Woo woos getting Sued Sued

[Eos of the Eons]

Homeopathic zinc cold remedy marketers sued.

Dennis and Debra Christensen of Almena, Michigan have filed suit
against the marketers of Zicam Cold Remedy Nasal Gel
http://www.zicam.com, a homeopathic product claimed to "reduce the
severity and duration of common cold symptoms even when treatment is started as late as the second day after onset of illness." The suit alleges that Dennis Christenson sustained permanent loss of his sense of smell following a single application of the product.

Several similar cases were reported at a recent meeting of the American Rhinologic Society. The case report authors state that direct application to the inner lining of the nose has long been known to produce loss of the sense of smell. The suit is posted at
http://www.homeowatch.org/legal/zicam.html
.



This is the first time I've seen consumers sue anyone for a naturopath type product's effects.

[Abdul Alhazred]

Originally posted by Eos of the Eons
This is the first time I've seen consumers sue anyone for a naturopath type product's effects.

I suppose then that this particular homeopathic remedy isn't just plain water.

I have used a spray of plain water up the nose to relieve runny nose. It's a folk remedy and maybe there is nothing to it, but no ill effects.

[Eos of the Eons]

Yeah, most people call anything homeopathy. Even people selling the stuff don't know it isn't true homeopathy, but the label gets them attention.

Hopefully these jokers will pay dearly.

Saline is great for a stuffy nose. One teaspoon of salt in one cup of water is about right. It's not homeopathy though. Saline is used a lot - you know, in implants and such :p

[Zep]

And in researching this subject, I came across this (http://www.vetlab.co.uk/voodoo/). Very funny!

[Eos of the Eons]

If we further investigate the use of Homoeopathic Magic for healing, we in fact encounter the discipline of puppet healing, or Voodoo


Big surprise :)

This is linked from there, very hilarious!

http://www.valleyskeptic.com/homeoa%7E1.htm

As if the above was not far fetched enough homeopathic "researchers" are now examining a notion that the water can be magnetized and that the "healing" properties can be transmitted over a wire. I guess the old saying of taking two aspirin and call me in the morning will now be without the aspirin, just call me and I will transmit healing powers over the phone line. I am not making this up.

This last one made me go "hmmmm"

It's official - Homeopaths can tell lies (26/4/2003)

Imagine that someone wanted to sell you water for several hundred dollars per litre, that they publicly admitted that it was nothing but water, that they sold several such waters for different purposes and admitted that there was no difference between the different products other than in the labelling and intended purpose. Imagine also that this someone claimed that these magic waters with nothing in them cured, sorry "relieved", various illnesses including colds, asthma, arthritis, osteoporosis, jet lag, PTSD following the World Trade Center destruction, and even the ill effects of vaccination. Imagine then that you were a concerned citizen who objected to the fraud and lies and wanted to do something about it. If you live in California, it looks like you would be out of luck because an appeals court has just established a precedent by ruling that some liars called King Bio Pharmaceuticals can say and do whatever they like
(26/4/2003)

http://www.ratbags.com/rsoles/comment/kingbio.htm

[shemp]

Originally posted by Abdul Alhazred


I suppose then that this particular homeopathic remedy isn't just plain water.

I have used a spray of plain water up the nose to relieve runny nose. It's a folk remedy and maybe there is nothing to it, but no ill effects.

Baloney! I tried it, and I almost drowned! Maybe next time I'll try a smaller garden hose.

[Psi Baba]

Originally posted by Eos of the Eons

This is the first time I've seen consumers sue anyone for a naturopath type product's effects.
The odd thing about this is that the zinc remedies (at least the oral lozenzes anyway, such as ColdEZE) are actual medicine and have been tested. They aren't wonder drugs by any means, but the mechanism has been demonstrated scientifically. However, at least one brand (there are probably others now) is describing theirs as homeopathic. ??? Like you said, it's probably to get attention on store shelves. That said, I don't know if the idea of a nasal gel has been tested. Probably not, and it appears to be turning out to be a bad idea. One of the problems with the lozenges is that it was shown that sweeteners tend to negate the effects of the zinc compound so that only the really nasty tasting ones (ie unsweetened) had much chance of working.

