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In re Viagra (Sildenafil Citrate) and Cialis (Tadalafil) Products Liability Litigation

United States District Court, N.D. California, San Francisco Division

April 3, 2017

IN RE VIAGRA (SILDENAFIL CITRATE) AND (CIALIS TADALAFIL) PRODUCTS LIABILITY LITIGATION This Document Relates to: ALL ACTIONS MDL No. 2691 Deadline Task

          [JOINT PROPOSED] AMENDED PRETRIAL ORDER NO. 6: DISCOVERY AND OTHER PROCEEDINGS RELATING TO GENERAL CAUSATION

          THE HONORABLE RICHARD SEEBORG UNITED STATES DISTRICT JUDGE

         On September 26, 2016, the Court entered Pretrial Order No. 6 (Discovery and Other Proceedings Relating to General Causation) (“PTO 6”) as to Plaintiffs and Defendant Pfizer Inc. Since that time, Defendant Eli Lilly and Company (“Lilly”) has been added to this MDL. As a result, in order to incorporate Lilly into the ongoing general causation discovery, the Court hereby amends PTO 6 as follows:

         I. SCOPE OF ORDER

         1. Application and Purpose of Order. This Order is intended to conserve judicial resources, eliminate duplicative discovery, serve the convenience of the parties and witnesses, and promote the just and efficient conduct of this litigation. This Order shall apply to all cases transferred to this Court by the Judicial Panel on Multidistrict Litigation (“JPML”) pursuant to its Orders of April 7, 2016 and December 7, 2016, any tag-along actions transferred to this Court by the JPML, and any related actions that have been or will be originally filed in, transferred to, or removed to this Court and assigned thereto as part of In re: Viagra (Sildenafil Citrate) and Cialis (Tadalafil) Products Liability Litigation, MDL No. 2691. This Order also may apply to state court actions, provided that the parties thereto so agree or the applicable court so orders. Plaintiffs' State/Federal Liaison Counsel agrees that he will support this Order being entered in any proceeding involving Viagra and/or Revatio and/or any proceeding involving Cialis and/or Adcirca in state court, including in the present action(s) in Missouri. This Order shall not be construed to affect the governing law or choice of law rules in any case subject to the Order.

         2. Scope of Discovery. This Order relates to discovery and other proceedings concerning general causation. For purposes of this Order, the term “General Causation” refers to discovery related to causation issues of general or widespread applicability (i.e., issues that are not specific to an individual Plaintiff). No party subject to the Order may serve any discovery not expressly authorized by the Order absent further Order of this Court or express agreement of the parties. This provision shall not preclude third party discovery; provided, however, that any party intending to serve such third party discovery shall give ten (10) days written notice to the other party of the proposed third party discovery. Further, this Order shall not preclude the parties from conducting non-general causation discovery, if needed, after the Court enters its ruling on General Causation and after meeting and conferring about the scope of such discovery. By May 1, 2018, the parties will by separate proposed Order provide the Court a proposed Discovery Plan and Proposed Schedule for the selection of cases to be included in a discovery pool and for bellwether trials and selection.

         3. Use of Discovery in Federal and State Courts. Discovery conducted pursuant to this Order may be utilized in state or federal court, in accordance with the applicable laws and rules of discovery and evidence. This provision shall not preclude any party from asserting in any action that any document, testimony, or other discovery produced pursuant to this Order is inadmissible at trial.

         II. WRITTEN DISCOVERY

         4. Waiver of Initial Disclosures. For all cases subject to this Order, the parties are relieved from complying with the requirements of Federal Rule of Civil Procedure 26(a) or any similar state court rule.

         5. Master Written Discovery by Plaintiffs. Plaintiffs may serve on each Defendant the following written discovery related to General Causation: (1) Master Set(s) of Requests for Production (not to exceed fifty (50) requests for production, except by leave of this Court upon good cause shown); (2) Master Set(s) of Interrogatories (not to exceed twenty-five (25) interrogatories, including all discrete subparts, except by leave of this Court upon good cause shown); and (3) Master Set(s) of Requests for Admission.

