Zyprexa Judge: NY Times Reporter is ‘Reprehensible’
20 CommentsBy Ed Silverman // February 13th, 2007 // 3:18 pm
In a 77-page order issued today, U.S. District Court Judge Jack Weinstein, who oversees product-liability litigation involving the schizophrenia drug, ruled that:
The Zyprexa documents, which detailed hidden side-effect data and improper marketing and were published by The New York Times, are protected under court order. Also, the court has the power to order the return of the ’stolen’ documents. And Weinstein ruled that restrictions on distributing the documents don’t violate First Amendment rights. However, he won’t prevent web sites from disseminating the documents.
In the end, Weinstein wrote “the disclosure of confidential proprietary material and trade secrets poses a significant risk of harm to Lilly.” A collection of patient and free-speech advocates contended that keeping the Zyprexa documents confidential, even after many were circulated on the Internet, was not only a First Amendment issue but violated public health.
Lilly sought injunctions against several people including David Egilman, formerly an expert witness in the Zyprexa litigation, and Jim Gottstein, a lawyer, both of whom Weinstein accused of conspiring to leak the documents to New York Times reporter Alex Berenson.
Unlike the other two, the reporter isn’t included in the injunction, but Weinstein wrote that “Berenson’s conduct in assisting in the stealing of the protected documents was reprehensible.”
Emilia DiSanto, a U.S. Senate committee staffer who has investigated numerous drugmakers in recent years over safety issues, also received the documents, but won’t be required to return them.
You can gain some insights into the issue by going to the Torts Prof Blog, which has done a great job following this saga. Many thanks to Bill Childs.
[tags]David Egilman, Eli Lilly, Zyprexa[/tags]
Laurie
“However, he won’t prevent web sites from disseminating the documents.”
OK, am I missing something here?? So the “actual” documents have to be returned, but the fact that they are all over the internet the court has no control over. The legal finagling here is bizarre..bottom line, Lilly got caught lying.
peagee
What I find so hard to believe is the difference between these two statements:
Feb 2007
“the disclosure of confidential proprietary material and trade secrets poses a significant risk of harm to Lilly.”
and
Feb 2005
“[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.”
Both statements made by Judge Weinstein.
WHO HIMSELF appears to have managed to defeat “the deterrent function of the justice system” today.
Playing ‘half games’ is as much defeating the deterrent function of the system as far as Lilly is concerned as it would have been finding for their ‘trade secrets’ in entirely.
It is in fact letting Eli Lilly GET AWAY WITH IT rather than deterring them from trying it yet again. Without that deterrent Eli Lilly undoubtedly will do so again as they have before and it will be at the cost of even MORE lives.
The People do not have to be experts in law, qualified as attorneys or justices to know what is just or unjust. In many cases it is just plain obvious and this case again shows that there is something VERY WRONG with the US Justice system.
peagee
Furthermore, its a DISGRACE that a Courtroom in the United States can put lives ACROSS THE GLOBE at risk by defending industrial ‘trade secrets’ despite the fact that those documents show misconduct, intent to conceal the cause of injury from victims and renders potential victims vulnerable.
There is RIGHT and WRONG. Its black and white in this case, risk to global public health versus industry profits. Too sad that a Judge who wrote such ‘wise words’, failed to live up to them in the end.
peagee
Its sad because the Judge with the wise words could have, in the sunset of his lfe,
MADE SUCH A DIFFERENCE.
He could have changed things for the better by discouraging ‘lack of transparency’.
He could have saved so many lives in the future.
All he need to do was to stand by his words and make the right judgement on this case.
SL
Seems something else needs to be added to the following:
* The science of medicine to become safer
* Academics authoring ghostwritten articles that distort data to be exposed
* Academics to be free to question or criticize datawithout victimization
* Regulators to become accountable
* Legislation to become effective
* The drug industry to be brought back under control
Lawyers and Lawmakers to be exposed when they use the law to put a gag on science and scientific enquiry, particularly when the integrity of the science involved appears questionable and may put public health at risk.
