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Proposed FRCP Rule 16.1: A New Avenue to Advocate Early Vetting in MDLs

Eric Goodheart and Breanna Fields


  • MDLs have seen a significant increase in the number of pending cases largely due to the growth of meritless claims driven by third-party litigation funding and aggressive advertising.
  • Proposed Rule 16.1(c)(4) aims to address the early exchange of information about the factual bases for claims and defenses in MDL proceedings.
  • While the proposed language does not explicitly require early exchange of information, it offers defendants a tool to ensure plaintiffs have a legitimate basis for their claims.
  • Requiring evidence of product use and injury diagnosis early in litigation would help eliminate meritless claims and make MDLs more manageable, potentially reducing costs for defendants.
Proposed FRCP Rule 16.1: A New Avenue to Advocate Early Vetting in MDLs
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In 1968, Congress enacted 28 U.S.C. § 1407 to provide a framework for multidistrict litigation (MDL). This statute provides that “[w]hen civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings.” 28 U.S.C. § 1407(a). But what began as an efficient means of consolidating mass litigation into a manageable framework has taken on a life of its own. In 2021, the number of currently pending cases in active MDLs reached the one-million mark milestone. The increasing speed at which MDLs are growing poses concerns: it took just one year for MDL filings to jump from 750,000 to one million. See MDLs Reach 1 Million Case Milestone: LCJ Calls for Fresh Scrutiny of Rules for MDLs, Rules 4 MDLs (Mar. 18, 2021). This has led to a disproportionate number of meritless claims as plaintiffs continue to rely on third-party litigation funding, aggressive advertising, and other methods to boost the size of MDLs and thus their potential settlement value. However, due to the size of these MDLs, most cases will never receive individualized attention unless selected as a bellwether trial or when remanded back to state court after sitting in the MDL for years.

Despite the massive increase in MDL lawsuits over the last several decades, the rules governing MDLs have remained entirely unchanged and mostly nonexistent. This has forced judges and attorneys alike to improvise ways to fit uniquely complex MDL lawsuits into the preexisting rules of civil procedure, which were not designed with these types of lawsuits in mind. Recently, the Advisory Committee on Civil Rules (Committee) has sought to put in place new rules to handle future MDLs. This article focuses on Proposed Rule 16.1(c)(4), regarding the early exchange of information and how product liability defendants can seek to leverage this rule to their benefit. While the examples provided below are specific to product liability matters involving medications or medical devices, defendants in other types of lawsuits should consider how they can effectively utilize this proposed rule.

Language of Proposed Rule 16.1(c)(4)

On March 28, 2023, the Committee discussed several proposed amendments to the Federal Rules of Civil Procedure, including a new rule that would provide case-management guidance in MDLs. On August 15, 2023, the Committee opened the draft rule to public comments. The public comment period will be open for six months and will include public hearings on October 16, 2023; January 16, 2024; and February 6, 2024.

As currently written, Proposed Rule 16.1(c)(4) seeks to address “[h]ow and when the parties will exchange information about the factual bases for their claims and defenses.” The Committee provided further context regarding this section of Proposed Rule 16.1:

Rule 16.1(c)(4). Experience has shown that in certain MDL proceedings early exchange of information about the factual bases for claims and defenses can facilitate the efficient management of the MDL proceedings. Some courts have utilized “fact sheets” or a “census” as methods to take a survey of the claims and defenses presented, largely as a management method for planning and organizing the proceedings.

The level of detail called for by such methods should be carefully considered to meet the purpose to be served and avoid undue burdens. Whether early exchanges should occur may depend on a number of factors, including the types of cases before the court. For example, it is widely agreed that discovery from individual class members is often inappropriate in class actions, but with regard to individual claims in MDL proceedings exchange of individual particulars may be warranted. And the timing of these exchanges may depend on other factors, such as whether motions to dismiss or other early matters might render the effort needed to exchange information unwarranted. Other factors might include whether there are legal issues that should be addressed (e.g., general causation or preemption) and the number of plaintiffs in the MDL proceeding.

Advisory Comm. on Civ. Rules, Meeting of the Advisory Committee on Civil Rules 116 (Mar. 28, 2023).

