IN THE UNITED STATES DISTRICT COURT
DISTRICT OF ALASKA
UNITED STATES OF AMERICA )
Ex rel. Law
Project for Psychiatric )
Rights,
an Alaskan non-profit )
corporation, ) CIVIL
ACTION NO.
) 3:09-CV-00080-TMB
Plaintiff, )
)
vs. )
) FILED
IN CAMERA AND
OSAMU H. MATSUTANI, MD, ) UNDER SEAL
WILLIAM HOGAN, individually,
and as )
Commissioner of the
Department of Health and ) FALSE
CLAIMS ACT
Social Services, TAMMY
SANDOVAL, ) MEDICAID FRAUD
Individually and as Director
of the Alaska )
Office of Children's,
Services, STEVE ) DEMAND
FOR JURY TRIAL
McCOMB, individually and as
Director of the )
Alaska Division of Juvenile
Justice, )
WILLIAM STREUR, individually,
and as )
Director of the Alaska
Division of Health )
Care Services, )
JUNEAU YOUTH SERVICES, Inc.,
an )
Alaskan non-profit
corporation, )
PROVIDENCE HEALTH &
SERVICES, )
an Alaskan non-profit
corporation, )
ELIZABETH BAISI, MD, RUTH )
DUKOFF, MD, CHARTER NORTH )
STAR BEHAVIORAL HEALTH
SYSTEM, )
an Alaska Limited Liability
Company, )
KERRY OZER, MD, CLAUDIA
PHILLIPS, )
MD, SOUTHCENTRAL FOUNDATION, )
an Alaska non-profit
corporation, SHEILA )
CLARK, MD, HUGH STARKS, MD, )
LINA JUDITH BAUTISTA, MD, )
HEIDI F. LOPEZ-COONJOHN, MD, )
ROBERT D. SCHULTS, MD, )
MARK H. STAUFFER, MD, )
RONALD A. MARTINO, M.D., )
IRVIN ROTHROCK, MD, JAN
KIELE, MD, )
ALTERNATIVES COMMUNITY MENTAL )
HEALTH SERVICES, d/b/a DENALI
)
FAMILY SERVICES, )
ANCHORAGE COMMUNITY MENTAL )
HEALTH SERVICES, an Alaska
non-profit )
Corporation, LUCY CURTIS, MD,
)
FAIRBANKS PSYCHIATRIC AND )
NEUROLOGIC CLINIC, PC )
PENINSULA COMMUNITY HEALTH )
SERVICES OF ALASKA, INC., )
BARTLETT REGIONAL HOSPITAL )
FOUNDATION, INC., THOMSON
REUTERS )
(Healthcare ) INC., WAL-MART
STORES, )
INC., SAFEWAY, INC., FRED
MEYER )
STORES, INC., )
)
Defendants. )
)
PLAINTIFF'S
COMPLAINT PURSUANT TO 31 U.S.C §§ 3729-3732 OF THE FEDERAL FALSE CLAIMS ACT
The United States of
America, by and through qui tam relator
Law Project for Psychiatric Rights, an Alaska non-profit corporation
(PsychRights), brings this action under 31 U.S.C §3729, et seq., as amended (False Claims Act) to recover all damages, penalties
and other remedies established by the False Claims Act on behalf of the United
States.
Table of
Contents
A. The FDA
Drug Approval Process
B. Drug
Company Sponsored False statements
C. Pediatric
Psychopharmacology: In General
F. Anticonvulstants
Promoted as "Mood Stabilizers"
Count 1: Hogan
and Streur Liability For Authorizing False Claims
Count 2: Sandoval
and McComb Liability For Submitting or Causing False Claims to be Submitted
Count 3: Wal-Mart,
Safeway and Fred Meyer Liability For Uncovered Drugs
Count 4: Thomson
False Statements in DRUGDEX
Count 7: Prescribers
Liability For Misdiagnoses
Count 8: Prescribers
Liability for Pediatric SSRI Prescriptions
Count 9: Pediatric
Risperdal Prescriptions
I.
Preliminary Statement
1.
This
is an action to recover damages and civil penalties on behalf of the United States
of America, for violations of the False Claims Act arising from false or
fraudulent records, statements, or claims, or any combination thereof, made,
used or caused to be made, used, or presented, or any combination thereof, by
the defendants, their agents, employees, or co-conspirators, or any combination
thereof, with respect to false claims for outpatient psychotropic medications
prescribed to children and youth for which claims were made to the federal
Medicaid Program and Children's Health Insurance Program (CHIP).
2.
The
False Claims Act was enacted during the Civil War. Congress amended the False
Claims Act in 1986 to enhance the Government's ability to recover losses
sustained as a result of fraud against the United States after finding that
fraud in federal programs was pervasive and that the False Claims Act, which
Congress characterized as the primary tool for combating government fraud, was
in need of modernization. Congress intended that the amendments create
incentives for individuals with knowledge of fraud against the government to
disclose the information without fear of reprisals or Government inaction, and
to encourage the private bar to commit legal resources to prosecuting fraud on
the Government's behalf.
3.
The
False Claims Act provides that any person who knowingly submits, or causes the
submission of, a false or fraudulent claim to the U.S. Government for payment
or approval is liable for a civil penalty of up to $11,000 for each such claim,
plus three times the amount of the damages sustained by the Government. The
False Claims Act defines “knowingly” to include acts committed with “actual
knowledge,” as well as acts committed “in deliberate ignorance” or in “reckless
disregard” of their truth or falsity. Liability attaches when a defendant
seeks, or causes others to seek, payment that is unwarranted from the
Government.
4.
The
Act allows any person having information about a false or fraudulent claim
against the Government to bring an action for himself and the Government, and
to share in any recovery. The Act requires that the complaint be filed under
seal for a minimum of 60 days (without service on the defendant during that
time) to allow the Government time to conduct its own investigation and to
determine whether to join the suit.
5.
As
a result of aggressive drug company promotion of the prescription of
psychotropic drugs to children and youth for conditions not approved by the
federal Food and Drug Administration (FDA), known as "off-label" use,
including,
(a) sponsoring and/or conducting fraudulent
research and the publication thereof in medical journals,
(b) paying what is known as Key Opinion Leaders
(KOLs) to support such off-label use,
(c) suppressing research showing negative
results,
(d) domination of psychiatrists' and other
prescribers' training and continuing medical education programs,
(e) speaking fees to promote the off-label
prescription of drugs, and
(f) free meals and other gifts to prescribers,
psychiatrists and other prescribers
pervasively prescribe psychotropic drugs knowing that false claims will be
presented to Medicaid and CHIP within the meaning of the False Claims Act.
6.
