White v Novartis Pharmaceuticals Corp.

Filing 179

ORDER RE: OBJECTIONS TO FINAL PRETRIAL ORDER signed by Judge William B. Shubb on 9/6/2011 ORDERING that Dft's exhibit list is amended to reflect that dft also intends to offer the exhibits identified at Exhibit A to this Order. All other objections 176 , 177 to the 174 Final Pretrial Order are OVERRULED. (Zignago, K.)

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1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 EASTERN DISTRICT OF CALIFORNIA 10 ----oo0oo---- 11 12 CHERYL J. WHITE, SUCCESSOR TO WILLIAM WHITE, NO. CIV. 06-665 WBS GGH 13 Plaintiff, ORDER RE: OBJECTIONS TO FINAL PRETRIAL ORDER 14 v. 15 16 NOVARTIS PHARMACEUTICALS CORPORATION, 17 Defendant. / 18 ----oo0oo---19 Defendant’s exhibit list is amended to reflect that 20 21 defendant also intends to offer the exhibits identified at 22 Exhibit A to this Order. 23 77.) to the Final Pretrial Order (Docket No. 174) are overruled. 24 25 All other objections (Docket Nos. 176- IT IS SO ORDERED. DATED: September 6, 2011 26 27 28 1 1 Exhibit “A”: Defendant’s Exhibits 2 3 Ex. No. 4 5 DX0583 6 7 DX0584 8 9 DX0585 10 11 DX0586 12 13 14 15 16 DX0587 DX0588 17 18 DX0589 19 20 DX0590 21 22 DX0591 23 24 DX0592 25 26 DX0593 27 28 DX0594 Doc. Grou p Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Date Description 6/21/2004 Petraglia ltr to Padzur 6/29/2004 Weiss eml to Dunsire 7/1/2004 E-mail string re: Discussion with Dr. Buoquot 7/7/2004 Pease e-mail to Miranda 7/7/2004 July 7, 2004 e-mail from Dorothy Pease to Robert Miranda with attachment 7/9/2004 Petraglia eml to Pease 7/9/2004 E-mail from Annmarie Petraglia to Dorothy Pease dated 7/9/04 re: Zometa Labeling 7/15/2004 Maladorno e-mail to Bess, Close, Renner 8/2/2004 Staten e-mail to Miranda 8/25/2004 8/04 Zometa Nonclinical Overview 9/21/2004 Dear Doctor Letter MedWatch Submission 9/24/2004 Dear Doctor Letter with package insert 2 1 2 Ex. No. Doc. Grou p Date 9/24/2004 Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Sept. 24, 2004 submission re: Zometa with attachments 9/29/2004 Zometa Briefing Book for Renal Safety and Treatment Duration Meeting 10/5/2004 Memo from Zometa Brand Team re: Label Change 3 4 5 6 DX0595 DX0598 Corp . Docs . Corp . Docs . Corp . Docs . DX0599 Corp . Docs . 7 8 DX0596 9 10 DX0597 11 12 Corp . Docs . 11/24/2004 Final Draft of Briefing Book for Sr Management review Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Nov. 15, 2004 submission re: Aredia with attachments Agarwala et al., Efficacy of alendronate, a bisphosphonate, in the treatment of AVN of the hip. A prospective open-label study, Rheumatology 2005;44:352-359 12/1/2004 Zometa Brochure 12/1/2004 Renner eml to Sablinska 12/23/2004 Narang eml to Burke 11/3/2004 13 14 15 16 11/15/2004 17 18 19 20 DX0600 21 22 DX0601 23 24 DX0602 25 26 DX0603 27 28 DX0604 Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Description 1/4/2005 Petraglia eml to Maladorno 3 1 2 Ex. No. 3 4 DX0605 5 6 DX0606 Doc. Grou p Corp . Docs . Corp . Docs . Date 1/11/2005 Maladorno eml to Camanis 1/31/2005 Orloff ltr to Petraglia 1/31/2005 E-mail from Annmarie Petraglia to Yong Hei and others dated 1/31/05 re: Teleconference with ODS 1/31/2005 Jan. 31, 2005 FDA Approval Letter for Zometa 2/1/2005 Zometa Multiple Myeloma Brochure 2/1/2005 Reviewer Guidance: Conducting A Clinical Safety Review Of A New Product Application And Repairing A Report On The Review, FDA 2005 2/1/2005 ODAC - Background information 2/2/2005 Feb. 2, 2005 FDA Supplemental Approval Letter for Aredia 2/9/2005 E-mail from Kara Kuriger to Thomas Bock and others re: 2/11/05 Ad Board 2/13/2005 Feb. 2005 e-mail string re: Let's reach a decision on one additional analysis 2/15/2005 Clinical Trial Team Minutes 2/15/05 7 8 9 DX0607 10 11 DX0608 12 13 DX0609 Corp . Docs . Corp . Docs . Corp . Docs . 14 15 DX0612 Corp . Docs . Corp . Docs . Corp . Docs . DX0613 Corp . Docs . 