Exhibit 99.2
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
UNITED STATES OF AMERICA, )
)
Plaintiff, ) Civil Action
) No.
)
v. )
)
)
ABBOTT LABORATORIES, a )
corporation, and MILES D. WHITE, ) CONSENT DECREE OF
and THOMAS D. BROWN ) PERMANENT INJUNCTION
individuals, )
)
Defendants. )
The United States of America, plaintiff, having filed a Complaint for
Injunction against Abbott Laboratories, a corporation, and Miles D. White,
Chief Executive Officer, Abbott Laboratories, and Thomas D. Brown, President,
Abbott Diagnostics Division, individuals, and defendants having appeared and
having consented to entry of this Decree without contest, without admitting
the allegations of the Complaint, and before any testimony has been taken,
and the United States of America having consented to this Decree:
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows:
1. This Court has jurisdiction over the subject matter herein, and has
personal jurisdiction over all parties to this action pursuant to 21 U.S.C.
Section 332(a), 28 U.S.C. Sections 1331, 1337, and 1345, and 42 U.S.C.
Sections 262 and 264.
2. Venue is proper in this District under 28 U.S.C. Section 1391(b) and
(c).
3. The Complaint for Injunction states a cause of action against the
defendants under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C.
Sections 301 ET SEQ. and the Public Health Service Act (PHSA), 42 U.S.C.
Sections 201 ET SEQ.
4. Except as provided in paragraph 5 of this Decree, the defendants,
Abbott Laboratories (Abbott), a corporation, and Miles D. White, Chief
Executive Officer, Abbott, and Thomas D. Brown, President, Abbott
Diagnostics Division, individuals, while they are officers or employees of
Abbott or any Abbott subsidiary, affiliate, or successor entity, and each and
all of Abbott's officers, agents, employees, representatives, and attorneys,
and those persons in active concert or participation with any of the
defendants, are permanently enjoined under 21 U.S.C. Section 332(a) from
directly or indirectly manufacturing, processing, packing, labeling,
holding, or distributing IN VITRO diagnostic devices, including finished
devices, accessories, and components, at Abbott's device manufacturing
facilities located at 100/200 Abbott Park Road, Abbott Park, Illinois
(Abbott Park), and at Route 41 & Martin Luther King Drive, North Chicago,
Illinois (K2), unless and until:
A. Defendants select an independent person or persons (the "expert(s)")
to make inspections of Abbott's device manufacturing facilities at Abbott
Park and K2 to determine whether the methods, facilities, and controls are
operated and administered in conformity with the Quality System Regulation, 21
2
C.F.R. Part 820. The expert(s) shall be qualified by education, training and
experience to conduct such inspections, and shall be without former or
current personal or financial ties (other than consulting agreements between
the parties) to the defendants or their immediate families; and
B. The expert(s) inspects Abbott's device manufacturing facilities and
manner of operation at Abbott Park and K2, and certifies in writing to FDA
that Abbott's corrective and preventive action (CAPA) system is in conformity
with the Quality System Regulation; and the defendants report in writing to FDA
the actions they have taken to bring Abbott's CAPA system into conformity
with the Quality System Regulation since the May through July 1999
inspection. Within twenty (20) days after FDA receives the expert(s)'s
certification and defendants' report, FDA representatives, may, in their
discretion, commence an inspection of Abbott's facilities at Abbott Park and
K2 and undertake such additional examination and analyses (as provided in
paragraphs 20 and 21) as they, in consultation with FDA's Office of
Compliance, Center for Devices and Radiological Health, and FDA's Office of
Compliance and Biologics Quality, Center for Biologics Evaluation and Research,
deem appropriate to determine whether Abbott's CAPA system is in conformity
with the Quality System Regulation; and
C. Within forty-five (45) days after FDA has completed its inspection,
or, if no inspection is conducted, within forty-five (45) days after receipt
of the expert(s)'s certification and
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defendants' report. FDA advises the defendants in writing that Abbott's CAPA
system is in conformity with the Quality System Regulation; and
D. After defendants have brought all of the devices listed in
paragraph 5(A) into conformity with the Quality System Regulation (except
that B12, Folate, Ferritin, Hepatitis HBe/Anti HBe, and HCG (testpack) may be
brought into conformity with the Quality System Regulation concurrently with
those products listed in paragraph 5(A), in accordance with paragraphs 7 and
