Zicam Lawyer and Lawsuit News Regarding Loss of Smell

Expert Witness for Makers of Zicam Claims Zicam Can Not Cause Loss of Smell

An expert witness for the makers of Zicam argues that Zicam does not and can not cause the loss of smell. 

Smell disorders have been associated with exposure to over 200 diseases, toxins, or medications [Doty, 2004]. Since many of these contributing factors are commonly occurring, the cause of smell loss in any individual may be multiply confounded. Where zinc nasal gel is implicated in anosmia, confounding factors may include virally mediated olfactory dysfunction, and severe inflammation.

The analysis of AE reports directed to Matrixx regarding its Zicam product -- based on the most aggressive presumptions of exposure and outcome -- indicate that smell disorders rates are equal to or less than that diagnosed in managed care organizations.

3. Dr Jafek's contention that Zicam causes permanent anosmia is not based upon sound scientific data.

Based upon my review of Dr. Jafek's previous testimony and his basis for it, I cannot conclude that he has any scientific basis for his contention that Zicam causes anosmia. Specifically, he bases his allegation on spontaneous reports of complaints of anosmia in some patients who were also exposed to Zicam for treatment of their URI. Based upon my analysis, it appears that his review of these reports and his subsequent poster presented at the American Rhinologic Society meeting represents an anecdotal description of poorly documented clinical findings, with no scientific support or rigorous study. Spontaneous reports of a suspected cause of an event can only at best represent a signal or hypothesis of a possible association. Further, his data is very problematic because it is based primarily upon an internet survey; patients were not always examined by a physician, and there was no objective smell test.

How Much Zicam Can Cause Loss of Smell?

This excerpt of a deposition of Dr. Robert Kern discusses how much Zicam can reach the area of the nose that is responsible for your sense of smell.

The deposition of ROBERT C. KERN, M.D., taken before Jana E. Cox, Certified Shorthand Reporter, at 333 West Wacker Drive, Chicago, Illinois, commencing at 2:00 p.m. on the 23rd day of March, A.D., 2005.

A. Well, my understanding of it from the reading of it -- as I recall, I did that before I actually tried to knock out this patient's smell -- was that you put a prong with an atomizer. You try to get it up as high and as close to the olfactory cleft as possible and spray the 1 percent zinc sulfate onto the olfactory epithelium directly. That's what they were trying to do. And they had recruited these otolaryngologists that were trained and hopefully aren't going to injure the person when they were doing this.

But what I did -- and specifically was I used a long atomizer that for my recollections of looking at Peet Richter picture was very similar. I put that prong medial to the middle turbinate, sprayed it directly on the area, theoretically at least duplicating what they're doing. And probably sprayed more than 1/2 CC and -- because they apparently took great pains to only give 1/2 CC, 1/2 CC to one CC. I wasn't able to accomplish anything. So it makes me skeptical that they really -- because I needed to knock out the person's sense of smell completely. I couldn't wound it. I had to eliminate it. Because otherwise if there was any information getting through, it was going to give this person this foul superimposed flavor to food. So I have a feeling that they may have weakened the sense of smell perhaps, but I'd be skeptical that whatever they completely eliminated it, and I'd be extremely skeptical that they completely eliminated permanently unless the person had some other underlying problem.

MR. WENZEL: Now, let's mark this document that we've been referring to as Exhibit 1-2.

(Kern Deposition Exhibit No. 1-2 marked as requested.)

BY MR. WENZEL:

Q. When the substance comes out of the atomizer, is it in a mist form?

A. Yes.

Q. And 1 CC, how does that compare with the typical single dose of Zicam nasal gel spray?

A. Well, if you look later on in those sheets there, one of them goes through that.

Q. Does that -- The following page that says -- Let's -- All right. Can you show me where that is, Doctor.

A. That is the white sheet of paper with neat handwriting.

Q. All my sheets are white.

A. Oh, that's true. Yours are going to be a little different. It's the one with “zinc sulfate heptahydrate” in the corner.

Q. Got it. All right. What does that tell us about the dose of zinc gluconate -- I mean the Zicam dose?

A. Well, this is calculating using 1 percent solution of zinc sulfate heptahydrate and using a half - 500 microliters or 1/2 CC dose to the olfactory epithelium, how much zinc is going to be in that, how much zinc ion. And by these calculations here, 1.4 milligrams of zinc is what they were delivering at the time of the Toronto study to the olfactory epithelium.

