Evelyn Pringle February 1, 2007
The judge in the Zypexa secret document case has sent a New York Times reporter an invitation to attend a hearing in the on-going Eli Lilly fiasco in the US District Court for the Eastern District of New York.
"This invitation," Judge Jack Weinstein wrote, "is intended to permit Alex Berenson to confront testimony received at a hearing in this court on January 16-17 implicating him in a conspiracy to obtain and publish confidential documents sealed by this court."
According to Lilly, it took no part in extending this invitation. However, since when does a judge send out invitations, unsolicited by either side in litigation, to witnesses or by the sounds of it a potential defendants?
Mr Berenson most likely earned the invite in December 2006, when he published several articles exposing the fact that for a decade, Eli Lilly had failed to warn consumers, members of the medical profession, and the FDA, about risks of severe weight gain, blood sugar problems, and diabetes associated with Zyprexa.
Mr Berenson also reported that Lilly had illegally promoted Zyprexa for off-label uses not approved by the FDA, quoting Lilly’s own internal documents as his source.
For years, Lilly has been allowed to keep this information hidden, while settling thousands of cases out of court, by falsely claiming that the millions of documents produced during litigation contained trade secrets and getting judges to seal them all with protective orders.
In what can only be considered a heroic act, an expert witness in the Zyprexa litigation, Dr David Egilman, apparently helped facilitate the outing of some of the secret documents when he provided them to attorney, Jim Gottstein, who then provided them to Mr Berenson at the New York Times.
Being Mr Egilman is doctor, when it became obvious that Lilly was going to continue to keep this information secret, after settling out of court with the second round of Zyprexa victims, it can easily be understood why he would believe certain documents had to be made public.
Doctors take an oath to do no harm. Allowing Lilly do go on marketing Zyprexa off-label for every ailment known to mankind without fully warning the public about the serious health risks associated with the drug would have resulted in many more injuries and deaths without a doubt.
A sincere desire by a doctor and an attorney to find a way to warn the public about a dangerous drug does not constitute a conspiracy by any stretch of the imagination.
The only evil conspiracy here involves Lilly’s off-label marketing of Zyprexa to the extent that it took a drug approved for the extremely limited indications of treating adults with schizophrenia or manic depression and turned it into its number one selling product.
In regard to the out-of-court settlements, which to date have cost Lilly about $1.2 billion, Lilly’s chief executive, Sidney Laurel, said in a January 4, 2007 press release: "While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians."
"We wanted to reduce significant uncertainties involved in litigating such complex cases," he stated.
Lilly’s press release expressed no remorse, only more denial, even when the secret documents quoted in the media at that time substantiated every allegation made by the plaintiffs in the cases that were settled out of court.
In the first two rounds of litigation combined, the company has reportedly settled with about 26,500 plaintiffs, but round three is coming up. According to Lilly‘s SEC filings, approximately 1,200 more claims have been identified that are not included in the settlements.
In a January 15, 2007, legal filing, Lilly attorneys claim the Zyprexa documents are not widely disseminated in stating: "Despite a concerted effort by a small group of individuals to take advantage of Dr. Egilman's and Mr. Gottstein's violation of CMO-3, and to violate the Temporary Mandatory Injunctions, this effort fell flat."
Wrong. Any reporter who wants the documents can get them off the internet within a hour max. Furthermore, any journalist interested in this issue already has them. Just because they are not being quoted, does not mean that the documents are not widespread.
The truth is, Lilly has been successful in using the court system to threaten and intimidate citizens, including journalists, into silence. After watching the harassment of all the people caught up in this dog-and-pony show, as Lilly causes them to run up massive legal bills, no sane journalist would openly quote from those documents.
Lilly has plenty to lose if the truth comes out and doctors and consumers decide the risks associated with Zyprexa far outweigh the benefits. In 2005, Zyprexa represented 30% of the company’s total sales.
But if Lilly is to be believed that it is not promoting the off-label use of Zyprexa, there seems to be no end in sight to the epidemic of mental illness sweeping the planet because according to Lilly’s latest SEC filing, Zyprexa sales rose another 12% to $1.16 billion in 2006.
Lilly has no one but itself to blame for the mess its in. If the company had ignored the articles in the Times, and went on its merry way of promoting Zyprexa off-label the same way it had for a decade, people would have lost interest in the story and forgotten what was in the documents.
Furthermore, if Lilly is looking for a scapegoat, the finger of blame should be pointed at the company’s high-priced legal team that screwed up royally by opening the door to First Amendment arguments.