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The presence of nonmeritorious lawsuits in MDLs imposes unnecessary burdens on the court, leadership counsel, and the parties. The presence of nonmeritorious claims also threatens to undermine the public’s perception of the MDL process more generally.
Filtering out nonmeritorious suits at an appropriate stage of the litigation is an important function of an MDL court, both to effectively manage the MDL itself and to ensure that cases remanded from the MDL present legitimate disputes for transferor courts to resolve. Certain circumstances generate a special need for increased scrutiny, including where plaintiffs’ injuries are difficult to verify, causation or exposure is contestable, and claim volumes are high. See Nora Freeman Engstrom, The Lessons of Lone Pine, 129 Yale L.J. 2, 33 (2019). Equally important, however, is ensuring that efforts to weed out nonmeritorious claims do not lead to unfair or counterproductive results, such as unduly burdening individual plaintiffs or improperly dismissing legitimate claims.
Three common tools that MDL courts use to identify and address nonmeritorious lawsuits are: (1) initial case census forms, (2) plaintiff fact sheets, and (3) Lone Pine orders.
Initial case census forms seek foundational data on filed and unfiled cases in the MDL. These forms are typically standardized and brief, often seeking basic information about product usage and injury. Such information can be helpful not only in identifying those plaintiffs who are unable to provide essential information to substantiate their claims, but also in ensuring that MDL leadership and bellwether trials are adequately representative.
Plaintiff fact sheets are standardized court-approved forms that seek a broader set of information. Fact sheets require individual plaintiffs to submit information (typically under oath) about their background, injury, past claims for compensation, and, where relevant, the identity of prescribing and diagnosing physicians and other healthcare providers. As with Lone Pine orders described below, failure to complete the fact sheet may (though does not always) lead to dismissal without prejudice. Scholars generally agree that fact sheets, when used appropriately, have benefits—for example, aiding in the selection of bellwether cases. See Nora Freeman Engstom & Todd Venook, Harnessing Common Benefit Fees to Promote MDL Integrity, 101 Tex. L. Rev. 1623 (2023). But some have also expressed concerns about the burden particularly bloated fact sheets may place on plaintiffs. See, e.g., Margaret S. Williams et al., Fed. Jud. Ctr., Plaintiff Fact Sheets in Multidistrict Proceedings: A Guide for Transferee Judges 7 (2019). Understanding these risks and benefits is increasingly significant as the role of fact sheets in MDLs continues to evolve.
Lone Pine orders require claimants to come forward with prima facie injury, exposure, and specific causation evidence by a specified date—or face dismissal. Lone Pine orders differ from plaintiff fact sheets in that Lone Pine orders require a claimant to provide evidentiary support, such as an affidavit from a physician, establishing their injury. Lone Pine orders have been issued both prior to and after discovery. Such orders aim to expedite plaintiff-side discovery, identify plaintiffs with meritless claims, and streamline the ensuing litigation by removing them, permitting the parties and the court to focus their attention and limited resources on disputed claims supported by at least some evidence. But while many believe that Lone Pine orders streamline and expedite complicated MDLs, some courts and scholars assert that they can be inconsistently applied and circumvent key procedural safeguards. See generally Engstrom, supra. Further, these orders may be more labor-intensive and expensive to complete than initial case census forms or plaintiff fact sheets, as they often require evidence of specific causation and supporting testimony from qualified experts. Perhaps unsurprisingly, some courts believe that Lone Pine orders are an “extraordinary procedure” that should only be used when all other protections have been exhausted. Id. at 39–40.
The below sections discuss these three tools and many of the unique questions and issues they present.
Courts exercise broad discretion in shaping the scope of the case census and adapting it to fit the needs of the particular MDL. The census may demand information regarding cases filed by all attorneys or only attorneys seeking leadership positions. The census may include filed cases only, unfiled claims only, or both. Extending the census to unfiled claims can help courts and leadership gain a clearer picture of the emerging scope of the MDL, plan for future resource allocations in the litigation, and assess why certain claims remain unfiled, among other benefits. But, the extension can also add burden and expense for plaintiffs’ leadership charged with corralling data from numerous individual plaintiffs’ counsel, and may limit plaintiffs’ ability to use the prospect of future case filings as strategic leverage early in a litigation. Examples of different approaches include the following.
(1) Filed cases only.
Plaintiffs and Defendants 3M Company, Aearo Technologies LLC, Aearo Holding LLC, Aearo Intermediate LLC, and Aearo LLC (collectively “Defendants”) agree that initial discovery (census) information will be necessary for all filed cases.
(2) Filed cases of all counsel, plus unfiled cases of leadership applicants only.
Initial Census Form
(3) Filed and unfiled cases of leadership applicants only (voluntary for non-leadership applicants).
Applicability: Counsel who have applied for leadership positions (i.e., Lead Counsel, Plaintiffs’ Executive Committee, Plaintiffs’ Steering Committee, or other appointments) (“plaintiffs’ leadership applicant firms”) in MDL No. 2913 are required to complete the applicable census questions for all of their law firm’s filed cases pending in federal court, as well as their firm’s retained clients who have potential claims related to JUUL products. The initial census does not seek any information regarding any individual or entity that has not executed a retainer agreement. Counsel who did not apply for a leadership position are not required to participate in the initial census but may choose to do so. Non-leadership applicant firms who choose to participate in the census will be entitled to the reciprocal census data provided by Defendants, as set forth below.
This Agreement provides for the creation of a new and voluntary Court-approved Census Registry, and associated tolling, for Potential Claimants who have not filed claims, but may file claims in the future, relating to the CPAP, BiPAP, and ventilator devices Philips RS has recalled (the “Recalled Devices”).
The census order also may encourage plaintiffs with unfiled claims to register them with the court via a voluntary registry. Registration of this type, even if not mandatory, may provide benefits to registrants, including tolling of statutes of limitations and cost-sharing in obtaining usage/injury documentation and other crucial records. However, to receive such benefits, courts often establish specific deadlines for compliance, including deadlines for registrants to submit claims to the registry.
Census Registry
Because the main goal of the census is to help the court and leadership counsel understand the population of matters composing the MDL, census forms typically request biographical information on each plaintiff (and/or unfiled claimant)—e.g., name, birthdate, sex, state of residence, as well as their injuries, their alleged product usage, and supporting documentation.
Courts also sometimes tailor census forms to capture information unique to the circumstances of a particular MDL. For example, the “initial census questions” in the 3M Combat Arms Earplug MDL, in addition to seeking plaintiffs’ biographical information, requested information on each plaintiffs’ military service because plaintiffs in that MDL were claiming that their hearing was impaired in the course of military service—and that information was key to substantiating plaintiffs’ claims.
Similarly, in Philips Recalled CPAP, involving claims over recalled CPAP, BiPAP, and ventilator machines, the census form requested information relevant to whether potential plaintiffs had registered their devices for repair or replacement and had received any such devices.
Pretrial Order No. 25, In re Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Prods. Litig., MDL No. 3014 (W.D. Pa. 2022).
REPLACEMENT DEVICE INFORMATION
8. Has Potential Claimant registered his or her Philips Respironics Device for repair or replacement on the Philips Respironics website [https://www.usa.philips.com/healthcare/e/sleep/communications/src-update]?
Yes No
If yes, please provide registration code: ________________.
