UNITED STATES DISTRICT COURT EASTERN DISTRICT OF WISCONSIN UNITED STATES OF AMERICA, and THE STATE OF WISCONSIN, ex rel. DR. TOBY TYLER WATSON, Plaintiffs, v. Case No. 11-CV-236 JENNIFER KING VASSEL, Defendant. AFFIDAVIT OF BRADLEY S. FOLEY IN SUPPORT OF DEFENDANT JENNIFER KING VASSEL’S MOTION IN LIMINE THAT THE PRESCRIPTION OF OFF-LABEL USE OF FDA APPROVED PRESCRIPTION MEDICATION WAS MEDICAID FRAUD STATE OF WISCONSIN ) ) ss. COUNTY OF MILWAUKEE ) BRADLEY S. FOLEY, being duly sworn under oath, deposes and states as follows: 1. I am one of the attorneys representing defendant Jennifer King Vassel in the above- referenced action and am authorized to make this affidavit on her behalf. 2. Attached as Exhibit A is a true and accurate copy of H. Rep. No. 881, 101st Congress, 2d Session at 98, reprinted in U.S. Congress and Administrative News, p. 2110. 3. Attached as Exhibit B is a true and accurate copy of the United States Pharmacopeia- Drug Information 2005, “Description and Limitations of Information Included,” located on page two. 4. Attached as Exhibit C is a true and accurate copy of a November 8, 2013 emails between an assistant United States Attorney and the plaintiff’s attorney. 5. Attached as Exhibit D is a true and accurate copy of United States Pharmacopeia- Case 2:11-cv-00236-JPS Filed 11/25/13 Page 1 of 2 Document 160
Transcript
UNITED STATES DISTRICT COURTEASTERN DISTRICT OF WISCONSIN
UNITED STATES OF AMERICA, and THE STATE OF WISCONSIN, ex rel. DR. TOBY TYLER WATSON,
Plaintiffs, v. Case No. 11-CV-236
JENNIFER KING VASSEL,
Defendant.
AFFIDAVIT OF BRADLEY S. FOLEY IN SUPPORT OF DEFENDANT JENNIFERKING VASSEL’S MOTION IN LIMINE THAT THE PRESCRIPTION OF OFF-LABELUSE OF FDA APPROVED PRESCRIPTION MEDICATION WAS MEDICAID FRAUD
STATE OF WISCONSIN )) ss.
COUNTY OF MILWAUKEE )
BRADLEY S. FOLEY, being duly sworn under oath, deposes and states as follows:
1. I am one of the attorneys representing defendant Jennifer King Vassel in the above-
referenced action and am authorized to make this affidavit on her behalf.
2. Attached as Exhibit A is a true and accurate copy of H. Rep. No. 881, 101st
Congress, 2d Session at 98, reprinted in U.S. Congress and Administrative News, p. 2110.
3. Attached as Exhibit B is a true and accurate copy of the United States Pharmacopeia-
Drug Information 2005, “Description and Limitations of Information Included,” located on page two.
4. Attached as Exhibit C is a true and accurate copy of a November 8, 2013 emails
between an assistant United States Attorney and the plaintiff’s attorney.
5. Attached as Exhibit D is a true and accurate copy of United States Pharmacopeia-
Case 2:11-cv-00236-JPS Filed 11/25/13 Page 1 of 2 Document 160
Drug Information 1997, Volume II, Advice for the Patient, Notice Section.
6. Attached as Exhibit E is a true and accurate copy of the Drugdex Warranty and
Disclaimer.
s/Bradley S. Foley Bradley S. Foley
Subscribed and sworn to before methis 25th day of November, 2013.
