Medical Marijuana - DQA Complaint(1)

8/14/2019 Medical Marijuana - DQA Complaint(1)

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JOSEPH D. ELFORD (S.B. N O . 189934)AMERICANS FOF SAFE ACC ESS1322 Webster St., Suite 402Oakland, CA 946 12Telephone: (4 15) 573-7842Fax: (5 10) 25 1-2036

ALAN B. MORRISON559 Nathan Abbott W ayStanford CA 943 05Telephone: (650) 725 9 648Fax: (650) 725 02539 / 1 [email protected] 1 (application to appear pro ha c vice pending)

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Counsel for PlaintiffAMERICANS FOR SAFE ACCE SS

IN THE UNITED STATES DISTRICT COURT1 1 FOR THE NOR THERN DISTRICT OF CALIFORNIAl 5

AWIERICAIVS FOR SA FE AC CE SS , No.

v.Plaintiff, )

11COM PLAINT FOR DECLARATORYRELIEF AhTD PERMANENTINJUNCTION

DEPARTMENT OF HEALTH ANDHUMAN SERVICES and FOO D AN D )DRUG ADM INISTRATION,Defendants.

I. INTRODUCTION1. Despite numer ous peer-reviewed scientific studies establishing that marijuana is

Americans for SafeAccess v. Department of Health and H uman Services,Complaint
mailto:[email protected]:[email protected]


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1 of Health and Huinan Services ("HHS") continues to tell the public that marijuana "has no1 currently accepted med ical use in treatment in the United States." This action is filed under the3 Data Quality Act, 44 U.S.C . 5 3516, Statutory and Historical Notes, P .L. 106-554 ("Data Quality4

Act" or "DQA"), and the Admin istrative Procedure Act ("APA"), 5 U.S .C . 5 701 et se q., to56 correct this false and misleading statement, as the Data Quality Act requires.

2. In 2001, Cong ress recognized a problem with the quality and integrity of1 18 information disseminated by federal agencies, which prompted it to enact legislation to ensure9 the "quality, objectivity, utility, and integrity of information" disseminated by federal agencies.10

11 1 1 44 U.S .C . 5 35 16, Statutory an d H istorical Notes, P.L . 106-554, Sec. 1 a)(3). Pursuant to thisI1Act, HHS has an obligation to consider requests from the public to correct erroneous statementsl 2l 3 that it has disseminated. Here, more than two years ago, plaintiff Americans for Safe Accessl 4 ("ASA") made such a request of HHS with respect to particular claims that marijuana lias no15

medical use. In suppo rt of its request, ASA supplied citations to numerous scientific studies

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confirming the medical efficacy of m arijuana, including a report from the prestigious N ational l 7 Institute of Med icine ("IOM") that was com missioned by the White House's Office of NationalI

Drug Control Policy ("ON DCP").20 3. HH S responded by eng aging in inexcusable delay and, ultimately, issuing a2 1

nonsubstantive rejection of ASA 's request. Left with no other administrative recourse, ASA2223 filed the instant suit challenging H HS ' arbitrary and unlawful behavior, since the federal24 gov erim ent's false statements deter sick and dying persons fiom seeking to obtain medicine that25 could provide them needed, and often life-saving, relief. When it comes to medical marijuana,26 HHS has failed in its avowed mission of "protecting the health of all Americans and p roviding27

essential human services, especially for those w ho are least able to help themselves."28

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2 4. Plaintiff ASA bring s this action on behalf of itself and its mem bers to redress the3 deprivation of rights secured to them under the APA , the Data Quality Act, and H HS' Guidelines4

implementing the DQA, 67 Fed.Reg. 61343 (Sept. 30,2002).55 . This Court has jurisdiction over this matter pursuant to 28 U.S .C. 55 133 1 and

8 6. Venue is proper in this judicial district under 28 U.S.C . 5 1391(e) and L ocal Rule9 3-5(b) because plaintiff ASA maintains its headquarters in Oakland, California, which is in this10

