Eli Lilly sues to hide Zyprexa documents (updated x 4)

The Eli Lilly leaked documents story has exploded.

Just to recap, on Dec. 17th last year the NYTimes reported on documents leaked from Eli Lilly that show that the company tried to play down the side effects of Zyprexa, a popular schizophrenia drug. The documents were released by the company to a lawyer suing them on behalf of plaintiffs who got diabetes and other problems while on the drug. These documents were under a court ordered seal.

Then an unrelated lawyer from an unrelated plaintiff case subpoenaed those documents, and he released them to the NYTimes and others. The documents have shown up in toto on several websites, embarassing the hell out of the company.

Now Eli Lilly has sought and received a temporary court order to block the distribution of said documents on the Internet. Particularly, they are trying to block a wiki where the documents were posted with other information about Eli Lilly and Zyprexa. That wiki is here. The proprietors of the wiki -- they are John Does in this case -- have responded by removing the documents, but they intend to defend themselves in court on the grounds that they are journalists and that to stop them is a violation of freedom of the press.

Here is a summary of the case by NPR Morning Edition:

On Dec. 17, 2006, the Times ran the first of several stories based on the leaked documents. According to the Times, they showed that Lilly had engaged in a decade-long effort to play down the risks of Zyprexa -- risks such as excessive weight gain and diabetes. Lilly strongly disputes the description of what the documents show.

For a couple of days, you could judge for yourself, because the Zyprexa documents were posted on the Web by individuals to whom they were also leaked.

On Dec. 18, Lilly obtained a temporary court order to get its documents back. The New York Times refused, but the Web links were shut down. Wednesday, U.S. District Judge Jack Weinstein will be asked to restore the links.

Fred von Lohmann of the Electronic Freedom Foundation in San Francisco will argue that the order to shut down the Web links violated the protections of the first amendment.

"Courts in the United States, thanks to the First Amendment, are not allowed to issue what are called 'prior restraints,' Von Lohmann said. "After all, the Pentagon Papers were also allegedly improperly obtained. And the courts have said over and over again 'It doesn't matter if the documents were improperly obtained. Courts do not issue stop-the-presses orders against people who happen to get the documents after they had been released.'"

Von Lohmann's client is anonymous. "John Doe" posted entries on a Wikipedia Web site about the Zyprexa documents. He doesn't have the stature of the reporters involved in the Pentagon Papers case. They worked for The New York Times and The Washington Post.

The entire issue may be moot, however, because the documents are already out there. Even if the judge is successful at stifling them in the US he won't be able to do it abroad.

Here is some analysis of the story from the NYTimes:

"Judges have a natural inclination that if documents have been stolen under their watch, they want to get them back," said Mr. von Lohmann, whose John Doe client was a contributor to the site zyprexa.pbwiki.com -- a wiki where a hive of users compiled and contributed links and information relating to the Zyprexa case. "But there are some limits to how many degrees of separation the court can reach."

There is also a traditionally high bar set for placing prior restraint on the press -- which, whether Judge Weinstein recognizes it or not, very much includes a colony of citizen journalists feeding a wiki.

Of course, the other, slightly more absurd side to all this is that attempting to stop the documents from spreading is, by now, a Sisyphean task.

"The court is trying to get the genie back into the bottle until it can sort out what's going on through the course of litigation, which takes place at non-Internet speed," said Jonathan Zittrain, a professor of Internet governance and regulation at Oxford and a founder of the Berkman Center for Internet & Society at Harvard Law School.

"Perhaps the court thinks that whoever is adding to the wiki is among the parties to the original case," Professor Zittrain said. "That's understandable, but it puts the court in a no-win situation. It's left issuing an order that sounds like no one in the world is allowed to post the documents."

I have a couple things to say about this case:

1) I would refer you to my earlier post about what I think about Eli Lilly. It incenses me that they would try to hide or play down the side effects of these drugs.

2) This is a huge test case for press freedom on the web. Is a wiki part of the press? Is a blog, for that matter? Are any of us journalists? I would argue that we are and that as a consequence we should receive the same protections, but we will see how this plays out. The judge may very well skirt the issue because he can't really put a stop to distributing the documents.

3) I am a firm believer in freedom of speech. I may catch hell for this, but I went and found out where you can download the documents if you like.

