Terry Goddard
Attorney General
Office of the Attorney General
State of Arizona
December 18, 2008
Dena Rosen Epstein
Consumer Protection &
Advocacy Section
Direct: ( 602) 542~ 7717
Dena. Epstein@ azag. gov
The Honorable Timothy S. Bee
President of the Senate
1700 West Washington Street
Phoenix, AZ 85007
The Honorable James P. Weiers
Speaker of the House
1700 West Washington Street
Phoenix, AZ 85007
The Honorable Robert L. Burns
Chairman, Joint Legislative Budget Committee
1700 West Washington Street
Phoenix, AZ 85007
Re: State v. Eli Lilly and Company
Dear Gentlemen:
Arizona recently joined with 32 other state Attorneys General to settle a multi- state
action against Eli Lilly and Company (" Lilly") based on its allegedly unlawful promotion of
the antipsychotic drug Zyprexa ® .
The settlement, in the form of a Consent Judgment, resolves the States' one and
one half year investigation of Lilly's promotional practices. ( A copy of the signed Judgment
is attached). Zyprexa ® is the brand name for the prescription drug olanzapine. The drug
was first marketed for use in adults with schizophrenia in 1996. Since then, the Food and
Drug Administration (" FDA") has approved Zyprexa ® for the treatment of certain types of
bipolar disorder.
Zyprexa ® belongs to a class of drugs traditionally used to treat schizophrenia and
commonly referred to as " atypical antipsychotics." When these drugs were first introduced
to the market in the 1990s, experts thought atypical antipsychotics would be less likely to
produce side effects seen in the first generation of antipsychotics, such as motion
disorders like tardive dyskenisa, and therefore could be used in the long- term treatment of
1275 West Washington Street, Phoenix, Arizona 85007- 2926. Phone 602- 542- 3702 • Fax 602 - 542- 4377
,.....,
The Honorable Robert Burns
The Honorable Kirk Adams
The Honorable Russell K. Pearce
December 18, 2008
Page 2
schizophrenia. While atypical antipsychotics may reduce some risks, according to the
settlement documents they also produced dangerous side effects, including weight gain,
hyperglycemia, diabetes, cardiovascular complications, and an increased risk of mortality
in elderly patients with dementia. Zyprexa ® has allegedly been associated with a high risk
of weight gain, hyperglycemia, and diabetes.
As alleged in the Complaint, Eli Lilly began an aggressive marketing campaign
called " Viva Zyprexa!" in late 2000. As part of that campaign, the company marketed
Zyprexa ® for a number of uses that were not approved by the FDA (" off- label" uses). For
example, Lilly marketed Zyprexa ® for pediatric use, for use at high dosage levels, for the
treatment of symptoms rather than diagnosed conditions, and in the elderly for the
treatment and/ or chemical restraint of patients suffering from dementia. While a physician
is allowed to prescribe drugs for off- label uses, the law prohibits pharmaceutical
manufacturers from marketing their products for off- label uses. The FDA has never
approved Zyprexa ® for use in children, for use to treat symptoms rather than diagnosed
conditions, or for the treatment of dementia in the elderly.
The Consent Judgment contains a number of restrictions to ensure that Lilly does
not promote Zyprexa ® for off- label uses and that it markets Zyprexa ® in compliance with
law. Among other things, under the Judgment Eli Lilly shall:
• Not make any false, misleading or deceptive claims regarding Zyprexa ® ;
• Not promote Zyprexa ® using selected symptoms of the FDA- approved
diagnoses unless certain disclosures are made regarding the approved diagnoses;
• Require its medical staff, rather than its marketing staff, to have ultimate
responsibility for developing and approving the medical content for all medical letters and
medical references regarding Zyprexa ® , including those that may describe off- label
information. This information shall not be distributed unless certain criteria are met;
• Provide specific, accurate, objective and scientifically balanced responses to
unsolicited requests for off- label information from a health care provider regarding
Zyprexa ® ;
• Not use grants to promote Zyprexa ® , or condition CME funding on Eli Lilly's
approval of speakers or program content;
• Contractually require continuing medical education providers to disclose Eli
Lilly's financial support of their programs and any financial relationship with faculty and
speakers; and
• Register clinical trials and submit results as required by federal law; register
Zyprexa ® Eli- Lilly sponsored Phase II, III and IV clinical trials beginning after July 1, 2005;
The Honorable Robert Burns
The Honorable Kirk Adams
The Honorable Russell K. Pearce
December 18, 2008
Page 3
and post on a publicly accessible website all Eli- Lilly sponsored Phase II, III and IV clinical
trials completed after July 1, 2004.
In addition, the Consent Judgment requires Lilly to pay a total of $ 62 million to the
participating states. Arizona's share of the settlement is $ 2,205,705. This recovery is to be
deposited in the Consumer Fraud Revolving Fund, pursuant to the terms of the Judgment
as well as AR. S. § 44- 1531.01( B). These monies are used pursuant to statute for
investigating violations of the Consumer Fraud Act and enforcing its provisions, as well as
for consumer education. AR. S. § 44- 1531.01( C).
Our notification to you of this settlement is made without prejudice to this office's
long- standing position that it is not under any legal obligation to provide notices of
settlements to the Joint Legislative Budget Committee. We are providing this notification to
you as a courtesy so that you will be aware of this important settlement.
Thank you for your consideration of this matter. If you have any questions, please
feel free to contact me at dena. epstein@ azag. gov or ( 602) 542- 7717.
