AstraZeneca Wins First Seroquel Lawsuit
26 CommentsBy Ed Silverman // March 18th, 2010 // 11:30 am
The drugmaker won the first trial over claims that its Seroquel antipsychotic causes diabetes and that risks weren’t properly conveyed to physicians or patients. A New Jersey state court jury decided against Ted Baker, 61, a Vietnam War vet, whose lawsuit (see here) is one of about 26,000 Seroquel cases facing AstraZeneca. Nine previous cases set for trial were dismissed by state or federal courts (background here and here).
“In the cases that have been prepared for trial to date, including the case decided by a jury in New Jersey, the facts show that the plaintiffs either already had diabetes or had so many pre-existing risk factors that they were already at a significantly increased risk of diabetes before they first took Seroquel,” AstraZeneca says in a statement.
photo thx to ohadweb on flickr creative commons
Jack Friday
One down, 25,999 to go!
Lisa Van Syckel
What about N.J.’s foster care babies that were prescribed seroquel, oh, that’s right, babies dont have rights.
M Helm, MD
“…the facts show that the plaintiffs either already had diabetes or had so many pre-existing risk factors that they were already at a significantly increased risk of diabetes before they first took Seroquel,” AstraZeneca says in a statement.
How does this relieve AZ of a duty to warn that their drug adds ADDITIONAL risks for diabetes, or complicates diabetes managment. This is like arguing that most of the patients who died related to Vioxx either had heart disease already, or were at risk for it or they were old, and likely to die soon anyway.
Legal scholars (and observers), am I missing something?
MsPiggy
When you have a “Billion Dollars” to spend on attacking the victims in these thousands of cases, it comes as little surprise what kind of justice is received.
I find it more than questionable that the DOJ has not made their final sweet heart deal public with AZ until after these first of many civil trials.
A sane person might wonder how this would have played out if AZ was defending itself in these litigation proceedings as a convicted and admitted felon over the drug Seroquel.
pharmavet
Dr. Helm, attached is the PI for Seroquel, containing the BOLD FACED WARNING about diabetes. If you need more information than that before prescribing Seroquel to a diabetic, then I suggest that you mail back the diploma to wherever med school you went to.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf
Former Pharma Marketing Director
Ms Piggy, you make a valid point….
The very money they are using to defend themselves come from some of the very same people they have harmed….
Yes, some people are helped with these drugs, but many more are harmed.
How many doctors actually prescribed it even after they had even just an inkling of the trouble it could cause?
Unless you start to hit the doctors too, you cannot fix this…
The doctors will hopefully then put the pressure on pharma to prove their data.
Currently if one lies (pharma) and the other swears too it (doctors) (because the only data they have to go on is the “corrupted/skewed” data from Pharma), then nothing will get fixed….
Response2PharmaVet
PharmaVet – you posted a link showing a 2009 warning. What kind of warnings were there regarding diabetes and glucose levels back in 2001?????? None. But that was a nice try…
Response2PharmaVet
Dr. Helm is owed an apology…
SteveM
Re: Legalisms
Because the Black Box warning and the PI are included in the info sheet tossed into the bag by the pharmacist, everyone in the delivery system has effectively played CYA.
The physician knows he can off-load side effect guidance to the pharmacist. So he says little or nothing about side effects to the patient. And the drug store offloads side-effect guidance to the package insert that is stuffed into the bag with the drug.
Meanwhile the patient just picks up the drug and when he pays, checks the electronic query that he does not need pharmacist guidance because he does not know what questions to ask. And when he gets home, he probably couldn’t interpret the PI info of the insert even if he read it.
In the end, the only person screwed is the patient. And his being screwed is not legally actionable because of the sly offloading of responsibility by all entities in the prescribing chain. So the professionals may actually give a shit about the patient’s well being. But only sort of…
Do I have that right?
Jack Friday
I think the issue is what AZ PROMOTED to doctors.
It would appear that there was a significant difference between the US and the UK on this matter.
http://i.bnet.com/blogs/spielmans-parry-ebm-to-mbm-jbioethicinqu-2010.pdf
http://news.bbc.co.uk/1/hi/8478924.stm
pharmavet
I think that Dr. Helm is a pseudonym anyway. I can’t find him or her on any directory of medical professionals. Or, as you would say, “nice try”.
pharmavet
BTW, metabolic effects of quetiapine and other atypical antipsychotics were reported as early as 2001. Just have to read the literature.
http://www.ncbi.nlm.nih.gov/pubmed/11603883
Justice in MI
I’m no legal scholar, but the core issue in these suits is not whether AZ covered up risks, but whether a “reasonable person” could conclude that the plaintiff’s diabetes was the result of using the drug. Usually, the issue of negligence or even felony fraud comes next (when assessing damages).
Based on the internal documents that have been released widely, we know that some number of people at AZ directly spoke about “burying” (their word) studies related both to Seroquel’s risks and benefits. We also know that one marketer, at least, referred to their “smoke and mirrors” (her phrase, applauded within the company) to camouflage the weight gain/diabetes risks.
It can, and will, be argued that these do not constitute the actions of the company as a whole. Neither, so it appears, were the recent Pfizer busts.
For all these reasons, it seems likely that, if AZ is eventually penalized in a civil or criminal context re: Seroquel, it will come through the Department of Justice via a charge of off-label promotion that defrauded Medicare, Medicaid, the armed forces, and other public agencies and institutions.