Under
Medicaid and CHIP,
(a) psychiatrists and other
prescribers,
(b) mental health agencies,
(c) pharmacies, and
(d) state officials,
all have specific responsibilities to
prevent false claims from being presented and are liable under the False Claims
Act for their role in the submission of false claims.
7.
The
defendants in this action are:
(a) psychiatrists who prescribed drugs that were
not lawfully reimbursable under Medicaid or CHIP knowing that claims would be
made to Medicaid and/or CHIP,
(b) mental health agencies employing such
psychiatrists knowing that such claims would be made to Medicaid and/or CHIP,
(c) pharmacies who filled such prescriptions and
made claims to Medicaid and/or CHIP for reimbursement,
(d) employees of the State of Alaska,
individually[1] and in
their official capacities, who were and are responsible for authorizing
reimbursement of false claims, and
(e) Thomson Reuters (Healthcare), which made
false statements in continuing medical education programs promoting off-label
pediatric use of psychotropic drugs.
8.
This
is an action for treble damages and penalties for each false claim and each
false statement under the False Claims Act, 31 U.S.C. §3729, et seq., as
amended.
II.
Parties
9.
Relator,
the Law Project for Psychiatric Rights, Inc., is an Alaskan non-profit
corporation (PsychRights), whose mission is to mount a strategic litigation
campaign in the United States against psychiatric drugging and electroshocking
people against their will. PsychRights
has made a priority the massive, mostly ineffective, and extremely harmful,
over-drugging of children and youth with psychiatric drugs.
10.
Defendant Osamu H. Matsutani, MD
(Matsutani), is a resident of the District of Alaska and caused and/or causes
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
11.
Defendant William Hogan (Hogan) is a
resident of the State of Alaska and the Commissioner of the State of Alaska's
Department of Health and Social Service (DHSS), and in such capacity is
responsible for the administration of Alaska's Medicaid program and CHIP,
including Alaska authorizing reimbursement for psychiatric drugs prescribed to
children and youth.
12.
Defendant Tammy Sandoval (Sandoval)
is a resident of the State of Alaska and the Director of the Office of
Children's Services within DHSS (OCS).
OCS has custody of children and youth whom it has been determined are in
need of assistance because of abuse or neglect, and submitted and/or submits,
or caused and/or causes, claims to be submitted to Medicaid and/or CHIP for
reimbursement of psychiatric drugs prescribed to such children and youth.
13.
Defendant Steve McComb (McComb) is a
resident of the State of Alaska and the
Director of the Division of Juvenile Justice within DHSS (DJJ). DJJ takes custody of Alaskan children and
youth offenders and submitted and/or submits, or caused and/or causes, claims
to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to such children and youth.
14.
Defendant William Streur (Streur) is
a resident of the State of Alaska and the Director of the Division of Health
Care Services within DHSS (HCS). HCS
authorizes reimbursement by Medicaid and CHIP for psychiatric drugs prescribed
to Alaskan children and youth.
15.
Defendant Providence Health &
Services, is an Alaskan non-profit corporation, doing business in the District
of Alaska (Providence). Providence
submitted and/or submits, or caused and/or causes, claims to be submitted to
Medicaid and/or CHIP for reimbursement of psychiatric drugs prescribed to
children and youth.
16.
Defendant Juneau Youth Services,
Inc., is an Alaskan non-profit corporation doing business in the District of
Alaska (JYS). JYS submitted and/or
submits, or caused and/or causes, claims to be submitted to Medicaid and/or
CHIP for reimbursement of psychiatric drugs prescribed to children and youth.
17.
Defendant Charter North Star
Behavioral Health System, L.L.C., is an Alaskan Limited Liability Company doing
business in Alaska (North Star). North
Star submitted and/or submits, or caused and/or causes claims to be submitted, to
Medicaid and/or CHIP for reimbursement of psychiatric drugs prescribed to
children and youth.
18.
Defendant Alternatives Community
Mental Health Services, d/b/a Denali Family Services (Denali), is an Alaska non
profit corporation, and submitted and/or submits, or caused and/or causes
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
19.
Defendant Peninsula Community Health
Services of Alaska, Inc. successor to Central Peninsula Mental Health
Association, Incorporated, is an Alaskan non-profit corporation doing business
in Alaska (Peninsula). Peninsula
submitted and/or submits, or caused and/or causes, claims to be submitted to
Medicaid and/or CHIP for reimbursement of psychiatric drugs prescribed to
children and youth.
20.
Defendant Bartlett Regional Hospital
Foundation, Inc. is an Alaskan non-profit corporation doing business in Alaska
(Bartlett). Bartlett submitted and/or
submits, or caused and/or causes, claims to be submitted to Medicaid and/or
CHIP for reimbursement of psychiatric drugs prescribed to children and youth.
21.
Defendant Fairbanks Psychiatric And
Neurologic Clinic, PC, is an Alaskan professional corporation doing business in
Alaska (Fairbanks Psychiatric).
Fairbanks Psychiatric submitted and/or submits, or caused and/or causes,
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
22.
Defendant Anchorage Community Mental
Health Services, Inc., is an Alaskan non profit corporation doing business in
Alaska (ACMHS). ACMHS submitted and/or
submits, or caused and/or causes, claims to be submitted to Medicaid and/or
CHIP for reimbursement of psychiatric drugs prescribed to children and youth.
23.
Defendant Southcentral Foundation is
an Alaskan non-profit corporation doing business in Alaska (SCF). SCF submitted and/or submits, or caused
and/or causes, claims to be submitted to Medicaid and/or CHIP for reimbursement
of psychiatric drugs prescribed to children and youth.
24.
Defendant Lina Judith Bautista, MD (Bautista),
is a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
25.
Defendant Elizabeth Baisi, MD (Baisi)
is a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
26.
Defendant, Ronald A. Martino, MD (Martino) is
a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
28.
Defendant, Kerry Ozer, MD (Ozer), is
a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
29.
Defendant, Hugh Starks, MD (Starks),
is a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
30.
Defendant, Ruth Dukoff, MD (Dukoff),
is a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
31.
Defendant, Claudia Phillips, MD
(Phillips) is a resident of the District of Alaska and caused and/or causes
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
32.
Defendant, Lucy Curtis, MD (Curtis)
is a resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
33.
Defendant, Heidi F. Lopez-Coonjohn,
MD (Lopez-Coonjohn) is a resident of the District of Alaska and caused and/or
causes claims to be submitted to Medicaid and/or CHIP for reimbursement of
psychiatric drugs prescribed to children and youth.
34.
Defendant, Robert D. Schults,
MD,(Schults) is a resident of the District of Alaska and caused and/or causes
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
35.
Defendant, Mark H. Stauffer, MD
(Stauffer) is a resident of the District of Alaska and caused and/or causes
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
36.