[Skeptical Greg]

Originally posted by Psi Baba

The odd thing about this is that the zinc remedies (at least the oral lozenzes anyway, such as ColdEZE) are actual medicine and have been tested. They aren't wonder drugs by any means, but the mechanism has been demonstrated scientifically. However, at least one brand (there are probably others now) is describing theirs as homeopathic. ??? Like you said, it's probably to get attention on store shelves. That said, I don't know if the idea of a nasal gel has been tested. Probably not, and it appears to be turning out to be a bad idea. One of the problems with the lozenges is that it was shown that sweeteners tend to negate the effects of the zinc compound so that only the really nasty tasting ones (ie unsweetened) had much chance of working.

We kicked this around a while back.. I think someone here actually emailed the ColdEZE people and asked them about their use of the word ' homeopathic '..

It boiled down to them using the term to avoid the need for FDA certification I think..


Discussed here.. (http://www.randi.org/vbulletin/showthread.php?s=&postid=1870029425&highlight=coldeze#post1870029425)

[phildonnia]

Originally posted by Abdul Alhazred


I suppose then that this particular homeopathic remedy isn't just plain water.

I have used a spray of plain water up the nose to relieve runny nose. It's a folk remedy and maybe there is nothing to it, but no ill effects.

Putting Ben-Gay up my nose seems to clear up a head cold. But it does pretty much ravage your sense of smell.

[Eos of the Eons]

quote:
--------------------------------------------------------------------------------
Originally posted by hgc
This might make those Zicam people regret mis-labeling their stuff homeopathic.
--------------------------------------------------------------------------------

:

It's funny how they label it homeopathic, and then it turns out to be really bad for you :p

[Rolfe]

It's obvious from the thread Diogenes linked to that these guys were well warned several months ago. Serves them right.

Rolfe, VetFFVoo.

[TillEulenspiegel]

The suit alleges that Dennis Christenson sustained permanent loss of his sense of smell following a single application of the product.


Hmmmm...
I think this is much a testement to the litigious nature of americans as a demonstration of the efficasy of homeopathic remedies.

I'm wondering tho, how would you test a loss of smell?? Someone sneaks up behind the patient and let's lose a horrendious fart?

[Eos of the Eons]

Originally posted by TillEulenspiegel
The suit alleges that Dennis Christenson sustained permanent loss of his sense of smell following a single application of the product.


Hmmmm...
I think this is much a testement to the litigious nature of americans as a demonstration of the efficasy of homeopathic remedies.

I'm wondering tho, how would you test a loss of smell?? Someone sneaks up behind the patient and let's lose a horrendious fart?

I'm sure there are several ways, but I'm gonna have to go look it up. I knew a lady that lost her sense of smell, and had to have surgery to restore some of it. The damage would be noticeable if you have to operate.

Every time I lose my sense of smell when I have stuffed nose, it drives me crazy. You can't even taste food anymore.

[TillEulenspiegel]

Well if the man suffered a loss I believe compinsation is in order. The rest of my post stands ( even tho satirical ).
I am not a doctor or chemist, but one would suppose that if he had such a reaction to a homeopathic remedy, which by nature has the active ingredent in miscule amounts , would have demonstraited itself in the plaintif's history. Such amounts can be found in total cereal and multi-vitamins. I think 3rdtwin would know. prahaps the salve was contaminated.. I tend to think that either dollar signs or improper application ( if the salve was pure ) would be most suspect.
My sister was an epicure and aspiring chef. Four years ago she fell off her bicycle and lost her sense of smell. As taste is composed of %75 smell..............

[Eos of the Eons]

Originally posted by TillEulenspiegel
Well if the man suffered a loss I believe compinsation is in order. The rest of my post stands ( even tho satirical ).
I am not a doctor or chemist, but one would suppose that if he had such a reaction to a homeopathic remedy, which by nature has the active ingredent in miscule amounts , would have demonstraited itself in the plaintif's history. Such amounts can be found in total cereal and multi-vitamins. I think 3rdtwin would know. prahaps the salve was contaminated.. I tend to think that either dollar signs or improper application ( if the salve was pure ) would be most suspect.
My sister was an epicure and aspiring chef. Four years ago she fell off her bicycle and lost her sense of smell. As taste is composed of %75 smell..............

