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MDL Early Vetting: The Increasing Use of Initial Census Forms

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We’re all familiar with the U.S. government Census; that once-every-ten-year collection of information that gives us a broader sense of the American population. The information gathered from the Census plays an important role in determining community funding. With more than $400 billion a year at stake, the Census helps define how money is dispersed within a community.  How does it help with MDLs?

Generally speaking, a census is an official count or survey of a population, typically recording various details on individuals. In multidistrict litigation, an initial case census is a tool implemented by judges and special masters to gather data on the inventory of filed and unfiled cases to gauge the extent of use and injury among claimants, appoint plaintiff leadership counsel and gauge the likelihood of a global settlement. The census method can also provide plaintiff-side counsel with a uniform set of questions to ask prospective clients during the intake process. 

Historic Mass Tort Claim Early Vetting 

Historically, attempts to deal with information relating to individual cases within an MDL have taken the form of modified discovery, albeit by different names. The goal has been to create a uniform set of questions and streamline the discovery process to avoid the need for typical individual case-specific discovery. The most common form of that substitute discovery has been the use of a “Plaintiff Fact Sheet” (“PFS”). The PFS has typically been a lengthy questionnaire, often consisting of dozens of pages, with numerous questions (including subparts and charts) ranging from personal background (residence, education, employment) to medical histories of the plaintiff and family members, identity of physicians, prior litigations filed by the plaintiff, insurance coverage and damages sought. Tucked away are numerous questions relating to product use (or exposure) and its duration. The typical PFS also includes document requests to support the answers to the wide range of information sought, including a request for medical authorizations to release a slew of records. 

Plaintiff fact sheets are typically due 30-60 days after a lawsuit is filed. In most MDLs, a short form complaint, which contains a condensed version of the causes of action in the master complaint, allows plaintiffs to assert product use and injury but do not require attestation or swearing that the information is true and correct under penalty of perjury.  

Defendants Target Claims for Early Dismissal 

The defense group Lawyers for Civil Justice announced that by its calculations, the cumulative number of cases in consolidated multidistrict litigations, dating back to the first MDL in 1968, has now topped 1 million. That fast expansion of MDLs, the group said, proves the need for safeguards to weed out unwarranted claims early in MDL proceedings, particularly in cases involving over-the-counter products that can be obtained without prescriptions, like earplugs or heartburn medicine. LCJ contends that advertising by plaintiffs’ lawyers and legal marketers has led to a spike in claims that are not subjected to rigorous vetting – and that the procedures MDL judges are currently using to block unjustified plaintiffs are not working adequately. 

Defendants and their representatives have argued that a considerable portion of the claims asserted in MDL mass tort situations is unsupportable. They allege problems with these claims include: 

  • The claimant in question did not use the drug or the medical device involved in the litigation, or 
  • The claimant did not have the health condition allegedly caused by the product, or  
  • The claimant used the product too briefly for it to cause the problem, or  
  • The claimant developed symptoms too long after discontinuing the product for the product to be a cause of the symptoms

They have argued for an earlier, rigorous, automatic requirement that every claimant submits proof of use of the product and development of pertinent symptoms promptly at the start of litigation.  

Federal Rules MDL Subcommittee Proposes Solutions 

The search for a better solution to the so-called “Early Vetting Gap” led the Advisory Committee on Civil Rules’ MDL Subcommittee to examine the idea of an “initial census,” which “has been the focus of work since the May 2019 gathering.” The Subcommittee explained the idea as follows: In place of reliance on PFS/DFS practice, the more promising idea has come to be known as a “census,” an effort to gain some basic detail on the claims presented – e.g., evidence of exposure to the product at issue – to permit an initial assessment of them. This need not be a substitute for a PFS, but instead an initial supplement. Importantly, the Subcommittee’s definition of “initial census” emphasized the critical feature of requiring evidence of exposure and harm early in the case. In the Subcommittee’s words: …another idea has emerged – that there should be an “initial census” of the claims submitted in “mass” MDLs. This approach would call for claimants to make a showing of exposure to the product or item involved in the litigation, and a showing that they have sustained an injury of the sort alleged in the lawsuit.  

As these discussions moved forward, parties in various cases began to develop a simplified alternative to a PFS that came to be called a “census” of claims pending in the MDL court. Variations of that method are in use in as many as four major MDL matters, including one pending before Judge Rosenberg, a member of the subcommittee. 

Initial Census Use in Major MDLs 

The initial census form is a short (usually no more than 3 pages), standardized form that is used in the early stages of a multidistrict litigation to obtain initial plaintiff information on proof of injury to conduct early vetting of potentially unsupported claims. Plaintiffs (individually or through their representative counsel) complete the questionnaire online or via fillable .pdf.  As data is entered into the online census platform, analytics can be generated from census form responses, providing visibility into the plaintiff inventory – including jurisdictions, allegations, and other trends. These real-time insights enable early vetting of claims, initial case assessment and/or claim verification data. 