Defendant, Irvin Rothrock, MD,
(Rothrock) is a resident of the District of Alaska and caused and/or causes
claims to be submitted to Medicaid and/or CHIP for reimbursement of psychiatric
drugs prescribed to children and youth.
37.
Defendant, Jan Kiele, MD (Kiele) is a
resident of the District of Alaska and caused and/or causes claims to be
submitted to Medicaid and/or CHIP for reimbursement of psychiatric drugs
prescribed to children and youth.
38.
Defendant Thomson Reuters
(Healthcare) Inc. (Thomson), does business in the District of Alaska, conducts
continuing medical education programs promoting off-label pediatric use of
psychiatric drugs, and publishes DRUGDEX, a pharmaceutical compendium, which
includes entries regarding psychiatric drugs prescribed to children and youth.
39.
Defendant, Wal-Mart Stores, Inc.
(Wal-Mart), does business in the District of Alaska, is a national retailer,
including of prescription drugs, and submitted and continues to submit claims
to Medicaid and/or CHIP for reimbursement of psychiatric drugs prescribed to
children and youth.
40.
Defendant, Safeway, Inc. (Safeway),
does business in the District of Alaska, is a national retailer, including of
prescription drugs, and submitted and continues to submit claims to Medicaid
and/or CHIP for reimbursement of psychiatric drugs prescribed to children and
youth.
41.
Defendant, Fred Meyer Stores, Inc.
(Fred Meyer), does business in the District of Alaska, is a national retailer,
including of prescription drugs, and submitted and continues to submit claims
to Medicaid and/or CHIP for reimbursement of psychiatric drugs prescribed to
children and youth.
III.
Jurisdiction and Venue
42.
This Court has jurisdiction over the
subject matter of this action pursuant to 28 U.S.C. §1331, and 31 U.S.C. §3732,
the latter of which specifically confers jurisdiction on this Court for actions
brought pursuant to 31 U.S.C. §§3729 and 3730.
43.
There have been no public disclosures
of allegations or transactions that bar jurisdiction under 31 U.S.C. §3730(e).
44.
This Court has personal jurisdiction
over the defendants pursuant to 31 U.S.C. §3732(a) because that section
authorizes nationwide service of process and because all the defendants have at
least minimum contacts with the United States, and can be found in, reside, or
transact or have transacted, business in the District of Alaska.[2]
45.
Venue exists in the United States
District Court for the District of Alaska pursuant to 31 U.S.C. § 3730(b)(1)
because all of the defendants have at least minimum contacts with the United
States, and all the defendants can be found in, reside, or transact or have
transacted business in the District of Alaska.
IV.
BackGround
The FDA Drug Approval Process[3]
46.
The FDA's Center for Drug Evaluation
and Research (CDER) oversees testing and approval of medications for the FDA,
but conducts no drug trials of its own.[4]
47.
The legal availability of a
psychotropic drug and its approval by the United States Food and Drug
Administration (FDA) for prescription by medical practitioners does not, in
itself, signify that it is safe or effective for use with children and youth
diagnosed with a mental illness.[5]
48.
Drug companies pay for and conduct all
tests and trials considered by CDER in the drug approval process, and CDER
judges a drug's efficacy and safety based on the data submitted by the
sponsoring drug company (Sponsor) in support of what is called a New Drug
Application (NDA).[6]
49.
Each FDA-approved drug has a
"Label," in which findings from the pre-clinical (laboratory and
animal) and clinical (human) trials are summarized, the exact content secretly
negotiated by the FDA and the Sponsor.[7]
50.
Experts in the field admit (a) there are no
biomarkers for psychiatric illness, (b) they do not understand the supposed
neurobiology or genetic underpinnings of psychiatric disorders, (c) they do not
understand the developmental factors and causes of mental illness, (d) there are few good animal models for psychiatric
research, and (e) all of these problems
are worse when diagnosing and researching treatments in children and youth.[8]
51.
Phase II and III trials are short,
typically lasting only three to eight weeks, with up to 70 percent of the
subjects dropping out before the trials' end, detecting only some of the acute
effects, and few that emerge over a longer time frame.[9]
52.
In clinical trials comparing a new
drug to an older one, very high doses of the older drug are often used, producing
more side effects for the older drug, and resulting in the intentionally
misleading conclusion that the newer drug is safer than the older one.[10]
53.
Primary outcomes of most psychiatric
drug clinical trials are rated by the researchers rather than the subjects,
ignoring relevant measures, such as in the Phase III pediatric trials of
antidepressants where not one of ten parent or child rated scales showed
advantages for antidepressant use over placebo.[11]
54.
Adverse effects of the drugs
occurring during clinical trials are carelessly investigated, at best,
resulting in a false impression of a drug's safety. [12]
55.
During clinical trials, adverse
events are often miscoded by the Sponsor.[13]
56.
During clinical trials, adverse
events are often arbitrarily determined to be unrelated to the drug being
studied, and ignored. [14]
57.
Sponsors announce in their study
protocols that they will gather data for weeks after clinical trial subjects
stop treatment, but do not submit these data to the FDA even though subjects
often rate their experience differently once the mind-altering drug has been
discontinued.[15]
58.
While the FDA often officially
"requires" Sponsors to conduct trials once the drugs have been
approved in what is known as the "post marketing phase" or
"Phase IV Trials," as of late 2006, more than 70 percent of these
promised post marketing or Phase IV trials had not even been started by
Sponsors. [16]
59.
Sponsors often design drug studies
solely to get positive results.[17]
60.
Sponsors often distort negative
results to make them appear positive.[18]
61.
Sponsors often publish purported
positive results multiple times to give the appearance the results have been
replicated multiple times.[19]
62.
In conducting clinical trials,
sponsors now extensively use Contract Research Organizations, which are
private, for profit companies that get paid to achieve positive results for the
Sponsors.[20]
63.
In 90 percent of studies pitting one
newer neuroleptic, also misleadingly called "antipsychotic," against
another, the best drug was the Sponsor's drug.[21]
64.
Sponsors keep negative data about
their drugs secret, claiming they are trade secrets or otherwise entitled to be
kept secret from prescribers and other people making decisions on whether to
give them to children and youth.[22]
65.
An example is two studies involving
Paxil for adolescents, "Study 329" and "Study 377," in
which the drug manufacturer did not submit the data to the FDA because it
demonstrated Paxil should not be approved for this population. [23]
66.
Another example is the manufacturer
of Seroquel hiding the results of Trials 15, 31, 56, and the COSTAR Trial.[24]
Drug Company Sponsored False statements
67.
Prior to the 1990s, most drug
research was funded by the government and conducted in academic centers.
68.
By the 1990s that was largely over,
and most of the funding is now coming from the pharmaceutical industry.
69.
