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First MDL-Specific Rule Approved by Committee on Rules of Practice and Procedure


New FRCP Rule 16.1 Will Help Courts and Parties Address Claim Insufficiency in MDLs


WASHINGTON, D.C. – June 4, 2024 – Today, the Committee on Rules of Practice and Procedure voted to approve proposed Rule 16.1, the first multidistrict litigation- (MDL) focused Federal Rule of Civil Procedure (FRCP), for which Lawyers for Civil Justice (LCJ) has long advocated. The proposed new Rule seeks to address the need for transparent, rules-based practices and procedures applicable to MDLs – where important, existing federal rules of civil procedure that should apply to all federal civil cases, are now commonly bypassed. The proposed rule identifies and addresses important MDL issues that courts and parties should consider at early management conferences, including early vetting of claims.


“Rule 16.1 will focus courts and parties on ensuring that the claims in an MDL actually belong in the proceeding, and will do so early on,” said Alex Dahl, General Counsel, Lawyers for Civil Justice. "If employed appropriately, the new Rule will prevent meritless claims from being asserted in the first place and also give courts a new management tool for addressing any such claims that are filed.”


LCJ has advocated throughout the years-long rulemaking process for an effective version of Rule 16.1, from welcoming the publication of Draft Rule 16.1, submitting a comment letter on modifications to Draft Rule, facilitating a letter by 55 companies, and submitting a supplemental comment letter on the issue of unexamined claims. Most recently LCJ submitted an additional comment letter on the agenda book version of Rule 16.1.


Recently released data from the Judicial Panel on Multidistrict Litigation (JPML) and the United States Courts analyzed by LCJ shows that 71.3% of the federal civil caseload (417,137 cases out of 584,986 federal civil cases) reside in MDLs as of the end of fiscal year 2023 (FY23). This data highlights the necessity of Rule 16.1 to address the unique procedural challenges posed by MDLs. Additionally, recent empirical evidence from LCJ shows that tens of thousands of unsupported claims have been asserted in recent large MDLs, such as:

  • Mentor Transobturator Sling – 75 percent of the cases were dismissed

  • Pelvic Mesh – 53 percent were dismissed

  • Zofran – 40 percent were dismissed

  • Cymbalta – 31 percent of the cases were dismissed


With today’s approval of proposed Rule 16.1, it will now be sent to the Judicial Conference for consideration. If approved, the Rule will then be reviewed by the U.S. Supreme Court, which is expected to send the final version to Congress in early 2025. Barring action by Congress to disapprove the new Rule, it will take effect on December 1, 2025. More information about the rulemaking process for the Federal Rules of Civil Procedure is available here.


“LCJ members have continued to advocate for a rule that brings the fair and well accepted practices of the FRCP into MDLs, where the need for clear guidance and predictability will be warmly welcomed,” said LCJ’s Executive Director Dan Steen. “We look forward to seeing Rule 16.1 take effect and be fully utilized, resulting – hopefully – in more transparency and balance in MDL proceedings.”


For more information on Lawyers for Civil Justice’s efforts to bring fairness, clarity and consistency to procedures in all civil cases, please visit and or contact us at



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