         6. Master Written Discovery by Defendants. Defendants may serve on the Plaintiffs' Steering Committee (“PSC”), to answer on behalf of all Plaintiffs, the following written discovery related to General Causation: (1) Master Request(s) for Production (not to exceed fifty (50) requests for production, except by leave of this Court upon good cause shown); (2) Master Set(s) of Interrogatories (not to exceed twenty-five (25) interrogatories, including all discrete subparts, except by leave of this Court upon good cause shown); and (3) Master Set(s) of Requests for Admission.

         7. Additional Written Discovery. Absent leave of Court, or by agreement of the parties, and subject to paragraph 2 above, no party may propound discovery on a party other than these Master Set(s) of Production, Master Set(s) of Interrogatories, and Master Set(s) of Requests for Admission.

         III. DEFENDANTS' PRODUCTION OF DOCUMENTS

         8. Pfizer's Production of Non-Custodial Documents. Pfizer shall produce (or where the parties agree it is appropriate, make available for review and/or inspection) to Plaintiffs a common set of non-custodial documents related to General Causation as follows:

         a. U.S. Regulatory Files and List of Clinical Trials. Within two days of the parties' submission of a Joint Proposed Protective Order, [1] Pfizer shall produce: (1) its FDA regulatory files for Viagra and Revatio; and (2) a list of clinical trials for Viagra and for Revatio. With respect to preclinical trials of Viagra or Revatio, Plaintiffs shall provide a list of the preclinical trials as to which they may seek additional information. With respect to preclinical and clinical trials, the parties shall meet and confer with regard to what additional material Pfizer shall produce with respect to any of the trials, and a timetable for any such production.

         b. European Regulatory Documents and Adverse Event Reports. On or before August 31, 2016, Pfizer shall produce: (1) its EMA regulatory file for Viagra and for Revatio; and (2) adverse event reports regarding Viagra and Revatio coded under the High Level Group Term (“HLGT”) “Skin Neoplasm Malignant and Unspecified.”

         c. Terminal Date. The terminal date for the initial document production under the immediately preceding subparagraphs a. and b. shall be April 30, 2016. If after that time Pfizer communicates with or receives communications from FDA or EMA regarding Viagra and/or Revatio with respect to skin neoplasms, skin cancer, and/or melanoma (except for adverse event reporting) Pfizer will supplement its production as to these issues. The parties will meet and confer regarding the scope and timing of such supplementation.

         9. Lilly's Production of Non-Custodial Documents

         a. Regulatory Files and Adverse Event Reports. Within one week of the Court approving a Joint Proposed Protective Order, Lilly shall produce (1) its FDA and EMA regulatory files for Cialis and Adcirca, excluding chemistry, manufacturing, and controls sections; clinical report forms; and SAS data sets; and (2) adverse event reports regarding Cialis and Adcirca coded under the High Level Group Term (“HLGT”) “Skin Neoplasm Malignant and Unspecified.” Plaintiffs reserve the right to request the documents Lilly intends to exclude in this production.

         b. Terminal Date. The terminal date for the initial document production under the immediately preceding subparagraph is September 30, 2016. A supplemental document production through the terminal date of December 31, 2016 shall be produced on or before April 30, 2017. If after that time Lilly communicates with or receives communications from FDA or EMA regarding Cialis and/or Adcirca with respect to skin neoplasms, skin cancer, and/or melanoma (except for adverse event reporting) Lilly will supplement its production as to these issues. The parties will meet and confer regarding the scope and timing of such supplementation.

         c. Clinical Trials. Lilly has already produced to Plaintiffs a list of clinical trials involving Cialis or Adcirca in which patients were enrolled. With respect to preclinical trials of Cialis or Adcirca, Plaintiffs shall provide a list of the preclinical trials as to which they may seek additional information. With respect to preclinical and clinical trials, the parties shall meet and confer with regard to what additional material Lilly shall produce with respect to any of the trials, and a timetable for any such production.

         10. Pfizer's Production of Custodial Documents Specifically Relating to Viagra and Revatio Only. Pfizer shall produce custodial documents of ten (10) custodians, absent agreement of the parties. Plaintiffs shall have the right to request additional custodial files upon a showing of good cause after meeting and conferring with Pfizer. Plaintiffs shall identify the ten (10) custodians for whom Pfizer shall produce documents on or before October 31, 2016. Pfizer shall produce the custodial documents on a rolling basis, and complete production of all custodial documents on or before February 20, 2017. The terminal date for the initial production of custodial documents shall be April 30, 2016. Pfizer ...


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