Healthcare Industry News:  schizophrenia 

Biopharmaceuticals Litigation

 News Release - February 14, 2007

Eli Lilly and Company Statement: Judge Grants Lilly's Request for a Permanent Injunction Involving Misleading Selection of Illegally Leaked Lilly Documents

INDIANAPOLIS, Feb. 14 (HSMN NewsFeed) -- 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 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 www.lilly.com.

Corporate News C-LLY

Zyprexa® (olanzapine, Lilly)



Source: Eli Lilly

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