Lilly's Legal Battle over Zyprexa Documents Continues

January 8, 2007, 12:00AM. By Evelyn Pringle

On January 3, 2007, a hearing was held before Judge Jack Weinstein, in a US District Court in New York, on a motion by Eli Lilly to extend an injunction to conceal company documents that show Lilly hid the lethal side effects of Zyprexa for a decade and engaged in an illegal off-label marketing scheme to promote the drug for unapproved uses.

Zyprexa is only FDA approved to treat adults with conditions related to schizophrenia and bipolar disorder, and yet its Eli Lilly's number one best selling drug with sales of over $4 billion last year.

Attorney, Ted Chabasinski, appeared at the telephonic hearing in New York on behalf of Judy Chamberlin and MindFreedom, a human rights advocacy group, to argue against the injunction and for the public's right to know the contents of the Zyprexa documents.

In a letter submitted before the hearing, Mr Chabasinski informed the court that MindFreedom is calling for the criminal prosecution of Lilly officials based on the information revealed in the documents.

The documents at the center of this controversy first surfaced several years ago in Zyprexa litigation but in August 2004, Lilly was able to use the court system to obtain a protective order to keep them under seal and out of the public eye.

In that litigation, Lilly was accused of failing to warn about the increased risk of severe weight gain with Zyprexa and the drug's association with diabetes; both claims are clearly substantiated in the documents in question.

In reviewing the original protective order issued on August 4, 2004, signed by Judge Weinstein, a key phrase would seem to be that the order is meant "to ensure that protection is afforded only for material so entitled".

Critics say the illegal conduct revealed in the documents was never entitled to protection.

In the end, Lilly settled the lawsuits out of court with an estimated 8,000 Zyprexa victims by paying out close to $700 million and requiring all litigants to sign confidentiality agreements promising never to discuss the charges in the lawsuits or the terms of the settlement agreement again.

Once the settlement took place, the protective order remained in effect and thus, Lilly was able to keep the incriminating information hidden from consumers, health care professionals, and probably most importantly more potential litigants.

The documents were made public last month after they were obtained by attorney, Jim Gottstein, in a lawsuit unrelated to the case in which they were under seal. After reading the documents, Mr Gottstein turned them over to the New York Times and the Times published two front-page articles describing how Lilly knew about the risks of weight gain and diabetes for over 10 years and quoted documents that instructed sales representatives to focus on getting primary care doctors, who did not ordinarily see patients with schizophrenia or bipolar disorder, to prescribe the drug off-label for the treatment of conditions not approved by the FDA as being safe and effective.

Since Lilly's illegal conduct was revealed, the company's legal team has spent the last 3 weeks frantically trying to get the documents back under seal and pursuing ways to punish Mr Gottstein for the disclosure of the information to begin with.

On December 18, 2006, Lilly convinced a judge to issue an injunction directing Mr Gottstein to not only return the documents to the court but to reveal the names of all persons and entities that he disclosed them to or discussed them with.

After Mr Gottstein complied with the order, on December 29, 2006, a second temporary injunction was issued to prohibit dissemination of the documents by persons named by Mr Gottstein to include Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski, Laura Ziegler, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Will Hall,

In reviewing the list of names above, it appears that Lilly has succeeded in using the court system, with every move funded by Zyprexa profits, to intentionally run up legal costs and silence critics ranging from legal experts who have testified against drug companies, to reporters, to members of prominent advocacy groups.

In stark comparison, the New York Times has actually published the information for tens of millions of people to read but Lilly has not asked for an injunction against the Times.

According to MindFreedom's director, David Oaks, "This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics."

The January 3, 2007, hearing was held based on a request by Lilly to extend the temporary injunction issued on December 29, and to force Jim Gottstein to appear in New York City for a deposition within 5 days.

Attorney Sean Fahey of the Pepper Hamilton LLP law firm argued the case for Lilly. Attorney, Ted Chabasinski, appeared on behalf of Judi Chamberline, and Attorney, John McKay, represented Jim and Terrie Gottstein.

In reviewing the transcript of the hearing, as far widening the scope of the injunction process by adding the names of more people who somehow obtained the documents, Judge Weinstein himself recognized the futility of issuing more injunctions in attempt to stop the dissemination of the documents stating:

"The court takes no position on whether and how they can be used by others who received them from other sources. After all, the New York Times has disseminated them. This court is not going to issue an order telling the New York Times to return the documents. So everybody has access to them. It takes no position on whether and how they can be used by others who may have them from other sources or from any sources, and on whether and how Lilly can protect itself against such use. But I don't want to be put in a position, as representative of the court, of issuing futile injunctions. So I'm going to limit the order to those who I've mentioned."

During the hearing, Judge Weinstein granted Mr Chabsinski's and Mr McKay's request for more time to respond to the motions and a new hearing date was set for January 16, 2007.

The injunction that was extended to January 16, now includes the name Eric Whalen and his web site at www.joysoup.net; the MindFreedom web site at www.mindfreedom.org, and the Alliance for Human Research Protection sites at www.ahrp.org and www.ahrp.blogspot.com, and specifically states:

"This temporary mandatory injunction further requires the removal of any such documents posted at any website; requires communication of this Order to anyone to whom these documents have already been disseminated, informing them of the terms of this Order; and enjoins the named individual, organization and entities from posting information to websites to facilitate dissemination of these documents."

According to Mr Chabasinski, the extended injunction was supposed to simply restate the content of the first two injunctions; but he says Lilly added new wording apparently without the judge's full knowledge or consent.

"Eli Lilly appears to be trying to chill free speech itself," says Mr Oaks, "and is slipping in wording to squash even general discussion of this controversy by its critics on the web."

In a January 4, 2007, letter to Judge Weinstein, Mr Chabasinski states, "At no time was there any discussion of changing the terms of the injunction."

"Nor did you indicate in any way that you intended to change the terms of the injunction," he wrote.

According to Mr Chabasinski, Lilly added provisions which in his view are a serious violation of his clients' First Amendment rights. "One could read these provisions," he told the court, "to forbid even the discussion of the issue of the suppressed documents."

Due process, he points out, requires notice and an opportunity to be heard on the matter.

"As you know," Mr Chabasinski wrote in the letter, "my position is that the documents under protective order are not trade secrets, but criminal evidence, since they show nothing but the attempts of the defendants to hide the lethal, toxic effects of Zyprexa."

He points out that Judge Weinstein has been presiding over the Zyprexa lawsuits and has access to an enormous amount of evidence about the culpability of Lilly and the injuries and deaths caused by the suppression of information about Zyprexa's toxicity.

"For the courts to protect behavior like this is a great injustice," Mr Chabasinski told the judge in the letter.

He pointed out that his clients and Mr Gottstein are now facing the possibility of being jailed for contempt of court if they violate the injunctions and asks the court to consider this scenario:

"Whistleblowers circulate documents which show incontrovertibly that the executives of a corporation have, with careful deliberation, engaged in a course of action that they know will lead, and does lead, to the death and injury of thousands of people, that is, they have committed heinous crimes."

But yet the whistleblowers end up going to jail for violating an order which protects the criminals. Mr Chabasinski also notes the absurdity of the end result of a situation like this:

"The criminals go completely unpunished with the protection of the courts and are allowed to continue to profit from their wrongdoing."

Based on the Mr Chabasinski's letter to the court, a hearing for reargument on the extension and modification of the December 29, 2006, temporary injunction has now been scheduled for January 8, 2007, at 2:00 pm.