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5/1/2024 By Elizabeth Hanke

Key is balancing the big picture and claim-specific details — and having a great database!

Why is it so challenging for defendants to manage, and more importantly make strategic use of, the data (and documents) collected in mass torts involving drug and medical devices?  Products-related litigation is a reality for all drug and medical device manufacturers — so much that even the liability insurance policies written for such companies include a “maintenance deductible”. This somewhat nebulous concept states that the insurance doesn’t really kick in unless you exceed the “expected” number of claims … but that’s a discussion for another blog.

Even the largest Multidistrict Litigations (“MDLs”) start with “a” case (or two) and can very quickly jump to tens, hundreds and even thousands of cases and plaintiffs. Consider the MDL ordered in the Eastern District of Pennsylvania in February 2024 for claims relating to the use of glucagon-like peptide-1 receptor agonists (“GLP-1 RAs”), which are medicines prescribed for, among other things, the treatment of type 2 diabetes. This includes Ozempic, Wegovy and Rybelsus which are brand names for the drug semaglutide manufactured by Novo Nordisk as well as Trulicity and Mounjaro, which are manufactured by Eli Lilly. Note: KCIC does not work on this case. It is used here as a hypothetical, with publicly available data.

The use of GLP-1 RAs is growing in popularly for diabetes and weight management. Ozempic was only approved for use in treating diabetes in 2017 and was approved in 2021 under the brand name Wegovy for use in treating obesity. Ozempic and Wegovy are the same drug, but dispensed in different doses depending on whether it is being used for diabetes (Ozempic) or obesity without diabetes (Wegovy). At the time the MDL was created, there were more than 55 cases, with most plaintiffs alleging that the drug’s manufacture downplayed certain gastrointestinal side effects. More than nine million prescriptions have since been filled for just Ozempic and Wegovy; with that popularity it seems inevitable that more litigation will follow.

Despite the reality of products-litigation, defendants still struggle to manage certain aspects of their data effectively AND efficiently. Frequently, interested parties track only the data points they need to do their job, with little collaboration or coordination with each other. Why? Because the data needs to be tracked on both a macro and micro level, and it can be overwhelming to try and do that all with an “off the shelf” litigation management system.

The GLP-1 RA MDL is still in the early stages but consider what a defendant such as Novo Disk needs to effectively manage the current litigation (and be prepared for any future litigation).

The company needs to answer macro-level questions about what’s going on with the litigation as a whole such as:

  • How many cases have been filed; when, where and by whom?
    • What plaintiff firms are involved?
    • What jurisdictions are involved?
  • How many plaintiffs are on the cases?
  • How many existing cases have been transferred to MDL and how many remanded?
  • What are the general allegations (e.g. failure to warn, product defects, warranty-related?)?
  • What are the injury allegations and are they meaningfully different between cases or drugs used?
  • What is the defense spend on the cases as a whole?
  • Is defense counsel responding consistently to all the cases?
  • Is there any potential insurance for these claims now or in the future?

In addition, micro-level, plaintiff-specific issues need to be addressed to defend the cases:

  • Procedural status and considerations tracked for each case, including applicable MDL case management orders.
    • Process for complaints moving to MDL from various jurisdictions.
    • Manage procedural and discovery documents being collected for each case and plaintiff; so many documents.
    • Manage remanded cases not going to the MDL.
  • Draft specific answers to complaints and basic interrogatories for each case.
  • Collect plaintiff-specific data; develop a plaintiff fact sheet and mechanism to collect consistently across all plaintiffs, ideally electronically.
    • Specific GLP-1 RA used and dose information for each plaintiff.
    • Key medical data points collected for each plaintiff (age, weight, diabetes related info, other health conditions, other medicine taken at the same time, etc. possibly taken at different times while on Ozempic).
    • Alleged injury — what it was, when it happened, and how that is relative to when the plaintiff used the drug?
    • Other plaintiff-specific factors that may end up on a plaintiff fact sheet (name, DOB, health history).
  • Identify bellwether-worthy cases.

None of the above questions and issues are unexpected to anyone working in this space, yet KCIC has worked with many defendants who — upon retaining us — couldn’t say how many cases they have, much less how many plaintiffs are on those cases. This is especially true if there is an MDL where cases can be transferred to, or if cases were dismissed and refiled in the MDL — sometimes with different combinations of plaintiffs on the refiled case. Managing the changes in plaintiffs on multi-plaintiff cases can be its own full-time job.

