be made challenging causation?

  • Can causation be challenged under special circumstances of exposure (dose, frequency of administration, genetic predisposition, etc.)?

  • What is the nature of the scientific evidence that will be mounted against the product from a causation perspective?

The ESCA should address both general causation (is the drug capable of causing the injury under any condition?) and specific causation (did the drug cause the injury in this particular plaintiff or group of plaintiffs?).  Publicly available scientific literature and in-house studies (published or unpublished) are key components of this evaluation. The assessment should focus not only on studies of the drug-injury combination, but also on the demographics of the disease state and the complete mechanistic profile of the drug. This information can be gleaned from primary scientific literature, books, secondary literature, meeting abstracts and presentations.

Warnings and Regulatory Liability

Warnings and regulatory liability issues are also important components of the ESCA. Questions pertaining to warnings include adequacy, timing and clarity. Because such an assessment straddles the scientific domain and the legal domain, it requires collaboration between the expert consulting team and the legal team.

With respect to the regulatory perspective, it is important to evaluate the entire “peri-approval” period, including the pivotal clinical trials, the summary basis of approval, and data that was part of the integrated summary of safety (ISS). This information must be carefully evaluated to determine what was known and when it was known. As with the warnings evaluation, the regulatory liability assessment requires the joint efforts of the expert consulting team and legal team.

Conclusions

In our view, it is imperative to conduct a substantive ESCA when a pharmaceutical or medical device company faces product liability litigation. The ESCA should include a detailed review of the available scientific evidence related to the case and evaluate the data relevant to a causation assessment, a warnings assessment, and the case for regulatory liability. The evaluation should be performed by a team that has a thorough understanding of scientific principles and the expertise required to develop an effective approach to addressing the relevant questions.

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