The documents from the Zyprexa case are being served here. The server is outside this country, and they are serving a .torrent file so I doubt anyone will be able to stop them. If you are unfamiliar with how to download things using BitTorrent, you can find out here.

UPDATE: Here are some helpful links for the legally-inclined.

The Electronic Frontier Foundation, who is defending the individuals who distributed the Eli Lilly documents, has this listing of briefs, injunctions, etc. related to the case.

Here is the full list of individuals named in the temporary injunction:

Terri Gottstein
Jerry Winchester
Dr. Peter Breggin
Dr. Grace Jackson
Dr. David Cohen
Bruce Whittington
Dr. Stephen Kruszewski
Lauri Ziegler
Judi Chamberlin
Vera Sherav
Robert Whittaker
Will Hall
Eric Whalen (of www.joysoup.net)
MindFreedom
Alliance for Human Research Protection (and here)
zyprexa.pbwiki.com

Apparently, these are the individuals who were at one time distributing copies -- digital or otherwise -- of the document. Frankly, I don't know if that is going to be enough to keep a lid on this.

MindFreedom issued this statement.

I also found this, which appears to be a very angry email to the guy at joysoup.net.

UPDATE: Evelyn Pringle has a great article about this on CounterCurrents.org. Money quote:

For its part, when the Times first broke the story, and Lilly started publicly mouthing off about obtaining injunctions to get the documents back, the Times basically said that it would not return them. "Our customary practice is to retain documents which we legitimately required during our news gathering process and which are likely to be relevant to future reporting," said Times attorney, George Freeman, in a Times article on December 20, 2006.

There are certainly no gripes against the Times itself because the information in the documents probably would have remained hidden forever had it not been for the Times. But a judge and a corporate giant can not decide that a reporter at the Times will be afforded more freedoms than any other reporter in this county.

The decision to allow one newspaper to publish important information and not others, should have all journalists enraged. Lilly's ability to get a court to issue an injunction against any journalist at the drop of a hat should be troubling to all members of the media.

Freedom of the press can not be based on the size of a publication or its readership, or in the case of the Times in this instance, the recognition of the power and availability of funds of a newspaper to rise up and fight against a violation of that right. (Emphasis mine.)

Amen to that. Read the whole thing.

This whole case is asinine. Why should the NYTimes get a free ride, and everyone else has to shut up?

UPDATED: TortsProf Blog proprietor Bill Childs sent me an email that had some very, very helpful legal analysis about this case:

I think it might be helpful to recognize that there are two distinct issues.

One is the probable violation of a protective order by the expert witness involved and the lawyer who distributed the documents. The judge's original findings suggested that he and the unrelated lawyer (who incidentally is not in the products liability litigation, but instead is an advocate in the field of forced medication, etc.) colluded to get the documents distributed in spite of a protective order that clearly reached at least the expert witness. To be sure, the expert and the lawyer disagree with that allegation and there have been no final findings.

The protective order contains a mechanism for getting documents dedesignated -- i.e., changed to being nonconfidential. This judge is one who is quite likely to be amenable to that sort of argument. No such effort has been made that I know of.

The second issue, which is really quite separate, is the attempt to get the documents back, and the prior restraint issues (and mootness issues) embodied in that attempt. To whatever extent the distributors are within the court's jurisdiction, there's at least a reasonable argument that it's not a 1st amendment issue, though I tend to agree with the EFF in their argument, especially on the mootness argument. (They actually cited one of my blog posts on the availability of the documents, and the NYT cited a different post for the title ["Judge Tries to Unring Bell Hanging Around Neck of Horse Already Out of Barn Being Carried on Ship That Has Sailed"].)

There are some legitimate reasons to have the protective orders, both to block the release of real trade secrets and to avoid the harm to a jury pool of releasing only one portion of documents. But they can, of course, be abused too, and that's why they have the safety valve mechanism, where parties OR non-parties can seek to have documents dedesignated. Again, so far as I know (but I might just not know), nobody's sought to have documents dedesignated, instead going immediately to wide distribution. That's why I think Lilly has a reasonable point on the first issue, and likely why the products liability plaintiffs' counsel has generally agreed with Lilly and has,
in fact, fired the expert in question.

