Lilly Settles With Zyprexa Document Leaker
5 CommentsBy Ed Silverman // September 7th, 2007 // 1:30 pm
You read it here first. David Egilman, the expert witness who last winter caused a huge controversy by providing The New York Times with sealed documents indicating Lilly downplayed or hid harmful Zyprexa side effects and improperly promoted the antipsychotic to doctors, has struck a deal with the drugmaker.
An order filed this morning in US District Court in Brooklyn, NY, shows that Egilman, a 54-year-old associate professor at Brown University, acknowledged violating a protective order that required court documents to remain sealed. And he’s agreed to pay $100,000, which Lilly will donate to the International Center for Clubhouse Development. By agreeing to the deal, Egilman avoided facing civil and criminal contempt penalties.
“Dr. Egilman has now confirmed in writing what Lilly has been saying since the Times published these documents: he was selective in which documents he released and they unfairly portrayed Lilly’s activities in its interactions with doctors, patients and the FDA,” says Mike Harrington, Lilly’s deputy general counsel, in a statement sent to Pharmalot.
The episode, which highighted drug safety, public health and First Amendment rights, attracted enormous attention from big pharma, plaintiffs’ lawyers, free-speech advocates and consumer groups over the societal benefit of disseminating the materials. But Jack Weinstein, the federal judge overseeing the Zyprexa litigation, found that Egilman, attorney Jim Gottstein, who hasn’t yet settled with Lilly, and New York Times reporter Alex Berenson conspired to leak and publicize the documents (here’s the order). The judge also called the reporter ‘reprehensible.’
The Lilly statement goes on to say that Egilman “intentionally and illegally” gave “an incomplete subset” of documents to Gottstein, who then passed them to Berenson for publication. And that Egilman “knew that these materials painted an incomplete picture of the issues related to Zyprexa.”
However, Egilman’s attorney, Alex Reinert says that Egilman didn’t admit to anything illegal. A quick read indicates he appears to be correct (although we recognize that other interpretations are possible). “If Lilly thinks the story is incomplete then all it has to do is release the documents,” says Reinert. “It has the power to do so, but keeps them secret.” This is Egilman’s affidavit
“I call on Lilly to release the documents,” Egilman tells Pharmalot. “I’ve never heard of a company hiding documents that prove its drug is safer than others. All that is needed for the forces of evil to succeed is for enough good people to remain silent.” Lilly may not want to do so, however, while several states are investigating its marketing of the antipsychotic. The drugmaker, by the way, has itself faced criminal charges in the past, most recently two years ago in connection with marketing the Evista osteoporisis drug.
Thanks to TortsProf for tech help.
TortsProf Blog
Egilman “Accepts Responsibility,” Settles with Lilly for $100K…
Pharmalot broke the story of David Egilman settling his part of the document leak with Lilly to the tune of $100,000 (to be donated to charity). The stipulation is available here: Download EgilmanSettlement.pdf, and his affidavit is here: Download Egil…
Friday Blog Roundup « The Pump Handle
[...] Ed Silverman at Pharmalot reports on a settlement between Eli Lilly and an expert witness who provided the New York Times with sealed documents showing the drugmaker hid harmful side effects of its antipsychotic drug Zyprexa; TortsProfBlog has more details. (For more backstory, see David Michaels’s post on the Zyprexa case.) [...]
David Egilman
Last December, as reported in the New York Times, I was subpoenaed for copies of internal documents that I acquired as a consulting witness in litigation against the pharmaceutical company Eli Lilly. I released all of the documents I had, which made their way to The Times and became the basis for four major articles. After the Times story, Lilly’s marketing of Zyprexa became the subject of lawsuits by seven states that claim the company hid side effects of the drug and promoted it for unapproved uses.
I reached a settlement with Lilly. I admitted responsibility for violating the protective order that kept Lilly’s documents secret. I did not admit to any illegal conduct. I agreed to pay the company $100,000. I admitted that Lilly has told a different story about the side effects of Zyprexa, but I do not believe, and did not admit, that Lilly’s “story” is based in fact. And notably, although Lilly claims that the stories that ran in the Times did not accurately reflect their marketing practices or their knowledge of Zyprexa’s side effects, Lilly has refused to release documents that they claim paint a different picture. Even today, Lilly fights in court to keep those documents secret from the public.
On the other hand the silence of Eli Lilly & Company and their doctors about the hazards of Oraflex, a drug they knew caused fatal liver failure, resulted in unnecessary deaths of American patients. Lilly pleaded guilty to 25 criminal charges of failing to inform the United States government about adverse reactions to Oraflex and mislabeling the drug. In addition Lilly pleaded guilty and paid $36 million in connection with its illegal promotion of Evista.
If Lilly has “secret†documents that indicate that its drugs are safe or that their marketing practices were appropriate, they have the right to release them and it is in their interest to do so. Their silence is deafening.
Silence can injure and kill. For public health, the sound of silence is the funeral dirge. I have not and will never play that tune.
David Egilman MD, MPH
Correction:
Lilly is being sued by some states and are being investigated by at least 7. I do not know if they have all sued Lilly yet.
david egilman
My comments above are based on the published literature and publicly available FDA documents.