`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF FLORIDA
`
`
`
`
`IN RE: ZANTAC (RANITIDINE)
`PRODUCTS LIABILITY
`LITIGATION
`
`
`
`_______________________________/
`
`THIS DOCUMENT RELATES TO: ALL CASES
`
`
`MDL NO. 2924
`20-MD-2924
`
`JUDGE ROBIN L. ROSENBERG
`MAGISTRATE JUDGE BRUCE E. REINHART
`
`
`PRETRIAL ORDER # 72
`Order Requiring Finalization of Registry Information and Certain Short-Form Complaints
`
`Near the inception of this MDL, on April 20, 2020, the Court entered Pretrial Order # 15.
`
`At that time, the parties were exploring the possibility that potential plaintiffs (“Claimants”) could
`
`preserve their claims without necessarily filing a case in court. DE 547. Each side stood to benefit
`
`from such an arrangement. For the Claimants, such an arrangement meant that they need not
`
`immediately pay a filing fee and prosecute their case—they could wait to do so until a later stage
`
`of the litigation. See id. This benefited the Defendants insofar as the Defendants had fewer filed
`
`cases to defend against and, relatedly, fewer jurisdictions in which to do so. See id. And one
`
`important benefit for all parties—Plaintiffs, Claimants, and Defendants—was that the
`
`consolidation and preservation of the Claimants’ claims in a central registry would allow for data
`
`to be accumulated about the Plaintiffs and the Claimants: the nature of their alleged injuries and a
`
`summary of the individual characteristics of the various Plaintiffs and Claimants such as age,
`
`location, duration of product use, etc. See id. This data was thought to be useful by all parties for
`
`the purposes of bellwether trial selection and potential future settlement discussions, and the Court
`
`therefore concluded that a registry would “assist in overall effective case management and the
`
`orderly and efficient progression of this proceeding.” Id. at 1.
`
`
`
`
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 2 of 10
`
`Now, almost two years after the inception of this MDL, the time has come for the data in
`
`the Registry to be finalized; the pleadings have closed, the Plaintiffs’ Leadership has designated
`
`the specific cancers it will pursue, the parties have begun the process of preparing Daubert
`
`challenges on the issue of general causation, and the bellwether trial selection process has begun.
`
`For this MDL to proceed in an orderly fashion, both the parties and the Court need to know with
`
`some degree of certainty who the Claimants are, what claims they intend to file, and where the
`
`Claimants will file their claims. The Court intends to obtain this certainty by setting a date
`
`whereupon the information in the Registry, as inputted by Claimants, will become final.1 The
`
`Court has the power to require this finality because each Claimant agreed to be bound to the terms
`
`of this Court’s Pretrial Orders and further agreed and consented to the authority of this Court to
`
`issue additional Pretrial Orders that govern them as Claimants. DE 1408 at 32. Consistent with
`
`that grant of authority, the Court hereby ORDERS as follows:
`
`Finalization of the Claimants’ Intended Forum
`
`1.
`
`All Brand Defendants shall provide to Litigation Management, Inc. (“LMI”) and
`
`Plaintiffs’ Co-Lead Counsel all applicable state(s) of citizenship for purposes of diversity analysis
`
`within ten (10) days of the entry of this Order. Brand Defendants shall also provide the following
`
`information: all specific finished dose formulations of Brand name Zantac manufactured,
`
`packaged, or sold, and dates of manufacture, package, or sale of each finished dose Zantac
`
`formulation. This shall be provided in a form directed by the Special Master in consultation with
`
`LMI, with copies to Adam Pulaski and Tracy Finken, no later than thirty (30) days from the entry
`
`of this Order.
`
`
`1 Pretrial Order # 15 is not modified or amended with the exception of the provisions set forth therein at page 15,
`paragraph 5 [DE 547]. This Order supersedes paragraph 5 on page 15 of Pretrial Order # 15.
`
`
`
`
`2
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 3 of 10
`
`2.
`
`Within two (2) days of the entry of this Order, LMI will provide to each Generic
`
`Defendant the information in the current Census Registry database being used for defense mapping
`
`that was provided pursuant to Pretrial Order # 50 and citizenship information that has been
`
`provided to LMI. Any Generic Defendant that consents to provide any necessary update or
`
`correction to such information within thirty (30) days will have no further obligations to provide
`
`any information to LMI.
