Janssen Pharmaceutica onder vuur in de VS wegens valse marketing van Risperdal
Soumis par Dirk Van Duppen le lun, 10/12/2007 - 03:11
De juridische tekst die volgt is voor het proces ingespannen door de Amerikaanse Staat Arkansas tegen Janssen Pharmaceutica omwille van de schade veroorzaakt aan de gezondheid van haar burgers door het anti-schizofreniemedicijn ("atypisch antipsychoticum") Risperdal (meest gebruikte antipsychoticum ook in België) op basis van frauduleuze medische informatie en bedriegelijke marketing. De totale schadeclaim voor de "citizens of Arkansas" bedraagt ongeveer 40 MILJOEN DOLLAR !!! Risperdal is ook één van de twee medicijnen van Janssen waarvan het patent binnenkort verstrijkt en die als één van de redenen werd vernoemd voor de afvloeiingen in het bedrijf in Beerse (prov. A'pen). Een ongeveer identieke klacht zou ook aangespannen zijn tegen Janssen in de Staat Massachuchetts.
* Er lopen momenteel in 15 Amerikaanse Staten gerechtelijke onderzoeken tegen de marketingpraktijken van antipsychoticaproducenten, waarvan Janssen er één is.
Hieronder volgt de lijst:
9 Staten hebben Eli Lilly gedagvaard voor Zyprexa: Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah and West Virginia.
4 Staten dagvaarden Janssen Pharmaceutica voor Risperdal: Louisiana, South Carolina, Texas and Pennsylvana
2 Staten hebben AstraZeneca gedagvaard voor Seroquel: Pennsylvania, South Carolina.
Deze drie medicijnen worden in België onder dezelfde merknaam ook courant gebruikt in de ambulante en resientiële psychiatrie en huisartsengeneeskunde.
Voor een inkijk in de rechtszaken zie:
http://www.psychsearch.net/lawsuits.html
(Bron: Parents Against TeenScreen USA; Netwerk Psychiatrie & Samenleving http://psychiatrie.blogse.nl = Vlaamse blog).
IN THE CIRCUIT COURT OF PULASKI COUNTY, ARKANSAS
STATE OF ARKANSAS ex reI. DUSTIN MCDANIEL, ATTORNEY GENERAL PLAINTIFF
vs. CASE NO. 07= (SJ,'FILE20 11./20./2007 Pat O'Brien Pulaski Ci.rcuit Cl
JANSSEN PHARMACEUTICA, INC., JANSSEN, LP and JOHNSON & JOHNSON, INC. DEFENDANTS
COMPLAINT
Plaintiff, State of Arkansas ex rel. Dustin McDaniel, Attorney General, for its Complaint
against the Defendants, states and alleges as follows:
The State brings this action on behalf of the Divisions of Behavioral Health Services
("DBHS") and Medical Services ("Medicaid") of the Arkansas Department of Human Services
("DHS"), and the Arkansas Department of Finance and Administration ("DFA"), specifically its
Employee Benefits Division ("DFAEBD"), as injured purchasers and/or reimbursers of
prescription drugs, and as representative of, and as parens patriae on behalf of the citizens of
Arkansas. Under the Arkansas Constitution and other positive law of the State, including
Arkansas's common law and including, among other laws, Ark. Code Ann. §§ 25-16-702, et
seq., 4-88-104, 4-88-201 et seq., and 20-77-901, et seq., the State is responsible for, and has a
duty to protect, the health, safety and welfare of its citizens.
The State seeks to obtain compensatory, punitive and other damages, restitution, civil
penalties, injunctive and other equitable relief against Defendants Janssen Pharmaceutica, Inc.,
Janssen, LP and Johnson & Johnson, Inc. ("Defendants"), as more fully set forth below and, in
support thereof, avers as follows:
I. PARTIES
1. The Plaintiff is the State of Arkansas, with this suit being brought by its Attorney
General, Dustin McDaniel, in the State's capacity as sovereign and in its proprietary capacity on
behalf of the DHS, DFA and as representative of, and as parens patriae on behalf of, Arkansas
citizens.
2. Defendant Janssen Pharmaceutica, Inc. ("JPI") is a Pennsylvania corporation. JPI
can be served by serving its president, Marvin Woodall at 500 Iolab Dr., Claremont,
Pennsylvania 91711. Janssen Pharmaceutica, Inc. is the general partner of Janssen, LP ("JLP").
JLP is a New Jersey Limited Partnership which can be served at its principal place of business at
1125 Trenton-Harbourton Road, Titusville, New Jersey 08560. Johnson & Johnson, Inc. is a
New Jersey Corporation which can be served at its principal place of business at One Johnson &
Johnson Plaza, New Brunswick, New Jersey 08933. Johnson & Johnson, Inc. is the parent
company of both JPI and JLP and is responsible as respondent superior for the actions of its
subsidiaries (all defendants referred to collectively herein as "Defendants").
3. The acts alleged to have been done by Defendants in Arkansas herein were
authorized, ordered done and/or ratified by Defendants' officers, directors, agents, employees or
representatives while engaged in the management, direction, control or transaction of
Defendants' business affairs
II. JURISDICTION & VENUE
4. This Court has jurisdiction over this matter pursuant to Ark. Code Ann. § 4-88-
104, § 20-77-908, § 16-4-101 and the common law of the State of Arkansas. Venue is proper
pursuant to Ark. Code Ann. § 16-106-101, § 16-106-102, § 16-60-103, § 20-77-908, § 4-88-104,
§ 4-88-112, and the common law of the State of Arkansas. The Defendants have transacted
business in the State of Arkansas.
