K-V v. Keck-State of South Carolina Docket: List of Dockets Filed So Far

K-V Pharmaceutical Company et al v. Keck, Assigned to: Chief Judge Margaret B Seymour
Cause: 42:1396 - Tort Negligence

Note you cannot click on any of the links and view the documents without setting up a Pacer account and paying for the documents. As I have time, I will post some of the main documents on the blog. 

Date Filed	#	Docket Text
07/25/2012	1	COMPLAINT against Anthony Keck ( Filing fee $ 350 receipt number 0420-4206208.), filed by Ther-Rx Corporation, K-V Pharmaceutical Company. (Attachments: # 1 Exhibit Index, # 2Exhibit 1 - FDA Questions and Answers, # 3 Exhibit 2 - FDA Statement on Makena, # 4 Exhibit 3 - FY2012 FDA Budget Request, # 5 Exhibit 4 - FDA Statement on Makena, # 6 Exhibit 5 - FDA Updated Statement on Compounded Versions, # 7 Exhibit 6 - CMS, # 8 Exhibit 7 - SCDHHS Medicaid Bulletin, # 9 Exhibit 8 - email from Anthony Keck to Joseph Auci, # 10 Exhibit 9 - Magellan Medicaid Administration)(mdea ) (Entered: 07/26/2012)
07/25/2012	4	Local Rule 26.01 Answers to Interrogatories by K-V Pharmaceutical Company, Ther-Rx Corporation.(mdea ) (Entered: 07/26/2012)
07/25/2012	5	Summons Issued as to Anthony Keck. (mdea ) (Entered: 07/26/2012)
07/26/2012	6	MOTION for Preliminary Injunction by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. (Attachments: # 1 Memo in Support Plaintiff's Memorandum in Support of Motion for Preliminary Injunction, # 2 Exhibit A - Declaration of Michael Jozwiakowski, # 3 Exhibit List to Declaration of Michael Jozwiakowski (Exhibit A), # 4Exhibit A-1 - March of Dimes, Prematurity Campaign, The Economic and Societal Costs, # 5 Exhibit A-2 - March of Dimes, Neonatal Death, # 6 Exhibit A-3 - March of Dimes, Born Too Soon, # 7 Exhibit A-4 - Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United States, # 8 Exhibit A-5 - Letter from John McCormick to Catherine Williams, # 9Exhibit A-6 - Letter from Julie Beitz to Robb Hesley, # 10 Exhibit A-7 - U.S. Food & Drug Administration, Review by the Division of Reproductive & Urologic Products, # 11 Exhibit A-8 - Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate, # 12 Exhibit A-9 - Letter from Paul Meis to Whom it May Concern, # 13 Exhibit A-10 - Follow-up of Children Exposed to Utero to 17 [alpha]-hydroxyprogesterone Caproate Compared with Placebo, # 14 Exhibit A-11 - Use of Progesterone to Reduce Preterm Birth, Nov. 2003, # 15 Exhibit A-12 - Use of Progesterone to Reduce Preterm Birth, Oct. 2008, # 16 Exhibit A-13 - Compounding Problems and Compounding Confusion, Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split, # 17 Exhibit A-14 - Report, Limited FDA Survey of Compounded Drug Products, # 18 Exhibit A-15 - 2006 Limited FDA Survey of Compounded Drug Products, #19 Exhibit A-16 - Compounded Drug Testing Report (2009), # 20 Exhibit A-17 - Investigation of Product Quality Between Extemporaneously Compounded Progesterone Vaginal Suppositories and a Approved Progresterone Vaginal Gel, # 21 Exhibit A-18 - Pathway to Global Product Safety and Quality, # 22 Exhibit A-19 - Media Briefing on Heparin (2008), # 23 Exhibit A-20 - Melanine Contamination in China (2009), # 24 Exhibit A-21 - Drug Safety, FDA Has Conducted More Foreign Inspections and Begun to Improve its Information on Foreign