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US District Court : EVIDENCE | expert's testimony excluded under Daubert; complaint dismissed

Case No. 04-CV-4199 (PJS/JJG)
Barry G. Reed, ZIMMERMAN REED PLLP, for plaintiffs.
Walter H. Swayze, III, SEGAL McCAMBRIDGE, for defendant.
Defendant The Quigley Corporation (Quigley) manufactures and distributes over-thecounter
cold remedies. From September 2003 through September 2004, Quigley distributed
Cold-Eeze Nasal Spray (Cold-Eeze), which contained zinc gluconate as its active ingredient.
Plaintiffs Howard J. Polski and Sheryl L. Polski, brother and sister, purchased and used Cold-
Eeze in December 2003. As a result, the Polskis allege, they suffered severe and permanent
impairment of their senses of taste and smell.
The Polskis bring several claims against Quigley: fraud, negligence, strict products
liability (failure to warn), strict products liability (defective design), breach of express and
implied warranties, and violation of Minn. Stat. 325F.69. Quigley moves to exclude the
testimony of the Polskis expert on causation, Dr. Bruce Jafek, and moves for summary
1Quigley brings two additional motions: a motion to sever the Polskis trials, and a
motion to exclude the testimony of expert witness Miriam R. Linschoten. Because the Court is
dismissing the Polskis claims, these two motions are denied without prejudice as moot.
judgment on all of the Polskis claims. For the reasons described below, Quigleys motions are
granted and the Polskis claims are dismissed with prejudice.1
Cold-Eeze was intended to alleviate the symptoms of the common cold by delivering zinc
gluconate into the nose. Swayze Aff. Ex. B, Feb. 14, 2007 [Docket No. 156] (Swayze Aff.).
The instructions for use stated that [f]or best results, begin treatment within 48 hours of onset of
symptoms. Swayze Aff. Ex. B. Users were instructed to insert the tip of the pump
approximately an eighth of an inch into the nostril, spray once, and inhale through the nose
slowly and deeply. Swayze Aff. Ex. B. Users were supposed to repeat this operation every
24 hours at least six (6) times per day until at least forty-eight hours after symptoms subsided.
Swayze Aff. Ex. B.
Before putting Cold-Eeze on the market, Quigley hired Clinical Research Laboratories,
Inc. (CRL) to conduct a double-blind, randomized clinical trial of the safety and efficacy of
Cold-Eeze. One of the purposes of the study was to determine whether the use of zinc nasal
spray could cause anosmia (the inability to smell). The trial involved seventy-nine human
subjects, twenty of whom were given a saline-spray placebo. The remaining fifty-nine were
given Cold-Eeze. The subjects used the spray every two hours (during waking hours) for
seventy-two hours. Swayze Aff. Ex. EE. Of the fifty-nine Cold-Eeze users, nearly all reported
at least some burning or stinging of the nostrils as a result of using the product. Id. Table II. But
none of the Cold-Eeze users reported any anosmia.
In December 2003, Sheryl and Howard Polski were planning to travel together to
California. About a week before the trip, Sheryl caught a cold. She went to a drugstore to buy
Cold-Eeze zinc lozenges, which she had used in the past to treat her colds. The pharmacist
recommended Cold-Eeze nasal spray, which she decided to try. S. Polski Dep. 49. She began
using the spray that same day, and continued using it, according to the instructions, for a couple
of days. S. Polski Dep. 50. Each time she used it, Sheryl experienced violent sneezing and
burning and stinging in her nose. S. Polski Dep. 51, 59. Nevertheless, when she got to
California, she purchased a second bottle of Cold-Eeze and started using it again. S. Polski
Dep. 52.
The Polskis returned to Minnesota between Christmas and New Years Eve. H. Polski
Dep. 69. Sheryl noticed a loss of her senses of taste and smell in January. S. Polski Dep. 54. At
first, Sheryl noticed that nuts would taste burnt. Eventually, though, she was unable to taste or
smell anything. S. Polski Dep. 30-31.
