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here - FDA Law Blog

Case 2:09-cv-05761-PA-RZ
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Attorneys for Plaintiffs
MUTUAL PHARMACEUTICAL COMPANY INC., AR
SCIENTIFIC, INC., and AR HOLDING COMPANY, INC.
UNITED STATES DISTRICT COURT
FOR THE CENTRAL DISTRICT OF CALIFORNIA
MUTUAL PHARMACEUTICAL
COMPANY, INC., a Pennsylvania
corporation; AR SCIENTIFIC, INC., a
Delaware corporation; and AR
HOLDING COMPANY, INC., a
Delaware corporation,
Plaintiffs,
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v.
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28
f-'~-I
VALLE & ASSOCIATES
JEFFREY B. VALLE (CALIFORNIA BAR NO. 110060)
(JVALLE~V ALLEASSOCIATES.COM)
THOMAS . FRIEDMAN (CALIFORNIA BAR NO.
205407)
(TFRIE'[email protected])
11911 San Vicente Blvd., SUIte 324
Los Angeles, CA 90049
Telephone: (310) 476-0300
FaCSImile: (310) 476-0333
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Page 1 of 44
PETER 1. WILLSEY (PRO HAC VICE PENDING)
(PWILLSEY COOLEY.COM)
T H
H HI CALIFORNIA BAR NO.
221612) (NKOTTAHACHC
COOLEYCOM)
BRENDAN 1. HU HE
VI E
NDlNG)
~BHUGHES~COOLEY OM)
77 6th StreeN.W., Suite 1100
Washington, DC 20001-3703
Telephone: (202) 842-7800
FacsImile: (202) 842-7899
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22
Filed 08/06/2009
COOLEY
KRONISH
MICHAEL
RHODES (CALIFORNIA
NO. 116127)
'RHODESMG COOLEY COM)
.K L
RNI BAR NO. 199196)
~KYLE@COOL YCOM)
401 Eastgate Mall
San Diego, CA 92121-1909
Telephone: (858) 550-6000
FaCSImile: (858) 550-6420
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Document 1
INDENA S.P.A., an Italian
corporation; ALCHEM
INTERNATIONAL LIMITED, an
Indian co oration· ALKALOIDS PVT
ct~sQ~o~
1
COMPLAINT FOR:
(1) CONTRIBUTORY FALSE
AND MISLEADING
ADVERTISING, FALSE
REPRESENTATION OF FACT,
AND UNFAIR COMPETITION
UNDER 15 U.S.c. § 1125(A);
(2) CONTRIBUTORY UNFAIR
COOLEYGODWARD
KRONISH LLP
ATT<WNI'YS AT LAW
W A<;llINGTON
97906 vSIDC
COMPLAINT FOR UNFAIR COMPETITION
Document 1
Filed 08/06/2009
, an
corporation; INDENA
USA, INC, a Delaware co,r:pora~ion;
LALILAB, INC, a North carolma
corporation; and FLAVINE NORTH
AMERICA, INC., a Delaware
corporation,
Page 2 of 44
8
UNDER
BUS. &
CODE 17200, ET SEQ.;
(3) CONTRIBUTORY FALSE
ADVERTISING UNDER CAL.
BUS. & PROF. CODE 17500, ET
SEQ.; AND,
(4) CONTRIBUTORY
COMMON LAW UNFAIR
COMPETITION AND
MISAPPROPRIATION
9
DEMAND FOR JURY TRIAL
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Defendants.
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Plaintiffs Mutual Pharmaceutical Company, Inc. ("Mutual"), AR Scientific,
12
Inc. ("AR Scientific") and AR Holding Company, Inc. ("ARHolding")
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(collectively, "Plaintiffs"), complain and allege against Defendants Indena S.p.A.,
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Alchem International Limited, Alkaloids PVT Ltd, Indena USA, Inc., Lalilab, Inc.,
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and Flavine North America, Inc. (collectively, "Defendants") as follows.
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INTRODUCTION
1.
Plaintiffs bring this lawsuit under 15 U.S.C. § 1125(a), California
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Business and Professions Code §§ 17200 and 17500, and under the common law of
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unfair competition and misappropriation of the State of California, against suppliers
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of colchicine active pharmaceutical ingredient ("API") used in unapproved
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prescription drug products containing colchicine as the sole active ingredient that
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are being unlawfully and unfairly advertised, marketed, promoted, distributed,
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and/or sold in competition with Plaintiffs' colchicine product (COLCRYSTM),
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which has been approved by the U.S. Food and Drug Administration ("FDA") and
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will be launched in the marketplace imminently.
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2.
Due to the proven public health concerns for drug safety and efficacy,
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it is against the law to market, distribute and/or sell any colchicine drug product that
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is not FDA-approved (21 U.S.C. § 301 et seq.).
COOLEYGODWARD
KRONISH LLP
A1'TO~NEYS
AT LAW
WASHINGTON
91906 vS/DC
2.
1
2
Document 1
Filed 08/06/2009
Page 3 of 44
2007,
application ("IND") No. 72,586
4.
3
Drug
colchicine.
Pursuant to the Orphan Drug Act ("ODA") (21 US.c. § 360aa-ee),
4
Mutual filed a Request for Orphan Drug Designation (Request No. 07-2458) on
5
September 10,2007.
5.
6
7
FDA on September 25,2007.
6.
8
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Mutual's Request for Orphan Drug Designation was granted by the
On June 20, 2008, Mutual submitted a New Drug Application
("NDN') (NDA No. 22-352) for 0.6 mg tablets containing colchicine as the sole
10
active ingredient pursuant to section 505(b) of the US. Food, Drug & Cosmetic Act
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(the "Federal FDCA"), 21 US.c. § 301 et seq., for the treatment of Familial
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Mediterranean Fever ("FMF").
7.
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On September 30, 2008, Mutual submitted an NDA (NDA No. 22-
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351) for 0.6 mg tablets containing colchicine as the sole API pursuant to section
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505(b) of the Federal FDCA for the treatment of gout flares.
8.
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its COLCRYSTM colchicine (0.6 mg) product for the treatment ofFMF.
9.
18
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Under the ODA, the FDA granted Mutual a 7-year period to
exclusively market COLCRYSTM for the treatment ofFMF, ending July 29, 2016.
10.
20
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On July 29, 2009, Mutual obtained FDA approval to market and sell
On July 30,2009, Mutual obtained FDA approval to market and sell
its COLCRYSTM colchicine (0.6 mg) product for the treatment of gout flares.
22
11.
Plaintiffs expect that the FDA will grant Mutual a 3-year period to
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exclusively market COLCRYSTM for the treatment of gout flares, ending July 30,
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2012.
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12.
Information regarding the FDA's approval ofCOLCRYSTM is publicly
26
available via the FDA website, as well as through various media outlets such as The
27
New York Times. The COLCRYSTM label is also available to the public through the
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FDA website.
COOLEYGODWARD
KRON1SH LLP
WASHINGTON
91906 vS/DC
3.
1
Document 1
Filed 08/06/2009
Page 4 of 44
1S
2
product, Plaintiffs AR Scientific and AR Holding share
3
or licensing rights in the product, as set forth in more detail herein.
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14.
ownership, distribution
Presently, Plaintiffs are the only lawful providers of an FDA-approved
drug product containing colchicine as the sole active ingredient.
15.
Despite Plaintiffs' unique status as the only entities that can lawfully
7
manufacture and market a drug product containing colchicine as the sole active
8
ingredient in the United States, Defendants nevertheless manufacture, import,
9
distribute, sell and/or otherwise make colchicine API available in the United States
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to pharmaceutical manufacturers (collectively, the "Illegal Manufacturers") for
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incorporation into illegal and unapproved colchicine products that are then
12
advertised, distributed and sold throughout the United States, including in the State
13
of California.
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16.
The Illegal Manufacturers include, among others, Generics Bidco I,
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LLC dba Qualitest Phannaceuticals, West-ward Phannaceutical Corp., Watson
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Pharmaceuticals, Inc., Excellium Phannaceutical, Inc., and Vision Phanna, LLC.
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17.
Through a variety of means detailed herein, the Illegal Manufacturers
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market, promote and sell their illegal colchicine products by relying on false and
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misleading statements, omissions, and other tactics likely to (a) create false
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impressions and confusion regarding the safety, efficacy and FDA approval status
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of their colchicine products and, concomitantly, Plaintiffs' COLCRYSTM product,
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and (b) cause phannacists, physicians, buyers and consumers to mistakenly
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conclude that Illegal Manufacturers' colchicine products are either interchangeable
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with Plaintiffs' FDA-approved COLCRYSTM product or, even worse, that the
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Illegal Manufacturers' products are safer than Plaintiffs' FDA-approved
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COLCRYSTM product - whereas the opposite is true.
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18.
The Illegal Manufacturers' unlawful marketing, advertising, promotion
and distribution not only causes confusion, but irreparably hanns Plaintiffs and
COOLEY GODWARD
KRONISHLLP
ATTORNEYS AT LAW
W A,HINGTON
91906 v5/DC
4.
poses
2
19.
Filed 08/06/2009
Page 5 of 44
consumers as
The Hlegal Manufacturers' misleading and
marketing
3
distribution practices include the distribution of false and misleading labels, product
4
inserts, product advertising and drug information through a variety of channels,
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including: (a) integrated drug dispensing databases and pricing services commonly
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known as "Price Lists" (hereinafter referred to as "Price Lists") such as Medi-Span,
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First Databank, Gold Standard and Redbook; (b) drug product ordering systems
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provided by drug wholesalers (hereinafter referred to as "Wholesaler Ordering
9
Systems"), such as McKesson Corporation, Cardinal Health, Inc.,
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AmerisourceBergen Corporation, Anda, Inc. and Kinray, Inc.; (c) drug ordering
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systems used by retail drugstore chains; and (d) numerous third-party Internet drug
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product retailers and wholesalers.
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20.
The Illegal Manufacturers' use of misleading, obsolete and/or
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incomplete information on packaging, labeling and "instructions for use" for their
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illegal colchicine products creates confusion among pharmacists, physicians, buyers
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and consumers, and enhances the harm to Plaintiffs and health risks to patients.
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21.
Plaintiffs have separately brought an action to enjoin the Illegal
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Manufacturers' ongoing illegal activities, and seek to prohibit the Illegal
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Manufacturers from falsely advertising, marketing, promoting, and/or distributing
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their unapproved colchicine products.
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22.
Defendants know, or reasonably should know, that the Illegal
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Manufacturers are unlawfully and unfairly advertising, marketing, promoting,
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distributing and selling finished colchicine products in the United States without
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approval from the FDA, or have done so in the past.
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23.
By supplying colchicine API to the Illegal Manufacturers, Defendants
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have provided and continue to provide the Illegal Manufacturers with the critical
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instrument used to commit their unlawful acts, rendering Defendants secondarily
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and contributorily liable for those unlawful acts.
COOLEYGODWARD
KRONI5HLLP
ATTORNEYS AT LAw
WASHiNGTON
to
Document 1
91906 vSIDC
5.
Document 1
Filed 08/06/2009
Page 6 of 44
2
API, Defendants are aiding and abetting the Illegal Manufacturers
3
interfering with Plaintiffs' ability to sell and distribute lawful colchicine products in
4
the United States.
5
25.
tortiously
Plaintiffs ask the COUli to immediately enjoin the Defendants from
6
manufacturing, importing, distributing, selling and/or otherwise making colchicine
7
API available to the Illegal Manufacturers, as such activities aid, abet and
8
contribute to the Illegal Manufacturers' false and misleading advertising and
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marketing of their unapproved colchicine products, which constitutes unfair
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competition and tortious interference with Plaintiffs' ability to sell and distribute
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lawful colchicine products in the United States.
