The Secret Eli Lilly Zyprexa Documents–A Case For CivilDisobedience

FindLaw columnist, Julie Hilden, a First Amendment lawyer, brings a fresh
perspective to the controversy surrounding the sealed Zyprexa documents.
In general, she notes, "companies' overprotecting drug-related information
predictably harms patients. It also has other bad effects: Research is
unnecessarily duplicated at different companies, in a waste of time and
effort, and cruel experiments on animals are duplicated, too."

She challenges the rationale given by  Judge Jack Weinstein for sealing the
documents in the first place.
http://ahrp.blogspot.com/2007/02/zyprexa-documents-court-ruling.html
His contention that the seal "expedited" the discovery process leading to an
expeditious settlement, she argues, is not a sufficient reason to seal the
documents: "it was probably well worth spending the time to go through the
documents more specifically, for there was a strong public interest in what
they contained."

Noting the severe, life-shortening, documented, side effects of Zyprexa, the
public interest far outweighs the expediency argument.
Furthermore, she argues, the expedited Zyprexa settlement is NOT in the
public interest, it is in Eli Lilly's interest:

"thanks to the protective order, with a settlement Eli Lilly would be able,
in effect, to buy secrecy for even those documents it produced that were not
trade-secret protected, and that the public did have an interest in seeing:
Indeed, these determinations might never even be made given the veil of
secrecy the protective order cast over the proceedings."    
 
Referring to the central players who brought the documents to public light,
Dr. David Egelman, attorney, Jim Gottstein, and New York Times reporter,
Alex Berenson, she notes: "Their motivation was both urgent and
understandable: They were concerned for the health and safety of those
taking Zyprexa."

However, she is critical of Berenson for not first requesting the documents
directly from Judge Weinstein–
before trying to circumvent the court ordered seal as a justified act of
civil disobedience.

"While Berenson's tactics, in my view, were both wrong and foolish, the
result of his actions was noble:
The public now knows specific information about the dangers of Zyprexa. Eli
Lilly should have released this information as soon as it knew it.
Berenson's decision to release it as soon as possible was the right one –
all the more so, because the patient population here was an especially
vulnerable one." 

Hilden raises an interesting point: "With companies' product formulas
protected by patents, is it really necessary, also, to protect research that
is of vital interest to the public under the rubric of trade secret law? "

Hilden then admonishes Lilly employees who knew for years about the evidence
that Zyprexa poises a threat to life-safety but failed to blow the whistle.
"the failure to engage in civil disobedience when posed with a clear moral
imperative that involves life and safety, is just another version of the
Nuremberg defense: "I was just following orders." 

See: Life in a Jar: Story of Irena Sendler, a Polish Catholic who saved
2,500 Jewish children in the Warsaw Ghetto http://www.irenasendler.org/  and
 http://news.bostonherald.com/international/europe/view.bg?articleid=188449

 

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

http://writ.news.findlaw.com/hilden/20070319.html
 
A New York Times Reporter's First Amendment Civil Disobedience Claim: The
Case of the Secret Eli Lilly Zyprexa Documents
By JULIE HILDEN
Monday, Mar. 19, 2007

Last month, Judge Jack Weinstein of the U.S. District Court for the Eastern
District of New York issued a decision in litigation that, as he noted in
his opinion, "raises intriguing questions of when it is appropriate to
conduct civil litigation in secrecy, and of what are appropriate limits on
civil disobedience by newspaper reporters, forensic experts, and attorneys."

The litigation involved top-selling anti-psychotic drug Zyprexa. The
plaintiffs claim that the drug's maker, Eli Lilly, gave inadequate warnings
regarding the risk of obesity and diabetes in Zyprexa users.

During the litigation, a reporter, an expert, and an attorney who was not
otherwise involved in the case decided to defy the court-imposed protective
order that was issued to maintain the confidentiality of certain documents.
Their motivation was both urgent and understandable: They were concerned for
the health and safety of those taking Zyprexa. But their tactics were
questionable:

In order to circumvent the protective order, they concocted a deceptive ruse
to ensure that the content of documents produced in the ongoing Zyprexa
litigation became public.

Moreover, they failed to try legal means before they resorted to illegal
ones, ignoring a specific procedure that would have allowed them to
challenge the documents' secrecy vis-à-vis the public in court. As I will
explain, this error complicated what would have otherwise been a simple case
of justified civil disobedience.