`
`3.
`
`LMI shall add a certification box to the Registry interface as soon as reasonably
`
`possible and as directed by the Special Master. The purpose of the checkbox is for a Claimant
`
`who has registered or a Plaintiff who has filed in this MDL (collectively, the “Registry
`
`Participants”) to certify his or her forum of choice. If a Registry Participant does not intend to file
`
`his or her claim in federal court, the Registry Participant shall not check the box. If the Registry
`
`Participant commits to file his or her claim in federal court (although no Registry Participant is
`
`ever required to file suit) then the Registry Participant shall check the box and publish said
`
`response to Defendants by no later than June 30, 2022.2 In checking the certification box, a
`
`Registry Participant also certifies that federal court jurisdiction exists over his or her claims. As a
`
`result of the Registry Participant’s certification that federal jurisdiction exists over the Registry
`
`Participant’s claims, the Registry Participant must not name a defendant with the same state of
`
`citizenship as the Registry Participant as discussed more fully below in paragraph 5.3 The Registry
`
`Participants who certify that they will file their lawsuits in federal court will be deemed “Certified
`
`Federal Participants.” Within a reasonable time after June 30, 2022, LMI shall provide a report to
`
`the Court, Special Master, and all Co-Lead Counsel indicating the total number of Registry
`
`
`2 The Court recognizes that the phrase “Registry Participants” includes Plaintiffs who already have filed cases in this
`MDL and therefore already have committed to file a claim in federal court. Nevertheless, such Plaintiffs shall check
`the certification box.
`3 Unless the Certified Federal Participant has a basis for federal jurisdiction other than diversity jurisdiction.
`
`3
`
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 4 of 10
`
`Participants, the total number of Registry Participants who allege a Designated Cancer (as defined
`
`below), and the number of Certified Federal Participants.
`
`4.
`
`This Order is not intended to alter any negotiations that the parties have reached
`
`regarding tolling or the right of any Defendant to terminate tolling pursuant to Pretrial Order # 15.
`
`Such negotiations, and any agreements reached, regarding tolling are between the parties and are
`
`not the subject of this Order. Such negotiation and agreements are not subject to enforcement by
`
`the Court unless (i) the parties to the agreement consent to the Court’s enforcement of the
`
`agreement, and (ii) the Court approves of the parties’ consent.
`
`Finalization of the Claimants’ and Plaintiffs’ Claims in the Registry
`
`5.
`
`Every Registry Participant with a Designated Cancer and every Certified Federal
`
`Participant with a Non-Designated Cancer must update answers to question 13 of his or her Census
`
`Plus Form that he or she previously submitted pursuant to Pretrial Order # 15 (“CPF”), which shall
`
`reflect any and all Brand Defendants,4 Generic Defendants, Retailer Defendants or others against
`
`whom the Certified Federal Participant anticipates filing or intends to file a lawsuit regarding
`
`Zantac or any generic equivalent ranitidine product (if any lawsuit is ever filed) (“Anticipated
`
`Defendant”). Because each Certified Federal Participant has certified that he or she intends to file
`
`in federal court (if he or she elects to file a lawsuit), none of the Anticipated Defendants may have
`
`the same citizenship as the Certified Federal Participant.5 No later than June 30, 2022, these
`
`answers regarding Anticipated Defendants will be published to the Defendants and become final.
`
`Subsequent to June 30, 2022, Certified Federal Participants will be estopped from seeking to alter
`
`the Anticipated Defendants and will be estopped from opposing the dismissal of a non-Anticipated
`
`Defendant from any proceeding in any tribunal. Notwithstanding anything in this Order to the
`
`
`4 Brand Defendants refers to GSK, Pfizer, Boehringer Ingelheim, Sanofi, Patheon, and Chattem.
`5 Unless the Certified Federal Participant has a basis for federal jurisdiction other than diversity jurisdiction.