5. Defendants did, individually or in conjunction with others, research, develop,
manufacture, create, design, test, label, sterilize, package, distribute, supply, market, sell,
promote, advertise, warn and otherwise distribute Risperidone ("Risperdal") in Arkansas and
specifically in Pulaski County.
III. INTRODUCTION
6. This is an action to recover funds expended by the State in providing medical
treatment to Medicaid, DBHS and DFAEBD participants suffering from Risperdal-related
illnesses and to recover funds expended in purchasing Risperdal or the reimbursement of
Risperdal prescriptions for uses that were not medically necessary. Many of the details and
critical facts related to Defendants' scheme are exclusively known by Defendants.
7. The State seeks to recover damages to the DFAEBD. The DFAEBD is a State-
sponsored program that administers prescription drug benefits for the State's active and retired
employees. The DFA oversees the DFAEBD. The DFAEBD reimburses pharmacies, doctors
and hospitals for prescriptions written for and dispensed to participants in the State's employee
health insurance program.
8. The State seeks to recover damages to the DBHS. The DBHS is a State-
sponsored program that purchases Risperdal or reimburses participating pharmacies for
Risperdal prescriptions for the State's mental hospitals, clinics and centers, joint State and
community sponsored mental health clinics and centers and facilities for the treatment and care
of alcohol and drug addicts. The DBHS is a direct purchaser of Risperdal for patients under its
care.
9. The State has discovered that Defendants have engaged in a protracted and willful
course of corporate misconduct and misrepresentation in violating numerous State laws, and in
actionable breach of the duties owed to the State and its citizens. Defendants have concealed
their wrongdoing from the State.
10. The State brings this action exclusively under the common law and statutes of the
State of Arkansas. No federal claims are being asserted and to the extent that any claim or
factual assertion set forth herein may be construed to have stated any claim under federal law,
such claim is expressly and undeniably disavowed and disclaimed by the State.
11. The claims asserted herein are brought solely by the State, and result from the
damages incurred by the State itself and are wholly independent of any claims that individual
users of Risperdal may have against Defendants.
12. Defendants manufacture Risperdal and promote the drug to physicians in
Arkansas through their representatives. For years, the State has incurred significant expenses
associated with the provision of necessary health care and other assistance necessary under its
Medicaid, DBHS and DFAEBD programs to citizens who suffer, or who have suffered, from
Risperdal-related injuries, diseases or sickness.
13. The State of Arkansas, as is true of many states, lacks a practical means of
ensuring that each prescription for every drug constitutes a medically necessary use of that drug.
The State thus relies on persons receiving payment and benefits to turn square corners in their
dealings with the Medicaid, DBHS and DFAEBD Programs. Nevertheless, this lack of practical
ability represents a loophole in the scheme of the Medicaid, DBHS and DFAEBD Programs.
1. 14. Defendants have recognized and aggressively exploited this loophole in two
2. 22. In part, this lawsuit describes how Defendants achieved, through a series of
ways. First Defendants have engaged in a direct, illegal, nationwide program of promotion of
unlawful acts and practices, the largest United States market share for atypical antipsychotics,
driven largely by their marketing of Risperdal for non-medically necessary uses.
23. In late 1993, Risperdal became the second atypical antipsychotic to receive FDA
approval. During the next several years, Janssen heavily marketed and promoted Risperdal for
its approved indication, treatment of adults with schizophrenia, and for multiple non-medically
necessary uses of the drug, for example, attention deficit-hyperactivity disorder (ADHD),
depression, anxiety, mood disorder, bipolar disorder, and aggression associated with late-onset
dementia. By late 1996, Defendants had significant market share for United States antipsychotic
drug use, and demonstrated the sales potential of marketing atypical antipsychotic drugs for non
medically necessary uses.
24. Medical literature dating as far back as the 1950s, and Defendants' own pre
clinical studies of Risperdal, demonstrated that Risperdal, like older antipsychotic medications,
had the potential to cause diabetes, diabetes-related injuries (e.g. weight gain and
hyperglycemia), cardiovascular and cerebrovascular complications, and other severe adverse
effects.
25. By the time Risperdal was first marketed, the neurochemical bases for the
efficacy and side-effects were generally known to Defendants, i.e., effects on dopamine,
serotonin, and histamine systems in the brain. Therefore, prior to marketing Risperdal,
Defendants should have been concerned about Risperdal causing neurological problems, weight
gain, diabetes, pancreatitis, hyperglycemia, cardiovascular complications, and metabolic
syndrome. And yet Risperdal's original label, and all label changes since, have not adequately
warned of these adverse effects.
26. Despite having been on notice, for years, of the potential for deadly diabetes-
related side effects, Defendants opted for the bare minima of clinical trials, of limited duration,
such that no side effects were likely to be revealed.
27. Further, Risperdal's pre-marketing clinical trials did not support an assertion that
it IS less likely to cause EPS than traditional antipsychotics. Upon information and belief,
Defendants' trials were designed to produce similar rates of EPS in patients sorted into placebo
groups and those taking Risperdal. In order to produce their desired result, Defendants selected
patients for the placebo groups that were already in the course of treatment with high doses of
typical antipsychotics.
28. The manifestation of EPS in a patient taking antipsychotic drugs is largely dose-
dependent. In other words, the larger the dose, the more likely EPS becomes. Further, patients
that develop EPS generally continue to experience EPS for months, even after discontinuing
antipsychotic drug treatment. Because of this, patients in Defendants' placebo groups continued
to experience EPS at the rate at which they had experienced EPS while on antipsychotic drug
treatment before participating in the trials. Meanwhile, patients in the Risperdal group
predictably developed EPS at the normal rate in a population taking antipsychotic drugs, a rate
which essentially matched the placebo Group.