9. Has Potential Claimant received a repaired or replacement device from Philips Respironics?
Yes No
In addition to information produced by plaintiffs and their healthcare providers, some courts require defendants to search their records and produce information about individual plaintiffs, at least where such records may exist.
Defendants’ Reciprocal Census Obligations: Within 30 days of the plaintiffs providing completed census information, Juul Labs, Inc. shall conduct a search of its database of online sales information, and for each individual who it can positively identify based on the information (name, email address(es), and physical address(es) associated with the account) provided in response to the census, shall produce sales data for such individuals indicating the type and quantity of products purchased per order, date of such orders, total order dollar amount, and order ship-to address, to the extent such data exist and can be located after a diligent search. If Juul Labs, Inc. does not provide any data with respect to a plaintiff who indicated that he or she purchased JUUL products directly from Juul online, Juul Labs, Inc. must certify under oath that a reasonable search was conducted based on the information provided and that no online sales information was located….
Sometimes, courts also issue a secondary census, styled in at least one MDL as a “Census Plus,” to gather additional information on specific types of claims and follow up on prior answers from the initial census form. However, the Federal Judicial Center has cautioned that courts should guard against imposing overly burdensome information requests. See Williams et al., supra at 7.
Pretrial Order #15 at 1, In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924 (S.D. Fla. Apr. 2, 2020) (issuing a “Census Plus” form for all personal injury and medical monitoring claims).
At the Court’s request, counsel for Plaintiffs and Defendants conferred to formulate an initial census process to assist in overall effective case management and the orderly and efficient progression of this proceeding. Jaime Dodge, Director of the Institute of Complex Litigation and Mass Claims at Emory Law School, and Special Master in this MDL, provided guidance and assistance to the parties in their negotiations to create a census process best situated to the unique needs of this litigation. This Order governs the form and schedule for service of an Initial Census Form (“ICF”) for all cases filed in MDL No. 2924 as well as certain unfiled cases, and a Census Plus Form (“CPF”) for personal injury and medical monitoring cases in this MDL.
A case census has valuable benefits, but it also may require the parties, and especially plaintiffs, to disclose information that they traditionally would not be required to produce until later stages of litigation. To mitigate the potential for gamesmanship, some courts narrow the purposes for which information produced in a census may be used, particularly for unfiled claims.
Recognizing that the Census Registry is drawn from the potential claims of Potential Claimants that are unfiled and in many cases not yet vetted by counsel, Philips and Plaintiffs’ leadership agree that information obtained through the Census Registry, including data and information contained on CRFs, or obtained from Data Release Forms, shall not be employed by any party in connection with or in opposition to the bellwether selection process, including to support or oppose (a) the selection of any case for any discovery or bellwether pool, (b) the selection of any case as representative of some broader segment of cases, or (c) the selection of a case for any trial or consolidation of cases. In the event that a Potential Claimant files suit against one or more of the Philips entities, then information obtained by Philips pursuant to that Potential Claimant’s CRF, subject to the reservations of Paragraph 14, may be used in the MDL litigation in any lawsuit asserting claims by that Potential Claimant.
Census forms often request non-public or otherwise sensitive information about individual plaintiffs, including health and treatment data (e.g., prescription drug usage and dates, healthcare providers, alleged injuries), as well as medical records. To protect such information from unauthorized disclosure, courts may impose special procedures and obligations on the parties, including, for example, anonymizing data generated from census submissions, filing certain materials under seal, and/or requiring the parties to treat census data as “confidential” under a protective order.
Protection of Data: The parties and Ankura [a third-party vendor providing data management solutions] are hereby ordered to take necessary steps to protect the security and confidentiality of the data and information collected through the census process. Information provided pursuant to this Order will be governed by the protective order entered in this MDL. Until the protective order is entered, the information shall not be shared with anyone other than counsel, and those acting under their supervision and control, and Ankura. Given the sensitive nature of some of the data collected, the Court will permit the parties to submit the initial census information under seal, subject to entry of the protective order, after which the parties will have 45 days to meet and confer regarding the appropriate designations for the various types of data collected. In the interim, to maximize the protections upon this data, Professor Dodge is directed to work with Ankura and the parties to prepare a report for the Court, which provides aggregated information relevant to the Court’s dual purposes of leadership selection and understanding the nature of this litigation, but omitting individual identifying information about any particular plaintiff or retained client….
[Census Registry Forms (CRFs)], the information and data reflected therein, and information and data produced in response to Data Release Forms shall be deemed “Confidential” information of Third Parties, and accorded treatment as such by Receiving Parties, as provided by the applicable Protective Order. Such treatment shall be afforded the CRFs and associated information and data regardless of the presence or absence of any formal confidentiality designation on the CRFs, information, or data themselves. Such information shall be made available to the parties and their counsel in MDL 3014 for use in the litigation.
Courts may establish consequences for failure to comply with census requirements and deadlines. See Bolch J. Inst., Duke L. Sch., Guidelines And Best Practices for Large and Mass-Tort MDLS 13 (2d ed., 2018) [hereinafter Bolch Guidelines] (recommending that courts “include procedures for dismissing claims due to substantial noncompliance with fact sheet requirements and deadlines”).
The Court expects all Counsel to comply with this Order. Failure to meet the requirements of this Order by the deadlines set herein will subject non-compliant Counsel to a show cause hearing as to why they have not complied with this Order.
Plaintiffs with filed cases who fail to submit complete [Census Plus Forms] and accompanying documentation by the deadline will receive notice in accordance with details to be provided through the vendor. Any Plaintiff in a filed case who does not timely cure an important deficiency, absent good cause shown, may be subject to sanctions, up to and including dismissal of the case.
The PFS is a common tool in MDLs. It is ubiquitous in product liability and other MDLs involving large numbers of plaintiffs. In recent years, fact sheets have become “widespread in the largest MDL proceedings.” Nora Freeman Engstrom & Todd Venook, supra at 1637.
As the Bolch Guidelines recognize, “[f]act sheets are one of the most useful and efficient initial mechanisms for obtaining individual discovery in large mass-tort MDLs.” Bolch Guidelines, supra at 10. Courts and parties rely heavily on the PFS as a means of screening cases where plaintiffs lack sufficient information necessary to bring a claim. Williams et al., supra at 2. PFSs are also useful for identifying and selecting bellwether cases, grouping cases for motions practice or into litigation tracks, and facilitating settlement negotiations. Id.
Still, some point to shortcomings in the PFS process. For instance, because PFSs may be filled out by different counsel for numerous parties, responses to PFSs may not be uniform in substance or in the level of detail. Further, if incorrect information is provided in response to a PFS, courts may face additional administrative burden and delay while errors are identified and corrected. Finally, in some cases, the PFSs have become unwieldy and overly detailed. These bloated PFSs impose significant burdens on plaintiffs with little corresponding benefit.
Despite these critiques, however, streamlined and straightforward PFSs are widely acknowledged as effective case management tools in MDLs.
For more on plaintiff fact sheets, see Bolch Guidelines, supra at 10–14.
At what stage in the MDL to deploy a PFS is among the threshold questions faced in any transferee court. There is no one-size-fits-all timing for deploying a PFS in the overall discovery process. The Bolch Guidelines note that PFSs may be useful at a “relatively early stage” in the litigation. Bolch Guidelines, supra at 11.