`
`4
`
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 5 of 10
`
`contrary, Certified Federal Participants who entered the Registry on or before February 28, 2022,
`
`will be estopped from amending an answer regarding an Anticipated Defendant, unless the
`
`Certified Federal Participant can provide: (1) a medical record, pharmacy record, loyalty record,
`
`or purchase receipt that supports the change(s), provided that the applicable record supporting such
`
`change(s) is ordered on or before May 15, 2022 but not received by June 24, 2022; (2) a record
`
`ordered by counsel prior to May 15, 2022 that the party to whom the request was submitted failed
`
`to produce to him or her despite reasonable follow up prior to June 24, 2022; (3) a record ordered
`
`prior to May 15, 2022 that, upon receipt and review, requires the Certified Federal Participant’s
`
`counsel to order other records, so long as such additional records are ordered within forty-five (45)
`
`days of receipt of the prior record; or (4) any other reason that the Court deems fair and equitable.
`
`Additionally, notwithstanding anything in this Order to the contrary, a Certified Federal Participant
`
`who enters the Registry on or after March 1, 2022, may amend an answer regarding an Anticipated
`
`Defendant if the Certified Federal Participant can provide: (1) a medical record, pharmacy record,
`
`loyalty record, or purchase receipt that supports the change(s), provided that the applicable record
`
`supporting such change(s) is ordered on or before ninety (90) days after entering the Registry; (2) a
`
`record ordered on or before ninety (90) days after entering the Registry that, upon receipt and
`
`review, requires the Certified Federal Participant’s counsel to order other records, so long as such
`
`additional records are ordered within forty-five (45) days of receipt of the prior record; or (3) any
`
`other reason that the Court deems fair and equitable.6
`
`6.
`
`By participating in the certification process described in this Order, a Certified
`
`Federal Participant agrees that (i) he or she is estopped from filing a lawsuit concerning Zantac or
`
`any generic equivalent ranitidine product in a state court, unless any of the exceptions in
`
`
`6 This Order shall not preclude the parties from reaching a contrary agreement concerning estoppel.
`
`5
`
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 6 of 10
`
`paragraphs 5 or 10 for changing Anticipated Defendants apply; and (ii) if he or she files a lawsuit
`
`concerning Zantac or any generic equivalent ranitidine product in a state court, such Certified
`
`Federal Participant will not oppose removal of the action to federal court and subsequent transfer
`
`of the action to this MDL, so that this Court will decide any dispute about whether the Certified
`
`Federal Participant is obligated to file his or her action only in federal court.
`
`7.
`
`Some of the Registry Participants are Plaintiffs in this MDL who have filed
`
`Short-Form Complaints that name Defendants. The Defendants named in a Plaintiff’s Short-Form
`
`Complaint must be identical to the Anticipated Defendants listed on a Plaintiff’s CPF.
`
`Accordingly, if a Plaintiff alters his or her Anticipated Defendants in the Registry, the Plaintiff
`
`shall also amend his or her Short-Form Complaint. Further, each Plaintiff shall also ensure that,
`
`as of June 30, 2022, the Defendants named in her or her Short-Form Complaint are identical to the
`
`Anticipated Defendants.
`
`8.
`
`Any attorney representing a Registry Participant (“Registry Counsel”) shall notify
`
`LMI within fourteen (14) days of any change in representation status of any Registry Participant.
`
`9.
`
`Registry Counsel shall also ensure that question 19 of the CPF accurately reflects
`
`the current state of residence of any Registry Participant, or state of residence at the time of death
`
`for decedents. Registry Counsel, upon notice of a Registry Participant’s death, shall promptly
`
`update questions 27 and 28 of the CPF, and ensure that, if notified of such occurrence prior to June
`
`15, 2022, the CPF is updated by that date.
`
`10.