Typically, KCIC sees the defendant, or its national coordinating counsel, implement the macro level tracking using a litigation management system, or they use everyone’s favorite litigation tracker: MS Excel. Even with these systems, an MDL presents challenges as existing cases move to the MDL while new cases are also being filed in and outside of the MDL, sometimes resulting in duplicative counts.

Individual local defense counsels may use their own tracking systems and discovery tools, and they are generally the document keepers. Let’s say each local counsel has a great system and does a fine job managing their own cases. Still, when the systems and protocols differ between firms, the data collected cannot be easily combined to answer macro-level, strategic, questions. It’s very common to see email being used to keep everyone informed of new cases; sometimes with 40-plus recipients being sent documents and summary listings of new cases. Those attachments are then downloaded and possibly renamed by each individual, all saved on different systems. The duplication of documents and effort is astounding and will eventually cause a backlog of information dissemination or worse — something will be missed.

This is especially a problem as the case progresses and important facts develop. Consider the GLP-1 RA example. As the underlying cases develop, particular facts may begin to emerge across cases, which could drive resolutions towards settlements or dismissals. The sooner a defendant can identify those facts, the better the outcome. These types of developments necessitate counsel wanting to search across “all” plaintiffs for certain facts. Examples may include: Which plaintiffs had certain other health concerns or co-morbidities? Did they take certain other medications?

In the GLP-1 RA example, we know one allegation was a failure to warn about certain gastrointestinal side effects. Presumably the warning label has since changed, so all cases involving plaintiffs who took, or continued to take a particular drug after the label was changed could arguably be dismissed. Identifying those plaintiffs quickly requires tracking the product usage dates in a usable database format consistently among all the defense counsel — not in a text-based system or in a case summary Word document. Comparing the dates of use of a drug with the date of injury and usage sounds easier than it is when in reality there are hundreds or thousands of plaintiffs.

Questions like these take a tremendous amount of time and effort by defense counsel and their paralegals. On medium to large cases, it is common to have several full-time staff dedicated to answering such data-based ad hoc questions needed for strategic decision making.

KCIC is often retained after the case volume reaches a level exceeding counsel data management capabilities, or when counsel are overwhelmed having to answers ad hoc questions. Each question requires them to look up the data and documents again (and again and again). Having to organize and collect data can distract them from their primary job of defending the cases! This is especially a challenge when there is a “virtual defense team” across multiple defense firms, each with certain specialties and directives.

While the case facts and necessary data points for any particular drug (or medical device) differs, there are enough similarities between them to be able to glean a few common suggestions for improvements:

  • Don’t wait for things to get crazy; coordinate processes and data collection between systems from day 1.
  • Use as few different data-management platforms and systems as possible; invest the time to make sure they can “talk” to each other.
  • Create a standardized numbering system shared by all parties for both the case-level complaints and plaintiff-level; this is incredibly valuable and possibly my top recommendation. Consistent ID’s make data collection more scalable and allow defendants to leverage electronic systems, even across different platforms.
  • Use a consistent team, or have significant overlap between teams, so that efficiencies (or lack of) and economies of scale can be identified and leveraged early in the case.
  • Have a well-documented process for disseminating new filings to various counsel and interested parties, ideally one that does not involve sending an attachment via email to 50+ people.
  • Create a shared document repository with consistent naming conventions, sufficient security protocols and meta-data tied to the aforementioned numbering system.
  • Track claim specific data points in a standardized “data” format linked to whatever text-based fields are needed. Using the text fields for context alongside data points allows for easier summarizing and minimizes the number of times the same documents need to be reviewed.
    • For example, use drop downs, date fields, standardized units, and multiple-choice questions to create broad categories while also using text-based fields to collect more claim-specific and nuanced context.

With extra planning and upfront time, a defendant in a drug or medical device litigation can save significant money while making data-driven strategic decisions, ensuring the best possible outcome whether they have 10 or 10,000 cases.

Elizabeth Hanke

About Elizabeth Hanke

For nearly 25 years, Elizabeth Hanke has been a trusted advisor in both the settlement and litigation arenas, and KCIC clients can always expect her to work passionately on their behalf.

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