SL
* Academics to be free to question or criticize data without victimization
Questions.
Is it not a physician’s LEGAL DUTY as in “DUTY OF CARE” to give the best care possible, for the patients’ sake and also to avoidi LEGAL charges of negligence or manslaughter?
If then a physician is aware of questionable data that could cause harm to his, or other physicians, patients, would it be his legal duty - in addition to it being clearly his moral duty?
If that data cannot be brought to the attention of others through the normal channels used in science - debate and determination of data’s integrity - due to lawers (and judges) protecting the industry, should he not have a legal DUTY OF CARE to expose the data by whatever means possible?
If that physician (who has certainly followed his moral duty of care to patients whether or not the law considers it a legal duty) is then hauled through a court by the ‘owners’ of such questionable data in order to stop him carrying out a DUTY OF CARE, is that not victimisation?
If an industry gags that doctor and the questionable data remains undebated academically, scientifically, and people suffer and/or die as a result, should the negligence/manslaughter charges be brought against the industry that prevented the doctor from carrying out his duty of care?
And shouldn’t the same be applied to lawyers and judges who knowingly assist the gagging of that physician?
I say “knowingly” because a comment above quotes an extract from Weinstein’s book particularly looking at protective orders and the distinction between industry interests and the interests of vulnerable patients.
ed
There are some good points and important questions raised here. Perhaps one way to resolve some of this, or at least to attempt a resolution, is to fight Weinstein’s order.
SL
* The science of medicine to become safer
I assume someone might answer by saying that Weinstein purports to be acting in the patients interests, as shown here:
http://www.nytimes.com/2007/02/14/business/14lilly.html?_r=2&oref=slogin&oref=slogin
“…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.”..”
However, from that statement, it seems clear that:
as the data in the documents may lead to confusion in the “PATIENT COMMUNITY” were the media to expose them ‘out of context’ - then clearly the data is to do with the DRUG and its effects rather than the documents being truly “trade secrets”.
If the data, when taken out of context, can confuse patients, then clearly there is something within those documents to cause confusion and alarm.
QUESTIONS:
How does Weinstein justify an action of gagging information on documents that contain data that can confuse and alarm the PATIENT COMMUNITY?
While it is reasonable to believe that media coverage MIGHT confuse the patient community, the media would be better informed were (independent) scientists and academics worldwide able to have access to those documents to decide on the integrity (or lack thereof) of the data contained in those documents. It is after all in the hands of the media because a doctor was concerned about the data but was unable to disclose it any other way.
If the documents are as benign as Lilly and Weinstein together appear to be suggesting, and as the documents also consist of matters that concern PATIENTS and are so not ‘trade secrets’, why has Weinstein done everything within his power to keep that information from the sight of scientists and academics?
SL
Ed, I believe you may be right.
Unfortunately the lawyer Jim Gottstein, who probably understands better than most lawyers about the importance of the documents in the context of the “patient community”, has for his integrity been gagged by the Judge in such a way that he is now open to victimization from Eli Lilly by way of financially ruinous contempt sanctions.
It takes a law firm with a great deal courage to take take on a company as powerful and wealthy as Eli Lilly as it is.
This won’t have been made easier after the example set by the actions of the Court and Eli Lilly so far.
SL
Genuine “science” necessarily involves (and evolves from) honest disclosure of data and open debate of that data, These qualities are intrinsic parts of what is classed as Scientific Integrity. Without scientific integrity there is no science.
Eli Lilly have worked hard to gag scientific enquiry, disclosure and open debate by keeping drug-related documents regarding the patient community away from independent scientists in medicine and, shamefully for the US justice system, they succeded with the willing assistance of a Court of law.
As Lilly have clearly demonstrated their disregard for science by their lack of scientific integrity, THEY SHOULD NOW STOP SELLING THEIR DRUGS UNDER THE BANNER OF SCIENCE.