Sincerely,
j; Jfic/
Dena Rosen Epstein
Acting Section Chief Counsel
Consumer Protection and Advocacy Section
DRE/ sp
Enclosure
cc: The Honorable Russell K. Pearce
The Honorable Marsha J. Arzberger
The Honorable Phillip M. Lopes
Mr. Richard S. Stavneak
Ms. Leah B. Ruggieri
Ms. Leezie Kim
Ms. Sheryl A. Rabin
Mr. David Gass
Mr. John T. Stevens, Jr.
# 334118v2
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•
Terry Goddard
Attorney General
2 ( Firm State Bar No. 14000)
Noreen R. Matts ( State Bar No. 010363)
3 Dena Rosen Epstein ( State Bar No. 015421)
Assistant Attorneys General
4 Office of the Attorney General
1275 West Washington Street
5 Phoenix, AZ 85007
consumer@ azag. gov
6
Attorneys for Plaintiff
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o FILED
/ P « 3/ 0' r:.: JS-~.
MICHAEL K. JEANES, Clerk
BY. C'. .. tJ.~
Deputy
IN THE SUPERIOR COURT OF THE STATE OF ARIZONA
IN AND FOR THE COUNTY OF MARICOPA
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STATE OF ARIZONA, ex reI. TERRY
GODDARD, Attorney General,
Plaintiff,
vs.
Case No.: CV2008- 024260
CONSENT JUDGMENT
( Assigned to the Honorable Jeanne Garcia)
16
ELI LILLY AND COMPANY, an Indiana
14 Icorporation,
15 Defendant.
The State of Arizona, having filed a Complaint alleging violations of the Arizona
17 Consumer Fraud Act, A. R. S. § 44- 1521, et seq.; Defendant Eli Lilly and Company, having been
18 served with a copy of the Complaint; having been fully advised of the right to a trial in this
19 matter and, after receiving advice of counsel, having waived the same; admits only that this
20 Court has jurisdiction over the subject matter and the parties for purposes of entry of this
24 the terms of this Consent Judgment shall be governed by the Jaws ofthe State ofArizona.
A.
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Consent Judgment and acknowledges that this Court retains jurisdiction for the purpose of
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enforcing this Consent Judgment. Eli Lilly and Company denies the allegations of the I
Complaint and denies having violated dIe Consumer Fraud Act. Further, it acknowledges that III
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PREAMBLE I I
The Attorneys Genera! of the Stales of Alabama, Arizona, California, Delaware, I
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District of Columbia, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland,
2 Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina,
3 North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee,
4 Texas, Vermont, Washington, and Wisconsin. ( collectively, the " Attorneys General," and the
5 " AGs"), conducted an investigation under the State Consumer Protection Laws regarding certain
6 Eli Lilly and Company (" Eli Lilly" or " Lilly") practices concerning Zyprexa ® ; and
its promotional practices, sampling practices, dissemination of information, and remuneration to
Health Care Professionals regarding Zyprexa ® (" Covered Conduct") in order to resolve the
AGs' investigation under the State Consumer Protection Laws and arrive at a complete and total
settlement and resolution of any disagreement as to the matters addressed in this Judgment and
thereby avoid unnecessary expense, inconvenience, and uncertainty; and
C. The Parties have agreed to resolve the issues raised by the Covered Conduct by !
entering into this Judgment. Eli Lilly is entering into this Judgment solely for the purpose of
settlement and nothing contained herein may be taken as or construed to be an admission or
concession of any violation of law or regulation, or of any other matter of fact or law, or of any .
liability or wrongdoing, all of which Eli Lilly expressly denies. Lilly does not admit any
violation of the State Consumer Protection Laws, and does not admit any wrongdoing that was I
or - could have been alleged by any Attorney General before the date of the Judgment under those
laws. No part of this Judgment, including its statements and commitments, shall constitute
evidence of any liability, fault, or wrongdoing by Eli Lilly. Except in an action brought by an
Attorney General to enforce this Judgment, this Judgment shall not be construed or used as a
waiver or limitation of any defense otherwise available to Eli Lilly, including, but not limited to .
the defense of feder~ l preemption, in other matters, or of Eli Lilly's right to defend itself from, I
or make any arguments in, any other matter, including, but not limited to, any investigation or
litigation relating to the existence, su!> ject ma. tter or terms of this Judgment. This Judgment is ... i
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B. Eli Lilly is willing to enter into a Consent Judgment ( the " Judgment") regarding
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made without trial or adjudication of any issue of fact or law or finding of wrongdoing or
2 liability of any kind. It is the intent of the Parties that this Judgment shall not be admissible in
3 any other matter, including, but not limited to, any investigation or litigation, or bind Eli Lilly in
4 any respect other than in connection with the enforcement of this Judgment. No part of this
5 Judgment shall create a private cause of action or confer any right to any third party for violation
6 of any federal or state statute except that a State may file an action to enforce the terms of this
7 Judgment. All obligations undertaken by Eli Lilly in this Judgment shall apply prospectively;
8 and nothing contained herein prevents or prohibits the use of this Judgment for purposes of
9 enforcement by the AGs; and
10 D. The AGs have reviewed the terms of the Judgment and find that such terms serve
11 the public interest; and
12 E. This Judgment ( or any portion thereof) shall in no way be construed to prohibit Eli
13 Lilly from making representations with respect to Zyprexa ® that are permitted under Federal
14 law or in Labeling for the drug under the most current draft or final standard promulgated by the
15 FDA or the most current draft or final FDA Guidances for Industry, or permitted' or required
16 under any Investigational New Drug Application, New Drug Application, Supplemental New
17 Drug Application, or Abbreviated New Drug Application approved by FDA, so long as the
18 representation, taken in its entirety, is not false, misleading or deceptive.