Like his sister, Howard Polski had used Cold-Eeze zinc lozenges in the past. Howard
also caught a cold in December 2003, and, on Sheryls recommendation, he decided to try Cold-
Eeze nasal spray. H. Polski Dep. 65, 71. While in California, Howard used up one bottle and
purchased a second. H. Polski Dep. 68. He experienced some burning and sneezing, but he did
not notice any problem with his ability to taste or smell during the California trip. H. Polski
Dep. 68, 74. About a week after returning to Minnesota, though, Howard noticed a problem with
his senses of taste and smell. H. Polski Dep. 75. Like Sheryl, Howard noticed at first that nuts,
2A diminished sense of smell is called hyposmia. Although the Polskis both testified
that they had essentially lost all ability to smell, later testing apparently indicated that they are
hyposmic rather than anosmic. For simplicitys sake, the Court will refer to the damage
allegedly caused by Cold-Eeze simply as anosmia.
especially peanuts, tasted very bitter and burnt, like charcoal. H. Polski Dep. 62. Eventually,
Howard, too, lost the ability to taste and smell.2 H. Polski Dep. 59-60.
Sometime in mid-January 2004, about four or five weeks after Sheryl first used Cold-
Eeze, the Polskis were eating a meal together when Howard confided that he could not taste any
of the food, and Sheryl replied that she also could not taste anything. H. Polski Dep. 75-76. In
April 2004, both Sheryl and Howard went to see Dr. Merrill Biel, an otolaryngologist to whom
they had been referred by their family physician. Dr. Biel performed MRIs on each of the
Polskis to check for tumors or other possible physical causes of the sensory loss. S. Polski
Dep. 28; Swayze Aff. Ex. II. The scans were normal. S. Polski Dep. 28-29; Swayze Aff. Ex. E
at 4. In September 2004, the Polskis filed this action, alleging that Cold-Eeze caused them to
lose the ability to taste and smell.
A. Quigleys Motion to Exclude Dr. Jafek
To prove that Cold-Eeze caused their injuries, the Polskis offer the expert testimony of
Dr. Bruce Jafek, a professor of otolaryngology (the diagnosis and treatment of disorders of the
ear, nose, and throat) at the University of Colorado School of Medicine. Quigley moves to
exclude Dr. Jafeks testimony under Fed. R. Evid. 702 and Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Rule 702, which governs the admissibility of expert testimony, provides:
If scientific, technical, or other specialized knowledge will
assist the trier of fact to understand the evidence or to determine a
fact in issue, a witness qualified as an expert by knowledge, skill,
experience, training, or education, may testify thereto in the form
of an opinion or otherwise, if (1) the testimony is based upon
sufficient facts or data, (2) the testimony is the product of reliable
principles and methods, and (3) the witness has applied the
principles and methods reliably to the facts of the case.
Fed. R. Evid. 702. District courts have wide latitude in determining whether an experts
testimony is reliable. Olson v. Ford Motor Co., 481 F.3d 619, 626 (8th Cir. 2007). In
determining whether an experts testimony is the product of reliable principles and methods,
district courts consider such factors as:
(1) whether the theory or technique can be (and has been) tested;
(2) whether the theory or technique has been subjected to peer review and
(3) whether the theory or technique has a known or potential error rate and
standards controlling the techniques operation; and
(4) whether the theory or technique is generally accepted in the scientific
Smith v. Cangieter, 462 F.3d 920, 923 (8th Cir. 2006). Because this inquiry is necessarily
fact-specific, there is no single standard for reliability. See Unrein v. Timesavers, Inc., 394 F.3d
1008, 1011 (8th Cir. 2005). Instead, these factors are flexible and should be adapted or rejected
as the case demands. Id. The burden of establishing that the proposed testimony meets the
standards of Rule 702 is on the proponent of the expert opinion in this case, the Polskis.
Wagner v. Hesston Corp., 450 F.3d 756, 758 (8th Cir. 2006).