Q. Okay. They were delivering 1 point how much zinc again?

A. It's the one that's underlined there. 1.4 milligrams per 1/2 CC. So that's what - Assuming it was all in there, that's, you know - Now, they talk about between 1/2 and 1 CC. So it could be double that, I suppose. I'm not sure exactly. It's not completely clear whether they -- whether they used one or two or whether it was a half for each side or what, but it's either that number or double that number.

Q. That's what they were using in the Toronto polio study; is that right?

A. Correct. The one that the subsequent claims of smell loss temporary and permanent that we discussed.

Q. Now, in Zicam what is the typical dose?

A. 120 microliters of the gel.

Q. Is it microliters, not milliliters?

A. No. 120 milliliters would be enormous.

Q. And how does --

A. That would be half a can or third of a can of Coke. That would be a lot.

Q. And how does 120 microliters compare with the amount that was used in the Toronto study?

A. Well, you can see also the number that's underlined at the bottom there.. 273 milligrams. So it's about five times less zinc was being delivered by 1 shot of zinc gluconate.

Q. Does the fact that the zinc gluconate in the Zicam product is in a gel form make any difference?

A. Yeah. I think it makes it less likely to get up to the olfactory epithelium.

Q. Why is that?

A. Because the gel will stick where it hits. So if hits anywhere along the way, the majority of it's going to stick. Whatever hits is going to stick. If

BY MR. WENZEL:

Q. All right. Now, the next page I have, the page that says up at the top “zinc sulfate heptahydrate”?

A. Yes.

Q. And what is it that you've done here on this page?

A. Well, this is the involved calculations for determining exactly how much zinc is in the two -- It is written out rather nicely here, but it's how much zinc. zinc ion is in 120 milligrams -- or I'm sorry -- 120 microliters of zinc gluconate or Zicam, which is in the lower right-hand corner. And then how much is in zinc sulfate heptahydrate 1 percent solution 1/2 a CC. So it's basically the amount of zinc. as I calculated, in the Toronto study versus how much is in zinc gluconate. That's where the ratio of 1.14 milligrams of zinc over, you know, 0.273 is about 5 to 1. That's where I came up with the number that five times as much zinc is being applied in the Toronto study. And even more when I tried to do it versus this here, which is the zinc -- Zicam down on the bottom.

What Else Besides Zicam Can Cause Loss of Smell?

Apparently, there are several drugs on the market that can cause the loss of all or part of your sense of smell.

Q Are any of her medications associated with smell loss or dysfunction?

A Some of them may be described as possibly causing loss of smell in the lists that have been generated.

Q Can you rule out her other medications as playing a causative role in her smell complaints?

A Yes, to a degree of medical probability.

Q And how is that?

A She was taking those medications before she used the product. She is taking them afterward. The change was the use of the Zicam.

Q Well, there was a big increase in dose of one of them right around the time of her complaints, wasn't there?

A Which one was that? I'm sorry. I must have missed that.

Q Pardon me. I think it was her Effexor?

A There were some changes in the Effexor, the BuSpar and the -- it may have been the Effexor. Okay.

Q Assuming that her Effexor was increased in dose around the time of her complaints, can you rule out Effexor as playing a role in causing her smell complaints?

A Yes.

Q How?

A Effexor is one of a group of drugs that have been considered possibly associated with loss of smell. However, it is incredibly uncommon and rare, and she used the others, particularly BuSpar, without changing her loss of smell. Therefore, I think, to a degree of medical probability, it is unlikely that it affects her with the source of her problem.

Q Well, how rare is smell loss in association with Effexor compared to smell loss in association with Zicam?

A I don't have an exact number in that regard.

Q Okay. She has -- this is a woman who has been treated for arthritis, fibromyalgia, headaches related to disc problems, two years of cervical steroid epidural blocks, polymyalgia, depression, laminectomy, foraminotomy, rheumatoid arthritis, osteoarthritis, restless leg syndrome, hiatal hernia, diverticulitis, gastroesophageal reflux disease, irritable bowel syndrome, migraines, incontinence and hypertension, correct?

A This lady has not had an easy life, and I think that's an accurate recording. I didn't write down all those things.