s/Carrie Wentland Notary Public, State of WisconsinMy Commission expires: 1/19/14
2
Case 2:11-cv-00236-JPS Filed 11/25/13 Page 2 of 2 Document 160
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USP Dl comprises three distinct volumes. The first volume, Drug
lnformat¡on for the Health Care Professional includes the drug
information monographs arranged in alphabetical order. The Volume I
general index includes established names, cross-references by brand
namps (both U.S. and Canadian), and older nonproprietary names' ln
addit¡on, an indications index, off-label use indices and appendices
presenting categor¡es of use and other useful information are included'
The. second volume, Advice for the Patient@, includes the lay language
versions of the pat¡ent consultation guidelines found in Volume l These
lay language versions are intended to be used at the discretion of the
health care provider as an aid to patient consultation if written information
would be of benefit or if ¡t is requested by the prescriber' Brand and
generic names are cross-referenced in the index of Advice for the Patient'
The third volume, Approved Drug Products and Legal Requ¡rements is
owned and published by USP and Thomson MICROMEDEX is a distribu-
tor of that volume. lt reproduces information from the Food and Drug
Administration on therapeutic equivalence and other requirements relat-
ing to drug product selection.The third volume includes USP and NF legal
requirements for labeling, slorage, packaging, and quality for drugs lt also
Case 2:11-cv-00236-JPS Filed 11/25/13 Page 2 of 3 Document 160-2
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Precautions to ConsiderCross-sensitivity and/or related problemsCarcinogenicityTumorigenicityMutagenicityPregnancy/Reproduction
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Breast-feedingPed¡atricsAdolescentsGeriatricsPharmacogeneticsDentalSurgicalCritical/Emergency careDrug interactions and/or related problemsLaboratory value alterations
With d¡agnostic test resultsWilh physiology/laboratory test values
Medical considerations/Contraind¡cationsPat¡ent monitoring
Side/Adverse EffectsThosê indicating need for medical attentionThose indicating need for medical attent¡on only if they continue or
are bothersomeThose not indicating need for medical attent¡onThose indicating need for medical attention if they occur after
medication is discontinued
OverdoseClinical effects of overdoseTreatment of overdose
Patient Consultat¡onBefore using this medicationProper use of this medicationPrecautions while using this medicationS¡de/adverse effects
General Dosing lnformationDiet/NutritionB¡oequivalence informationSafety considerations for handling this medicationFor treatment of adverse effects
Dosage forms (each separate)Usual adult doseUsual adult prescribing limitsUsual pediatric doseUsual pediatric prescribing limitsUsual geriatric doseStrengths usually availablePackaging and storagePreparation of dosage formStabititylncompatibil¡ties
Aux¡liary labelingCautionAdditional information
Selected Bibliography
Description and L¡mitations of lnformation lncluded
USP Dl conlains selected information and takes into account practiceconcerns. lt ¡s meant to aid the health care professional and the patient inminimizing the risks and enhancing the benefits of the drugs used.Collectively, the USP D/ is valuable when assessing quality of care.Ultimately, the informat¡on required is defined by the practice standards ofmedicine, pharmacy, nursing, dentistry, and the other health professionsas well as by the information needs of the patient.
USP Dl is not intended to be "full disclosure,' information.Readers are advised that the information in USp D/ may contain state-
ments that differ from those in the 'full disclosure" information labelingapproved or required by the United States or Canadian governments.Readers should also remember that FDA-approved full disclosure infor-mation can differ from brand to brand of the same generic drug product.It should not be inferred that the inclusion of information that is not in theapproved labeling has been sought or agreed to by the manufacturer.
Selected brand names are incl well as inthe indexes of both Volumes I and oses only.The inclusion of a brand name is ment of apârticular product. The ômission of a pârticular brand name does not indi_cate that the agent was judged to be inferior or inadequate. The inclusionof various brands in Volumes I and ll bears no relationship to, and is notintended to affect, any applicable brand interchange requirements.
ion codes (primaryning of each mono-
iJi,lflä'1, í,'#"iWhere appropriate, controlled substance classifications are ¡ncluded at
the beginning of the monograph. United States schedules include:
Schedule l-No legal medical use is recognized by the U.S. ControlledSubstances Act. Use of Schedule I substances for research pur-poses is permitted with proper registration. Schedule I substancesare not included in USp DI.Examples: Heroin, LSD, peyote.
quantities of these drugs are authorized but the prescriber mustprovide a written, signed prescription order to the pharmacy with-in 72 hours.Examples: Amphetamines, anabolic steroids, meperidine, mor-phine, short-acting barbiturates
Schedule lll-lncludes drugs hav¡ng.significant abuse potential, but to alesser degree than Schedule ll substances. prescriptions can berefilled up to five times within six months after the dâte of issue ifauthorized by the presc are permitted.Examples: Certain barbit chedule ll, opi-ates in combination with as acetamino_phen or aspirin.
Schedule lV-lncludes drugs having a low abuse potential.Prescriptions can be refilled up to five times within six monthsafter the date of issue if authorized by the prescriber. Telephoneorders are permitted.Examples: Benzodiazepines, certain long-acting barbiturates,chloral hydrate, pentazocine, propoxyphene.