19 DEFINITIONS
20 The following definitions shall be used in construing this Judgment:
21 1. " Clinically Relevant Information" shall mean information that reasonably prudent
22 ' clinicians would consider relevant when making prescribing decisions regarding Zyprexa ® . .,
23 2. " Consultant" or " Consulting" shall mean a non- Lilly Health Care Professional
24 engaged to advise regarding marketing or promotion of Zyprexa ® .
25 3. " Effective Date" shall mean the date · on which a copy of this Judgment, duly I
26 executed by Lilly and by the Signatory Attomey General, is approved by, and becomes a I
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Judgment of, the Court or on November 1st, 2008, whichever is later.
2 4. " Eli Lilly and Company" shall mean Eli Lilly and Company, including all of its
3 affiliates, subsidiaries and divisions, predecessors, successors and assigns doing business in the
4 United States.
5 5. " FDA Guidances for Industry" shall mean draft or final documents published by
6 Ithe United States Department of Health and Human Services, Food and Drug Administration
7 (" FDA") that represent the FDA: s thinking on a tOpIC.
8 6. " Health Care Economic Infonnation" shall mean data and other infonnation
9 relating to the inputs and outcomes of health care therapies and services, including, but not
10 limited to, the price, cost- effectiveness, and quality of life implications ofZyprexa ® .
8. " Labeling" shall mean all FDA- approved labels, which are a display of written~ I
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7. " Health Care Professional" or " HCP" shall mean any physician or other health
12 Icare practitioner who is licensed to provide health care services or to prescribe pharmaceutical
products.
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25 12. " Lilly Medical" shall mean Lilly personnel assigned to the Lilly U. S. medical
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1 13. " Lilly Non- Medical" shall mean Lilly personnel other than Lilly personnel
2 assigned to the U. S. Zyprexa ® medical organization.
3 14. " Lilly Regulatory" shall mean Lilly personnel or their designee responsible for
4 Lilly's adherence with FDA regulations.
5 15. " Lilly Sales" shall mean the Lilly sales force responsible for U. S. Zyprexa ® . sales...
6 16. " Medical Letter" shall mean a non- promotional, scientific communication to
7 address Unsolicited Requests for medical infonnation from Heps.
8 17. " Medical Reference" shall mean a non- promotional reference communication that
9 is used for responding to or answering a HCP's Unsolicited Request for medical infonnation.
to 18. " Multistate Executive Committee" shall mean the Attorneys General and. their"
II staffs representing Arizona~ California, Florida, Illinois, Ohio, Oregon, Texas and Vennont.
121 19. " Multi~ ate Working Group" shall mean the Attorneys General and their staff
13 · 1 representing Alabama, Arizona, California, De: laware, District of Columbia, Florida, H~ waii, I
14 Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Mis. souri, I
15 Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma;
16 Oregon, Pennsylvania, Rhode Island, South Dakota,. Tennessee, Texas, Vennont, Washington,
17 and Wisconsin.
18 20. " Off- Label" shall mean a use not consistent with the indications section of the
communicated.
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Zyprexa ® Labeling approved by the FDA at the time information regarding suc~ use was
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21 21. " Parties" shall mean Lilly and the Signatory Attorney General: .
22 22. " Promotional," " Promoting" or " Promote" shall mean claims to Heps about
23 Zyprexa ® intended to increase sales or attempt to influence prescribing practices of the Heps. .
24 23. " Promotional Materials" shall mean any item with the product name, logo, or
25 message used to Promote Zypre~! l~:"~"" "
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26 24. " Promotional Slide Kit" shall mean Promotional Materials regarding" Zyprexa< Rl in r
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the form of a slide kit for use in speaker programs.
2 25. " Promotional Speaker" shall mean a non- Lilly HCP speaker used to Promote
3 Zyprexa ® .
4 26. " Reprints Containing Off- Label Information" shall mean articles or reprints from a
5 peer reviewed journal or reference publication describing an Off- Label use ofZyprexa ® .
6 27. " Signatory Attorney General~' shall mean the Attorney General of Arizona, or his
7 authorized designee, who has agreed to this Judgment.
