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Makers of Zyprexa Risperdal and Seroquel Under Fire
Washington, DC: Eli Lilly, Johnson
& Johnson, and AstraZeneca, are all named defendants in a new
lawsuit filed by the state of Pennsylvania on February 26, 2007, to
recover money paid through public health care programs to purchase Zyprexa, Risperdal, and Seroquel, and the costs of medical care for the people injured by these drugs.
Pennsylvania is the 5th state to sue Lilly over its illegal marketing
of Zyprexa. And according to SEC filings, Lilly was served with four
Canadian lawsuits in 2005, with claims "similar to those in the
litigation pending in the United States."
So far, two states have sued Johnson & Johnson over Risperdal, but
Pennsylvania is the first state to file a lawsuit against
The drugs belong to a class known as "atypical" antipsychotics, FDA
approved only to treat adults with schizophrenia or bipolar disorder,
and yet they are some of the most widely prescribed drugs in the world.
In 2006, Zyprexa sales were $4.3 billion, Seroquel's earned $3.4
billion, and Risperdal had sales of $4.1 billion, according to SEC
A July 2006, report by Decision Resources, a leading advisory firm on
healthcare issues, listed antipsychotics in 2005, as the
fourth-highest-ranking class of drugs, and said two of the top ten
drugs in worldwide sales were atypicals.
According to the lawsuit, the defendant drug makers concealed the risks
of atypicals and exaggerated their benefits while persuading doctors to
prescribe the drugs off-label for dementia, attention deficit
disorders, and mood and behavior disorders.
When the FDA approves a drug it also approves the label, which lists
the indications for which the drug can be prescribed, along with
instructions for use and warnings about the risks associated with the
drug. Once a drug is approved to treat one condition, doctors may
prescribe it for others if they think it will be effective, but by law
drug companies are not allowed to influence physicians to prescribe a
drug for indications other than those listed on the label.
On March 1, 2007, four days after the Pennsylvania lawsuit was filed,
two of the three drug companies became the target of another
investigation, when Representative, Henry Waxman (D-Cal), the chairman
of the House Oversight and Government Reform Committee, sent letters to
Eli Lilly and AstraZeneca, requesting information related to the exact
same charges alleged in lawsuits filed by individual states.
The letter sent to Lilly states in part, "Allegations have been raised
that Eli Lilly misled physicians and inappropriately promoted off-label
uses of Zyprexa," and requests information relevant to these
The letter asks for a list of all Zyprexa trials, studies, or reports;
all presentations given to employees who promoted Zyprexa; information
shown to physicians; presentations related to physician prescribing
patterns, continuing medical education, and off-label use; and all
documents and correspondence related to funding for nonprofit
professional organizations or consumer patient groups.
In addition, Rep Waxman wants Lilly to turn over all internal company
documents that were kept under seal for years with a court order, but
were provided to him by Attorney, James Gottstein, in December 2006,
which Rep Waxman subsequently returned to Lilly on December 21, 2006,
to honor the court order.
According to the New York Times, some of these documents reveal that
Lilly knew about Zyprexa's link to high blood sugar and extreme weight
gain that often leads to diabetes, and others show the details of
off-label marketing scheme called "Viva Zyprexa."
Rep Waxman's letter to AstraZeneca basically asks for the same
documents requested from Lilly except that he requests more information
related to the physicians and authors involved in company sponsored
studies and writing the reports.
Late last year, the atypical makers also received subpoenas from the
attorney general of California seeking much of the same information.
In pursuing the Pennsylvania lawsuit, Governor Edward Rendell, has
hired private attorneys. According to the complaint, the defendants
cost Pennsylvania millions of dollars "for non-medically accepted
indications and non-medically necessary uses of Zyprexa, Seroquel and
Risperdal," as well as "significant sums of money for the care and
treatment" of patients injured by the drugs.
The Pennsylvania case comes on the heels of lawsuits by two
Pennsylvania whistleblowers, Allen Jones and Stefan Kruszewski, who
say, drug companies are making a fortune from the off-label sale of
drugs to patients whose care is funded by Medicaid and Medicare.
At the heart of the off-label scheme, they say, are the preferred drug
lists, or medication formularies, maintained in many states. Once drugs
are added to the list, they must be prescribed as a first line of
treatment for all patients in state run institutions and patients in
the general population who are covered by public health care programs.
In the summer of 2002, psychiatrist, Dr Kruszewski, was employed with
the Pennsylvania Department of Public Welfare, and charged with
reviewing psychiatric care provided by state-funded agencies to
identify waste, fraud, and abuse. He was also responsible for reviewing
the deaths of individuals in state care who died under suspicious
circumstances in facilities inside and outside of Pennsylvania.