One important consideration that courts often weigh is whether there are threshold defenses applicable to all or many plaintiffs’ claims, such as preemption, that should be resolved before the court collects information regarding individual plaintiffs. If not, an early PFS process may be useful to organize the proceeding and facilitate the appropriate dismissal of unsupported claims. See Williams et al., supra at 3–4.
Courts adopt different methods for the submission of PFSs, including requiring litigants and their counsel to submit PFSs directly to a vendor, as well as requiring submission to opposing counsel and plaintiffs’ leadership counsel.
If a vendor is used, the court will generally require the parties to submit PFSs to the vendor and require that the vendor establish processes for making those PFSs available to the parties and the court. The court may issue a case management order appointing a vendor and delineating the protocol for working with this vendor, as agreed upon by the parties. See Williams et al., supra at 9. The court also generally will require the parties and any vendor to address issues of cost-sharing, access protocols, and security, given the sensitive information contained in the PFS and accompanying document productions. Id.
Courts also may direct that counsel for individual plaintiffs submit their completed PFSs to defense counsel and plaintiffs’ leadership counsel, either in addition to or in lieu of direct submission to the vendor. If the latter, counsel often nevertheless channel submitted PFSs to a vendor to manage collection and ongoing access.
Stipulated Order Regarding MDL Centrality at 1, In re Abilify (Aripiprazole) Prods. Liab. Litig., MDL No. 2734 (M.D. Fla. Apr. 12, 2017) (agreeing to use a third-party vendor for Plaintiff Fact Sheet management).
Manner of Completion and Service of Plaintiff Profile Forms, Plaintiff Fact Sheets, Defendant Fact Sheets, and Authorization Forms. Plaintiffs and Defendants must use the online MDL Centrality System designed and provided by BrownGreer PLC [a third-party claims management vendor] and accessible at www.mdlcentrality.com/abilify to complete and serve these forms, as follows…
Second Amended Pretrial Order #10 at 1-2, In re Heparin Prods. Liab. Litig., MDL No. 1953 (N.D. Ohio Feb. 5, 2009) (direct submission to leadership).
Simultaneous to service upon Receiving Defendant Counsels, each Plaintiff also shall serve a copy of the completed PFS, including Exhibit A (without medical records, authorizations for medical records, or attachments) on Plaintiffs’ Federal Court Liaison Counsel.
Case Management Order #12 at 1, In re Yasmin & Yaz (Drospirenone) Mktg., Sales Pracs. & Prods. Liab. Litig., MDL No. 2100 (S.D. Ill. Mar. 3, 2010) (submission to opposing counsel).
The parties have agreed upon a Plaintiff Fact Sheet (“PFS”) that includes document requests in Section XII and a variety of Authorizations. See Exhibit 1. Each Plaintiff shall produce to Defendants a completed PFS, executed Authorizations and documents responsive to Section XII of the PFS (“Responsive Documents”) pursuant to the terms of this Order.a
Courts also may choose to stagger PFS submissions and/or impose other conditions to facilitate efficient submission of PFSs. For example, the Mirapex court ordered the production of certain PFSs in “waves” and further directed that “no ‘wave’ or group of forty-five [cases] shall consist of more than sixty percent (60%) of cases from one individual Plaintiff’s law firm.” Spreading PFS submission obligations among plaintiffs’ firms avoids rewarding disengaged counsel, while also generating more representative data on case inventories that can facilitate planning for the court and parties.
Pre-Trial Order No. 2, In re Mirapex Prods. Liab. Litig., MDL No. 1836 (D. Minn. Sept. 5, 2007).
Unless the parties agree otherwise or by Order of the Court, completed and verified Plaintiff’s Fact Sheets, signed and dated Authorizations and all responsive documents shall be produced on the following schedule for all cases filed in or transferred to the Multi-District Litigation No. 1836, In Re: Minnesota District Court, Mirapex Products Liability Litigation as of the date of this Order, with the exception of those previously designated as “Wave #1″ trial cases. Plaintiff’s Fact Sheets will be served in five (5) waves as follows: Forty-five (45) Fact Sheets by October 15, 2007; Forty-five (45) Fact Sheets by December 1, 2007; Forty-five (45) Fact Sheets by January 15, 2008; and Forty-five (45) Fact Sheets by March 1, 2008; and Forty-five (45) and/or the remainder of un-served Fact Sheets for filed cases as of the date of this order by April 15, 2008. The Fact Sheets shall be served in order based on the date of filing. In addition [sic] no “wave” or group of forty-five shall consist of more than sixty percent (60%) of cases from one individual Plaintiff’s law firm.
After deciding that the proceeding would benefit from a PFS, courts typically instruct the parties to directly negotiate with each other and arrive at a proposed PFS. Where the parties are unable to reach agreement on a proposed PFS, the court will direct the parties to outline their differences and respective positions, and the court will resolve any outstanding disputes. The court also may elect to conduct its own review of PFSs from other MDLs.
Meet and Confer Regarding Fact Sheets: On or before April 20, 2015, the parties shall meet and confer regarding the content and form of a Plaintiff Fact Sheet. If the parties agree on the content and form of a Plaintiff Fact Sheet, they shall utilize that agreed Fact Sheet in this litigation. If, however, the parties are unable to agree, they shall, on or before April 27, 2015, submit a proposed Fact Sheet to the Court outlining the differences between the parties’ proposals.
Order at 1, Document No. 199, In re Biomet M2a Magnum Hip Implant Prods. Liab. Litig., MDL No. 2391 (N.D. Ind. Jan. 29, 2013) (selecting a proposed PFS from separate submissions by the parties).
At the January 7 case management conference, I indicated that I would review the parties’ proposed Plaintiffs’ Fact Sheets and consult those used in other MDL dockets, and inform the parties of my views on the proposed sheets. Having done so, I believe the more extensive sheet proposed by the defense, while more burdensome to individual plaintiffs, will move the cases toward resolution more quickly and with lesser expense overall. Accordingly, as between the two proposals before me, the Biomet proposal is preferable. Given the additional burden the more detailed fact sheet places on plaintiffs, I think the longer 90-day period proposed by the plaintiffs is a more reasonable time within which to complete and return the PFS. The parties’ revised proposed case management order should include the defendant’s tendered PFS, subject to any agreed modifications.
The contents of a fact sheet will differ according to the needs of a given case. As the Bolch Guidelines note:
Streamlined plaintiff fact sheets (one to two pages) are appropriate in some MDLs to identify quickly some cases that should not have been added to the cases centralized in the MDL in the first instance. In other MDLs, including large mass torts, more extensive plaintiff fact sheets (five to twenty pages) can serve a broader purpose, providing some useful information to the court and parties to inform selection of bellwether trials and settlement negotiations.
Bolch Guidelines, supra at 10.
Still, there are some general categories of information common to PFSs. The Federal Judicial Center, for instance, notes that PFSs generally include five categories of information. Williams et al., supra at 1, 7. These are:
A PFS might also include:
The Bolch Guidelines’ recommendations are similar, recommending the following categories of information.
Bolch Guidelines, supra at 11.
Sometimes, parties may be tempted to issue long and detailed PFSs, but scholars typically emphasize that judges should strive to ensure that fact sheets do not become bloated or unnecessarily burdensome. Extolling the virtues of simplicity, Professor Nora Freeman Engstrom and Todd Venook argue that, in most MDLs, bare-bones PFSs that ask for the following information can help cull a large portion of non-meritorious claims while minimizing unnecessary burdens on plaintiffs:
Engstrom & Venook, supra at 1638–39.