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13
26.
Plaintiffs also seek damages resulting from Defendants' contributory
unfair and unlawful conduct as set forth in the Prayer for Relief herein.
14
PARTIES
15
MUTUAL PHARMACEUTICAL COMPANY, INC.
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27.
Plaintiff Mutual Phannaceutical Corporation ("Mutual") is a
17
corporation organized under the laws ofthe State of Pennsylvania and has its
18
principal place of business at 1100 Orthodox Street, Philadelphia, Pennsylvania
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19124.
20
28.
Mutual is a phannaceutical company that focuses on drug
21
development, marketing, and distribution, and offers a wide range of products,
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including its COLCRYSTM product, which will be marketed and distributed
23
imminently.
24
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AR SCIENTIFIC, INC.
29.
Plaintiff AR Scientific, Inc. ("AR Scientific") is a corporation
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organized under the laws of the State of Delaware and has its principal place of
27
business at 1100 Orthodox Street, Philadelphia, Pennsylvania 19124.
28
COOLEYGODWARD
KRONISH LLP
Arl'URNEYS Al LAW
IV ASlilNGTON
97906 vS/DC
6.
30.
Document 1
Filed 08/06/2009
AR Scientific is a nh'llT11~rpl
Page 7 of 44
focuses on
2
marketing and distribution of branded pharmaceutical products, including its
3
COLCRYSTM product, which will be marketed and distributed imminently,
4
5
31.
by the scope ofNDA No, 22-351 and NDA No, 22-352,
6
7
AR Scientific has the right to distribute any approved products covered
AR HOLDING COMPANY, INC.
32.
Plaintiff AR Holding Company, Inc, ("AR Holding") is a corporation
8
organized under the laws of the State of Delaware and has its principal place of
9
business at 1105 N, Market Street, Suite 1300, Wilmington, Delaware 19801,
10
33.
AR Holding Company is a pharmaceutical company that focuses on
11
the management and protection of intellectual property rights related to branded
12
pharmaceutical products, including its COLCRYSTM product, which will be
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marketed and distributed imminently,
14
34.
Mutual has assigned to AR Holding all right, title and interest in NDA
15
No, 22-351 and NDA No, 22-352 for colchicine tablets and all know-how, material
16
permits, consents and approvals, retaining a license to make, use, offer for sale, sell,
17
import, develop and commercialize the products covered by the scope ofNDA No,
18
22-351 and NDA No, 22-352 and retaining its status as regulatory agent responsible
19
for all FDA regulatory filings,
20
35.
All Plaintiffs retain rights in commercializing any products covered by
21
the scope ofNDA No, 22-351 and NDA No, 22-352 and are irreparably harmed by
22
the unfair competition and deception complained of herein,
DEFENDANT INDENA S.p.A.
23
24
36.
On information and belief, Defendant Indena S,p,A. ("Indena") is an
25
Italian corporation organized under the laws of Italy, with a principal place of
26
business at Viale Ortles 12 Milan, Italy, 20139,
27
28
37.
On infonnation and belief, Defendant Indena is in the business of
manufacturing, importing, distributing, selling and otherwise making available APIs
COOLEYGODWARD
KRONISHLLP
W A~HINGTON
97906 vSIDC
7,
Document 1
in the United Sates,
2
38.
Filed 08/06/2009
Page 8 of 44
UlvLUUUl6
information and beliet~ lndena unlawfully imports colchicine API
3
into the United States and sells it to Illegal Manufacturer(s), who in tum incorporate
4
such colchicine API into their illegal finished colchicine drug products sold in the
5
United States without approval from the FDA.
6
DEFENDANT ALCHEM INTERNATIONAL LIMITED
7
39.
On information and belief, Defendant Alchem International Limited
8
("Alchem") is an Indian corporation organized under the laws ofIndia, with a
9
principal place of business at 25/2 Main Mathura Road, Kaili Village, Ballabgargh,
10
Haryana, 121004, India.
40.
11
On information and belief, Alchem is in the business of
12
manufacturing, importing, distributing, selling and otherwise making available
13
APIs available in the United Sates, including colchicine API.
41.
14
On information and belief, Alchem unlawfully imports colchicine API into
15
the United States and sells it to Illegal Manufacturer(s), who in tum incorporate such
16
colchicine API into their illegal fmished colchicine drug products sold in the United
17
States without approval from the FDA.
DEFENDANT ALKALOIDS PVT LTD.
18
42.
19
On information and belief, Defendant Alkaloids PVT Ltd.
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("Alkaloids") is an Indian corporation organized under the laws ofIndia, with a
21
principal place of business at 3 Bentinck Street, Kolkata, West Bengal, 700001,
22
India.
23
43.
On infonnation and belief, Alkaloids is in the business of
24
manufacturing, importing, distributing, selling and otherwise making available
25
APIs available in the United Sates, including colchicine API.
26
27
44.
On information and belief, Alkaloids unlawfully imports colchicine API
into the United States and sells it to Illegal Manufacturer(s), who in turn incorporate
28
COOLEY GODWARD
KRONISHLLP
ATTORNEYS AT LAW
WASHINGTON
97906 v5/DC
8.
Page 9 of 44
United States without approval from the FDA
3
4
Filed 08/06/2009
, illegal
1
2
Document 1
DEFENDANT INDENA USA, INC.
45.
On information and belief, Defendant Indena USA, Inc, ("In dena
5
USA") is a corporation organized under the laws of the state of Delaware, with a
6
principal place of business at 811 First Avenue, Suite 218, Seattle, Washington
7
98104,
8
9
10
11
46.
On information and belief, Defendant Indena USA is in the business of
manufacturing, importing, distributing, selling and otherwise making available APIs
available in the United Sates, including colchicine APL
47.
On information and belief, Indena USA unlawfully imports colchicine
12
API into the United States and sells it to Illegal Manufacturer(s), who in tum
13
incorporate such colchicine API into their illegal finished colchicine drug products
14
sold in the United States without approval from the FDA
15
DEFENDANT LALILAB, INC.
16
48.
On information and belief, Defendant Lalilab, Inc, ("Lalilab") is a
17
corporation organized under the laws of the state of North Carolina, having a
18
principal place of business at 1415 Hamlin Road, Durham, North Carolina 27704,
19
49.
On information and belief, Lalilab is in the business of manufacturing,
20
importing, distributing, selling and otherwise making available APIs available in
21
the United Sates, including colchicine APL
22
50.
On infonnation and belief, Lalilab unlawfully imports colchicine API into
23
the United States and sells it to Illegal Manufacturer(s), who in tum incorporate such
24
colchicine API into their illegal finished colchicine drug products sold in the United
25
States without approval from the FDA
26
27
28
DEFENDANT FLAVINE NORTH AMERICA, INC.
51.
On information and belief, Defendant Flavine North America, Inc,
("Flavine") is a corporation organized under the laws of the state of Delaware,
COOLEY GODWARD
KRONJSHLLP
An<>KNO, AT LAW
WASHINGTON
97906 vS/De
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Document 1
52.
Page 10 of 44
10
having a pnnclpal place of
2
Filed 08/06/2009
On information and belief: Flavine is
,P'-"PV
07624,
the business of manufacturing,
3
importing, distributing, selling and otherwise making available APIs available in
4
the United Sates, including colchicine API.
5
53.
On information and belief, Flavine unlawfully imports colchicine API into
6
the United States and sells it to Illegal Manufacturer(s), who in turn incorporate such
7
colchicine API into their illegal finished colchicine drug products sold in the United
8
States without approval from the FDA
9
10
JURISDICTION AND VENUE
54.
This action arises under 15 US.c. § 1125(a), and under the statutory
11
and common law of the State of California. This Court has subject matter
12
jurisdiction for each of the claims herein as follows:
(a)
13
Contributory liability for false or misleading representation of
14
fact and unfair competition in violation of the Lanham Act, § 43(a), 15 U.S.C.
15
§ 1125(a), with original jurisdiction vested in this Court by virtue of 15 U.S.C.
16
§ 1121 and 28 US.C. § 1338;
17
(b)
Contributory liability for statutory unfair competition under
18
California Business and Professions Code § 17200 et seq" with supplemental
19
jurisdiction vested in this Court by virtue of28 US.C. § 1367(a);
20
( c)
Contributory liability for statutory false advertising under
21
California Business and Professions Code § 17500 et seq., with supplemental
22
jurisdiction vested in this Court by virtue of28 US.C. § 1367(a); and
(d)
23
Contributory liability for common law unfair competition and
24
misappropriation arising under the laws of the State of California, with
25
supplemental jurisdiction vested in this Court by virtue of 28 US.c. § 1367(a).
26
27
55.
This Court also has jurisdiction over the claims pursuant to 28 US.C.
§ 1331.
28
COOLEY GODWARD
KRONISHLLP
ATH)RNn~ AT LAW
Vl'I\SI-lINGTON
97906 vS/DC
10.
are
1
Document 1
Filed 08/06/2009
inf:r.,.,,1Prl
on
Page 11 of 44
allege,
2
Court has persona! jurisdiction over Defendants because they have extensive contacts
3
with the State of Califomia and this judicial district including by viliue of the fact
4
that they are assisting the Illegal Manufacturer(s) to advertise, promote and sell
5
unlawful colchicine products in this judicial district and the causes of action asselied
6
in this Complaint arise out of those contacts.
7
57.
Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b),
8
(c), and (d) because Defendants have extensive contacts with the State of Califomia
9
and this judicial district including by virtue of the fact that they are assisting the
10
Illegal Manufacturer(s) to advertise, promote and sell unlawful colchicine products in
11
this judicial district and the causes of action asserted in this Complaint arise out of
12
those contacts.
13
FACTUAL BACKGROUND
14
FMF, GOUT AND COLCHICINE
15
58.
Colchicine is an alkaloid derived from the plant ofthe Lily family
16
Colchicum autumnale. Plant extracts containing colchicine have been used to treat gout
17
for more than two thousand years, and pseudogout and Familial Mediterranean Fever
18
("FMF") for several decades. The active phannacological component of the plant,
19
colchicum, was isolated in 1820 and, in 1883, a fairly pure colchicum was extracted and
20
subsequently called colchicine. Colchicine is a drug with both a narrow therapeutic-
21
toxicity window and a marked variability between individuals in drug disposition. See
22
Terkeltaub R., "Colchicine Update: 2008," Semin. Arthritis Rheum (in press).
23
59.
While colchicine, when taken properly, has proven to be effective in
24
the treatment ofFMF and gout, drugs containing colchicine can have serious health
25
and safety risks ifnot administered properly.
26
60.
According to information culled from the FDA's Spontaneous Reporting
27
System (Adverse Drug Reaction (ADR) Database, covering data from January 1, 1969
28
through October 31, 1997) and the Adverse Event Reporting System (AERS
COOLEyGODWARD
KRON!SHLLP
AnORNEysATLAW
W!l~HINCTON
97906 vS/De
11.
Document 1
Filed 08/06/2009
1
N,ov'ember
2
January 1 2008 there were 751 repmis
3
interacting dmg and there were 234 reports with death listed as the outcome.
4
Significantly, the majority of the death reports were associated with oral colchicine
5
(169 of234; ~72%), which is consistent with the vastly greater use ofthe oral product.
6
Less than 10% of death reports (21 of 234) were associated with intravenous use of
7
colchicine.
8
9
61.
1907 tLvongh
dlt
Page 12 of 44
1
./ f
1)
U
1
2007), as
which colchicine was a suspect or
Similarly, the World Health Organization ("WHO") summary of safety
for colchicine showed 1,380 adverse reports submitted from 79 countries between
10
1968 and March 2006. Overall, among these reports, gastrointestinal adverse events,
11
diarrhea, vomiting and nausea were the most common. Noteworthy serious events
12
include acute renal failure, thrombocytopenia, leucopenia and death.