Schedule V- lncludes products having the lowest abuse potential of thecontrolled substances. No limitations on refills other than those
fi
VICase 2:11-cv-00236-JPS Filed 11/25/13 Page 3 of 3 Document 160-2
Jim GottsteinBrad Foley; Mark Larson; 'Thomas L. Storm';[email protected]; 'Rebecca Gietman';
Rebecca Gietman;Thomas L. StormRE: DrugPoints -- Not
Jim: lt's not that CMS doesn't have an official position. I am not authorized to speak for CMS and my contacts that I
referenced in my original email were not at CMS.
Stacy
From : J im Gottstei n Imailto :iim.gottstein@ psychriq hts.org]Sent: Friday, November 08, 2013 3:48 PM
To: Ward, Stacy G. (USAWIE)Cc: 'Brad Foley'; 'Mark Larson'; 'Thomas L. Storm'; tobywatson@qmail,com; 'Rebecca Gietman';
[email protected]; Rebecca Gietman; Thomas L. StormSubject: RE: DrugPoints -- Not
1'hanks Stacy,
I clicln't intend to misstate what you said, u'hen I wrote "it does not appear . . ." I don't think I did, but apologize
to the extent I did. It is curious that the Centers for Meclicare and Medicaicl Services doesn't just know the
Arìs\\,er. Or have an official position. ll any event, at this point, I tliink we just have to go with the American
ITospital Þ'ormulary Servioe ancl DRIJGDEX as the only.rpplicable compenclia.
Thank you for your assistance
Jim
From; Ward, Stacy G. (USAWIE) fmailto:Stacy,G,Ward@usdoi,gov]Sent: Friday, November 08, 2013 11:18 AM
To: Jim GottsteinCc: Brad Foley; Mark Larson; Thomas L. Storm; [email protected]; Rebecca GietmanSubject: RE: DrugPoints -- Not
Jim: aswediscussed, lhavecheckedwithacoupleofsourcesandneitherofthemhadheardofDrugPoíntsbeingthesuccessortotheU.S.Pharmacopeia. Thisisnottheofficial positionoftheCentersforMedìcareandMedicaidServices,nor the United States' government. I was símply trying to obtain information to get you off in the right direction.
Stacy Gerber WardAssistant United States AttorneyE.D. Wisconsin I aFrom : J im Gottstein fmailto :jim. [email protected]]Sent: Friday, November 08, 2013 1:59 PM
To: Ward, Stacy G. (USAWIE)Cc: iim.gottstein@psy ; Brad Foley; Mark Larson; Thomas L. Storm; tobywatson@gmail,com; Rebecca
1
Case 2:11-cv-00236-JPS Filed 11/25/13 Page 1 of 2 Document 160-3
GietmanSubject: DrugPoints -- Not
Hi Stacy,
Thanks for following up on my question and advising me that it does not appear DrugPoints or any other
publication is the successor to United States Pharmacopeia-Drug Information, leaving just the American
Hospital Formulary Service Drug Information, and DRUGDEX as the compendia incorporated by reference
into 42 U.S.C. g 1396r-S(kX6), $ 1396r-8(gx1)@Xi). See, U.S. v. King-Vassel, 728F.3d707,716 (2013)
James B. (Jim) Gottstein, Esq.President/CEO
Law Project for Psychiatric Rights406 G Street, Suite 206Anchorage, Alaska 99501 USAPhone: (907) 274-7686 Fax: (907) 27 4-9493j im. gottstein@psychri ghts. ors
The Law Project for Psychiatric Rights is a public interest law firm devoted to the defense of people facing the
horrors of forced psychiatric drugging and electroshock. We are fuither dedicated to exposing the truth about
these drugs and the courts being misled into ordering people to be drugged and subjected to other brain and
body damaging interventions against their will. Currently, due to massive growth in psychiatric drugging ofchildren and youth and the current targeting of them for even more psychiatric drugging, PsychRights has made
attacking this problem a priority. Children are virtually always forced to take these drugs because it is the
adults in their lives who are making the decision. This is an unfolding national tragedy of immenseproportions. Extensive information about all of this is available on our web site, http://psvchrights.org/. Please
donate generously. Our work is fueled with your IRS 501(c) tax deductible donations. Thank you for yourongoing help and support.