One result is that medical journals
became a marketing arm for the drug companies.
70.
Drug companies pay Medical Science
Liaisons (MSLs) to induce "Key Opinion Leaders" (KOLs) to make false
statements in support of prescribing their psychotropic drugs for non FDA
pediatric approved uses, including having such false statements published in
peer-reviewed journals.
71.
Drug companies pay Key Opinion
Leaders to make false statements to influence prescribers to prescribe
particular psychotropic drugs for pediatric uses not authorized by the FDA,
including having such false statements published in peer-reviewed journals.
72.
Drug companies write articles for
publication in peer-reviewed journals that make false statements in support of
prescribing particular psychotropic drugs for pediatric uses not approved by
the FDA, and pay Key Opinion Leaders and other supposed researchers, to
represent that they are the author(s) of such articles, in what is known as
"Ghost Writing."
73.
An example of drug company
sponsorship of peer-reviewed articles making false statements in support of
prescribing a psychotropic drug for pediatric uses not approved by the FDA is a
paper on "Study 329" containing false statements published by the
Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in
July 2001, in which its listed authors claimed that Paxil was "generally
well tolerated and effective for major depression in adolescents." The
paper became one of the most cited in the medical literature in supporting the
use of antidepressants in child and adolescent depression Paxil's manufacture
claimed it demonstrated "REMARKABLE Efficacy and Safety."[25]
74.
Drug companies pay psychiatrists to make
false statements to other prescribers to induce them to prescribe particular
psychotropic drugs for pediatric uses not approved by the FDA.
75.
Drug companies pay for Continuing
Medical Education (CME) programs in which false statements are made to induce
prescribers to prescribe psychotropic drugs to children and youth for uses not
approved by the FDA.
76.
Drug companies pay prescribers to
attend CME programs in which false statements are made to induce prescribers to
prescribe psychotropic drugs for pediatric uses not approved by the FDA.
77.
Drug companies pay sales
representatives to make false statements to prescribers to induce them to
prescribe particular psychotropic drugs to children and youth for uses not
approved by the FDA.[26]
78.
Drug companies give or gave gifts to
prescribers to induce them to prescribe particular psychotropic drugs to
children and youth for uses not approved by the FDA.[27]
79.
Drug companies make false statements
to induce prescribers to misdiagnose pediatric patients for indications that
can then be used to justify prescribing their drugs as being for FDA approved
indications, or supported by one or more of the Compendia.
80.
The drug industry spent $7 billion in 2004 on
marketing directly to doctors.
81.
The drug industry spends three times
as much on marketing as for research and development.
82.
There is one drug sales
representative to every two and one half doctors in the United States.
83.
Less than one minutes spent by sales
representatives with doctors results in a 16 percent change in such doctors'
prescribing in favor of the drug companies' drug(s).
84.
After three minutes with a sales
representative there is a 52 percent change in such doctors' prescribing in
favor of the drug companies' drug(s).[28]
Pediatric Psychopharmacology: In General
85.
Mainstream mental health practice
endorses a "medical model" of mental illness that supports medicating
children and youth with little or no evidence of the drugs' safety or efficacy.[29]
86.
Prescriptions of psychotropic drugs
to youths tripled in the 1990s and are still rising.[30]
87.
At least forty percent of all
psychiatric drug treatments today involve concomitant or multiple psychotropic
medication use, commonly referred to as "polypharmacy."[31]
88.
Most psychotropic medication classes
lack scientific evidence of their efficacy or safety in children and youth.[32]
89.
No studies have established the
safety and efficacy of polypharmacy in children and youth.[33]
90.
Almost all psychiatric drugs have
been shown to cause brain damage in the form of abnormal cell growth, cell
death and other detrimental effects, which is especially harmful for growing
and developing children and youth.[34]
91.
Psychotropic drugs given to children
and youth cause drug-induced adverse effects and behavioral changes, including
apathy, agitation, aggression, mania, suicidal ideation and psychosis, known as
"behavioral toxicity."[35]
92.
Psychotropic drugs given to children
and youth suppress learning and cognition and produce cognitive neurotoxicty,
interfering with the basic mental development of the child, which adverse
effects often do not go away after the drugs are withdrawn.[36]
93.
No studies show that giving
psychotropic drugs to children and youth increases learning or academic
performance in the long term.[37]
94.
Adverse drug effects are often
confused with symptoms of disorders, leading to the addition of inappropriate
diagnoses, increased doses of current medications, and even more complex drug
regimens.[38]
95.
Nine of ten children and youth seeing
a child psychiatrist receive psychotropic medication.[39]
96.
Use of most classes of psychotropic
drugs among 2-4 year-olds, or preschoolers, continues to increase with almost
half of those receiving prescriptions given two or more medications
simultaneously.[40]
97.
The fastest increases have been in
newer drugs, which by definition, have little or no established efficacy or
safety profiles.[41]
98.
Treatment of preschoolers with
psychotropic drugs has barely been studied.[42]
99.
There is insufficient evidence on the
administration of psychotropic drugs to preschoolers to provide guidelines for
treatment, establish efficacy of treatment, guarantee safe use, or evaluate
short- and long-term consequences on development of drug prescriptions to
preschoolers. [43]
100. Children and youth in child welfare
settings are two and three times more likely to be medicated than children and youth
in the general community.[44]
101. Medicaid-enrolled children and youth
are more likely to receive psychotropic medication, be treated with multiple
medications, and receive medications as sole treatment for psychiatric
diagnoses than other children and youth.[45]
102. Both because minority and poor
children and youth are more likely to be involved in child protection and
foster care placements, and because the drugs are paid for by Medicaid and
other governmental programs, these children and youth are given more psychotropic
drugs than other children and youth.