Establishments, but More Progess is Needed (2010), # 25 Exhibit A-22 - Testimony of Randall W. Lutter, Ph.D. (Mar. 7, 2007), # 26 Exhibit A-23 - U.S. Food and Drug Administration, FDA Statement on Makena (Nov. 8, 2011), # 27 Exhibit A-24 - Press Release, KV Pharmaceutical Company, Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena and Compounded 17P Formations, # 28 Exhibit A-25 - FDA, Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 29 Exhibit A-26 - Centers for Medicare and Medicaid Services, Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 30 Exhibit A-27 - FDA, Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena))Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) Modified on 7/26/2012 to edit text (mdea, ). Modified on 7/26/2012 to reflect additional attachments filed as entries 7 , 8 and 9 (mdea, ). (Entered: 07/26/2012)
07/26/2012	7	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Thomas McHugh (Exhibit B). (Attachments: # 1 Exhibit List to Declaration of Thomas McHugh (Exhibit B), # 2 Exhibit B-1 - 2003 NIH Study re Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate, # 3 Exhibit B-2 - 2007 NIH Study re Follow-up of Children Exposed in Utero to 17 alpha-hydroxyprogesterone Caproate Compared with Placebo, # 4 Exhibit B-3 - Agreement between the NICHD Maternal-Fetal Medicine Units Network and Adeza Biomedical Corporation regarding 17-hydroxyprogesterone caproate, # 5 Exhibit B-4 - Feb. 3, 2011 Letter from Julie Beitz, FDA, Office of Drug Evaluation III, to Robb Hesley, Hologic, Inc., re Accelerated Approval for NDA 021945, # 6 Exhibit B-5 - Feb. 10, 2011 Letter from R. Hesley, Hologic, to S. Monroe, FDA, # 7 Exhibit B-6 - KV Form 8-K (March 8, 2011), # 8 Exhibit B-7 - March 30, 2011 FDA Statement, # 9 Exhibit B-8 - March 30, 2011 CMS Statement, # 10 Exhibit B-9 - Medicaid Bulletin issued by the SCDHHS, # 11 Exhibit B-10 - SCDHHSs July 3, 2012 interpretation of its policy, # 12 Exhibit B-11 - Magellan Medicaid Administration Drug Lookup, # 13 Exhibit B-12 - CMS June 15, 2012 Informational Bulletin, # 14Exhibit B-13 - FDAs June 15, 2012 Press Release, # 15 Exhibit B-14 - FDAs June 29, 2012 Question and Answer document, # 16 Exhibit B-15 - KV Form 10-K for the year ending March 31, 2012 (relevant pages))(Willis, Marguerite) (Entered: 07/26/2012)
07/26/2012	8	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Scott Goedeke (Exhibit C). (Attachments: # 1 Exhibit List to Declaration of Scott Goedeke (Exhibit C), # 2 Exhibit C-1 - Feb. 3, 2011 Letter from Julie Beitz, FDA, Office of Drug Evaluation III, to Robb Hesley, Hologic, Inc., # 3 Exhibit C-2 - Ther-Rxs Medicaid Drug Rebate Agreement, # 4 Exhibit C-3 - US FDA, Review by the Division of Reproductive & Urologic Products, NDA 21-945, 17a-Alpha Hydroxyprogesterone Caproate at 9 (Aug. 2, 2006), # 5 Exhibit C-4 - Zsakeba T. Henderson, et al., Attitudes and Practices Regarding Use of Progesterone to Prevent Preterm Births, Am. J. Perinatology 529, 532 (2009), # 6 Exhibit C-5 - Joanna E. Adamczak, et al., What prevents eligible patients from receiving 17-alpha-hydroxyprogesterone caproate therapy, Am. J. of Obstetrics & Gynecology (Jan. 2011), # 7 Exhibit C-6 -March C-6 - March 2011 testimony of FDA Commissioner Margaret Hamburg1 testimony of FDA Commissioner Margaret