Early Exchange of Information

Unfortunately for defendants, this proposed language does not go as far as expressly requiring the early exchange of information in MDLs. However, this language provides all defendants with a new avenue for seeking information at the outset of a lawsuit to ensure that plaintiffs have a good-faith basis for being in the MDL. A common problem faced by product liability defendants is that due to the size of MDLs, many plaintiffs without legitimate claims are able to remain in the MDL with the hope that they will receive a settlement before the weaknesses of their cases are discovered. To minimize this problem, defendants should advocate an early exchange of information that requires plaintiffs to provide early evidence that they are bringing claims in good faith. By educating judges in the early stages of MDL litigation about issues specific to drug and device lawsuits and the benefits of early vetting, defense counsel can better position their clients to efficiently resolve meritless disputes.

Two common examples seen in product liability MDLs are that many plaintiffs have no evidence that they (1) ever used a specific defendant’s product or (2) were diagnosed with the injury allegedly caused by the product in question. This applies to lawsuits involving both pharmaceutical medications and medical devices. A simple way to root out such meritless claims is for the parties to agree to an early exchange of information that requires plaintiffs at the outset of the case to submit evidence showing proof of use of the product in question and a record showing a diagnosis of the injury in question. If this rule is ultimately passed, defendants can cite Rule 16.1(c)(4) while asserting that the early exchange of information about the factual bases for plaintiffs’ claims and defenses would root out meritless claims.

Specific Benefits of Early Exchange of Information

Requiring early proof of use of a defendant’s product is advantageous for two reasons.

First, product liability MDLs often involve several defendants who manufacture or market similar medications, and plaintiffs who have ingested medications manufactured or marketed by multiple defendants. Sometimes, plaintiffs file a complaint naming every MDL defendant with the hope that later discovery will shed light on the universe of medications that the plaintiff actually ingested. Requiring evidence that a plaintiff was actually treated with a particular defendant’s drug or device at the outset of litigation would root out meritless claims where a plaintiff never encountered such a product. If a plaintiff cannot provide evidence in the early stages of litigation that a certain defendant’s product was involved, that defendant should not be forced to undergo the costs of litigating a meritless claim.

Second, many medications have branded and generic versions. Defendants should argue that a plaintiff be required to show a record with a National Drug Code (NDC) or product identification number identifying by which drug or device a plaintiff was allegedly injured. This is particularly important when a medical record references the brand name of a drug but a corresponding pharmacy record indicates that a plaintiff actually ingested the generic version of that drug.

Precedent for Early Exchange of Information

Plaintiffs will likely push back on this early exchange of information by arguing that this is information that they hope to uncover during discovery. However, Federal Rule of Civil Procedure 11(b)(3), while rarely invoked in MDLs, requires that “the factual contentions have evidentiary support or, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery.” A plaintiff is capable of obtaining his or her medical records before a lawsuit is ever filed. Given that the collection and exchange of medical records is a necessary step for plaintiffs to take during a lawsuit, there is no reason why plaintiffs cannot obtain these records before a lawsuit is filed.

Indeed, there are comparable situations where medical records must be reviewed before a lawsuit is brought. For example, medical malpractice claims brought in North Carolina are subject to North Carolina Rule of Civil Procedure 9(j), which requires an expert witness to review a plaintiff’s records and testify that the medical care did not comply with the applicable standard of care. Failure to comply with this rule results in dismissal of the lawsuit. The purpose of this rule is to ensure that medical malpractice claims have a legitimate basis for being brought before they are filed.

Requiring a review of the records before a plaintiff can join an MDL would rule out many meritless claims and make MDLs more manageable. But even if prefiling review is absent, the new Proposed Rule 16.1(c)(4) would provide additional grounds for advocating early postfiling review and production of this essential and basic information.

Advice for MDL Defendants

Thus, in response to plaintiffs’ counterarguments, defendants can argue that MDLs are fundamentally different than single-party litigation, as evidenced by Proposed Rule 16.1(c)(4). If plaintiffs want the inherent benefits of being included in an MDL, they should be willing and able to meet this threshold evidentiary showing. Defendants can also argue that if a plaintiff cannot find a record showing proof of use, the plaintiff may file a declaration under penalty of perjury based on personal knowledge containing specific information about the date the product was allegedly used, where the product was purchased, who prescribed the product, whether the product was branded or generic, what the product or box looked like, and any other information that the plaintiff recalls to support the allegation that the product was actually ingested by the plaintiff. However, courts must be careful not to turn these declarations into a rubber stamp that permits meritless claims into MDLs.

Thus, although Proposed Rule 16.1(c)(4) is not a panacea for defendants seeking to root out meritless claims, it does provide defendants in product liability and other lawsuits with additional support to advocate the importance of the early exchange of information in MDLs.