Q Can you rule out her underlying medical conditions, any or all of them, as playing a role in her smell complaints?

A Yes.

Q How?

A She had those before she used the medication. Afterwerds, she had loss of smell therefore, by the temporal association, I think it's more likely, to a degree of medical probability, that the loss of caused by the Zicam.

Q Well, the temporal association was with a pretty severe upper respiratory infection, wasn't it, Doctor?

A That wasn't my impression. It was my impression that she hadn't developed a cold.

A Yes. With the assumption that she did not take Zicam, then I still would begin to put her over into the idiopathic. If we have all the additional information that she lost it in proximity to a cold and that she did not take Zicam, then I would make a diagnosis, instead, of post-viral anosmia.

Q (BY MS. SHARKO) Now, have you in the Hilton case and I gather this is coming in the Lusch case, offered the opinion that you can observe scarring or inflammation in the area of the olfactory epithelium?

A I think in some patients you can. I don't know that that's pertinent to this particular case since I didn't examine these patients.

How Does Zicam Cause The Loss of Smell?

That’s the question Dr. Bruce Jafek is attempting to answer in this deposition.

Q. Okay. And is it your opinion to a reasonable degree of scientific probability that zinc gluconate in Zicam is the chemical equivalent to the zinc sulfate which was used in the 1930's in the polio experiments?

A. It's my opinion that the zinc ions contained in the zinc gluconate are the same as the zinc ions contained in the zinc sulfate and the zinc chloride and the other zinc salts that were used throughout the years to study loss of olfaction.

Q. That wasn't my question. My question is, is it your opinion to a reasonable degree of scientific probability that the zinc gluconate in Zicam is the chemical equivalent to the zinc sulfate which was used in the 1930's in the polio experiments?

A. And my answer is that zinc chloride or zinc sulfate and zinc gluconate of course are different compounds. What makes them similar is the presence of the zinc ions when placed in solutions. It is my testimony that the zinc ions are the same.

Q. I appreciate that they both have zinc. Lots of things in the world have zinc. My question is different though.

A. Yes.

Q. My question is, is it your opinion to a reasonable degree of scientific probability that the zinc gluconate in Zicam is the chemical equivalent to the zinc sulfate that was used in the polio experiments?

A. It is my opinion that the zinc ion in the two substances is equivalent. The two substances of

Q. How much zinc does a human receive when Zicam is used in accordance with the package directions?

A. I don't know.

Q. How much zinc does a person receive upon administration of the zinc sulfate in the polio experiment?

A. There is no standard answer to that question, nor is there in the Zicam.

Q. Is the apparatus shown in Exhibit Jafek which was used in the polio experiments the same, in your opinion, to a reasonable degree of medical probability, as the container which is used to administer Zicam?

A. Both are designed to squirt a substance in the nose. In that sense, they're equivalent. In terms of the structure, they are different.

Q. In terms of structure they're very different, aren't they, doctor?

A. I said that they were different. I'm not sure how you would define very.

Q. Well, doctor, the polio apparatus has a long skinny needle or cylinder that's inserted in a nose way back up to the olfactory cleft and the Zicam is a plastic tip that's designed to be inserted angled one-eighth of an inch into the nose. Correct?

A. The atomizer that you gave me the picture of is designed to try to insert into the olfactory cleft. Whether that actually happened in all the patients is open to question. In terms of the atomizer, it is designed to be inserted into the nose and it has its own self-contained propellent which is different from the bulb that's on that particular apparatus. The two are equivalent in the sense that they are designed to deliver a substance into the nose.

Q. Now, the children and the -- strike that. The people in the polio experiments were put in a very special position to have the zinc sulfate administered to them, correct?

A. Some of them they tried to put into a special position. I can't comment on the varying degrees of success. All I can say is that some of the children had permanent loss of the sense of smell.

Q. Were you familiar with the Shaninian paper?

A. I am familiar with the Shaninian position and his description of how he would like to have tried to put kids. Having had children and grandchildren, I'm not sure that I could ever get one of my children into that particular position for a prolonged period of time in order to spray a painful substance into their nose, so I don't know how successful he was. That's what they were trying though.

