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Lilly's Legal Battle Over Zyprexa Documents Continues
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; the newspaper 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 three 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 Chamberlin 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.
Evelyn
Pringle is a columnist for OpEd News and an investigative journalist
focused on exposing corruption in government and corporate America. She
can be reached at: evelyn-pringle@sbcglobal.net
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