103. Children are particularly vulnerable
to harm from psychiatric drugs because their brains and bodies are developing.[46]
104. There is little or no empirical
evidence to support the use of drug interventions in traumatized children and
youth.[47]
105. Fewer than ten percent of
psychotropic drugs are FDA-approved for any psychiatric use in children.[48]
106. The use of psychiatric drugs in
children and youth far exceeds the evidence of safety and effectiveness.[49]
Neuroleptics
107. As of June, 2008, The following
"second-generation" neuroleptics have been approved by the FDA for
the following pediatric uses:[50]
108. Dr. Joseph Biederman of Harvard
Medical School was paid by the manufacturer of Risperdal to conduct research to
generate and disseminate false statements supporting the pediatric use of
Risperdal, which were used to gain FDA approval for pediatric use.[51]
109. The following first-generation
neuroleptics have been approved for the following pediatric uses:[52]
110. Neuroleptics have been used to treat
psychoses since the 1950s despite high toxicity and limited effectiveness.[53]
111. Starting in the 1990s, the newer,
more expensive, second-generation neuroleptics were, through false statements,
heavily promoted as safer and more effective than the first-generation
neuroleptics.[54]
112. In 2005, in the largest ever study
regarding the treatment of people diagnosed with schizophrenia, the Clinical
Antipsychotic Trials of Intervention Effectiveness (CATIE) study, conducted by
the National Institute of Mental Health, it was found that the
second-generation neuroleptics were neither more effective nor better tolerated
than the older drugs and that seventy five percent of patients quit either type
of drug within eighteen months due to inefficacy or intolerable side effects,
or both.[55]
113. Neuroleptics are most often
prescribed to children and youth to suppress aggression rather than for
psychosis.[56]
114. The latest randomized-controlled
trial of neuroleptics for aggression, which had no drug company sponsorship,
found inert placebo more effective than Haldol, a first-generation neuroleptic,
or Risperdal, a second-generation neuroleptic, in reducing aggression in
patients with intellectual disability.[57]
115. There are few clinical trials of
second-generation neuroleptics for pediatric use, and most existing trials are
short-term with the results favoring the funder's drugs.[58]
116. Overall, current prescriptions of
neuroleptics to children and youth overwhelmingly exceed the available evidence
for safety and effectiveness.[59]
117. No studies show that
second-generation neuroleptics are safe or effective for children and youth.[60]
118. The following observed effects of
neuroleptics are regularly misconstrued as therapeutic by physicians and other
practitioners:
(a)
Increased
indifference, including to psychotic symptoms,
(b)
Reduced
spontaneity and affect,
(c)
Reduced
ability to monitor one's state, and
(d)
Increased
compliance with social norms.[61]
119. The following are undesirable
observed behavioral effects of neuroleptics:
(a)
Cognitive
and motor impairments,
(b)
Sedation
and drowsiness,
(c)
Confusion
and memory problems,
(d)
Anxiety,
(e)
Depression
and mood swings,
(f)
Abnormal
thinking, and
(g)
Hostility
and aggression.[62]
120. The following are undesirable
observed physical effects of neuroleptics:
(a)
Weight
gain and high blood sugar (second-generation),
(b)
Extrapyramidal
symptoms (abnormal movements of body parts),
(c)
Diabetes
(second-generation) and other endocrine problems, Cardiac problems,
(d)
Liver
problems and jaundice,
(e)
Neuroleptic
malignant syndrome, which occurs at a rate of one to two percent per year, is
often fatal, can occur with any neuroleptic, at any dose, at any time,
characterized by extreme muscular rigidity, high fever and altered
consciousness, and
(f)
Death.[63]
121. Exrapyramidal symptoms (involuntary
abnormal movements) caused by both first and second-generation neuroleptics
include:
(a)
Akathisia,
an inner distress, often manifested by rocking, pacing and agitation, and known
to cause extreme violence including suicide and homicide;
(b)
Dystonia,
which are sudden, bizarre, sustained muscle spasms and cramps;
(c)
Dyskinesia,
which consists of uncontrollable, disfiguring, rhythmic movements of the face,
mouth and tongue and sometimes of the extremities;
(d)
Parkinsonism,
which manifests as rigid muscles, slowed movement, loss of facial expression,
unsteady gait and drooling.[64]
122. Long-lasting extrapyramidal symptoms
affect twelve to thirteen percent of children who receive first-generation
neuroleptics for more than three months.[65]
123. The rate of acute extrapyramidal symptoms
affecting children who receive second-generation neuroleptics has not been
extensively studied, but from what is known, it appears the rates are
comparable to the first-generation neuroleptics.
124. Among the extrapyramidal symptoms
caused by both the first and second-generation neuroleptics is often
irreversible Tardive Dyskinesia, resulting from the brain damage caused by the
neuroleptics, characterized by (a) disfiguring and stigmatizing involuntary
movements, (b) difficulties in walking, sitting still, eating and speaking[66] and (c) impaired nonverbal function.[67]
125. The second-generation neuroleptics
cause elevated prolactin levels, resulting in sexual and menstrual
disturbances, infertility and decreased bone density,[68] and has resulted in severe gynecomastia (the development of abnormal
breast tissue) in both boys and girls, but particularly disturbing and
disfiguring for boys.[69]
126. Fifty percent of patients on
second-generation neuroleptics gain twenty percent of their weight, primarily
as fat, that has been linked to what is called "Metabolic Syndrome,"
which dramatically increases the risk of obesity, elevated blood sugar and
diabetes, elevated cholesterol and blood lipids, and hypertension.[70]
127. All the second-generation
neuroleptics also cause potentially lethal pancreatitis.
128. Withdrawal of children and youth from
neuroleptics often results in very disturbed behavior worse than anything
experienced prior to starting on the medication.[71]
129. Between 1998 and 2005, Clozaril
(clozapine) was reported to the FDA as suspected to have caused the death of
3,277 people, Risperdal (risperidone) 1,093 and Zyprexa (olanzapine) 1,005.[72]
130. Currently, second-generation
neuroleptics carry the following FDA "Black Box" warnings:[73]
131. A government sponsored study showed a
lifespan decrease of twenty-five years for people diagnosed with schizophrenia
who take these medications long-term.[74]
132. Another study showed a 20 fold
increase in suicide rates for patients diagnosed with schizophrenia who were
given neuroleptics from 1994-1998 compared to those in the period from
1875-1924 who were not given neuroleptics.[75]
133. Between 1993 and 2002, the number of
non-institutionalized six to eighteen year olds on neuroleptics increased from
50,000 to 532,000.[76]
134. Nationwide, neuroleptics are
typically prescribed to children for non-psychotic conditions.[77]
135. Seventy-seven to eighty-six percent
of youths taking neuroleptics do so with other prescribed psychotropic drugs.[78]
136. In the 1996-2001 time period,