8), the expert(s) certifies in writing to FDA that the manufacturing
processes for a product group not covered by paragraph 5(A) have been
validated and that the products and processes that have been certified are in
conformity with the Quality System Regulation. Within five (5) working days
after FDA receives the expert(s)'s certification, FDA may request any
certified validation package(s) that the agency wishes to review. FDA may
inspect Abbott's facilities at Abbott Park and K2 after receiving the
expert(s)'s certification to determine whether those products and the
processes for those products are in conformity with the Quality System
Regulation; and
E. FDA notifies the defendants in writing, for each group of
products it has reviewed, that the group appears to be in compliance with the
Quality System Regulation and may be distributed. FDA will provide such
notice (if appropriate) within sixty (60) days of completing any inspection
pursuant to paragraph 4(D), or if no inspection is undertaken, within sixty
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(60) days of receiving validation package(s) requested by FDA pursuant to
paragraph 4(D), or if no validation package(s) is requested and no inspection
is undertaken, within ten (10) working days of receiving the expert(s)'s
certification pursuant to paragraph 4(D);
F. To enable users to standardize or obtain alternative test
methods, the injunctive provisions of paragraph 4 shall not take effect until
30 days after the date of entry of this Decree.
5. The injunctive provisions set forth in paragraph 4 shall not prohibit
the defendants from:
A. Manufacturing, processing, packing, labeling, holding, and
distributing the following products, including their necessary accessories,
components, calibrators and controls, the continued availability of which FDA
currently believes to be medically necessary:
1. AFP;
2. Anti-Delta;
3. Amikacin;
4. Ausab;
5. Auszyme Monoclonal;
6. Beta 2 Microglobulin;
7. CA 125;
8. CA 15-3;
9. Carbamazepine/Free Carbamazepine;
10. CEA;
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11. Chlamydia (LCx probe only);
12. CK-MB;
13. CMV (IGG, IGM);
14. CMV Total AB EIA;
15. Corzyme;
16. Cyclosporine;
17. Digitoxin;
18. Digoxin II;
19. Drugs of Abuse/Toxicology Panel;
20. Estriol/Free Estriol, FSH, LH, Progesterone,
Estradiol, Prolactin;
21. Fetal Lung Maturity II;
22. Gentamicin;
23. Glycated Hemoglobin;
24. Gonorrhea (LCx probe only);
25. HAVAB;
26. HAVAB-M;
27. HBsAg Confirmatory Test for Auszyme
Monoclonal;
28. HCG (not testpack);
29. HCV EIA 2.0;
30. HIVAB HIV-1/HIV-2 (rDNA) EIA;
31. HTLV-I/HTLV-II EIA;
32. HIVAG-1 Monoclonal;
33. HIVAG-1 Monoclonal Blocking Antibody;
34. Hepatitis B Core IGM;
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35. Homocysteine;
36. Methotrexate;
37. Myoglobin;
38. N-Acetylprocainamide;
39. PAP assay;
40. Phenobarbital;
41. Phenytoin/Free Phenytoin;
42. Procainamide;
43. Quinidine;
44. Rubella (IGG, IGM);
45. Tacrolimus;
46. Theophylline;
47. Thyroid Panel (TSH, T3, T4,
Free T3, Free T4, T Uptake);
48. Tobramycin;
49. Total b-HCG;
50. Total PSA;
51. Toxoplasmosis (IGG, IGA, IGM);
52. Troponin;
53. Valproic Acid/Free Valproic Acid;
54. Vancomycin;
B. After providing written notice to FDA that Abbott intends to do
so, and unless FDA objects within five (5) working days after receiving such
notice, manufacturing, processing, packing, labeling, holding and shipping
limited quantities of devices for the sole purpose of validating the
processes and
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systems associated with the manufacturing, processing, packing, labeling, or
holding of IN VITRO diagnostic devices;
C. Manufacturing, processing, packing, labeling, holding, and
exporting any IN VITRO diagnostic device, including finished devices,
accessories, components, calibrators, and controls, in compliance with 21
U.S.C. Section 381(e) or Section 382, as appropriate. CA19-9 may be exported in
accordance with the procedures set forth in 21 U.S.C. Section 381(e). Partially
processed biological products not intended for sale in the United States and
intended for manufacturing into finished products outside the United States
may be exported solely for further manufacturing into viral marker test kits
not intended for reimportation into the United States. These products must be
labeled on the outside of the shipping package that they are intended for
export only. Prior to export, defendants shall notify the appropriate public
health authorities in the countries to which these partially processed
biological products are intended to be exported that these products shall not
be reimported into the United States and that FDA has alleged that the
methods used in, and the facilities and controls used for, their manufacture,
