Lilly's
Legal Battle Over Zyprexa Documents Continues
By Evelyn Pringle
09 January, 2007
Countercurrents.org
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,
[email protected]
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist
focused on exposing corruption in government and corporate America)
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