neuroleptic use in children increased the most dramatically in Medicaid
populations, with prescriptions increasing 61 percent for preschool children,
93 percent for children aged six to twelve, and 116 percent for youth aged
thirteen to eighteen.[79]
137. The sales of atypical neuroleptics
have skyrocketed in recent years, propelling overall sales of neuroleptic drugs
past all other classes, to $14.6 billion in 2008.[80]
AntiDepressants
138. The following antidepressants have
been approved for the following pediatric uses:[81]
139. Meta-analyses of controlled clinical
trials of antidepressants submitted to the FDA by Sponsors show 75 percent to
82 percent of the response, as measured by clinician-rated scales, was
duplicated by placebo.[82]
140. Fifty Seven percent of the antidepressant
controlled clinical trials submitted to the FDA failed to show a difference
between the drug and placebo.[83]
141. Only three of fifteen (20%) published
and unpublished controlled pediatric trials of the selective serotonin reuptake
inhibitor (SSRI) antidepressants found the drugs more effective than placebo in
depressed children and no trial found the drugs better as measured by the
children themselves or their parents observing them.[84][85]
142. There is no evidence that the older
tricyclics or monoamine oxidase inhibitor (MAO) antidepressants have any
efficacy with depressed youths.[86]
143. Tricyclic antidepressants commonly
produce abnormalities in cardiovascular function in children and there are
reports of cardiac arrest and death in children.[87]
144. Short term desirable observed effects
of the newer SSRI antidepressants at usual doses include:
(a)
Increased
physical activity,
(b)
Elevated
mood,
(c)
Decreased
expressions of distress, such as crying and hopelessness, and
(d)
Improved
sleep and appetite.[88]
145. Undesirable observed behavioral
effects of antidepressants include:
(a)
Anxiety
and nervousness,
(b)
Agitation
and irritability,
(c)
Mood
swings, including mania,[89]
(d)
Aggressiveness,
(e)
Thoughts
of suicide,
(f)
Apathy,[90] and
(g)
Attempted
and actual suicide.[91]
146. Undesirable observed physical effects
of antidepressants include:
(a)
Gastrointestinal
distress (nausea, vomiting, stomach pain, constipation, diarrhea),
(b)
Sexual
problems (loss of libido, anorgasmia, erectile dysfunction),
(c)
Sleep
disruption (insomnia, hypersomnia),
(d)
Urinary
retention,
(e)
Blurred
vision,
(f)
Weight
gain, and
(g)
Headaches
and dizziness.[92]
147. The following six clusters of
withdrawal effects are likely upon abrupt discontinuation of SSRIs:
(a)
Neurosensory
effects (vertigo, tingling and burning),
(b)
Neuromotor
effects (tremor, spasms, visual changes),
(c)
Gastrointestinal
effects (nausea, vomiting, diarrhea, weight loss),
(d)
Neuropsychiatric
effects (anxiety, depression, crying spells, irritability, suicidal thinking),
(e)
Vasomotor
effects (heavy sweating, flushing), and
(f)
Insomnia,
vivid dreaming and fatigue.[93]
148. In 2004, the FDA issued a
"Public Health Advisory" about all antidepressants, warning they
cause anxiety and panic attacks, agitation and insomnia, irritability and
hostility, impulsivity and severe restlessness, and mania and hypomania,[94] after the British equivalent of the FDA banned the use of all
antidepressants except Prozac in children and youth under 18.[95]
149. In 2005, the FDA issued a "Black
Box" warning of suicidality in children and adolescents, that "Antidepressants increased
the risk of suicidal thinking and behavior (suicidality)."
150. The FDA also warns of increased
agitation, irritability, aggression, worsening anxiety, severe restlessness,
and other unusual behaviors in youth treated with antidepressants.[96]
151. Currently the FDA requires a
"Black Box" warning on the label for all antidepressants, stating,
"WARNING Suicidality and
Antidepressant Drugs—Antidepressants increase the risk of suicidal thinking and
behavior (suicidality) in short-term studies in children, youth, and young
adults, with Major Depressive Disorder and other psychiatric disorders."[97]
152. Continuing to expose children and
youth to antidepressant drugs who experience one or more of the negative
effects they induce, such as mania, is likely to lead to those effects being
misinterpreted as psychiatric symptoms and increases in dosage or additional
drugs when reducing or stopping the offending drug would solve the problem.[98]
Anticonvulsants Promoted as "Mood Stabilizers"
153. Starting in the 1980s and 1990s drug
companies promoted the use of anticonvulsants, i.e., antiepileptics and
antiseizure drugs, for people diagnosed with Bipolar Disorder.[99]
154. None of these drugs, including
Tegretol, Equetro, Neurontin, Lamictal, Depakene, Depakote, Topamax, Trileptal,
and Gabitril have been approved for pediatric psychiatric indications.[100]
155. The following anticonvulsants carry
the following FDA "Black Box Warnings:"
156. A 40-fold increase in the diagnosis
of pediatric Bipolar Disorder over ten years ensued upon the promotion of these
drugs for children and youth given this diagnosis.[102]
157. No studies confirm the efficacy and
safety of anticonvulsants to treat children diagnosed with Bipolar Disorder.[103]
158. More than ninety percent of children
diagnosed with Bipolar Disorder receive more than one psychotropic drug and less
than forty percent receive any psychotherapy.[104]
159. In an open trial of lithium
divalproex or carbamezepine (Tegretol) on youth, in which fifty eight percent
received at least one of the two drugs plus a stimulant, an atypical
neuroleptic, or an antidepressant, half of all participants did not respond to
the drug treatment.[105]
160. In 2008, the FDA warned that
anticonvulsants double the risk of suicidal behavior or ideation, with
treatment of epilepsy having the highest risk, ruling out psychiatric status as
a confounding variable.[106]
161. Desired observed behavioral effects
of anticonvulsants include:
(a)
Reducing
aggression and impulsivity, and
(b)
Calming
restlessness and excitability.[107]
162. Undesired observed behavioral effects
of anticonvulsants include:
(a)
Depression
and sedation,
(b)
Hostility
and irritability,
(c)
Aggression[108] and violence,[109]
(d)
Anxiety
and nervousness,
(e)
Hyperactivity,
(f)
Abnormal
thinking,
(g)
Confusion
and amnesia,
(h)
Slurred
speech, and
(i)
Sedation
and sleepiness.[110]
163. Undesired observed physical effects
of anticonvulsants include:
(a)
Nausea
and dizziness,
(b)
Vomiting
and abdominal pain,
(c)
Headaches
and tremors,
(d)
Fatal
skin rashes,
(e)
Hypothyroidism,
(f)
Blood
disorders,
(g)
Pancreatitis,
liver disease,
(h)
Birth
defects and menstrual irregularities, and
(i)
Withdrawal
seizures.[111]
V.
Applicable Law
Medicaid & CHIP
164. Medicaid is a public assistance
program providing for payment of medical expenses for low-income patients.
Funding for Medicaid is shared between the federal government and state
governments. The Medicaid program subsidizes the purchase of more prescription
drugs than any other program in the United States.
165. Although Medicaid is administered on
a state-by-state basis, the state programs must adhere to federal guidelines.
Federal statutes and regulations restrict the drugs and drug uses that the
federal government will pay for through its funding of state Medicaid programs.