On the second issue, as I said, I tend to agree with EFF, both for constitutional and practical reasons. But it's possible to support the EFF's position on that question while still thinking the documents ought not to have come out in that particular way. (Link added.)

Definitely keep an eye on TortsProf Blog because he is really on top of the legal aspects of this case.

I guess I hadn't considered the possibility that there were legal means for the release of these documents. That leaves me a little ambivalent. On the one hand, I don't like the idea of briddling websites while allowing the NYTimes to do what it pleases, and I do think that these documents are of important public interest and should be publically available. On the other, it sounds like the plaintiff's counsel in the case against Lilly should have used "legal" means to release the documents, rather than allowing them to be leaked.

This makes me much more curious to see what happens in this case. I am curious to find out whether the judge is going to punish the bad behavior of plaintiff's counsel expert witness by punishing unrelated websites -or- whether he will throw his hands up and say what's done is done.

Incidentally, the update on what we can expect to happen next in this case was available on the EEF website:

EFF was back in court January 16-17 defending the right of an anonymous wiki contributor to post links to important internal Eli Lilly documents about its biggest-selling drug, Zyprexa. After hearing two days of testimony from those involved (and not involved) with the disclosure of the Lilly documents, the judge has ordered additional briefs and promised a decision sometime in early February.

Unfortunately, he also extended his January 4 injunction that bars anyone from posting the documents or information that would "facilitate the dissemination of the documents" (presumably, including links) to zyprexa.pbwiki.com until he is able to issue his ruling.

The good news is that the documents continue to be readily available on the Internet (one law professor said he was able to find and download them in 19 minutes).

The bad news is that the judge's order constitutes a prior restraint on free speech -- the court's injunction prohibits the whole world from publishing the documents on zyprexa.pbwiki.com. It's hard not to compare this outcome with the Pentagon Papers case, where the Supreme Court threw out even a temporary injunction against publication of stolen Pentagon documents in the New York Times and Washington Post. (It's also reminiscent of Proctor & Gamble v. Bankers Trust, where the court threw out a prior restraint against Business Week over documents leaked from a lawsuit).

But based on the evidence introduced in court, it appears clearer than ever that Eli Lilly will not be able to justify any ongoing restriction on publication of these documents by those who were not involved in the initial leak. So we are looking forward to Judge Weinstein's ultimate ruling.

So basically, the injunction was extended for three weeks while we wait for the judge's ruling. I am kind of wondering if I will get a nasty email about helping to "facilitate the dissemination of the documents", but we'll what happens. I will keep you apprised on the situation.

UPDATED: MindFreedom is certainly feeling bullish about how the hearing went:

Then the court room woke up when Vera Sherav (photo on right) of the group Alliance for Human Research Protection got on the stand. Now, I was just taking notes over the phone so I may not have gotten her words exactly right, but Vera actually got to the point about the contents of the files, and she was passionate.

Vera said emphatically, "People are dying from these drugs... Getting these documents is very important to me." Vera talked about sharing the information, such as with a Wall St. Journal reporter.

Vera said, "These documents show that Eli Lilly knew Zyprexa causes diabetes. They knew from a doctor they hired. Instead of warning doctors who are widely prescribing the drug, Eli Lilly set about an aggressive marketing campaign. Little children are being given these drugs. Little children are being exposed to horrific diseases that are ending their lives. And to continue to conceal these facts from the public... it's just a safety issue!"

Vera agreed this kind of human rights advocacy work is her "life calling."

More than once Eli Lilly moved to strike one of Vera's passionate statements from the record, but the judge overruled the attorney saying that Vera's testimony showed her "state of mind."

And her state of mind was fixed on justice. (Emphasis mine.)

Let me make something clear because a lot of the people who are associated with this case are people that I would consider part of the anti-psychiatry movement. I am not, but I still have a problem with Eli Lilly. I want to make clear why.

As a matter of principle I have no problems with Zyprexa. If I become a psychiatrist and I have to choose drugs to prescribe, I can think of several circumstances under which I would prescribe it. Schizophrenia is a horrible disease, and Zyprexa is demonstrably better than the alternatives in several ways that make it an attractive drug.

