Statement of Eli Lilly and Company on Dr. David Egilman Settlement:
September 07 2007 - 1:08PM
PR Newswire (US)
Egilman Admits Wrongdoing in Illegally Releasing Documents to New
York Times and Resolves Case to Avoid Possible Civil and Criminal
Sanctions INDIANAPOLIS, Sept. 7 /PRNewswire-FirstCall/ -- Eli Lilly
and Company has entered into a settlement agreement with Dr. David
Egilman, a former plaintiffs' expert witness in the Zyprexa(R)
product liability lawsuits, in which Dr. Egilman admitted violating
a protective order in the Zyprexa litigation and illegally passing
confidential Lilly documents to an Alaska attorney in a failed
attempt to evade the protective order. Dr. Egilman acknowledged
that his selective leaks of these documents, excerpts of which were
published and discussed in a series of articles in The New York
Times, presented an incomplete picture of Lilly's activities. "Dr.
Egilman has now confirmed in writing what Lilly has been saying
since the Times published these documents: he was selective in
which documents he released and they unfairly portrayed Lilly's
activities in its interactions with doctors, patients and the Food
and Drug Administration," said Michael J. Harrington, deputy
general counsel, Eli Lilly and Company. "We hope that putting this
issue behind us will help to ensure vulnerable patients will not be
deterred from treatment based on misleading and inaccurate
information. Our intent all along has been simply to have a fair
legal process," he added. Lilly, in return, agreed to forego
seeking criminal and civil penalties against Dr. Egilman for his
illegal activities. In this agreement, Dr. Egilman acknowledged
that: -- He requested that Lilly enter into this agreement to
resolve this dispute; -- He accepted responsibility for his
violation of the protective order covering documents that Lilly
provided in discovery; -- He intentionally and illegally provided
to attorney James Gottstein an incomplete subset of material that
was covered by a confidentiality agreement - as it had been
produced by Lilly in good faith in the process of discovery in the
Zyprexa litigation - with the understanding that Gottstein would
pass it on to Alex Berenson of The New York Times; -- He knew that
these materials painted an incomplete picture of the issues related
to Zyprexa; -- He did nothing to provide Gottstein or Berenson with
information on the health benefits of Zyprexa; and -- He knew from
experience that this illegal dissemination of materials would
benefit the plaintiffs in the Zyprexa litigation. Today's agreement
applies only to Dr. Egilman. Under it, Dr. Egilman agreed to pay
Lilly $100,000.00, which will be donated by Lilly to a charity of
its choosing, specifically the International Center for Clubhouse
Development. The International Center for Clubhouse Development is
a global resource offering communities around the world a more
holistic, inspiring and cost-effective solution for issues facing
people living with mental illness. The organization's web site is
located at http://www.iccd.org/. On February 13, 2007, the
Honorable Jack B. Weinstein, Senior Judge of the United States
District Court for the Eastern District of New York, issued a
permanent injunction against Dr. Egilman and Mr. Gottstein, who,
according to the judge, conspired with Berenson of the Times to
leak selective confidential Lilly documents to the newspaper. The
Judge's order recognized that the "selective out-of-context"
disclosure "may lead to confusion in the patient community and
undeserved reputational harm" to Lilly. In addition, it reaffirmed
the validity of the confidentiality order, as well as Lilly's
designation of its documents as confidential. Zyprexa Background
Zyprexa is indicated in the United States for the short- and
long-term treatment of schizophrenia, acute mixed and manic
episodes of bipolar I disorder, and maintenance treatment of
bipolar disorder. Since Zyprexa was introduced in 1996, it has been
prescribed to approximately 22 million people worldwide. Zyprexa is
not approved for the treatment of patients with dementia- related
psychosis. Elderly patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at an increased risk of death
compared with those patients taking a placebo. In addition,
compared to elderly patients with dementia-related psychosis taking
a placebo, there was a significantly higher incidence of
cerebrovascular adverse events in elderly patients with
dementia-related psychosis treated with Zyprexa. Hyperglycemia, in
some cases extreme and associated with ketoacidosis or hyperosmolar
coma or death, has been reported in patients treated with atypical
antipsychotics, including Zyprexa. As with all antipsychotic
medications, a rare and potentially fatal condition known as NMS
has been reported with Zyprexa. If signs and symptoms appear,
immediate discontinuation is recommended. Clinical manifestations
of NMS are hyperpyrexia, muscle rigidity, altered mental status and
evidence of autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Additional signs may include elevated creatinine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure. Also, as
with all antipsychotic treatment, prescribing should be consistent
with the need to minimize Tardive Dyskinesia (TD). The risk of
developing TD and the likelihood that it will become irreversible
are believed to increase as the duration of treatment and the total
cumulative dose of antipsychotic increase. The syndrome may remit,
partially or completely, if antipsychotic treatment is withdrawn.
The most common treatment-emergent adverse event associated with
Zyprexa in placebo-controlled, short-term schizophrenia and bipolar
mania trials was somnolence. Other common events were dizziness,
weight gain, personality disorder (COSTART term for nonaggressive
objectionable behavior), constipation, akathisia, postural
hypotension, dry mouth, asthenia, dyspepsia, increased appetite and
tremor. Full prescribing information, including a boxed warning, is
available at http://www.zyprexa.com/. Lilly, a leading
innovation-driven corporation, is developing a growing portfolio of
first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs. Additional information about Lilly is
available at http://www.lilly.com/. P-LLY Zyprexa(R) (olanzapine,
Lilly) (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
) http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
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CONTACT: Marni Lemons, +1-317-433-8990, +1-317-532-7826 mobile, or
Tarra Ryker, +1-317-276-3787, +1-317-332-7502 mobile, both of Eli
Lilly and Company
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