2Case 2:11-cv-00236-JPS Filed 11/25/13 Page 2 of 2 Document 160-3
VOLUME
Drug Inforrnationin Lay Language
lTrn EDITION
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By authority of the United States Pharmacopeial Convention, Inc
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Case 2:11-cv-00236-JPS Filed 11/25/13 Page 1 of 2 Document 160-4
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and information,revisednew inclusionTheeasefor leference.ofintendedbrand lsnames onlyof selectedThemarket. listingof theonare brands drugsThere many b¡andsotherfromdifferenthas propertieslistedthe brandthathas knowledgethemean USPCdoesnâme not any particularàof brand includedbeenhas notthatfacl b¡anda namethethe USPC.endorsement
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About USP DI
DI Update.For further information about USp DI or to comment on how the information published in this volume might
better meet your infóimãilãn n""¿r, pr"use-lontact: ÚsÈ oiuirion of Information Development, 12601 Twinbrook
Case 2:11-cv-00236-JPS Filed 11/25/13 Page 2 of 2 Document 160-4
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AltCareDex@ System;(Title). ln: AltcareDexG) System (electronic version). Truven ]-tealth Anatytics, Greenwood Village, Colorado,usA. Available at: http://www.micromedexsolutioné,com/(cited; monthtdaylyeaÒ.
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AltMedDex@ System:(Title).'ln: AltMedDex@ System (electronic version). Truven l-lealth Analytics, Greenwood Village, Colorado,USA. Available at: http://www.micromedexsolutions.com/ (cited: ntonthldaylyear).
AltMed-REAXTM for the Patient:(Title). ln: AltMed-REAXTM for the Patient (eleetronic version). Truven Health Analytics, Greenwood Village,Colorado, USA, Available at: http:/iwww,micromedexsolutions,com/ (cited: month|daylyear).
DISEASEDEX rM Emergency Medicine:DISEASEDEX rM Emergency Medicine. ln: DISEA_SEDEX - Emergency Medicine (electronic version). TruvenHealth Analytlcs, Greenwood Village, colorado, usA. Avaitable atì htt[://www.miciomåàóxsolutions.com/(ciled: month/ dayl year).
DISEASEDEX rM General Medicíne:(Title). ln; DISEASEDEX - General Medicine (electronic version). Truven Health Analytics, Greenwood Village,Colorado, USA. Available at: http://www.micromedexs¡tutions,com/ (cited: monthldaytyeatr¡,
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Dosing & Therapeutic Tools Database:Anon: Cephalosporin Generations. ln: Dosing & Therapeutic Tools Database (electronic version), TruvenHealth Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/(cited: month I dayl year).
DRUGDEX@ System:(Title). ln: DRUGDEX@ System (electronic version), Truven Health Ahatytics, Greenwood Village, Colorado,usA Available at: http://www.micromedexsolutions.con / (cited: monthldaylyear).
P&T QUIK@ Reports:(Tìtle), (Month Year). ln: P&T QUIK@ Reports (electronic version). Truven Health Analytics, GreenwoodVillage, Colorado, USA. Available at: http:/iwww.micromedexsolutions.com/ (cited: monthtdaylyear).
POISINDEX@ System:(Title). ln: POISINDEX@ System (electronic version). Truven Health Analytics, Greenwood Village, Colorado,UsA. Available at; http://www.micromedexsolutions.con / (cited: ntonthtdaylyear).
TOMES@ System:
HAZARDTEXT@ Haza ¡"d Management:(Title). ln: TOMES@ System (electronic version) l ruven Health Analytics, Greenwood Village, Colorado,USA, Available at: http://www.micromedexsolutions,com/ (cited: mon-thldaylyear).
INFOTEXT@ Document:(Title) (INFOTEXT@ Document), ln: TOMES@ System (electronic version). l'ruven l-lealth Analytics,Greenwood Village Colorado, USA. Available at: http:/lwww.micromedex'solutions.com/ (cited:monthldaytyear).
MEDITEXT@ Medicat Management:(Title) (MEDITEXT@ M.edical Management), ln: TOMES@ System (electronic version). 'l'ruven HealthAnalytics, Greenwood Village, Colorado, USA. Available at:'http://www.micromedexsolutions.com/(cited: monfh I d ayl year).
REPROTEXT@ Database:(Title) (REPROTEXT@ DocLrment), ln: REPROTEXT@ Þatabase (etectronìc version), Truven l-lealthAnalytics, Greenwood Village, Colorado, USA, Available at: http:/Arvww,micromedexsolutions.com/(cited : monflr I d ayl year).
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tives and printed in a manner that will distinguish them fromemarks MUST appear as indicated on the following screenation. The symbols (R) or @ and (TM) or rM are a fórm ofademarks.
AfterCare@ I nstructions databaseAltCareDex@ SystemAltMedDex@ SystemAltMedDex Points@ SystemAltMedDex@ ProtocolsAltMed-REAXTM SystemCareNotes@ SystemClinical Checklist@ClinicalPoints@ SysternDISEASEDEXTM System
