Court Ruling: Injunction on Release of Zyprexa Documents

The documents contain evidence of Lilly’s marketing strategy promoting Zyprexa for unapproved, off-label uses while concealing from doctors and the public evidence  of increased risk for acute weight gain and increased risk for diabetes, hyperglycemia,  and cardiovascular disease.
http://tinyurl.com/2m4yvc 

Despite Lilly’s efforts to suppress the documents, they are available on
internet websites.  Judge Jack Weinstein rejected Lilly’s effort to seek a court injunction
against internet posting  of the documents.In his ruling  Judge Weinstein acknowledged:

“The internet, with its almost infinitely complex worldwide web of strands and nodes,
is a major modern tool of free speech and freedom both here and abroad.  Its
reach extends as far as, and perhaps exceeds, that of newspapers and other
traditional media.   The law is rightly hesitant about allowing government —
including the courts — to inhibit and restrict the use of such modern instruments of
communication.”

Furthermore, the judge reasoned:
“it is unlikely that the court can now effectively enforce an injunction
against the Internet in its various manifestations, and it  would constitute a dubious
manifestation of public policy were it to  attempt to do so.”

Because medicines may cause harm and even kill, drug manufacturers must
obtain a special government license (from the FDA) to market drugs on the basis
of scientific evidence  demonstrating their products’ safety and efficacy. Under the law,
prescription drug companies violate their licensure agreement by concealing evidence of drug hazards.
They also violate the law if they substitute marketing hype instead of science to promote drugs
for unapproved, off-label uses that pose life-threatening risks for consumers.

The legitimate role of protective orders was defined in his book,  Individual Justice in Mass Tort
Litigation (February 2005),  acknowledging that courts have a higher function of justice:

“[p]rotective orders may have a legitimate role when there is no public
impact or when true trade secrets are involved. But we can strike a fairer
balance between privacy interests of corporations and the health and safety
of the public. A publicly maintained legal system ought not protect those
who engage in misconduct, conceal the cause of injury from the victims, or
render potential victims vulnerable. Moreover, such secrecy defeats the
deterrent function of the justice system.”   Page 70.

Yesterday’s ruling addressed violations of legal procedures and injunctions:
“First Amendment doesn’t protect reporters from breaking the law.
Neither members of the media, nor any other branch of our government are
authorized to violate court orders.”

The Judge came down heavily on three individuals who brought the content of
the documents to public light calling the disclosure of sealed documents
“unprincipled” stating “These illegalities impede private and peaceful resolution of
disputes.”

Not yet addressed are motions filed with the court requesting that the documents
be unsealed for reasons of public health and safety issues. The AHRP motion was filed
Jan. 23, arguing:

“…the public’s right to know information critical to any informed decision to take a particular
drug. Pharmaceutical companies have a record of concealing information about
adverse effects of their products and giving the public only that which will further the
companies’ sales, even at the expense of public health.”

“Litigation against pharmaceutical companies is often the only means of
curtailing the marketing…of drugs to those for whom the risks outweigh any benefits.
Too often however, drug companies and plaintiffs’ lawyers agree to suppress from public
view, by way of protective orders, the critical information revealed in the litigation process.”
See: http://www.thejabberwock.org/blog/motion2.pdf

Judge Weinstein responded (Jan. 25) indicating that a hearing could be
scheduled after the injunction  procedures. http://tinyurl.com/2r5zmu

A second motion for unsealing of the Zyprexa documents also argues from the
perspective of the public interest. The latter motion was filed (Feb. 7) by the Bazelon
Center on behalf of: U.S. Psychiatric Rehabilitation Association,
Mental Health America (formerly the National Mental Health Association),
Consumers Union, former heads of mental  health systems in  Rhode Island,
Virginia, South Carolina, New Hampshire and Illinois, and leading professors of
psychiatry and social medicine. This motion also argues that:

“A key factor in determining whether “good cause” exists for keeping
documents confidential is whether public interest requires disclosure.”

“About two million people worldwide took Zyprexa in 2005, and more than 20
million people in total have taken the drug since its introduction in 1996. Given
the sheer number of people taking the drug, there is a strong public interest in
having complete information about its potential risks available to mental health
professionals, researchers, government regulators, and consumers.”
http://lawprofessors.typepad.com/tortsprof/files/ZYPREXAMOTION.pdf

Underscoring the danger that concealed Zyprexa -related injuries pose for
individuals and the public health, on the same day the Judge issued his ruling,
the Housel Government Oversight and Investigations Committee
held hearings about drug safety. FDA’s senior safety officer, Dr. David
Graham, testified that the FDA and Eli Lilly knew but failed “for a long time” to
inform doctors and the public that Zyprexa (olanzapine) induces diabetes.
See: FDA handling of Lilly drug needs probe-scientist, Reuters. Feb 13, 2007
http://www.reuters.com/article/governmentFilingsNews/idUSN1321515720070213