OSV
A few statements regarding Eli Lilly and Zyprexa.
DR DAVID GRAHAM (FDA SCIENTIST)
& DR EGILMAN (EXPERT WITNESS), JIM GOTTSTEIN (LAWYER):
ARTICLE LINK
“…on February 13, 2007, FDA scientist Dr David Graham, the guy brave enough to blow the whistle on Merck and Vioxx, testified at a US House of Representatives Energy and Commerce subcommittee hearing and said the off-label use of antipsychotics like Zyprexa to sedate nursing home residents kills roughly 15,000 people a year.
Dr Graham also told members of the committee that Lilly and the FDA had known “for a long time” that Zyprexa caused weight gain that can lead to diabetes…”
“…After reviewing the documents as a plaintiff’s expert in the underlying Zyprexa litigation, Dr Egilman became so alarmed over what he found that as a doctor, he believed he had an obligation to find a way to make the information public…”
“…Mr Gottstein argues that the public has a right to know the truth about the risks associated with the drug. “The files show that the manufacturer hid vital information about the drug’s safety,” he states, “not only from patients, but also from doctors.”
“Zyprexa has killed and permanently sickened thousands of people who have taken it,” he says.
Mr Gottstein openly admits that he wanted to get the information out to save lives. “The bottom line is patient safety,” he said…”
“…If the disclosure of these documents prevents even one person from taking Zyprexa without knowing about the health risks involved, the ends will justify the means, and Mr Gottstein and Dr Egilman should be declared saints…”
OSV
(Above link was to: http://www.opednews.com/articles/genera_evelyn_p_070214_more_zyprexa_postcar.htm)
http://www.ahrp.org:80/children/healy0402.php
PROFESSOR DAVID HEALY, UNIVERSITY OF WALES, (PSYCHIATRIST, PSYCHOPHARMACOLOGIST, *FORMER* CONSULTANT TO PHARMACEUTICAL COMPANIES, ‘WHISTLEBLOWER’, EXPERT WITNESS)
“…At much the same time Lilly began studies on Zyprexa in children. There are parallel problems to Pfizer’s studies. The studies in adults with Zyprexa that Lilly submitted to the FDA demonstrate, as far as I can establish, a higher death rate on Zyprexa than on any other anti-psychotic ever recorded.
In addition to this Lilly have suppressed data on suicidal acts on Zyprexa from these trials. The data are not available in the scientific literature, nor from FOI requests to the FDA, nor from enquiries to the company…”
Nor from Judge Weinstein’s courtroom. ….
HOW DARE LAW COURTS WORK TO ASSIST INDUSTRY IN CRIME WHEN THOUSANDS OF LIVES ARE BEING LOST!
HOW DARE THEY!
Appalled
They’ve been doing it for ages.
http://ahrp.blogspot.com/2007/02/zyprexa-documents-court-ruling.html
“…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…”
CONSPIRED?
So…LEGALLY, from a Judge’s point of view:
it’s NOT conspiracy when Lilly hides data VITAL for physicians to know, such as studies that show a higher death rate on Zyprexa than on any other antipsychotic ever recorded and as a result of that non-disclosure thousands of people have died.
Its NOT conspiracy when Eli Lilly hide documents that show they knew the additional risk of diabetes and how they encouraged off-label use of their drug despite it having a higher death rate than on any other antipsychotic ever recorded, so adding to the death toll.
Its NOT conspiracy when courts purporting to uphold “JUSTICE” ignore the risk of lives being lost to citizens and instead seal documents away from view of those Professors and Physicians who, without such data and documents, continue in ignorance to unwittingly cause the deaths of THOUSANDS of citizens.
