The drugmaker is talking to federal prosecutors about settling civil and criminal investigations into its marketing of the antipsychotic and the money would be paid to federal and state governments,
The New York Times reports. If a deal is reached, the fine would be the largest ever paid by a drugmaker for breaking the federal laws that govern how pharma can promote medicines.Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged docs to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed, the Times writes. Lilly may also plead guilty to a misdemeanor criminal charge, but would be allowed to continue selling Zyprexa to Medicare and Medicaid, the biggest Zyprexa customers, according to the Times.
Lilly would neither confirm nor deny the settlement talks. “We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information,” Lilly said in a statement today to the Times. “As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so.” Lilly also said that it had always followed state and federal laws when promoting Zyprexa.
The Lilly fine would be distributed among federal and state governments, which spend about $1.5 billion on Zyprexa each year through Medicare and Medicaid. The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa has also been linked to weight gain.
Apparently, the talks were sparked by publicity a year ago over Zyprexa documents that the Times published, which led to a separate controversy. A federal judge ruled that a Times reporter; a former expert witness for plaintiffs' lawyers, and a psychiatric-rights attorney from Alaska conspired to leak the documents, which were sealed but detailed how Lilly hid side-effect info and off-label marketing practices.'
The former expert witness, David Egilman, later settled with Lilly by paying $100,000 that the drugmaker agreed to donate to charity, although he didn't admit to anything illegal.
Federal prosecutors in Philadelphia are leading the settlement talks for the government, and state attorneys general’s offices are also involved. Lawyers at Pepper Hamilton, a firm based in Philadelphia, and Sidley Austin, a firm based in Chicago, are negotiating for Lilly, the Times writes. Nina Gussack, who is representing Lilly at Pepper Hamilton, wouldn't comment, as did Joe Trautwein, an assistant US attorney in Pennsylvania.
Both sides want to reach a deal, the Times says. Besides the escalating pressure of the federal criminal inquiry, Lilly faces a civil trial scheduled for March in Anchorage, Alaska, in a lawsuit brought by the state of Alaska to recover money the state has spent on Zyprexa. A loss in that lawsuit would damage Lilly’s bargaining position in the Philadelphia talks.
The settlement negotiations in Philadelphia began several months ago, according to the Times. Last fall, the two sides were close to a deal in which Lilly would have paid less than $1 billion to settle the case, which at the time consisted only of a civil complaint. Then Justice Department lawyers pressed for a grand jury investigation to examine whether Lilly should be charged criminally for its promotional activities, according to the Times. A few days ago, facing the possibility of both civil and criminal charges, Lilly began new talks with prosecutors in Philadelphia.
9 Comments
Ed,
Do we know where the NJ AG stands on this!! I do know that some NJ legislators expressed concerns to her office.
What scares the living hell out of me, is the fact that Lilly is stll pushing for its approval in kids. FDA will approve antipsychotics for kids, but wont approve a potentially life saving vaccine for Prostate Cancer. Where's the Justice
Civil litigation wont deter these individuals, Place them in a Prison where murderers are housed.
I must disagree with Lisa on one point. If if it were not for the threat of civil litigation, Lilly would never have made this settlement nor would they have made the earlier settlement with injured patients.
Many of us would like to see our outrage over situations like this translated into criminal prosecution. "Settlements," by definition, preclude that. But again, if it weren't for the possibility of both civil and criminal liability, there would be no settlements at all, and the Zyprexa "campaign" would still be going on its merry, sweet little way. More destruction.
And again - FDA preemption, if/when the Supreme Court upholds it, will mean no accountability at all.
The Whole Zyprexa Scandal makes me sick.... I worked with a girl who was precribed this crap.. When the days she could function enough to actually show up for work, she was so spaced out her tongue would fly round her mouth like a lizard and she was constantly on edge... She ended up in the psych ward five times from Zyprexa...
It's not just Lilly who should go down for this.. The psychiatrists who so eagerly prescribed this poison should be paying compensation too...
Unbelievable... Human rights abuses by pharma commited everyday affecting thousands of people..
This is more Big Pharma mess. I guess that old Sidney Taurel knows when he better get out rather than have to deal withmore and more fines. This potential "settlement" only deals with the period of time from 2000 to 2003. What about 2003 to 2007? Was it 4 more years of off-label promotion of this "toxic" drug to people that didn't need it? How many more people have suffered from side effects and health problems that they didn't need to have because of the greed-driven irresponsibility at Lilly? Anything to make a buck! Whether it harms people or not! This cavalier attitude has no place in Big Pharma and should only be practiced by those selling true consumer products.
Why do the corporations do this type of stuff? Because they can and escape with a settlement. Eli Lilly made $1.3 billion on Zyprexa in 2007. One of their other major sellers was the life-style drug Cialis, which we all know allows men to be ready for the right time all weekend long, leads couple to take baths in separate tubs everywhere, and may provide for erections for 4 hours or more (not as great as they sound for the unlucky men who have them).
Sidney and John Lechleiter, CEO-to-be, must get paid the big bucks because they have testicles made of steel. John L. is on the news wires claiming that the media is giving pharma a bad rap and at the same time Lilly has its highly-paid lawyers trying to negotiate a settlement with the government in order to avoid criminal prosecution. The individuals who approved and committed the misdeeds escape and it's the patients who were prescribed the drugs unnecessarily that suffer. I simply don't understand why being linked to unethical, illegal, wrongful acts that injure others is not a crime! Until these execs pay with hard time in jail, this stuff is never going to stop!
John Leihleiter recently claimed that Lilly is not hiding secrets. Did he do so with his fingers crossed? They may not be hiding secrets, but they sure seem to have committed more than their share of illegal acts for maximum profits!
"Until these execs pay with hard time in jail, this stuff is never going to stop"
Couldn't agree more...
BP Watch
AMEN!!!!
"Until these execs pay with hard time in jail, this stuff is never going to stop!"
I wish it were so simple. Read Howard Brody (_Hooked_) on the "Vice President Assigned to Going to Jail."
Companies figure in criminal penalties in the same way that other "cost of doing business" potentials are figured in.
Spare a thought here for Dr David Egilman.
Knowing of the risk of hyperglycaemia +/- diabetes with Zyprexa, he exposed Lilly's off-label marketing to the light of public scrutiny. These lawsuits were made possible because of his actions. More importantly, the increased caution that has come with the resulting publicity has saved countless lives.
He deserves to be acknowledged as an international hero. Instead he has been fined $100,000 for his efforts.