Thing is, you missed it completely...the active ingredient in this case is not miniscule, and it has already been pointed out that it is not homeopathy, but someone using that label to sell the product because some people like the word homeopathy. It is a recognizable term.

Their product is just crap. So they had to label it as something that some gullible folks would buy.

Nope, not contaminated, just a bad product that the idiots who made it don't have to test when they label it homeopathy.

That is the reason why homeopathy needs to be regulated by the FDA, and therefore taken off the market.

Exactly on the taste point. These people, and it's not just the one suing, have all lost more than their smell.

[TillEulenspiegel]

I'm sorry but I am ignorent of the make-up of the salve, the link you posted for some reason is inaccessible. I assumed ( incorrectly it appears) that the definition in the thread, "homeopathic" was literal.

[Eos of the Eons]

Yeah, their site is down.

You can only go to this link for the lawsuit

http://www.homeowatch.org/legal/zicam.html

You can google zicam as well, and see their outrageous claims

https://www.immunesupport.com/shop/product.cfm?product__code=N080&save=PRICZIIM




Ingredients:

Active Ingredients: Zincum Glucoincum* 2x
Inactive Ingredients: Benzalkonium chloride, glycerine, hydroxyethlycellulose, purified water, sodium chloride, and sodium hydroxide.
:

[TillEulenspiegel]

The fact that the product and it's claims are crap is a given . I could not find a per dose or by weight amount for the zinc compound which is sited as the active ingredient. The plaintiffs attorney also raised the delivery mechanism a smart legal move and probably pertinent to the medical questions.

[reprise]

Zinc was one of the many supplements being recommended as an "immune booster" to HIV/AIDS patients about a decade ago. IIRC, the margin between the therapeutic dose and the toxic dose is quite small with zinc (and hearing problems are one sign of overdose).

That said, zinc is an extremely common ingredient in all kinds of skin preparations (especially those for nappy rash and acne) - take a look at Aussie sportsmen to get an idea of just how widely used it is - and I can't see any warnings on any of the products we have which contain zinc or in any of my medical reference books about not using it on mucous membranes. It will be interesting to see how this case develops.

[Eos of the Eons]

Calamine lotion has zinc. My bottle has a warning to keep it away from mucous membranes.

[Zep]

What is becoming VERY obvious these days is that the non-approved lotions and potions that want to sell will label themselves with whatever they need to sell. If "homeopathic" is a good label then they will use that. That the product itself has nothing whatsoever to do with any homeopathic preparation content or method is obvious (accepting for sake of argument that these were valid anyway).

In other words, I could make up a slop from whipped sump oil, grass clippings, a sprinkling of dirt, ground cucumber peel and tap water, and call it "Dr Zep's Homeopathic Face Emulsion".

It's MARKETING, that's all.

[Eos of the Eons]

Originally posted by Zep
What is becoming VERY obvious these days is that the non-approved lotions and potions that want to sell will label themselves with whatever they need to sell. If "homeopathic" is a good label then they will use that. That the product itself has nothing whatsoever to do with any homeopathic preparation content or method is obvious (accepting for sake of argument that these were valid anyway).

In other words, I could make up a slop from whipped sump oil, grass clippings, a sprinkling of dirt, ground cucumber peel and tap water, and call it "Dr Zep's Homeopathic Face Emulsion".

It's MARKETING, that's all.


Yes, and there will be no warnings because it is not regulated, and you really never know what is in anything labelled 'homeopathic'.

So the warning in general is buyer beware. But most people aren't aware of what a bunch of crock it all is, so they think it is better than anything regulated, and that's why there are no warnings...cause it couldn't possibly hurt you because it is better for you than regulated products. Ungh.

And why do people think that? Because people selling the sh*tznitz tell them that it is better and safer.

