seroquel lawsuit

[pumpkin]

There are some interesting articles circulating on the internet today about professors who recieved inappropriate payments to promote Seroquel and other anti-psychotic drugs for various Pharma- murderers.

[KARMA]

Has anyone heard anything about the Missouri State Court Trials? They were suppose to be in October.

[pumpkin]

A new study has found that use of newer atypical antipsychotics, such as Seroquel and Zyprexa, can cause rapid and dramatic weight gain among children.

The study, conducted by scientists at Zucker Hillside Hospital and the Feinstein Institute for Medical Research, was published today by the Journal of the American Medical Association. Researchers looked at 272 children between 4 and 19 years old in New York and Long Island to evaluate the weight gain side effects of antipsychotics on children.

After only 11 weeks, researchers found that Zyprexa side effects resulted in an average weight gain of 18.7 pounds and side effects of Seroquel resulted in an average weight increase of 13.5 pounds. Other drugs in the same class include Risperdal, which was found to increase weight by 11.7 pounds on average, and Abilify, which had an average weight gain of 9.7 pounds. By comparison, children who were not taking any of the medications had an average weight gain of less than half a pound.

In addition to the weight gain effects, researchers found changes in the children’s glucose levels, lipids, triglycerides and cholesterol which could not be explained simply by factoring in the weight gain. Zyprexa, again, caused the most metabolic changes, particularly in glucose and lipid parameters. Seroquel also had a significant effect on lipids.

The dramatic weight gain over short periods of time found among children raise concerns about the long-term health problems the children may be exposed to, such as diabetes and metabolic syndrome.

The results come as AstraZeneca faces thousands of Seroquel lawsuits that allege the company failed to adequately warn about the risk of weight gain, which caused users to develop diabetes and other serious health conditions. Although internal documents produced during the Seroquel litigation suggest that the company was aware of the Seroquel diabetes problems, the drug maker continues to fight the cases and has spent over $600 million in defense costs before the first case has gone to trial. All federal Seroquel cases have been consolidated in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida.

Eli Lilly has also faced legal a number of legal claims over side effects of Zyprexa. The drug maker has already paid over $2.5 billion to settle individual and government Zyprexa lawsuits for failing to adequately disclose the risk of diabetes and weight gain. They have been accused of fraudulent marketing of the drug for uses that they had not established were safe or effective.

[pumpkin]

I haven't heard a word about the Missouri Trials.

[pumpkin]

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AstraZeneca: Third Quarter and Nine Months Results 2009
Thu Oct 29, 2009 8:59am EDT

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STOCKHOLM--(Business Wire)--
AstraZeneca (STO:AZN)(LSE:AZN)

Third quarter revenue increased by 10 percent at constant exchange rates (CER)
to $8,200 million.

-US sales of Toprol-XL, benefiting from withdrawal of generic products,
accounted for 3 percent of global revenue growth at CER.
-US sales of Novel Influenza A (H1N1) vaccine totalled $152 million in the third
quarter, accounting for 2 percent of global revenue growth at CER.-Emerging
Markets revenue was up 15 percent at CER; on track for double-digit growth for
the full year.

Core operating profit in the third quarter increased by 29 percent at CER to
$3,609 million on revenue growth and operational efficiencies. Core EPS in the
third quarter increased by 27 percent at CER to $1.68.

Reported EPS in the third quarter increased by 22 percent at CER to $1.46.
-Agreement in principle reached with the US Attorney`s Office in Philadelphia to
resolve its investigations related to Seroquel sales and marketing practices.
This accounts for $520 million of the $538 million provisions taken in the first
nine months,$108 million of which taken in third quarter (see Note 4).

[pumpkin]

The Philadelphia inquiry included allegations that it promoted the drug for non-indicated uses. AstraZeneca did not comment on whether it had admitted any liability as part of the deal to resolve the investigation

[pumpkin]

Ok. Interesting stuff going on in Pennsylvania today.
I hope this leads to a FAIR settlement for us.

[pumpkin]

The U.S. Attorney's Office in Philadelphia has been leading an investigation into AstraZeneca's marketing of Seroquel, including allegations that the company promoted the drug for uses for which it isn't approved by the Food and Drug Administration, the company said Thursday.

The investigation has also scrutinized "selected physicians who participated in clinical trials involving Seroquel," the company said, adding that the investigations are the subject of two sealed whistleblower lawsuits filed under the False Claims Act.

A spokeswoman for the Attorney's Office declined to comment.

AstraZeneca said it reached the "agreement in principle" in September to "resolve the investigations" for $520 million, "subject to the negotiation and finalization of appropriate implementing agreements, including civil settlement agreements and a corporate integrity agreement."

[pumpkin]

AstraZeneca says it has agreed in principle to pay $520 million to end the probes, with negotiations ongoing to finalize the civil settlements and a corporate integrity agreement. Company executives declined to provide more details about the investigation, beyond the fact that off-label Seroquel marketing allegations were part of it.

Read more: http://www.fiercepharma.com/story/az-agrees-p...