Quigley concedes that Dr. Jafek is qualified as an expert in the area of nasal health. As
noted, he is a professor of otolaryngology at the University of Colorado School of Medicine a
position he has held for thirty years. He helped to found the Taste and Smell Center at the
University of Colorado, and he has compiled an impressive list of accomplishments and
publications. As other courts have pointed out, though, Dr. Jafek is not a toxicologist or an
epidemiologist. See, e.g., Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp. 2d 1316, 1322
(M.D. Ala. 2006); Sutherland v. Matrixx Initiatives, Inc., No. 04-0129, slip op. at 12 (N.D. Ala.
Nov. 7, 2007) (Swayze Aff. Ex. PP). Quigley does not challenge Dr. Jafeks qualifications,
however, and thus the Court will assume that he is qualified as an expert by knowledge, skill,
experience, training, or education to testify about the causes of anosmia.
Dr. Jafek authored two reports in this case, one for each plaintiff. In each report,
Dr. Jafek opines that: (1) Cold-Eeze, when used as directed, comes into contact with the
olfactory epithelium (the smell tissue located high inside the human nose); (2) the zinc
gluconate in Cold-Eeze is toxic to the olfactory epithelium; (3) Cold-Eeze, when used as
directed, delivers a sufficient amount of zinc gluconate to the olfactory epithelium to damage the
sense of smell; (4) the damage that the zinc gluconate in Cold-Eeze causes to the olfactory
epithelium is permanent in some cases; and (5) the zinc gluconate in Cold-Eeze (and not
something else, such as a virus) caused the Polskis to lose their sense of smell. Swayze Aff.
Ex. E. The Court examines each of these opinions to determine whether they meet the
requirements of Rule 702 and Daubert.
1. Cold-Eeze comes into contact with the olfactory epithelium
The Polskis allege that the zinc gluconate in Cold-Eeze damaged the olfactory epithelium
in each of their noses and caused them to lose their senses of taste and smell. As Dr. Jafek
acknowledges, in order to damage the sense of taste and smell, the Cold-Eeze must actually
come into contact with the olfactory epithelium. Swayze Aff. Ex. E at 8 4 (Howard report).
The olfactory epithelium is located approximately five centimeters into the nose, at the
top of the turbinates (spongy bone structures that regulate the flow of air in the nose). Reed Aff.
Ex. D at D2, Apr. 18, 2007 [Docket No. 169]; Stedmans Medical Dictionary 1362 (28th ed.
2006). It is extremely difficult to reach the olfactory epithelium, as Dr. Jafek himself explained
in a 1983 article entitled Ultrastructure of Human Nasal Mucosa:
[O]lfactory mucosa is almost anatomically inaccessible in living humans.
It is sheltered, for good reason, as it contains naked nerve endings in direct
contact with the outside world, which proximally communicate with the
brain. To reach it, the biopsy instrument must pass approximately 7 cm
deep to the nostril, the terminal portion blindly, into a 1.0 mm crevasse
between adjacent nasal bones (septum/perpendicular plate and superior
turbinate of ethmoid).
Swayze Aff. Ex. FF at 1576.
In the 1930s, polio researchers conducted a number of experiments in which they
attempted to chemically alter or damage the olfactory epithelium, which was thought to be the
sole portal for the polio virus. The intranasal application of zinc sulfate soon emerged as a
promising therapy. (Dr. Jafek relies on these peer-reviewed studies to show that zinc damages
the olfactory epithelium and causes smell loss.) In a 1937 article in the Journal of the American
Medical Association, Drs. Max Peet, Dean Echols, and Harry Richter described an experiment in
which they applied a zinc-sulfate solution directly to the olfactory epithelium. Direct application
was necessary because, the researchers found, anything short of direct application failed to
deliver sufficient zinc to the hard-to-reach olfactory epithelium:
[I]n practically all instances the solution did not go above the
middle turbinate if an ordinary atomizer was used with the tip of
3In 2005, Dr. Jafek performed an experiment in which he sprayed another zinc nasal
spray (Zicam) into the noses of two sectioned cadaver heads. Defs. Mem. Supp. Mot. in Limine
to Preclude Bruce Jafek 3, 29 [Docket No. 117]. Dr. Jafek does not describe or directly cite this
experiment in his expert reports, however. Thus, although the parties refer to the cadaver
experiment in their memoranda, the Court concludes that Dr. Jafek is not relying on that
experiment to show that Cold-Eeze can reach the olfactory epithelium. Even if he were, the
Court would find the cadaver study to be an unreliable basis for Dr. Jafeks opinions for the
reasons stated in Benkwith, 467 F. Supp. 2d at 1325; Wyatt v. Matrixx Initiatives, Inc., No. 4-
the spray introduced only slightly within the nostril. . . . It is
evident that to be effective the spray must be directly applied to the
olfactory area. We wish especially to emphasize this point.