8 28. " State Consumer Protection Laws" shall mean the consumer protection laws under
9 which the Attorneys General have conducted the investigation~ ALABAMA - Deceptive Trade
10 Practices Act, Ala. Code § 8- 19- 1 et seq.; ARlZONA - Consumer Fraud Act, A. R. S. § 44.. 1521,
11 et seq.; CALIFORNIA - Bus. & Prof. Code, § § 17200 et seq., and 17500 et seq.; DELAWARE12
" Consumer Fraud Act, 6 DeLC. Section 2511, et seq.; DISTRICT OF COLUMBIA- Consumer
13 - Protection Procedures Act, D. C. Code § 28- 390 I, et seq.; FLORIDA - Deceptive and Unfair
14 Trade Practices Act, Fla. Stat. Ch. 501.201 et seq.; HAWAII - Uniform Deceptive Trade
15 Practice Act, Haw. Rev. Stat. Ch. 481A and Haw. Rev. Stat. § 480- 2.; IL~ INOIS - Con- sumer
16 Fraud and Deceptive Business Practices Act, 815 ILCS § 505/ 1 et seq.; INDIANA:"" Deceptive
17 Consumer Sales Act, Ind. Code § 24- 5- 0.5- 1 et seq.; IOWA - Iowa Consumer Fraud Act, Iowa
18 Code Section 714.16; KANSAS - Consumer Protection Act, K. S. A. 50- 623 et seq.; M<\ INE19
Unfair Trade Practices Act, 5 M. R. S. A. § 207 et seq.; MARYLAND - Consumer Protection
20 Act, Md. Code Ann., Com. Law § 13- 101 et seq.; MASSACHUSETTS - Consumer Protection
21 Act, M. G. L. c. 93A et seq.; MICHIGAN - Michigan Consumer Protection Act, MeL 445.901 et
22 seq.; MISSOURI - Missouri Merchandising Pract! ces Act, Mo. Rev. Stat. § 407.010 et st! q.;
23 NEBRASKA - Unifonn Deceptive Trade Practices Act, NRS § § 87- 301 et seq.; NEVADA24
Deceptive Trade Practices Act, Nevada Revised Statutes 598.0903 et seq.; J-..' EW JERSEY25
New Jersey Consumer Fraud Act, 56: 8- 1 et seq.; NEW YORK - General Business Law Article
26 22- A Sections 349, 350 and Executive Law 63 ( 12); NORTH CAROLINA - Unfair and
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1 Deceptive Trade Practices Act, N. C. Gen. Stat. § 75- 1.1 et seq.; NORTH DAKOTA - Unlawful
2 Sales or Advertising Practices, N. D. Cent. Code. § 51- 15- 02 et seq.; OHIO- Consumer Sales
3 Practices Act, R. C. 1345.0 I, et seq.; OKLAHOMA - Oklahoma Consumer Protection Act 15
4 O. S. § § 751 et seq.; OREGON - Unlawful Trade Practices Act, ORS 646.605 to 646.656;
5 PENNSYLVANIA- Unfair Trade Practices and Consumer Protection Law: 73 P. S.. § 201 · 1 et
6 seq.; RHODE ISLAND - R. I. Gen. L. § 6- 13.1- 1 et seq.; SOUTH DAKOTA - Deceptive Trade
7 Practices Act, S. D. Codified Laws § 37 · 24, et seq.; TENr- l'ESSEE - Tennessee Consumer
8 Protection Act, Tenn. Code Ann. § § 47- 18- 101 et seq.; TEXAS - Deceptive Trade Practices 9
Consumer Protection Act, Tex. Bus. and Com. Code § 17.47, et seq.; VERMONT - Consumer
10 Fraud Act, 9 V. S. A. § 2451 et seq.; WASHINGTON - Unfair Business Practices/ Consumer
11 Protection Act, R. C. W. 19.86 et seq.; WISCONSIN - Wis. Stat. § 100.18 ( Fraudulent
12 Representations).
13 29. " Unsolicited Request'~ shall mean a request for information regarding Zyprexa ®
14 from a HCP communicated to an agent of Lilly that has not been prompted.
15 30. " Zyprexa@" shall mean all FDA approved drug formulations containing
16 olanzapine as its sole active ingredient and Promoted by Lilly.
Promotional Activities
17 COMPLIANCE PROVISIONS
18 I.
19 A. Lilly shall not make any written or oral claim that is false, misleading or deceptive
20 regarding Zyprexa ® .
21 B. For'six years from the Effective Date of this Judgment, Lilly shall not Promote
22 Zyprexa ® for Off- Label uses.
23 C. For six years from the Effective Date of this Judgment, Lilly shall not present
24 patient profiles/ types based on selected symptoms of the FDA- approved indication( s) when
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26 1. The drug's specific FI? A- approved in~ kation( s) being Promoted isiare stated
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1 clearly and conspicuously in the same spread ( i. e., on the same page or on a facing page) in
2 Promotional Materials as references to selected symptoms.
indication( s) on the same slide in which selected symptoms are tirst
presented;
( ii) Lilly shall include a short- hand reference to the statement described
in Section I. C. I. a.( i) on the same slide as each subsequent reference to
selected symptoms ( e. g., " See complete list of FDA- approved indications at
p. X"); and
( iii) Lilly shall require any presenter of Lilly's Promotional Slide Kits to
present the statement required in Section I. C. l. a.( i), as part of the
mandatory slides.
Promotional Materials have a reference indicating that the full constellation of
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( i) Lilly shall state clearly and conspicuously the FDA- approved
15 symptoms and the relevant diagnostic criteria are available in the Diagnostic and Statistica!,
16 Manual of Mental Disorders ( DSM- IV or current version), where applicable.
17 II. Dissemination of Medical Information
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A.
1.
General Terms
The content of Lilly's communications concerning Off- Label uses of Zyprexa ®
20 shall not be false, misleading or deceptive.
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B.
1.
Medical Letters and Medical References
The following subsections shall be effective for six years from' the Effective Date
23 ofthis Judgment.
24 2. Lilly Medical shall have ultimate responsibility for developing and approving the
25 medical content for all Medical Letters and Medical References regarding Zyprexa ® , including
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26 any that may describe Off- Label information. Additional approvals may be provided by Lilly
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1 Regulatory and Lilly Legal. Lilly shall not distribute any such materials unless:
manner.
Materials.
scientific balance.