Liars.

[Zep]

Actually...that concoction I described DOES WORK! Take a look at my avatar! I used to be all wrinkly - NOW look at me! 1.2% fewer wrinkles!!! Buy today at a fraction of the usual price - 5/4ths.

[TillEulenspiegel]

Well if these folks think they can dodge the medical constriants that apply to drugs and otc remidies ( cough medicine, claritin ) by using a lable it will become painfully obvious they will become aware of thier responsibilities under the liability laws.

[Rolfe]

Originally posted by TillEulenspiegel
Well if these folks think they can dodge the medical constriants that apply to drugs and otc remidies ( cough medicine, claritin ) by using a lable it will become painfully obvious they will become aware of thier responsibilities under the liability laws.
Assuming that they are selling something really harmful, as these guys seem to have been doing. This was really stupid. Just take care that the composition is reasonably innocuous, and laugh all the way to the bank. Muttering the mantra "placebo effect" as you go. (In fact you don't even need that - lots to be made from people who will buy it just to see if it works, and when it doesn't will just write the cost off to experience.)

In fact we had all sorts of mayhem on an earlier thread because a poster (OK, it was Steve Grenard) had picked up on a number of fake-homoeopathy marketing sites where preparations were being marketed as "2X" and things like that. It took an inordinate number of posts to persuade him that this wasn't homoeopathy, and that agreeing that a 1:100 preparation of an active substance might have an effect was not the same as saying that homoeopathy is valid.

The original exemptions from drug licensing laws given to homoeopathic remedies rested on the assumption that there was nothing or next to nothing in them, and in a situation where the main concern was seriously toxic patent medicines, it seemed reasonable.

Now, wouldn't it be nice if the authorities ruled that in order to be labelled homoeopathic, a product had to have nothing but the carrier material(lactose/water/alcohol) present! I'd like to see the labelling they'd have to put on in that case! (This homoeopathic product is certified legitimate, having been officially tested and shown to contain no arnica/belladonna/pulsatilla etc. whatsoever. :) )

Rolfe.

[Eos of the Eons]

Now, wouldn't it be nice if the authorities ruled that in order to be labelled homoeopathic, a product had to have nothing but the carrier material(lactose/water/alcohol) present! I'd like to see the labelling they'd have to put on in that case! (This homoeopathic product is certified legitimate, having been officially tested and shown to contain no arnica/belladonna/pulsatilla etc. whatsoever. :)
That's my dream :D

[reprise]

Does the FDA have different requirements than our TGA?

The Catch-22 of our TGA regulations is that if the TGA requires you to comply with anything more than their manufacturing standards then your product is pretty much trivial - it's made of ingredients which have such a long history of safety that they are available OTC to pretty much anybody. By NOT requiring the product to be on any of the TGA's schedules, the TGA pretty much declares that you're buying snake-oil.

[Eos of the Eons]

By NOT requiring the product to be on any of the TGA's schedules, the TGA pretty much declares that you're buying snake-oil.

I do wish, but I'm pretty sure they just allow anything to be called food, and then sold as homeopathy/naturopathy/etc.

What all is on TGA's schedule? Things like Primrose Oil? I'll look up a list or something.

[reprise]

Originally posted by Eos of the Eons
I do wish, but I'm pretty sure they just allow anything to be called food, and then sold as homeopathy/naturopathy/etc.

What all is on TGA's schedule? Things like Primrose Oil? I'll look up a list or something.

While TGA requirements are extremely convoluted, the specific schedules relate to how particular "ingredients" (for want of a better word) are regulated and under what circumstances they can be sold.

Many, many items must meet the TGA's standards for manufacture, but that is all. Those products have been tested for toxicity and side effects but not much else because they have a long history of use without significant incident.

You can buy very small packets of OTC analgaesics here (24 at the moment and the TGA wants to drop it to 12) - aspirin, paracetamol (the active ingredient in Tylenol, it's called something else in other places) in supermarkets here. The TGA rules state that you cannot buy larger amounts without purchasing them from a pharmacist or without a doctor's prescription because these are drugs which are perfectly safe when used on an incidental basis but which can be extremely harmful when consumed on a regular basis or in large amounts.

