Court Says Pfizer May Be Liable For Side Effects Of Drug, Even Though Man Took Non-Pfizer Generic Version
from the slippery-slope dept
An interesting case in the Alabama Supreme Court has ruled that a man who developed a movement disorder (tardive dyskinesia) after taking a generic version of the drug Reglan can sue Pfizer, the maker of Reglan, even though it did not make the actual generic he had taken (he took generics from both Actavis and Teva, both of whom he's sued as well). This one is a tricky one on the question of secondary liability, thanks to the oddities of the pharmaceutical world. While, naturally, it sounds absurd that Pfizer can be sued for a drug it didn't make, the regulatory world makes it slightly more complicated -- in part because current law says that generic drug companies could not be sued over failures in labeling of risks, because they're basically copying the labels from the brand name manufacturer. Other courts have ruled that the brand name manufacturers can't be sued -- so in theory that could leave the takers of generics with no legal recourse if there were failures to accurately label the drugs they took. Given that, it seems slightly more reasonable to think the brand manufacturer may be more responsible for what's on the label -- but since they can't monitor quality control of the generic, the whole thing seems like quite the legal muddle all around.
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Filed Under: drugs, generics, liability, pharmaceuticals, reglan, tardive dyskinesia
Companies: actavis, pfizer, teva
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That said, if there's not a strong reason to believe that the drug itself was the cause of the side effects, then Pfizer can - and will - argue that it's the generic manufacturer's process or quality control that was at fault.
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Hope the man wins, this would put some pressure on pharma companies to lobby aggressively to reduce secondary liability, which in turn may help others.
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As much as I'm not a fan of big pharma, I wonder.... would the company that patented a particular cell phone technology be held responsible once that patent had expired if other companies duplicating that technology exactly to specification created products that caused brain cancer?
It's probably unreasonable to demand that generic drug companies perform their own testing, especially after the drug has been FDA-approved and in use for 20 years.... but on the other hand it is their product.
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If, however, it can be shown that the generic recipe, manufacturing process or other factors altered the composition of the drug away from their original version, they may not be liable because they had no oversight or control over that process.
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And really, if it's registered for over 20 years then shouldn't any sane and reasonable person think it's not Pfizer's fault?
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Re: Re:
It could be a number of things.
- Contamination, on the production, store or user.
- Modification of the original formula for any number of reasons like trying to reduce costs.
- Adverse reaction due to unforeseen combination with other substances(i.e. Food, other drugs, life style and so on).
- Crazy person trying to get money from a company.
- Crazy person focusing his anger issues where it shouldn't.
- Crazy person with valid claims about what is happening but that only happen to him or in a local area which would imply local factors in play.
Without that, you just can't trust the secret clinical trials that Pfizer did and will never disclose to anybody in the near future, because they could have know about it but without access to that data nobody will ever know if what they say is true or not, they could just change the reports to look like they never knew about it and we would have to accept that, on the other hand with a public trial in hand and with many cases of the same effect happening to others everywhere it would be very hard to come out and say they didn't know, when that is the first thing that jumps the eye on the open public clinical trial.
What really surprises me, is how judges are making those type of decision based solely on their gut feeling apparently because we have no data that can be trusted only the word of the manufacturer to go on.
Quote:
That can't end well.
I understand why in the past things should be done this way, but in the internet age, where you have hyper connectivity and you can gather tremendous amounts of data, it seems a bit old to let somebody use only their instincts to make judgments.
When did anybody see a person make a good decision based on instinct most of the time?
Aside from soap operas, in real life I never saw anybody be happy with most of the decisions they made upon snap judgements without knowing anything about what they were dealing with, not once, and so it seems to me that this old way of doing things goes against not only common sense but the interest of true justice.
On the part of conducting trials, well, I agree they should not conduct their own trials, what should happen is doctors and hospitals should track that and report it somewhere, so when this crap happens they at least know if it is something universal or it just happens to one brand which would suggest tampering or contamination.
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If we demand that every medication ever developed must be 100% safe for 100% of the population we will never have any new medications.