13
62.
FMF is an inherited disorder characterized by recurrent bouts of fever
14
and peritonitis, sometimes with pleuritis, skin lesions, arthritis and, rarely,
15
pericarditis. FMF may lead to the development of renal amyloidosis, which in tum
16
may result in renal failure. FMF occurs frequently in people having genetic origins
17
in the Mediterranean basin, though it has occurred in other populations such that it
18
should not be diagnosed solely on the basis of ancestry. The onset of the condition
19
usually occurs between age 5 and 15 years, but can occur later or much earlier. See
20
THE MERCK MANUAL, 18 ED., Merck Research Laboratories (2006). If untreated,
21
FMF can be fatal.
22
TH
63.
FMF "affects less than 200,000 persons in the United States,"
23
qualifying it as a "rare disease or condition." The FDA and Congress refer to drugs
24
that treat such rare diseases as "orphan drugs." See 21 U.S.C. § 360bb(a)(2).
25
64.
To encourage the development and ensure the supply of FDA-
26
approved drugs that combat rare diseases, Congress passed the ODA. The key
27
provision of the ODA is the 7-year period of Orphan Drug Exclusivity ("ODE")
28
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KRONISH LLP
ATTOI(NiOY5 AT LAW
WASHINGTON
97906 vSIDC
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Filed 08/06/2009
Page 13 of 44
suc;ce;sst!ull) invests
2
3
approval for an orphan-designated drug.
65.
Gout results from the precipitation of monosodium urate crystals into
4
tissue most usually in joints causing recurring acute arthritis or chronic arthritis. See
5
THE MERCK MANUAL, 18T!; ED., Merck Research Laboratories (2006).
6
66.
Gout is one ofthe most common forms of inflammatory arthritis. It
7
frequently results in significant short-term disability, occupational limitations and
8
utilization of medical services.
9
67.
According to a 2002 National Ambulatory Medical Care survey, there
10
were 3.9 million visits for (acute or chronic) gout ofthe 973 million ambulatory care
11
visits in the United States. See Krishnan E, Lienesch D, Kwoh CK, "Gout in
12
Ambulatory Care Settings in the United States," J. Rheumatol. 35,498-501 (2008).
13
68.
Acute gout (i.e. gout flares) is characterized, at least initially, by
14
intense pain and swelling at the site of urate accumulation, often initially within the
15
metatarsophalangeal joint of the big toe. The urate crystals can accumulate in and
16
around joints to form firm yellow or white papules/nodules called tophi. See THE
17
MERCK MANUAL, 18m ED., Merck Research Laboratories (2006).
18
69.
It is estimated that 3 to 5 million individuals in the United States
19
experience acute gout attacks and/or suffer from chronic gout. See Krishnan E,
20
Lienesch D, Kwoh CK, "Gout in Ambulatory Care Settings in the United States,"
21
J. Rheumatol. 35,498-501 (2008).
22
70.
Colchicine has been used to treat acute gout, and has also been used as
23
a prophylactic treatment. See THE MERCK MANUAL, 18TH ED., Merck Research
24
Laboratories (2006).
25
26
27
FDA WARNINGS CONCERNING COLCHICINE AND OTHER UNAPPROVED DRUGS
71.
Since at least as early as June 2006, the FDA has emphasized that
unapproved drugs represent a public health threat:
28
COOLEYGODWARD
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97906 vS/DC
13.
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Page 14 of 44
Food
Drug Administration
strengthening its
against lnonnrm!pn
2
***
3
9
"Right now, many unapproved drugs represent a public health
threat because consumers wrongly assume that these widely
marketed and available drugs are approved and have been
f()und to be safe and effective by the FDA," said Acting FDA
'Commissioner Dr. Anarew von Eschenbach, "While we want to
ensure continued patient access to necessary treatments, as a
IJhysician I feel strongly that patients expect and deserve all
their prescription medicines to be FDA approved, These
unapproved drugs have bypassed the agency approval process
through which FDA ensures, based on reliable scientitic data,
that marketed drugs are safe, effective, properly manufactured,
and accurately laneled, (Emphasis added)
10
"FDA News: FDA Acts to Improve Drug Safety and Quality," FDA website at
11
http://www,fda.govlbbs/topicsINEWS/2006INEWOI384.html (June 8, 2006)
12
(emphasis added).
4
5
6
7
8
13
14
72.
among healthcare providers about non-FDA approved drugs:
15
There are several reasons why an unapproved drug may be
available. One example is when only one company may have
approval to market a drug, but other compames are illegally
marketing their versions of the drug without having gone
through the FDA's approval process, Another scenario is that a
combmation of ingreaients is approved by the FDA, but a
company is marketing a single ingredient without approval.
16
17
18
19
23
Some older products continue to be marketed illegally for
historical reasons. "Many drugs were marketed before Congress
made changes to the law reqUiring drugs to undergo FDA
review," Autor says. There are una,l?proved drugs whose makers
claim the dru~s are "grandfathered under older standards and
therefore don t require approval under the current regulatory
framework. "But tile truly 'grandfathered' drugs represent only a
few, at most of all the unapproved druE;s being marketed,"
Autor says. hMost unapproved drugs do require FDA approval. "
24
***
20
21
22
Some drugs have been sold for so many years that rhysicians
and rharmacists may not know they are unapprovyCl. T.hey even
may be unaware that unapproved drugs are advertised m
meClical journals and listed in the Physicians' Desk Reference
(PDR) and other reference books. These practices give the false
Impression that the drugs were reviewedand approved by the
FDA.
25
26
27
28
COOLEYGODWARD
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The FDA has recognized there is an additional problem of confusion
97906 v5!DC
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2
3
Document 1
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Page 15 of 44
Magazine, Janumy-February 2007, (emphasis added),
73.
Significantly, on February 6, 2008, prior to the approval of Mutual's
4
NDA, the FDA issued a statement that it "strongly encourages the manufacturers of
5
[unapproved drugs1to pursue FDA approval." In particular, the FDA stated with
6
regard to unapproved colchicine drug products:
7
There are no approved products that contain only colchicine as an
active ingredient.
8
***
9
Like all other unapproved drugs{ colchicine tablets that are
marketed withoutFDA approva could be subject to FDA
enforcement at any time, Accordingly, FDA strongly encourages
the manufacturers of those products to pursue FDA approval.
10
11
12
"Questions and Answers About FDA's Enforcement Action Against
13
Unapproved Injectable Colchicine Products," FDA website at http://www,
14
fda,gov/Cderldrug/unapproved_ drugs/colchicine_ qa,htm (February 6, 2008),
15
74.
16
The FDA further warned that:
Colchicine is a highly toxic drug that can easily be administered
in excessive doses, especially when given intravenously, There is
a narrow margin between an effective dose of the drug and a
toxic dose that can result in serious health risks, including death,
17
18
19
See "FDA Takes Action to Stop the Marketing of Unapproved Injectable
20
Drugs Containing Colchicine," FDA website at http://www,fda.gov/bbs
21
/topicsINEWS/2008/NEWOI791.html (February 6, 2008).
22
75.
Additional news articles or stories indicate that the marketing of such
23
non-FDA approved drugs and uncertified medicines is "a serious safety issue" and
24
further illustrate consumer confusion. See Robert Cohen, "Uncertified Medicines a
25
'Serious' Safety Issue, Thousands of Drugs lack FDA Approval," THE STAR LEDGER,
26
(July 9, 2006) and Helen Palmer, "Unapproved Drugs, by Prescription,"
27
MARKETPLACE, http://marketplace.publicradio.orgldisplay/web/2006/06/09/
28
unapproved drugs by prescription! (June 9, 2006); Rita Rubin, "Hundreds of
COOLEYGODWARD
KRONlSH
LLP
ATTORNEYS AT LAW
W ASIlINGTON
97906 vSIDC
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Document 1
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Page 16 of 44
1
Unapproved Drugs Sold
2
news/healtbJ2006-09-17 -unapproved-drugs-cover x.htm (September 18, 2006); Marc
3
Kaufman, "Unapproved Drugs Called Tbreat'," THE WASHINGTON POST,
4
http://www.washingtonpost.com/wp-
5
dyn!contentlarticle/2006/06/081AR200606080 1542.html (June 9, 2006).
6
7
8
9
ONLY PLAINTIFFS HAVE FDA ApPROVAL TO MARKET A PRODUCT HAVING
COLCHICINE AS THE SOLE ACTIVE INGREDIENT
76.
In part due to the publication ofthe revised Compliance Policy Guide
("CPG") on marketed unapproved drugs in June 2006 and the simultaneous
10
publication ofthe related guideline (and subsequently the February 2008 guideline)
11
and news releases referenced in this Complaint, the industry has long had notice that
12
NDAs were required and would have to be submitted by anyone who wanted to
13
legally market drug products containing colchicine as the sole active ingredient.
14
77.
Thus, the industry has been aware that it would be necessary to
15
establish the efficacy and safety of drug products containing colchicine as the sole
16
active ingredient (through the filing ofNDAs supported by clinical data) in order to
17
obtain FDA approval and to legally market such colchicine drugs.
18
78.
Unlike any other entity to date, Mutual undertook the steps and
19
expenses necessary to establish the safety and efficacy of drug products containing
20
colchicine as the sole active ingredient for purposes of obtaining FDA approval.
21
79.
As noted above, Mutual followed FDA procedures and submitted an IND
22
for colchicine on February 9, 2007, followed by a Request for Orphan Drug Designation
23
on September 10,2007 (which was granted by the FDA on September 25, 2007).
24
25
80.
Mutual subsequently submitted a series ofNDAs related to the safe
and effective use of its COLCRYSTM product for various conditions:
26
27
28
COOLEYGODWARD
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ATTORNEYS AT LAW
W AStilNGTON
97906 v5/DC
16.
1
3
Filed 08/06/2009
"""""""""
I--"------"---~---·---""""""""""""""""""
Indication
I
2
Document 1
I NDA
I
FMF
June 20, 2008
Gout Flares
r----
bmission Date i
"--
September 30, 2008
Page 17 of 44
Approval
"----""------
-
-
July 29, 2009
-"
July 30, 2009
4
5
81.
i
On July 29, 2009, after a review of clinical studies demonstrating the
6
safety and effectiveness of Mutual 's 0.6 mg tablets containing colchicine as the sole
7
active ingredient in treating FMF, the FDA approved Mutual's NDA and granted
8
Mutual a 7-year ODE to exclusively market and sell COLCRYSTM for the treatment
9
ofFMF until July 29, 2016.
10
82.
On July 30, 2009, after a review of clinical studies demonstrating the
11
safety and effectiveness of Mutual's 0.6 mg tablets containing colchicine as the sole
12
active ingredient in treating gout flares, the FDA approved Mutual's NDA and is
13
expected to grant Mutual a 3-year period to exclusively market and sell
14
COLCRYSTM for the treatment of gout flares until July 30, 2012.
15
83.
As such, no other companies can obtain FDA approval for a drug
16
product containing colchicine as the sole active ingredient for the treatment of
17
either FMF or gout flares until after the expiration of the respective exclusivity
18
periods.
19
84.
The FDA's approval was based in part on its comprehensive review of
20
clinical studies demonstrating the safety and efficacy of Mutual's COLCRYSTM
21
product, and FDA inspections of Mutual' s manufacturing facilities.
22
85.
Mutual's FDA-approved COLCRYSTM product provides physicians
23
and patients with a predictable, safe and effective treatment for the symptoms of
24
both FMF and gout flares.
25
86.