16 17 DX0610 18 19 DX0611 20 21 22 23 24 25 26 27 28 DX0614 DX0615 Corp . Docs . Corp . Docs . Description 4 1 2 Ex. No. Doc. Grou p DX0616 Corp . Docs . Date 3 4 5 2/23/2005 E-mail from Yong Hei to Stephanie Petrone dated 2/23/05 re: Zometa Protocol Amendment 3/1/2005 FDA Guidance for Industry "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment" 3/4/2005 ODAC report by Sablinska 3/4/2005 Draft ODAC Meeting Slide Presentation 3/4/2005 ODAC Background Information 4/6/2005 Post-ODAC teleconference minutes 6 7 8 DX0617 9 10 DX0618 11 12 DX0619 13 14 DX0620 15 16 DX0621 17 18 DX0622 19 20 DX0623 21 22 DX0624 23 24 DX0625 25 26 DX0626 27 28 DX0627 Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Description 4/28/2005 FDA Teleconference Minutes dated 4/6/05 Email forwarding FDA Letter re: 15 day reporting dated 4/22/05 4/27/2005 Orloff ltr to Petraglia 5/5/2005 NPC Dear Dentist Letter 8/19/2005 Periodic Safety Report (Draft) 10/1/2005 10/05 CES Appendix, 4/6/2005 5 1 2 Ex. No. 3 4 DX0628 5 6 DX0629 7 8 DX0630 9 10 DX0631 11 12 DX0632 13 14 DX0633 15 16 DX0634 17 18 DX0635 19 20 DX0636 21 22 DX0637 23 24 DX0638 25 26 DX0639 27 28 DX0640 Doc. Grou p Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Date Description 10/12/2005 McGrath ltr to FDA 10/18/2005 PSUR 7 10/28/2005 10/05 Zometa Clincial Expert Statement 12/7/2005 Zometa Clinical Expert Statement - Appx. 1 12/7/2005 Zometa Clinical Expert Statement 12/7/2005 Zometa Clinical Expert Statement - Appx. 1 1/1/2006 AAOMS ONJ guidelines 2006 2/26/2006 5/1/2006 McGrath eml to Staten Updated Rec. for the Prevention, Diagnosis, and Treatment of ONJ in Patients with Cancer 6/21/2006 Letter to Healthcare Professionals 6/21/2006 Letter to Doctors 6/21/2006 Letter to Patient Advocacy Groups 9/22/2006 McGrath ltr to Justice 6 1 2 Ex. No. 3 4 DX0641 5 6 DX0642 7 8 DX0643 9 10 DX0644 11 12 DX0645 13 14 DX0646 15 16 DX0647 17 18 DX0648 19 20 DX0649 21 22 DX0650 23 24 DX0651 25 26 DX0652 27 28 DX0653 Doc. Grou p Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Date Description 11/22/2006 Clinical Study Report, Study No:ZOL446E US 32 8/17/2007 Aredia CES Appendix 9/12/2007 Sept. 12, 2007 letter from Lynne McGrath to Mary Parks with attachments 11/8/2007 FDA ltr to McGrath Zometa 2003 MPH Tactics 6/16/2004 Field Communication New Zometa PI Osteonecrosis of the Jaw - Slide Deck Taking Care of Yourself While Living With Cancer 2/1/2005 Zometa Brochure 4/1/2005 Assessment and Management of Bone Metastases 4/1/2005 To Protect Your Bones 10/5/2004 Field Communication Label Change for Zometa 6/10/2003 Email from Epstein to Ebeling 7 1 2 Ex. No. 3 4 DX0654 5 6 DX0655 7 8 DX0656 9 10 DX0657 11 12 DX0658 13 14 DX0659 15 16 DX0660 17 18 DX0661 19 20 DX0662 21 22 DX0663 23 24 DX0664 25 26 DX0665 Doc. Grou p Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Date Description 6/25/2004 Email from Hohneker to Johnson 2/26/2004 Email from Miranda to Dunsire and others 2/25/2004 Email from Maladorno to Miranda 2/27/2004 Email from Petraglia to Goessl and others 2/9/2004 Email from Petraglia to Narang 8/4/2004 Email from Petraglia to Miranda Exhibit 5501 from Petrone 8/21 Deposition 5/9/2004 Email from Hei to Ruggiero and others 5/11/2004 Email from Abam to Ruggiero Draft Epidemiology Report 3/4/2005 Appendix 2 Osteonecrosis in Cancer Patients 8/22/1995 Fax to Macalush from Hedin 27 28 8 1 2 Ex. No. Doc. Grou p DX0666 Corp . Docs . 3 4 Date Description 2/3/2005 Field Communication Update on Osteonecrosis of the Jaw (ONJ) 2/8/2005 Field Communication Update on Osteonecrosis of the Jaw (ONJ) 5 6 7 DX0667 8 9 DX0668 10 11 DX0669 12 13 DX0670 14 15 DX0671 16 17 DX0672 18 19 DX0673 20 21 DX0674 22 23 DX0675 24 25 DX0676 26 27 DX0677 Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Zometa Brochure 4/15/2005 Draft Module - Selling Zometa Slide Deck - Leave No Patient Behind 2/16/2005 Field Communication 8/10/2005 Email from Lantwicki to Hei 6/10/2005 Email from Scott to Lantwicki Exhibit D-12 from Scott Deposition 6/21/2005 Dear Healthcare Professional Letter 6/21/2005 Dear Doctor Letter 6/21/2005 Dear Patient Advocate Letter 28 9 1 2 Ex. No. 3 4 DX0678 5 6 DX0679 7 8 DX0680 9 10 DX0681 11 12 DX0682 13 14 DX0683 Doc. Grou p Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Corp . Docs . Date Description 3/24/2004 CV of the Experts Non-Clinical 4/26/2004 Email from Tarassoff to Dunsire and others 5/9/2005 Advisory Board Executive Summary Slide Deck Osteonecrosis of the Jaw 4/28/2004 NEM Minutes 7/15/2004 NEM Minutes 3/1/2004 Zometa Label 8/1/2004 Zometa Label 8/1/2004 Aredia Label 15 16 17 DX0684 18 19 DX0685 20 21 DX0686 Corp . Docs . Corp . Docs . Corp . Docs . 22 23 24 25 26 27 28 10

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