Showing posts with label K-V v. Cook. Show all posts
Showing posts with label K-V v. Cook. Show all posts

Friday, September 21, 2012

K-V v. Cook (Georgia)

On September 10 2012, K-V filed a Motion for Leave to File a Surreply in Opposition to Defendants' Motion to Dismiss with Brief in Support.  To view that motion click here.  On September 18, 2012  Georgia  filed a Response to Motion for Leave to File a Surreply in Opposition to Defendant's Motion to Dismiss.  to view that response click here.

Thursday, August 30, 2012

Article About Georgia to Cover Cost of Makena From Courthouse New Service

Georgia Ordered to Cover Costly Pregnancy Drug
ATLANTA (CN) - Georgia is violating Medicaid laws by failing to cover Makena, the only drug approved to treat preterm births, a federal judge ruled.
Makena is a progesterone-based drug designed to reduce the risk of premature birth in women pregnant with a single baby who have had a prior preterm birth. After the Food and Drug Administration approved the treatment in early 2011, KV Pharmaceutical charged $1,500 for Makena, while a compounded version was available for $20 a week. KV Pharma lowered the price to $690 in April 2011, but it continued to face protests from patient and doctor groups.
Though the Medicaid Act requires states to cover Makena for its FDA-approved indications, KV Pharma claimed that some states favored a compounded version of the drug over Makena and imposed unlawful restrictions on its product.
It filed federal complaints over the restrictions in Georgia and South Carolina.
In the Georgia case, the drugmaker insisted that Makena is theoretically a "covered outpatient drug." And yet, the Georgia Department of Community Health (DCH) restricted access to Makena by asking physicians to document the "medical necessity" of prescribing it over CHC, short for compounded hydroxyprogesterone caproate.
KV Pharma also sued the FDA in July for allowing compounding pharmacies to offer the lower-cost version of the drug, which contains the same active ingredients, but does not undergo the approval process.
The Northern District of Georgia refused to stay KV Pharma's lawsuit against the state pending the outcome of its action against the FDA, noting that the resolution of that lawsuit is irrelevant to the Georgia case.
U.S. District Judge Charles Pannell ruled that KV Pharma is likely to prove that Georgia Medicaid is breaking the law by failing to cover Makena.
"Because the court finds that the FDA drug approval process means something, the defendants' current policy favoring CHC over Makena is the opposite of what it should be," Pannell wrote. "As a result of the upside-down policy, the FDA-approved drug is not covered."
KV Pharma proved that the loss of revenue from Makena sales had contributed to its financial difficulties, including its filing for bankruptcy earlier this month, the court found.
Though Georgia may pay more for Makena, it will not suffer irreparable damages, and patients will benefit from an FDA-approved drug, the ruling states.
Pannell granted a preliminary injunction to KV Pharma, finding that Makena's Medicaid coverage would not disserve public interest.
"The parties agree that it is in the public interest to prevent preterm births," the ruling states. "Requiring the defendants to take steps to do so by utilizing the only FDA-approved drug as opposed to non-approved CHC, even at a higher cost, advances this public interest."
 
Article is found here.

Wednesday, August 8, 2012

Docket Entries for K-V Pharmaceutical v. Cook Et. Al filed in the Northern District of Georgia Federal District Court

