Editor: What was your general reaction to the hypothetical on page 3?
Wise: I have seen real-life situations where causation has been even more attenuated. Ten years ago, the plaintiffs' bar was mindful of the need for a scientific basis of causation. Today's mentality appears to deem causation as irrelevant. Plaintiffs go to court without an expert who can accurately support their claim, but they are able to woo the jury into making a judgment irrespective of causation.
The predominance of our current caseload is in the pharmaceutical industry. Even within such a heavily regulated industry, we still see cases filed without regard to causation. I feel compassion for manufacturers in less regulated fields because they may not have similar compliance records to buttress their defense.
Editor: What skills sets are needed on the litigation team to help ensure that all relevant medical information is accessible?
Wise: An expert with a strong medical background as well as sophistication in how litigation works should be engaged to look at the company's studies and form an independent scientific opinion. While the company's PR agencies do damage control in the press, the litigation team needs to ensure that it has access to accurate medical information. The sooner an expert is engaged to tell corporate counsel the truth about the science, the stronger the team's legal strategy will be.
An early determination should be made as to which experts will be considered as testifying experts. Corporate counsel's discussion with the experts should include an assessment of potential damages.
A work flow within a records management database should be designed for tracking cases. The scientific literature should be tracked as well.
One of our recent cases involved a prescription drug. When early studies identified potential risks, warning labels were affixed. As the product entered the market place, thousands of people were taking it. The product's epidemiology was emerging as the litigation progressed. Their database proved vital for tracking the litigation and following the science as they evolved.
Editor: How would a TriageTM of the relevant records help to prepare an effective case management strategy?
Wise: Triage describes the process of sorting through data and setting priorities for addressing particular fact patterns. A Triage of documents in a products liability case begins with identifying the key elements of medical risk. We then look for documented exposure to the manufacturer's product and information about any harm to the plaintiffs.
As we look through the medical records, we ask if anyone has yielded a causation opinion. For example, if a toxicologist says that the product has caused the problems in the plaintiffs, we give our client a heads up on information related to that opinion.
We try to give insight into each plaintiff. For example, the plaintiff may have had pre-existing conditions that explain what has happened to the plaintiff. Our goal is to find data that the jury can use to assess the plaintiff's credibility.
Although actual values are not needed early in the litigation, it's helpful to group plaintiffs by nature and extent of injuries, patterns related to causation and other factors that might give the in-house counsel a closer read on how much the litigation may cost.
By doing a light-touch cost analysis of the plaintiffs, you begin to evaluate risk across the litigation. From that, you can determine how best to allocate your resources.
In one of our recent projects, the company's strategy focused on the fact patterns where some of the plaintiffs had definite exposure to the product and the causation of their illness was documented by medical science. The litigation team decided to take a proactive approach to segregating these high-risk cases for settlement and later tackling those with low risk, which proved to be an effective allocation of their resources.
Another of our recent projects arose out of an explosion in Puerto Rico. We started with a Triage of the 1500 relevant medical records to distinguish cases in which plaintiffs were pleading emotional damages versus physical damages. The bifurcation of cases enabled the litigation team to determine an appropriate strategy for each category.
To identify your high-risk cases, you need a fluid database that is not overfilled with data. Giving the decision makers a real-time overview of what is happening in the litigation can save millions of dollars.
Editor: What factors can drive up litigation costs?
Wise: A big factor is not accepting that litigation is a business reality. Anyone manufacturing a product will be sued. Including litigation defense in your business plan can save a lot of litigation costs.
Unnecessary costs in defending cases result from duplication of efforts. Frequently lead counsel, subject area specialists, associates, paralegals and everyone else in a law firm working on a matter are all touching files. To avoid unnecessary duplication, some companies mandate that only one or two people can bill for examining documents.
Poor communication can also drive costs. A budget supported by a clear work plan needs to be established early in the litigation so that everyone understands their assignments. Conformance with the budget should be monitored throughout the progress of the litigation to control costs.
A poorly designed infrastructure is a big mistake. Not investing in labor-saving technology is a false economy.
Resources need to be allocated effectively and their availability communicated. If the litigation team is not aware of the resources available to them, you are paying for a service without benefiting from it.
We have recently been named one of the primary service providers for DuPont. They save costs by qualifying their outside vendors and then listening to their advice.
Cost controls can come in many forms, including penalties for running over budget and rewards for coming under budget. They should be done in an orderly way.
Editor: What are the elements of a strong infrastructure?
Wise: The technology needs to be easy to use and inexpensive. To meet users' expectations, the document management system must have the capacity to support a massive amount of data and heavy pull on the system.
The system must be highly stable with no downtime. Local redundancy in real time is needed. That is, if someone is writing to one server, it needs to be mirrored in another. Disaster recovery planning should ensure that the information will not be lost and business can go on as usual in the event of fire, flood, terrorist attack or other destructive event.
On most litigations teams, the degree to which lawyers, paralegals and others on the litigation team use technology varies greatly from team member to team member. Most of the users will just go online to look at materials. Team leaders need the capability to make work assignments and track the litigation calendar. The finance people need to be able to track productivity and what the ultimate billing will look like based on the budget.
The system needs to be managed securely so that those who are responsible for keeping the documents untouched are able to implement security controls from their desks.
The lead litigators need to be able to trend how the litigation is going. They need to know in real time when new medical or other facts come to bear rather than being surprised on the eve of trial.
Editor: What scalability and interoperability issues need to be considered in implementing a strong infrastructure?
Wise: Look for a systems design that accommodates change in a cost effective way so that you are not constantly retrofitting and having to purchase new software. The infrastructure needs to be built in a thoughtful way to take advantage of new capabilities as technology improves.
Any new product needs to be compatible with the existing systems both within the legal department and within its law firms. Law firms have made a lot of investments in technology, and it is unrealistic to expect everyone to abandon their familiar tools.
Editor: How can search tools help a litigation team to develop meaningful reports?
Wise: Search tools can alert litigators to the unfolding of science. Let's say that the company's initial studies did not reveal any product risks, but independent studies later reveal troublesome facts. The litigation team will want to know the emerging facts in real time. An effective search tool can generate a report on the universe known at the time of the litigation is filed and can build on the data fields to populate later reports.
Our search tools use optical character recognition, which enables a user to do spontaneous searches on any printed word. In one product liability case, we learned that that lawsuits related to a competitor's similar products were filed. We were able to use OCR to determine how many plaintiffs in our case used the competitor's products. That was something that could have cost thousands of dollars if the records had been searched by hand.
Editor: How can defense of cases filed in multiple jurisdictions be effectively coordinated?
Wise: A clear line of authority is essential so that everyone knows their roles and responsibilities. For example, if one in-house counsel has the authority to push the whole litigation strategy, it should be clear to everyone in the picture.
An effective communication plan should be supported with tools like websites and database search engines. On the occasion when face-to-face meetings are required, they should be effectively run.
An eye should always be kept on the bottom line. A budget should be established as soon as possible, adapted as necessary as the litigation evolves and reviewed when the matter closes so that cost effective practices can be implemented and long-term savings enjoyed.