You cannot purchase some forms of vitamin A here without a doctor's prescription AND a health department authority. You can no longer purchase L-tryptophan or selenium at all without a doctor's prescription The TGA is RE-active, rather than PRO-active, but as someone who has been involved in the drug approval process I have some sympathy towards their stance in respect of therapeutic agents which only cause problems for a very few people and even then under quite specific conditions but which benefit the majority. I'd hate to be doing their job, particularly at a time when people are clamouring for snake-oil solutions and then trying to sue people after the fact for the very things they wanted access to in the first place.

I'm lethally allergic to aspirin. I don't want the TGA to take it off the shelves because of my allergy - that would put so many other people at risk it's not funny - but more and more often the TGA IS starting to make rulings based on a couple of exceptional reactions to products which do not adversely affect the majority of the population. There is nothing on this planet to which some person will not adversely react, but litigation driven legislation is BAD legislation IMHO - which is precisely why at the same time I will fight for my right NOT to immunise my daughters against pertussis I will fight FOR my right to have them immunised against everything else; they are not at risk from any other vaccine.

Anyway, I'm rambling now, but I still think that our TGA and the US FDA are doing one hell of a tough job and especially in light of the ever-growing faith in "alternative" medicine (and the fact that some health insurance funds here rebate the cost of visiting alternative medicine practitioners).

[Kumar]

Some intresting details on homeopathy at;

http://www.lifepositive.com/Body/homeopathy/homeopathic-treatment.asp

[Eos of the Eons]

Re-active vs Inactive. TGA reactive, and FDA so far seems inactive. I don't see the FDA doing one single thing to raise alarms about "ever-growing faith in "alternative" medicine " and the harm they can cause.

Sounds at least like TGA is working on awareness, which is a must. Of course people need to know what adverse reactions to look for. I get a strange reaction to risperdal that I was supposed to take for a few months - and only 1/2 mg/day. I still got the one weird reaction (not harmful to my health) that wasn't even mentioned on the product label with the already 50 or so listed. I guess they didn't list it because it doesn't cause any harm. I still would have liked to know that it was the medication that was doing that to me, and not because I was pregnant or something :p My son doesn't get that side effect, so it is helping in ways that are priceless.

So, if people are aware of the risks associated with these products that are mis-labeled as homepathic or otherwise, then does that protect the folks selling it? Or can people still sue since the products are making false claims? I think it's only fair. People really wouldn't want them if they were labelled properly and if they did know that it may be harmful despite the claims made by people selling it.

I can understand that good products like aspirin should carry a warning-it protects the manufacturers and keeps consumers aware.

It's all the false claims that drives me insane. The nose spray claimed that people got over a cold 75% faster if they used it. Of course it didn't contain any warnings about causing loss of smell.

It's not fair that regulated products have warnings-and therefore look harmful compared to all these unregulated products that look harmless because of the lack of labels and with the false claims they make-they look way better than anything regulated.

The more law suits the better-to raise awareness, until these products are labelled properly.

[Eos of the Eons]

Originally posted by Kumar
Some intresting details on homeopathy at;

http://www.lifepositive.com/Body/homeopathy/homeopathic-treatment.asp :p Interesting? Ack, I couldn't get past the first sentence.

I have some interesting articles as well, I hope this is a good comparision to that link :)

http://www.quackwatch.org/01QuackeryRelatedTopics/homeo.html

[peptoabysmal]

I used zicam about two weeks ago. My wife passed a rather nasty cold on to me, and I just didn't have the downtime to allow for it. It actually knocked the cold out in about three days. Either that, or I have an extremely good immune system due to being a smoker. Usually it takes me about 1 - 2 weeks to get rid of a nasty cold.

The good news is that I don't smell any more than I used to. Uh, well maybe not good news, I don't smell any less either :D

[RichardR]

Originally posted by Diogenes
We kicked this around a while back.. I think someone here actually emailed the ColdEZE people and asked them about their use of the word ' homeopathic '..