29. Based on the similar levels of EPS in the placebo and Risperdal groups,
Defendants claimed, in their marketing, that patients taking Risperdal were as likely to develop
EPS as patients taking nothing and thus less likely to develop EPS than patients taking traditional
antipsychotics.
Risperdal's discontinuation because such presentations imply that the only adverse
events associated with Risperdal result from a patient being taken off the drug;
f) Defendants' claims that Risperdal is safer or more effective than other antipsychotics;
g) Defendants' claims that Risperdal "enhances daily living" or that it offers "quality
control of symptoms for daily living";
h) Defendants' claims that Risperdal can "control health-related quality oflife";
i) Defendants' failure to warn that the use of Risperdal by healthy elderly patients
created a greater potential for hepatic and renal dysfunction and cardiovascular
sensitivity;
j) Defendants' marketing Risperdal outside its education by representing that Risperdal
is a safe and effective treatment for hostility in the elderly; and
k) Defendants' claims that Risperdal is a safe and effective treatment for "psychotic
symptoms associated with a broad range of disorders," including schizophrenia,
schizophreniform disorder, schizoaffective disorder, bipolar disorder and elderly
psychosis.
33. FDA further found that Defendants' promotion of Risperdal lacked fair balance
because:
a) The risk information in its promotional literature "appears in pale and tiny font
at the bottom or back of a journal ad or other presentation, or after the closing
of a letter", thus lacking the "prominence and readability that is reasonably
comparable to the presentation of efficacy information"; and
b) It minimized important information related to tardive dyskinesia and
extrapyramidal symptoms.
34. Upon information and belief, despite studies and data that confirm the lack of
efficacy and significant health and safety risks associated with the promotion of Risperdal for the
elderly, Defendants continue this practice.
35. Prior to Risperdal's FDA approval, Defendants had a well-developed strategy to
expand the market for Risperdal beyond adult patients with schizophrenia. Upon information
and belief, Defendants sought ghost written research and paid "key opinion leaders" to support
Defendants' marketing aims. These "key opinion leaders" were nothing more than third-party
consultants and researchers who were put on Defendants' payroll to support and lend credibility
to Defendants' specious scientific and marketing representations.
36. Among these goals were plans to create a series of studies designed to illustrate
Risperdal's superior profile to both (a) placebo and (b) a representative typical antipsychotic
while providing funding to engage key opinion leaders in publication-eligible trials.
37. Defendants failed to provide a prominent warning of the increased risk of diabetes
and hyperglycemia and the need to provide patients with baseline diabetes screening and glucose
monitoring. A warning, though still inadequate, did not appear until it was forced by the FDA in
mid-September of 2003.
38. On September 11, 2003, the FDA informed all manufacturers of atypical
antipsychotic drugs, including Defendants, that due to an increasing prevalence of diabetes-
related illnesses associated with this class of drugs, all labeling must bear the following language
in the Warnings section:
Hyperglycemia, in some cases extreme and associated with ketoacidosis or
hyperosmolar coma or death, has been reported in patients treated with atypical
antipsychotics. Assessment of the relationship between atypical antipsychotic use
and glucose abnormalities is complicated by the possibility of an increased
background risk of diabetes mellitus in patients with schizophrenia and the
increasing incidence of diabetes mellitus in the general population. Given these
confounders, the relationship between atypical antipsychotic use and
hyperglycemia-related adverse events is not completely understood. However,
epidemiologic studies suggest an increased risk of treatment emergent
hyperglycemia-related adverse events in patients treated with atypical
antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in
patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on
atypical antipsychotics should be monitored regularly for worsening of glucose
control. Patients with risk factors for diabetes mellitus (e.g., obesity, family
history of diabetes) who are starting treatment with atypical antipsychotics should
undergo fasting blood glucose testing at the beginning of treatment and
periodically during treatment. Any patient treated with atypical antipsychotics
should be monitored for symptoms of hyperglycemia including polydipsia,
polyuria, polyphagia, and weakness. Patients who develop symptoms of
hyperglycemia during treatment with atypical antipsychotics should undergo
fasting blood glucose testing. In some cases, hyperglycemia has resolved when
the atypical antipsychotic was discontinued; however, some patients required
continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
39. Despite FDA's mandate that Defendants immediately warn of the dangers
described above, Defendants waited two more months, until November of 2003, to send
prescribing physicians a "Dear Doctor Letter" advising of the new warnings.
40. On April 19, 2004, that November letter was rebuked by the FDA for being
brazenly "false" and "misleading."
41. According to FDA, Defendants' November letter misled doctors by failing to
disclose information relating to hyperglycemia and diabetes mellitus, minimizing the risks of
potentially fatal hyperglycemia-related adverse events, failing to recommend regular glucose
control monitoring to identify diabetes mellitus and misleadingly claiming that Risperdal is safer
than other atypical antipsychotics.
42. FDA demanded that Defendants immediately cease the dissemination of
promotional materials for Risperdal containing claims similar to the foregoing and provide a plan
of action to correct the effects of its false and misleading letter.
43. Finally, FDA admonished Defendants that the violations detailed above did not
constitute an exhaustive list, and that it would continue to "evaluate other aspects" of
Defendants' promotional campaign for Risperdal. FDA reserved the right to determine that
"additional measures" would be necessary to "fully correct the false or misleading messages
resulting from your [Defendants'] violative conduct."
58. Risperdal reached the users and consumers thereof in substantially the same
condition which it was in when originally manufactured, distributed and sold by Defendants. At
the time Risperdal was sold or placed on the market, it was in a defective condition and
unreasonably dangerous to users and consumers.
59. The defective condition of Risperdal directly and proximately caused Arkansas
residents to suffer various Risperdal-induced diseases, injuries and sicknesses, and directly and
proximately caused the State to expend millions of dollars in order to provide necessary health
care to these citizens through its Medicaid, DBHS and DFAEBD programs, thereby directly
damaging the State.
