
The First MDL-Specific Federal Rule of Civil Procedure Now in Effect
Rule 16.1 Requires Parties to Address Meritless Claims Early on in MDL Proceedings
ABOUT
On December 1st, 2025, the first Federal Rule of Civil Procedure (FRCP) ever developed specifically to govern multidistrict litigation (MDL) proceedings took effect. MDLs are a special procedure where cases that share some common issues of fact are consolidated before one federal district court judge for the purpose of coordinating or consolidating discovery and other pre-trial proceedings.
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This new FRCP -- Rule 16.1 -- puts vetting of claims on the agenda for an early conference among the parties, and provides a comprehensive structure for the initial management of MDLs. One of its key features encourages the parties to exchange information at the outset about the factual basis of claims and defenses to help discourage or reduce meritless cases from infecting the management of MDLs.
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Prior to this Rule, ad hoc practices often resulted in many cases being filed in MDLs that either do not have proof of the signature injury or exposure to the product in question. These meritless cases, which account for approximately one-third of the claims in some mass-tort MDLs, can disrupt case management by complicating or even preventing settlement negotiations and upsetting the bellwether trial selection process.
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LCJ launched its Rules4MDLs campaign in April 2018 following its August 2017 Request for Rulemaking to the Advisory Committee on Civil Rules, which proposed amending the FRCP to solve several recurring problems in MDL proceedings.
SPOTLIGHT
Drug & Device Law Blog​
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Excellent MDL Early Vetting Order Raises Hopes for Rule 16.1
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June 23, 2025

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