If there is a 100% chance that something is going kill me but there is a drug that has a 50% chance of saving me and a 50% chance of killing me I'm taking the drug.
People, in life sometimes you get f**ked. Sorry, deal with it.
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and an amazingly great excuse (valid or not.. probably very valid). That the large expense in the development and testing of the drugs NEEDS a method of earning money and being big for the very reason that sometimes drug side effects do not become apparent in trials but only after general release.
It happens a lot, and it is not the fault of the drug companies or their testing methods, it's just a fact of life.
But the generic companies cannot afford to cover cost of these expected (statistically) problems. So someone has to have responsibility, that is the big pharma companies.
Who also need the money to fund research and testing on new drugs, drugs that may pass clinical trials but once in general use display side effects.
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Re: Re:
some side effects may be very severs, including death, that does not mean that drug is useless, or that it does not save far more people than it kills.
Also, there is simply no such thing as a clinical trial no matter how honest or well run that will show all possible side effect to all possible people.
It is not a matter of fudging the figures or cheating or breaking the rules to get approval.
It is just a fact of life, and masnick cannot seem to understand..
changes are if you have 100% chance of dying, it would be a 0.00000000000001 chance of the drug killing you .
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In this case it appears to be more an allergic reaction than a side effect. This guy will not win this case if his argument is that it is a side effect of the drug, and not a reaction to the active compound.
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Obviously you can prove that.
Because I can show without a doubt that there are such things and they occur more often than they should.
Researcher Sentenced To Probation For Falsifying Clinical Drug Trial (2012)
Missouri CRO fined for falsifying clinical trial work for Boehringer (2011)
People downright just lie about having collected data or fudge the numbers.
Although there is no such thing as adverse-effect-free-drug, there is such a thing as hiding-adverse-sales-effects-from-consumers.
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An adverse allergic reaction is also an adverse effect moron.
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Just a quick search ... and harsh opinion.
Followed by:
That warning, or similar ones, were very prominent on a number of sites about the drug.
Another source says: "Metoclopramide may be the most common cause of drug-induced movement disorders"
I think as a patient you have a duty to know what you are taking, and what the possible side effects are. Certainly even the most cursory look into possible side effects would have alerted you that this could be a problem.
The doctor who prescribed the drug should have been aware of the possible side effect and had a duty to inform and monitor his/her patient. Similarly, the pharmacy who filled the prescription should have warned the patient, either with labeling or a handout.
While I am not fan of the pharmaceutical companies and their practices, my quick research, with no real direct knowledge in this case, tells me the patient should have been aware of the risk. Any liability likely lies with the doctor or pharmacy as they should have been aware and had a duty to inform, the doctor had a duty to monitor as well.
I just posted about this the other day, many drugs have side effects that are potentially worse than what you are treating. As a consumer in the modern age of the internet as it is so easy to get information about almost anything I think you have to assume some responsibility for researching the drugs you are prescribed.
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Side affects
Lastly due to natural genetic variations between people, with the hundreds of millions of people in this country there is bound to be at least one individual that will have a never seen before negitive reaction to a drug. This lawsuit is stupid and only meant to bankrupt pharmacutical companies.
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FDA
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And this is exactly what the industry is hoping for.
I find the drug ads to be very misleading, they show people having a great time taking drugs and point out that you should too. Then, at the end of the ad is the fast talk about possible side effects. This seems to be targeting the hypochondriacs in the audience.
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Re: Just a quick search ... and harsh opinion.
These warnings are available now, very possible as a result of this guy's condition/lawsuit.
The questions are:
Were the warnings there when he started taking the drug?
Did Phizer know about the side effects when they created the drug initially and not report them?
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Re: Re: Just a quick search ... and harsh opinion.
This looks like a fishing expedition similar to many of these type of cases. Find a court that will allow an action, try a successful case, then put your ad on tv, a la 1-800-BadDrug.
It's like me suing Bayer because I got an ulcer from taking aspirin. Utter load of flapdoodle.
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Re: FDA
So quite the opposite. As is characteristic of many TD stories there is much more to this one than meets the eye. And honestly, it takes a fairly comprehensive understanding of medicine and medical practice to be able to sort through the fog and shape-shifting...