60. At all pertinent times, it was foreseeable by Defendants that certain of the
Arkansas Medicaid, DBHS and DFAEBD participants who used Risperdal would become ill and
suffer injury, disease and sickness as a result of using Risperdal as Defendants intended, and it
was further foreseeable by Defendants that the State would be required to expend millions of
dollars each year in order to provide necessary medical treatment and facilities to those citizens.
61. Defendants individually, and through their representatives, fraudulently misled
the public, physicians treating Medicaid, DBHS and DFAEBD participants and the State, with
regard to the health risks of Risperdal, all for the purpose of increasing Defendants' profits from
the sale of Risperdal.
62. Specifically, and in addition to the allegations above, Defendants knew of the
hazards associated with Risperdal. Defendants nevertheless affirmatively and actively concealed
information which clearly demonstrated the dangers of Risperdal and affirmatively misled the
public and physicians treating Medicaid, DBHS and DFAEBD participants with regard to the
material and clear risks of Risperdal. Defendants did so with the intent that physicians treating
Medicaid, DBHS and DFAEBD participants would continue to prescribe Risperdal. However,
Defendants knew that prescribing physicians would not be in a position to discover the true risks
of Risperdal and would rely upon the misleading information that Defendants promulgated.
Defendants further knew that physicians treating Medicaid, DBHS and DFAEBD participants
would write Risperdal prescriptions that would be paid for by the State's Medicaid, DBHS and
DFAEBD programs.
63. At all pertinent times, Defendants purposefully and intentionally engaged in these
activities, and continue to do so, knowing that when the State's Medicaid, DBHS and DFAEBD
participants use Risperdal as it was and is intended to be used, that the State's Medicaid, DBHS
and DFAEBD participants would be substantially certain to suffer disease, injury and sickness,
including diabetes, stroke, pancreatitis, seizures and other illnesses, and that the State would be
directly injured thereby, all as described above.
64. Also at all pertinent times, Defendants purposefully and intentionally engaged in
these activities, and continue to do so, knowing that the State, in the absence of any such efforts
by Defendants, would be obligated to, and would, provide health care and other necessary
facilities and services for certain of the State's Medicaid, DBHS and DFAEBD participants
harmed by the intended use of Risperdal, and that the State itself would thereby be directly
harmed.
65. Upon information and belief, the statements, representations and promotional
schemes publicized by Defendants were deceptive, false, incomplete, misleading and untrue.
Defendants knew, or should have known, that their statements, representations and
advertisements were deceptive, false, incomplete, misleading and untrue at the time of making
such statements. Defendants had an economic interest in making such statements. Neither the
State nor the physicians in Arkansas who prescribed Risperdal had knowledge of the falsity or
untruth of Defendants' statements, representations and advertisements when Medicaid, DBHS
and DFAEBD claims for Risperdal were submitted; moreover, the State had a right to rely on
Defendants to act honestly when dealing with the State. Each of the Defendants' statements,
representations and advertisements were material to the State's purchase or reimbursement of
Risperdal in that the State does not intentionally cover drugs for non-medically necessary uses.
66. The State has a right to rely upon the representations of Defendants and was
directly and proximately injured by such reliance, all as described above.
67. Upon information and belief, a significant percentage of Arkansas Medicaid,
DBHS and DFAEBD participants, believed to number in the hundreds, if not thousands, suffered
serious diseases and/or potentially life-threatening medical conditions after taking Risperdal.
Such risks of use were known, or should have been known, to Defendants who failed to warn
Arkansas physicians treating Medicaid, DBHS and DFAEBD participants ofthose risks.
V. CAUSES OF ACTION
COUNT I
VIOLATION OF THE ARKANSAS MEDICAID FRAUD FALSE CLAIMS ACT
1. 68. The State incorporates by reference the foregoing allegations as if set forth at
2. 69. A significant percentage of patients who use or have used Risperdal are persons
3. 70. As entities providing goods to providers under the Arkansas Medicaid Program,
4. 71. Submission of Risperdal prescriptions to Medicaid for reimbursement constitute
length herein.
whose prescriptions are paid for in whole or in part by Medicaid.
Defendants are persons within the meaning of Ark. Code Ann. § 20-77-901 (6).
claims within the meaning of Ark. Code Ann. § 20-77-90 1(2).
72. Defendants' purposeful false statements and representations regarding the safety
and efficacy of Risperdal for non-medically necessary uses violate the Medicaid Fraud False
Claims Act. Defendants' purposeful false statements and representations regarding Risperdal
caused the submission of claims for Risperdal to Medicaid for reimbursement. Defendants'
conduct constitutes Medicaid fraud within the meaning of Ark. Code Ann. § 20-77-902(1 )-(3),
(10).
73. Defendants' have purposely offered to pay remuneration, including kickbacks,
bribes and rebates, both directly and indirectly, in cash and in kind, to physicians and
pharmacists participating in the Medicaid program. These payments were in exchange for the
recipients' submission to Medicaid of non-medically necessary claims for Risperdal.
Defendants' conduct constitutes Medicaid fraud within the meaning of Ark. Code Ann. § 20-77-
902(7)(A)(i)-(ii).
WHEREFORE, pursuant to Ark. Code Ann. § 20-77-903, the State respectfully requests
that this Honorable Court enter judgment in its favor and against Defendants and that the State be
awarded reimbursement for all expenditures made for non-medically necessary prescriptions of
Risperdal, three (3) times the amount Defendants knowingly caused to be submitted for wrongful
reimbursement of Risperdal, ten thousand dollars per false claim, the State's reasonable expenses
in enforcing the Medicaid Fraud Act and such other relief as justice and equity may require.
