FRCP 16.1 Now in Play for MDLs—Game Changer or Not?

Rule 16.1 of the Federal Rules of Civil Procedure, titled “Multidistrict Litigation,” takes effect today, December 1, 2025. The adoption of this rule provides a long-awaited framework specific to district courts’ management of MDL proceedings. However, many critics of the new rule are concerned that it does not impose mandatory obligations on MDL courts, and thus lacks the teeth required to establish meaningful change.

Background

 MDLs are created when the Judicial Panel on Multidistrict Litigation (JPML) transfers cases “involving one or more common questions of fact … to any district for coordinated or consolidated pretrial proceedings.”^[1] The number of cases transferred into the MDL court depends on the litigation, but the largest MDLs have tens of thousands to hundreds of thousands of cases transferred for pretrial proceedings.

For decades, clear procedural rules specific to the management of MDLs were absent from the Federal Rules of Civil Procedure, leaving only the Manual for Complex Litigation and the JPML’s Rules and Procedures as guideposts for district courts managing MDL proceedings. Although the Federal Rules of Civil Procedure govern many aspects of MDLs, due to their complexity, MDLs are unique in many ways from other federal court litigation and require more robust procedural guidance. While MDLs are meant to streamline and efficiently resolve complex cases, the absence of any procedural rules tailored to MDLs made it increasingly difficult for district courts to manage these massive and intricate dockets. The need for a formal, uniform framework became more apparent recently, with MDLs dominating the federal caseload and calls for early vetting of claims becoming more vocal.

Recognizing these concerns, the Advisory Committee on Civil Rules established in 2017 the MDL Subcommittee to find an “appropriate way to address MDL proceedings in the Civil Rules.” The new Rule 16.1 is the result of the MDL Subcommittee’s efforts to “provide a framework for the initial management of MDL proceedings.”

What Is New In Rule 16.1?

First, Rule 16.1 emphasizes proactive and early case management in MDLs. Specifically, the rule provides that an MDL court “should schedule an initial management conference” for the development of an initial management plan for pretrial activity. If the court decides to conduct an initial management conference, it should require the parties to meet, prepare, and submit a report on a variety of issues, including consolidating pleadings, discovery, and pretrial motions. Thus, if followed, the rule will allow the MDL court, the parties, and their counsel to address procedural and substantive matters early on. However, it is important to note that the rule does not impose mandatory obligations on the court; it sets forth what the court should do and what it should require of the parties, but does not use terms such as “shall” or “must” with respect to the court’s decision-making.

Second, if the court orders the parties to prepare a report in advance of the Rule 16.1 initial conference, and unless the court orders otherwise, the report must include the parties’ initial views on whether leadership counsel should be appointed in the MDL proceedings, and if so, the timing of the appointment as well as the leadership counsel’s structure (including their responsibilities and authority in conducting pretrial activities)―hopefully streamlining a sometimes contentious and time-consuming process in MDL proceedings.

Third, Rule 16.1 sets the stage for early vetting of claims filed within an MDL. Assuming the court orders the parties to prepare a report in advance of the initial management conference, the parties are required to submit their views on “how and when the parties will exchange information about the factual bases for their claims and defenses.” The Advisory Committee Notes to the rule clarify that this language was included to address concerns “that some claims and defenses have been asserted without the inquiry called for by Rule 11(b)” and emphasize that “in many cases an early exchange of information about the factual bases for claims and defenses can facilitate efficient management.” MDL defendants should try to leverage this language to urge the court to require plaintiffs to present early proof substantiating their claims (such as proof of product purchase or disease diagnosis), which will help defense counsel identify non-meritorious or unsupported claims at the outset, avoid expending significant resources litigating those claims, and have a more accurate sense of the size of the claims at issue in the MDL.

Notably, despite the helpful framework the new rule provides, it does not mandate that the MDL court take any particular action with respect to the issues described above. For example, a court is not required to make early decisions regarding MDL leadership. Nor is it required to mandate that parties exchange information on their claims and defenses early on. Rather, the only thing that is required, assuming the court sets an initial management conference and orders the parties to prepare a report in advance of the conference, is for the parties to submit their respective views on how information will be exchanged. For this reason, many stakeholders are concerned that Rule 16.1 will do little, if anything, to improve the status quo.

How to Leverage New Rule 16.1

The implementation of Rule 16.1 presents an opportunity for defendants to push for early vetting of claims in both new and existing MDLs. Defense counsel should cite to the text of Rule 16.1 and its Advisory Committee Note to underscore to MDL courts that early vetting of claims is now an expected component of MDL proceedings―in particular, the Advisory Committee Note’s endorsement that the “early exchange of information about the factual bases for claims and defenses can facilitate efficient management.” However, if a particular MDL judge is resistant to changing their docket management procedures, the rule’s non-mandatory language does not provide parties with a meaningful ability to appeal or otherwise challenge a court’s decision to disregard Rule 16.1.

Defense teams should also expect resistance from plaintiffs, who may argue that early vetting is overly burdensome and/or not required by the plain language of the rule. In response, defense counsel can point to the Advisory Committee Note’s reminder that the Federal Rules of Civil Procedure are still in effect in all MDL proceedings. See Fed. R. Civ. P. 16.1 committee note (“The Rules of Civil Procedure, including the pleading rules, continue to apply in MDL proceedings.”).^[2] Defense counsel should push back on any attempts by plaintiffs to use the MDL framework to evade these and other basic requirements, including their non-frivolous pleading obligations under Rule 11.   

As with any new rule, it will certainly take some time for Rule 16.1 to take hold, and to see how effective it will be. For now, using the text of Rule 16.1 and its Advisory Committee Note, as well as the broader Federal Rules of Civil Procedure, should enable defense counsel to push back against evasive tactics from plaintiffs, and ultimately strengthen arguments for an early, and definite, procedure for the timely dismissal of unmeritorious claims.

Conclusion

For some, the adoption of Rule 16.1 holds promise for making MDL proceedings more manageable and potentially more conducive to early resolution. For skeptics, however, whether MDL courts will actually change their case management procedures because of this non-mandatory rule remains to be seen. Regardless, it will likely be several years before the impact of Rule 16.1 is clear.

The Crowell team will continue to monitor the impact of Rule 16.1 on MDL practice nationwide.