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Re: Re: Just a quick search ... and harsh opinion.
and
So it was listed even in 2004 (though slightly less prominently). I don't know when he took the drug, but if it was 2004 forward the warning was there for certain.
There are a lot of questions such as:
Was he taking any other drugs (legal or illegal) that may have interacted with Reglan?
Did he modify dosage administered at all or did he strictly follow the prescribed dosage and schedule?
Did his doctor make him aware of the possible side effects?
Did the doctor follow up or prescribe for more than 12 weeks?
Did his doctor prescribe a high dosage?
Did the pharmacy properly label the drug?
There are a lot of questions. But if I had been prescribed that drug, I would have been questioning my doctor, even as far back as 2004.
The point I was making is there should be a certain level of personal responsibility. Obviously, we don't have all the details in this case.
A long time ago, I worked in a pharmacy and was always amazed that people did not listen to what they were told about the drugs they were taking and many, frankly, didn't seem to care at all. They were too trusting of their doctors in my opinion.
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Re: Re: FDA
I'd agree that having such a strict deadline for translation is rather dumb, especially if said drug was being used in the Netherlands without issue. However, if important documentation is supplied in a format that neither the FDA nor some people who might require that information can understand, I don't see why demanding a translation is stupid.
"As is characteristic of many TD stories there is much more to this one than meets the eye."
...and I'm sure you'll be here furnishing us with links and/or details of what that is rather than criticising without bothering to back up your own claims? Right?
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Re: Re: Re: Just a quick search ... and harsh opinion.
When I find a doctor that I trust and is knowledgeable, I follow their advice. They're the ones that have been to medical school and trained to do their jobs. So while I'll ask some questions, I trust the professionals over what I can find on a quick Google search.
While I don't do computer repair and general tech support any more, nothing would annoy me more than someone who had no idea what they were doing to ask me for help *and then not follow my advice or let me fix the problem*. When someone was paying me for my skills and advice, I don't expect them to go and do something else just because the internet told them to - so I treat the professionals I pay as I expect to be treated.
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It is a hard question here: Does FDA have a responsibility to monitor the drugs? To what extend do they have the possibility to pull a product completely?
The law has to account for FDAs possibilities all the way and if their responsibility or possibility to remove a product is limited, their approval process has to be that much more rigorous...
In this case it is so long ago that the product was approved, that it is amazing it took so long to pull it! While the former patent holder vs. generic company is a patent-angle, it is not as much of a question in this case as the political angle.
When a sideeffect has been kept secret or only just been found 20 years after the drug was approved, it is a question of the authority regulating the market and if their procedures are good enough rather than a problem of what company is at fault...
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Re: Re: Re: Re: Just a quick search ... and harsh opinion.
They may be your doctor, but it is your body. Ultimately you know how you feel, what your problems are... better than any doctor ever will. How well you are able to communicate that can have a huge bearing on the success of treatment.
Educating yourself, about the treatment the doctor prescribes and asking questions helps with the communications process. Why should the doctor care if you don't?
I do a lot of IT consulting these days. I am never upset by those who have no clue when they ask questions, or even choose not to follow my advice. I get paid either way. I may bluntly say; "You asked my advice, whether you follow that advice is up to you.", but I am never offended. If it causes me too much trouble over time I may fire my client (I have only had to do that twice). I actually prefer clients who are engaged in the process. I am not saying clients should be abusive, or obstinate to what I tell them, but honest discussion always leads to a better outcome.
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Here are the facts: According to an Institute of Medicine estimate 7,000 people die in the US every year due to medications. Do the math: 7,000/315,000,000 people = 0.00002
That means the annual risk is about 2 Billion times more likely than your lifetime "estimate" -
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hurh?
Oh yeah, logic... never mind.
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Re: Just a quick search ... and harsh opinion.
You would think. You would certainly hope so. However, when it comes to DRUGS this is not something you can assume. You cannot simply treat a doctor like some sort of scientific equivalent of a Bishop or cult leader.
Quite often, your local pharmacist will be far more competent about this stuff because that's what they actually study and that's what they do day in and day out.