COUNT II
VIOLATIONS OF THE ARKANSAS MEDICAID FRAUD FALSE CLAIMS ACT
74. The State incorporates by reference the foregoing allegations as if set forth at
length herein.
75. A significant percentage of patients who use or have used Risperdal are persons
whose prescriptions are paid for in whole or in part by Medicaid.
76. As entities providing goods to providers under the Arkansas Medicaid Program,
Defendants are persons within the meaning of Ark. Code Ann. § 20-77-901 (6).
77. Submission of Risperdal prescriptions to Medicaid for reimbursement constitute
claims within the meaning of Ark. Code Ann. § 20-77-901(2).
78. Since the inception of their marketing of Risperdal, Defendants knowingly
misrepresented that Risperdal is more effective in the treatment of the negative symptoms of
schizophrenia and less likely to produce certain adverse events involving involuntary movement
disorders, which are commonly associated with antipsychotics. Defendants knew these
representations were unsubstantiated and false at the time they were made and that Risperdal is
no more effective than appropriate doses of first generation antipsychotic drugs and no less likely
to produce these adverse events. Defendants touted Risperdal's added efficacy dimension and
the reduction of these adverse events as justification for its higher cost. As a result of these
representations, and in an effort to spare their patients from experiencing these adverse effects,
Arkansas doctors treating Medicaid participants opted for Risperdal instead of less expensive
first generation antipsychotics.
79. Defendants' purposeful false statements and representations regarding the safety
and efficacy of Risperdal relative to other antipsychotics violate the Medicaid Fraud False
Claims Act. Defendants' purposeful false statements and representations regarding Risperdal
caused the submission of claims for Risperdal to Medicaid for reimbursement. Defendants'
conduct constitutes Medicaid fraud within the meaning of Ark. Code Ann. § 20-77-902 (1)-(3),
(10).
80. Defendants have purposely offered to pay remuneration, including kickbacks,
bribes and rebates, both directly and indirectly, in cash and in kind, to physicians and
pharmacists participating in the Medicaid program. These payments were in exchange for the
recipients' submission to Medicaid of claims for Risperdal instead of claims for less expensive
antipsychotics. Defendants' conduct constitutes Medicaid fraud within the meaning of Ark.
Code Ann. § 20-77-902 (7)(A)(i)-(ii).
WHEREFORE, pursuant to Ark. Code Ann. § 20-77-903, the State respectfully requests
that this Honorable Court enter judgment in its favor and against Defendants and that the State be
awarded reimbursement for the amount of the incremental cost of reimbursement for Risperdal
instead of available first generation antipsychotics, three (3) times the amount Defendants
knowingly caused to be submitted for wrongful reimbursement of Risperdal, ten thousand dollars
per false claim, the State's reasonable expenses in enforcing the Medicaid Fraud Act and such
other relief as justice and equity may require.
COUNT III
RECOVERY OF THE COST OF TREATMENT FOR INJURIES CAUSED BY RISPERDAL
1. 81. The State incorporates by reference the foregoing allegations as if set forth at
2. 82. The method by which Risperdal was marketed in Arkansas rendered it defective
3. 83. The design and/or manufacture of Risperdal rendered it a dangerously defective
length herein.
and unreasonably dangerous.
drug in that its use causes dangerous, and potentially life-threatening, medical conditions when
taken as recommended by Defendants and such risks were not generally known by Arkansas
physicians, the State and/or Arkansas Medicaid, DBHS and DFAEBD participants.
84. Risperdal was a dangerously defective drug in that Defendants failed to conduct
adequate pre-marketing testing, notwithstanding the known side effects associated with
Risperdal and anti-psychotic medications generally.
85. Risperdal was dangerously defective because it lacked a sufficient warning of the
risks associated with its use and also because:
(a) the lack of an adequate warning caused Arkansas physicians treating
Medicaid, DBHS and DFAEBD participants to prescribe Risperdal in
inappropriate circumstances and on inappropriate classes of patients;
(b) Defendants had a duty to warn Arkansas physicians treating Medicaid,
DBHS and DFAEBD participants of the risks and potentially life threatening side effects associated with Risperdal use and failed to do so;
and
(c) the warning and/or labeling provided by Defendants for Risperdal failed to
include the risks and or potentially life-threatening side effects associated
with Risperdal use that were known to, or readily ascertainable by,
Defendants and such risks were concealed from Arkansas physicians
treating Medicaid, DBHS and DFAEBD pmiicipants.
86. Risperdal is abnormally and unreasonably dangerous as marketed III that the
health risks and costs associated with Risperdal greatly outweigh any claimed utility of Risperdal
to the State and its Medicaid, DBHS and DFAEBD participants.
87. Risperdal reached the users and consumers thereof in substantially the same
condition that it was when originally manufactured, distributed and sold by Defendants. At the
time Risperdal was sold or placed- on the market, it was in a defective condition and
unreasonably dangerous to Arkansas Medicaid, DBHS and DFAEBD participants.
88. Arkansas Medicaid, DBHS and DFAEBD participants, and their physicians, used
Risperdal in the manner in which it was intended to be used, without any substantive alteration
or change in the product.
89. As a result of Risperdal's defective nature, certain Arkansans whose care IS
provided by Medicaid, DBHS and DFAEBD were injured.
90. The State was forced to expend significant sums of money, through its Medicaid,
DBHS and DFAEBD programs, to treat Medicaid, DBHS and DFAEBD participants who
sustained Risperdal-related injuries.
91. The State is entitled to recover the costs of such treatment as parens patriae.
WHEREFORE, the State respectfully requests that this Honorable Court enter judgment
in its favor and against Defendants and award the State compensatory damages and any other
relief as justice may require.