Lilly Sales and Lilly Marketing personnel shall not develop the medical content of
Clinically Relevant Information is included in these materials to provide
These materials are distinguishable from sales aids and other Promotional
b. Data in these materials are presented in an unbiased, non- Promotional
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9 Medical References or Medical Letters regarding Zyprexa ® . This provision does not prohibit
10 Lilly Sales or Lilly Marketing personnel from suggesting topics for Medical Letters or Medical
II References.
12 I 4. Lilly Sales representatives shall not distribute Medical References or Medical ' I
13 II Letters regarding Zyprexa ® .
141 5: Lilly shall not knowingly disseminate any Medical Leiter describing. any Off-!
151 Label use of Zyprexa ® that makes any fillse or misleading representation regarding'; Zyprexa ® I
16 or any false or misleading statement concerning a competing product.
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C.
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Responses to Unsolicited Requests for Off- Label information
The following subsections shall be effective for six years from the Effective Date
19 of this Judgment.
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20 I 2. In responding to an Unsolicited Request for Off- Label information regarding'
21 Zyprexa ® , including an! request for a specific article related to Off- Label uses, " Lilly.... shall I
22 advise the requestor that the request concerns an Off- Label use and inform the requestor of the. l ,
23 drug's FDA- approved indication( s) and/ or dosage and other relevant Labeling information.
24 3. IfLilly elects to respond to an Unsolicited Request for Off- Label information from
25 a HCP regarding Zyprexa ® , Lilly Medical personnel shall provide specific, accurate, objective,
26 and scien~ ifically balanced responses. Any such response shall not Promote Zyprexa ® for an
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Off- Label use.
2 4. Any written response to an Unsolicited Request for Off- Label information
3 regarding Zyprexa ® shall include:
the request in accordance with Section I1. B; or
from the request.
Lilly Non- Medical personnel may not respond In writing to an Unsolicited
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an existing Medical Letter prepared in accordance with Section II. B;
a Medical Letter or other document such as slides prepared in response to
a report containing the results of a reasonable literature search using terms
10 Request for Off- Label information regarding Zyprexa ® .
Off- Label information regarding Zyprexa ® from a HCP only by informing the HCP of the I
presence or absence of published studies concerning the Off- Label topic or acknowledge
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6. Lilly Non- Medical personnel may respond orally to an Unsolicited Request for
14 whether the topic is an area of research, and by offering to request on behalf of the HCP that a
15 Medical Letter or other information set forth above in II. C. 4 be sent to the Hep in. Jollow up.
16 Lilly Non- Medical personnel shall not characterize, describe, jdentify, name, or offer ahy
17. opinions about or summarize any such Off- Label information.
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D.
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Reprints
The following subsections shall be effective for six years from the Effective Date
20 ofthis Judgment.
Reprints Containing Off- Label Infonnation
and dissemination of Reprints Containing Off- Label Information' regarding
Zyprexa ® .
Reprints Containing Off- Label Information regarding Zyprexa ® :
Lilly Medical shall be responsible for the identification, selection, approval
( i) shall be accompanied by the full prescribing infornlation for the
b.
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be disseminated by Lilly Medical personnel to HCPs. Lilly Non- Medical
personnel shall not disseminate these materials to HCPs, absent the exception
described below in ( i).
product and contain a disclosure in a prominent location, which would
include the first page or as a cover page where practicable, indicating that
the article may discuss Off- Label information; and
( ii) shall not be referred to or used in a Promotional manner.
Reprints Containing Off- Label Infonnation regarding Zyprexa ® may only
clinical necessity to have Lilly Non- Medical personnel disseminate a
Reprint Containing Off- Label Information directly to HCPs, the President
of LillyUSA may approve a Clinical Necessity Exception to the prohibition
described in Section II. D. 2. c. above for that Reprint Containing Off- Label
Infonnation.
( ii) If the Clinical Necessity Exception is invoked, Lilly will notifY each
Signatory Attorney General of its intent to invoke the - Clinical Necessity
Exception at least 30 business days prior to disseminating through Lilly
Sales representatives of any Reprint Containing Off- Label Infonnation on
Zyprexa ® .
( a) If a Signatory Attorney General believes the Reprint I
Containing Off- Label Information to be disseminated does not meet i
the Clinical Necessity Exception, then the Sta~ will provide LilIy · 1
with written notice within 30 business days and provide Lilly an
opportunity to discuss its desired use of the Reprint Containing OffLabel
Information pursuant to the limited exception.
( b) If the State and Lilly do not come to a resolution, then the
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( i) In the event of an extraordinary circumstance in which there is a
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State may initiate legal action to prevent the dissemination of the
Reprint Containing Off- Label Information by Lilly Non- Medical
personnel.
( c) If the State initiates legal action to prevent the dissemination
of the Reprint Containing Off- Label Information by Lilly NonMedical
personnel, Lilly shall not use Lilly Non- Medical personnel
to disseminate such Reprint Containing Off- Label Information In
that State until the issue has been resolved.
3. Nothing in this Judgment shall preclude Lilly from disseminating reprints which
have an incidental reference to Off- Label information. If reprints have an incidental reference to
Off- Label information, such reprints shall contain the disclosure required by Section II. D. 2. b( i)
in a prominent location, as defined above.
E. Health Care Economic Information
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1. Nothing in this Judgment shall preclude Eli Lilly from providing Health Care
Economic Information to a formulary committee or other similar entity or its members in the
course of the committee or entity carrying out its responsibilities for the selection of drugs for
managed care or other similar organization pursuant to the standards ofFDAMA Section 114 if
the information directly relates to an approved indication for Zyprexa ® and if it is based on
competent and reliable scientific evidence.