Furthermore, there is a danger that yesterday’s ruling might be interpreted
as encouragement rather than deterrant for pharmaceutical companies to engage
in illegal marketing practices to promote hazardous drugs.
Bloomberg News compares AstraZeneca’s marketing and the concealment of the
risks of its of its antipsychotic  drug, Seroquel, to the Zyprexa marketing strategy.
See: AstraZeneca Faces 10,000 Lawsuits Over Seroquel Drug By Margaret Cronin
Fisk BLOOMBERG NEWS:
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a.ZTdmV67chI

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

~~~~~~~~~~~~~
<a href="http://www.nytimes.com/2007/02/14/business/14lilly.html">http://www.nytimes.com/2007/02/14/business/14lilly.html</a>
<strong>THE NEW YORK TIMES
Judge Rules Drug Documents Must Be Returned to Eli Lilly
By LANDON THOMAS Jr.
Published: February 14, 2007</strong>

A federal district judge in Brooklyn ruled yesterday that confidential
marketing materials belonging to Eli Lilly & Company about its top-selling
anti-psychotic drug Zyprexa must be returned to the company by a doctor and
a lawyer who, the judge said, engaged in a scheme to leak them to the news
media.

The documents were part of evidence provided by Lilly as part of a lawsuit
filed by patients who claimed that side effects from Zyprexa caused
excessive weight gain and diabetes.

In the 78-page decision, Judge Jack B. Weinstein of Federal District Court
ordered Dr. David Egilman, a special expert for the plaintiffs, and James B.
Gottstein, a lawyer in Alaska, to return the documents to Lilly.

A New York Times reporter, Alex Berenson, was given a copy of the documents,
which showed that Lilly executives had kept information from doctors about
Zyprexa's links to obesity and higher blood sugar, a claim Lilly has denied.
He wrote front-page articles based on the information.

Eli Lilly has now paid $1.2 billion to settle more than 28,000 cases from
individuals who contended that they developed diabetes or other diseases
from taking Zyprexa.

In the ruling, Judge Weinstein said Mr. Berenson obtained the documents
after he discussed with Dr. Egilman ways to circumvent a protective order.
Mr. Berenson put Dr. Egilman in touch with Mr. Gottstein, the judge said, so
that they might "employ a pretense to subpoena the documents." According to
Judge Weinstein, the documents were sent to Mr. Gottstein via an expedited
subpoena, which Lilly was unaware of. Mr. Gottstein then sent the papers to
Mr. Berenson and others.

No other news organizations received the documents, the judge said, because
Mr. Berenson told Mr. Gottstein that if the material was not delivered
exclusively to him, the newspaper would not publish an article.

Mr. Berenson did not appear at an earlier hearing on the matter, where he
was invited to testify. George Freeman, a lawyer for The New York Times
Company, said that as a matter of "long-held principle," the company
believed it would be "inappropriate for any of our journalists voluntarily
to testify about newsgathering methods."

In a statement yesterday, Mr. Freeman said: "For the reasons set forth in
our letter responding to Judge Weinstein's invitation, we declined to
testify voluntarily about our newsgathering methods. Unfortunately, that
resulted in an opinion which vastly overstates Alex's role in the release of
the documents. We continue to believe that the articles we published were
newsworthy and accurate, and we stand by them."

Mr. Gottstein, who is president and chief executive of the Law Project for
Psychiatric Rights, said, "I was just trying to follow the law."

He said that a subpoena allowed him to adhere more closely to the protective
order than if Dr. Egilman had given the documents directly to Mr. Berenson.

A spokeswoman for Eli Lilly, Marni Lemons, said: "Our adversaries carefully
selected the documents to tell a story that they wanted to tell. These
cherry-picked documents in no way reflect the strategies or activities of
Eli Lilly & Company. Lilly feels vindicated because the judge issued an
injunction that prohibits future wrongdoing by those who took the law into
their own hands."

While the judge asked Mr. Gottstein and Dr. Egilman to return the documents,
he did not ask Mr. Berenson to do so. Many of the documents are available on
the Internet and the ruling does not ask that any newspaper or Web site take
any action with regard to the papers.

Judge Weinstein reserved some harsh words for Mr. Berenson, whose conduct he
called "reprehensible," and for The Times, pointing out that unlike the case
of the Pentagon Papers, in which classified government documents were given
to a Times reporter, "here a reporter was deeply involved in the effort to
illegally obtain the documents."

The judge said that the documents' disclosure posed "significant risk of
harm to Lilly," and that their "out of context" appearance in the news media
might "lead to confusion in the patient community and undeserved
reputational harm."
~~~~~~~~~~~~~~

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a.ZTdmV67chI
BLOOMBERG NEWS
Eli Lilly Zyprexa Papers Must Be Returned, Judge Says (Update3)
By Patricia Hurtado

Feb. 13 (Bloomberg) — Confidential Eli Lilly & Co. marketing documents
about its best-selling schizophrenia drug, Zyprexa must be returned to the
company by a doctor and a lawyer who conspired to leak them to the press, a
federal judge ruled.