I judicial district, and a substantial portion o f the events giving rise to the comp laint occurred inIl 12 ( I this judicial district.13 111. TH E PAR TIES14 7. Plaintiff AM ER ICA NS FO R SA FE ACC ESS ("ASA") is a non-profit corporation15

headquartered in Oakland, California that has as its primary purpose working to expand and16

I protect the rights of patients to use marijuana for medical purposes, including providing outreachl 7 I and education to the public regardin g the use of marijuana for medical purposes. AS A's19 members and con stituents include seriously ill persons who would have benefited from the use of20 marijuana for medical purposes, but w ho w ere deterred from using m arijuana to ease their2 1 I1 suffering, in part, by H HS ' statem ent that marijuana "has no currently accepted m edical use in 22 treatment in the United S tates." AS A has dev oted significant resources to com bat this false23 1 14 statement, including the expend iture of more than one hundred thousand dollars and hundreds of25 hours of staff time producing and disseminating educational materials explaining that scientific26 studies demonstrate that marijuana is effective in treating symptoms associated with cancer,27

HIVIAIDS, multiple sclerosis, arthritis, gastrointestinal disorders, and chron ic pain. HHS '28

Anaericans for Safe Acces s v.Department of Health and Human Services,Complaint


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* 1 ) use in treatment in the Un ited States adversely affects the membership and constituency of ASA3 and causes ASA to suffer injury to its ability to carry ou t its mission , as well as causing AS A to4

1 1 suffer economic loss in staff pay, funds expended to produce educational materials, and in the1I1( inability to undertake other efforts to improve the access of seriously ill persons to medicalmarijuana.8. Despite HHS' dissemination of false and misleading information about the

effectiveness of marijuana in relieving the pain o f victims of certain diseases, four A SAmembers obtained the correct information and it dramatically improved their lives.

a. For instance, ASA 's Executive Director, Steph Sherer, suffers from a" I condition known as torticollis, w hich causes her to experience inflammation, mu scle spasms,

pain throughout her body, and decreased mobility in her neck. Until Novem ber of 2001 , Ms.Sherer did not believe that marijuana had m edical use, due to statements that it did not on federal

/ II1websites; however, after Ms. Sherer suffered kidney dam age from the large am ounts of

l 7 conventional pain killers she was taking, her physician recomm ended that she try marijuana.l 8

Ms . Sherer heeded her physician's advice and has successfully used marijuana since Novem berof 2001 to reduce her inflammation, muscle spasms, and pain. Ms. Sherer founded AS A to sharemedical information with others in April of 2002.

b. Victoria Lansford ("Lansford") is also an ASA constituen t and memb erwho resides in Blackfoot, Idaho. Ms. Lansford suffers from fibromyalgia, which causes her to1 suffer severe chronic pain and mu scle spasms. Until 2002, Lansford used a regimen o f pain

I 1 medications, including a morphine patch and Oxycon tin, because she did not believe m arijuana27 had medical use, due in part to HH S' statements. In 2002, on the recommendation of her sister,Americans for Safe Access v. Department ofH ealth and Human Services,Complaint


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1 Lansford started using medical m arijuana to treat her chronic pain and muscle spasms. This use2 of marijuana has significantly improved Ms. L ansford7shealth and she has been able to stop3 using the highly addictive O xyco ntin.4

c. Jacqueline Patterson is an ASA member and constituent who resides in 56 Marin, California. Patterso n has cerebral palsy, which among its other symptom s impairs1 1 Patterson's speech and causes her to suffer muscle spasticity and pain. Until June of 2001, Ms.8 Patterson did not believe that marijuana was medicine because of the federal government's9 statements that it was not, but he r husband eventually convinced her to try it. Since beginning to10

l l use medical marijuana, M s. Patterso n has significantly improved he r ability to speak and rarelyl 1 I1 suffers the serious muscle spa sm s she experienced in her right arm .l 2 1 1 d. Shane K intvel is an ASA mem ber and constituent who experiencesl 3l 4 (chronicpain and muscle spasm s as a result of a serious back injury. Until 2002, Mr. Kintvel 15

used conventional prescription pai n medications, including morphine, to treat his chronic pain.16