According to Law, in Judge Weinstein’s view at least, CONSPIRACY is:
When people such as Dr Egilman and Jim Gottstein who have theINTEGRITY and COURAGE to risk everything by standing up for what is RIGHT (and do so against powerful people lacking integrity and courage representing all that is WRONG such as corruption in industry protected by corruption in the justice system), in an effort to put a stop to the killing of human lives resulting from such corruption…
CONSPIRACY is: justice, integrity, courage, ethics, concern for the lives of others over and above the risk to their own..
Eli Lilly, is a company that has become used to legal protection allowing them to seal documents that are shown in courts and seen by expert witnesses, in cases where they are involved in settlements for damages. ERGO: WHERE THOSE DOCUMENTS SHOW HARM. Having had that protection from the JUSTICE SYSTEM for decades, they have become used to having a free hand in avoiding accountability for their actions to amass huge profits, just as US courts have become used to abusing the principles of “justice” to protect them.
Clearly, “justice”, the US way, is used as a cover to protect fraud and corruption. Had the courts not assisted industry in this way, hundreds of thousands of people across the world would still be alive today.
But that, apparently, is not CONSPIRACY.
SHAME ON YOU, JUDGE WEINSTEIN.
BringBackETHICSinLAW
“Richard Zitrin practices law in San Francisco and teaches at the University of California, Hastings, College of the Law. He is also the founder of the Center for Applied Legal Ethics at the University of San Francisco. ”
http://www.twincities.com/mld/twincities/news/editorial/16665951.htm
“…Courts have the power to grant protective orders only to limit the disclosure of highly personal information and legitimate trade secrets. But when all the lawyers in a case agree, judges often grant protection even if the trade secrets in question show how the product does not work, not how it does.
Neither lawyers nor judges should ever be party to such agreements. It is simply unacceptable as a matter of public policy to permit secret deals that conceal evidence of dangers to the public….”
“…Unfortunately, disclosure is still the exception. But we should have learned our lesson by now. From Zomax and Halcion in the 1980s to shredding Firestone tires and GM gas-tank fires in the 1990s, to Vioxx and Zyprexa today, when lawyers cut secret deals behind the public’s back, what we don’t know can and does hurt us. The civil justice system belongs to all of us, and no one should be allowed to use it to keep the public in the dark….
HopeForTheFutureInLaw
So you see, from an ETHICAL lawyer’s LEGAL perspective, it isn’t lawyer Jim Gottstein who is the ‘bad guy’ in the Zyprexa case.
“…Neither lawyers nor judges should ever be party to such agreements. It is simply unacceptable as a matter of public policy to permit secret deals that conceal evidence of dangers to the public….”
The hope for the future is that Richard Zitrin’s law students will breed better lawyers and judges who will bring ethics back into law and a stop to the current situation:
That of judges colluding with industry fraud instead of protecting citizens from harm.
ReputationsOfDistinction
“…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.”
OH COME ON JUDGE! We’re not stupid - and neither are you. The documents are benign and yet the contents are so explosive that they could cause significant harm to Lilly?
LILLY ALREADY HAS A WELL DESERVED REPUTATION OF CAUSING HARM TO OTHERS.
Here’s a few and many/all of them may be due to LAWYERS AND JUDGES sealing documents and data away from the eyes of physicians and patients (or upholding laws that allow others, such as regulators, to do so) thus causing the deaths of innocent citizens.
EVISTA
http://www.bestsyndication.com/?q=012507_eli-lilly-fda-legal-lawsuits-pharmaceutical-company.htm
“…In the case of EVISTA, approved for treating post-menopausal women with osteoporosis, Lilly CONCEALED DATA that showed an increased risk of cancer. On October 24, 2002, the Cancer Prevention Coalition issued a press release that said Lilly suppressed evidence that women taking the drug were at an increased risk of developing ovarian cancer.