[pumpkin]

I know I have several articles here that say the same things. I don't think it's over kill. Each article has a little more information than the last.

[KARMA]

I agree pumpkin. AZ is just a big money corporation willing to pay hush money to keep the truth from coming out. I think congress should investigate and attempted murder charges should be pressed. They must pay the victims for the damages and suffering, not just attorneys to back off.

[pumpkin]

Zyprexa had to pay over 1. billion in settlements to those who got sick from taking that medicine. I think Seroquel (AZ)should have to pay at least that to us. The one article says they are negotiating with our lawyers on the civil payments.

[LukeKJV]

AstraZeneca close to settling Seroquel investigations in USA
29 October 2009
As AstraZeneca posted a healthy set of financials for the third quarter, the company also revealed that it has reached an agreement in principle with authorities in the USA to resolve investigations into off-label marketing of the antipsychotic Seroquel.

The US Attorney’s Office in Philadelphia has been directing an investigation relating to Seroquel (quetiapine) involving a review of sales and marketing practices. These include allegations that AstraZeneca promoted the drug for non-indicated uses, and a second probe related to “selected physicians who participated in clinical trials involving Seroquel”.

The Anglo-Swedish drugmaker has now announced that a deal was agreed last month to settle the investigations,“subject to the negotiation and finalisation of appropriate implementing agreements”. It has set aside $520 million, which forms part of a $538 million provision.

As of October 9, AstraZeneca was defending 14,444 lawsuits and to date, over 2,600 additional cases have been dismissed by order or agreement and 1,635 with prejudice. The first two trials are now scheduled to begin in Delaware and New Jersey state courts in mid-January 2010.

AstraZeneca added that it is aware of 142 other cases that have been filed but not yet served and “has not determined how many additional cases, if any, may have been filed”. It said that some of the cases also include claims against other pharmaceutical firms such as Eli Lilly, Janssen Pharmaceutica, and/or Bristol-Myers Squibb, adding that it will “defend against the cases vigorously.”

AstraZeneca went on to note that by the end of the third quarter, legal defence costs of $623 million have been incurred in connection with Seroquel-related product liability claims.

By Kevin Grogan

http://www.pharmatimes.com/WorldNews/article....
were in for a long haul

[pumpkin]

mbers behind AstraZeneca’s Seroquel settlement with the U.S. Disrict Attorney in Pennsylvania. The headline number is $520 million, the amount AZ will pay to end a probe of its marketing practices on the atypical antipsychotic, which allegedly resulted in off-label use of the drug in children and the elderly.

But the real cost to AZ is already much more than that, and the bill keeps growing. According to AZ’s own disclosures, the cost of its alleged malfeasance on Seroquel will top $1.1 billion. Here’s why:

In its Q3 2009 statement, AZ disclosed that the settlement was part of a $538 million “provision” that it had taken earlier — meaning that when all is said and done, AZ expects the legal bill to go higher. In addition, AZ said its liability insurers have already begun to dispute paying the bill for the Seroquel mess, which prior to the settlement cost AZ $623 million in fees:

The insurers that issued the applicable policies for 2003 have reserved the right to dispute coverage for Seroquel-related product liability claims on various grounds, and AstraZeneca currently believes that there are likely to be disputes with some or all of its insurers about the availability of some or all of this coverage. As of 30 September 2009, legal defence costs of approximately $623 million have been incurred in connection with Seroquel-related product liability claims.

Those fees are to do with civil litigation, which is separate from the settlement with the Pennsylvania DOJ. AZ’s Seroquel bills do not end there. The company also disclosed the current tally of Seroquel suits filed against it:

* Suits pending: 14,444
* Additional cases dismissed: 2,603
* Of those, dismissed with prejudice: 1,635

If you compare those most recent numbers with the older ones here, you can see that new cases are arriving faster than they can be dismissed. That’s not surprising — the legal system moves slowly — but it suggests that AZ has some way to go before it’s out of the woods.

Lastly, AZ believes that despite signing a settlement with the DOJ — which we have not yet seen and may contain damaging disclosures — the company intends to keep fighting the civil plaintiffs. It said:

AstraZeneca intends to litigate these cases on their individual merits and will defend against the cases

Bottom line: AZ’s Seroquel liabilities are currently $1.1 billion and heading north. How much will the company feel this pain? Not much. Q3 sales of Seroquel were $1.2 billion up 12 percent, and up 14 percent for the first nine months of the year.

[pumpkin]

I am sure that there is stuff to know about the PA cases and what the whistleblowers have to say that will help our cases.

[LukeKJV]

AstraZeneca Pays $520M To Settle Seroquel Probes
6 Comments
By Ed Silverman // October 30th, 2009 // 7:11 am

This was predictable. After Lilly and, more recently, Pfizer settled long-running investigations into off-label marketing practices of their various drugs - notably, antipsychotics - it was expected that AstraZeneca would follow suit. And so AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistleblower lawsuits over its Seroquel antipsychotic.