The documents were first submitted in litigation in New York federal court
where patients suing Lilly claimed it failed to adequately warn that Zyprexa
can cause illnesses including diabetes. The plaintiffs also said Lilly
promoted the drug for unapproved uses. The court had ordered the documents
sealed.

According to today’s order, New York Times reporter Alex Berenson suggested
Dr. David Egilman, an expert witness in the suit, contact James Gottstein, a
lawyer in Alaska. Egilman arranged to pass sealed documents to Gottstein
under a subpoena by the attorney for another case, an exception to the seal
order. The documents were passed to Berenson, who wrote about them.

Such unprincipled revelation of sealed documents compromises the ability
of litigants to speak and reveal information candidly to each other,'' wrote
U.S. District Judge Jack Weinstein in Brooklyn.
These illegalities impede
private and peaceful resolution of disputes.”

Lilly has paid $1.2 billion to settle the claims of more than 26,000 former
Zyprexa patients in consolidated cases presided over by Weinstein. The
company had global Zyprexa sales of $4.2 billion in 2005, about 29 percent
of Lilly’s total. Lilly declined to provide sales numbers for the drug in
2006.

`Irreparable Harm’
Weinstein ordered Egilman and Gottstein to obey an earlier order demanding
the return of the documents to Indianapolis-based Lilly “to prevent
irreparable harm” to the company.

While Weinstein didn’t enjoin Berenson in the order, he called the
reporter’s actions “reprehensible.”

New York Times spokeswoman Diane McNulty noted that Berenson and the
newspaper declined Weinstein’s invitation to come to court to explain how
they obtained the documents. Unfortunately, that resulted in an opinion
which vastly overstates Alex's role in the release of the documents,''
McNulty said.
We continue to believe that the articles we published were
newsworthy and accurate and we stand by our reporting.”

Lucy Dalglish, executive director of Reporters Committee for Freedom of the
Press, called the judge’s order “troubling.”

Any time you have a federal judge finding that a reporter participated in
a conspiracy, that's a frightening notion,'' she said.
This is an area
where I don’t think the law is crystal clear.”

No Sanctions
Dalglish added that, while Weinstein didn’t issue any sanctions against
Berenson, “it’s not often that you have a federal judge on the record
finding that a reporter engaged in a conspiracy.”

The documents given to Berenson detail Lilly’s efforts to market Zyprexa for
conditions other than schizophrenia and bipolar disorder, for which the drug
was approved by the U.S. Food and Drug Administration, according to two New
York Times stories written by Berenson.

Weinstein wrote that Egilman, Gottstein and Berenson conspired to obtain
and publish documents in knowing violation of a court order'' and
they
executed the conspiracy using other people as agents in their crime.”

Egilman’s lawyer, Edward Hayes, said his client will comply with the court’s
order.
“My client thought he was complying with the order, but he didn’t,” Hayes
said.

`Vindicated’
This was not a conspiracy to harm Eli Lilly'' said Gottstein, who added
that he is considering an appeal.
The court’s order sealing the documents
provided for release of the documents in circumstances like these, and I
made a concerted good faith effort to follow those provisions.”

Gottstein added that “Did I want to get this information in front of the
public and the medical profession? Of course. Additional lives may well have
been saved.”

Berenson, who is on a leave of absence to write a book until March, didn’t
return calls left at his office or on his mobile phone seeking comment.
George Freeman, a New York Times lawyer who represented Berenson in the
case, didn’t return a call seeking comment.

“Judge Weinstein vindicated the rights of Lilly and the needs of people
with mental illness, their doctors and their families,” said Marni Lemons,
a company spokeswoman.

The judge said the First Amendment doesn’t protect reporters from breaking
the law.  “Neither members of the media, nor any other branch of our
government are
authorized to violate court orders.” he wrote.

Papers concerning the release of the documents are filed under In Re:
Zyprexa Litigation, 07-CV-0504, U.S. District Court, Eastern District of New
York (Brooklyn). The main case is In Re Zyprexa Products Liability
Litigation, No. 04-MD-1596, U.S. District Court, Eastern District of New
York (Brooklyn).

To contact the reporter on this story: Patricia Hurtado in Brooklyn Federal
Court at pathurtado@Bloomberg.net .

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