For an example PFS reflecting common categories of requested information, see Plaintiff Fact Sheet, In re Elmiron (Pentosan Polysulfate Sodium) Prods. Liab. Litig., MDL No. 2973 (D. N.J., May 5, 2021), portions of which are excerpted here. There, the plaintiffs alleged that Elmiron, a drug used to treat interstitial cystitis, caused them to suffer vision problems that, in some cases, led to blindness, including macular degeneration.
III. ELMIRON TREATMENT
Cannot answer with [above responses] ___ If you checked this, please provide your response.
|
Approximate Dates of Use |
Dose and Frequency of Use |
Prescribing Healthcare Provider(s) and Address(es) |
Name and Address of Pharmacy Used |
. . .
IV. ALLEGED INJURIES AND DAMAGES
|
Name and Address of Healthcare Provider(s) Who Rendered Care and Treatment for Injury(ies)/Condition(s) |
Injury(ies)/Condition(s) for which Treatment Was Rendered |
Approximate Date(s) of Treatment |
. . .
II. PLAINTIFF’S MEDICAL BACKGROUND. . .
For another example, see Exhibit A to Case Management Order: Plaintiff Fact Sheets, In re ACTOS End-Payor Antitrust Litig., MDL No. 2299 (W.D. La. July 9, 2012), portions of which are excerpted here. The plaintiffs in the ACTOS MDL alleged that their use of Actos, a prescription medication approved for use in the treatment of type 2 diabetes, increased their risk of developing bladder cancer.
II. Personal Information for the Actos® User
. . .
III. Use of Actos®
Date(s) of Use | Medication Prescribed | Dose | Name and Address of Prescribing Physician | Name and Address of Dispensing Pharmacy or where Actos was obtained |
If yes, state the name and address of the healthcare provide and the date the recommendation was made:
. . .
IV. Healthcare Providers and Pharmacies
Identify the following for each healthcare provider with whom you have consulted during the previous ten (10) years, or five (5) years prior to your first ingestion of Actos®, whichever is longer, to the present (or, if you are a minor, please list all healthcare providers):
Name & Specialty | Address & Phone Number | Dates of Treatment (Provide approx date(s) if precise date(s) are unknown) | Reason for Treatment |
. . .
V. Injuries and Damages Alleged
Other sample PFSs include Plaintiff Fact Sheet, In re Boston Scientific Pelvic Repair System Prods. Liab. Litig., No. 2326 (S.D. W.Va. Mar. 6, 2013); In re Tylenol (Acetaminophen) Mktg., Sales Pracs. & Prods. Liab. Litig., MDL No. 2436 (E.D. Pa. June 20, 2013).
In deciding which questions should be in a PFS, a transferee judge should weigh the benefits of obtaining additional information against the burden and cost placed on the plaintiffs. See, e.g., Elizabeth Chamblee Burch, Nudges and Norms in Multidistrict Litigation: A Response to Engstrom, 129 Yale L.J. Forum 64, 80 (2019) (expressing concern about requiring a plaintiff’s litigation history in a PFS, arguing that it is not relevant to any party’s claim or defense); Advisory Committee on Civil Rules, Agenda Book 152 (Oct. 16, 2020) (lamenting that some plaintiff fact sheets have become long and complicated, even though “the first page or few pages of a PFS . . . often will suffice”); Margaret S. Williams & Jason A. Cantone, An Empirical Evaluation of Proposed Civil Rules for Multidistrict Litigation, 55 Ga. L. Rev. 221, 264–65 n.183 (2020) (compiling examples of fact sheets that run for 53 pages, inquire into third-party financing, or ask the plaintiff to “list all places of residence for the past 10 years”).
In addition to the specific categories of information requested in the fact sheet form itself, as noted, PFSs generally also include authorizations for the release of relevant medical and pharmacy records and other relevant documentation based on the plaintiff’s claims, such as records relating to psychiatric and/or mental health treatment, employment, education, disability, workers’ compensation, health insurance, medicaid/medicare, and social security. Courts and parties should take care to use authorization forms that comply with HIPAA and any other applicable laws and regulations, and courts should, again, take care to ensure that the PFS demands the disclosure of only truly relevant information.
I, ________________________, hereby authorize you to release and furnish to: The Marker Group at 13105 Northwest Freeway, Suite 300, Houston, Texas 77040, copies of the following information:
* All medical records, including inpatient, outpatient, and emergency room treatment, all clinical charts, reports, documents, correspondence, test results, statements, questionnaires/histories, office and doctor’s handwritten notes, and records received by other physicians. Said medical records shall include all information regarding AIDS and HIV status.
* This authorization does allow the release of mental health or other psychiatric records, unless this box is checked ☐
* All autopsy, laboratory, histology, cytology, pathology, radiology, CT Scan, MRI, echocardiogram and cardiac catheterization reports.
* All radiology films, mammograms, myelograms, CT scans, photographs, bone scans, pathology/ cytology/histology/autopsy/immunohistochemistry specimens, cardiac catheterization videos/CDs/films/ reels, and echocardiogram videos.
* All pharmacy/prescription records including NDC numbers and drug information handouts/monographs. All Worker’s Compensation records, Social Security and disability records.
* All billing records including all statements, itemized bills, and insurance records.
* All employment records, including attendance reports, performance reports, W-4 forms, W-2 forms, medical reports and/or any and all other records relating to my employment, past and present.
For additional examples of authorizations used in prior MDLs, see the PFSs cited earlier in this module.
Bellwether trials are individual trials conducted by MDL judges with the goal of producing reliable and representative information about other cases centralized in the MDL. See Williams et al., supra at 2. For additional information on bellwether trials, click here. Information collected from PFSs can aid in the identification and selection of bellwether cases for trial.
Some courts adopt a uniform, comprehensive PFS for all cases and require all plaintiffs to complete it. Other courts require plaintiffs selected for more in-depth discovery, e.g., as part of a bellwether pool, to complete a full PFS. Other plaintiffs are made to complete only a streamlined questionnaire.
Other courts apply more comprehensive fact sheets only once the pool of potential bellwether trial cases has already been selected—and require them only for those actions.
Plaintiffs selected into the initial bellwether group, as to be later determined by the Court or agreement of counsel, shall submit a full PFS, in the form agreed upon by the parties and attached hereto as Exhibit C. A fully signed and completed PFS shall be due within ninety (90) days from the date the Court enters an Order placing a plaintiff’s case into an initial bellwether group. Each PFS shall be served with a complete copy of the already collected medical records. With respect to Plaintiffs who are not selected for inclusion in the initial bellwether group, the PFS shall be due within forty-five (45) days of the date the Court enters an order placing a Plaintiff’s case within a subsequent bellwether group or otherwise placing the case into a pool requiring case-specific discovery or remanding the case to the transferor court.
Plaintiffs’ responses to PFSs are generally treated as answers to interrogatories under Fed. R. Civ. P. 33 and—to the extent they seek medical records or other documentation—requests for production of documents under Fed. R. Civ. P. 34. Fed. Jud. Ctr., Manual for Complex Litigation § 40.1, p. 777–78 (4th ed. 2004); see also Williams et al., supra at 1, 7. PFSs are generally subject to supplementation in accordance with Fed. R. Civ. P. 26.