Antipsychotics, you may recall, have become extremely controversial in recent years as the pills were more widely prescribed for young children and the elderly for indications not approved by the FDA (see this). In some nursing homes, for instance, seniors are experiencing tremors and a higher risk of harmful falls or even death while on the meds, which are known to cause weight gain and diabetes.

The investigation, which was underway at the same time that AstraZeneca has been battling numerous lawsuits over allegedly undisclosed Seroquel side effects, was led by the US Department of Justice’s Philadelphia office. Interestingly, the investigators reviewed not only Seroquel sales and marketing practices, but some physicians who participated in Seroquel clinical trials.

Separately, at least 34 states are pursuing separate investigations of AstraZeneca’s marketing practices as part of a joint investigation and others may be conducting their own probes. In other words, AstraZeneca may have to dole out more money for its practices.

An AstraZeneca spokesman says the drugmaker “is committed to strong, effective compliance programs, both in the U.S. and globally, to embed a culture of ethics and integrity in all our business practices. It has been and remains a key goal.”
http://www.pharmalot.com/2009/10/astrazeneca-...
it looks like 2010 is going to be an interesting year for us!
Best wishes to all-my creater says "you reap what you sow".

[Corruption everywhere]

I'd like to see them go to jail as well

[Luke KJV]

AZ Promoted Seroquel as Superior to Haldol When Company Data Said It Wasn't
By Jim Edwards | Nov 4, 2009
AstraZeneca (AZN) executive warned in an internal email that the company’s data did not show its antipsychotic drug Seroquel was superior to an older drug, Haldol, but the company promoted that notion anyway, according to documents in a lawsuit filed against the company.
The National Alliance on Mental Illness still maintains a web page about Seroquel suggesting that the AZ drug has fewer side effects than Haldol. BNET recently revealed that a NAMI board member was a paid consultant for AZ.
AZ’s marketing of Seroquel is the focus of 14,444 lawsuits and the company has racked up $1.1 billion in potential legal liabilities over the drug. Plaintiffs allege that AZ failed to warn them that Seroquel caused weight gain and diabetes. AZ has settled some of the allegations against regarding mispricing of the drug, but vows to fight the other accusations. The company gave this statement (see comments below fir full statement):
AstraZeneca believes the totality of the science around Seroquel – including company-sponsored studies, research sponsored by the federal government, and physician experience – confirms it is an effective and appropriate treatment choice for patients with serious mental illness.
The safety and efficacy of Seroquel has been evaluated in clinical trials with thousands of patients and AstraZeneca has shared all required data with the FDA, both before and after the agency approved it as safe and effective.
A 2008 filing in the Seroquel cases describes a March 2000 meta analysis comparing studies of Seroquel to other drugs which. This chart describes the results of the analysis:View graph @ http://i.bnet.com/blogs/seroquel-comp-chart.j...
Seroquel was only found to be beneficial compared to a placebo, and compared to Haldol (haloperidol) it was actually worse.
John Tumas, AstraZeneca’s U.S. publications manager for Seroquel, sent this email on March 23, 2000, to his colleagues, regarding the analysis:View email @ http://i.bnet.com/blogs/tumas-email.jpg...
BNET readers will remember that Tumas was also the writer of a 1999 email which chastised colleagues who had “buried” the results of three previous trials that were unfavorable to Seroquel. He wrote:The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.
AZ began promoting Seroquel as superior to Haldol in a May 2001 press release, on which the headline was:Data Suggest SEROQUEL is More Effective than Haloperidol in Patients with Treatment-Resistant Schizophrenia.
AZ also funded NAMI, according to NAMI’s 2002 annual report. NAMI currently maintains a web page on Seroquel which says that the “most important” thing about Seroquel is its superior side effect profile to Haldol:
read more @ http://industry.bnet.com/pharma/10005119/az-p...
Note the dates my friends-they knew March 2000 that seroquel was less superior to other rx's available but went on with their lie & even paid off NAMI (2002) in the usual AZ style to boost the public's perception of this awful drug.
Well done az, keep digging even if you make it to china the results will be the same-put down that shovel-tell the truth,a lie only creates problems your digging a deeper hole if you continue into 2010.

[Kevin Mccarthy]

For those skeptical or prejudice against lawsuits, I was notified that I have to have an insulin pump because the diabetes is so brittle.

This costs 300-$450 per month plus the cost of the pump. My insurance will only cover the cost of the pump itself.

[pumpkin]

omg i know that diabetes can be an expensive disease. I just had to deal with an abscessed tooth which was caused by the diabetes making my mouth too acidious. If I didn't have dental insurance that one tooth would have cost me over 1000.00 I have had to pay over 400.00 out of pocket just for this one little tooth, which had to be pulled. It would have cost much more to do a root canal and try to save the tooth. Anyway this is just a small example of the monetary cost of having diabetes. Those of us who have the diabetes know the other costs of this disease all too well. I have had to ask my doctor about getting a handicapped hang tag for my car because the neuropath in my feet makes it difficult to get around. I hope we all get Fair settlements soon