Here are the documents that have been filed in K-V v. v. Cook et al
Assigned to: Judge Charles A. Pannell, Jr, cause of action: 42:1396(a) State Plans for Medical Assistance.  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.  Note I  will not be able to post the transcript of the hearing dated 8/7/2012 at this time.
Date Filed#Docket Text
07/17/20121 COMPLAINT filed by K-V Pharmaceutical Company, Ther-Rx Corporation. Consent form to proceed before U.S. Magistrate and pretrial instructions provided. ( Filing fee $ 350 receipt number 113E-4048681) (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Civil Cover Sheet)(adg) Please visit our website at http://www.gand.uscourts.gov to obtain Pretrial Instructions. (Entered: 07/18/2012)
07/17/20122 MOTION for Preliminary Injunction and MOTION for Permanent Injunction with Brief in Support by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Text of Proposed Order, # 2 Brief, # 3 Declaration of Jozwiakowski, # 4 Exhibit 1, # 5 Exhibit 2, # 6 Exhibit 3, # 7 Exhibit 4, # 8 Exhibit 5, # 9 Exhibit 6, # 10 Exhibit 7, # 11 Exhibit 8, # 12 Exhibit 9, # 13 Exhibit 10, # 14 Exhibit 11, # 15 Exhibit 12, # 16 Exhibit 13, # 17 Exhibit 14, # 18 Exhibit 15, # 19 Exhibit 16, # 20 Exhibit 17, # 21 Exhibit 18, # 22 Exhibit 19, # 23 Exhibit 20, # 24 Exhibit 21, # 25Exhibit 22, # 26 Exhibit 23, # 27 Exhibit 24, # 28 Exhibit 25, # 29 Exhibit 26, # 30 Exhibit 27, # 31 Declaration of Thomas McHugh, # 32 Exhibit 1, # 33 Exhibit 2, # 34 Exhibit 3, # 35 Exhibit 4, # 36 Exhibit 5, # 37 Exhibit 6, # 38 Exhibit 7, # 39 Exhibit 8, # 40 Exhibit 9, # 41 Exhibit 10, # 42 Exhibit 11, # 43 Exhibit 12, # 44 Exhibit 13, # 45 Exhibit 14, # 46 Declaration of Scott Goedeke, # 47 Exhibit 1, # 48 Exhibit 2, # 49 Exhibit 3, # 50 Exhibit 4, # 51 Exhibit 5, # 52 Exhibit 6, # 53 Exhibit 7, # 54 Exhibit 8, # 55 Exhibit 9, # 56 Exhibit 10, # 57 Exhibit 11, # 58 Exhibit 12, # 59 Exhibit 13, # 60 Exhibit 14, # 61 Exhibit 15, # 62 Declaration of Dr. Lawrence Robillard)(adg) (Entered: 07/18/2012)
07/17/20123 Certificate of Interested Persons and Corporate Disclosure Statement by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012)
07/17/20124 APPLICATION for Admission of Margaret D. Hall Pro Hac Vice by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012)
07/17/20125 APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012)
07/18/2012  Submission of 2 MOTION for Preliminary Injunction and MOTION for Permanent Injunction, submitted to District Judge Charles A. Pannell. (adg) (Entered: 07/18/2012)
07/18/20126 Amended Certificate of Interested Persons and Corporate Disclosure Statement by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) Modified on 7/19/2012 (adg). (Entered: 07/18/2012)
07/18/20127 Summons Issued as to David A. Cook, Jerry Dubberly. (adg) (Entered: 07/19/2012)
07/19/2012  RETURN of 5 APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice, 4 APPLICATION for Admission of Margaret D. Hall Pro Hac Vice to attorneys for correction re: signature and payment. (pb) (Entered: 07/19/2012)
07/19/20128 APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice (Application fee $ 150, receipt number 113E-4053115)by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 07/19/2012)
07/19/20129 APPLICATION for Admission of Margaret "Peg" Donahue Hall Pro Hac Vice (Application fee $ 150, receipt number 113E-4053153)by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 07/19/2012)
07/20/2012  NOTICE Expedited Briefing Schedule for MOTION for Preliminary Injunction [Doc. No. 2]. The defendants' response brief shall be filed no later than Monday July 30, 2012 at 4 p.m. The plaintiffs may file a reply brief no later than Thursday August 2, 2012 at 4 p.m. The court will schedule a hearing, if necessary, upon receipt of all briefs. (mam) (Entered: 07/20/2012)
07/24/201210 NOTICE of Appearance by Michelle Townes on behalf of David A. Cook (Townes, Michelle) (Entered: 07/24/2012)
07/24/201211 NOTICE of Appearance by Jason S. Naunas on behalf of David A. Cook (Naunas, Jason) (Entered: 07/24/2012)
07/25/2012  APPROVAL by Clerks Office re: 9 APPLICATION for Admission of Margaret "Peg" Donahue Hall Pro Hac Vice (Application fee $ 150, receipt number 113E-4053153), 8 APPLICATION for Admission of Drew W. Marrocco Pro Hac Vice (Application fee $ 150, receipt number 113E-4053115). Attorney Margaret (Peg) Donahue Hall, Drew W. Marrocco added appearing on behalf of K-V Pharmaceutical Company, Ther-Rx Corporation (pb) (Entered: 07/25/2012)
07/26/201212 ORDER GRANTING 8 Application for Admission Pro Hac Vice of Drew W. Marrocco. Signed by Judge Charles A. Pannell, Jr. on 7/26/2012. (adg) (Entered: 07/26/2012)
