With all the hype around technology-assisted review (TAR) (a.k.a. predictive coding), you might think it’s just the latest technology toy for lawyers to figure out and then defend in front of a judge. For some legal practitioners, that’s certainly the case. But for others, TAR is another tool in the ever-expanding toolbox — one that can be applied not just reactively in a document production, but also for risk assessment purposes.
Despite its cutting-edge reputation, on the document production front TAR is approaching mainstream. But what if it could also be used proactively in business to help manage information — or gain insight into problems before they occur? Using these tools to identify patterns of behavior, risk decision points, and control data expansion has the potential to not only save money, but also facilitate proper risk planning and training in the ordinary course of business in all industries.
This approach has particular pay-offs for the pharmaceutical industry — which is highly litigious and fraught with potential products liability allegations — from research and development all the way through post-product launch.
Anecdotally, it has been uttered in more than a few plaintiff’s briefs that the litigation hold trigger should apply at product launch because “every pharmaceutical company knows” they will have litigation over a drug once it is launched. While that’s certainly not the standard imposed by law, nor is it good practice, there is some predictive benefit that might be gleaned.
For the general counsel’s office, which too often is involved after an allegation has been made, it can be helpful to do a risk assessment pre-launch to identify what kinds of issues a company might face once a drug or product is in wider circulation. This not only brings the legal team closer together with their business colleagues but helps foster more informed risk decision making from the beginning.
The idea of a pre-launch risk assessment is not new. Some companies have been doing this for years — they send teams of lawyers to interview key custodians on the clinical, drug safety, and marketing sides of the company, and review selected documents to gauge what the potential post-launch litigation environment might look like.
But deploying a team of lawyers for each new product launch is an expensive proposition, and in-person interviews across many departments can be time-consuming, cumbersome, and worse, expensive.
What if the lawyers “shiny new toy” could facilitate that analysis more quickly and get the information in the hands of decision makers at the company sooner? If deployed with finesse, TAR might just provide that service.
No Magic Bullet
But TAR is not a magic bullet — not when being used to cut costs and time for large document review projects, nor when being applied proactively. As with any production effort, a measured approach, supported by knowledgeable subject matter experts and a capable legal team, will be required for success.
So how would it work? First, identify the key players in the product development and launch. Who in research and development worked at the preclinical level on the synthesis and screening? What experiments did they run? Who worked on the Phase I-III clinical trials studying the pharmacokinetics, toxicology, efficacy and safety results? What trials were run?
If you identify the key players at this level, if they operate like most business people today, you can gain great insight into their work by looking at their email and electronic documents — or document collections like a SharePoint or other collaborative workspace. The resulting body of data and documents may not contain every lab notebook entry and study data file, but certainly the highlights from all of their work will reside in their collection of e-mail and documents.
Next, gather all the supporting information comprising the new drug application submitted to the United States Food and Drug Administration. Today, most of that information is in electronic form for submission, so capture is relatively easy and straightforward. Who worked on the new drug application submission? Gather a few key regulatory players and collect their data. Finally, gather some of the early marketing and sales key players’ data.
In total, your goal is to look at fewer than 10 to 12 custodians with very distinct time period date restrictions that can be applied — from the initial research and development phase through the eventual product launch and post-launch marketing phases.
Once you’ve gathered all your preliminary data from key custodians or collaborative workspaces, the process is simple. First, engage outside counsel that will likely be the go-to for advice and counsel on the product at issue — this could be anything from a lawsuit to a regulatory inquiry.
Ideally, choose a firm with experience in the appropriate practice area, ideally working with your company or a similarly positioned company within the pharmaceutical industry. For example, if you’ve just launched a cardiac drug, engage counsel that has handled other cardiac products for the company. Then, assign in-house counsel familiar with your company’s internal processes and a consultant knowledgeable about the process and TAR to manage the project.
By loading discrete data collections into a TAR tool and reviewing them for important or interesting documents, counsel can gain a high-level understanding of all issues — helpful and not so helpful — that might come up once the drug is officially launched. These can include safety indicators in a study, anomaly study results, potential for off-label marketing, potential future indications, or many other issues that may have been otherwise overlooked at this point in the development cycle.
Because outside counsel has been engaged proactively, attorneys can draft a privileged communication based on these results, and prepare both the general counsel and senior management team for any litigation landscape post-launch. More importantly, if anything is troublesome, corrective action can be taken proactively. This has the potential to reduce the risk of litigation before it even occurs — or even before product launch.
Post-launch, TAR can also be helpful to identify potentially noncompliant behavior. Product-by-product sampling of some key sales representatives’ email, for example, can be done to see if there are any training or compliance issues. If anything is found, a more thorough investigation can be launched on the company’s timeline rather than reactively in response to an external investigation. Again, done by the legal department in a proactive capacity, results can be protected by privilege and can be used to truly alter behavior before actionable issues arise, thereby reducing compliance risk.
So, while applying TAR for document production may be the latest technological innovation, it’s hardly the only application for the tool in the legal industry. If companies incorporate a process for proactively identifying potential future risks, the smart and careful application of the technology, supervised by counsel, can go a long way toward reducing the costs and burdens of the enterprise, resulting in a well-informed go-to-market plan — and even the potential to prevent problems from arising in the first place. •