In order to obtain the data sufficient to submit its various NDAs to
26
support FDA approval of COLCRYSTM, Mutual has spent millions of dollars to
27
develop its COLCRYSTM formulation and establish its safety and efficacy for
28
treatment of both FMF and gout flares.
COOLEYGODWARD
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ATTtl~NEYS
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17.
1
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Document 1
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Page 18 of 44
These costs have included
2
clinical trials which comprise, among other things, performing pharmacokinetic and
3
clinical studies and reporting clinical data to the FDA, as well as regulatory, legal
4
and manufacturing costs.
5
88.
Mutual designed and conducted a multicenter, randomized, double-blind,
6
placebo-controlled, parallel group, dose comparison study in which 185 adults (out of
7
a total of575 trial participants) were exposed to at least one dose of colchicine to
8
demonstrate the safety and efficacy of its FDA-approved colchicine product. Mutual's
9
study was referred to as the Acute Gout Flare Receiving Colchicine Evaluation
10
II
("AGREE") Trial (Clinical Trial MPC-004-06-001).
89.
In the AGREE trial, patient adverse events were monitored throughout.
12
Among other things, patients were instructed to record pain, dosing and
13
gastrointestinal tolerability.
14
90.
Thereafter, Mutual sponsored six additional pharrnacokinetic studies in
15
which 119 healthy volunteers were exposed to at least one dose ofCOLCRYS. In all
16
six studies, adverse events were monitored throughout. Clinical laboratory tests,
17
including hematology, blood chemistries and urinalysis, were obtained at screening,
18
study check-in and discharge.
19
91.
Plaintiffs' efforts resulted in the discovery and development of new
20
dosing regimens of COLCRYSTM that reduce the total amount of colchicine used
21
by patients and which in tum result in a significant decrease in the most common
22
side effects from colchicine use (i. e., adverse effects involving the gastrointestinal
23
tract, including cramping, nausea, diarrhea, abdominal pain and vomiting). In fact,
24
the clinical trials established that patients have historically been given
25
approximately three times the necessary colchicine dosage to achieve the desired
26
effect despite a narrow therapeutic index.
27
28
92.
Additionally, as illustrated in the below table, through these efforts
Plaintiffs have discovered potentially serious drug interactions between colchicine
COOLEY GODWARD
KRONI$H LLP
AnU]{NEY, AT LAW
WASHINGTON
91906 vSIDC
18.
Document 1
1
and
2
potential negative interactions.
3
4
5
6
7
8
9
Filed 08/06/2009
Page 19 of 44
other drugs, as
,-----
Drug
~trong LY PJA4
Inhibitors
atazanavlr,
clarithromycin,
indinavir,
itraconazole,
ketoconazole,
nefazodone,
nelfi!1avir, ritonavir,
saqUlnavlr,
tehthromycin
10
11
I Noted or Anticipated
Outcome
SI~ll1t1Cant mcrease m
co chi cine rlasma
levels; fata colchicine
toxicity has been
reported with
clarithromycin, a strong
CYP3A4 inhibitor.
Similarly, significant
increase in colchicine
plasma levels is
anticipated with other
strong CYP3A4
inhibitors.
Lllmcal Comment
I
lJout l'lares
!<WH
0.6 m (1
tablet x I
dose,
followed b1
0.3 mg (ha f
tableti I
hour ater.
Dose to be
repeated no
earlier than 3
days.
Maximum
daily dose of
0.6 mg (may
be given as
0.3 mg twice
a day)
IJout Flares
J<IVlJ<
f
12
13
14
15
16
17
!Vl0~e.rate
Inhibitors
CYP3A4
ampr~navlr,
aprepltant,
dlltiazem,
erythromycin,
fluconazole,
fosamfrrenavir,
grape rujt juice,
verapamil
Slfcllp~ant mcrease In
co chlcme pla~ma
concentratIOn IS
anticipated.
Neuromuscular toxicity
has been reported with
diltiazem and verapamil
interactions.
18
19
20
Maximum
1.2m~2
tablets x I
daily dose of
1.2 mg (may
dose. ose
to be
be given as
0.6 mg twice
repeated no
earlier than 3 a day)
days.
P-gp Inhibitors
cyclosp.onne,
ranolazme
21
22
23
24
IJout Flares
mcrease In
co chlcme rlasma
levels; fata colchicine
0.6 mg (I
toxicity has been
tabletbx 1
reported with
dose. ose
to be
cyclosporine, a P-~p
repeated no
iithibitor. Similar y,
earlier than 3
si~nificant increase in
co chi cine plasma levels days.
is anticip'ated with other
P-gp inliibitors.
Si~nip~ant
l"MF
Maximum
daily dose of
0.6 mg(may
be given as
0.3 mg twice
a day)
25
26
(Note: Chart reproduced from the FDA-approved product label/insert for
27
COLCRYSTM for the treatment ofFMF and gout flares).
28
COOLEyGODWARD
KRON!SH LLP
ATT[)I(NH~
AT LA.w
WASHINGTON
97906 v51DC
19.
Document 1
Filed 08/06/2009
93.
ImCM+C
Page 20 of 44
do not Hl~lU''';
2
information on specific dosing regimens that help ameliorate potcntial negative
3
drug interacti ons.
4
94.
Moreover, Mutual is actively investing resources to create and
5
maintain a stockpile of COLCRYSTM in order to meet anticipated demand for the
6
product, which will require additional expenditures. Mutual currently has enough
7
finished product to supply four months ofCOLCRYSTM at the current market
8
demand. Mutual also has enough API to manufacture another 140,000,000
9
COLCRYSTM tablets to meet future market demand.
10
95.
To date, no other company has invested the time, energy and money to
11
obtain Orphan Designation or seek FDA approval for another drug product
12
containing colchicine as the sole active ingredient.
13
14
15
16
DEFENDANTS ENABLE ILLEGAL MANUFACTURERS TO FALSELY ADVERTISE AND
MARKET UNAPPROVED COLCHICINE DRUG PRODUCTS AS BEING SAFE,
EFFECTIVE AND FDA-ApPROVED, THROUGH THE USE OF PRICE LISTS AND
WHOLESALER ORDERING SYSTEMS
96.
The Federal FDCA explicitly prohibits the commercial distribution
17
and marketing of prescription drugs that lack an approved NDA. 21 U.S.C. §
18
351(d),355(a).
19
97.
Nevertheless, upon information and belief, Illegal Manufacturers
20
advertise, market, sell and distribute their unapproved and illegal colchicine drug
21
products to a wide array of purchasers through a variety of commercial channels of
22
trade throughout the United States.
23
98.
The purchasers of Illegal Manufacturers' unapproved colchicine
24
products include, but are not limited to, various national and regional drugstore
25
chains, wholesale generic buyers and independent pharmacies.
26
99.
In addition to the foregoing direct purchasers, three other categories of
27
individuals play important roles in purchases of the Illegal Manufacturers'
28
products: physicians, who prescribe colchicine drug products; pharmacists, who fill
COOLEY GODWARD
KRONISH LLP
ATTORNEYS AT LAW
WA5H1NGT(lf(
97906 vS/OC
20.
Document 1
Filed 08/06/2009
patients, who
2
3
HUU,,",'}
Page 21 of 44
use
Illegal
Manufacturers' unapproved and dangerous colchicine products,
100. To advertise, market, sell, and distribute their unapproved and illegal
4
colchicine products, Illegal Manufacturers disseminate advertisements and product
5
information through several adveliising channels, including Price Lists, Wholesaler
6
Ordering Systems, pharmacy computers and websites,
7
101. Price Lists provide drug and pricing databases which may be integrated
8
with other computerized information systems used by, among others, phannacists,
9
insurance companies and buyers to obtain information material to decisions
10
regarding the prescription, dispensing and purchasing of drug products, and also to
11
automatically provide drug information that patients need for safe use of their
12
drugs, The Price Lists include, but are not limited to, Medi-Span, First Databank,
13
Gold Standard and Redbook
14
102. Among other resources, pharmacists rely on the drug databases
15
provided by the Price Lists to determine whether a drug prescribed to a patient may
16
cause fatal or other injurious interactions with other drugs being taken by the
17
patient; to avoid dispensing the wrong drug or the wrong dosage of a drug; to
18
obtain instructions for use; and to make sure drugs are dispensed with appropriate
19
cautionary labels and other patient information,
20
103. As an example of the information provided by the Price Lists, Medi-
21
Span indicates on its website that it "provides pharmacists with the up-to-date,
22
accurate and comprehensive drug information they need to support drug dispensing
23
activities in inpatient, outpatient, specialty and mail-order pharmacies:' See
24
http://www.medispan.com/pharmacies.aspx.
25
104. The infonnation provided by the Price Lists also assists governmental
26
and private health plans with improving the quality of care and reducing medication
27
costs for their beneficiaries by minimizing the prescribing and dispensing of drugs
28
that are medically inappropriate and/or less cost-effective than alternative drugs.
COOLEYGODWARD
KHON!SH LLP
AnUI<NoYS AT LAW
WASHINGTON
97906 vSIDC
21.
Document 1
Filed 08/06/2009
\'IllOl,esa.ler Ordering Systems dll'UW
pharroai~islts
Page 22 of 44
to select
2
the drug products that they intend to dispense
their phannacies. Many
3
wholesalers-including, but oot limited to, McKesson Corporation, Cardinal Health,
4
Inc., AmerisourceBergen Corporation, Anda, Inc. and Kinray, Inc.-provide their
5
Wholesaler Ordering Systems to pharmacists over the Internet.
6
106. After a phannacist selects and purchases a drug product listed on a
7
Wholesaler Ordering System, the relevant wholesaler delivers the drug product directly
8
to the pharmacy or any other location specified by the pharmacist or his headquarters.
9
107. Drug manufacturers, such as the Illegal Manufacturers, must take
10
affinnative steps to provide the drug and pricing information for their unapproved
11
colchicine products to various advertising channels, including the Price Lists and
12
Wholesaler Ordering Systems.
13
108. On infonnation and belief, the Illegal Manufacturers supply
14
misleading, obsolete and/or incomplete information about their unapproved and
15
illegal colchicine products to the Price Lists, Wholesaler Ordering Systems, and
16
other advertising channels.
17
109. For example, on infonnation and belief, First Databank, one of the
18
largest Price Lists, requires that drug manufacturers submit an FDA letter of
19
approval when submitting a new prescription drug for listing on First Databank.
20
Thus, on infonnation and belief, in order to be listed on First Databank, Illegal
21
Manufacturers Excellium, Vision, Watson, and West-ward either misrepresented to
22
First Databank that their unapproved colchicine products were FDA-approved or that
23
their unapproved colchicine products did not need to be approved by the FDA in
24
order to be sold lawfully.