III. Continuing Medical Education ( CME) and Grants
A. The following subsections shall be effective for six years from the Effective Date
ofthis Judgment.
B. Lilly shall disclose information about grants, including CME grants, regarding
Zyprexa ® consistent with the current disclosures of the Lilly Grant ' Office Registry at
www. lillygrantoffice. com ( hereinafter, " LGO website") or as required by applicable law.
1. Lilly shall maintain this information on the LOO website once posted for at least
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I two years and shall maintain the information in a readily accessible format for review by the
2 States upon written request for a period of five years.
3 C. The Lilly Grant Office shall manage all requests for funding related to CME
4 regarding Zyprexa ® . Approval decisions shall be made by the Lilly Grant Office alone, and
5 shall be kept separate from the Lilly Sales and Lilly Marketing organizations.
6 D. Lilly shall not use grants to Promote Zyprexa ® . This provision includes, but is not
7 limited to, the following prohibitions:
8 1. Lilly Sales and Lilly Marketing personnel shall not initiate, coordinate or
9 implement grant applications on behalf of any customer or HCP;
10 2. Lilly Sales and Lilly Marketing personnel shall not be involved In selecting
II grantees or CME- funded speakers; and
12 3. Lilly Sales and Lilly Marketing personnel shall not measure or attempt to track in
13 any way the impact of grants or speaking fees on the participating HCPs' subsequent prescribing
14 habits, practices or patterns.
15 E. Lilly shall not condition funding of a CME program grant request regarding
16 Zyprexa ® upon the requestor's selection or rejection of particular speakers.
17 F. Lilly shall not suggest, control, or attempt to influence selection of the specific
18 topic, title, content, speakers or audience for CMEs regarding Zyprexa ® , consistent with
19 ACCME guidelines.
20 G. Lilly Sales and Lilly Marketing personnel shall not approve grant requests
21 regarding Zyprexa ® , nor attempt to influence the Lilly Grant Office to reward any customers or
22 HCPs with grants for their prescribing habits, practices or patterns.
23 H. Lilly shall contractually require the CME provider to disclose to CME program
24 attendees Lilly's financial support of the CME program and any financial relationship with
25 faculty and speakers at such CME. As part of the disclosure of a financial relationship with
26 faculty and speakers, Lilly shall contractually require the CME program to identify the URL of a
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. . .
Lilly website, and reference that website as the source for further infonnation concerning grant
2 funding regarding Zyprexa ® .
3 I. After the initial delivery of a CME program, Lilly shall not fund the same
4 program, nor shall it provide additional funding for re- distribution of the same program, if it
5 knows that the program's speakers are Promoting Zyprexa ® for Off- Label uses.
6 IV. Payments to Consultants and Speakers
7 A. The following subsections shall be effective for six years from the Effective Date
8 of this Judgment.
9 B. This Section shall apply to U. S. based Consultants and Promotional Speakers to
10 the Lilly Marketing organization.
11 C. Lilly shall provide to each Signatory Attorney General, in an electronic
12 spreadsheet fonnat, a list ofHCP Promotional Speakers and Consultants who were paid by Lilly
I
13 any taxable income in excess of$ 100 for Promotional speaking and/ or Consulting perfonned for
14 Lilly in the U. S., a list of all titles of Promotional presentations made, and the following
15 additional information with respect to each individual Promotional Speaker and/ or Consultant:
16
17
18
1.
2.
3.
total compensation from Lilly for any Consulting or Promotional speaking fees;
total number of Promotional speaking events paid for by Lilly;
the state the Promotional Speaker/ Consultant has provided to Li! ly for contact
19 purposes;
20 4.
21 and
the state( s) in which the Promotional Speaker gave the Promotional presentations; I
22
23
25
5. any other compensation from Lilly as set forth in IRS Form 1099.
On or before July I, ~ 009. ~ iIly shall provide the data requested in Nos. 1- 4 for the I
24 period January 1, 2009- March 31 ~ 2009. On or before October 1, 2009, Lilly shall provide' the
I " :
data" requested in Nos. 1- 4 for the period April 1, 2009- June 30; 2009. On or before January I,
26 2010, Lilly shall provide the data requested in Nos. 1- 4 for the period July 1, 2009 - I
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· . .
September 30, 2009. On or before April I, 2010 and on or before April 1 of each subsequent
2 year, Lilly shall provide the data requested in Nos. 1- 5 for the full preceding calendar year.
3 D. Lilly shall disclose to the Promotional Speaker or Consultant that the information
4 in Section IV. C. above may be disclosed.
5 V. Product Samples
6 A. The following subsections shall be effective for six years from the Effective Date
7 of this Judgment.
8 B. Lilly Sales representatives may only sample Zyprexa ® to a HCP whose clinical
9 practice is consistent with the product's current Labeling. Currently, Lilly samples Zyprexa ® to
10 the following practices: emergency medicine, family practice, general practice, internal
11
12
13
medicine, and psychiatry.
C. If a HCP whose clinical practice is inconsistent with the product's Labeling
requests samples, Lilly personnel shall refer the practitioner to I- 800- LillyRx where the I
14 practitioner can speak directly with a Lilly representative who will provide answers to their
15 questions about Zyprexa ® and may provide them with samples if appropriate ( i. e., if the
16 physician requests the sample for an on- label use).