A plaintiff’s responses to the PFS shall be treated as answers to interrogatories under Fed. R. Civ. P. 33 and responses to requests for production of documents under Fed. R. Civ. P. 34, and shall be supplemented in accordance with Fed. R. Civ. P. 26.
Plaintiff’s responses to the PFS shall be treated as answers to interrogatories under Fed. R. Civ. P. 33 and shall be signed by Plaintiff. The responses to requests for production of documents included in the PFS are made under Fed. R. Civ. P. 34 and need only be signed by counsel. The PFS shall be supplemented in accordance with Fed. R. Civ. P. 26.
Pretrial Order No. 7 at 2, In re Fluoroquinolone Prods. Liab. Litig., MDL No. 2642 (D. Minn Apr. 26, 2016) (setting the deadline for pending cases to be three months from the date of the order and, for future cases, sixty days after they become part of the proceeding).
The FJC notes that it is unlikely that all parties will comply with initial deadlines. See Williams et al., supra at 15. Anticipating that reality, courts sometimes expressly allow for extensions of PFS deadlines.
Extension of Deadlines. The Parties may agree to an extension of the deadlines set in this Order for the completion and service of Fact Sheets and Records Authorizations. Consideration should be given to requests for extensions to stagger PFS deadlines where a single law firm has a large number due on or near the same dates, and correspondingly for Defendants with a large number of DFS due on or near the same dates. If the parties cannot agree on reasonable extensions of time, the requesting party may apply to the Court for such relief upon a showing of good cause and no prejudice to the other party. With any extension agreed to by the parties or granted by the Court, the twenty (20) day cure period set forth in Paragraph 3 of Pre-Trial Order No. 13 (Plaintiff Fact Sheets and Authorizations) and in Paragraph 3 of Pre-Trial Order no. 14 (Defendant Fact Sheets) shall begin on the day after the expiration of the extension period.
Not all plaintiffs will complete fact sheets in a timely or adequate manner, which raises the question of how missing or deficient fact sheets should be surfaced and addressed. The Bolch Guidelines recommend “that the parties should agree ahead of time on the process for addressing deficiencies.” Bolch Guidelines, supra at 13. Those processes typically involve the defendant notifying plaintiffs’ leadership and/or individual plaintiffs’ counsel of any failures to produce a PFS or deficient responses within a PFS. Plaintiffs then have a reasonable opportunity to cure the deficiency (typically 10-30 days). Id.
Pretrial Order #50 at 4, In re Roundup Prods. Liab. Litig., MDL No. 2741 (N.D. Cal. Sept. 26, 2018).
Plaintiffs will then be given an opportunity to cure any deficiencies within the following timeframes: (a) 21 days (three weeks) from receipt of the deficiency letter for Group 2 plaintiffs; (b) 42 days (six weeks) from receipt of the deficiency letter for Group 3 plaintiffs; and (c) 28 days (four weeks) from receipt of the deficiency letter for Group 4 plaintiffs.
If a plaintiff fails to cure the deficiencies within the allotted time, one or more of the following enforcement mechanisms may be used.
Pfizer moves to dismiss the claims of twenty (20) Plaintiffs with prejudice because Plaintiffs have not complied with their discovery obligations and this Court’s Orders. Seven of these Plaintiffs have never served a Plaintiff Fact Sheet in accordance with Case Management Order Nos. 5 & 6, despite repeated requests from Pfizer. (Dkt. No. 410 at 2; Dkt. No. 410-1 at 2). Thirteen other Plaintiffs have never cured material deficiencies in the Plaintiff Facts Sheets, despite repeated follow-up and requests by Pfizer. (Dkt. No. 410 at 2; Dkt. No. 410-1 at 4-5 (listing deficiencies); Dkt. Nos. 410-5 (letter to Plaintiff’s counsel delineating deficiencies)).
IT IS HEREBY FURTHER ORDERED that before any party raises with the Court an issue regarding an alleged deficient or late fact sheet, that party shall notify the relevant opposing party of the alleged deficiency or tardiness within three (3) weeks of receipt of the deficient fact sheet or missed deadline. If defendants are raising the issue, Mr. Coffin [Plaintiffs’ Co-Lead Counsel] shall be served with a copy of the letter via email. If plaintiffs are raising the issue, Ms. Sharko [Defense Lead Counsel] shall be served with a copy of the letter via email. If a letter is timely sent regarding a Plaintiff Fact Sheet, the trigger for defendants to serve their completed Fact Sheets shall be stayed. The opposing party shall respond by phone or letter within two (2) weeks of the date of service of the notifying letter. After the expiration of the two (2) weeks, if the issue is not resolved, the moving party may put the dispute on the agenda for the next court conference. If a case appears on the agenda for two court conferences, the moving party may request that an Order to Show Cause be entered to the delinquent party. That Order to Show Cause shall be returnable at the next court conference and require the delinquent party to show cause why the party’s complaint or answer should not be dismissed or stricken with prejudice.
Any Plaintiff who remains non-compliant with Paragraph 3 above, may be placed on the call docket by the Defendants subject to possible dismissal with prejudice or other appropriate relief. The call docket will be taken up after the status conferences, which date will be published by the Court on the Court’s website. No later than fourteen days before the call docket, Defense Liaison Counsel shall file the list of the cases by name and number subject to dismissal under this order. There shall be no briefing by any party. At the hearing, Liaison Counsel or their designees will advise the Court of any cases that may be removed from the list by agreement. At the call docket, each party will have the opportunity to address the Court, in person or via telephone, or through Liaison Counsel or its designee, regarding the matter. Any Plaintiff who fails to appear at the call docket and establish good cause for the failure to make discovery disclosures as required herein, may have her case dismissed with prejudice, or be subject to any other such relief as the Court may order.
Any plaintiff who fails to comply with the PFS obligations under this order, including failure to timely submit a PFS or failure to submit a substantially complete PFS, may, for good cause shown, be subject to sanctions to be determined by the court, upon motion of the defendants. The court expects the parties to meet and confer before such a motion is filed, and will adjudicate such motions on an expedited basis.
Order at 4, In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2327 (S.D. W. Va. June 15, 2015) (denying defendant’s request seeking $100 per day for each plaintiff who had not submitted a plaintiff profile form).
To the extent that Ethicon seeks payment of $100 per day for each day the PPF was late, its Motion for Sanctions is DENIED. Such a large amount—a total of over $7,700 in this case— cannot possibly be construed as a reasonable expense for the purposes of Rule 37(b)(2). Considering the economic and administrative realities of multidistrict litigation, where the cost of preparing and serving even the most elementary of motions can quickly and easily add up, I find that a more representative, though minimal, valuation of Ethicon’s expenses is in the amount of $500. This number accounts for the time and money Ethicon spent identifying Ms. Schexnaildre as one of the non-compliant plaintiffs; assessing the effect of her discovery violations; drafting a motion for sanctions; serving the motion; and replying to the plaintiff’s brief in opposition. All knowledgeable MDL counsel would consider these efforts, which could have been avoided had the plaintiff followed the court’s order, to be worth $500 at the least.
Pretrial Order No. 1018, In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1997 WL 704719 (E.D. Pa. July 24, 1997) (ordering fines of $500 per plaintiff questionnaire containing false or misleading information).