Q. You don't treat children, do you, doctor?

A. I do.

Deposition From Alabama Zicam Lawsuit

In this deposition, Dr. Bruce Jafek discusses why he believes that Zicam can cause the loss of smell if it contacts the olfactory epithelium.  This is from the case of Wyatt v. Mattrix Initiatives, Inc. and was filed in the federal district court for the Northern District of Alabama.

Q (BY MS. SHARKO) You told me this morning that your opinion is that when you're comparing animal data to human data, you have to look at the area of olfactory epithelium, correct?

A I think I pointed out that the area of olfactory epithelium is important in terms of evaluating toxicity studies.

Q And it's your opinion, I understand from prior depositions, that Zicam is toxic to the olfactory epithelium, correct?

A That is correct.

Q And one predicate of your opinion is that the dose of Zicam that's administered goes to the olfactory epithelium as opposed to elsewhere in the nose, correct?

A As a general statement, that's correct. You left out the word “all” that you used in the previous question. My opinion is based on the fact that the bolus of Zicam has a straight pathway to the olfactory epithelium and, therefore, can do its toxicity effects.

Q And in order to have toxic effects, it's your opinion, is it not, that all of the Zicam has to go up onto the olfactory epithelium, correct?

A No, I don't think that's what I said.

Q Well, how much of it has to get there to cause damage, in your opinion, to a reasonable degree of medical probability?

A If we extrapolate -- if we extrapolate from Slotnick's studies in which he showed that 8 microliters was able to produce variable effects, what we might call an effect of 50 from his curve, and if we observe that the area of the human smell tissue is just a little bit bigger than that of the mouse, then what has to get there is 10 to 12 microliters, just as an approximation, and the usual applicant dose is 140.

Deposition of Plaintiffs’ Expert In Zicam Lawsuit

This is the deposition of Dr. Gerhard Schrauzer, Ph.D., a retired chemistry professor.  This is a very lengthy deposition, but in this excerpt, the professor discusses some of his research into whether Zicam or zinc nasal products can cause loss of smell.  This deposition was taken in 2006 in the case of O’Hanlon v. Matrixx Initiatives, Inc., which was filed in the U.S. District Court for the Central District of California.

Q What scientific method have you employed to form your opinion that the actual cause of Dennis O'Hanlon's smell dysfunction was Zicam rather than a viral process or anything else?

A I have compared some of the other substances he was exposed to and eliminated those as possible causes of agents. Like he used a leather spray, Armor leather spray. I checked the Internet, for example, if there is any ever case of anosmia caused by Armor leather spray, which is a very popular spray. And I haven't found not one single evidence that ever anybody -- and this is an older product -- has ever reported loss of smell after using Armor leather spray. And when I looked up the Internet for Zicam, I got hundreds of cases. So that is how I based my evidence.

Q What other possible causes did you consider and rule out based on Internet research with respect to Dennis O'Hanlon's smell dysfunction?

A I was for a while thinking -- well, no. None other. No.

Q Putting aside the question of Internet research, what other possible causes did you consider and rule out as causes of Dennis O'Hanlon's smell dysfunction?

A I looked at his medical records. I was interested if he possibly suffered brain trauma at one time or had some other condition that -- or was on certain drugs that could cause changes in smell acuity, and I couldn't see any reason.

Q Prior to your involvement in this litigation, had you ever done any formal research into the causes of anosmia?

A Formal research, no.

Q Prior to your involvement in this litigation, had you ever done any research into the determination of whether intranasal zinc application can cause anosmia?

A No.

Q Prior to your involvement in this litigation, had you ever attempted to determine the cause of a specific individual's smell dysfunction?

A Yes.

Q Tell me what you did --

A Well, as a chemist, you see, there are certain substances that will result in temporary paralysis of the olfactory functions. Hydrogen sulfide is a good example. Hydrogen selenide is a good example. I worked close with hydrogen sulfide. S-u-i-f-i-d-e. And, you see, we chemists are exposed to such substances. We have students that may be exposed to such substances. So a knowledge of toxicology is very important. So we know that certain substances causes disturbances of smell function and taste function.

MR. LAZARUS: Move to strike as nonresponsive.

BY MR. LAZARUS:

Q Doctor, my question is whether you've ever, before your involvement in Zicam litigation, undertaken to determine whether an individual who has suffered smell dysfunction developed that condition as a result of any specific cause?

MR. WENZEL: As to his work on Zicam cases?