17 VI. Clinical Research
18 A. Lilly shall report research regarding Zyprexa ® In an accurate, objective and
19 balanced manner as follows or as required by applicable law:
20 1. To the extent permitted by the National Library of Medicine and as required by the
21 FDA Amendments Act ( Public Law No. 110- 85), Lilly shall register clinical trials and submit ·
22 results to the registry and results data bank regarding Zyprexa ® as required by the FDA
23 Amendments Act and any accompanying regulations that may be promulgated pursuant to that
24 Act. With respect to Zyprexa ® , Lilly will register on a publicly accessible website the initiation
25 of all Lilly- sponsored Phase II, III, and IV clinical trials beginning after July 1, 2005 and will
26 I post results on a publicly accessible website of all Lilly- sponsored Phase II, III and IV clinical
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. . .
1 trials that were completed after July 1,2004.
2 B. When presenting information about a clinical study regarding Zyprexa ® in all
3 Promotional Materials, Lilly shall not do any of the following in a manner that causes the
4 Promotional Materials to be false or misleading:
5 1. present favorable information or conclusions from a study that is inadequate in
6 design, scope, or conduct to furnish significant support for such information or conclusions;
7 2. use the concept of statistical significance to support a claim that has not been
8 demonstrated to have clinical significance or validity, or fails to reveal the range of variations
9 around the quoted average results;
10 3. use statistical analyses and techniques on a retrospective basis to discover and cite
11 findings not soundly supported by the study, or to suggest scientific validity and rigor for data
12 from studies the design or protocol of which are not amenable to formal statistical evaluations;
13 4. present the information in a way that implies that the study represents larger or
14 more general experience with the drug than it actually does; or
15 5. use statistics on numbers of patients, or counts of favorable results or side effects,
16 derived from pooling data from various insignificant or dissimilar studies in a way that suggests
17 either that such statistics are valid if they are not or that they are derived from large or
18 significant studies supporting favorable conclusions when such is not the case.
19 VII. Terms Relating to Payment
20 A. No later than 30 days after the Effective Date of this Judgment, Lilly shall pay $ 62
21 Imillion . to be divided and paid by Lilly directly to each Signatory Attorney.. General <? f the
22 I Multistate Working Group in an amount to be designated by and in the sole discretion of the
23 Multistate Executive Committee. Said payment shall be used by the States as and for attorneys'
24 fees and other costs of investigation and litigation, or to be placed in, or applied to, the consumer
25 protection enforcement fund. including future consumer protection enforcement, consumer
26 education, litigation or local consumer aid fund or revolving fund, used to defray the costs of the
' I
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inquiry leading hereto, and may be used to fund or assist in funding programs directed at mental
illness treatment, including but not limited to education and outreach or for other uses permitted
by state law, at the sole discretion of each Signatory Attorney General. The Parties acknowledge
that the payment described herein is not a fine or penalty, or payment in lieu thereof.
VIII. Conflicts
1
2
3
4
5
6 A. If subsequent to the Effective Date of this Judgment, the federal government or
7 any state, or any federal or state agency, enacts or promulgates legislation or regulations with
8 respect to matters governed by this Judgment that creates a conflict with any provision of the
9 Judgment and Eli Lilly intends to comply with the newly enacted legislation or regulation, Eli
10 Lilly shall notifY the Attorneys General ( or the Attorney General of the affected state} of the
II same. Ifthe Attorney General agrees, he/ she shall consent to a modification of such provision of
12 the Judgment to the extent necessary to eliminate such conflict. If the Attorney General
13 disagrees and the Parties are not able to resolve the disagreement, Eli Lilly shall · seek a
14 modification from an appropriate court of any provision of this Judgment that presents a conflict
15 with any such federal or state law or regulation. Changes in federal or state laws or regulations
16 with respect to the matters governed by this Judgment, shall not be deemed to create a coriflict
17 with a provision of this Judgment unless Eli Lilly cannot reasonably comply with both such law
18 or regulation and the applicable provision ofthis Judgment.
19 B. If, subsequent to the Effective Date ofthis Judgment, the laws or regulations of the
20 United States, or the draft or final FDA Guidances for Industry, are changed so as to expressly
21 authorize conduct that is expressly prohibited by this Judgment, then such, ~. onduct shall not
22 constitute a violation of this Judgment. Provided however, if Lilly intends to engage in the
23 expressly authorized conduct, Lilly shall notify the Attorneys General ( or the Attorney General
24 Iof the affected state) within 30 business days prior to any change.
25 .. IX. Release
26 A. By its execution of this Judgment, State of Arizona releases and forever
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1 discharges, to the fullest extent permitted by law, Eli Lilly and all of its past and present
2 subsidiaries, divisions, affiliates, co- promoters, controlled joint ventures, predecessors,
3 successors, and assigns and each and all of their current and former officers, directors,
4 shareholders, employees, agents, contractors, and attorneys ( collectively, the " Released Parties")
5 of and from the following: all civil claims, causes of action, damages, restitution, fines, costs,
6 attorneys fees, and penalties that the Arizona Attorney General could have asserted against the
7 Released Parties under the Arizona Consumer Fraud Act, A. R. S. § 44- 1521, et seq., successor
8 statutes, or common law claims concerning unfair, deceptive or fraudulent trade practices
9 impacting consumers related to any conduct that has occurred at any time up to and including
10 the Effective Date of this Judgment arising from the Covered Conduct that is the subjece of this
11 Judgment ( collectively, the " Released Claims").
12 B. Notwithstanding any term of this Judgment, specitically reserved and excluded
13 from the Released Claims as to any entity or person, including Released Parties, are any and all
I
14 ofthe following:
15 1. Any criminal liability that any person or entity, including Released Parties~ has or
16 may have to the State ofArizona;
17 2. Any civil or administrative liability that any person or entity, including Released
18 Parties, has or may have to the State of Arizona that is not expressly covered by the release in
19 I Section IX. A. above, including but not limited to any and all of the following claims:
" wholesale acquisition cost;"
violations, Medicaid fraud or abuse, Medicaid- related common law claims; andior
kickback violations related to any State's Medicaid program;
20
21
22
23
24
2S
26
a.
b.
c.
d.
