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.
Filed Under: drugs, generics, liability, pharmaceuticals, reglan, tardive dyskinesia
Companies: actavis, pfizer, teva
Comments on “Court Says Pfizer May Be Liable For Side Effects Of Drug, Even Though Man Took Non-Pfizer Generic Version”
I just infringed the facepalm on the internet patent
If Pfizer did not report dangerous side effects of a drug that they got FDA approval for, then the buck stops with them. If studies indicate a high likelihood of heart palpitations for patients using a drug and the pharma company buries those studies, it’s not the generic manufacturer’s fault that they couldn’t warn patients of the danger.
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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If Pfizer didn’t report a known side effect, that’s definitely incriminating. I didn’t see mention in the article as to whether users of the name-brand version were also reporting these symptoms.
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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I’d say it’s rather simple. Pfizer will just have to show their OWN medicine does not cause said effects shifting the blame to the generic companies. But this should be tested BEFORE reaching Pfizer in a lawsuit against the generic drugs.
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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The only way to know is to conduct an open clinical trial and ask everybody who is taking those drugs to participate to see what they have or not.
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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tl;dr
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Where does it saying anything about them not reporting dangerous side effects. What if the side effect only occurs in 0.0001% of patients? At some point some responsibility has to land on the patient. When you take a medication there is a chance something will effect you in ways never imagined. Who knows why?
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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your right there is no such thing as a drug that has no side effects on the entire population.
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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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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Tom NJ makes some valid points above, but you’re not helping him when to resort to math challenged hyperbole in order to appear to strengthen his argument.
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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Well, darryl, because that is who left that comment (the lack of proper grammar/punctuation usage and the hyperbole is evidence of it being him), isn’t known for fact checking or not using hyperbole.
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.
Even though I read this with a grin in my face seeing Pfizer in trouble, I just can’t believe that the law is so fraked-up.
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.
Quite simple to my mind. If the generic drug was identical to Pfizer’s version, and manufactured to the same standards without additional impurities, less stable ingredients, etc. being involved, I don’t see why they shouldn’t have some liability equivalent to if he had taken Pfizer’s version. They would have been the ones to carry out the clinical trials, government approval and labelling of risks associated with the drug and so carry some blame if this process was incomplete or incorrect.
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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I would ask: What is the FDA culpability in this? Why was the drug approved in the first place?
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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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.
I think the burden should be on the generic manufacturer to prove that they manufactured it correctly.
It’s pretty simple to me. The law should read “if you make it, you take responsibility for anything that goes wrong in the use of it.”
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I think responsibility should be struck from the language. It has no meaning anymore.
don’t you understand anything, this is a huge HELP for the big companies AND a strong support for not having generics.
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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I think you might have gone off on a tangent: the case is stone grey at best, because of the way the law is worded. It’s very interesting, to say the least, but not always because of the generics, but as a complicated legal case.
side effects have to occur with more than one person, a side effect is an effect that a small but SIGNIFICANT number of people are effected.
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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Assuming the guy is honest and normal, you are full of shite.
An adverse allergic reaction is also an adverse effect moron.
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His point is that every side effect is an adverse effect, but not all adverse effects are side effects.
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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Wait, nevermind, you meant that allergies are warned against alongside side effects.
sounds like a conspiracy case to justify blocking generic drugs from the market.
Just a quick search ... and harsh opinion.
Looking up the drug, the very first thing is the following:
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.
Re: Just a quick search ... and harsh opinion.
That warning, or similar ones, were very prominent on a number of sites about the drug.
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?
Re: Re: Just a quick search ... and harsh opinion.
Sorry, this is well known in the medical field already, or should be. I hate reglan and never prescribe it because I have seen more acute and life threatening reactions to it.
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.
Re: Re: Just a quick search ... and harsh opinion.
Further research shows that ‘Stronger Warnings’ were required by the FDA in 2009. However, courtesy “The Way back Machine” here is one of the sources I used as shown in April 2004.
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.
Re: Re: Re: Just a quick search ... and harsh opinion.
They were too trusting of their doctors in my 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.
Re: Re: Re:2 Just a quick search ... and harsh opinion.
That is fine when you have one doctor. Many times people have numerous doctors and one doctor is not aware of what the others are prescribing.
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.
Re: Re: Re:3 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.
Re: Re: Re:4 Just a quick search ... and harsh opinion.
It happens every day. What happens when you are in an accident out of state, unconscious and in an emergency room.
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.
Re: Re: Re:2 Just a quick search ... and harsh opinion.
Re: Re: Re:2 Just a quick search ... and harsh opinion.
I fully expect people to not take my advice paid or otherwise on my word alone, I hope they try other things fail and see the value of what I offered them.
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.
Side affects
The article doesnt address the fact that generic medication is not the same as the name brand. The active ingredient is the same but not all of the other compounds mixed with it. Also the quality of the generic pills varies widely not to meantion the accuracy of the dosage level as marked.
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.
FDA
Is anyone else wondering what the FDA does for us these days? They just take the clinical trials run by the drug companies look at the labels the drug companies create, ask them ‘is this thing you want to make billions of dollars selling safe?’ and pat everyone on the back for a job well done?
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No, actually they hold up plenty of good drugs for the stupidest of reasons. One example, the FDA pulled the one product that prevented post-op nerve scarring after back surgery. This is the number one cause of failure after surgery. Why did they pull approval? Because the safety manuals were written in Dutch. And the product was being produced in…? Yes, dear, the Netherlands. Company could not comply fast enough, the product was never allowed back in the states.
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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Erm, forgive my ignorance but what does the safety manual consist of? Is it something that would need to be understood by anyone in the US – be it be FDA staff to know what the safety procedures were (do those procedures have to be compliant, for example), or by anyone else working on US soil? Does it contain important information they would need before making their decisions?
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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I thought that Mr. Applegate had done a pretty good job of tying up the warning issue.
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.
“so in theory that could leave the takers of generics with no legal recourse”
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.
hurh?
why the heck isn;t the generic manufacturer responsible for its own products? They copy from the other guy so they’re not responsible? What the hell logic is that?
Oh yeah, logic… never mind.
Re: hurh?
Yes, they copy from the big guys.
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.
Re: hurh?
It makes sense because of the stupidity of the clinical trial process. The original manufacturer tested the product and determined (supposedly) what the side-effects were. The generic maker does not have to do this because they are allowed to assume that the original manufacturer did their trials right and is not lying.
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.
Suing Pfizer for generic drugs
I believe the real issue is quality control with the generic. If the generic manufacturer can establish they simply followed the Pfizer specs and forwarded any Pfizer warnings or advisories, there is no reason to hold them responsible, and every reason to go after Pfizer.
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.
Wyeth and Reglan
What did Pfizer know?
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!