07/26/201213 ORDER GRANTING 9 Application for Admission Pro Hac Vice of Margaret Donahue Hall. Signed by Judge Charles A. Pannell, Jr on 7/26/2012. (adg) (Entered: 07/26/2012)
07/30/201214 MOTION to Stay with Brief In Support by David A. Cook, Jerry Dubberly. (Attachments: # 1 Brief Memorandum of Law in Support of Motion to Stay, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Text of Proposed Order)(Naunas, Jason) (Entered: 07/30/2012)
07/30/201215 RESPONSE in Opposition re 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction filed by David A. Cook, Jerry Dubberly. (Attachments: # 1 Brief Memorandum of Law in Support of Defendants' Opposition to Motion for Preliminary and Permanent Injunction, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6)(Townes, Michelle) (Entered: 07/30/2012)
07/30/201217 Minute Entry for proceedings held before Judge Charles A. Pannell, Jr: Telephone Conference held on 7/30/2012. Hearing set on Motion for Preliminary Inj and Motion to Stay on 8/6/2012 at 11:00 a.m. Hearing Concluded. (Court Reporter Martha Frutchey)(adg) (Entered: 08/01/2012)
07/31/201216 ORDER Setting Hearing on Motion 2 MOTION for Preliminary Injunction and 14 MOTION to Stay : Motion Hearing set for 8/6/2012 at 11:00 AM in ATLA Courtroom 2307 before Judge Charles A. Pannell Jr. The plaintiffs' responsetime to the motion to stay is shortened to 8/3/2012 at 4:00 PM. The defendants may file a reply brief, if desired, at any time prior to the August 6 hearing. Signed by Judge Charles A. Pannell, Jr on 7/31/2012. (adg) (Entered: 07/31/2012)
08/02/201218 REPLY to Response to Motion re 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4)(Varghese, Manoj) (Entered: 08/02/2012)
08/02/201219 Exhibit 4 re 18 REPLY to Response to Motion re 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) Modified on 8/3/2012 to correct docket text (adg). (Entered: 08/02/2012)
08/03/201220 RESPONSE in Opposition re 14 MOTION to Stay filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 08/03/2012)
08/05/201221 NOTICE Of Filing by K-V Pharmaceutical Company, Ther-Rx Corporation Second Declaration of Thomas McHugh (Varghese, Manoj) (Entered: 08/05/2012)
08/05/201222 APPLICATION for Admission of Erin M. Shoudt Pro Hac Vice (Application fee $ 150, receipt number 113E-4081988)by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 08/05/2012)
08/07/2012  NOTICE In the event the preliminary injunction is granted, the court is considering requiring the payment of bond. The parties are directed to submit (via electronic filing) their proposals for bond amount no later than August 8, 2012 at noon. The court is aware of Eleventh Circuit case law giving discretion to waive the bond requirement. The parties need not discuss these decisions or their applicability to this case. The purpose of soliciting the proposals is to allow the parties to address the appropriate bond amount not whether bond will be required.(mam) (Entered: 08/07/2012)
08/07/201223 TRANSCRIPT of Proceedings held on 8/6/12 (Mot for Prelim Inj Hrg) before Judge Charles A. Pannell, Jr. Court Reporter/Transcriber Martha J. Frutchey, Telephone number 404-215-1573. Transcript may be viewed at the court public terminal or purchased through the Court Reporter/Transcriber before the deadline for Release of Transcript Restriction. After that date it may be obtained through PACER. Redaction Request due 8/28/2012. Redacted Transcript Deadline set for 9/7/2012. Release of Transcript Restriction set for 11/5/2012. (Attachments: # 1 Notice of Filing Transcript) (pjm) (Entered: 08/07/2012)
08/07/201224 Minute Entry for proceedings held before Judge Charles A. Pannell, Jr: Motion Hearing held on 8/7/2012; 2 Motion for Preliminary Injunction TAKEN UNDER ADVISEMENT; 2 Motion for Permanent Injunction TAKEN UNDER ADVISEMENT; 14 Motion to Stay TAKEN UNDER ADVISEMENT; Opening statements by counsel. Paul C. Brown, sworn & testified for defendants. Court heard from counsel. Written order to follow. Hearing Concluded. (Court Reporter Martha Frutchey)(adg) (Entered: 08/07/2012)
08/07/2012  APPROVAL by Clerks Office re: 22 APPLICATION for Admission of Erin M. Shoudt Pro Hac Vice (Application fee $ 150, receipt number 113E-4081988). Attorney Erin M. Shoudt added appearing on behalf of K-V Pharmaceutical Company, Ther-Rx Corporation (pb) (Entered: 08/07/2012)
08/07/201225 MOTION to Dismiss Complaint For Injunctive And Declaratory Relief by David A. Cook, Jerry Dubberly. (Attachments: # 1 Brief Memorandum of Law in Support of Motion to Dismiss)(Naunas, Jason) (Entered: 08/07/2012)
08/07/201226 PROPOSED ORDER Proposed Order on Motion for Preliminary Injunction re: 18 Reply to Response to Motion, 2 MOTION for Preliminary Injunction MOTION for Permanent Injunction. (Varghese, Manoj) (Entered: 08/07/2012)