That's not even getting into the problem that there is a wide range of competence and dedication among doctors.
If you are just a blind follower, you are really taking your life into your hands.
You don't need to be a sheep. You can buy yourself a copy of the PDR or just use Google.
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Re: hurh?
If the drug is a good copy, then they should not have any liability.
It should all be on the relevant doctor and the FDA approval process which also includes the original big pharma company that made mad money on this stuff.
The generic manufacturer is in the same boat as us when it comes to product safety. They too are depending on the fact that this stuff is safe and it passed through a research and vetting process.
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Re: Re: Re: Re: Just a quick search ... and harsh opinion.
Those people are intelligent enough to try out other things and once in a while somebody may surprise you finding a new way of doing something that works better than what you thought would be better, of course not always, it is rare but it does happen even if by accident.
I have no problems with people experimenting is how we learn, is how we improve, if I am paid to offer advice and they chose not to follow it, that doesn't bother me.
Why should it?
I get paid either way.
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Nor is he known for replying back when someone uses facts/evidence to put him in his place. But for those of us who weren't aware, thanks for the information you provided.
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Re: hurh?
You really do have to blame the company that did a poor job of testing.
I think that is a systematic problem more than anything. Who has a better incentive to mislead the clinical trials for a product than the company that will make billions of dollars selling the thing if it passes? I wouldn't want to pass this on to the government - because they slow down everything and typically do a crappy job protecting citizens anyway, but telling the big pharma companies "hey, make sure this stuff is safe before you overcharge millions of people for it" doesn't seem like a reasonable solution.
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Re: Re: Re: FDA
The opinion is here: http://alabamaappellatewatch.com/wp-content/uploads/2013/01/Wyeth-v.-Weeks.pdf
And see here for the consequences from an injury lawyer perspective: http://injurylawyer-news.com/category/reglan-lawsuits/
And also: http://www.druginjuryattorneyblog.com/2013/01/brand_name_drug_makers_may_be.html
Still looking for the link to FDA document talking about the example. I stand by my criticism of the statement made. There are good drugs and devices with years of experience that fail or are very slow to get to market because the bar is set inordinately high. The delay in getting the Bryan disk is typical (see: http://www.medscape.com/viewarticle/489858_4 ). This was in clinical use in 2002 in Australia and Europe, submitted to the FDA soon after, clinical trials in 2002, reviewed in 2007 (http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4305b1-09.pdf) and approved in 2009. If that seems to be expeditious, then we simply disagree in perspective.
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Suing Pfizer for generic drugs
Look up "respondeat superior", it will explain this.
Of course, Pfizer may be able to show the generic does not meet their quality standards, or the proper warnings, etc., were not on the generic, and that all changes.
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You can have an allergic reaction to pretty much any chemical. There is still a relatively short list of allergens, though, as those are the ones that actually effect a significant portion of the population.
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Re: Re: Re: Re: Re: Just a quick search ... and harsh opinion.
Which is just stupid. At least one of the Docs should have your entire medical history available. In this day and age, there is no excuse to not have every Doc able to access the list of meds you are currently on, even if you have to physically carry the document to them.
Anyone in this situation voluntarily is likely doing so because they have been told not to take a certain medication and want it anyways.
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Re: Re: Re: Re: Re: Re: Just a quick search ... and harsh opinion.
Then there are certain things some people are too embarrassed about and don't want anyone to know about. Mental Health and sexual issues are two that come to mind right away.
And of course you have those who are doing as you suggest as well and are trying to get what some doctor won't give them.
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I think the burden should be on the generic manufacturer to prove that they manufactured it correctly.
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Wyeth and Reglan
When did Pfizer know it?
What did Pfizer do about it?
Why did Pfizer sell Reglan?
For how much?
Did they provide the buyer (Schwartz) full disclosure?
Did they sell any other generic drugs at the same time
they sold off Reglan?
Why or why not?
Have they acquired any generics since then?
Why?
There's plenty of questions that need answering. Hopefully
The Alabama Supreme Court will ask them. We know the U.S.
Supreme Court couldn't care less!
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