The court finds that Andrea S. Lestelle (“Lestelle”) and Roy F. Amedee (“Amedee”) violated Fed. R. Civ. P. 11 to the extent that certain answers provided on the 225 verified questionnaires submitted on behalf of their plaintiff clients had no evidentiary support and were either false or misleading in that a computer-generated “no” appeared in lieu of a truthful answer. (See Sofamor Danek’s 7/23/97 Hr’g Ex. entitled, “Comparative Analysis.”) The court further finds that Lestelle and Amedee were negligent and hence violated Fed. R. Civ. P. 37 to the extent that they failed to exercise due care in the manner in which they directed and supervised both their office staff and the implementation of the computer program they knew was to be used in completing said questionnaires, such negligence resulting in widespread false and misleading answers provided on the 225 verified questionnaires submitted in discovery pursuant to court Order. Id. The court also finds that due to Lestelle and Amedee’s failure to properly administer the discovery represented by the answers to the questionnaires the defendants were put to considerable delay, confusion, expense, uncertainty, and disruption during the period from June 30, 1996, to July 23, 1997. Accordingly, Lestelle and Amedee are hereby sanctioned in the amount of $500 per questionnaire or a total of $112,500 for which they shall be jointly and severally liable regardless of whether those plaintiffs for whom the 225 questionnaires were submitted are no longer pursuing their claims or are no longer a part of this multidistrict litigation. In addition, Lestelle and Amedee shall pay the reasonable costs associated with Sofamor Danek’s counsel having to take the depositions of seven (7) plaintiffs in connection with the instant motions. Both the $112,500 and the reasonable costs associated with the taking of seven (7) plaintiffs’ depositions shall be paid to counsel for Sofamor Danek within sixty (60) days of the date of this Order.
Similar to a PFS, a court may require the defendant to produce a defendants’ fact sheet (“DFS”) reflecting certain information it possesses about individual plaintiffs and their claims. For example, a defendant may possess records documenting specific marketing materials that it sent to or that were received by individual plaintiffs, warranty correspondence, or other information concerning the plaintiff’s purchase or use of defendant’s product.
Generally, the amount of information requested in a DFS is narrower than a PFS, given the limited scope of information about individual plaintiffs defendants typically possess, though issues such as relevant timeframe and quality of corporate record-keeping can increase the burden on defendants in responding to a DFS.
When a DFS is warranted, courts generally manage the DFS process in tandem with the PFS process. This means that the court typically requires the parties to negotiate or submit templates for both the PFS and DFS, the court settles on appropriate PFS and DFS forms, and the court then imposes complementary deadlines for completion of both. The court also tends to impose similar dispute mechanisms to resolve any deficient responses. As with the PFS, courts treat DFS responses as formal discovery responses subject to the Rules of Civil Procedure and verification under penalty of perjury. For more on DFSs, see Bolch Guidelines, supra at 11–12.
Whether to enter a Lone Pine order depends on the unique factual circumstances of each MDL. Lone Pine orders are typically issued only if the litigation features many (i.e., hundreds or thousands of) litigants. Engstrom, supra at 2, 38, 39 (noting that large cases present unique case management challenges that may potentially warrant use of a Lone Pine order); but cf. Opinion & Order, Ashford v. Hercules, No. No. 2-15cv27 (S.D. Miss. Oct. 16, 2015) (issuing Lone Pine order in a case involving forty-nine plaintiffs). If there is “credible evidence [that] directly undercuts plaintiffs’ key assertions,” the entry of an order may be appropriate. Engstrom, supra at 38–39; McManaway v. KBR, Inc., 265 F.R.D. 384, 388 (S.D. Ind. 2009) (“A Lone Pine order should issue only… after the defendant has made a clear showing of significant evidence calling into question the plaintiffs’ ability to bring forward necessary medical causation and other scientific information.”).
Still, scholars note that courts should exercise caution before entering a Lone Pine order. They point out, for instance, that a Lone Pine order may erode a litigant’s sense of justice, and that they can be particularly susceptible to arbitrary or abusive action Engstrom, supra at 9. Other concerns include the potential for Lone Pine orders to generate a lack of consistency, predictability, and horizontal equity. Id. And, a Lone Pine order’s entry may deprive plaintiffs of protections guaranteed by Fed. R. Civ. P. 56. Id. In part for these reasons, some courts have declined to enter a Lone Pine order until the later stages of an MDL and after exhausting other procedural devices.
Avandia Mktg., Sales Pracs. & Prods. Liab. Litig., No. 2007-MD-1871, 2010 WL 4720335, at *1 (E.D. Pa. Nov. 15, 2010) (issuing a Lone Pine order after a master settlement agreement was reached).
Defendant’s Motion for a Lone Pine Order (Doc. No. 769], Plaintiffs’ Responses thereto (Doc. No. 798, 800], and Defendant’s Reply [Doc. No. 839], the Court notes it shares Defendant’s concern that the Plaintiff Fact Sheets are often unsupported by submitted documents and Plaintiffs have not provided significant support for their stated position that cases can be fairly evaluated based on those Fact Sheets. It is now clear to the Court additional support for Plaintiffs claims is necessary in furtherance of settlement agreements, for the selection of cases for bellwether trials, and for the timely remand of cases to the sending courts for resolution. The Court’s overriding concern is the need to objectively identify which of the many thousand plaintiffs have injuries which can credibly be attributed to Avandia usage, as alleged in their complaints (or Plaintiff Fact Sheets if the filing of a complaint has been tolled).
Upon consideration of the above-listed factors, and mindful of the need to maintain safeguards for plaintiffs, the Court finds that entering a Lone Pine order is appropriate at this stage of the MDL.
First, during its six years in this Court, this MDL has comprised some 1,000 cases. During targeted discovery, Merck produced over 11 million pages of documents and submitted 24 company witnesses to deposition. Additionally, the parties have conducted extensive fact discovery on the 12 cases that were selected for trial. The parties – and the Court – are intimately familiar with the discovery in this MDL. Accordingly, a Lone Pine order would impose a minimal burden on plaintiffs, as it merely asks them to produce information they should already have. See In re Vioxx Prods. Liab. Litig., 557 F. Supp. 2d 741, 744 (E.D. La. 2008) (“The Court finds that at this advanced stage of the litigation, it is not too much to ask a Plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury.”).
Second, given that cases are more likely to result in dismissal once discovery focuses on issues related to causation, the Court has reason to believe that spurious or meritless cases are lurking in the some 1,000 cases on the MDL docket. As Merck points out, more than 50% of the cases set for trial have been dismissed, and some 31% of cases that have been selected for discovery have been dismissed. Plaintiffs’ habit of dismissing cases after both parties have expended time and money on casespecific discovery demonstrates that this MDL is ripe for a Lone Pine order.
Third, whether this MDL culminates in a global or partial settlement, or the remand of cases back to their home districts, a Lone Pine order will boost efficiency. In the event the parties reach a settlement, the elimination of spurious claims will ensure that only plaintiffs with meritorious cases are compensated. If the MDL concludes without settlement, and cases are transferred back to their home districts, Lone Pine will ensure that the home districts receive only viable cases.
Nolan v. Exxon Mobil Corp., No. CV 13-439-JJB-EWD, 2016 WL 1213231, at *11 (M.D. La. Mar. 22, 2012).