It boiled down to them using the term to avoid the need for FDA certification I think.. [/URL] That's correct. I emailed them about it. Read about it in this thread. (http://www.randi.org/vbulletin/showthread.php?s=&threadid=11321&highlight=zicam)

[TillEulenspiegel]

The FDA has a designation, "GRAS" generally recognized to be safe that covers substances like vitamins aspirin, tylanol ( Acetaminophen in the states) additives to foods like iron, B!, Zinc. The reality here is if you take over the proscribed limits of ANY of those substances , you can die. vitamins toxicity is a phrase that probably less the %1 of the populas has ever heard. Remember phen-phen? How about ma huang (aka pseudo ephidrin or epedra) Most people who take alternative medicines from the Chinese formulary do not realize that the Chinese extracts are medicines in "therapeutic" doses.

Large doses of certain compounds can be dangerous especially when the folks who seem to be attracted to this kind of "medicine" often combine other compounds that either enhance the effects of other ingredients or combine to form other more dangerous compounds. More is better right ?

The GRAS should probably be pruned to exclude the Chinese formulary and other OTC's should require strict dose limits, hell open up a bayre aspirin box look at the warnings and countra-indications there. Hell we even ( in the states ) put warning signs on gas pumps not to drink it or light a match ........if we can do that for the hairbrains in our midsts , don't you think we should provide guide lines for things they ingest?

[BTox]

First, as correctly pointed out, Zicam is in no way homeopathic. Only by label copy to avoid FDA consideration as a new drug. Second, I suspect these are bogus adverse reaction claims, not unlike those made by anti-vac kooks. If they have suffered loss of smell, it is most likely unrelated to use of this product.

[Eos of the Eons]

Originally posted by BTox
First, as correctly pointed out, Zicam is in no way homeopathic. Only by label copy to avoid FDA consideration as a new drug. Second, I suspect these are bogus adverse reaction claims, not unlike those made by anti-vac kooks. If they have suffered loss of smell, it is most likely unrelated to use of this product.

Vaccines aren't woo woo like the zinc crap. And there is a warning on my calamine lotion to make sure it doesn't contact mucous membranes. There must be some reason that the warning is there hey?

You'd think if they were kooks like the anti-vac folks, then they'd go after something that the drug companies "are profiting from" and not a fellow woo woo.

I do feel the zicam dorks deserve what happens to them. The article did mention more than a few people had adverse reactions to the stuff. I know if I didn't know better than to touch anything labelled 'homeopathy' I would try the stuff to get over a cold 75% faster.

I hate colds.

[BTox]

Originally posted by Eos of the Eons


Vaccines aren't woo woo like the zinc crap. And there is a warning on my calamine lotion to make sure it doesn't contact mucous membranes. There must be some reason that the warning is there hey?

I don't know off hand what is in calomine lotion, but it wouldn't be just zinc to have that warning. Zinc at higher concentrations and dosages has been and still is safely used in toothpaste, mouthwash and other oral products for many decades.

Originally posted by Eos of the Eons
You'd think if they were kooks like the anti-vac folks, then they'd go after something that the drug companies "are profiting from" and not a fellow woo woo.

I do feel the zicam dorks deserve what happens to them. The article did mention more than a few people had adverse reactions to the stuff. I know if I didn't know better than to touch anything labelled 'homeopathy' I would try the stuff to get over a cold 75% faster.

I hate colds.

The makers of zicam are making money from this and other products. I don't consider them woowoo. Anecdotal but zinc lozenges work quite well for me when I get a cold. Consistently have resulted in much milder symptoms and significantly quicker resolution. You should try them!

[Eos of the Eons]

I'd take lozenges if they were approved and tested. I also use zinc cream. The active ingredients in calamine lotion are

calamine 76mg/ml
zinc oxide 76 mg/ml

I won't buy any products from woo woos who don't even know enough about homeopathy that they mislabel their products as such.

[BTox]

That's a high concentration of zinc, much higher than any formulated for oral use. Again, they know exactly what homeopathy is. I don't fault them, I fault DSHEA for allowing this legal loophole.