processing, packing and holding are not in conformity with current good
manufacturing practice. Defendants shall provide a copy of this Decree to the
appropriate public health authorities in these countries as part of such
notice. Defendants shall maintain records documenting the export of such
partially processed biological products. Records shall be kept identifying
the manner in which the
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defendants complied with the notification requirements described in this
paragraph. All of these records shall be made immediately available for FDA
inspection on request;
D. Distributing, at K2, finished devices and unopened accessories,
components, and materials that are completely manufactured, processed,
packed, and labeled at facilities other than Abbott Park or K2;
E. Manufacturing, processing, packing, labeling, holding, and
distributing limited quantities of devices, including their necessary
accessories, components, calibrators, and controls, for the sole purpose of
conducting clinical investigations in accordance with the FDCA, as long as
Abbott obtains written agreement from the recipient(s) that the product is
for investigational use only.
6. In recognition of the government's right to seek monetary equitable
relief for the distribution of medically necessary IN VITRO diagnostic
devices that the government alleges were not manufactured in compliance with
the Quality System Regulation, but without admitting that allegation or any
violation of the law, Abbott agrees to pay to the United States Treasury,
within ten (10) days of the date of entry of this Decree, the amount of one
hundred million dollars ($100,000,000).
In addition, for each product listed in paragraph 5(A) that FDA has
determined has not been brought into conformity with the Quality System
Regulation within three hundred and sixty-five (365) days after the date of
entry of this Decree and which
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Abbott continues to sell after such date, Abbott shall, at the end of every
ninety (90) day period following three hundred and sixty-five (365) days after
the date of entry of this Decree, pay to the United States Treasury an
amount equal to sixteen percent (16 %) of the gross revenue generated by the
sale of such non-conforming product(s) in the United States, from and
including the date on which such ninety (90) day period began, to but not
including the date on which the certification of such conformity (as
described in paragraph 9) is received by FDA, even if FDA does not determine
that such conformity has been achieved until a later date; provided, however,
that Abbott will increase its payments appropriately if FDA later determines
that such compliance was not achieved until a later date. The amount(s) paid
under this paragraph shall be determined by a qualified financial auditor,
who shall be paid by Abbott, acceptable to Abbott and FDA, and without former
or current personal or financial ties to the defendants or their immediate
families. Abbott shall cooperate fully with the auditor and provide all
records reasonably requested by the auditor to make the determination
described in this paragraph. The parties acknowledge that the payment(s)
under this Decree are not a fine, penalty, forfeiture or payment in lieu
thereof.
7. Within sixty (60) days after the date of entry of this Decree,
defendants shall submit to FDA a proposed master compliance plan, a proposed
validation plan and a proposed overall validation procedure for accomplishing
validation of
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manufacturing processes affecting products covered by paragraphs 4 and 5 and
for bringing defendants' processes used to manufacture IN VITRO diagnostic
products into conformity with the Quality System Regulation. The master
compliance plan and validation plan shall: (a) identify the specific
manufacturing processes to be validated and the products affected by such
process(es); (b) include a proposed validation schedule; and (c) provide that
Abbott's manufacturing processes for products listed in paragraph 5(A) shall
be brought into conformity with the Quality System Regulation within three
hundred and sixty-five (365) days after the date of entry of this Decree. FDA
shall respond to defendants' proposed master compliance and validation plan
and overall validation procedure within thirty (30) days of receipt. Abbott
understands that it may be necessary for FDA to adjust the number of
submissions that Abbott proposes to make within a period of time, to enable
FDA to meet the time frames for review set forth in paragraph 8 of this
Decree. After the schedule has been approved, FDA and Abbott may stipulate in
writing to a revised schedule.