`
`In the event any Defendant does not provide accurate information to LMI pursuant
`
`to paragraphs 1 or 2 of this Order or an error occurs by LMI in data mapping, and such inaccuracy
`
`impacts whether a Registry Participant has diversity of citizenship with all Anticipated Defendants
`
`listed in his or her CPF as outlined in paragraph 5, then within fourteen (14) days after the Registry
`
`
`
`
`6
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 7 of 10
`
`Participant or his/her counsel becomes aware of the accurate information, the Registry Participant
`
`may amend his/her CPF and/or any certification he or she provided pursuant to paragraphs 3 and
`
`5 – such amendment shall be limited to the scope of the new information only. In the event any
`
`Defendant does not provide accurate information to LMI pursuant to paragraphs 1 or 2 of this
`
`Order or an error occurs by LMI in data mapping, and such inaccuracy impacts whether a Registry
`
`Participant could identify additional Anticipated Defendants, but naming those additional
`
`Anticipated Defendants would not impact whether the Registry Participant has diversity of
`
`citizenship with all such Anticipated Defendants, then within fourteen (14) days after the Registry
`
`Participant or his/her counsel becomes aware of the accurate information, the Registry Participant
`
`may amend his/her answer to question 13 of his/her CPF – such amendment shall be limited to the
`
`scope of the new information only – but may not amend any certification he/she provided pursuant
`
`to paragraphs 3 and 5.
`
`Finalization of Claimants’ and Plaintiffs’ Alleged Injuries Involving Non-Designated Cancers
`
`On January 25, 2022, Plaintiffs’ Leadership Counsel filed a disclosure identifying
`
`11.
`
`the types of cancer for which they have provided general causation reports in this MDL (the
`
`“Designated Cancers”). DE 5147. Other cancers besides the Designated Cancers and other
`
`injuries are alleged in various Plaintiffs’ Short-Form Complaints and by Claimants in the Registry
`
`(the “Non-Designated Cancers”). Because Plaintiffs’ Leadership Counsel has elected not pursue
`
`the Non-Designated Cancers, the Court must act to determine (i) how many Certified Federal
`
`Participants wish to pursue the Non-Designated Cancers in this MDL; (ii) what, precisely, the
`
`Non-Designated Cancers are; and (iii) how, if at all, the Court will adjudicate the Non-Designated
`
`Cancers in this MDL.
`
`
`
`
`7
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 8 of 10
`
`12.
`
`To that end, all Registry Participants with a Designated Cancer shall update their
`
`alleged injury in question D(4) of the CPF by June 30, 2022; after this date, changes may only be
`
`made for newly diagnosed cancers or injuries or based upon contemporaneous medical records
`
`showing a different cancer. In addition, the Court has decided that all Certified Federal
`
`Participants who allege a Non-Designated Cancer7 shall file a Short Form Complaint using the
`
`process in Amended Pretrial Order # 31, if he or she has not already done so, by no later than June
`
`30, 2022. See DE 1496. In the event a Certified Federal Participant who alleges a Non-Designated
`
`Cancer in the Registry does not file a Short Form Complaint consistent with this Order, the Court
`
`may remove the Certified Federal Participant from the Registry, consistent with the process set
`
`forth in Pretrial Order # 15.
`
`13.
`
`Any Plaintiff who previously filed a Short Form Complaint claiming a
`
`Non-Designated Cancer or injury, but who no longer wishes to pursue claims for the
`
`Non-Designated Cancer or injury, shall so indicate by amending his or her Short-Form Complaint
`
`by June 30, 2022. Alternatively, should a Plaintiff seek to dismiss his or her case because he or
`
`she is pursuing a Non-Designated Cancer, the Answers to the Second Amended Master Personal
`
`Injury Complaint [DE 4101, 4102, 4103, 4105, and 4205] will constitute answers that preclude a
`
`Plaintiff from unilaterally dismissing his or her case under Federal Rule of Civil Procedure
`
`
`7 This filing deadline applies to Plaintiffs and Claimants wishing to pursue claims only for Non-Designated Cancers
`or injuries, as well as to Plaintiffs and Claimants wishing to pursue claims for both Designated Cancers and
`Non-Designated Cancers or injuries, within the same complaint. There are a number of Plaintiffs and Claimants who
`have indicated that they have multiple cancers or injuries; many of these appear to allege that Zantac use caused a
`particular cancer, which cancer then led to other cancers or injuries resulting from the initial cancer. To the extent
`that the Plaintiff/Claimant alleges that Zantac caused a Designated Cancer, which then metastasized and he/she was
`then diagnosed with a Non-Designated Cancer – or developed another injury due to the original Designated Cancer –
`the Plaintiff/Claimant is pursuing a claim that Zantac caused a Designated Cancer and thus is not subject to paragraph
`12 of this Order. In contrast, if the Plaintiff/Claimant alleges that Zantac caused a Non-Designated Cancer, which
`then metastasized into a Designated Cancer, then the Plaintiff/ Claimant is pursuing a Non-Designated Cancer and
`thus is subject to paragraph 12 of this Order.