The Judge Should Not Have Imposed the Protective Order In the First Place
Initially, the parties in the Zyprexa litigation agreed that the documents
they produced to each other in civil discovery should be sealed and thus
inaccessible to the public. Accordingly, Judge Weinstein imposed a
protective order ensuring that no one other than the judge, the parties to
the litigation, and those working for them or acting on their behalf would
have access to the documents. Among the sensitive documents that were sealed

were a number produced by Eli Lilly relating to Zyprexa's side effects.

Judge Weinstein explains in his opinion that he imposed the protective order
"so that discovery could be expedited and the individual cases promptly
settled or otherwise disposed of on their merits." Let's focus briefly on
each of these rationales for imposing the order:

First, how would discovery be "expedited" by the protective order? That
would happen because, without a protective order, Eli Lilly would fight
against having to produce some of its documents, on the ground that they
contained trade secrets or other legally-protected information. Then the
court would have had to make specific determinations as to which documents
Eli Lilly would have to show the plaintiffs and the public, and which it
could legitimately keep to itself.

What's so bad about that? It's time-consuming, but so is virtually all
litigation. Rulings could have been made on categories of documents; they
need not have been made document-by-document. Also, Judge Weinstein could
easily have sent specific issues to the Magistrate Judge assigned to the
case (who did deal with some of the issues relating to the document ruse),
or the parties could have attempted mediation on these issues.

In addition, it was probably well worth spending the time to go through the
documents more specifically, for there was a strong public interest in what
they contained. The filing of the lawsuit alone demonstrated that a
significant number of people were at least alleging that Zyprexa had side
effects that were not fully disclosed. Moreover, conditions such as obesity
and diabetes can hardly be faked (though their cause can always be
disputed). Also, medical weight records will typically show when a person
became obese, and medical records will also show when a person was diagnosed
with diabetes; thus, the timing, too, would be very difficult to fake.
These are not subjective, self-reported symptoms, after all. Thus, the
simple filing of the suit showed that there was at least some correlation
here between Zyprexa use and obesity and diabetes; the question was whether
there was causation, too.

In light of these facts, it seemed very likely, even at the outset of the
case, that the public had an interest in the release of the Eli Lilly
Zyprexa documents. This is especially true since Zyprexa users are a
vulnerable population; Zyprexa is prescribed for schizophrenia and bipolar
disorder. (Ultimately, the public interest in the documents was clear: The
New York Times eventually considered them to be significant enough to merit
a series of lead stories.)

Second, how would the protective order encourage the cases to be "promptly
settled or otherwise disposed of on their merits"?
Once again, some time would be saved during discovery. But more to the
point, thanks to the protective order, with a settlement Eli Lilly would be
able, in effect, to buy secrecy for even those documents it produced that
were not trade-secret protected, and that the public did have an interest in
seeing: Indeed, these determinations might never even be made given the veil
of secrecy the protective order cast over the proceedings.

Thus, with the protective order, Eli Lilly now was induced by both a "stick"
and a "carrot": If it agreed to a settlement, it could avoid the "stick" of
potentially whopping damages, and enjoy the "carrot" of keeping even those
documents that did not contain trade secrets, and were of legitimate
interest to the public, a secret. The secrecy could be enforced by a term of
the settlement agreement under which the parties would promise to continue
to keep the documents confidential, and never to speak of their contents.

Predictably, the settlement amount would be higher than the actual value of
the plaintiffs' injuries due to the alleged side effects, for it would take
into account the benefit of maintaining secrecy for the Lilly documents.
That secrecy cost the plaintiffs nothing to give to Lilly, yet Lilly
doubtless would have paid for it. (This dynamic is why plaintiffs tend to
get a partial windfall when settlement occurs under a protective order, or
even prior to the filing of a complaint.)

In sum, analyzing the rationales that undergirded the protective order show
why its imposition might, on the whole, not have been in the public
interest: It might have both given the public short shrift, and given the
plaintiffs more money than they deserved based on their injuries.
Fortunately, however, Judge Weinstein wisely included a provision in the
protective order setting down the proper procedure to be followed by those –
within or outside the litigation – who sought to challenge it.

A Major Mistake on the Part of the New York Times Reporter: Failing to Try
Legal Methods First
That's where New York Times reporter Alex Berenson made a crucial mistake:
He failed to try to avail himself of the protective order's procedures,
before going through with a ruse to circumvent it.