8. After Abbott's expert(s) has certified to FDA that a process(es)
affecting any product listed in paragraph 5(A) has been validated and/or that
a product(s) listed in paragraph 5(A) has been completely validated, FDA will
determine, within sixty (60) days of receipt of the certification, whether
the process(es) and/or product(s) have been validated and are in conformity
with the Quality System Regulation on the basis of (in
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FDA's discretion) inspection, analyses, and/or review of all relevant records.
9. Abbott's expert(s) shall, if appropriate, certify to FDA that all
processes affecting products listed in paragraph 5(A) have been brought into
conformity with the Quality System Regulation. Within twenty (20) days after
FDA receives the expert(s)'s certification, FDA may commence an inspection of
Abbott's facilities at Abbott Park and K2 and undertake such additional
examination and analyses (as provided in paragraphs 20 and 21) as it, in
consultation with FDA's Office of Compliance, Center for Devices and
Radiological Health, and FDA's Office of Compliance and Biologics Quality,
Center for Biologics Evaluation and Research, deems appropriate to determine
whether the defendants' processes for products listed in paragraph 5(A) are
in conformity with the Quality System Regulation; and within forty-five (45)
days after FDA has completed its inspection, FDA will advise the defendants
in writing whether Abbott's processes for products listed in paragraph 5(A)
are in conformity with the Quality System Regulation.
10. During the first three hundred and sixty-five (365) days after
the date of entry of this Decree, for each process identified pursuant to
paragraph 7 that affects a product in paragraph 5(A), Abbott shall pay the
sum of fifteen thousand dollars ($15,000) per process, per business day, for
failure to accomplish an adequate validation, as determined by FDA, in
accordance with the validation schedule approved under paragraph
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7. During the same period, Abbott shall also pay fifteen thousand dollars
($15,000) per business day for failure to bring the CAPA system into
conformity with the Quality System Regulation as determined by FDA within one
hundred and twenty (120) days after the date of entry of this Decree. For
purposes of this paragraph, if Abbott submits to FDA the certification of the
expert(s) that an adequate validation has been accomplished or that the CAPA
system has been brought into conformity with the Quality System Regulation
within the schedules under this Decree, no payment shall be imposed unless
and until FDA notifies Abbott that such validation is not adequate or that
the CAPA system is not in such conformity, in which case payment shall be due
for each business day commencing on the day on which the action was due to be
completed by Abbott. The total payments under this paragraph shall not exceed
10 million dollars ($10,000,000).
11. After entry of this Decree, FDA and defendants may, through a
written joint stipulation, add products to paragraph 5(A).
12. The defendants shall destroy, at Abbott's expense and under FDA
supervision, all finished IN VITRO diagnostic devices that, on the date of
entry of this Decree, are in Abbott's possession, custody, and control within
the United States, and that were manufactured, processed (in any way), packed,
or labeled at Abbott Park or K2, and all components that are in inventory at
Abbott Park or K2; EXCEPT THAT: (1) defendants need not destroy any product
(or any component thereof) that falls
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within the terms of paragraph 5; and (2) defendants need not destroy any
product (or any component thereof) that falls within a group that FDA has
approved under paragraph 4 if defendants submit to FDA a proposed
reconditioning plan for the product or component, FDA in writing approves the
plan, and FDA in writing finds the reconditioning to be satisfactory. No
product (or any component thereof) in inventory need be destroyed if within
thirty (30) days of any FDA request for such destruction defendants have
sought judicial review as provided in paragraph 26, and until judicial review
is complete and FDA's position has been upheld. FDA shall respond in writing
to any proposed reconditioning plan within sixty (60) days of receipt.
13. After defendants have achieved compliance with paragraphs 4(A)-4(D)
and FDA has notified them pursuant to paragraph 4(E), defendants shall retain
an independent person or persons (the "auditor(s)") to conduct audit
inspections of all IN VITRO diagnostic device manufacturing operations at
Abbott Park and K2 no less than twice a year, for a period of four (4) years
unless extended by FDA in writing. The auditor(s) shall be qualified by
education, training and experience to conduct such inspections, and shall be
without current or former personal or financial ties (other than the
consulting agreements entered into by the parties) to the defendants or their
immediate families and may, if defendants choose, be the same person
described as the expert in paragraph 4(A) above.