MR. LAZARUS: Prior to his involvement.

MR. WENZEL: Oh, prior to his -- sorry.

MR. LAZARUS: That's all right.

THE WITNESS: I'm not a medical doctor.

BY MR. LAZARUS:

Q I understand that and that's why I'm asking the question. Have you ever attempted to determine the specific cause of an individual's smell dysfunction prior to your involvement in this litigation?

A Right. And I have had one case of a person that lost his taste and smell following a viral infection. Yes.

Q Did you make a determination as to whether his smell and taste dysfunction was caused by a viral infection or some other potential cause?

A Based on his testimonial it was a viral infection.

Q Did you rule out other potential causes to determine that it was a viral infection in that instance?

A No.

Q Did you leave that to a medical doctor?

A Not even that. This was a person who had suffered permanent smell and taste function loss after a severe viral infection, and 30 years later he was still trying to sniff his food in order to get some taste sensation out of it. And he told me it was a viral infection, so -- that was one example.

Q Based on that, you concluded as a matter of scientific process that his smell dysfunction was caused by a viral infection?

A I concluded nothing. I just took the information.

Q Doctor, what is it in your professional background, training, and experience that qualifies you to offer opinions concerning what does and does not qualify under homeopathic medicine as a homeopathic remedy?

MR. WENZEL: Objection. Asked and answered and previously testified to.

MR. LAZARUS: I don't think so.

MR. WENZEL: He said he developed homeopathic products himself.

BY MR. LAZARUS:

Q Is that it?

A Yes.

Q And what homeopathic product did you develop?

A The selenium, for example, is a homeopathic product.

Q Did you develop selenium as a homeopathic product?

A I developed supplements, yes. And if you want to know, as an aside, I was even accused by our medical faculty that I was doing the big no-no in studying homeopathy at the University of California San Diego. Seriously, the levels -- and that is, of course, what separated me from the pharmacologists that -- and that is the real fundamental issue here also bordering on the Zicam case. My research has shown that levels very, very low can have profound effects, and that is basically what homeopathic practitioners have been preaching all along. But I've done that scientifically without using the terminology of homeopathy, eventually being damaging to my career.

Q When you say your research has shown that levels very, very low can have profound effects, are you talking about selenium?

A Not only selenium but also other metals. Cobalt, zinc, copper.

Q Is it fair to say that all the work that you've done to investigate whether intranasal application of zinc compounds can cause smell dysfunction has come since you began working with attorneys in cases against Matrixx and Quigley?

A Yes.

Q Were you aware that Robert Henkin is a member of the scientific advisory board of the Quigley Company, which is a maker of Cold-Eeze?

A I didn't know that.

Q Have you published in any scientific journal any of the opinions that are stated in or on the report in this case?

A No.

Q Have you made any effort to do so?

A Absolutely not.

Q Have you submitted any of the opinions stated in your report for any form of formal peer review?

A No.

Q Did you consider yourself an expert on the olfactory effects of intranasal zinc prior to being retained in the Zicam litigation?

A No. I was retained as a chemist.

Q Aside from the case reports by Drs. Jafek, Davidson and Hirsch, are you aware of any peer review publication of opinions that Zicam is the cause of anosmia?

A No.

Q Are you aware of any peer review publication of the opinion that Zicam can reach the olfactory epithelium in the absence of sniffing?

A Could you kindly repeat this.

Q Are you aware of any peer review publication which states the conclusion that Zicam can reach the olfactory epithelium in the absence of any sniffing?

A The only published paper I would consider is the paper by Davidson and Alexander.

Q And Davidson and Alexander concluded that ordinarily a sniff will be required to cause Zicam to reach the olfactory epithelium. Correct?

A I think so. Yes.

Defense Expert Testifies In Hearing In Zicam Lawsuit

This testimony was given in February of 2007 in Lusch v. Matrixx Initiatives, Inc., a lawsuit in the federal district court of Oregon.

Personally, I like how the defense expert is put on the spot about using Zicam on his own nose.

Q. Okay. So then tell us, Doctor, what experiments you did on the Zicam cold remedy gel that you personally observed.

What -- what is the -- were the mass and the speed and the distance calculations that you performed?