Response2PharmaVet
Let me know when you find the 2001 PDR, Pharma. You were quick to look up Dr. Helm – did you check the warnings on the 2001 label?
pharmavet
Sorry, I don’t keep old copies of the PDR around. That’s why I read the literature. Not everything reported in the scientific literature makes its way into the PDR. Most doctors who practice scientific medicine know better than to just rely on the PDR. You don’t have to read all the journals either. The diabetogenic effects of atypical antipsychotics were being discussed at scientific meetings back in the late 1990′s. I suppose if you don’t keep up with your journal reading or go medical meetings these findings might seem new.
Ed Silverman
Hi Folks,
For those who were wondering, we aret told: The jury found in AstraZeneca’s favor (with a vote of 7-1) on the first question on the verdict sheet, so they didn’t have to answer the remaining questions. Here is what the first question said:
Did AstraZeneca fail to provide an adequate warning to Mr. Baker’s prescribing physicians concerning a risk of diabetes from Seroquel that AstraZeneca either knew or should have known at the time Seroquel was prescribed for Plaintiff up until the time that Plaintiff was diagnosed with diabetes?
Hope this helps
ed
Justice in MI
Thanks, Ed. It helps!
Given all the released documents that suggest ways such warnings were mitigated, even negated, it will be interesting to see how other cases unfold.
johns
NJ sucks
Justice in MI
This from the WSJ story on the ruling. Based on it, it sounds like the arguments combined the questions of whether AZ “played down” the risk until a strengthened warning in 04 and the causality question for this plaintiff:
“At the nearly four-week-long trial, Mr. Baker’s lawyers presented evidence and elicited testimony which they said showed AstraZeneca was long aware of a link between Seroquel and diabetes, but played down this risk until U.S. regulators forced a strengthened warning in the drug’s prescribing label in 2004.
AstraZeneca’s lawyers, however, countered that the company had responsibly studied the drug’s risks and communicated its findings to regulators. Also, they argued Mr. Baker had numerous other risk factors for diabetes, including obesity, and that Seroquel wasn’t a substantial contributing factor.”
Can anyone from AZ confirm that there should be no “celebratory” emails sent within the company?
pharmavet
The reason that there will be no celebratory e-mails in AZ is that eventually the legal costs will far outweigh the amount of SQ that AZ can sell. Guys like Mark Lanier will not be satisfied until they have wrung every last nickel out of every last pharma co. until they have ultimately destroyed what once was (and in some quarters still is)a proud industry.
Don Martin
Ok, they dodged a bullet there ,because he had pre-exsisting factors…
What until they the childrens cases go to trial..not too many mitigating factors to argue..
Justice in MI
Vet–Let’s table Mark Lanier for a moment. Do you think any of the fen-phen cases had merit? How about Baycol? As I’ve heard it, even Bayer’s defense lawyer expressed the thought that juries got it right in some number of those cases.
As far as AZ, I would truly love to see (as the jury presumably did) the context in which those “embarrassing emails” did not mean what they seemed. If I had that context I would teach it–promise. It would be a great example of exactly the point often made–that materials of this sort may _not_ mean what they seem. Would be an important lesson.
pharmavet
I agree on the Baycol point. See my post from the rhabdo thread.
Millie
I’m in the UK.. three months after starting Seroquel, guess what, I was diagnosed with Diabetes! I didnt have a clue what was being put into me – I trusted the Psychiatrist who prescribed it for me(I was too unwell at the time to argue!) Now I know for a fact that I didn’t have a blood sugar issue in the 3 months before taking Seroquel because my doctor had given me a blood test for another matter(and checked my sugar levels at the same time) I was not in ‘the range’ to develop diabetes, no family history, physically healthy and a good diet.
The only reason I found out I was diabetic was because my doc just wanted to rule out anything because I had started drinking water like a mad thing! Lo and behold! I was diabetic.
Still I didn’t know it was the Seroquel causing my sugar level problems (despite doing exactly what I was told about my diet)- it was only when I had to have a blood test to start Lithium and my sugar levels were through the roof that I was told BY A NURSE that it was the Seroquel causing the problem.
I went to see my Psychiatrist(not the one who had initially prescribed it) and told him what was going on – he dismissed my fears, saying he had never heard of it before. Not giving up, I made him go online in front of me and read the evidence! He was shocked. Needless to say I am now off it, and my sugar levels have dropped markedly.
You know, I could of coped with the weight gain issue (not that I actually put on a lot) – but I have to live with Diabetes and all its implications now. Not only do I have mental health problems, but now I have to have extra medication for the diabetes – not really cost effective for our NHS!
AZ should be putting warnings about Diabetes and other side effect in neon letters on the literature that comes with this medication. When you are desperately ill, you dont argue with the doctors, you put your trust in them – my own Psychiatrist is living proof that they are not educated enough about the drug. AZ should take a responsible part in the education and the Physicians need to stop prescribing the ‘latest wonder drug’ to the masses.
Lisa Van Syckel
Don Martin,
The child cases will never see the inside of a courtroom, and will be resolved quietly. Children are the new cash cows, and are very lucerative, industry will be too nervous to loose this revenue.
Don Martin
Thanks Lisa..because we want justice for our daughter