[Wyvern]

Originally posted by BTox
First, as correctly pointed out, Zicam is in no way homeopathic. Only by label copy to avoid FDA consideration as a new drug. Second, I suspect these are bogus adverse reaction claims, not unlike those made by anti-vac kooks. If they have suffered loss of smell, it is most likely unrelated to use of this product.
I tend to agree that this is a bogus liability claim. I tried to research the zinc compound found in the Zicam and found nothing to indicate that it or the zinc ion that would be found in solution form would cause this kind of damage. The claimant admits there was only one application of the product. If the product could cause such severe damage after only one application of the product used in the intended manner, you bet your @ss there would be one helluva class action lawsuit happening. ;) Like BTox, I don't believe the use of this product has anything to do with the user's loss of sense of smell.

[Rolfe]

Originally posted by Wyvern

I tend to agree that this is a bogus liability claim. I tried to research the zinc compound found in the Zicam and found nothing to indicate that it or the zinc ion that would be found in solution form would cause this kind of damage. The claimant admits there was only one application of the product. If the product could cause such severe damage after only one application of the product used in the intended manner, you bet your @ss there would be one helluva class action lawsuit happening. ;) Like BTox, I don't believe the use of this product has anything to do with the user's loss of sense of smell.
Except that there does seem to have been some scientific evidence that the product was capable of doing exactly that.c. By failing to conduct an even minimal investigation into the historical and scientific evidence that relates intranasal zinc application to permanent, total and irreversible anosmia;I doubt that a court would have gone along with an absolutely unsubstantiated post hoc ergo propter hoc argument without some further evidence, and there does seem to be a suggestion that this was an already-known if unusual idiosyncratic reaction.39. The unreasonably dangerous aspect of the product could easily be eliminated by defendants without compromising its usefulness or desirability, if any such usefulness or desirability even exists.

40. At the time of the product's manufacture and distribution, Defendant Matrixx had actual knowledge that the product was defective and that there was a substantial likelihood that the defect would cause the injury that is the basis of this cause of action; Defendant Matrixx further willfully disregarded that knowledge in the manufacture and/or distribution of this product.
But I agree, the main take-home message of this is that allowing anything labelled "homoeopathic" to be exempt from safety (or efficacy) regulations is nuts.

Rolfe.

[Wyvern]

Originally posted by Rolfe



Except that there does seem to have been some scientific evidence that the product was capable of doing exactly that.
quote:
--------------------------------------------------------------------------------
c. By failing to conduct an even minimal investigation into the historical and scientific evidence that relates intranasal zinc application to permanent, total and irreversible anosmia;
--------------------------------------------------------------------------------


No, making a claim in a court document alleging that testing was not conducted to determine whether or not there would be any possibility of harm does not equal scientific evidence that harm could occur.


Originally posted by Rolfe


I doubt that a court would have gone along with an absolutely unsubstantiated post hoc ergo propter hoc argument without some further evidence, and there does seem to be a suggestion that this was an already-known if unusual idiosyncratic reaction.
quote:
--------------------------------------------------------------------------------
39. The unreasonably dangerous aspect of the product could easily be eliminated by defendants without compromising its usefulness or desirability, if any such usefulness or desirability even exists.

40. At the time of the product's manufacture and distribution, Defendant Matrixx had actual knowledge that the product was defective and that there was a substantial likelihood that the defect would cause the injury that is the basis of this cause of action; Defendant Matrixx further willfully disregarded that knowledge in the manufacture and/or distribution of this product.
--------------------------------------------------------------------------------


Again, it's just someone making an allegation. Any evidence that exists has yet to be provided in court.



Originally posted by Rolfe

But I agree, the main take-home message of this is that allowing anything labelled "homoeopathic" to be exempt from safety (or efficacy) regulations is nuts.


I agree with this as well! I just don't believe that this case is going to accomplish that or anything else, other than getting the claimant some money to prevent further cost of litigation. :)

[Eos of the Eons]

Interesting.So they knew it wasn't homeopathy, and knew it meant loopholes. Why did they want this loophole and not a legitimized product? Cheaper? Was the product ever tested in trials?