A. I would say that my study is -- was simply a one-time firing, probably in my office, where I actuated the unit and just looked to see what's the physical form of the spray coming out. So it's -- I did not measure the mass or the velocity or -- there was nothing to measure a distance to.

Q. So the opinion that you gave here today, and you talked in detail about testing and modeling and pharmacodynamics and pharmakinetics, and all of those things; mass, distance, and all that have stuff.

What you did, Doctor, with the product that's in issue in this case, is you sat in your office and you fired it off. Right? One time?

A. I think that I did all of the other things that I talk about in here, which is reviewing the literature.

I just wanted -- I'm curious. I wanted to know what Zicam looked like. I also needed, of course, to look at my observations and see if there's anything fundamentally different from what Dr. Jafek did. In fact, I would say that what I did is, you know, a perfectly reasonable one-off experiment, and carries the same weight as a single one-off experiment with a cadaver. I don't think it's necessary to rely on it, but it's about that level of scientific inquiry.

Q. So you equate sitting in your office in your chair, firing this thing off one time, to a cadaver study?

A. I would say they're not that different. In terms of their utility, there's not much difference.

Q. So then -- then all the discussion you had this afternoon about the nasal passages and -- and, you know, you've said, I guess, now, that you don't really have a superior expert understanding of nasal anatomy, but you testified to it a little bit ago. You said that it's not a straight shot.

That doesn't make any difference?

You can get the same result from firing it up somebody's nose as you can sitting in your chair in your office and shooting the thing, what was it, four to six feet?

A. Sounds about right, yes.

Q. Actually, didn't you say you fired it off and at one -- in one case, didn't you say you fired it off and it hit the ceiling?

A. I can't recall if it did or it didn't, but it certainly is a long, narrow plume that goes up in the air quite a long way.

So my observation is not dissimilar from what Dr. Jafek reports.

Q. Okay. So --

A. And just like Dr. Jafek reported, it was a one-time observation.

Q. Right. So -- so what you did with the product itself --

A. Um-hmm.

Q. -- and what we're talking about here is -- you know, Zicam. Right?

A. Correct.

Q. That's the product.

Okay. What you did is your -- you didn't conduct any calculations about mass and speed and distance and particle size. You didn't measure anything. You sat in your office and fired it off?

A. I did what I was asked to do, which was to answer questions. I think you asked this morning, or Mr. Lazarus asked, you know, what was I asked to do. So I was asked to answer questions. I could, I think, have answered the questions quite appropriately without ever needing to see Zicam, but I'm curious. I mean, I really wanted to see what I'm looking at here.

Q. So you wanted to go the extra mile. You sat in your chair in your office and you fired it towards the ceiling. Right?

A. Well, I think you are not letting me finish the -- the answer.

But I mean, I think have quite a bit of background knowledge, as I outlined for you this morning. I've been doing this for a long time.

So once I've established that Zicam is a nasal product -- and not at all products -- it's not all cut and dry. So I think it's a perfectly reasonable thing to go, to look at.

So, remember that I've been looking at lots of products for a very long period of time here. There are powders that go into the nose. I would go as far as to say that I'm familiar with delivery systems that Dr. Jafek has never seen, but of course I can't know that. But I think it's perfectly reasonable to make sure that I am able to answer questions about the deposition of a nasal spray. And to do that, I can't imagine anything more reasonable than to fire it.

Q. Well, didn't you talk this afternoon about, what was it, gamma scintography studies? And mathematical modeling? And measuring mass and speed and distance? And pharmacodynamics and pharmakinetics?

You talked about all of those things. You didn't do any of that with Zicam, did you?

A. It's true that I did not do any of that with Zicam --

Q. Okay.

A. -- because I think I can actually learn quite a lot from the written description of Zicam, and I can actually see quite a lot from observation of the plume. So I -- I can learn something from that. It's a useful thing to do.

Q. So the sum total of your personal experience with the product is firing it in your office. Right?

A. Yes, I think that's true.

Q. Okay. So you didn't even try the product on your own nose, did you?

A. No, I did not try it on my own those.

Q. And so you don't know, for example -- and I see you've got one sitting up there, and I don't know if you want to try it now. But if you put that thing deep in your those, and you fire it off, you think it would reach your nasal epithelia?