Hamburgny, # 8 Exhibit C-7 - FDAs Nov. 8, 2011 Press Release, # 9 Exhibit C-8 - FDAs June 15, 2012 Press Release, # 10 Exhibit C-9 - FDA, Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 11 Exhibit C-10 - CMS Release No. 155, # 12 Exhibit C-11 - CMS Release No. 158, # 13 Exhibit C-12 - CMS June 15, 2012 Press Release, # 14 Exhibit C-13 - Feb. 20, 2012 KV Letter to Mr. Keck, # 15 Exhibit C-14 - March 22, 2012 Keck Letter to KV, # 16 Exhibit C-15 - July 3, 2012 email exchange between Mr. Auci and Mr. Keck, # 17 Exhibit C-16 - Correspondence to SCDHHS by Providers in SC who would like to prescribe Makena to their Medicaid patients)(Willis, Marguerite) (Entered: 07/26/2012)
07/26/2012	9	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Dr. Lawrence Robillard (Exhibit D). (Willis, Marguerite) (Entered: 07/26/2012)
07/27/2012	10	SUMMONS Returned Executed by Ther-Rx Corporation, K-V Pharmaceutical Company. Anthony Keck served on 7/26/2012, answer due 8/16/2012. (Attachments: # 1 Affidavit of Personal Service on Anthony Keck)(Willis, Marguerite) (Entered: 07/27/2012)
07/27/2012	11	AFFIDAVIT of Service for Motion for Preliminary Injunction, Memorandum in Support of Motion for Preliminary Injunction served on Byron Roberts on 07/27/2012, filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Affidavit of Personal Service on Byron Roberts)(Willis, Marguerite) (Entered: 07/27/2012)
07/27/2012	12	MOTION to Appear Pro Hac Vice by Margaret Donahue Hall ( Filing fee $ 250 receipt number 0420-4210779) by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) additional attachment entry 15 added on 7/30/2012 (asni, ). addtional attachment entry 19 added on 8/2/2012 (asni, ). (Entered: 07/27/2012)
07/27/2012	13	MOTION to Appear Pro Hac Vice by Drew William Marrocco ( Filing fee $ 250 receipt number 0420-4210820) by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) (Entered: 07/27/2012)
07/30/2012	15	Additional Attachments to Main Document 12 MOTION to Appear Pro Hac Vice by Margaret Donahue Hall ( Filing fee $ 250 receipt number 0420-4210779) Certificate of Good Standing. (Willis, Marguerite) (Entered: 07/30/2012)
07/30/2012	16	AFFIDAVIT of Service for Motion for Preliminary Injunction, and Plaintiffs' Memorandum in Support of Motion for Preliminary Injunction served on Brenda James on behalf of Anthony Keck on July 26, 2012, filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Affidavit of Personal Service on Anthony Keck)(Willis, Marguerite) (Entered: 07/30/2012)
07/31/2012	17	TEXT ORDER granting 13 Motion to Appear Pro Hac Vice Signed by Chief Judge Margaret B Seymour on 7/31/2012.(asni, ) (Entered: 07/31/2012)
08/01/2012	18	NOTICE of Hearing on Motion 6 MOTION for Preliminary Injunction : Motion Hearing set for 8/28/2012 03:00 PM in Columbia # 3, Matthew J. Perry Court House, 901 Richland St, Columbia before Chief Judge Margaret B Seymour. Plaintiff is responsible for notifying defendant of hearing.(mdea ) (Entered: 08/01/2012)
08/02/2012	19	Additional Attachments to Main Document 12 Motion to Appear Pro Hac Vice for Margaret Donahue Hall. (Willis, Marguerite) (Entered: 08/02/2012)
08/02/2012	20	TEXT ORDER granting 12 Motion to Appear Pro Hac Vice for Margaret Donahue Hall Signed by Chief Judge Margaret B Seymour on 8/2/2012.(asni, ) (Entered: 08/02/2012)