Early in his investigation, Dr Kruszewski noticed that almost all of
the patients under state care were on drug cocktails consisting of
antipsychotics, antidepressants, and anticonvulsants. The populations
he found drugged most often, he said, were children in state care, the
disabled, people in state prisons, and children in the juvenile justice
For instance, he says, Neurontin was only approved for controlling
seizures, but "was being prescribed for anxiety, social phobia, PTSD,
oppositional defiant behavior, and attention deficit disorder with no
evidence to support these uses."
When he informed his superiors about the high rate of off-label
prescribing and warned about the risk of liability to the state of
Pennsylvania if it continued, he was told, "it is none of your
In June 2003, Dr Kruszewski inspected a facility in Oklahoma that
housed children from Pennsylvania after an unexpected death of a child,
and found children were being overmedicated and housed in deplorable
living conditions, in addition to being sexually and physically abused
by staff and kept in unnecessary restraints and seclusion.
In a report, Dr Kruszewski recommended removing the children from the
facility, "in order to protect other innocent individuals from morbid
and mortal consequences of severe over-medication, including chemical
restraints; emotional, physical and sexual abuse; seclusion; and dirty
and inadequate living conditions."
A day later, Dr Kruszewski was accused of "trying to dig up dirt," and
was subsequently fired in July 2004, because he refused to keep quiet
and accept that it was none of his business, he says.
A year later, Dr Kruszewski filed a whistleblower lawsuit alleging that
patients under state care were being drugged for profit and prescribed
as many as 5 psychiatric drugs at the same time, and that four children
and one adult had died.
In his action, Dr Kruszewski alleged that his superiors violated his
right to free speech by firing him because he made statements about the
abuses in the state system, which were a matter of public concern.
Dr Kruszewski is represented by attorneys from Government
Accountability Project, Thad Guyer, Stephania Ayers, Tom Devine, and
Mark Cohen, in Federal Court in the Middle District of Pennsylvania
with Chief Judge Yvette Kane presiding.
Defendant, Christopher Gorton, is the Chief Medical Officer for DPW,
who fired Dr Kruszewski. He filed a motion for summary judgment to
dismiss the First Amendment claim on the basis that the law does not
protect whistleblowers if they are fired for making comments they would
be expected to make in the context of their employment.
In reading the Court's March 2, 2007, Decision denying Mr Gorton's
motion, it appears that Mr Gorton tried to have it both ways. When Dr
Kruszewski was employed and tried to report the harm to people under
state care, he was told it was none of his business and to quit digging
up dirt. Under oath in a deposition, Dr Kruszewski stated that he was
told that the subjects of his statements were not part of his job
However, in his motion, Mr Gorton now claims that Dr Kruszewski's
comments were made pursuant to his official employment duties. In her
written opinion, Judge Kane, quoted relevant case law to describe
comments that are protected:
"A public employee's statement is protected activity when (1) in making
it, the employee spoke as a citizen, (2) the statement involved a
matter of public concern, and (3) the government employer did not have
an adequate justification for treating the employee different from any
other member of the general public as a result of the statement he
"The statements in question can be categorized," Judge Kane wrote, "as:
(1) reports regarding poor quality of care, including abuse of patients
by staff at treatment facilities; (2) complaints about the lack of
qualifications of another private contract doctor; and (3) statements
about use and costs of medications."
In order to grant a motion for summary judgment, a judge has to find
that there are no genuine disputes of material fact that would require
a jury to resolve. In this case, Judge Kane found there were disputes
regarding Dr Kruszewski's job duties and whether his statements were
substantial and motivating factors in his termination.
In his motion, Mr Gorton claims the statements were not protected
speech, but then says, even if they were, they were not a factor in his
decision to terminate Dr Kruszewski, because he was unaware of the
statements when he decided to fire Dr Kruszewski.
However, Judge Kane found evidence in the record that, "if credited by
a fact-finder," she wrote, "would support Plaintiff's claim that Gorton
knew of at least some of Plaintiff's protected statements."
"Because there remain genuine disputes of material fact," she states,
"regarding Plaintiff's job duties and whether Plaintiff's statements
were substantial and motivating factors in his termination, the Court
cannot grant summary judgment for Defendant Gorton."
According to Dr Kruszewski, apart from all the legal wrangling, his
focus remains on trying to protect Pennsylvania citizens against
unwarranted drugging, sexual and physical abuse, and unnecessary
restraint and seclusion.