Here's how the ruse worked: Berenson – with the help of one of the experts
in the case, who was bound by the protective order — convinced an Alaskan
attorney to subpoena the documents by intervening in a separate case. (In a
civil case, attorneys can typically serve subpoenas themselves, without
court approval; if the recipient believes the subpoena is improper, she can
legally fight it in court, and not comply until she gets a ruling.) Since
the protective order contained an exception for the production of
information sought pursuant to a valid subpoena, the documents were
produced.
Not only did the ruse participants hide their real identities with the
subpoena gambit, using the Alaska attorney as a "beard," they also "gamed"
Lilly regarding the timing of the matter – so that Lilly believed it had
more time to challenge the documents' production, than it actually did.
Ultimately, the documents ended up all over the Times, then all over the
Web.

Going through with the ruse without first seeking an exception from the
protective order was a foolish mistake by Berenson. For one thing, if he had
simply asked, the judge might have granted him an exception, at least for
some subset of the documents: As Judge Weinstein's opinion shows, he is
well-aware of the First Amendment interests involved, and takes them very
seriously.

On the other hand, Judge Weinstein's opinion also specifically indicated
that he deemed many of the documents protected either by trade-secret law or
as confidential commercial information. Thus, in the end, how the judge
would have balanced the First Amendment interests against these protections,
had Berenson actually asked for a ruling on a protective-order exemption, is
not precisely clear.

Nonetheless, it would have been worth Berenson's at least trying to procure
the exemption. If he'd done so and failed, he still could have gone through
with the ruse (which he could even have initiated simultaneously, if he felt
time was of the essence in getting the information out there one way or
another). After all, no "red flags" would have gone up for Eli Lilly, since
the requester, in the ruse, wasn't Berenson or any other reporter; it was an
attorney in Alaska.

Had Berenson taken this path, his actions would have raised only the pure
question of civil disobedience I will discuss below: Was this a case where
lawbreaking should be punished, or applauded? The gratuitous lawbreaking of
trying to "game" the protective order, rather than moving to alter it, makes
the moral issue more complicated.

In the end, Berenson lucked out in that Eli Lilly never sought an injunction
– or, to my knowledge, sanctions — against him or the Times. But it might
have been very hard to predict, in advance, that this would be the case. So
Berenson's mistake not only made his case for civil disobedience weaker, but
it also might have had more practical costs as well.

Interestingly, Judge Weinstein not only didn't enjoin Berenson or the Times,
he also didn't enjoin the websites – in essence because it would have
amounted to closing the barn door after the horses had already escaped. (As
I discussed in a prior column, trade secrets violations can be very
difficult – both as a matter of law and a matter of practicality – to punish
when secrets are released on the Internet, particularly when the first
releaser may well be anonymous.)

If Berenson Had Tried and Failed to Get a Protective Order Exception, Would
the Ruse Have Been Justified, In Order to Get the Documents Before the
Public?
While Berenson's tactics, in my view, were both wrong and foolish, the
result of his actions was noble: The public now knows specific information
about the dangers of Zyprexa. Eli Lilly should have released this
information as soon as it knew it. Berenson's decision to release it as soon
as possible was the right one – all the more so, because the patient
population here was an especially vulnerable one.

In general, companies' overprotecting drug-related information predictably
harms patients – as well as possibly running afoul of the FDA. It also has
other bad effects: Research is unnecessarily duplicated at different
companies, in a waste of time and effort, and cruel experiments on animals
are duplicated, too.

With companies' product formulas protected by patents, is it really
necessary, also, to protect research that is of vital interest to the public
under the rubric of trade secret law? In this instance, both diabetes and
obesity can take years off one's life, as well as potentially affecting the
quality of life, and there are other drugs for schizophrenia that patients
might have chosen in lieu of Zyprexa, had they been fully informed.

Perhaps the saddest aspect of this case is that no insider at Eli Lilly
dared to make these side effects public, even when they were known within
the company. According to the Times, the effort to play down Zyprexa's
health risks had spanned a decade. How many employees participated? How many
knew what was happening?

Doubtless, the employees had signed confidentially agreements (a topic I
discussed in another column). However, in the end, the failure to engage in
civil disobedience when posed with a clear moral imperative that involves
life and safety, is just another version of the Nuremberg defense: "I was
just following orders." Whatever one thinks of Berenson's conduct, the true
culprits here are all the unnamed employees who knew of genuine health
risks, but declined to become whistleblowers to expose them.
________________________________________

Julie Hilden, a FindLaw columnist, graduated from Yale Law School in 1992.
She practiced First Amendment law at the D.C. law firm of Williams &
Connolly from 1996-99. Hilden is also a novelist. In reviewing Hilden's
novel, 3, Kirkus Reviews praised Hilden's "rather uncanny abilities," and
Counterpunch called it "a must read…. a work of art." Hilden's website,
www.juliehilden.com, includes free MP3 and text downloads of the novel's
first chapter.
 

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