COUNT IV
VIOLATlON OF THE ARKANSAS DECEPTIVE TRADE PRACTICES ACT
1. 92. The State incorporates by reference the foregoing allegations as if set forth at
2. 93. By labeling, distributing, marketing, promoting and selling Risperdal through length herein.
Arkansas physicians and pharmacies to the State, and Arkansas consumers, Defendants are
engaging in trade or commerce directly, or indirectly, affecting the people of the State.
1. 94. Pursuant to the Arkansas Deceptive Trade Practices Act ("DTPA"), Ark. Code
2. 95. Defendants have repeatedly and wi11:fully engaged in the following conduct which
Ann. § 4-88-113, the Arkansas Attorney General has the authority to seek restitution and
penalties for violations thereof.
constitutes a deceptive trade practice and a violation of the DTPA:
(a) Misrepresenting that Risperdal is safe and effective for indications for
which safety and efficacy had not been demonstrated which caused
Arkansas physicians treating Medicaid, DBHS and DFAEBD participants
to prescribe Risperdal in inappropriate, non-medically necessary
circumstances;
(b) Making false and misleading misrepresentations of fact regarding
Risperdal's risk profile, including but not limited to misrepresenting the
likelihood and severity of the side effects associated with Risperdal,
including diabetes, stroke, high blood pressure, weight gain and other
serious and potentially life-threatening conditions;
(c) Misrepresenting and concealing material facts and/or failing to inform and
educate Arkansas physicians as to the risks and dangers associated with
Risperdal use when such facts were well known to, or readily
ascertainable by, Defendants;
(d) Misrepresenting and concealing material facts which were known to
Defendants, and unknown to Arkansas physicians, when Defendants knew
that Arkansas physicians rely on such facts when deciding whether to
prescribe Risperdal to their patients;
.(e) Misrepresenting that Risperdal is safer and more effective than less
.expensive first generation antipsychotics;
.(f) Misrepresenting Risperdal as being of a particular standard, quality or
.grade when it is not; and
.(g) Intentionally creating a likelihood of confusion or misunderstanding in the minds of Arkansas physicians as to whether Risperdal was safe or
medically necessary for Medicaid, DBHS and DFAEBD participants.
1. 96. Due to the secrecy of the foregoing conduct, the State has only recently been
2. 97. Defendants made, and continue to make, orally and in writing, false, misleading
made aware of its actionable nature.
or deceptive representations in advertisements, promotions and statements, and otherwise
disseminated, and continue to disseminate, false, misleading or deceptive information to the
public, including Arkansas citizens, physicians and the State regarding non-medically necessary
uses of Risperdal and the health risks and benefits associated with using Risperdal.
98. Moreover, as detailed above, Defendants have violated Arkansas Code Ann. § 4-
88-201 et seq. in that Defendants have targeted "elder or disabled persons," as such persons are
defined in the statute, through Defendants' violations of the DTPA described above, and have
actually committed such DTPA violations against such elder or disabled persons. Defendants
knew or should have known that their conduct was directed to elder or disabled persons, such
conduct was in disregard of the rights of the elder or disabled persons, the elder or disabled
persons were more vulnerable to the Defendants' conduct because of age, poor health, infirmity,
impaired understanding, restricted mobility, and/or disability than other persons, and the elder or
disabled persons actually suffered substantial physical, emotional, or economic damage resulting
from the Defendants' conduct. In addition to any civil penalty otherwise set forth or imposed by
the Court, the Court should impose an additional civil penalty of ten thousand dollars ($10,000)
for each violation, or such other amount as the Court finds just and appropriate not to exceed ten
thousand dollars ($10,000).
99. Defendants acted knowingly in committing the violations of the DTPA described
herein.
100. Each Risperdal prescription written without an adequate warnmg, for a non-
medically necessary use or where a first generation antipsychotic was available constitutes a
separate and distinct violation of the DTPA.
101. As a consequence of Defendants' illegal and deceptive sales and marketing
practices, the State made monetary expenditures on behalf of Arkansas Medicaid, DBHS and
DFAEBD participants who were prescribed Risperdal for conditions which were not medically
necessary and/or where a first generation antipsychotic was as safe and effective and less
expensIve.
102. As a consequence of Defendants' illegal and deceptive sales and marketing
practices, Arkansas consumers who were prescribed Risperdal expended money for conditions
which were not medically necessary and/or where a first generation antipsychotic was as safe
and effective and less expensive.
103. As a further consequence of Defendants' illegal and deceptive sales and
marketing practices, many Arkansas Medicaid, DBHS and DFAEBD participants, including
children and elderly, were prescribed Risperdal by their physicians and sustained serious and
potentially life-threatening side effects.
104. The State was forced to expend significant sums of money for the treatment of
those Arkansas Medicaid, DBHS and DFAEBD participants who sustained serious and
potentially life-threatening side injuries as a result of using Risperdal.
105. The Attorney General has determined that the imposition of an injunction against
Defendants prohibiting the conduct set forth herein is in the public interest.
106. The State seeks the entry of a permanent injunction prohibiting Defendants'
unlawful and deceptive conduct and the imposition of all appropriate remedies available under
the DTPA.
107. The State seeks restitution for all expenditures incurred by it resulting from non
medically necessary or non-medically accepted uses of Risperdal caused by Defendants'
unlawful and deceptive sales and marketing practices and the difference in cost between the
State's expenses for Risperdal and what the State would have spent on first generation
antipsychotics, absent Defendants' violations ofthe DTPA.
108. The State seeks compensatory damages for all State expenditures resulting from
the treatment of those Arkansas Medicaid, DBHS and DFAEBD participants who sustained
injuries, side effects and/or adverse medical events after using Risperdal.