14. At the conclusion of each audit inspection, the
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auditor(s) shall prepare a written audit report (the "audit report")
evaluating whether the defendants are in compliance with the Quality System
Regulation, identifying any deviations from that regulation ("audit report
findings"), and separately identifying those deviations that the auditor
believes are significant. The auditor(s) shall provide a copy of the audit
report in draft form to the defendants, so that they may comment on the
findings. As part of every audit report except the first audit report, the
auditor(s) shall assess the actions taken by defendants to correct all
previous audit report findings. The final audit reports shall be delivered
contemporaneously to FDA and the defendants by courier service or overnight
delivery service. In addition, the final audit reports, drafts, and all of
the defendants' comments on drafts, shall be maintained by Abbott in separate
files at the Abbott Park and K2 facilities and shall be made immediately
available for FDA inspection on request.
15. Defendants shall, within thirty (30) days of receipt of each audit
report, correct any audit report findings, unless FDA notifies the defendants
that a different time period is necessary. If, after receiving an audit
report, defendants believe that correction of audit report findings will
take longer than thirty (30) days, defendants shall, within ten (10) working
days of receipt of the audit report, propose a schedule for completion of
corrections ("correction schedule"), which must be approved by FDA prior to
its implementation. FDA will notify
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the defendants of its decision regarding a proposed schedule within ten (10)
working days of receipt of the proposal. The time period for correction will
not run during the time that FDA is reviewing defendants' proposed schedule.
Defendants shall complete all corrections according to the approved correction
schedule. Within twenty (20) days after the scheduled completion of the
corrections, the auditor(s) shall review the actions taken by defendants to
correct the audit report findings. Within five (5) working days of the
completion of the auditor's review, the auditor shall report
contemporaneously in writing to FDA and the defendants whether each of the
audit report findings has been corrected.
16. Except as provided in paragraph 5, Abbott and each of the
individual defendants, while they are officers or employees of Abbott or any
Abbott subsidiary, affiliate, or successor entity, and each and all of
Abbott's officers, agents, employees, representatives, and attorneys, and
those persons in active concert or participation with any of the defendants,
are permanently enjoined under 21 U.S.C. Section 332(a) from directly or
indirectly: introducing or delivering, or causing to be introduced or
delivered, into interstate commerce any IN VITRO diagnostic device
manufactured, processed, packed, held, labeled or distributed at Abbott Park
or K2, including any component, part, or accessory of such device, that is
adulterated within the meaning of 21 U.S.C. Section 351(h); or causing the
adulteration of any IN VITRO diagnostic device manufactured, processed,
packed, held,
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labeled or distributed at Abbott Park or K2, while such device is held for
sale after shipment of one or more of its components in interstate commerce.
17. If at any time after this Decree has been entered, FDA
determines that Abbott has failed, with respect to IN VITRO diagnostic
products manufactured, processed, packed, held, labeled or distributed at
Abbott Park or K2, to comply with the Quality System Regulation any
requirement of this Decree, the FDCA, the PHSA, or any regulation promulgated
pursuant to the FDCA or the PHSA, or has failed to correct audit report
findings within time frames specified by FDA, or, when no time frame has been
specified, within thirty (30) days of receipt of an audit report, FDA may, as
and when it deems necessary, order defendants in writing to take one or more
of the following actions:
A. submit additional reports, notifications, or information
to FDA and/or users;
B. submit any application or any supplement to an existing
device or biological product application to FDA;
C. cease manufacturing, processing, packing, labeling,
holding, and/or distributing any specified device(s), including any devices
identified in paragraph 5;
D. recall, at Abbott's expense, any specified device(s),
including any accessories and components;
