Zyprexa: Judge Rules Drug Documents Must Be Returned to Eli Lilly

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February 14, 2007

Judge Rules Drug Documents Must Be Returned to Eli Lilly

By LANDON THOMAS Jr.

http://www.nytimes.com/2007/02/14/business/14lilly.html

A federal district judge in Brooklyn ruled yesterday that confidential

marketing materials belonging to Eli Lilly & Company about its top-selling

anti-psychotic drug Zyprexa must be returned to the company by a doctor

and a lawyer who, the judge said, engaged in a scheme to leak them to the

news media.

The documents were part of evidence provided by Lilly as part of a lawsuit

filed by patients who claimed that side effects from Zyprexa caused

excessive weight gain and diabetes.

In the 78-page decision, Judge Jack B. Weinstein of Federal District Court

ordered Dr. Egilman, a special expert for the plaintiffs, and

B. Gottstein, a lawyer in Alaska, to return the documents to Lilly.

A New York Times reporter, Berenson, was given a copy of the

documents, which showed that Lilly executives had kept information from

doctors about Zyprexa’s links to obesity and higher blood sugar, a claim

Lilly has denied. He wrote front-page articles based on the information.

Eli Lilly has now paid $1.2 billion to settle more than 28,000 cases from

individuals who contended that they developed diabetes or other diseases

from taking Zyprexa.

In the ruling, Judge Weinstein said Mr. Berenson obtained the documents

after he discussed with Dr. Egilman ways to circumvent a protective order.

Mr. Berenson put Dr. Egilman in touch with Mr. Gottstein, the judge said,

so that they might “employ a pretense to subpoena the documents.”

According to Judge Weinstein, the documents were sent to Mr. Gottstein via

an expedited subpoena, which Lilly was unaware of. Mr. Gottstein then sent

the papers to Mr. Berenson and others.

No other news organizations received the documents, the judge said,

because Mr. Berenson told Mr. Gottstein that if the material was not

delivered exclusively to him, the newspaper would not publish an article.

Mr. Berenson did not appear at an earlier hearing on the matter, where he

was invited to testify. Freeman, a lawyer for The New York Times

Company, said that as a matter of “long-held principle,” the company

believed it would be “inappropriate for any of our journalists voluntarily

to testify about newsgathering methods.”

In a statement yesterday, Mr. Freeman said: “For the reasons set forth in

our letter responding to Judge Weinstein’s invitation, we declined to

testify voluntarily about our newsgathering methods. Unfortunately, that

resulted in an opinion which vastly overstates ’s role in the release

of the documents. We continue to believe that the articles we published

were newsworthy and accurate, and we stand by them.”

Mr. Gottstein, who is president and chief executive of the Law Project for

Psychiatric Rights, said, “I was just trying to follow the law.”

He said that a subpoena allowed him to adhere more closely to the

protective order than if Dr. Egilman had given the documents directly to

Mr. Berenson.

A spokeswoman for Eli Lilly, Marni Lemons, said: “Our adversaries

carefully selected the documents to tell a story that they wanted to tell.

These cherry-picked documents in no way reflect the strategies or

activities of Eli Lilly & Company. Lilly feels vindicated because the

judge issued an injunction that prohibits future wrongdoing by those who

took the law into their own hands. "

While the judge asked Mr. Gottstein and Dr. Egilman to return the

documents, he did not ask Mr. Berenson to do so. Many of the documents are

available on the Internet and the ruling does not ask that any newspaper

or Web site take any action with regard to the papers.

Judge Weinstein reserved some harsh words for Mr. Berenson, whose conduct

he called “reprehensible,” and for The Times, pointing out that unlike the

case of the Pentagon Papers, in which classified government documents were

given to a Times reporter, “here a reporter was deeply involved in the

effort to illegally obtain the documents.”

The judge said that the documents’ disclosure posed “significant risk of

harm to Lilly,” and that their “out of context” appearance in the news

media might “lead to confusion in the patient community and undeserved

reputational harm.”

*

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