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.
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