Science and Law
27th July 2016

Science in The Courtroom: How to best prepare for a Science-Based Controversy

Science plays a central role in many aspects of the corporate structure: legal cases, regulatory affairs, consumer and media outreach programs, and of course medical research and development. As a result it is critical for legal teams to maintain a keen awareness of the science related to their cases.

Science in The Courtroom: How to best prepare for a Science-Based Controversy

Science plays a central role in many aspects of the corporate structure: legal cases, regulatory affairs, consumer and media outreach programs, and of course medical research and development. As a result it is critical for legal teams to maintain a keen awareness of the science related to their cases.

Maintaining Effective Scientific Awareness

Before we explore the four stages of a science-based controversy it’s beneficial to understand how a typical day-to-day process that a corporate entity follows to maintain scientific awareness.

In a typical organization, individuals (or small teams) are tasked with developing a process to monitor science that is relevant to the objectives of their organization.

Typically, their responsibility is to manually monitor, collate, disseminate and then package the information into a consumable format and then deliver it to into the corporate awareness.

This important (but laborious and time-consuming) process delivers science-based information that is then used as the bedrock on which to develop strategies that identify opportunities or threats. This information is then used to effectively manage risk to the organization.

What to do when controversy strikes

The process described above has been used for decades in day- to-day operations across a host of different industries to identify opportunities and risks.

However, controversy turns this methodical process into a maelstrom of uncertainty. Effectively and efficiently managing controversy calls for an entirely different set of skills, tools, and resources. To stay current with scientific information, and therefore have the right data to most effectively manage the threat or opportunity.

The following figure highlights the role of scientific awareness during four typical stages of a science-based controversy.

 

Stage 1: Pre-Controversy

Before a controversy hits, corporate scientific awareness tends to be passive and diffuse. Individuals or small teams funnel the scientific information into the corporate structure. These individuals or teams are referred to by many different names depending on the industry:

  • Risk Managers
  • Pharmacovigilance
  • Medical Information Services
  • Horizon Scanning

Stage 2: Post-Controversy

After a controversy is recognized, the scientific awareness becomes much more focused. It is during this phase that key decisions are made and questions are asked:

  • Is the product or exposure worth defending?
  • Is the Company going to confront the assertions head on?
  • Should the organization argue that the science supports a more nuanced position?

Stage 3: Regulatory Actions Filed

Next come the regulatory actions. [Giovanni to include Links] EPA, FTC, FDA, DEA. Very often we see these government agencies leading the charge before the legal actions are filed.

Stage 4: Litigation

The legal actions are, of course, being filed earlier and earlier in the process. This stage often defines the fate of a product: the product prevails, the product adjusts, or the product is removed from the market.

Throughout all four stages, we see scientific studies designed and conducted with the goal of developing clarity on the issue. And sometimes these studies definitively test the allegations at issue.

With today’s minute-by-minute news cycle and omnipresent social media, you’d be excused for thinking that there exist effective tools to help manage and monitor the science in Stages 2 through 4. The reality, is that most organizations engage in a hugely labor intensive process that is somewhat haphazard and incomplete.

We have written before on the five critical steps to effectively maintain an awareness of the scientific literature. Briefly, these steps include:

  1. Target and identify the right science so you can be sure the information you need is properly identified and nothing is missed.
  2. Alert the team to relevant science so you can be sure everyone who needs it, is informed and fully up-to-speed.
  3. Archive the science in an easily retrievable fashion so you have a centralized location to store and access the articles and information you need.
  1. Compile and tabulate the science relevant to specific litigation topics so you can fully leverage it to create effective cross examination modules that allow you to confront opposing experts with the totality of scientific information on your topic.
  2. Analyze and critique the science as it relates to the litigation so you can tear apart studies used by your opponent and highlight the studies that support your case.

Three Use Cases

Read about  three remarkable examples of organizations and their differing approach to scientific awareness and the very different outcomes , see our companion blog post: Science in the Courtroom: Three use cases that highlight the fundamental need to maintain scientific awareness.

 

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