Eli Lilly and Company Statement: Judge Grants Lilly's Request for a Permanent Injunction Involving Misleading Selection of Illeg
February 14 2007 - 11:48AM
PR Newswire (US)
INDIANAPOLIS, Feb. 14 /PRNewswire-FirstCall/ -- Yesterday, the
Honorable Jack B. Weinstein, Senior Judge of the United States
District Court for the Eastern District of New York, granted Eli
Lilly and Company's request and issued a permanent injunction
against several individuals, including Dr. David Egilman (a
plaintiffs' expert witness in the Zyprexa product liability
lawsuits) and attorney James Gottstein, who, according to the
judge, conspired with journalist Alex Berenson of The New York
Times to leak selective confidential Lilly documents to the
newspaper. The injunction prohibits Dr. Egilman, Mr. Gottstein and
eight other individuals from further distributing the documents,
and it requires that each return to the court all such documents
and any copies of them in their possession. Robert A. Armitage,
Lilly's Senior Vice President and General Counsel said, "Lilly is
pleased that Judge Weinstein vindicated the rights of Lilly and the
needs of those individuals with mental illness, their doctors and
their families. This ruling reaffirms the validity of the
protective order so that litigation can proceed in a fair and
lawful manner, but it will also help ensure vulnerable patients
will not be deterred from treatment based on misleading and
inaccurate information." 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.
"Judge Weinstein recognized that the confidentiality order
protected not only Lilly's confidential documents, but also the
sensitive and private information contained in the medical records
of the individuals suing Lilly," said Armitage. "Lilly appreciates
that the court understood the grave nature of the breach of trust
committed by individuals who would take the law into their own
hands rather than following the rules set by the court with the
agreement of all of the parties in the litigation." In a detailed
opinion nearly 80 pages long, Judge Weinstein described the
"conspiracy" in which Dr. Egilman, who was bound by a court order
of confidentiality, surreptitiously provided the confidential
documents to Mr. Gottstein, an Alaska attorney, who then promptly
provided them to the Times reporter, all in a concerted and
deliberate effort to violate the court's order of confidentiality.
By breaching the confidentiality order that covered all parties to
the litigation, the three individuals disclosed Lilly's trade
secrets and other proprietary business information. From the day
that Zyprexa was approved in 1996, the product information provided
to physicians identified the potentially clinically-significant
weight gain that was observed in more than half of all patients
treated long- term with Zyprexa, as well as the cases of diabetes
and elevated blood sugar observed in clinical trials. Treating
physicians have been kept aware of the risks associated with
Zyprexa and warnings about side effects have been updated
throughout the life of the product. "Although both Dr. Egilman and
the Times reporter refused to testify in court about their actions,
Lilly looks forward to the opportunity to tell the complete story
about Zyprexa and the company's actions during upcoming Zyprexa
trials," Armitage said. "As the Court understood, the dissemination
of selective and distorted information does not serve the public
interest. Some of the leaked documents are drafts or preliminary
planning or discussion documents, and include the discussion of
issues and ideas that were never implemented. The picture that Dr.
Egilman and others have painted is, at best, misleading, and in
many cases false. These reports do not represent a complete, much
less an accurate view of Zyprexa, or Lilly company strategy and
activities," Armitage added. 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 20 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/. Corporate News C-LLY Zyprexa(R)
(olanzapine, Lilly) (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO)
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Tarra Ryker, +1-317-276-3787, or
Marni Lemons, +1-317-433-8990, both of Eli Lilly and Company
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