E. take any action(s) authorized by the FDCA or the PHSA.
18. Any order issued pursuant to paragraph 17 shall be
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issued by the Chicago District Director, the Director, Office of Compliance,
Center for Devices and Radiological Health, or the Director, Office of
Compliance and Biologics Quality, Center for Biologics Evaluation and
Research, as is appropriate, and shall specify the failures giving rise to
the order. Unless a different time frame is specified by FDA, within five
(5) working days after receiving an order pursuant to paragraph 17,
defendants shall advise FDA in writing either that: (1) defendants are
undertaking or have undertaken all corrective action(s) requested by FDA, in
which event defendants shall also describe the specific action(s) taken or
to be taken and the time frame(s) in which the action(s) will be completed;
or (2) defendants do not agree with FDA's order. If defendants notify FDA
that they do not agree with FDA's order, defendants shall explain in
writing the reasons for their disagreement. FDA will review defendants'
response and, in writing, affirm, modify, or withdraw its order as FDA deems
appropriate. While defendants' response is under review by FDA, the order
has no effect. After FDA review, unless FDA withdraws the order, FDA's order
shall take effect as the final order. Immediately upon receipt of the final
order, defendants shall proceed with implementation of all corrective action
deemed necessary by FDA as set forth in the final order. Defendants shall
continue to implement FDA's final order, unless and until FDA or the Court
issues an order to the contrary.
19. If FDA orders a cessation of operations with respect to
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specified device(s) under paragraph 17(C), defendants shall not resume
manufacturing, processing, packing, labeling, holding, and/or distributing such
devices until: (a) an expert(s) consultant certifies in writing to FDA that
defendants have remedied the failure(s) upon which the cessation was based;
(b) FDA inspects Abbott's facilities at Abbott Park and/or K2 to confirm the
adequacy of the corrective action(s) (if it chooses to do so); and (c) FDA
notifies defendants in writing (which FDA agrees to do within ten (10) days
of receipt of the expert certification or within thirty (30) days after the
completion of the FDA inspection, as applicable, if it believes such failures
have been remedied), that defendants may resume manufacturing, processing,
packing, labeling, holding, and/or distributing such devices. Any FDA
inspections shall be conducted pursuant to paragraphs 20 and 21, and shall
commence no later than twenty (20) working days after FDA's receipt of the
expert(s)'s certification.
20. Representatives of FDA shall be permitted, without prior notice
and as and when FDA deems necessary, to make inspections of Abbott's facilities
at Abbott Park and K2, including buildings, equipment, in-process and
finished materials, containers, and labeling therein; to take photographs and
make video recordings; to take samples of Abbott's finished and unfinished
materials and products, containers, and labeling; and to examine and copy all
records relating to the receipt, manufacture, processing, packing, labeling,
holding, and
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distribution of any and all devices in order to ensure continuing compliance
with the terms of this Decree. FDA shall provide Abbott with a receipt for
any samples taken, and with copies of any photographs or recordings made.
The inspections shall be permitted upon presentation of a copy of this Decree
and appropriate credentials. The inspection authority granted by this Decree
is separate from, and in addition to, the authority to make inspections under
the FDCA, 21 U.S.C. Section 374.
21. Abbott shall pay the costs of all supervision, inspections,
reviews, examinations, and analyses conducted pursuant to this Decree at the
standard rates prevailing at the time the activities are accomplished. As of
the date of this Decree, these rates are: $57.08 per hour and fraction
thereof per representative for inspection work; $68.42 per hour or fraction
thereof per representative for analytical and review work; $0.31 per mile
for travel expenses and $154.00 per day for subsistence expenses where
necessary. FDA shall submit a detailed bill of costs to the General Counsel,
Abbott, Department 364. In the event that the standard rates generally
applicable to FDA supervision, inspection, review, examination or analysis
are modified, these rates shall be increased or decreased without further
order of the Court.
22. Within ten (10) days of the date of entry of this Decree, Abbott
shall serve copies thereof upon each of its officers, and all persons who are
in active concert or participation with Abbott's Diagnostics Division or the
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defendants in the areas of manufacturing or quality systems for IN VITRO
diagnostic devices. Also within ten (10) days, Abbott shall post a copy of
this Decree on Abbott's intranet Web site in such manner to ensure that it
will be viewed by all employees of Abbott's Diagnostics Division, and shall
prominently post a copy of this Decree in the employee common areas in both
the Abbott Park and K2 manufacturing facilities. Abbott shall ensure that
the Decree remains posted on Abbott's intranet and in the employee common
areas for a period of no less than six (6) months. Should any person become
associated with Abbott subsequent to the periods described above who would
have received a copy of this Decree had his/her association commenced before
entry of this Decree, Abbott shall, within ten (10) days of the commencement
of such association, serve a copy of this Decree on such person. Within
thirty (30) days of the date of entry of this Decree, Abbott shall provide to
FDA and to plaintiff's attorney an affidavit of compliance stating the fact
and manner of compliance with the provisions of this paragraph and
identifying the names and positions of all persons upon whom this Decree has
been served.
