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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
By IULIA FILIP
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."
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.
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 |
---|---|---|
07/17/2012 | 1 | 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) |
07/17/2012 | 2 | 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) |
07/17/2012 | 3 | Certificate of Interested Persons and Corporate Disclosure Statement by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012) |
07/17/2012 | 4 | APPLICATION for Admission of Margaret D. Hall Pro Hac Vice by K-V Pharmaceutical Company, Ther-Rx Corporation. (adg) (Entered: 07/18/2012) |
07/17/2012 | 5 | 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) | |
07/18/2012 | 6 | 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) |
07/18/2012 | 7 | 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) | |
07/19/2012 | 8 | 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) |
07/19/2012 | 9 | 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) | |
07/24/2012 | 10 | NOTICE of Appearance by Michelle Townes on behalf of David A. Cook (Townes, Michelle) (Entered: 07/24/2012) |
07/24/2012 | 11 | 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) | |
07/26/2012 | 12 | 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) |
07/26/2012 | 13 | 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) |
07/30/2012 | 14 | 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) |
07/30/2012 | 15 | 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) |
07/30/2012 | 17 | 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) |
07/31/2012 | 16 | 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) |
08/02/2012 | 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. (Attachments: # 1Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4)(Varghese, Manoj) (Entered: 08/02/2012) |
08/02/2012 | 19 | 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) |
08/03/2012 | 20 | RESPONSE in Opposition re 14 MOTION to Stay filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Varghese, Manoj) (Entered: 08/03/2012) |
08/05/2012 | 21 | NOTICE Of Filing by K-V Pharmaceutical Company, Ther-Rx Corporation Second Declaration of Thomas McHugh (Varghese, Manoj) (Entered: 08/05/2012) |
08/05/2012 | 22 | 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) | |
08/07/2012 | 23 | 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) |
08/07/2012 | 24 | 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) | |
08/07/2012 | 25 | 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) |
08/07/2012 | 26 | 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) |
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