Similarly, I do not as a matter of principle have a problem with off-label uses for drugs or drug marketing. Off-label uses are a matter for physicians to decide with patients when they believe that the weight of the scientific evidence supports an unapproved use. Likewise, drug companies need to make money or else there will be no more new drugs. Selling drugs sometimes requires marketing to doctors, and as long as it isn't excessive or coercive I have no problem with it.

All drugs have side-effects -- some of them particularly nasty. The decision that you make with your doctor is whether the benefits outweigh the costs.

The problem that I have with Eli Lilly is that they failed to adequately inform doctors of the consequences of their drugs and actively tried to hide those consequences.

Categories

More like this

By David Michaels The state of Pennsylvania has filed lawsuits against three drug manufacturers, claiming the firms fraudulently marketed antipsychotic drugs. According to Bloomberg News, the state alleges that Eli Lilly & Co. âhid the risks and exaggerated the benefits of its antipsychotic…
Yet again, a drug company is playing damage control for failing to come clean about a drug's side effects. It makes me so mad when companies do stuff like this because it is such a preventable problem. In this case, the drug in question is Zyprexa (olanzapine) -- presently one of the go-to drugs…
By David Egilman On September 15, 2008 pharmaceutical giant Eli Lilly pleaded guilty to committing the crime of off-label marketing of Zyprexa, an antipsychotic.  Lilly has profited handsomely from the marketing of this drug, making over $30 billion. The Department of Justice (DOJ) claims that the…
The following post is by Dr. David Egilman, a familiar figure to those who have been following the case of Eli Lillyâs schizophrenia drug Zyprexa. See Alex Berensonâs New York Times articles on the case for more background, or read David Michaelsâs post about Zyprexa and sequestered science. --…

I don't know if this was left out by accident or intentionally, but you seem to have written about this subject without mentioning that ZyprexaKills (which is a good thing to do since there is apparently a rumor that people who are interested in this topic search for that keywords).

Scary. I started taking Zyprexa for my bipolar disorder at the beginning of last year. I was actually told by my psychiatrist that the drug might cause weight gain. In the first couple of months after taking the drug I gained about 8 kilos that's about 17.6 pounds!

But Lilly was concerned that Zyprexa's sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

The idea that Eli Lilly can "play down" such a dangerous side effect is quite sickening to me. Tomorrow I will be calling my doctor and trying to find an alternative.

This case appears to be in the Federal District which includes California. (I have not read all the PDFs.)

Here is what the SUPREME COURT OF THE STATE OF NEW YORK said about a similar web-site. Note that there are conditions regarding the quality and conduct of the web-site. Note also that EFF was involved in this case, too. About three quarters through the file

"c. Media Defendants

"This court finds that Narco News is a media defendant and is entitled to heightened protection under the First Amendment (New York Times Co. v Sullivan, supra, 376 US, at 270-280).

"The Internet is similar to a televison and radio broadcast in the sense that the electronic missive is able to reach a large and diverse audience almost instantaneously (Matherson v Marchello, 100 AD2d 233, 293 [2d Dept 1984]). However, the character of a particular website depends on the format and program design (see, Lunney v Prodigy Servs. Co., 94 NY2d 242, 249 [1999], cert denied 529 US 1098 [2000]). A careful review of defendants' submissions on Narco News's website indicates that the Narco defendants' format is similar to a regularly published public news magazine or a newspaper except for the fact that the periodical is published "on line" or electronically, instead of being printed on paper. The fact that the Narco News website can accept readers' comments, or letters to the editor, via a separate e-mail address only strengthens the need for First Amendment protections for the medium Since principles of defamation law may be applied to the Internet (Lunney v Prodigy Servs. Co., supra, 94 NY2d, at 248), this court determines that Narco News, its website, and the writers who post information, are entitled to all the First Amendment protections accorded a newspaper/magazine or journalist in defamation suits (Huggins v More, 94 NY2d 296, 301 [1999]). Furthermore, the nature of the articles printed on the website and Mr. Giordano's statements at Columbia University constitute matters of public concern because the information disseminated relates to the drug trade and its affect on people living in this hemisphere (id. at 302)."

http://www.eff.org/Censorship/SLAPP/Forum_shopping/BNM_v_Narco_News/200…

For more information

http://www.narconews.com/docs/ontrial.html