I1He w as led to believe that marijuana would no t be effective for this purpose from information he

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1I1 received from his doctors and h is review of federal governm ent websites. In approximately July I S l V of 2002, however, Mr. Kintvel began using marijuana in place of prescription medications. 20 1 Acco rding to the progress m easured by Dr. Michael McMillan, Mr. K intvel's current treating 21 ~I physician, Kintvel is now com pletely m obile, has discontinued his use of morphine, and has lost22

111more than fifty pounds that he had gained from taking large amo unts of morphine and being

23 24 unable to exercise.

9. Defendant DEPA RTM ENT OF HEALTH AN D HUM AN SERV ICES ("HHS")

I126 is an administrative a gency o f the federal government with its headquarters in Washington, D.C. 27 HH S claims on its website that it is the "governm ent's principal agency for protecting the health 28Americans for Safe Access v. Departm ent of Health and Human Services,Complaint! I


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I1 of all Americans and providing essential human services, especially for those who are least ableto help themselves." See http://www.hhs.govl. In April of 2000, in response to a request to

3 I / reclassify marijuana, HHS stated its finding that marijuana "has no currently accepted medical4

use in treatment in the United States." Fe de ral Register, 66 Fed.Reg. 2003 8, 20039 (April 18,5

1I11 2001). HHS continues to disseminate this and related statements in its publications and on government web sites See h t t p : / / w . a c c e s ~ . g p ~ . g o v / s u docs/fedreg/aO 104 18c html;8 http://www.deadiversion.usdoj.gov/fed-regs/notices/200 1lfr04181fr04 18a.htm. 9 10. Defendant FOO D AN D DR UG ADM INISTRAT ION ("FDA") is a federal 10

I1agency within the Department o f Health and Huma n Services. FDA claims as its mission that itl 1 1 I is "responsible for advancing th e public health by helping to speed innovations that make l 2l 3 medicines and foods more effective, safer, and more affordable; and helping the public get the14 accurate, science-based information they need to use medicines and foo ds to improv e their 15

health." See http/lwww.fda.gov/opacom/morechoices/mission.html.he FDA was assigned the16

' Itask of evaluating marijuana for medical use by HHS and, in 2001, concluded that m arijuana did

l 718 ( 1 not have any medical use. HH S' statements to this effect are predicated o n the FDA 's findings.19 IV. THE DATA QUALITY ACT AND HHS' IMPLEMENTING GUIDELINES20 11 . Passed in 2001 as an amendm ent to the Paperwork Reduction A ct, 44 U.S.C 52 1 ' I 3502(1), the Data Quality Act ("DQA") requ ires administrative agencies to develo p guidelines to22 l i ensure the "quality, objectivity, utility, and integrity of information" they disseminate to the2324 / I American public. In furtherance of this goal, the DQA requires all federal ag encies to1 ) bb[e]stablishdrninistrative mechanism s allow ing affected persons to seek and obtain correction

of information maintained and disseminated by the agency that does not comp ly with the27 I 'I ' guidelines." 44 U.S.C. 5 35 16, Statutory an d H istorical N otes.28Anzericans for Safe A ccess v. Depar tment o f Heal th a nd Hu man Serv ices ,ComplaintI I
http://www.hhs.govl/http://www.deadiversion.usdoj/http://www.deadiversion.usdoj/http://www.hhs.govl/


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I t 12 . In coinpliance with the DQ A m andate, HHS prom ulgated G uidelines for seeking I 1 and obtaining corrections o f information it disseminates. The HHS Guidelines are codified at 673 Fed.Reg. 61343 (Sept. 30 ,20 02 ) and can also be found at4

http://www.hhs.gov/infoquality/partl .htm l. Similar Guidelines, which are also applicable to 5