There are currently four proceedings where initial census forms are in use:  

  • In re Juul (Judge Orrick, N.D. CA.): In October 2019, Judge Orrick directed counsel involved in the MDL proceeding In re Juul Labs, Inc., Marketing, Sales Practices, and Product Liability Litigation (MDL 2913) to develop a plan to “generate[e] an initial census in this litigation,” with the assistance of Prof. Jaime Dodge of Emory Law School, who has organized several events attended by members of the MDL Subcommittee. The census requirements applied to all counsel who sought appointment to leadership positions. Responses were submitted in December 2019, after which the judge appointed leadership counsel. Disclosures from defendants were due in January 2020. The census requirements under Judge Orrick’s order apply not only to cases on file but also any other clients with whom leadership counsel had entered into retention agreements. The census in this case was not primarily designed as a vetting device, but it is possible that having in hand a list of the sorts of information the court expects from claimants may prompt some counsel to be more focused in evaluating potential claims than would otherwise occur.  
  • In re 3M (Judge Rodgers, N.D. FL): The claims relate to alleged hearing damages related to earplugs that were largely distributed by the military. After appointment of leadership counsel, the judge had counsel design an initial census. But that undertaking involved obtaining military records, an effort that added a layer of complexity to the census. In addition, the due date for census responses was different depending on whether the case had been formally filed or was entered into an “administrative docket” the judge had created. As a general matter, the census was completed in December 2019. 
  • In re Zantac (Judge Rosenberg, S.D. FL): This litigation involves a product designed for treatment of heartburn. The MDL includes class claims and individual personal injury claims, and some may go back decades. The Panel order for transfer was entered in February 2020. The litigation is still in the early stages of organization, but much has been done, particularly with regard to the use of census methods. There are 645 filed cases, of which 27 are putative class actions, and a substantial number (in the thousands) of unfiled cases on a registry. The court ordered an initial census including all filed claims and any unfiled claims represented by an applicant for a leadership position. There were 63 applicants for leadership positions. The court received initial census forms for all the filed cases, including personal injury, consumer, medical monitoring claims among other claims. The Court indicated that this was helpful to her consideration of leadership applicants, which have since been appointed. The Court also created a registry, which allowed for the filing of a 4-page “census plus” form for unfiled claimants; in broad terms, registry claimants received tolling of the statute of limitations from participating defendants and certain assistance with medical/ purchase records. The census plus form, which was also required for all filed plaintiffs, required information on which product(s) were used, the injuries alleged, and a certification by the plaintiff/claimant. In addition, the form required plaintiffs/claimants to either attach documents showing proof of use and injury, state that they were already ordered privately or through the registry but not yet received or indicate that no records are expected to exist. The census plus forms are due on a rolling basis, with the first due date (for filed plaintiffs) having passed in July; the second tranche of forms were due in August, but this was extended for certain claimants due to a technical error with a private vendor to September, and will be followed by the third main tranche in November. 
  • In re Allergan (Judge Martinotti, D.N.J.): This litigation involves medical implant devices alleged to cause a very specific harmful medical condition in some users. Initial phases of the litigation have focused on selection of leadership counsel. It is possible, but not certain, that a census will be used once leadership counsel are appointed. In this litigation, it may be that records of implants and development of the signature medical consequence would be suitable subjects for a census. Judge Martinotti had extensive experience with complex litigation while on the New Jersey state court before appointment to the federal bench. 

On August 23, 2021, The MDL Subcommittee of the Advisory Committee on Civil Rules held a meeting via Zoom. Participating were Judge Robin Rosenberg (Subcommittee Chair), Judge Robert Dow (Advisory Committee Chair), Judge Joan Ericksen, Ariana Tadler, Joseph Sellers, Helen Witt, David Burman, Prof. Edward Cooper (Advisory Committee Reporter), Prof. Richard Marcus (Subcommittee Reporter), and Julie Wilson (Rules Office). Before the meeting, Prof. Marcus had prepared a variety of alternative rule proposals. Two of them looked to adding a new provision in Rule 16(b) for “MDL” or “complex” cases. Another was the sketch of a Rule 23.3 that has been circulated in the past. Finally, there was a proposal to add a change to Rule 26(f) to add consideration of a possible provision for “vetting” or a plaintiff fact sheet, or a “census” during the Rule 26(f) conference of the parties, an item also proposed to be added to Rule 16(b) as a matter for possible inclusion in a scheduling order. It was also noted that the Discovery Subcommittee may be considering adding something about privilege logs to Rule 26(f) or Rule 16(b), which might raise a concern about those provisions becoming overly long “laundry lists.” 

The committee will meet again on October 5 where they will provide additional notes on the August 23 meeting as well as the sketch for Rule 23.3 governing MDL leadership appointments and common benefit fees. 

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