This court agrees with Plaintiffs that entry of a Lone Pine order is an “extraordinary procedure” that should be used “where existing procedural devices explicitly at the disposal of the parties by statute and federal rule have been exhausted or where they cannot accommodate the unique issues of this litigation.” In re Digitek Product Liability Litigation, 264 F.R.D. 249, 259 (S.D. W.Va. 2010). See also, Simeone v. Girard City Bd. Of Edn., 872 N.E.2d 344, 352 (Ohio Ct. App. 2007) (“In most of the Lone Pine cases we have reviewed…the Lone Pine order was issued only after one party was refusing to comply with discovery requests or when the plaintiffs failed to set forth a prima facie claim.”). Here, while Defendants may disagree with Plaintiffs’ expert’s current assertions regarding general causation, level of exposure, or migration pathways, the court finds such generalized evidence, especially in light of the more particularized allegations set forth in the Third Supplemental and Amending Complaint, fairly give Defendants notice of Plaintiffs’ particularized claims. Moreover, given that class certification was recently denied, the court does not find that this suit is in a procedural posture warranting an extreme remedy such as a Lone Pine order. While the court recognizes the potential logistical difficulties inherent in utilizing traditional discovery methods in a case involving over 200 plaintiffs, Defendants have not shown that such methods have been exhausted or cannot accommodate the parties’ needs.
Instead of issuing a Lone Pine order, courts sometimes choose to filter out non-meritorious cases using other discovery tools, such as PFSs and Rule 45 document subpoenas. For example, in the midst of fact discovery in the Paraquat MDL, the court highlighted its concern “about the presence of cases on its docket that present implausible or far-fetched theories of liability, and therefore would not have been filed but for the availability of this multidistrict litigation.” Case Management Order No. 18 at 3, In re Paraquat Prods. Liab. Litig., MDL No. 3004 (S.D. Ill. Feb. 26, 2024).
To address its concern, the Paraquat court ordered limited discovery on product use and alleged injuries for a sampling of cases. See Case Management Order No. 20, In re Paraquat Prods. Liab. Litig., MDL No. 3004 (S.D. Ill. Jan. 22, 2024) (selecting sample cases for limited discovery to address the court’s concern “that a significant number of plaintiffs in the MDL . . . do not plausibly allege exposure to paraquat”); Case Management Order No. 20A, In re Paraquat Prods. Liab. Litig., MDL No. 3004 (S.D. Ill. Feb. 7, 2024) (identifying additional sample cases for limited discovery following dismissal of numerous cases from original sampling).
Following plaintiffs’ voluntary dismissal of most of the sample cases and a further analysis by the MDL special master that concluded that many plaintiffs in the MDL had not produced any documentary evidence in support of their exposure allegations, the court ordered “each Plaintiff in this MDL to serve third-party subpoenas pursuant to Federal Rule of Civil Procedure 45 seeking documentary evidence providing proof of use and/or exposure to paraquat.” Case Management Order No. 21 at 3, In re Paraquat Prods. Liab. Litig., MDL No. 3004 (S.D. Ill. Jan. 26, 2024). In doing so, the court invoked common justifications for issuing a Lone Pine order, albeit without citing Lone Pine itself, namely weeding out “cases that present implausible theories of liability,” including those where “(i) a plaintiff states that they have no information concerning their exposure to paraquat (as opposed to a different product); or (ii) a plaintiff has no medical evidence to support a diagnosis of Parkinson’s disease; or (iii) a plaintiff claims to have used paraquat in a form in which it never existed (e.g., in powder or pellet form); or (iv) there are other evidentiary issues such as those that led to the voluntarily dismissal of the bellwether plaintiffs.” Id. at 1 (quoting Case Management Order No. 18, In re Paraquat).
Some courts issue Lone Pine orders before plaintiffs have had any opportunity to conduct discovery, while others believe that pre-discovery orders are “impermissible.” See Engstrom, supra at 40. Scholars have noted that pre-discovery orders in particular can deprive plaintiffs of the protections provided by Rule 56 because they impermissibly shift the burden of production to the nonmoving party (here, the plaintiff), nullify a plaintiffs’ access to discovery, and insulate a trial judge from meaningful appellate review. Id. at 43. Still, some courts see pre-discovery Lone Pine orders as a viable means of streamlining the litigation and focusing the court’s and the parties’ limited resources on the strongest claims in dispute.
Pre-Discovery. Some courts issue Lone Pine orders before the initiation of standard discovery processes, including class and merits discovery.
Modern Holdings, LLC v. Corning Inc., No. 5:13-cv-00405, (E.D. Ky. Sept. 28, 2015).
In this case as in all cases, this Court has a significant interest in facilitating the efficiency of case management to resolve the dispute and preserve resources where possible, and as Plaintiffs’ complaint approaches its two-year anniversary, case management efficiency is now as important as ever. This Court is convinced that the most efficient way to proceed with discovery and class certification is in two separate phases. In the first phase, Plaintiffs will make prima facie evidentiary disclosures pursuant to this Court’s Lone Pine Order. In the second phase, bifurcation of discovery will take place; discovery will be limited at first to only those issues relevant to class certification per Rule 23, at which point parties may file all motions related to the class certification issue. Only upon resolution of the class certification question will full merits discovery then proceed.
During Discovery. Other courts have entered Lone Pine orders after discovery has commenced, and prior to a settlement, to determine which cases possess sufficient factual support to remain in the MDL.
On December 10, 2015, the Court entered Case Management Order No. 8, which required all plaintiffs to provide evidence or certification of loosening of a NexGen Flex femoral component, a 5950 NexGen MIS Stemmed Tibial Component, or any other tibial component implanted with a NexGen Flex femoral component. (See Doc. 1256 in Case No. 1: 1 l-cv-05468, 11-2.) On January 22, 2016, the Court entered Case Management Order No. 9, which required each plaintiff to designate his or her case as a “Track One” or “Track Two” case. (See Doc. 1651 in Case No. I: 11-cv-05468, 11 1-4.) Plaintiffs in Track One were required to submit one or more of the following: (1) a medical record demonstrating knee flexion greater than 120 degrees; (2) a certification by counsel that he or she had reviewed the medical records and conferred with the client, and as a result, had a reasonable and good faith basis for contending that the client achieved high flexion activity; and/or (3) a medical record demonstrating implantation and subsequent loosening of a 5950 NexGen MIS Stemmed Tibial Component. (Id)
On January 22, 2016, the Court also entered Case Management Order No. 10, wherein the Court stated its commitment to have full resolution of these consolidated proceedings by the end of 2017. To that end, the Court identified a bellwether trial schedule and a plan for global mediation. (See Doc. 1652 in Case No. 1: 1 l-cv-05468). It is now clear to the Court that additional support for Plaintiffs claims is necessary in furtherance of the goals set forth in Case Management Order No. 10. Therefore, the Court now determines that an order in the nature of the order used in Lore v. Lone Pine Corp., No. L33606-85 (NJ. Super. Ct. Law Div., Monmouth Co., Jan. 1, 1986), is necessary to ensure that certain cases in Track One have sufficient merit to proceed to trial.