25
110. In addition, on infonnation and belief, Illegal Manufacturers Watson,
26
Excellium and West-ward have provided misleading, obsolete, and/or incomplete
27
information about the FDA-approval status of their unapproved colchicine products
28
to Anda, Inc., one ofthe largest distributors of generic phannaceuticals in the U.S.,
COOLEY GODWARD
KRONISH LLP
ATTORNEY" AT LAW
WASHINGTON
97906 v5/DC
22.
m
Document 1
Filed 08/06/2009
display on Anda's
Page 23 of 44
:".VGPm
of a false
"AB" rating for Watson's unapproved colchicine product and a misleading "NR"
rating for Excellium's and West-Ward's unapproved colchicine products, The
"AB" rating for Watson's unapproved colchicine product is likely to mislead
consumers into believing that the product has been approved by the FDA because
only drugs that are approved by the FDA and determined to be therapeutically
equivalent to an FDA-approved drug can be designated with an "AB" rating,
Further, relevant consumers are likely to mistakenly believe that the "NR" rating
for Excellium' sand West-Ward's unapproved colchicine products means that their
products do not need to be approved by the FDA in order to be sold lawfully,
111. Likewise, on information and belief, Illegal Manufacturers Excellium,
Watson, Vision and West-ward provided misleading, obsolete, and/or incomplete
information about the FDA approval status of their unapproved colchicine products
to Kinray, Inc" one of the largest privately-held drug wholesalers, which resulted in
the display of a misleading "NR" or "N/A" rating on Kinray's Wholesaler Ordering
System, Again, relevant consumers are likely to mistakenly believe that the "NR"
or "N/A" rating means that their unapproved colchicine products do not need to be
approved by the FDA in order to be sold lawfully,
112. On information and belief, the Illegal Manufacturers to which
Defendants provide colchicine API are aware that pharmacists and buyers believe
that all prescribed drugs identified on the Price Lists and the Wholesaler Ordering
Systems are safe, effective and FDA-approved,
113. Survey evidence demonstrates the inaccurate perception of relevant
consumers that the pharmacy computer systems such as Price Lists and Wholesaler
Ordering Systems perform a gatekeeper function by displaying only those drug
products that have been approved by the FDA
114. Thus, by listing their unapproved and illegal colchicine products on the
Price Lists, Wholesaler Ordering Systems, and other advertising channels, Illegal
91906 vSIDC
23,
1
Document 1
Filed 08/06/2009
and
to
Page 24 of 44
relE~Var
consumers
2
Illegal Manufacturers' products are safe, effective and FDA-approved. These
3
statements are misleading and material to drug purchasing decisions.
4
115. The Illegal Manufacturers' sale of their unapproved and illegal colchicine
5
products through the Price Lists and Wholesaler Ordering Systems is particularly
6
detrimental to Plaintiffs because the Price Lists and Wholesaler Ordering Systems are
7
the primary channels of trade used to advertise, market and sell drug products.
8
9
116. By manufacturing, importing, distributing, selling and/or otherwise
making colchicine API available to the Illegal Manufacturers, Defendants aid, abet
10
and contribute to the Illegal Manufacturers' harmful and illegal actions.
11
DEFENDANTS ENABLE ILLEGAL MANUFACTURERS TO MARKET AND SELL
THROUGH INTERNET PHARMACIES, WHICH THEY KNow OR SHOULD KNow ARE
FALSELY ADVERTISING ILLEGAL MANUFACTURERS' UNAPPROVED COLCHICINE
PRODUCTS AS BEING SAFE, EFFECTIVE AND FDA-ApPROVED
12
13
14
117. On information and belief, Illegal Manufacturers have intentionally
15
caused their unapproved colchicine products to be advertised and sold nationally,
16
including in California on the websites of various Internet pharmacy retailers and
17
wholesalers. For example, Illegal Manufacturers advertise and/or make available
18
their illegal colchicine products on buygenericdrugs.com (See
19
http://www.buygenericdrugs.comlprice search.aspx? drugname=colchicine.)
20
118. With regard to illegal sales of the Illegal Manufacturers' colchicine
21
products at buygenericdrugs.com, the website contains misleading and false
22
statements that are likely to mislead consumers into believing that Illegal
23
Manufacturers' colchicine products are FDA-approved. For example, the
24
buygenericdrugs.com site includes the following statements: (1) "FDA Approved
25
Generic Prescription Drugs" and (2) "Save on FDA Approved Generic Drugs
26
Today." (See http://www.buygenericdmgs.com/.)
27
28
119. Similarly, the buygenericdrugs.com website contains a stylized FDA
symbol, and states that "All generic drugs have been approved for use by the Food
COOLEY GODWARD
KRONISHLLP
ATTUIWn& AT LAW
W A5HINGTON
97906 vSIDC
24.
Document 1
1
Filed 08/06/2009
Page 25 of 44
Illegal
2
colchicine products, which are offered for sale on the website. (See
3
http://www.buygenericdrugs.coml. )
4
120. Additionally, at the bottom ofthe web page from which consumers can
5
order illegal colchicine product from buygenericdrugs.com, consumers are presented
6
with the following misleading claim: "We are an American based company offering
7
FDA approved generics." (See http://www.buygenericdrugs.com/price search.aspx?
8
drugname=colchicine.)
9
121. The Illegal Manufacturers know, or reasonably should have known,
10
that buygenericdrugs.com makes false representations relating to their colchicine
11
products. However, upon information and belief, Illegal Manufacturers continue to
12
market and sell their unapproved colchicine products through buygenericdrugs.com
13
despite the website's false statements, thereby becoming complicit in, and
14
contributorily liable for, buygenericdrugs.com's wrongful acts.
15
122. On information and belief, Illegal Manufacturers knew, or reasonably
16
should have known, that Internet retailers (such as buygenericdrugs.com) that sell
17
Illegal Manufacturers' colchicine products market them as FDA-approved generic
18
drugs to an unsuspecting public.
19
123. On information and belief, Illegal Manufacturers have taken
20
affirmative steps to display false and/or misleading information on the Internet
21
websites that misrepresent that Illegal Manufacturers' colchicine products are safe,
22
effective and FDA-approved.
23
24
25
26
124.
On information and belief, Defendants know, or should reasonably
know, about the Illegal Manufacturers' activities set forth in this Complaint.
125. As such, Defendants are contributorily liable for any consequences
detrimental to Plaintiffs as a result of the Illegal Manufacturers' illegal activities.
27
28
COOLEY GODWARD
KRONISH LLP
ATTORNEYS AT LAW
W ASHJN(;TON
97906 vSIDe
25.
CO:MPLAINT FOR UNFAIR COMPETITION
2
3
Page 26 of 44
ILLEGAL MANUFACTURERS' LABELING AND INSTRUCTION MATERIALS FOR
UNAPPROVED COLCHICINE PRODUCTS ARE DANGEROUS AND Lm::1i:LY TO n",,('W1V
PURCliASERSlUsERS
126. Due to Mutual's extensive work qualifying its COLCRYSTM product,
process and facilities for FDA approval, the labeling, promotion and advertising of
5
Mutual's COLCRYS ™ product lists and warns of numerous drug-drug interactions,
6
food interactions and contraindications, including potentially fatal health risks due
7
to the interaction of colchicine with clarithromycin and ritonavir, as well as new
8
significant safety information regarding the dangerous accumulation of colchicine
9
during chronic (i.e., prophylactic) dosing.
127. Illegal Manufacturers' labels fail to mention many ofthe drug-drug
11
interactions, food interactions and contraindications required by the FDA on
12
Mutual's approved label. For example, the contraindication warnings on Illegal
13
Manufacturers' product insert/labels fail to mention that patients with renal or
14
hepatic impairment should not be given colchicine in conjunction with P-gp or
15
strong CVP3A4 inhibitors, since these patients face life-threatening and fatal
16
colchicine toxicity even when taken in therapeutic doses.
17
128. The FDA has also required Mutual to include a Medication Guide with
18
its COLCRYSTM product, which includes important warnings regarding various
19
drug-drug interactions (e.g. ketoconazole and nefazodone) and food interactions
20
(e.g. grapefiuit and grapefruit juice). The Medication Guide is written so that
21
consumers can easily understand the serious health risks involved when taking
22
COLCRYSTM in combination with certain foods and drugs.
23
24
25
129. On information and belief, Illegal Manufacturers do not include
Medication Guides with their unapproved products.
130. As noted in this Complaint, colchicine is not an innocuous drug and is
26
a narrow therapeutic index drug with significant risk for adverse reactions from
27
drug accumulation or drug-drug interactions. If incorrectly administered,
28
colchicine can pose serious health risks-including the risk of death. The risks of
COOLEYGODWARD
KRONISH LLP
AT LAW
W A,HINGTON
Filed 08/06/2009
4
10
ATTORNEY~
Document 1
97906 vS/DC
26.
1
are
2
and labeling according to
Document 1
Filed 08/06/2009
Page 27 of 44
regulations.
3
131. Mutual has demonstrated that colchicine blood levels increase
4
approximately 250% when co administered with ritonavir or ciarithromycin. Had
5
Mutual not conducted the safety studies required for FDA approval, this potentially
6
serious accumulation would not be documented.
7
132. Additionally, Mutual discovered that after 10 days of "traditional"
8
dosing of two tablets a day-as recommended on Illegal Manufacturers' labels-
9
blood levels had increased 65% and were still accumulating notwithstanding the
10
safety implications of the narrow therapeutic index of colchicine.
11
133. Based on these discoveries, the FDA has required Mutual's approved
12
labels to include the foregoing important information regarding the circumstances
13
and dosing regimens that result in dangerous increases in colchicine blood levels.
14
134. In fact, the FDA has required Mutual to also implement a Risk
15
Evaluation and Mitigation Strategy ("REMS") program and an FDA-approved
16
Medication Guide alerting patients to the potential for serious drug-drug
I7
interactions with colchicine and increased susceptibility to severe colchicine
18
toxicity in patients with renal or hepatic impairment.
19
135. In approving COLCRYSTM, the FDA noted several important safety
20
issues that are addressed by the COLCRYSTM label, but that are not addressed in
21
Illegal Manufacturers' unapproved product labels. Specifically, the FDA noted that
22
the correct dosing ofCOLCRYSTM significantly reduced adverse events. The FDA
23
also noted that the COLCRYSTM product insert/labels warn about potentially life-
24
threatening drug-drug interactions that can occur unless the proper dosing is
25
followed. These interactions can occur even at prescribed doses of colchicine, and
26
with medications that are given for a limited time, such as antibiotics. See FDA
27
MedWatch: Colchicine Marketed as COLCRYS - (http://www.fda.gov/Safety/Med
28
W atch/SafetyInformationiSafetyAlertsforHumanMedicalProducts/ucm 174596.
COOLEYGODWARD
KHONISH LLP
AT1'llRNno AT LAW
W A,flINCTON
91906 vS/DC
27.
Document 1
Filed 08/06/2009
Safety
ntC)mmtlon for
Page 28 of 44
1
htm); FDA
Professionals:
2
New Safety Information for Colchicine (marketed as
3
CO LCRYS )(http://www .fda. gov IDrugs/DrugSafety IPostmarketDrugSafety Informat
4
ionforPatientsandProviders/DrugSafety Informati onfor HeathcareProfessionals/ucm 1
5
74315.htm)
6
136. In its release dated July 30, 2009, the FDA highlighted important
7
safety considerations found in the approved COLCRYSTM prescribing information,
8
which is designed to assure safe use of COLCRYSTM: "First, FDA analyzed safety
9
data for colchicine from adverse events reported to the Agency, the published
10
literature, and company-sponsored pharmacokinetic and drug interaction studies.
11
This analysis revealed cases of fatal colchicine toxicity reported in certain patients
12
taking standard therapeutic doses of colchicine and concomitant medications that
13
interact with colchicine, such as clarithromycin. These reports suggest that drug
14
interactions affecting the gastrointestinal absorption and/or hepatic metabolism of
15
colchicine playa central role in the development of colchicine toxicity. Second,
16
data submitted supporting the safety and efficacy of Colcrys in acute gout flares
17
demonstrated that a substantially lower dose of colchicine was as effective as the
18
higher dose traditionally used. Moreover, patients receiving the lower dose
19
experienced significantly fewer adverse events compared to the higher dose."
20
137. None of this critical safety information appears on the labeling and
21
packaging of the Illegal Manufacturers' unapproved colchicine tablets. The Illegal
22
Manufacturers are not required to have a REMS program or Medication Guide for
23
their colchicine products because they are not FDA-approved.