Federal reimbursement for prescription drugs under the Medicaid program is, as
relevant, limited to “covered outpatient drugs.” 42 U.S.C. §1396b(i)(10),
1396r-8(k)(2), (3). [112]
166. Outpatient drug prescriptions, as
relevant, are covered under Medicaid, i.e.,
reimbursable only if the drug is prescribed for a medically accepted
indication, defined as indications approved by the Food and Drug Administration
(FDA), or supported by one or more of the following Compendia:
(i)
American
Hospital Formulary Service Drug Information,
(ii)
United States Pharmacopeia-Drug
Information (or its successor publications), or
(iii)
DRUGDEX Information System,
(Covered Outpatient Drugs).[113]
167. Whether a particular use is supported
by a compendium depends on a variety of factors, including the type of drug and
indication at issue, the compendium's assessment of the drug's efficacy in
treating the indication, the content of the compendium citation, and the scope
and outcome of the studies as described in the compendium.[114]
168. State Medicaid programs are not allowed to
authorize reimbursement for
prescriptions that are not for an indication that is either approved by
the FDA or supported by one or more of the Compendia.[115]
169. States are required to have a drug
use review program to assure that prescriptions are (i) appropriate, (ii)
medically necessary, and (iii) not likely to result in adverse medical results.
[116]
170. Among other things, such drug review
programs, informed by the Compendia, must review each prescription before it is
filled to ensure it is properly reimbursable under Medicaid.[117]
171. Every Medicaid provider must agree to
comply with all Medicaid requirements.[118]
172. CHIP is a partnership between states
and the United States to provide medical insurance for eligible children and
youth who do not qualify for Medicaid but who lack the economic means to afford
private health insurance.
173. Alaska participates in CHIP, which is
called "Denali Kid Care," and has adopted Medicaid for its benefits
package.[119]
False Claims Act
174. False Claims Act liability attaches
to any person who knowingly presents or causes a false or fraudulent claim to
be presented for payment, or to a false record or statement made to get a false
or fraudulent claim paid by the government.[120] 31 U.S.C. §3729(a)(1)&(2).
175. Under the False Claims Act,
"knowing" and "knowingly" mean that a person, with respect
to information:
(1) has actual knowledge of the information;
(2) acts in deliberate ignorance of the truth or falsity of the
information; or
(3) acts in reckless disregard of the truth or falsity of the
information,
and no proof of specific intent to defraud is required. 31 U.S.C. §3729(b).
176. The False Claims Act reaches beyond
demands for money that fraudulently overstate an amount otherwise due;
extending to all fraudulent attempts to cause the Government to pay out sums of
money.[121]
177. False statements include not only affirmative
misrepresentations but also material omissions so that the existence of either
one suffices to satisfy the false statement requirement of the False Claims
Act.[122]
178. A claim for a prescription is
rendered false if a drug manufacturer falsified studies or engaged in other
unlawful, fraudulent conduct to procure FDA approval or inclusion in a
compendium.[123]
179. A claim for a prescription is
rendered false if a drug manufacturer falsified studies or engaged in other
unlawful, fraudulent conduct in the promotion of a drug that resulted in the
prescription.
180. Illegal off-label marketing that
results in the submission of impermissible claims for reimbursement states a
claim under the False Claims Act.
181. A claim is false if a physician
submitted a claim for reimbursement for which he or she received a kickback in
exchange for prescribing a particular drug.
182. The False Claims Act is violated not
only by a person who makes a false statement or a false record to get the
government to pay a claim, but also by one who engages in a fraudulent course
of conduct that causes the government to pay a claim for money.
183. The mere fact that a particular use
is a medically accepted indication does not eliminate the possibility of
fraudulent conduct or abuse that renders the claim false and ineligible for
payment.
184. It is the duty and responsibility of
psychiatrists and other prescribers to keep abreast of and inform themselves of
the actual benefits and risks of drugs and not ignore information contradicting
drug company sponsored false statements when such information becomes
available.
185. Psychiatrists and other prescribers
derive substantial income from Medicaid, including CHIP/Denali Kid Care,
through the prescribing of psychotropic medication to children and youth.
186. Mental health agencies employing
psychiatrists and other prescribers derive substantial income from Medicaid,
including CHIP/Denali Kid Care, through the prescribing of psychotropic
medication to children and youth.
187. The State of Alaska derives
substantial income from Medicaid, including CHIP/Denali Kid Care, for
reimbursement of prescriptions of psychotropic medication to children and youth.
VI.
Causes of Action
Count
1:
Hogan and Streur Liability For Authorizing
False Claims
188. Defendants Hogan and Streur are
responsible for the administration of Alaska's Medicaid program, including
CHIP/Denali Kid Care, and are liable under the False Claims Act for Alaska
authorizing false claims for reimbursement by the Government, when doing so
(1) with actual knowledge;
(2) in deliberate ignorance; or
(3) in reckless disregard
that such claims are false.
189. Defendants Hogan and Streur
(1) had or have actual knowledge;
(2) acted or act in deliberate ignorance; or
(3) acted or act in reckless disregard,
in having Alaska authorize claims for reimbursement of outpatient
pediatric prescriptions for psychotropic drugs by Medicaid and/or CHIP that are
not for an indication approved by the FDA or supported by one or more of the
Compendia, and are liable under the False Claims Act therefor.
Count
2:
Sandoval and McComb Liability For Submitting
or Causing False Claims to be Submitted
190. Defendants Sandoval and McComb
administer programs that have submitted and continue to submit, or have caused
and continue to cause to be submitted, or both, claims to Medicaid and/or CHIP
for reimbursement of outpatient pediatric prescriptions for psychotropic drugs
that are not for an indication that is approved by the FDA or supported by one
or more of the Compendia,
(1) with actual knowledge;
(2) in deliberate ignorance; or
(3) in reckless disregard
that such claims are false, and are liable under the False Claims Act
therefor.
Count
3:
Wal-Mart, Safeway and Fred Meyer Liability
For Uncovered Drugs
191. Wal-Mart, Safeway, and Fred Meyer
(Pharmacies) have submitted and continue to submit claims to Medicaid and/or
CHIP for reimbursement of outpatient pediatric prescriptions for psychotropic
drugs that are not for an indication that is approved by the FDA or supported
by one or more of the Compendia
(1) with actual knowledge;
(2) in deliberate ignorance; or
(3) in reckless disregard
that such claims are false, and are liable under the False Claims Act
therefor.
Count
4:
Thomson False Statements in DRUGDEX
192. In 2002, Thomson's scientific and
health-care division, which includes DRUGDEX, accounted for $780 million of
Thomson's $7.8 Billion in revenue.
193. One of Thomson's scientific and
health-care division's biggest operations is running continuing medical
education seminars paid by pharmaceutical companies which promote off-label
prescribing of such drug companies' drugs under patent through making false
statements exaggerating their effectiveness and downplaying their harms.[124]
194. Thomson, through DRUGDEX, makes false
statements in supporting the prescription of psychotropic drugs to children and
youth for indications not approved by the FDA.