Plaintiff’s Expert Witness In Zicam Litigation Questions Safety And Efficacy Of Zicam

I took Zicam a year or so ago when I had a bad cold.  It didn’t help at all, so I have to agree with this expert’s opinion that Zicam is no more effective than a placebo.  Had I known that there was any risk at all that Zicam would cause me to lose my sense of smell, I never would have taken it.  This expert attempts to put the risk into numeric form.

The risk benefit ratio becomes a numbers game. We fly in an airplane knowing the risk of death is 3 or 4 in a million. We take antibiotics for acute sinusitis knowing there is a 1:1000 risk of infection spreading to the brain or eye and knowing there is a 1:100,000 risk of a serious allergic reaction to the antibiotic. We accept these risks for the benefits seem favorable. No one would use nasal zinc knowing that the risk of losing their sense of smell is 1 in 100. Would they use the product knowing the risk is 1 in 1000, 1 in 10,000, 1 in 100,000 or even 1 in 1,000,000. None of us enjoy the common cold and if there were an effective medicine, many would take it. But if we knew the benefit was placebo, few, if any, would risk losing their sense of smell, even if that risk were small.

It is my calculation that if we add up all the zinc induced anosmia cases we know, for example, those in class action suits, individual suits and those who have telephoned Matrixx complaining of olfactory loss after use of Zicam nasal gel products, we easily arrive at an estimate of at least 500 people. If we double that, assuming only half of those injured complained, we conservatively conclude that 1000 people are anosmic secondary to their zinc exposures. Furthermore, if we assume Matrixx has sold 10,000,000 vials of Zicam nasal gels, then the relative risk is 10,000/10,000,000 or 1/10,000 or 0.001%. The risk of being killed driving is 50,000 deaths per year divided by 200 million adults or 0.0025%. This is 21/2 times the risk of anosmia, but I accept that risk for I benefit from driving. I would not accept that risk for a placebo nasal spray, which neither prevents, cures, nor ameliorates the common cold.

Another way to ask this question is whether a human subject committee, called an institutional review board (IRB) would approve a clinical trial with zinc nasal gel such as Zicam Cold Remedy Nasal Gel. I believe they would not. Most sensible people would not knowingly incur this risk of permanent anosmia for so little potential benefit. This opinion is supported in the January 2007 Consumer Report, “Oral Zinc is probably safe if you take less than 40mg a day.” The evidence on its efficacy, however, is also mixed. Consumer Reports' take is that “The possible risk posed by nasal zinc outweighs any benefit. It is not clear whether oral zinc is worth taking for colds.” Eby and Halcomb in Alternative Therapies 2006 conclude, “We contend that it is unethical to introduce any potentially permanent anosmia-inducing agent such as zinc or other heavy metals into the interior of the nose in a manner that could result in contact with the olfactory region to treat a temporary discomfort such as a common cold or allergy. We found no reason to recommend intranasal zinc gluconate or zinc orotate lozenges in treating common colds.” Based on the lack of any verified, demonstrable benefit from the use of zinc gluconate based nasal gels, such as Zicam Cold Remedy Nasal Gel, juxtaposed against the potential for permanent anosmia posed by such products, it is clear that zinc gluconate based nasal gels fail risk benefit analysis.

Zicam Defense Lawyer Takes The Deposition Of A Physician Who Treated Someone Who Lost Their Smell After Using Zicam

This is the deposition of Dr. Michael Loper, M.D.  Dr. Loper treated James Evans for anosmia, which is the medical term for loss of smell.  The following questions-and-answers are typical of the questions a defense lawyer will ask in Zicam litigation.

Q. Any other information that you believe is relevant to your opinions that you hold in this case with regard to the Zicam causing the severe loss of smell other than what we've already talked about here today?

A. Yes, sir.

Q. Okay. What would that be?

A. I think that Mr. Evans lost his smell due to Zicam mainly due to three opinions or subjective opinions. The first is I've already mentioned to you the temporal proximity. In other words, his loss of smell occurred at -- on the same day that he used the Zicam.

My second, I guess I would say, of course this could vary between second and third, but I think it's important that Mr. Evans lost his smell so rapidly that many conditions that I see of smell loss occur slowly over time.

And thirdly, this is not in my medical record, but I recall Mr. Evans telling me that when he sprayed the Zicam in his nose that he got a fairly intense burning, felt something was wrong immediately, and those would be the main reasons why I would attribute his smell loss to the use of Zicam.