24
138. Thus, Illegal Manufacturers' deficient labels not only pose a serious
25
risk to the public, but make Plaintiffs FDA-approved COLCRYSTM product appear
26
to be more dangerous than Illegal Manufacturers' unapproved and illegal colchicine
27
products, when in fact the opposite is true.
28
COOLEYGODWARD
KRONISH LLP
ATT0~NEY" Al LAW
WA~ffINGTON
97906 vSIDC
28.
Document 1
Filed 08/06/2009
Iliega!
damage
because
2
they confuse and mislead physicians, pharmacists, buyers, patients and
3
falsely believing that Plaintiffs' COLCRYSTM product is dangerous, unsafe and
4
fraught with risk compared to Illegal Manufacturers' misleadingly and deceptively
5
labeled products which, on information and belief, contain colchicine API supplied
6
by the Defendants.
into
7
140. Indeed, without judicial intervention, it would not be unreasonable for
8
consumers to ask, for example, why the FDA requires Mutual to list the additional
9
potentially negative drug interactions and severe warnings regarding its FDA-
10
approved COLCRYSTM product that are not "required" or featured with the Illegal
11
Manufacturers' illegal, non-FDA-approved products which, on information and
12
belief, contain colchicine API supplied by the Defendants.
141. This confusion arises from the Illegal Manufacturers' unfair
13
14
competition and false advertising, which is only made possible by use of the
15
Defendants' colchicine API.
16
142. Absent Defendants' actions of supplying colchicine API, Illegal
17
Manufacturers would be unable to manufacture their unlawful colchicine products,
18
which in turn would render them unable to commit the wrongful and unlawful acts
19
described above.
20
FIRST CAUSE OF ACTION
21
(CONTRIBUTORY FALSE ADVERTISING OR MISLEADING REPRESENTATION OF FACT
AND UNFAIR COMPETITION UNDER 15 U.S.C. § 1125(A) AGAINST DEFENDANTS)
22
23
24
143. Plaintiffs reallege and incorporate herein the allegations contained in
paragraphs 1-142 of this Complaint.
144. The Illegal Manufacturers advertise, market, promote and distribute
25
26
their unapproved colchicine products throughout the United States and California to
27
drug wholesalers, distributors, drug store chains, independent pharmacies and
28
others.
COOLEY GODWARD
KRON1SHLLP
ArTC'RNEY, AT LAW
WA,HINGTON
Page 29 of 44
97906 vSIDC
29.
Document 1
Filed 08/06/2009
engage in such
I
2
acts in a manner that misleads relevant consumers into believing that their
3
colchicine products are comparable to and/or safer than Plaintiffs' FDA-approved
4
COLCRYSTM product.
5
146. The Illegal Manufacturers' colchicine product labels, instructions for
6
use, commercial adveliising and promotions (including the placing of the
7
aforementioned misleading information in advertising channels, including Price
8
Lists, Wholesaler Ordering Systems, drug ordering systems used by drug store
9
chains, and Internet websites) constitute false and misleading descriptions or
10
representations of fact that their colchicine products are safe, effective and/or FDA-
11
approved, and that the safety and warning information provided with the Illegal
12
Manufacturers' unapproved colchicine products is complete.
13
147. On information and belief, members of the public (including
14
pharmacists, purchasers, caregivers, patients and physicians) are misled by the
15
Illegal Manufacturers' misrepresentations and/or descriptions offact, understanding
16
them alone and/or together to claim that the Illegal Manufacturers' colchicine
17
products are safe, effective and/or FDA-approved. The Illegal Manufacturers'
18
commercial advertising and/or promotions thus misrepresent the nature,
19
characteristics and qualities of their unapproved colchicine products.
20
148. On information and belief, Defendants know, or reasonably should
21
know, that the Illegal Manufacturers are not permitted to manufacture and distribute
22
colchicine products in the United States, nor are they permitted to import colchicine
23
API into the United States.
24
25
26
know, of the unlawful acts of the Illegal Manufacturers described herein.
150. On information and belief, Defendants manufacture, import, distribute,
27
sell and/or otherwise make colchicine API available to the Illegal Manufacturers'
28
for use in their unapproved colchicine products.
COOLEYGODWARD
KRONISH LLP
ATTORNEYS AT LAW
W ASHtNGTON
Page 30 of 44
97906 vSIDC
30.
Document 1
151. As a direct
Filed 08/06/2009
Page 31 of 44
of
false
2
and misleading representations and false and/or deceptive advertising of the Illegal
3
Manufacturers, Plaintiffs have suffered, cUlTently suffer, and will continue to suffer
4
damage and irreparable injury, including injury to their business, reputation and
5
goodwill, and Defendants have been knowingly complicit in such actions by
6
supplying the Illegal Manufacturers with colchicine API. Defendants are therefore
7
contributorily liable for these unlawful acts.
8
9
152. Pursuant to 15 U.S.C. § 1117, Plaintiffs are entitled to damages from
Defendants for these Lanham Act violations, an accounting of profits made by
10
Defendants on sales of colchicine API, as well as recovery of costs of this action.
11
Furthermore, Plaintiffs are informed and believe, and on that basis allege, that
12
Defendants' conduct was undertaken willfully, making this an exceptional case
13
entitling Plaintiffs to recover additional damages and reasonable attorney fees
14
pursuant to 15 U.S.C. § 1117.
15
153. Defendants' contributory conduct has caused, and will continue to
16
cause, immediate and irreparable harm to Plaintiffs for which there is no adequate
17
remedy at law. As such, Plaintiffs are also entitled to injunctive relief as set forth in
18
15 U.S.C. § 1116.
19
SECOND CAUSE OF ACTION
20
(CONTRIBUTORY STATUTORY UNFAIR COMPETITION UNDER
CALIFORNIA BUSINESS AND PROFESSIONS CODE § 17200 ET SEQ. AGAINST
DEFENDANTS)
21
22
23
24
155. On information and belief, Defendants provide colchicine API to
25
Illegal Manufacturers that illegally distribute and/or sell drug products containing
26
colchicine API as the sole active ingredient for which the Illegal Manufacturers
27
have not obtained FDA approval pursuant to the Federal FDCA.
28
CooLE<YGODWARD
KRON1SHLLP
ATTORNEYS AT LAW
WASHINGTON
97906 vS/DC
31.
1
1
Document 1
Filed 08/06/2009
On j'rilOJrmilt1cm and beiief, Defendants
KD"u[
Page 32 of 44
or reBlso11atll:y
2
know, that Illegal Manufacturers have made, published, disseminated and circulated
3
false, deceptive and misleading statements, representations and advertisements in
4
California, thereby misrepresenting the nature, quality and characteristics of the
5
Illegal Manufacturers' colchicine products with the intent of selling, distributing
6
and increasing the consumption of, and interest in, the Illegal Manufacturers'
7
colchicine products.
8
9
know, that Illegal Manufacturers have intentionally deceived the public by
10
misrepresenting that their colchicine products have been approved for sale under
11
the Federal FDCA.
12
158. By the actions set forth in this Complaint, Defendants have willfully
13
aided, abetted and contributed to the Illegal Manufacturers' unlawful and unfair
14
competition under the statutory law of the State of California, Cal. Bus. & Prof.
15
Code § 17200, et seq.
16
159. As a result of Defendants' actions set forth in this Complaint, Plaintiffs
17
have suffered and will continue to suffer damage to their business, reputation and
18
goodwill.
19
160. As a direct and proximate result of Defendants' willful and intentional
20
actions, Plaintiffs have suffered damages in an amount to be determined at trial and,
21
unless Defendants are restrained, Plaintiffs will continue to suffer irreparable damage.
22
THIRD CAUSE OF ACTION
23
(CONTRIBUTORY STATUTORY FALSE ADVERTISING UNDER
CALIFORNIA BUSINESS AND PROFESSIONS CODE § 17500 ET SEQ. AGAINST
DEFENDANTS)
24
25
26
27
28
COOLEYGODWARD
KRON!5H LLP
ATTORNEYS AT LAW
WASHINGTON
97906 v5/DC
32.
1
Document 1
On information
Filed 08/06/2009
Page 33 of 44
belief, Illegal
2
promote, sell and distribute their colchicine products to drug wholesalers and
3
distributors, drug store chains, phannacies and others, and encourage them to
4
substitute their products in lieu of Plaintiffs , FDA-approved colchicine product,
5
stating, implying or suggesting that their colchicine products are equivalent to
6
Plaintiffs' FDA-approved COLCRYSTM product.
7
163. On infonnation and belief, Illegal Manufacturers intend purchasers and
8
users to believe that their colchicine products are comparable to or interchangeable
9
with Plaintiffs' FDA-approved COLCRYSTM product and, when Plaintiffs launch
10
their COLCRYSTM product in the marketplace, to substitute Illegal Manufacturers'
11
unapproved colchicine products for prescriptions of Plaintiffs' FDA-approved
12
COLCRYSTM product on that basis.
13
164. Illegal Manufacturers colchicine product labels, product inserts,
14
commercial advertising and/or promotion including the listing of unapproved
15
colchicine drugs on the Price Lists, Wholesaler Ordering Systems and Internet
16
websites, constitute false or misleading descriptions or representations that their
17
colchicine products are safe, effective and approved by the FDA.
18
165. Illegal Manufacturers' recommendations of dosage and administration
19
of their colchicine products in their labels, product inserts, commercial advertising
20
or promotions, constitute false or misleading descriptions or representations of fact.
21
166. Consumers are misled by Illegal Manufacturers' representations,
22
understanding them alone and/or together to claim that Illegal Manufacturers'
23
colchicine products are safe, effective and FDA approved for the treatment and
24
prevention ofFMF and/or gout flares.
25
167. On infonnation and belief, Defendants know, or reasonably should
26
know, that Illegal Manufacturers' unapproved colchicine products are not
27
comparable to Plaintiffs' FDA-approved COLCRYSTM product, and that Illegal
28
Manufacturers' colchicine product labels, product inserts, commercial advertising
CooLEY GODWARD
KRON1SH LLP
ATTORNE\'S AT LAW
WASHINCTON
97906 vSiDC
33.
Document 1
Filed 08/06/2009
Page 34 of 44
1
and/or nrn,mr,r,
2
that Illegal Manufacturers' colchicine products are safe, effective and approved by
3
the FDA
4
5
6
de,;cnptl<Dns or rej:lres:el11tattons
or
know, of the unlawful acts of the Illegal Manufacturers described herein.
169. On infonnation and belief, Defendants manufacture, import, distribute,
7
sell and/or otherwise make colchicine API available to the Illegal Manufacturers'
8
for use in their unapproved colchicine products.
9
170. By the actions set forth in this Complaint, Defendants have willfully
10
aided, abetted and contributed to the Illegal Manufacturers' false advertising under
11
the statutory law of the State of California, Cal. Bus. & Prof. Code § 17500, et seq.
12
171. As a result of Defendants , actions set forth in this Complaint, Plaintiffs
13
have suffered and will continue to suffer damage to their business, reputation and
14
goodwill.
15
172. As a direct and proximate result of Defendants , willful and intentional
16
actions, Plaintiffs have suffered damages in an amount to be detennined at trial and,
17
unless Defendants are restrained, Plaintiffs will continue to suffer irreparable damage
18
FOURTH CAUSE OF ACTION
19
(COMMON LAW UNFAIR COMPETITION BASED UPON
MISAPPROPRIATION OF PLAINTIFFS' PROPERTY AGAINST DEFENDANTS)
20
21
22
23
24
know, the Illegal Manufacturers have implicitly and explicitly made false and
25
misleading misrepresentations in California to drug wholesalers, distributors, drug
26
stores, pharmacies, pharmacists, patients and others, that their colchicine
27
products-which contain Defendants' colchicine API-are FDA approved and/or
28
comparable or equivalent to Plaintiffs' FDA-approved COLCRYSTM product, and
COOLEY GODWARD
KRONISH LLP
ATTORNf.YS AT LAW
WASHINGTON
97906 vS/DC
34.