State or federal antitrust violations;
Reporting practices, including " best price," " average wholesale price," or
Medicaid violations, including federal Medicaid drug rebate statute
State false claims violations~
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. .
Law which the Released Parties have or may have. to individuai consumers.
Cure Provision
The Parties agree that a State will provide Lilly with written notice if it believes
e. actions of state program payors arising from the purchase of Zyprexa ® ,
except for the release of civil penalties under the state consumer protection laws;
and
.' I.
I
2
3
4
5
6 X.
7 A.
f. Any liability under the State of Arizona's above- cited Consumer Protection
8 that Lilly is in violation of any of its obligations under the Judgment (" Notice"). Lilly shall have
9 30 business days after the date of receipt of the Notice to demonstrate to the State's satisfaction
10 that:
11 I 1. Lilly is in compliance with the obligations of the Judgment cited by that State as
12 . being violated;
13 2. the violation has been cured, including, but not limited to. by remedial actions I
14 having been taken against an employee for actions incunsistent with this Judgment; or
15 3. the alleged violation cannot be cured within the 30 business day period,. but that:
16 ( a) Lilly has begun to take action to cure the violation; ( b) Lilly is pursuing such action with due
17 diligence; and ( c) Lilly has provided a reasonable timetable for curing the violation.
18 B. Except as set forth in Section X. D. below, the State may not take any action during
19 the 30 business day cure period. Nothing shall prevent the State from agreeing in writing to
20 provide Eli Lilly with additional time beyond the 30 business days to responc, I to the notice.
21 C.
22 before a court pursuant to Section VIll. A, except as provided for in Section D below..
23 D. Nothing prohibits a State from taking actions necessary to protect public health
24 and safety as provided by applicable law.
25 XI. General Provisions
26 A.
,
All Notices under this J~ dgment shall be provided to Nina Gussack, Paul Kalb,
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· .
General Counsel
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285
and the General Counsel ofEli Lilly and Company by Overnight Mail at:
Nina Gussack
Pepper Hamilton
3000 Two Logan Square
Ei~ hteenth and Arch Streets
Philadelphia, PA 19103- 2799
Paul E. Kalb
" Sidley Austin LLP
1501 K Street, NW
Washington, DC 20005
2
3
4
5
6
7
8
9
10
11 B. This Judgment represents the full and complete terms of the settlement entered
12 into by the Parties hereto. In any action undertaken by the Parties, no prior versions of thisI I
13 I Judgment, no prior versions of any of its terms, that were not entered by the Court in this 1
14 Judgment, may be introduced for any purpose whatsoever.
15 C. This Court retains jurisdiction of this Judgment and the Parties hereto for the
16 purpose of enforcing and modifying this Judgment and for the purpose. of granting such
17 additional relief as may be necessary and appropriate.
18 D. This Judgment may be executed in counterparts, and a facsimile or . pdf signature
IIII
.- j
i
I
,
Hon. Jeanne Garcia
,2008.
26
24 I
25 I
TUC- CLU · 2008- 001S / 295126
19 shall be deemed to be, and shall have the same force and effect as, an original signature.
20
21.11 DATEDthis '}! D dayOf~
22 I
23
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"
CONSENT TO JUDGMENT
2 1. Eli Lilly and Company, an Indiana corporation, states that no promise of any kind
3 or nature whatsoever was made to it to induce it to enter into this Consent Judgment and that it
4 has entered into the Consent Judgment voluntarily.
5 2. Eli Lilly and Company has fully read and understood this Consent Judgment,
6 understands the legal consequences involved in signing it, asserts that this is the entire
7 agreement of the parties, and that there are no other representations or agreements not stated in
8 writing herein, and no force, threats, or coercion of any kind have been used to obtain its
9 signature.
10 3. Eli Lilly and Company acknowledges that Plaintiffs, State of Arizona's,
I 1 acceptance of this Consent Judgment is solely for the purpose of settling this litigation and does
12 not preclude the Plaintiff, or any other agency or officer of this State, or subdivision thereof,
13 from instituting other civil or criminal proceedings not released herein as may be appropriate
14 now or in the future.
15 4. Eli Lilly and Company represents and warrants that the person signing below on
..., ........... nichael J. Harrington
Its: Deputy General Counsel
16 its behalf is duly appointed and authorized to do so.
17 DATED this -/ J!- day of October, 2008.
18 ELI LILLY AND COMPANY
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FOR ELI LILLY:
Date: ~~ hLv ' 1-, ' lotfb
Counsel for Eli Lilly and Company
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3 Approved as to form:
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5 By:
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· ,-
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1 FOR THE STATE:
2
TERRY GODDARD
3 Attorney General
4
5
6 By: Co ' l- ft-- IJ...:-. Date: OciIrtJr 7r ~ ()){ f
Dena Rosen E stein, Unit Chief Counsel
Noreen R. Matts, Unit Chief Counsel
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Arizona State Agency Publications