“There is ample scientific evidence that Evista poses risks of ovarian cancer,” said Dr Samuel Epstein, MD, Chairman of the Prevention Coalition…”
“Lilly’s own study,” Dr Epstein wrote, “found that the drug was shown to induce ovarian cancer in rats and, at doses well below the therapeutic, in mice.…”
PROZAC
http://www.socialaudit.org.uk/58096-DH%20to%20WARK.htm
[Professor Healy]
” Lilly have resorted to treatment non-response and a range of other headings to code what happened.”
“…records on Prozac, Seroxat/Paxil and Lustral/Zoloft, you will find cases of homicidality coded as nausea for instance.”
“Discontinuation of patients from studies for primary adverse effects such as nausea when in fact there has been a suicidal act;”
“But it is also worth adding specifically that this has been a feature of all trialsof Zoloft/Lustral, Seroxat/Paxil and Prozac throughout… ”
CYMBALTA / YENTREVE
http://www.slate.com/id/2126918/
“…Over four months beginning in January, I filed several Freedom of Information Act requests on behalf of the Independent on Sunday, a British newspaper, for all safety data related to Cymbalta and Yentreve. I received a database that included 41 deaths and 13 suicides among patients taking Cymbalta.
Missing from the database was any record of Johnson [HEALTHY VOLUNTEER taking part in theclinical trial to help pay college fees], or at least four other volunteers known to have committed suicide while taking Cymbalta for depression.
When I asked the about the missing results, FDA officials cited a federal regulation
[text links to http://www.24-7pressrelease.com/view_press_release.php?rID=16662
“…A court in Sweden has recently ordered the document to be made public.
This was done after the Swedish Medical Products Agency (MPA) and the British MHRA in their response to FOIA [FREEDOM OF INFORMATION ACT] requests had treated this document as if it was a “state secret”.
In its arguments to the court the Swedish MPA even said that issuance of it would hurt the relations between Sweden and UK…”
OTHER LILLY FACTS
http://en.wikipedia.org/wiki/Eli_Lilly_and_Company
“…Eli Lilly is also one of many drug companies that give soft money to advocacy groups and political action committees (PACs) to help influence lawmakers and regulators…”
Justice in the face of thousands of lives lost appears to be:
Protect the industry.
Make Laws allowing others to protect the industry.
If absolutely necessary, give industry a monetary fine (for causing the deaths of citizens) which they can afford, and allow them to carry on as if nothing had happened.
Imprison citizens who intentionally cause loss of life to another BUT treat industry as an ‘entity in itself’ and never find any individuals within it responsible (by their intentional actions of altering or hiding documents or promoting off label use) for the deaths of thousands of innocent citizens.
Victimise those who try to expose industry corruption to save lives, by treating them as if THEY were the criminals.
Back to point 1, protect industry.
There’s an old saying “The Law is an Ass”.
Perhaps, where judges and lawyers protect industry rather than protect citizens, it should be ‘The Law is a dangerous Farce“.
ed
Awful lot here to digest. My thoughts?
Plaintiffs’ lawyers shouldn’t strike deals to allow every document, or e-mail, to remain confidential. I understand the reasons this is done, usually justified for the sake of expediency, among other things.
But if more lawyers would ‘just say no,’ and force the issue in court, judges wouldn’t be so quick to think that issuing protective orders is acceptable because both parties are in agreement. In general, of course, such actions run the risk that important information will never see the light of day and, therefore, the risk of further harm increases, at least theoretically (I’m speaking in general terms, not about this particular case).
As some lawyers like to say about me, I’m just a journalist (albeit, one with a modest business background). But like most anyone else, I can sense fair play and lhave an interest in societal good. To that end, I think throwing blankets in the form of protective orders over every piece of paper and electronic file is a disservice.
Hello
This whole thing is bull. These people should be given a medal for warning people about this company and warning people about the effects of Zyprexa. There is no way that these people should be brought up on any form of charges and if they do this legal system has gone totally for the companies and not for the people.
Zoloft side effects.
Zoloft.
Weight gain and zoloft. Zoloft. Generic zoloft price. Compare prozac and zoloft.
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