23. Abbott shall notify FDA within fifteen (15) days before any
change in ownership or character of its business, such as dissolution,
assignment, or sale resulting in the emergence of a successor corporation, the
creation or dissolution of subsidiaries, or any other change in the Abbott
corporate structure or in the sale or assignment of any business assets,
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such as buildings, equipment, or inventory, that may materially affect
compliance with this Decree. Abbott shall provide a copy of this Decree to
any potential successor or assignee before any sale or assignment.
24. Except as may otherwise be agreed to by FDA in writing, the
defendants shall send via overnight mail or courier service all
communications with FDA required under this Decree to: (1) Director, Chicago
District Office, Food and Drug Administration, 300 S. Riverside Plaza, Suite
550 South, Chicago, Illinois 60606; (2) Director, Office of Compliance,
Center for Devices and Radiological Health, Food and Drug Administration,
HFZ-300, 2098 Gaither Road, Rockville, Maryland 20850; and (3) Director,
Office of Compliance and Biologics Quality, HFM-600, Center for Biologics
Evaluation and Research, 1401 Rockville Pike, Suite 200 N, Rockville,
Maryland 20852-1448. All communications shall reference this civil action by
case name and civil action number, and shall be sequentially numbered.
Certifications under paragraph 4(D) and notices under paragraph 5(B) shall be
sent by facsimile as well as by overnight mail or courier service.
25. Should the United States bring, and prevail in, a civil or
criminal contempt action against any defendant(s) for a violation of the
terms of this Decree, that defendant(s) shall pay attorneys' fees, travel
expenses incurred by witnesses, court costs, expert witness fees, and
analytical, review, and investigational expenses incurred in bringing such
action.
26. All decisions conferred upon FDA in this Decree shall
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be vested in the discretion of FDA, and, in the event of a decision adverse to
defendants, shall include a written explanation of FDA's reasons. FDA's
decisions shall be final and, unless explicitly provided elsewhere in this
Decree, defendants shall abide by FDA's decisions unless revoked or modified by
FDA or by this Court. If defendants seek judicial review, FDA's decisions shall
be reviewed by this Court under the arbitrary and capricious standard set forth
in 5 U.S.C. Section 706(2)(A). Any such review of an FDA decision brought
before this Court shall be based exclusively on the record before FDA at the
time FDA made the decision at issue, and no discovery shall be taken by any
party.
27. If defendants maintain a continuous state of compliance with this
Decree and the Quality System Regulation for a period of five (5) years after
the date of entry of this Decree and FDA has not notified the defendants that
there has been a significant violation of this Decree or the Quality System
Regulation during such time, the government will not oppose the defendants'
petition to the Court to dissolve this Decree.
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28. This Court retains jurisdiction of this action for the purpose of
enforcing or modifying this Decree and for the purpose of granting such
additional relief as may be necessary or appropriate.
SO ORDERED:
Dated this 2nd day of November, 1999.
Judge Leinenweber
----------------------------
UNITED STATES DISTRICT JUDGE
ENTRY CONSENTED TO:
DAVID W. OGDEN
Acting Assistant Attorney General
Abbott Laboratories Civil Division
Department of Justice
/s/ Arthur N. Levine
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by: Arthur N. Levine SCOTT LASSAR
Attorney for Abbott United States Attorney
Laboratories and the individual
defendants
/s/ Miles D. White /s/ Jeffrey Chasnow
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Miles D. White Jeffrey B. Chasnow
Attorney
/s/ Thomas D. Brown Office of Consumer Litigation
- ---------------------------- Civil Division
Thomas D. Brown Department of Justice
P.O. Box 386
Washington, D.C. 20044
(202) 616-0509
Attorneys for Plaintiff
OF COUNSEL:
MARGARET JANE PORTER
Chief Counsel
BARBARA STRADLING
Associate Chief Counsel
Food and Drug Administration
5600 Fishers Lane, Room 6B-20
Rockville, MD 20857
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