I 1 HHS , have been prom ulgated by the Office of Budget and Management ("OMB") and are1 codified at 67 Fed.Reg . 8452 (F eb. 22, 2002).8 13. The HH S Guidelines recognize that "' [qluality' is an encom passing term9 comprising utility, objectivity, an d integrity." HH S Guideline D.2.a. The G uidelines define the

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I ! erm "utility" as referring to th e "usefulness of the information to its intended users, including l 2 1I1the public. . . ." HH S Gu ideline D.2.b. "Objectivity" requires that "disseminated informationl 3 [be] presented in an accurate, clear, complete, and unbiased manner." HHS Guideline D.2.c.l 4 The G uidelines further recogniz e that agencies responsible for dissemination of "vital health and115

medical information" have additional responsibilities to "ensur[e] the timely flow of vital16

I1information from agencies to m edical providers, patients, health agencies, and the public." HH S

l 718 / I Guideline D.2.c.2.19 14. To allow pub lic participation in ensuring these goals, the HHS Guidelines provide20 for both an initial petition to correct erroneous information that HHS has disseminated and an2 1 I1 administrative appeal (or "Information Quality Appeal"). With regard to an initial petition, the 22 Guidelines state that "[tlhe agenc y will respond to all requests for correction within 60 calendar23 I 24 days of rece ipt If the request requ ires more than 60 calendar days to resolve, the agency will 25 inform the complainant that m ore tim e is required and indicate the reason w hy and an estimated

I I decision date." HHS G uideline E. If the initial petition is denied by HHS, the HHS Guidelines27 provide for an adm inistrative appeal, and the "agency will respond to all requests for appeals 28Americans for Safe Access v. Department of Health and Human Services,ComplaintI I
http://www.hhs.gov/infoquality/partlhttp://www.hhs.gov/infoquality/partl


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1 within 60 calendar days of receipt. If the request requires more than 60 calendar days to resolve,2 the agency will inform the comp lainant that m ore time is required and indicate the reason why3 and an estimated decision date." HHS G uideline E.4

V. FACTS5 15. On October 4, 20 04 , ASA filed with HHS a "Request for Correction of1 ) Information Disseminated by H HS Regarding th e Medical Use of Marijuana" (hereinafter

8 "petition"). Copies of the petition, the initial agency response, AS A's appeal, the final agency9 response to the appeal, and all agency interim responses can be accessed atI0

I1 http://aspe.hhs.govlinfoquality/requests.shtml, item 20.I 16 . AS A's petition alleges that HHS has disseminated to the public, and is continuingl 2 1Il 3 to disseminate to the public, the statement that marijuana "has no currently accepted medical use14 in treatment in the United States." The petition alleges that this HHS statem ent, and the findings15

underlying it, are inaccurate, in violation o f the DQA and the OM B and HH S DQ A G uidelines.I617 ' The ASA petition alleges with specificity why the HH S information dissemination is inaccurate,

I 'I1 and requests specific corrections. In particular, the ASA petition alleges that numerous peer-19 reviewed studies, including the 1999 Institute of Medicine ("IOM") study comm issioned by the20 OND CP establish that marijuana is accepted in the U nited States as effective in treating various2 1

' I 17 . On Decem ber 1 , 2004, H HS sent ASA an interim response to its October 4,2 00 4,24 petition. The interim response stated that H HS had not yet completed its review of the ASA1 25 petition, due to other agency priorities and the need to coordinate agency review. HHS26 contended that it needed to co nsult with th e Drug Enforcement Ad ministration ("DEA"), which17

Americans for SafeAccess v. Department of Health and Human Services,ComplaintI I
http://aspe.hhs.govlinfoquality/requests.shtmlhttp://aspe.hhs.govlinfoquality/requests.shtml


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I was considering a petition to resched ule ma rijuana, to prepare a response, an d that it hoped to( 1 provide a response within the next 60 days. 18 . By letter dated Decem ber 20, 2004, ASA protested that HH S, by consulting with

4 DEA, was inexcusably exp anding its review to include considerations outside the scope of5 I1 ASA 's petition and that such expansion would unduly delay an administrative response to the1 requested correction of information.