And I guess fourthly I would say we've already discussed this, but the lack of anything else that would -- any object finding that would account for his smell loss.

Q. Do you know how long Mr. Evans had suffered from his cold prior to applying the Zicam in his nostrils?

A. No, sir, I don't.

Q. Other than him telling you that it was a mild cold, do you have any way to quantify exactly how severe the cold was that he suffered from that resulted in him applying the Zicam in either nostril?

A. No, sir.

Q. Okay. Did he quantify for you the amount of time that expired or amount of time that transpired between the application of Zicam and when he experienced the loss of smell?

A. If he did, I didn't quantify it.

Q. Okay. And you don't have any recollection either prior to me asking these questions or now, as we sit here in this deposition, as to what period of time would have transpired between the application of the Zicam and the loss of smell?

A. The only documentation -- the only recollection or documentation is that my note in the chart the decreased smell that day.

Q. Okay. And as far as the amount of decrease in smell that day, did you quantify that?

A. I did not.

Q. Okay. Are you aware -- and I apologize if I've already asked this question, but are you aware as to whether or not Mr. Evans applied the Zicam in both nostrils?

A. No, sir, I don't know that.

Q. So as far as when the intense burning occurred, other than it occurred immediately after the Zicam was applied, you're not aware as to which nostril it was applied in prior to the immediate burning occurring?

A. No, sir.

Q. Okay. What other objective findings would be important for you in diagnosing Mr. Evans to attribute the loss of smell to a reason other than the application of the Zicam?

A. I would say if I had a patient who had long-term smell -- or who had smell loss that at some point I might consider x-ray of his sinuses, CAT scan of the sinuses. MRI of the olfactory nerves. At some point in time I would probably want to do a formal smell test.

Q. And so obviously from looking at your file and what comprises your file you were not able to do the CAT scan or the MRI of the olfactory nerves or a formal smell test, correct?

MR. MILES: Object to form.

A. Correct.

MR. WALLIS: All right. I don't have any further questions. Thank you.

Defense Expert In Zicam Lawsuit Doesn’t Believe That Zicam Can Reach The Top Of The Nasal Cavity

Dr. Richard Dalby, Ph.D., filed this expert report in Evans v. Matrixx Initiatives, Inc., a lawsuit filed in federal court in Florida in 2008.  He doubts that Zicam could ever reach the olfactory area of the nose, which is at the top of the nasal cavity.

3. Based on existing data and experience with the delivery characteristics of other nasal products, what is the likelihood that Zicam gel, when used as directed, is deposited or distributed to the roof of the nasal cavity (i.e., the area at and above the upper portion of the superior turbinate) in any significant amount?

Research with other aqueous nasal sprays demonstrates that only droplets smaller than pm in diameter have a significant chance of reaching areas at and above the superior turbinate. Aside from nebulizer-derived aerosols, which typically produce droplets smaller than 10 ??m, commercially available aqueous nasal sprays do not deliver any significant amount of the formulation to the superior turbinate or olfactory region.

Zicam has even less potential to reach the roof of the nasal cavity in any significant amount compared to any other commercially available nasal sprays because of the comparatively large droplet size resulting from its higher viscosity. Due both to its viscosity and to the direction in which a user essentially directs the spray into the interior of the lateral nasal wall, it is highly unlikely that any significant amount of Zicam will reach the olfactory region when the product is used as directed. In many instances, most of the formulation will remain in the nasal opening. On rare occasions when Zicam passes the nasal valve, I expect Zicam to deposit mostly on the leading edge of the inferior turbinate and in the inferior airway (the meatus below the inferior turbinate and above the floor of the nasal cavity).

For these reasons, it is my opinion that no significant amount of the Zicam formulation is likely to come into contact with the superior regions of the nasal cavity when the product is used as directed.

I understand that some researchers have advocated the theory that the combined pump, actuator and formulation of Zicam are “over-powered” and that this would cause the normal protective function of the nose (described above) to be overwhelmed or in some way defeated and allow a significant fraction of the sprayed formulation to reach the olfactory region. This theory has no scientific basis and ignores the likelihood of inertial impaction enhanced by the large size of the droplets in combination with the anatomical obstacles. I am not aware of any scientific evidence that would support such a theory.