WHEREFORE, the State respectfully requests that this Honorable Court enter judgment
in its favor and against Defendants and also seeks;
(a) a permanent injunction preventing Defendants from deceptively marketing
and/or promoting Risperdal as appropriate for non-medically necessary
uses;
(b) restitution of all State expenditures for prescriptions caused by
Defendants' deceptive marketing and/or promotion of Risperdal;
.(c) compensatory damages for all expenditures made by the State on behalf of
Arkansas Medicaid, DBHS and DFAEBD participants who sustained
injuries associated with Risperdal use;
.(d) imposition of $10,000 civil penalty for each method, act or practice
.deemed to violate the Act;
.(e) imposition of an additional $10,000 civil penalty for each DTPA violation
.committed against an elder or disabled person;
.(f) the State's reasonable expenses in prosecuting the Act; and
.(g) such other relief as justice and equity may require.
COUNT V
NEGLIGENCE
109. The State incorporates by reference the foregoing allegations as if set forth at
length herein.
110. Defendants owed the State a duty to use reasonable care III the design,
manufacture and marketing of its product, Risperdal.
111. Defendants negligently, carelessly, recklessly, willfully and/or intentionally
engaged in the following conduct:
.(a) Marketing and/or promoting Risperdal for non-medically necessary uses;
.(b) Failing to adhere to all applicable laws and regulations pertaining to the marketing, promotion and/or labeling of pharmaceutical products, such as
Risperdal;
.(c) Marketing and/or promoting Risperdal as appropriate for children;
.(d) Failing to adequately train their sales force so that when Arkansas
physicians treating Medicaid, DBHS and DFAEBD participants raised
safety concerns regarding Risperdal important safety information was
withheld;
(e) Supplying a product that they knew, or should have known, contained
inadequate warnings of side effects and risks that were known to, or based
on facts available to Defendants;
(f) Supplying a product lacking sufficient warnings and/or instructions when
they knew, or should have known, the side effects associated with
Risperdal were not generally known by Arkansas physicians treating
Medicaid, DBHS and DFAEBD participants;
(g) Representing that Risperdal was safer than less expensive, first generation
antipsychotics;
.(h) Continuing to promote, market and/or sell Risperdal after they knew, or should have known, of the serious side effects and risks associated with
Risperdal use;
(i) Allowing Risperdal to be used indiscriminately for uses which are not
medically appropriate; and
.(j) Not disclosing data pertaining to such use.
112. Defendants' negligent, careless, reckless, willful and/or intentional conduct was
the proximate cause of injuries and damages sustained by the State.
113. At all relevant times, Defendants knew, or should have known, that Risperdal
was, and is, hazardous to human health.
114. Risperdal is abnormally and unreasonably dangerous as marketed in that the
health risks and costs associated with Risperdal greatly outweigh any claimed utility of Risperdal
to Medicaid, DBHS and DFAEBD participants.
115. As a direct result of the umeasonable marketing practices of Defendants,
Risperdal was, and is, defective and umeasonably dangerous.
116. Risperdal reached the users and consumers thereof in substantially the same
condition as when originally manufactured, distributed and sold by Defendants. At the time
Risperdal was sold or placed on the market, it was in a defective condition and umeasonably
dangerous to Medicaid, DBHS and DFAEBD participants.
117. Arkansas Medicaid, DBHS and DFAEBD participants used Risperdal in the
manner in which it was intended to be used, without any substantive alteration or change in the
product.
118. Due to the negligent, careless, reckless, willful and/or intentional conduct of
Defendants, as set forth above, the State expended millions of dollars of Medicaid, DBHS and
DFAEBD funds in purchasing Risperdal prescriptions and was also forced to expend significant
sums of money for the care and treatment of Arkansas Medicaid, DBHS and DFAEBD
participants injured by Risperdal, all of which was foreseeable to Defendants.
119. The reprehensible nature of Defendants' conduct entitles the State to an award of
punitive damages.
WHEREFORE, the State respectfully requests that this Honorable Comi enter judgment
in its favor and against Defendants and award the State compensatory and punitive damages and
any other relief as justice may require.
COUNT VI
BREACH OF WARRANTY
120. The State incorporates by reference the foregoing allegations as if set forth at
length herein.
121. Through their sales and marketing practices to Arkansas physicians treating
Medicaid, DBHS and DFAEBD participants, Defendants warranted that Risperdal was fit and
appropriate for patients suffering from conditions for which it was not proven safe and effective.
122. Through their sales and marketing practices to Arkansas physicians treating
Medicaid, DBHS and DFAEBD participants, Defendants warranted that Risperdal had no
significant risks or side effects that were not identified on its labeling. Defendants further
warranted that Risperdal was safer than less expensive, first generation antipsychotics.
123. Arkansas physicians treating Medicaid, DBHS and DFAEBD participants relied
on the warranties made by Defendants regarding the appropriate uses and safety profile for
Risperdal.
124. Defendants breached the express and implied warranties they made to the State,
through Arkansas physicians treating Medicaid, DBHS and DFAEBD participants, since the
product was not appropriate for many of the uses for which it was promoted. Also, Risperdal is
far less safe than warranted by Defendants.
125. The State expended millions of dollars in Medicaid, DBHS and DFAEBD
expenditures for non-medically necessary uses of Risperdal and in purchasing Risperdal when a
less expensive, first generation antipsychotic was available. The State also spent significant
sums of money, through its Medicaid, DBHS and DFAEBD programs, for medical treatment for
those Arkansas citizens who developed serious side effects and/or adverse reactions after using
Risperdal. The State's expenses were caused by Defendants' express and implied warranties.