Post-Settlement. Courts, especially in the MDL context, often issue Lone Pine orders after a settlement agreement has been reached for some or all categories of cases, frequently with the goal of corralling plaintiffs to opt into the settlement. Engstrom, supra at 35, n.139; 40–41; see Order and Reasons, In re Taxotere (Docetaxel) Prods. Liab. Litig., 2024 WL 718698, at *4, MDL No. 2740 (E.D. La. Feb. 21, 2024) (“The Court finds that a Lone Pine order is appropriate at this stage, particularly in light of the parties’ recent settlements. Any potential inequities outweigh the need for additional case management procedures as to the remaining, unsettled cases before they proceed to remand.”).
However, many scholars emphasize that it is critically important that the court not use the threat of filing a (burdensome and expensive) Lone Pine order to coerce reluctant plaintiffs into a settlement. See Engstrom, supra at 37 n.143; Nora Freeman Engstrom & Amos Espeland, Lone Pine Orders: A Critical Examination and Empirical Analysis, 168 U. Pa. L. Rev. Online 91, 109–10 (2020); Elizabeth Chamblee Burch, Monopolies in Multidistrict Litigation, 70 Vand. L. Rev. 67, 68–78 (2017); accord Model Code of Judicial Conduct R. 2.6(B) (“A judge may encourage parties to a proceeding and their lawyers to settle matters in dispute but shall not act in a manner that coerces any party into settlement.”).
Consistent with the Court’s inherent authority to manage these judicial proceedings, and in light of the settlements entered after many years of difficult and costly litigation in this MDL, the Court finds it appropriate at this time to exercise its discretion to enter this Order to fairly, effectively, and efficiently manage any cases going forward against Defendants by Litigating Plaintiffs. This Order requires all Litigating Plaintiffs to produce certain specified information regarding their claim(s) and provides deadlines to meet certain requirements relating to product use, alleged injury, causation, time-based defenses, and related dispositive motion practice, prior to any further supplemental discovery. Litigating Plaintiffs, including Plaintiffs who represent themselves pro se, shall be bound by the requirements of this Order and shall fully comply with all obligations required of Counsel by this Order, unless otherwise stated….
In January and February 2016, shortly after the first bellwether case was tried in Massachusetts state court — where a large number of similar cases within state jurisdiction have been consolidated before Judge Kirpalani — and on the literal eve of back to back bellwether trials scheduled to begin in this court — where the United States Judicial Panel for Multidistrict Litigation had assigned to me similar cases from throughout the country — the parties reported a private global settlement that could resolve the vast majority of the thousands of products liability cases filed regarding the defendants’ GranuFlo and NaturaLyte products used during kidney dialysis treatment.
. . .
As the December 31, 2016 deadline for opting-in to the proposed settlement approached, the defendants on November 18, 2016 moved [Dkt. No. 1797] for an order (“Lone Pine Order”) designed to identify the viability of cases as to which communications regarding the settlement had not yielded adequate information.
. . .
While the prospective global settlement is a private one negotiated by the parties as to which this court’s role has been limited to facilitation through an effective stay of the litigation and providing a limited mechanism for review of certain of the settlement master’s determinations, the prospect that some number of non-settlement cases will require resolution on the merits and the likelihood that a number of cases in this litigation have not been carefully reviewed by plaintiffs’ counsel to determine whether in fact they have merit, requires a case management order under the general rubric of Fed. R. Civ. P. 16 to assure that the larger purposes of the assignment of the Judicial Panel for Multidistrict Litigation are served.
As the multidistrict portion of this litigation draws to a close and preparations are made for remand of pending cases back to local courts for further proceedings and individual trials, this court needs to determine which of the plaintiffs without attorneys want to pursue their claims to trial. To accomplish this purpose, the court will use the Declaration of Intent for Pro Se Plaintiffs form attached to this order as “Exhibit B.” The Declaration of Intent requires you to indicate whether you intend to pursue his or her [sic] claim, or whether you would like the court to dismiss your lawsuit. If you either indicate that you would like your individual lawsuit to be dismissed or don’t return the Declaration of Intent by January 13, 2017, the court will dismiss your case without prejudice, meaning that you might be able to file your case again.
If you submit a Declaration of Intent within the time limit set in this order, you will also be required to do one of the following:
(1) You may have the Plaintiff’s Expert Declaration of Causation form (attached as “Exhibit C” to this order) completed by an orthopedic surgeon and sent to the Plaintiffs’ Steering Committee by April 17, 2017.
OR
(2) You may attend a hearing in person on Monday, April 24, 2017, at 1:30 p.m. (E.D.T.) before United States District Court Judge Robert L. Miller, Jr., at the United States District Court for the Northern District of Indiana, Robert A. Grant Federal Building, 204 S. Main Street, South Bend, Indiana 46601. At this time the court will address the activation of the individual case for discovery and entry of a scheduling order, as well as the obligations of unrepresented litigants in prosecuting claims before the court.
If you do not:
complete and return the Declaration of Intent by January 13, 2017,
AND
either:
OR
your case will be dismissed with prejudice, meaning that it cannot be filed again.
Lone Pine orders generally require more detailed information than PFSs. These orders “typically require each plaintiff… to make three distinct evidentiary showings: (1) that she was exposed to the defendant’s contaminant and the circumstances of his exposure, (2) that she has suffered, or is suffering, a bona fide impairment (and, often, the circumstances of her diagnosis), and (3) proof of causation—which is to say, either an expert affidavit or expert report expressly connecting (1) with (2).” Engstrom, supra at 20. For further discussion, see Engstrom & Espeland, supra at 105–06.
Case Management Order No. 40A, In re Taxotere (Docetaxel) Prods. Liab. Litig., 2024 WL 2303810, MDL No. 2740 (E.D. La. May 21, 2024) (entering Lone Pine order requiring certain plaintiffs to produce, in part, the following).
Expert Medical Declaration Confirming Permanent Alopecia on Physical Examination and, if Medically Necessary, Scalp Biopsy. By July 31, 2024, Wave 3 Plaintiffs must upload to MDL Centrality a signed expert declaration, authored by a qualified physician in good standing with his or her state licensing authority. The declaration shall state that, based on the expert’s physical examination of Plaintiff, and a review of the pertinent medical records, the expert is prepared to testify that, to a reasonable degree of medical probability, Plaintiff has suffered permanent chemotherapy-induced alopecia (“PCIA”) as alleged in her Complaint(s).
The expert declaration must include:
Where the physician’s normal practices would require the same in order to rule out other forms of alopecia, said declaration must also include the gross and microscopic pathological findings, on scalp biopsy, of the plaintiff.
The expert medical declaration must be uploaded to MDL Centrality using the “Proof of Injury – Post-Order Expert Medical Declaration” document-type field within the deadlines set forth in this Order. The medical declaration shall be physically signed by the physician under penalty of perjury.
No expert report pursuant to Federal Rules of Civil Procedure 26(a)(2)(B) is currently required.
Order Regarding Preservation of Records and Prima Facie Evidence of Usage, Injury and Causation Requirements for Pending Cases Not Participating in the NuvaRing Resolution Program and Newly Filed or Transferred Cases, In re NuvaRing Prods. Liab. Litig., MDL No. 1964 (E.D. Mo. Feb. 7, 2014) (requiring certain plaintiffs, including those not participating in settlement, to provide additional documentation to substantiate their claims).
Accordingly, for good cause shown and in order to promote the fair and efficient administration of this litigation, it is hereby ORDERED that all plaintiffs who have elected not to participate in the global settlement of this litigation, shall submit for docketing in their respective cases on or before 5:00 p.m. Eastern time, March 29, 2017, the following:
