Case details

Court: dcd
Docket #: 1:83-cv-01603
Case Name: ALPHARMA, INC. v. LEAVITT, et al
PACER case #: 25742
Date filed: 1983-06-06
Date terminated: 2005-03-11
Assigned to: Judge John Garrett Penn
Nature of Suit: 890 Other Statutory Actions
Jury Demand: None
Jurisdiction: U.S. Government Defendant

Parties

Represented Party Attorney & Contact Info
A.L. LABORATORIES, INC.
Plaintiff
TERMINATED: 10/23/1995
James H Wallace , Jr.
WILEY REIN LLP 1776 K Street, NW Washington, DC 20006 (202) 719-7240 Fax: (202) 719-7049 Email: jwallace@wileyrein.com
LEAD ATTORNEY ATTORNEY TO BE NOTICED

James M. Johnstone
2809 Boston Street Suite 411 Baltimore, MD 21221 (410) 342-0192 Fax: (202) 719-7049 Email: jmjatty@infionline.net

Douglas James Behr
KELLER & HECKMAN, LLP 1001 G Street, NW Suite 500 West Washington, DC 20001-4545 (202) 434-4213 Fax: (202) 434-4646 Email: behr@khlaw.com
ATTORNEY TO BE NOTICED

A.L. PHARMA, INC.
Plaintiff
James M. Johnstone
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

James M. Ludwig
COBURN & SCHERTLER 1150 Connecticut Avenue, NW Suite 900 Washington, DC 20036 (202) 862-4343 Fax: 202-628-4177

Richard L. McConnell , Jr.
WILEY REIN LLP 1776 K Street, NW Washington, DC 20006 (202) 719-7265 Fax: (202) 719-7049 Email: RMcConnell@wileyrein.com

Douglas James Behr
(See above for address)
ATTORNEY TO BE NOTICED

MARGARET M. HECKLER
Defendant
TERMINATED: 10/23/1995
Jacqueline H. Eagle
OLSSON, FRANK AND WEEDA, P.C. 1400 16th Street, NW Suite 400 Washington, DC 20036-2216 (202) 789-1212 Fax: (202) 234-3550 Email: jeagle@oflaw.com
TERMINATED: 02/07/2007 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Jeffrey Bruce Chasnow
U.S. DEPARTMENT OF JUSTICE 1331 Pennsylvania Avenue, NW Washington, DC 20004 (202) 616-0509
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Marcia A. Johnson
U.S. DEPARTMENT OF JUSTICE Commercial Litigation Branch 1100 L Street, NW Washington, DC 20005
TERMINATED: 06/08/1992 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
U.S. DEPARTMENT OF JUSTICE P.O. Box 386 Washington, DC 20044 (202) 307-0052 Fax: (202) 514-8742 Email: suzette.smikle@usdoj.gov
LEAD ATTORNEY ATTORNEY TO BE NOTICED

ARTHUR HULL DR. HAYES, JR.
Defendant
TERMINATED: 10/23/1995
Jacqueline H. Eagle
(See above for address)
TERMINATED: 02/07/2007 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Marcia A. Johnson
(See above for address)
TERMINATED: 06/08/1992 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

JOSEPH P. HILE
Defendant
TERMINATED: 10/23/1995
Jacqueline H. Eagle
(See above for address)
TERMINATED: 02/07/2007 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Marcia A. Johnson
(See above for address)
TERMINATED: 06/08/1992 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

DONNA E. SHALALA
Defendant
Secretary, of Health and Human Services TERMINATED: 11/15/2006
Jeffrey Bruce Chasnow
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Drake S. Cutini
DEPARTMENT OF JUSTICE Consumer Protection Branch P.O. Box 386 Washington, DC 20044 (202) 307-0044 Fax: (202) 514-8742 Email: drake.cutini@usdoj.gov
ATTORNEY TO BE NOTICED

DAVID A. KESSLER
Defendant
in his Official Capacity as Commissioner of Food & Drugs
Jeffrey Bruce Chasnow
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Catherine L. Copp
FOOD & DRUG ADMINISTRATION Office of the Commissioner 5600 Fishers Lane GCF-1 Rockville, MD 20857 (301) 827-1139
ATTORNEY TO BE NOTICED

Drake S. Cutini
(See above for address)
ATTORNEY TO BE NOTICED

RONALD G. CHESEMORE
Defendant
Associate commissioner for Regulatory Affairs for the Federal Drug Adminstration
Jeffrey Bruce Chasnow
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Catherine L. Copp
(See above for address)
ATTORNEY TO BE NOTICED

Drake S. Cutini
(See above for address)
ATTORNEY TO BE NOTICED

MICHAEL O. LEAVITT
Defendant
Secretary of Health and Human Services
Drake S. Cutini
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Suzette A. Smikle
(See above for address)
LEAD ATTORNEY ATTORNEY TO BE NOTICED

Documents

Date Filed Document # Attachment # Short Description Long Description Upload date SHA1 hash
1983-12-31 1 0 ANSWER for defendant,by counsel (ew) (Entered: 09/04/1987)
1992-04-24 55 0 ORDER by Judge John G. Penn :parties to file supplemental memorandum in support of motions for summary judgment due by 6/8/92 (N) (pmh) (Entered: 04/24/1992)
1992-06-08 56 0 SUPPLEMENTAL MEMORANDUM by plaintiff in support of their motions for summary judgment; exhibit (1) (cjp) (Entered: 06/09/1992)
1992-06-08 57 0 RESPONSE by defendant JOSEPH P. HILE, defendant MARGARET M. HECKLER, defendant HAYES JR. to order due by 6/8/92 [55-1], order [55-2] (cjp) (Entered: 06/09/1992)
1992-06-15 58 0 ERRATA by plaintiff(s) A L LABS. for a supplemental memorandum in support of plaintiffs' motions for summary judgment filed 06/08/92 with two typographical errors (kmk) (Entered: 06/16/1992)
1993-12-21 59 0 MEMORANDUM by Chief Judge John Garrett Penn (N) (clv) (Entered: 12/21/1993)
1993-12-21 60 0 ORDER by Chief Judge John G. Penn : defendants' motions for summary judgment are granted; plaintiff's motions for summary judgment are denied; case is dismissed with prejudice; all other pending motions are denied as moot; (N) (clv) (Entered: 12/21/1993)
1994-02-18 61 0 NOTICE OF APPEAL by plaintiff(s) A L LABS. from order [60-1] , entered on: 12/21/94; $5.00 filing fee paid; $100.00 docketing fee paid; copies mailed to: James Wallace, James Johnstone, and Marcia Johnson. (kmk) (Entered: 02/22/1994)
1995-10-23 62 0 CERTIFIED COPY of Judgment filed in USCA dated 8/25/95, on appeal [61-1] , affirming the judgment of USDC in part , reversing the judgment of USDC in part , remanding case with instructions ; Opinion. USCA # 94-5041 (mbd) (Entered: 10/25/1995)
1995-10-30 63 0 MEMORANDUM by defendants JOSEPH P. HILE, MARGARET M. HECKLER and HAYES JR. re: Remand from the Court of Appeals; attachment (1). (tth) (Entered: 11/01/1995)
1995-10-31 64 0 NOTICE OF FILING re: Affidavit of Helen K. Harris; attachment. (tth) (Entered: 11/02/1995)
1995-11-16 65 0 MEMORANDUM by plaintiff A.L. LABS. regarding remand from the Court of Appeals; attachment (1); exhibits (2) (tth) (Entered: 11/17/1995)
1995-11-20 66 0 REPLY (MEMORANDUM) by defendants JOSEPH P. HILE, MARGARET M. HECKLER and HAYES JR. regarding remand from the Court of Appeals [65-1] by A L LABS. . (tth) (Entered: 11/21/1995)
1995-11-29 67 0 ATTORNEY APPEARANCE for defendant MARGARET M. HECKLER by Jeffrey Bruce Chasnow. (kmk) (Entered: 11/29/1995)
1995-11-27 68 0 STIPULATION filed and fiated by Chief Judge John G. Penn regarding A.L. PHARMA will not contend that NADA 128-550 will be or has been automatically Court of Appeals' Order at any time prior to close of business on 12/04/95. This stipulation is without prejudice to the position of either party with respect to the effect of the Court of Appeals' remand or any other issue pending before this Court. (kmk) Modified on 06/19/1996 (Entered: 11/29/1995)
1995-11-29 69 0 ATTORNEY APPEARANCE for defendant DAVID A. KESSLER, defendant RONALD G. CHESEMORE by Catherine L. Copp (kmk) (Entered: 11/29/1995)
1995-12-04 70 0 ORDER by Chief Judge John G. Penn: that the FDA rule approving NADA 128-550 was not automatically vacated on 11/24/95; and it is FURTHER ORDERED that the FDA rule approving NADA 128-550 will not automatically be vacated if this Court does not rule by the close of business 12/04/95; and is FURTHER ORDERED that the FDA rule approving NADA 128-550 will remain in full effect unless and until the Court finds that the FDA has otherwise failed to comply with the Court of Appeals order. (N) (kmk) Modified on 06/19/1996 (Entered: 12/04/1995)
1995-12-04 71 0 TRANSCRIPT filed for date(s) of November 29, 1995. Reporter: Harry Deutsch (tth) (Entered: 12/05/1995)
2004-06-28 72 0 NOTICE of Appearance by Douglas James Behr on behalf of all plaintiffs (Behr, Douglas) (Entered: 06/28/2004)
2004-07-29 73 0 ORDER providing parties with opportunity to supplement the record in accordance with the following schedule: Parties may file supplemental briefs or materials on or before August 11, 2004 and replies on or before August 27, 2004. See Order for details. Signed by Judge John Garrett Penn on July 29, 2004. (clcjgp) (Entered: 07/29/2004)
2004-08-11 74 0 NOTICE of Appearance by Drake S. Cutini on behalf of all defendants (Cutini, Drake) (Entered: 08/11/2004)
2004-08-11 75 0 SUPPLEMENTAL MEMORANDUM from Plaintiff's Memo. Re: Remand from the Court of Appeals. (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 Exhibit 9# 10 Exhibit 10# 11 Exhibit 11)(Behr, Douglas) (Entered: 08/11/2004)
2004-08-11 76 0 RESPONSE to Court Order of July 29, 2004 filed by RONALD G. CHESEMORE, DAVID A. KESSLER, DONNA E. SHALALA. (Cutini, Drake) (Entered: 08/11/2004)
2004-08-24 77 0 Unopposed MOTION for Order to Alter Briefing Schedule by RONALD G. CHESEMORE, DAVID A. KESSLER, DONNA E. SHALALA. (Cutini, Drake) (Entered: 08/24/2004)
2004-09-10 78 0 REPLY to 73 Defendant's Response to Court Order of July 29, 2004 filed by A.L. PHARMA, INC.. (Behr, Douglas) (Entered: 09/10/2004)
2004-09-10 79 0 REPLY to Plaintiff's Supplemental Brief of August 11, 2004 filed by RONALD G. CHESEMORE, DAVID A. KESSLER, DONNA E. SHALALA. (Cutini, Drake) (Entered: 09/10/2004)
2005-02-07 80 0 MEMORANDUM OPINION Court is satisfied that the FDA provided an adequate justification for its conclusion that the two drugs are bioequivalent, therefore, the Court adheres to its decision that the FDA complied with the remand. The result reached by the FDA resulted from "reasoned decisionmaking." An appropriate order dismissing this case with prejudice will be entered. Signed by Judge John Garrett Penn on February 4, 2005. (clcjgp) (Entered: 02/07/2005)
2005-02-07 81 0 ORDER this case is dismissed with prejudice for the reasons set forth in the accompanying Memorandum Opinion. Signed by Judge John Garrett Penn on February 4, 2005.(clcjgp) (Entered: 02/07/2005)
2005-04-01 83 0 NOTICE OF APPEAL as to 81 Order by A.L. PHARMA, INC.. Filing fee $ 255, receipt number 133319. (rje, ) (Entered: 04/04/2005)
2006-10-11 84 0 USCA JUDGMENT (certified copy) as to 83 Notice of Appeal filed by A.L. PHARMA, INC.; It is hereby ordered and adjudged that the judgment of the District Court appealed from in these causes is hereby set aside and the case remanded; USCA#05-5137 (zjsc) (Entered: 10/13/2006)
2006-10-13 85 0 APPLICATION for Status Hearing After Remand by A.L. PHARMA, INC.. (Behr, Douglas) (Entered: 10/13/2006)
2006-10-16 86 0 NOTICE of Appearance by Suzette A. Smikle on behalf of all defendants (Smikle, Suzette) (Entered: 10/16/2006)
2006-10-18 87 0 ORDER re 84 USCA Judgment. This matter is remanded to the Food and Drug Administration to address the matters raised in the Opinion and Order of the Court of Appeals. Signed by Judge John Garrett Penn on October 18, 2006.(clcjgp) (Entered: 10/18/2006)
2006-10-18 88 0 ORDER denying as moot 85 plaintiff's Request For Status Hearing After Remand. Signed by Judge John Garrett Penn on October 18, 2006.(clcjgp) (Entered: 10/18/2006)
2006-12-20 89 0 ORDER The Food and Drug Administration shall file the explanation required by the Court of Appeals on or before January 26, 2007. See Order for details. Signed by Judge John Garrett Penn on December 20, 2006. (clcjgp) (Entered: 12/20/2006)
2007-01-23 90 0 Unopposed MOTION for Extension of Time to And Incorporated Memorandum in Support by MICHAEL O. LEAVITT, DAVID A. KESSLER, RONALD G. CHESEMORE. (Attachments: # 1 Text of Proposed Order)(Smikle, Suzette) (Entered: 01/23/2007)
2007-01-25 91 0 ORDER granting 90 defendants' Unopposed Motion for Extension of Time. Defendants shall file a response on or before February 9, 2007. Signed by Judge John Garrett Penn on January 25, 2007.(clcjgp) (Entered: 01/25/2007)
2007-02-09 92 0 NOTICE OF FILING by MICHAEL O. LEAVITT, DAVID A. KESSLER, RONALD G. CHESEMORE re 89 Order (Attachments: # 1)(Smikle, Suzette) (Entered: 02/09/2007)
2007-05-02 93 0 ORDER In view of the Food and Drug Administration's response 92 to the Court's Orders [87, 89] plaintiff may file a response on or before June 1, 2007 and defendants may file a reply on or before June 15, 2007. See Order for details. Signed by Judge John Garrett Penn on May 2, 2007. (clcjgp) (Entered: 05/02/2007)
2007-06-01 94 0 MEMORANDUM by A.L. PHARMA, INC.. (Attachments: # 1 Exhibit Exhibits A-K# 2 Exhibit Exhibit L# 3 Exhibit Exhibits M-N)(Behr, Douglas) (Entered: 06/01/2007)
2007-06-08 95 0 Unopposed MOTION for Extension of Time to File Response/Reply by MICHAEL O. LEAVITT, MARGARET M. HECKLER, HAYES, JR, DONNA E. SHALALA, DAVID A. KESSLER, RONALD G. CHESEMORE, JOSEPH P. HILE (Attachments: # 1 Text of Proposed Order)(Smikle, Suzette) (Entered: 06/08/2007)
2007-07-06 96 0 Unopposed MOTION for Extension of Time to File Response/Reply by MICHAEL O. LEAVITT, MARGARET M. HECKLER, HAYES, JR, DONNA E. SHALALA, DAVID A. KESSLER, RONALD G. CHESEMORE, JOSEPH P. HILE (Attachments: # 1 Text of Proposed Order)(Smikle, Suzette) (Entered: 07/06/2007)
2007-08-30 97 0 MOTION to Dismiss for Lack of Jurisdiction by MICHAEL O. LEAVITT, DAVID A. KESSLER, RONALD G. CHESEMORE (Attachments: # 1 Text of Proposed Order)(Cutini, Drake) (Entered: 08/30/2007)
2007-09-10 98 0 RESPONSE to Defendants' 97 Motion to Dismiss filed by A.L. PHARMA, INC.. (Behr, Douglas) Modified on 9/11/2007 (tg, ). (Entered: 09/10/2007)
2007-11-15 99 0 Mail Returned as Undeliverable. Mail sent to Jeffrey Bruce Chasnow (cp, ) (Entered: 01/29/2008)