US: Judge to Unseal Documents on the Eli Lilly Drug Zyprexa

A federal judge in Brooklyn decided on Friday to unseal confidential materials about Eli Lilly's
top-selling antipsychotic drug Zyprexa, citing "the health of hundreds
of thousands of people" and "fundamental questions" about the way drugs
are approved for new uses.

The decision by Judge Jack B. Weinstein
of Federal District Court came as part of a ruling that gave
class-action status to a case brought by insurance companies, pension
funds and unions that want Lilly to repay them billions of dollars they
spent on the drug. They contend that Lilly hid the side effects of the
drug and marketed it for unapproved uses.

The confidential
documents were produced by Lilly in response to a related lawsuit filed
by patients who said that Zyprexa had caused excessive weight gain and diabetes. The papers were placed under a protective court order soon after the suit was filed in 2004.

"Lilly's
legitimate interest in confidentiality does not outweigh the public
interest in disclosure at this stage," Judge Weinstein wrote.

A
spokeswoman for Lilly, Marni Lemons, said the company would not appeal
the decision to make the documents public but that it would appeal the
judge's certification of a class action.

The issue of
confidential information arose in 2006, when some of the Zyprexa papers
were provided to a reporter for The New York Times, Alex Berenson. He
wrote front-page articles based on evidence they contained that Lilly
executives had kept information from doctors about Zyprexa's links to obesity and high blood sugar.

Eli
Lilly denied having withheld such information and said that the
documents Mr. Berenson had seen were "cherry-picked" to give a
one-sided view.

The publication of sealed information led Judge
Weinstein to issue a sharply worded ruling last year, stating that Mr.
Berenson had engaged in a conspiracy with a doctor and a lawyer and
that they had used others "as their agents in crime."

The judge
said the sealed documents belonged to Lilly and ordered the doctor,
David S. Egilman, and the lawyer, James B. Gottstein, to return them.
Dr. Egilman had been serving as an expert consultant for the plaintiffs
at the time, and Mr. Gottstein was working on Zyprexa litigation in
Alaska.

Since then, insurance companies, unions, medical
researchers and other publications have filed formal requests for
copies of the documents. Many of the papers were entered into open
court proceedings in Alaska, and copies of some have been posted on the
Internet.

In his ruling on Friday, Judge Weinstein repeated that
the information had been "obtained illegally" by The Times but also
cited "this country's general policy of accessibility of court records."

Dr. Egilman said on Friday that he felt vindicated.

"The public can now decide for itself what these documents stand for," he said.

Mr. Gottstein said he still disputed Judge Weinstein's rulings that he had obtained the documents illegally.

"I
think I did get them properly," he said, adding that the new order
unsealed only a small number of the Zyprexa documents that Lilly has
provided to the court. "There are a lot of other documents that are
hidden."

AMP Section Name:Pharmaceuticals
  • 182 Health
  • 208 Regulation
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