19. Nevertheless, H H S provided a series of interim responses over the next severalmonths stating that it needed add itional time to coordin ate agency review. O n April 20, 2005,

I HHS denied AS A's petition withou t presenting any evidence that its statements about the lack ofl 1 I t medical efficacy of marijuana are justified. HHS mad e no mention of its DQA Guidelinel 2 1 ( D.2.c.2, which requires it to ensure the "timely f low o f vital information from agencies to' ) ( medical providers, patients, health agencies, and the public."

20. On May 19, 2005, ASA filed an appeal of the HH S rejection of its October 4,

I1 2004, petition, pursuant to the HH S Guidelines. Se e HHS Guideline E. I - i i 21. AS A's May 19 ,20 05 , appeal protested that: (a) HHS was evading its data qualityl 8responsibilities and delaying a response in contravention of its Guidelines, especially by

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referring the issues raised by the A SA Petition to a proceeding outside HHS ; (b) the issues raisedby ASA's request for correction under the Data Quality Act are different and m ore limited thanthose raised in the DE A res chedu ling proceeding, s o merging the proceedings w ould not allow

24 the consideration of data quality issues "on a timely basis," as required by the H HS Guidelines,

I1and (c) HHS had ign ored its Gu idelines stating that data quality complaints mus t be acted upon

26 in a timely fashion where there i s a reasonable likelihood that persons were suffering actual harm27 from the inaccurate information being disseminated by the agency. ASA alleged that "seriously

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24 . Furthermore, as a direct and proximate result of defendants' actions, AS A and its1 mem bers and constituents -- which include seriously ill persons who wo uld have b enefited, or3 might benefit from the use of marijuana for m edical purposes, but w hose use o f marijuana for4

health reasons has been impeded by H HS ' flawed statement that marijuana d oes not have5

' I medical use -- have been irreparably harmed .1 25. if not enjoined by this Court, defendants will continue to dissem inate 8 scientifically flawed statements that m arijuana "has no currently accepted medical u se in9 treatment in the United States," in derogation of the rights of AS A, its con stituents, and other10

i i similarly situated persons, and it will refuse to correct this false and misleading information.I VII. CAUSE OF ACTION l 2 26 . HH S' denial of dm petition and appeal of ASA under the D QA constitutes finall 3 1l 4 agency action that is arbitrary, capricious, an abuse of discretion, not in accordance w ith law, and1 5

in excess of statutory authority and limitations within the m eaning of the APA (5 U.S.C.16

I1 VIII. REL IEF SOUGH T1 ) WH EREF ORE , ASA , on behalf of itself, its constituents, and o thers similarly situated,l 920 seeks the following relief:2 1

1. A declaration that the HH S' denial of ASA 's petition an d admin istrative appeal is23 1 I arbitrary and capricious, an abuse o f discretion, and not in accordance with law under the APA ;

2. A permanent injunction:enjoining d efendants from continuing to dissem inate statements thatmarijuana "has no currently accepted medical u se in treatment in theUnited States;" and

Americans for Safe Access v. Department of Health and Hunzan Services,ComplaintI I


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b. requiring HH S to mak e ap propriate corrections to all statements that it hasdisseminated that marijuana "has no currently accepted m edical use intreatment in the United States;"

3. Costs and attorneys fees incurred in this action; and4. Such other and further relief as may be just and proper.

DATED: February 2 1,2 00 7 Respectfully Submitted,

Attorney fo r PlaintiffAMERICANS FOR SAFE ACCESS

mericansfor Safe Access v. Department ofHealtlz an d Human Services,omplaint


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I CERTIFICATION OF INTERESTED ENTITIES OR PERSONS2 Pursuant to Civil L.R . 3- 16, the undersigned certifies that as of this date, other tha n -the3 named parties, there is 110 such interest to report.4 5 6 DATED: February 2 1, 20 07 Respectfully S ubm itted, 7 8

9 ~ t t o b e ~or Plaintiff10 AMERICANS FOR SAFE ACCESS

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Medical Marijuana - DQA Complaint(1)

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