A federal judge in New York issued a stern but meaningless order concerning Lilly’s internal documents about the bipolar disorder drug Zyprexa.

The judge forced a medical consultant and a lawyer to “return” thousands of sensitive documents to Eli Lilly. The losers in the ruling include David Egilman, a Vermont medical expert for Zyprexa plaintiffs, and James Gottstein, an Alaska attorney who was not involved in the Zyprexa litigation but happened upon the documents through an unrelated case. Here’s a ClinPage story about the mess from December.

In referring to NYT reporter Alex Berenson and to Jack Weinstein, a federal judge, the NYT wrote the following about itself: “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.’”

Berenson is said to be writing a book about the Zyprexa safety issues and on leave from the newspaper. The word “conspiracy” is being thrown around a lot online about the delivery of the documents to the newspaper, but it strikes us as overblown.

Lilly had sought to shut down websites with the formerly secret papers. Here’s a quote from the company’s press release on the topic. It’s from Robert A. Armitage, senior VP and general counsel: “Lilly looks forward to the opportunity to tell the complete story about Zyprexa and the company’s actions during upcoming Zyprexa trials. 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.”

Gottstein and Egilman appear to have two complaints against the company: that Lilly downplayed evidence of diabetes and obesity causally linked to Zyprexa; and that Lilly sales teams inappropriately promoted Zyprexa for off-label indications such as dementia and Alzheimer’s, which are far larger markets than bipolar or psychotic mental illness.

On the issue of weight gain caused by Zyprexa, Lilly has settled 28,000 cases in two class-action settlements for a total of $1.2 billion. Other cases are still being fought. The drug’s original label noted potential complications from weight gain. The off-label allegation is being investigated by several states, according to the NYT, but it’s not clear whether any federal officials are probing the matter.

What it means to “give back” documents in the age of the internet remains murky. Recognizing that the formerly sealed PDFs have now been scattered to the winds, the court issued no ruling about websites where the Zyprexa documents can be found after a moment of searching. At the risk of stating the obvious, the web means that once documents are in the public domain, they stay there.

“No newspaper or Web site is directed to do anything or to refrain from doing anything,” Weinstein wrote. “No person is being enjoined from expressing an opinion or writing about the documents.”

It is hard to overstate the stakes. According to this blogger, Lilly’s forensic computer experts had access to Egilman’s computer for three days. According to Egilman’s lawyer, the drug company seeks to eventually put the physician in jail. (We find that hard to believe, to be honest, if only because it would mobilize and electrify new critics of the industry.) The blog quotes extensively from an article in the British Medical Journal, which says that Lilly is pursuing 16 individuals and organizations on the leaking of the documents. The BMJ says Gottstein and Egilman judiciously selected a few hundred pages out of some 11 million related to the case. And we thought we were overwhelmed by email.

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