His original lawsuit alleges that drug companies used "political
friendships, money, and other emoluments" to achieve "a level of
influence with Pennsylvania's state government" to promote "the use of
These charges echo those previously made by the other Pennsylvania
whistleblower, Allen Jones, who was also a fraud investigator in the
Pennsylvania Office of Inspector General, Bureau of Special
Investigations, and was fired after he informed his superiors that drug
companies were funneling money to state officials and policy makers in
positions of influence over the state's preferred drug formulary known
Last year, Mr Jones settled a whistleblower lawsuit in Pennsylvania,
also with the assistance of the Government Accountability Project.
While he did not agree to a gag order regarding his concerns, he did
agree not to discuss the terms of the settlement.
During his investigation, Mr Jones found collusion between drug
companies and several state officials and specifically, Steven
Fiorello, Pennsylvania's chief pharmacist, a valuable player because he
monitored pharmacy operations at 9 state hospitals and served on the
committee that determined which drugs would be prescribed to patients
in state hospitals.
On November 21, 2006, Mr Fiorello was arraigned on two felony counts of
conflict of interest and misdemeanor counts of accepting money and
failing to disclose the income on his yearly financial interest
A year and a half earlier, the Pennsylvania State Ethics Commission had
determined that Mr Fiorello had repeatedly violated state ethic laws by
using his position to earn money from drug companies. To settle the
charges with the Ethics Commission, Mr Fiorello paid fines totaling
$27,269, before the case was referred for criminal prosecution.
Down in Texas, another state official, Dr Steven Shon was fired from
his job in October 2006, after the state's attorney general, Greg
Abbot, found J&J had improperly influenced Dr Shon to list
Risperdal in a state formulary called the "Texas Medication Algorithm
Project," or TMAP, while receiving money from J&J.
In December 2006, Mr Abbott joined another whistleblower lawsuit filed
by Mr Jones, against J&J, alleging in part, that the company
misrepresented the safety and effectiveness of Risperdal and unduly
influenced Dr Shon and others, to make it a drug of choice for persons
covered by public health care programs in Texas.
TMAP required doctors to prescribe atypicals rather than the older,
less expensive antipsychotics. "The plan," Mr Jones explains, "was part
of a larger scheme designed to infiltrate public institutions to
influence prescribing practices in which drug companies bought the
opinions of a few key doctors and state policymakers, and opened the
door for spending billions of tax dollars on dangerous drugs."
The Texas lawsuit describes exactly how the TMAP preferred drug list
was developed in Texas in 1997, and according to the complaint, Dr Shon
traveled around the country at J&J's expense to convince officials
in other states to adopt the TMAP model, which is now used in 17 states.
The lawsuit says, J&J promoted Risperdal by influencing
policymakers with trips, perks, travel expenses, speaking fees and
other payments and that Risperdal was recommended as the drug of choice
for children, even though it was not approved for use with children.
TMAP was highly successful in getting doctors to prescribe atypicals to
kids. According to an investigation of psychiatric drug use by Texas
children on Medicaid, ACS-Heritage, a medical consulting firm, found
19,404 teens were prescribed an antipsychotic in July or August of
2004, with nearly 98% being atypicals.
ACS also found that more than half of the doses were inappropriately
high, almost half of the prescriptions did not appear to have diagnoses
warranting their use, and one-third of the children were on two or more
The Texas lawsuit alleges that J&J concealed Risperdal's link to
hyperglycemia, stroke, and renal failure, to qualify for reimbursement
under Medicaid, and that Texas seeks to recover money paid to purchase
the drug for off-label uses and the cost of medical care for the people
injured by Risperdal.
In 2005 alone, according to the Texas Health and Human Services
Commission, Texas paid for approximately 308,000 Risperdal
prescriptions at a cost of $73.5 million.
Critics say, the Governor of Pennsylvania is suing atypicals makers now
to portray a hard stance against the pharmaceutical industry because he
wants to run for higher office, when in reality, he has known about the
PennMap off-label scheme for years.
The consensus is that Mr Rendell believes he missed a chance for
national prominence by allowing the two whistleblowers to be fired and
sweeping the results of their investigations under the rug. Critics
point out that PennMap is still in place even though TMAP has been
discredited in Texas and other states.
In November 2005, USA Today quoted FDA Drug Safety Officer, Dr David
Graham's estimate that 62,000 Americans die each year from the
off-label prescribing of atypicals. According to Mr Jones, this
translates into nearly 10,000 deaths occurring in Pennsylvania during
Governor Rendell's first term.
During a congressional hearing last month, Dr Graham testified that the
off-label use of atypicals to sedate people in nursing home kills
roughly 15,000 people a year. Based on this estimate, Mr Jones says,
about 2,400 Pennsylvania senior citizens died in the Governor's first
"During this time," Mr Jones reports, "Pennsylvania citizens, insurers
and taxpayers paid in the neighborhood of one billion dollars for drugs
proven to be no more effective, and far more deadly, than the older
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