WHEREFORE, the State respectfully requests that this Honorable Court enter judgment
in its favor and against Defendants and award the State compensatory damages and any other
relief as justice may require.
COUNT VII
FRAUD & MISREPRESENTATION
126. The State incorporates by reference the foregoing allegations as if set forth at
length herein.
127. As part of their promotion of Risperdal, Defendants, through their sales
representatives and other advertising and promotion, willfully, knowingly and deceptively
communicated to Arkansas physicians treating Medicaid, DBHS and DFAEBD participants that
Risperdal was safe and effective for non-medically necessary uses and that it was safer and more
effective than less expensive first generation antipsychotics, all of which were knowingly false.
128. Defendants had a duty to disclose the conditions for which Risperdal was
arguably proven safe and effective, and not to go beyond those uses in their sales and marketing
to Arkansas physicians, the intermediary between Defendants and the State.
129. Defendants intended to induce Arkansas physicians treating Medicaid, DBHS and
DFAEBD participants to prescribe Risperdal for Arkansas Medicaid, DBHS and DFAEBD
participants for whom Risperdal was not medically necessary.
130. Arkansas physicians treating Medicaid, DBHS and DFAEBD participants as well
as the State, were justified in relying on Defendants to educate the physicians as to the
appropriate uses and risks of Risperdal.
131. The State, through its Medicaid, DBHS and DFAEBD programs, was forced to
expend significant amounts of money for non-medically necessary Risperdal prescriptions which
were directly caused by the fraudulent and misleading statements of Defendants.
132. Defendants willfully, knowingly and deceptively withheld material facts
regarding the risks and side effects associated with Risperdal use from Arkansas physicians
treating Medicaid, DBHS and DFAEBD participants.
133. Defendants had a duty to disclose known risks and side effects associated with
Risperdal use, particularly, but not solely, when specifically asked about those risks by Arkansas
physicians.
134. Defendants intentionally withheld information regarding the safety risks and side
effects associated with Risperdal use with the intention of inducing Arkansas physicians to
prescribe Risperdal for Arkansas Medicaid, DBHS and DFAEBD participants in greater
quantities than they otherwise would have, or was otherwise appropriate.
135. Arkansas physicians treating Medicaid, DBHS and DFAEBD participants, as well
as the State, were justified in their reliance on Defendants to educate them as to the risks and
dangerous and potentially life-threatening side effects associated with Risperdal use.
136. Defendants knew that the State and Arkansas Medicaid, DBHS and DFAEBD
participants would not be in a position to discover and understand the true risks of using
Risperdal, and the public relied upon the misleading information that Defendants promulgated to
Arkansas physicians to the detriment of the State.
137. Defendants knew that the representations that were relied upon by Arkansas
physicians treating Medicaid, DBHS and DFAEBD participants were false or were made
recklessly without any knowledge of the truth.
138. Each of Defendants' misleading and deceptive statements, representations and
advertisements related to non-medically necessary and other inappropriate uses of Risperdal
were material to the State's purchase of Risperdal in that the State would not have been required
to reimburse pharmacies for many non-medically necessary uses of Risperdal if Defendants had
marketed Risperdal legally.
139. The State, through its Medicaid, DBHS and DFAEBD programs, was forced to
expend significant amounts of money to treat Arkansas citizens who contracted serious and
potentially life-threatening medical conditions resulting from Defendants' deceptive withholding
of adequate safety information regarding Risperdal use and/or misrepresenting Risperdal's safety
profile.
WHEREFORE, the State respectfully requests that this Honorable Court enter judgment
in its favor and against Defendants and award the State compensatory and punitive damages and
any other relief as justice may require.
COUNT VIII
UNJUST ENRICHMENT
140. The State incorporates by reference the foregoing allegations as if set forth at
length herein.
141. Defendants knowingly, willfully and intentionally marketed and promoted
Risperdal for conditions and illnesses for which it was not medically necessary.
142. Defendants knowingly, willfully and intentionally withheld information from
Arkansas physicians treating Medicaid, DBHS and DFAEBD participants regarding the risks
associated with Risperdal use.
143. As a result of the deceptive marketing practices of Defendants, Arkansas
physicians treating Medicaid, DBHS and DFAEBD participants prescribed Risperdal in far
greater numbers than would have been generated absent Defendants' deceptive and illegal
conduct. The inflated levels of Risperdal reimbursement for Medicaid, DBHS and DFAEBD
participants resulted in a financial windfall for Defendants.
144. The State paid, reimbursed and/or otherwise conferred a benefit upon Defendants
to the extent of the inflated numbers of Risperdal prescriptions that directly resulted from
Defendants' fraudulent marketing practices relative to Arkansas Medicaid, DBHS and DFAEBD
participants who were not suffering from illnesses for which Risperdal is the medically necessary
treatment.
145. Further, Defendants have been unjustly enriched as a result of their false
representations that Risperdal is safer and more effective than less expensive, first generation
antipsychotics. The State would have purchased far less Risperdal in the absence of Defendants'
fraudulent representations.
146. Defendants have been unjustly enriched to the extent of the increased revenue
received by Defendants from Risperdal prescriptions that were ultimately reimbursed by the
State and resulted from Defendants' deceptive and illegal marketing program and disgorgement
of those profits is appropriate.
WHEREFORE, the State respectfully requests that this Honorable Court enter judgment
in its favor and against Defendants and that Defendants be required to make restitution to the
State for all expenditures made for non-medically necessary prescriptions of Risperdal as well as
the incremental cost of reimbursing for Risperdal instead of less expensive first generation
antipsychotics and such other relief as justice and equity may require.
REQUEST FOR JURY TRIAL
The State respectfully requests that all issues presented by its above Complaint be tried
before a jury, with the exception of those issues that, by law, must be tried before the court.