195. Thomson's false statements supporting
the prescription of psychotropic drugs to children and youth through continuing
medication seminars and DRUGDEX for indications not approved by the FDA were
made knowing they would be used to support claims being paid or approved by
Medicaid and/or CHIP, and Thomson is liable under the False Claims Act
therefor.
Count
5:
JYS, ACMHS, SCF, North Star, Providence,
Fairbank Psychiatric, Denali, Peninsula & Bartlett Liability for Uncovered
Drugs
196. JYS, ACMHS, SCF, North Star,
Providence, Fairbank Psychiatric, Denali, Peninsula, and Bartlett (Providers)
have submitted and continue to submit, and/or have caused and continue to cause
claims to be submitted to Medicaid and/or CHIP for reimbursement of outpatient
pediatric prescriptions for psychotropic drugs that are not for an indication
that is approved by the FDA or supported by one or more of the Compendia
(1) with actual knowledge;
(2) in deliberate ignorance; or
(3) in reckless disregard
that such claims are false, and are liable under the False Claims Act
therefor.
Count
6:
Matsutani, Baisi, Dukoff, Ozer, Phillips,
Clark, Stark, Bautista, Lopez-Coonjohn, Schults, Stauffer, Rothrock and Kiele
liability For Uncovered Drugs
197. Matsutani, Baisi, Dukoff, Ozer,
Phillips, Clark, Stark, Bautista, Lopez-Coonhohn, Schults, Stauffer, Rothrock
and Kiele (Prescribers) have written and, upon information and belief, continue
to write prescriptions for pediatric prescriptions for psychotropic drugs that
are not for an indication approved by the FDA or supported by one or more of
the Compendia, thereby causing claims for such prescriptions to be made to
Medicaid and/or CHIP for reimbursement
(1) with actual knowledge;
(2) in deliberate ignorance; or
(3) in reckless disregard
that such claims are false, and are liable under the False Claims Act
therefor.
Count
7:
Prescribers Liability For Misdiagnoses
198. Prescribers make false statements
misdiagnosing children and youth for indications to justify prescribing drugs
approved by the FDA or supported by one or more of the Compendia, thereby
causing claims for such prescriptions to be made to Medicaid and/or CHIP for
reimbursement,
(1) with actual knowledge;
(2) in deliberate ignorance; or
(3) in reckless disregard
that such claims are false, and are liable under the False Claims Act
therefor.
Count
8:
Prescribers Liability for Pediatric SSRI
Prescriptions
199. Drug companies procured FDA approval
and support in the Compendia for pediatric use of SSRI antidepressants through
falsified studies or other unlawful, fraudulent conduct.
200. When writing pediatric prescriptions
for SSRI antidepressants, Prescribers
(1) had or have actual knowledge;
(2) acted or act in deliberate ignorance; or
(3) acted or act in reckless disregard
that FDA approval and support in the Compendia for pediatric use of SSRI
antidepressants was obtained through falsified studies or other unlawful,
fraudulent conduct, and are liable under the False Claims Act for such claims
made to Medicaid, including CHIP/Denali Kid Care.
Count
9:
Pediatric Risperdal Prescriptions
201. FDA approval and support in the Compendia
of Risperdal for pediatric use was the result of falsified studies or other
unlawful, fraudulent conduct.
202. At least from November 25, 2008, when
the New York Times reported that the pediatric research center established by
Dr. Biederman through funding by Johnson & Johnson, the manufacturer of
Risperdal, was established to "move forward the commercial goals" of
Johnson & Johnson and "the rationale of [the] center is to generate
and disseminate data supporting the use of risperidone in" children and
youth, Prescribers
(1) had or have actual knowledge;
(2) acted or act in deliberate ignorance; or
(3) acted or act in reckless disregard
that FDA approval and support in the Compendia for pediatric use of
Risperdal was obtained through falsified statements or other unlawful,
fraudulent conduct and are liable under the False Claims Act for claims made to
Medicaid, including CHIP/Denali Kid Care, for false claims caused by such
prescriptions.
VII.
Medicaid Claims
203. At least the following Medicaid
claims for reimbursement of pediatric psychotropic medications to Alaskan
children and youth were made for the following date ranges:[125]
204. Prior to, within, and after the time
frame of the table in the previous paragraph, the same rough pattern and magnitude
of false claims to Medicaid were made, and continue to be made.
205. Wal-Mart, Safeway, and Fred Meyer
have submitted millions of false Medicaid claims for reimbursement of pediatric
psychotropic medications as set forth herein.
206. As a result of the false statements
made by Thomson through its continuing medication programs and/or in DRUGDEX,
millions of false Medicaid claims for reimbursement of pediatric psychotropic
medications have been made.
VIII.
Defendants' Liability
207. By virtue of the acts described
above, defendants knowingly (a) submitted, (b) caused to be submitted, or (c)
authorized payment, of false or fraudulent claims to the United States
Government for payment or approval.
208. The Government, unaware of the
falsity of the claims made or caused to be made by the defendants, paid and
continues to pay the false claims.
209. By reason of the defendants' acts,
the United States has been damaged, and continues to be damaged, in substantial
amount to be determined at trial. Federal health insurance programs have paid
hundreds of thousands of such claims through State of Alaska submissions and,
through the Pharmacy Defendants, through other states, amounting to many
hundreds of millions of dollars, for reimbursement of claims for pediatric
psychotropic prescriptions that are not allowed under Medicaid.
IX.
Prayer for Relief
WHEREFORE, Plaintiff, the Law Project
for Psychiatric Rights, an Alaska non-profit corporation, requests the Court
enter the following relief:
A.
That defendants be ordered to cease
and desist from violating 31 U.S.C. §3729 et
seq.
B.
That this Court enter judgment
against Defendants in an amount equal to three times the amount of damages the
United States has sustained because of defendants' actions, plus a civil penalty
of not less than $5,500 and not more than $11,000 for each violation of 31
U.S.C. §3729;
C.
That PsychRights be awarded the
maximum amount allowed pursuant to §3730(d) of the False Claims Act.
D. That PsychRights be awarded all costs
of this action, including attorneys' fees and expenses; and
E.
That PsychRights recover such other
relief as the Court deems just and proper.
DATED:
April 27, 2009.
Law
Project for Psychiatric Rights, an Alaskan non-profit corporation
By:
James
B. Gottstein, Esq.
Law Project for
Psychiatric Rights, Inc.
406 G Street, Suite 206
Anchorage, Alaska 99501
Tel: (907) 274-7686
Fax: (907) 274-9493
E-mail:
jim.gottstein@psychrights.org
Certificate
of Service
The undersigned hereby certifies that a copy
of this Complaint and written disclosure of substantially all material evidence
and information PsychRights possesses will be served on the Government as
provided in FRCP 4.
Dated: ____________________
James
B. Gottstein, Esq.