I figure the company is still getting what it deserves. I'm still sure it is capable of causing damage because of the irresponsible handling of the product. It's not homeopathy, and it's still labelled as such.

I will look forward to hearing more on the proof. Can't say anything for sure right now I guess.

[BTox]

Originally posted by Eos of the Eons
Interesting.So they knew it wasn't homeopathy, and knew it meant loopholes. Why did they want this loophole and not a legitimized product? Cheaper? Was the product ever tested in trials?

They wanted the loophole because it would take 3-4 years and much $$ to get this product approved via NDA process. And yes, it was tested in trials.


Originally posted by Eos of the Eons
I figure the company is still getting what it deserves. I'm still sure it is capable of causing damage because of the irresponsible handling of the product. It's not homeopathy, and it's still labelled as such.

I will look forward to hearing more on the proof. Can't say anything for sure right now I guess.

You are sure it is capable of doing damage based on what evidence? I find it highly unlikely that dosing ~100 ug of zinc in the nasal cavity can cause sense of smell loss. These are people (and lawyers) looking for money, nothing more.

[Eos of the Eons]

Originally posted by BTox


They wanted the loophole because it would take 3-4 years and much $$ to get this product approved via NDA process. And yes, it was tested in trials.




You are sure it is capable of doing damage based on what evidence? I find it highly unlikely that dosing ~100 ug of zinc in the nasal cavity can cause sense of smell loss. These are people (and lawyers) looking for money, nothing more.


Can't argue with you. I don't know enough about zinc. Hmm, I guess folks better spend the time and money on the NDA process to keep away those folks who are looking for money.

[BTox]

Originally posted by Eos of the Eons



Can't argue with you. I don't know enough about zinc. Hmm, I guess folks better spend the time and money on the NDA process to keep away those folks who are looking for money.

Of course, having an FDA approved drug doesn't stop anyone from suing you. Ask any ethical drug company ;)

[Eos of the Eons]

Originally posted by BTox


Of course, having an FDA approved drug doesn't stop anyone from suing you. Ask any ethical drug company ;)


Isn't there more protection for you if you do get sued though. If not, then why not be like zicam? Where's the incentive to be legit?

[BTox]

Originally posted by Eos of the Eons

Isn't there more protection for you if you do get sued though. If not, then why not be like zicam? Where's the incentive to be legit?

Nope, FDA approval doesn't offer any legal protection. If the makers of zicam were making claims against something more serious and not self-resolving (like a cold), FDA would've gone after them. They don't claim it prevents colds, only that it reduces the severity and duration. Even a prevents colds claim would get them in trouble.

[Eos of the Eons]

Not legal protection, but proof that the product is safe and effective. That would be protection. A product that goes through without loopholes, isn't it supposed to be proven safe and effective? If not, then what is the use?

Isn't Zicam hanging without this approval? How are they going to prove their product is just as legitimate as aspirin?

[Brown]

For a discussion of a US Supreme Court case arising out of these facts (but not stemming from the lawsuit mentioned in the opening post), see this thread (http://forums.randi.org/showthread.php?p=6883181#post6883181).

[Eos of the Eons]

For a discussion of a US Supreme Court case arising out of these facts (but not stemming from the lawsuit mentioned in the opening post), see this thread (http://forums.randi.org/showthread.php?p=6883181#post6883181).
Oh, now the alties are rejecting it and using this as an opportunity to bash "big pharma" and claim vaccines are as haphazardly handled as this Zicam BS. Not the same as vaccines, sorry, they actually are tested and scrutinized, and no altie is attempting to sell them as homeopathy to get past the guidelines that vaccine manufacturers have always been subject to. Antivaxxers and woo woo selling homeopathy have an awful hypocritical habit of bashing something proven to have an active ingredient. They sure have been quick to dump Zicam as one of theirs, and villify it. It's odd they haven't defended the product as being "stolen by big pharma" in the usual fashion, and big pharma isn't being accused of hatin "alt products" in this case. I guess the alties don't want this Zicam stuff to hock anymore?