`
`
`
`
`8
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 9 of 10
`
`41(a)(1)(A)(i). Any Plaintiff who wishes to voluntarily dismiss his or her case shall comply with
`
`Federal Rule of Civil Procedure 41(a)(1)(A)(ii) or (a)(2).
`
`14.
`
`Subsequent to June 30, 2022, the Court intends to evaluate the number of filed cases
`
`pursuing claims for Non-Designated Cancers and injuries, as well as the types of cancers and
`
`injuries being alleged, to determine the best course of action for these cases. At a future time, the
`
`Court may enter additional orders and establish deadlines and procedures for the Plaintiffs raising
`
`personal injury claims for cancers and injuries other than the Designated Cancers, including setting
`
`expedited expert discovery and Daubert deadlines for these cases.
`
`15.
`
`The Special Master will direct LMI to provide by March 15, 2022, and subsequently
`
`at the Special Master’s discretion, an interim report to Plaintiffs’ and Defendants’ Co-Lead
`
`Counsel listing the Plaintiffs and Claimants alleging Non-Designated Cancers. Such report shall
`
`contain the LMI ID number, alleged cancer or other injury, counsel of record, and any other
`
`information that the Special Master deems useful to the parties. To facilitate the accuracy of this
`
`report, all Registry Counsel are directed to notify LMI within fourteen (14) days of any change in
`
`representation of any personal injury Plaintiff or Claimant.
`
`Resolution of Disputes or Lack of Clarity Pertaining to this Pretrial Order
`
`16.
`
`By participating in this certification process, a Certified Federal Participant agrees
`
`that all disputes about the Certified Federal Participant’s compliance with this Court’s Pretrial
`
`Orders will be decided by this Court.
`
`17.
`
`Any Registry Participant, Registry Counsel, or Defendant who seeks any
`
`clarification or reconsideration of this Order must file a motion for leave8 to file a motion seeking
`
`such relief within twenty-one (21) days of the date this Order is entered. Any Registry Participant
`
`
`8 See Pretrial Order # 24, section 10.
`
`
`
`9
`
`
`
`Case 9:20-md-02924-RLR Document 5348 Entered on FLSD Docket 02/28/2022 Page 10 of 10
`
`who does not agree to be bound by the terms of this Order must exit the Registry within twenty-one
`
`(21) days of the date this Order is entered, by notifying Registry Coordinating Counsel (Adam
`
`Pulaski and Joe Petrosinelli) and the Special Master. LMI shall maintain the exit date of
`
`individuals that exit the Registry pursuant to this paragraph, as well as those that exit due to
`
`deficiencies or termination of tolling. In such circumstances, all data shall be preserved, and
`
`Counsel and the Special Master shall continue to have the same access to the CPF, data, and/or
`
`analytics, as when the Registry Participant was in the Registry.
`
`18.
`
`The Court understands that pro se litigants are not provided with access to LMI’s
`
`database as a matter of course. To the extent that a pro se Claimant or Plaintiff has an obligation
`
`to update his/her CPF pursuant to this Order, the pro se individual is directed to email LMI at
`
`zanclaimants@lmiweb.com with his/her name, the name of the Zantac user (if different) and
`
`applicable LMI ID number (or docket number, if the individual is a Filed Plaintiff and does not
`
`have an LMI ID number). The Special Master shall, with consent of Registry Coordinating
`
`Counsel, address in her discretion the data needs of pro se litigants together with any other data
`
`collection or technology issues that may arise in the implementation of this Order.
`
`DONE and ORDERED in Chambers, West Palm Beach, Florida, this 28th day of
`
`February, 2022.
`
`_______________________________________
`ROBIN L. ROSENBERG
`UNITED STATES DISTRICT JUDGE
`
`
`
`
`10
`
`