Document 1
Filed 08/06/2009
1
products can be
2
Plaintiffs' FDA-approved COLCRYSTM product.
Page 35 of 44
3
175. On infonnation and belief, Defendants know, or reasonably should
4
know, that the Illegal Manufacturers have deceptively and intentionally failed to
5
inform purchasers and users that their colchicine products have not been approved
6
by the FDA, and have not been tested or demonstrated to be therapeutically
7
equivalent to Plaintiffs' FDA-approved COLCRYSTM product.
8
9
know, that the Illegal Manufacturers' employ selective and misleading
10
representations and omission of relevant facts as to (i) the lack of FDA approval of
11
the Illegal Manufacturers' colchicine products and (ii) the purported equivalency to
12
Plaintiffs' FDA-approved COLCRYSTM product, which are likely to cause
13
confusion, mistake or deception concerning the nature, characteristics and qualities
14
of the Illegal Manufacturers' colchicine products in comparison, connection or
15
association with Plaintiffs' FDA-approved COLCRYSTM product.
16
17
know, that the adverting and marketing programs used by the Illegal Manufacturers
18
encourage the sale and substitution of their colchicine products for Plaintiffs' FDA-
19
approved colchicine product, are likely to result in unlawful substitution of their
20
colchicine products for Plaintiffs' FDA-approved COLCRYSTM product, and are
21
likely to deceive doctors, pharmacists, patients and others, about the nature,
22
characteristics and qualities of their colchicine products in comparison, connection
23
or association with Plaintiffs' FDA-approved COLCRYSTM product.
24
178. Mutual has invested significant amounts of time, skill, money and
25
resources in testing and qualifying its colchicine for the treatment ofFMF and gout
26
flares, including working with the FDA in order to obtain FDA approval for its
27
COLCRYSTM product. Additionally, Mutual has made future time and cost
28
COOLEYGODWARD
KRON!SH LLP
ATTORNEY~ AT L",w
WASHINGTON
97906 vSIOC
35.
II
Case
2:09-cv-05761-PA-RZ
ii
Document 1
Filed 08/06/2009
Page 36 of 44
II
1 II
!
21 consumer
3
effects of its FDA-approved COLCRYSTM product
179. By their actions, Defendants' have tacilitated the Illegal
4
Manufacturers' misappropriation of Plaintiffs' property in the form of its time,
5
effort, goodwill, reputation and unique FDA approval status of their FDA-approved
6
COLCRYSTM product.
7
180. By their actions, Defendants have facilitated and contributed to the
8
misappropriation of Plaintiffs' property under the common law of California and, as
9
a result, Plaintiffs have suffered and will continue to suffer damage to their
10
business, reputation and goodwill.
11
12
13
14
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs pray that this Court enter judgment against the
Defendants as follows:
A.
That Defendants and all of their respective officers, agents, servants,
15
representatives, employees, attorneys, and all other persons acting in concert with
16
them be preliminarily and pennanently enjoined from participating in the sale and
17
importation of colchicine API for use in connection with the manufacture,
18
distribution and/or sale of any colchicine product(s) in the United States by any entity
19
lacking an FDA-approved NDA or ANDA for such colchicine product(s);
20
B.
That Defendants be required to file with the Court and serve on the
21
Plaintiffs an affidavit setting forth in detail the manner in which they have complied
22
with the terms of the injunction;
23
c.
That Defendants be adjudged to be contributorily liable for violation of
24
the provisions of 15 U.S.C. § 1125(a) by knowingly participating in acts offalse
25
advertising or misleading representation of fact and unfair competition against
26
Plaintiffs, namely, the use of false or misleading descriptions or representations of
27
fact by the Illegal Manufacturers regarding the nature, quality and characteristics of
28
COOLEY GODWARD
KRONISHLLP
ATH)j{NIiYS AT LAW
W A~HINGTON
97906 v5/DC
36.
2
3
Document 1
Filed 08/06/2009
Page 37 of 44
mislabeled colchicine API products into the United States;
D.
That Plaintiffs be awarded damages pursuant to 15 U.S.c. § 1117(a),
4
sufficient to compensate them for the damage caused by Defendants' participation
5
in the false and misleading statements made by the Illegal Manufacturers;
6
7
8
E.
That Plaintiffs be awarded Defendants' profits derived by reason of
said acts, or as determined by said accounting;
F.
That such damages and profits be trebled and awarded to Plaintiffs,
9
and that they be awarded their costs, attorneys' fees and expenses in this suit under
10
15 U S.C. § 1117, as a result of Defendants' willful, intentional and deliberate acts
11
in concert with the Illegal Manufacturers in violation of the Lanham Act;
12
G.
That Defendants recall and remove all colchicine API supplied to
13
Illegal Manufacturers, from any distribution supply chains and from any entity to
14
which Defendants have supplied colchicine API that lacks an FDA-approved NDA
15
or ANDA for a colchicine-containing drug product;
16
H.
That Plaintiffs be awarded damages in an amount sufficient to
17
compensate it for the damage caused by Defendants' contributory unfair
18
competition and false advertising under California Business and Professions Code
19
§§ 17200 and 17500 and common law, including exemplary damages provided by §
20
17206 ofthe California Business and Professions Code;
21
22
23
I.
That Plaintiffs be granted injunctive relief under California Business
and Professions Code §§ 17200, § 17500 and 15 US.C. § 1116 et seq.
J. That Plaintiffs be awarded damages in an amount sufficient to compensate
24
them for the damage caused by Defendants' tortious interference with Plaintiffs'
25
economic advantage in violation of the common law of the State of California;
26
K.
That Plaintiffs be granted injunctive relief under 15 US.C. § 1116 et seq.;
27
L.
That Plaintiffs be granted prejudgment and post judgment interest;
28
COOLEYGODWARD
KRONISHLLP
ATTOi(NEI'S AT LAW
W AiiHINGTON
97906 vSIDC
37.
1
2
3
4
M.
Document 1
Filed 08/06/2009
Page 38 of 44
Plaintiffs be granted costs and attorneys' fees associated with the
prosecution of this action; and
N.
That Plaintiffs be granted such further relief as the Court may deem just
Dated: August 5, 2009
5
COOLEY GOD WARD KRONISH LLP
~~NIA
6
7
BARNO. 116127)
PETER J. WILLSEY (Pro Hac Vice
pending)
JOHN S. KYLE (CALIFORNIA BAR NO.
8
9
199196)
NISHAN KOTTAHACHCHI
(CALIFORNIA BAR NO. 221612)
BRENDAN J. HUGHES (Pro Hac Vice
pending)
10
11
12
MUTUAL PHARMACEUTICAL
COMPANY, INC., AR SCIENTIFIC, INC.,
and AR HOLDING COMPANY, INC.
13
14
15
16
17
18
19
20
21
22
23
24
25.
26
27
28
COOLEvGOOWARD
KRONISHLLP
ATH'UNH5
AT LAW
WAHflN<;TON
97906 v5IDC
38.
Document 1
Filed 08/06/2009
Page 39 of 44
II
II
I
DEMAND FOR JURY TRIAL
1
2
3
Pursuant to Rule 38 of the Federal Rules of Civil Procedure and Local Rule
38-1, Plaintiffs demand a trial by jury on all issues triable of right by a jury.
4
5
Dated: August 5, 2009
COOLEY GODWARD KRONISH LLP
6
7
MICHAEL G. RHODES (CALIFORNIA BAR
NO. 116127)
PETER J. WILLSEY (Pro Hac Vice pending)
JOHN S. KYLE (CAL1FORNIA BAR NO.
199196)
NISHAN KOTTAHACHCHI (CALIFORNIA
BAR NO. 221612)
BRENDAN 1. HUGHES (Pro Hac Vice pending)
8
9
10
II
12
MUTUAL PHARMACEUTICAL COMPANY,
INC., AR SCIENTIFIC, INC., and AR HOLDING
COMPANY, INC.
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
COOLEY GODWARD
KWNISHLLP
A1TORN~Y~ AT LAW
WA~I"lIN,·.T{lN
97906 vS/DC
39.
Document 1
Filed 08/06/2009
Page 40 of 44
UNITED STATES DISTRICT
CENTRAL DISTRICT OF CALIFORNIA
NOTICE OF ASSIGNMENT TO UNITED STATES MAGISTRATE JUDGE FOR DISCOVERY
This case has been assigned to District Judge Florence-Marie Cooper and the assigned
discovery Magistrate Judge is Carolyn Turchin.
The case number on all documents filed with the Court should read as follows:
CV09- 5761 FMC (CTx)
Pursuant to General Order 05-07 of the United States District Court for the Central
District of California, the Magistrate Judge has been designated to hear discovery related
motions.
All discovery related motions should be noticed on the calendar of the Magistrate Judge
NOTICE TO COUNSEL
A copy of this notice must be served with the summons and complaint on all defendants (if a removal action is
filed, a copy of this notice must be served on all plaintiffs).
Subsequent documents must be filed at the following location:
[X]
Western Division
312 N. Spring St., Rm. G-8
los Angeles, CA 90012
U
Southern Division
411 West Fourth St., Rm.1-053
Santa Ana, CA 92701-4516
U
Eastern Division
3470 Twelfth St., Rm. 134
Riverside, CA 92501
Failure to file at the proper location will result in your documents being returned to you.
CV-18 (03/06)
NOTICE OF ASSIGNMENT TO UNITED STATES MAGISTRATE JUDGE FOR DISCOVERY
Document 1
Filed 08/06/2009
Page 41 of 44
/>,0 44() (Rev 02/(9) Summons in a Civil Action
UNITED STATES DISTRICT COURT
for the
Central District of California
MUTUAL PHARMACEUTICAL COMPANY, INC" a Pennsylvania corporation;
AR SCIENTIFIC, INC" a Delaware corporation; and AR HOLDING
COMPANY, INC., a Delaware corporation
PlaintiffS
v.
IN DENA S.P.A. an Italian corporation; ALCHEM INTERNATIONAL LlMlTED., an Indian corporation;
ALKALOIDS PVT LTD., an Indian corporation; INDENA USA. INC., a Delaware corporation; LALiLAB,
INC, a North Carolina corporation; and FLAVtNE NORTH AMERICA. INC., a Delaware corporation,
Defendants
)
)
)
)
)
)
)
Civil Action No.
1
SUMMONS IN A CIVIL ACTION
To: (Defendant's name and addres~)
A lawsuit has been filed against you.
Within 20 days after service of this summons on you (not counting the day you received it) - or 60 days if you
are the United States or a United States agency, or an officer or employee of the United States described in Fed. R. Civ.
P. 12 (a)(2) or (3) - you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of
the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiffor plaintiff's attorney,
whose name and address are:
Michael G. Rhodes
Cooley Godward Kronish LLP
4401 Eastgate Mall
San Diego, CA 92121
(858) 550-6000
If you fail to respond, judgment by default will be enterect ag~lh;;You for the.reli<{ demanded in the complaint.
You also must file your answer or motion with the court.
1
(
I
/
I•
.
I
•
.
!
(H/
\
.
'. (sLERK OF C [jRT
Date:
AUG - 6 2009
!
!
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S!g!;L-k:"~!.':-:
/
Document 1
Filed 08/06/2009
Page 42 of 44
AO 440 (Rev, 02!()9) Summons in a Ci\'il Action (Prrgc 2)
Civil Action No.
PROOF OF SERVICE
(This section should not beji/ed with Ihe COllrt unless required by Fed. R. Civ. P. 4 (I))
This summons for (name of individual and title, ifany)
was received by me on (date)
o
I personally served the summons on the individual at {JJ/ace)
on (date)
o
J left the summons at the individual's residence or usual place of abode with
;or
(name)
, a person of suitable age and discretion who resides there,
on (date)
o
, and mailed a copy to the individual's last known address; or
, who is
I served the summons on (name of individual)
designated by law to accept service of process on behalf of (name of organization)
on (date)
o
I returned the summons unexecuted because
o
Other (specify):
My fees are $
for travel and $
; or
for services, for a total of $
I declare under penalty of perjury that this information is true.
Date:
Server's signature
Printed name and title
Server's address
Additional information regarding attempted service, etc:
; or
0.00
Document 1
Filed 08/06/2009
Page 43 of 44
UNITED STATES DISTRICT COURT, CENTRAL DISTRICT OF CALIFORNiA
CIVIL COVER SHEET
I (a) PLAINTIFFS (Check box if you are representing yourself 0)
Mutual Phannaceutical Co., Inc., AR Scientific, Inc., and AR Holding Company,
DEFENDANTS
Indena S.P.A., Alchem International Limited, Alkaloids PYI Ltd., lndena USA,
Inc., Lalilab, Inc., and Flavine North America, Inc.
Inc.
(b) Attorneys (Firm Name, Address and Telephone Number. If you arc representing
yourself, provide same.)
Attorneys (If Known)
Nishan Kottahachchi, Cooley Godward Kronish LLP
777 6th Street, NW
Washington, DC 2000] (Tele: 202-842-7800)
II. BASIS OF JURISDICTION (Piace an X in one box only.)
i
o I U.S. Government Plaintiff
III. CITIZENSHIP OF PRINCIPAL PARTIES - For Diversity Cases Only
(Place an X in one box for plaintiff and one for defendant.)
3 Federal Question (U.S.
Government Not a Party)
PTF DEF
01 01
Incorporated or Principal Place
Citizen ofThis State
PTF DEF
04 04
ofBusincss in this State
02 U.s. Government Defendant
02
02
Incorporated and Principal Place 05
of Business 111 Another State
05
Citizen or Subject ofa Foreign Country 03
03
Foreign Nation
06
04 Diversity (Indicate Citizenship Citizen of Another State
of Parties in Hem Ill)
06
IV. ORIGIN (Place an X in one box only.)
til Original
Proceeding
02 Removed from
State Court
V. REQUESTED IN COMPLAINT:
CLASS ACTION
03 Remanded from
Appellate Court
04 Reinstated or
Reopened
JlJRY DEMAND: iiYes
0 5 Transferred from another district (specify):
06 Multi07 Appeal to District
District
Judge from
Litigation
Magistrate Judge
0 No (Check 'Yes' only if demanded in complaint.)
ri MONEY DEMANDED IN COMPLAINT: $ To be detennined at tda1
under F.R.C.P. 23: 0 Yes liNo
VI. CAUSE OF ACTION (Cite the U.s. Civil Statute under which you are filing and write a brief statement of cause. Do not cite jurisdictional statutes unless diversity,)
Contributory False and Misleading Advertising, False Misrepresentation of Fact, and Unfair Competition under IS USC. Sec. 1125(A)
VII. NATURE OF SUIT (Placclln X in one box only.)
OWi3l<.ST/ITq!)'E.% ..•• I,
o 400 State ReapportIOnment 1[, ;10
Act
0950
'.' ....... . . < '.
Airpla~~NjijR>i'
0310
0315 Airplane Product
Liability
0320 Assault, Libel &
Slander
0330 Fed. Employcrs'
Liability
0340 Marine
0151
0345 Marine Product
0152
Liability
0350 Motor Vehicle
0355 Motor Vehicle
0153
Product Liability
0360 Other Personal
Injury
0160
0362 Personal Injury0190
Med Malpractice
0195
0365 Personal JnjuryProduct Liability
0196
D 368 Asbestos Personal
Environmental Matters '\jiil';~@:\?il'!'lj'~t¥i,'ii "':';:;;
Injury Product
Energy Allocation Act 0210 Land Condemnation
. . . Liabilit)'
Freedom of Info. Act
0220 Foreclosure
)ii""iMi\i!lJ;Jj§l1!II,0!li ;,~:,
Appeal of Fee Detenni- 0230 Rent Lease & Ejectment 0462 Naturalization
Application
nation Under Equal
0240 Torts to Land
0463 Habeas CorpusAccess to Justice
0245 Tort Product Liability
Alien Detainee
Constitutionality of
0290 Ali Other Real Property
0465 Other Immigration
State Statutes
Actions
0410 Antitrust
0430 Banks and Banking
0450 CommercenCC
Rates/etc.
0460 Deportation
0470 Racketeer Influenced
and Corrupt
Organizations
0480 Consumer Credit
0490 Cable/Sat TV
0810 Selective Service
0850 Securities/Commodities!
Exchange
0875 Customer Challenge 12
USC 3410
,(890 Other Statutory Actions
0891 Agricultural Act
0892 Economic Stabilization
0893
0894
0895
0900
>': !;',Ii
Insurance
Marine
Miller Act
Negotiable instrument
Recovery of
Overpayment &
Enforcement of
Judgment
Medicare Act
Recovery of Defaulted
Student Loan (Excl
Veterans)
Recovery of
Overpayment of
Veteran's Benefits
Stockholders' Suits
Other Contract
Contract Product
Liability
Franchise
FOR OFFICE USE ONLY,
0120
0]30
0140
0150
CasoNombec
.~.
PERSONAL
PROPERTY
0370 Other Fraud
0371 Truth in Lending
0380 Other Personal
Property Damage
0385 Properly Damage
Product Liability
•· •• 1lA\ilR);!Jl'!tCy .'.
0422 Appeal 28 USC
158
0423 Withdrawal 28
USC 157
clvl1'.RJ(l\lTS
0441 Voting
0442 Employment
0443 HousingiAccommodations
0444 Welfare
0445 American with
Disabilities Employment
0446 American with
Disabilities Other
0440 Other Civil
Rights
.•....
" ·PRiS'ONER
IPE'ri6QNS
0510 Motions to
Vacate Sentence
Habeas Corpus
0530 General
0535 Death Penalty
0540 Mandamus!
Other
0550 Civil Rights
0555 Prison Condition
I
FQRFEITURE I
PENALTY,.
o 61 0
Agriculture
0620 Other Food &
Drug
".;..
;St~'d;:d;
,0
Aot
0720 Laoor/Mgmt.
Relations
0730 Labor/Mgmt.
Reporting &
Disclosure Act
0740 Railway Labor Act
0790 Other Labor
Litigation
0791 Emp!. Ret. Inc
S1!~u.r.i.ty, A~t.
•.'PRQpli&TYR)Q11t,
0820 Copyrights
0830 Patent
0840 Trademark
0625 Drug Related
Seizure of
.' ",'$j'lCi/iWS.ECwjti,. i '
Property 21 USC 0861 HIA (1395ff)
0862 Black Lung (923)
881
0630 Liquor Laws
0863 DIWC/DlWW
(405(g))
0640 R.R. & Truck
0650 Airline Regs
0864 ssm Title XVI
0660 Occupational
Safety IHealth
~k ':..: . ~ :~~" "~~¥S;.'.. ,",,,&t!~
0870 Taxes (U.S. Plaintiff
0690 Other
or Defendant)
0871 IRS-Third Party 26
USC 7609
~1B;j~&l)~""
tv 0 9 ~ 05761
AFTER COMPLETING THE FRONT SIDE OF FORM
CY-7! (05/08)
..··.:r"l~T$·
CV~71,
COMPLETE THE INFORMATION REQUESTED BELOW.
CIVIL COVER SHEET
Page 1 of2
Document 1
UNITED STATES f)ISTRlCl'
COURT~
Filed 08/06/2009
Page 44 of 44
CENTRAL DlSTRJCf OF CALIFORNIA
CIVIL COVER SHEET
VIII(a). IDENTICAL CASES: Has this action bcen previously filed in this court and dismissed, remanded or dosed? 5fNo 0 Yes
Iryes, list case number(s): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
VIII(b), RELATED CASES: Have any cases been previously filed in this court that are related to the present case? 0 No
lfyes, list case number(s): 09-cv-OS700 PA (Rex)
ri Yes
Civil cases are deemed related if a previously filed case and the present case:
(Check all boxes that apply) riA Arise from the same or closely related transactions, happenings, or events; or
IiiB. CaB for determination of the same or substantially related or similar questions of law and fact; or
ric. For other reasons would entail substantial duplication of labor if heard by different judges; or
DO. Involve the same patent, trademark or copyright, and one of the factors identified above in a, b or c also is present.
IX. VENUE: (When completing the following information, use an additional sheet ifnecessary.)
(a)
0
List the County in this District; California County outside of this District; State if other than California; or Foreign Country, in which EACH named plaintiff resides
Check here If the government, its agencies or employees is a named plaintiff. If this box is checked, go to item (b).
County in this District'"
California County outside of this District; State. if other than California; or Foreign Country
Mutual Phannaceuticai Company, Inc. ~ Philadelphia County, Philadelphia,
Pennsylvania
(b) List the County in this District; California County outside of this District; State if other than California; or Foreign Country, in which EACH named defendant resides.
0 Check here irthe government, its agencies or employees is a named defendant If this box is checked, go to item (c).
County in this District"
california County outside of this District; State, if other than California; or Foreign Country
AR Scientific, Inc. - Philadelphia County, Philadelphia, Pennsylvania
(c)
List the County in this District; California County outside artois District; State ifotherthan California; or Foreign Country, in which EACH claim arose.
Note' In land condemnation cases usc the location orthe tract orland involved
County in this District'"
California County outside of this District; State, if other lhan California; or Foreign Country
AR Holding Company, Inc.·
New Castle County, Wilmington, Delaware
X SIGNATURE OF ATTORNEY (OR PRO PER)' ----J'-"'''''---ff-''-'"'--------- Date August 6, 2009
Notice to CounsellParties: The CY-71 (15-44) Civil Cover Sheet and the infonnation contained herein neither replace nor supplement the filing and service of pleadings
or other papers as reqlJlfed by law. This form, approved by the Judicial Conference orllle United States in September 1974, is required pursuant to Local Rule3-1 is not filed
but is used by the Clerk of the Court for the purpose of statistics, venue and initiating the CIvil docket sheet. (For more detailed instructions, ~"ee separate instructions sheet.)
Key to Statistical codes relating 10 Social Security Cases
Nature of Suit Code
Abbreviation
Substantive Statemeut of Cause of Action
861
HIA
All claims for health insurance benefits (Medicare) undcr Title 18, Pari A, of the Social Security Act, as amended
Also, include claims by hospitals, skilled nursing facilities, etc., for certification as providers of services under the
program. (42 U.s.c. 1935FF(b))
862
BL
AI! claims for "Black Lung" benefits under Title 4, Part B, of the Federal Coal Mine Health and Safety Act of 1969.
(30 U.S.C. 923)
863
DlWC
All claims filed by insured workers for disability insurance benefits under Title 2 of the Social Security Act, as
amended; plus all claims filed for child's insurance benefits based on disability. (42 U.S.c. 405(g))
863
DIWW
All claims filed for widows or widowers insurance benefits based on disability under Title 2 of the Social Security
Act, as amended. (42 U.s.c. 405(g»)
864
ssm
All claims for supplemental security income payments based upon disability filed under Title 16 of the Social Security
Act, as amended.
865
RSI
All claims for retirement (old age) and survivors benefits under Title 2 of the Social Security Act, as amended. (42
U.S.c. (g))
CV-71 (05108)
CIVIL COVER SHEET
Page 2 of2

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