Ordinary spraying with the atomizer tip introduced below the
middle turbinate will not suffice except in isolated instances.
Reed Aff. Ex. D at D3 at 2186, Apr. 18, 2007. In short, the researchers found that [o]rdinary
spraying with the atomizer tip introduced below the middle turbinate something roughly
akin to the typical consumers use of Cold-Eeze did not succeed in bringing zinc into contact
with the olfactory epithelium. To reach the olfactory epithelium, the researchers recommended
inserting a long, needle-like sprayer upward along the septum until definitely past the middle
turbinate. Id. The accompanying picture shows such a sprayer (much thinner than the Cold-
Eeze sprayer) carefully inserted high into the nose (much higher than the Cold-Eeze sprayer
could have been inserted). Id.
Notwithstanding the findings of these researchers about the difficulty of reaching the
olfactory epithelium and notwithstanding the fact that Dr. Jafek relies on other findings of
these same researchers Dr. Jafek insists that Cold-Eeze does indeed come into contact with
the olfactory epithelium because, when sprayed, Cold-Eeze travels in a straight liquid stream.
This stream, according to Dr. Jafek, is capable of passing through the straight passageway to the
olfactory epithelium (illustrated by the long, straight sprayer pictured in the Peet article). This is
the only basis upon which Dr. Jafek concludes that Cold-Eeze reaches the olfactory epithelium.3
1230, slip op. at 9 (N.D. Ala. Mar. 30, 2007) (Swayze Aff. Ex. UU [Docket No. 178]); and
Sutherland, No. 04-0129, slip op. at 16-18 (N.D. Ala. Nov. 7, 2006).
4See Benkwith, 467 F. Supp. 2d at 1324-26 (excluding Dr. Jafeks opinion that Zicam,
another zinc nasal spray, reaches the olfactory epithelium); Sutherland, No. 04-0129, slip op. at
16 (N.D. Ala. Nov. 7, 2006) (Why [Dr. Jafek] did not conduct an experiment on a live human
being using a pump and gel with Zicams viscosity leaves this court stumped.).
Dr. Jafek is undoubtedly an expert in nasal anatomy, but the Court concludes that his
theory that Cold-Eeze, when used as directed, reaches the olfactory tissue in humans is not
sufficiently reliable to be admitted under Rule 702. This does not mean that Dr. Jafeks theory is
necessarily wrong; it simply means that the theory meets none of the indicia of reliability
identified in Daubert and therefore must be excluded.
First, and most importantly, Dr. Jafek (or any other qualified expert) could cheaply,
quickly, and ethically test Dr. Jafeks theory in living human beings, using a substance of similar
viscosity to Cold-Eeze but without any zinc or allegedly toxic substances. Yet neither Dr. Jafek
nor anyone else has actually tested Dr. Jafeks theory. This is no small matter. Dr. Jafeks
theory that zinc sprayed out of a Cold-Eeze bottle reaches the olfactory epithelium is very
difficult to square with his earlier writings, in which he asserted that the olfactory epithelium is
almost anatomically inaccessible in living humans. Swayze Aff. Ex. FF at 1576. It is also
very difficult to square with the findings of the Peet researchers, who succeeded in getting zinc
into contact with the olfactory epithelium only when they manually guided a needle-like sprayer
high up the noses of their patients. As other courts have observed,4 Dr. Jafeks failure to test his
theory particularly given his theorys inconsistency with his own writings and the writings of
others, and particularly given the ease with which his theory could be tested casts serious
doubt on the theorys reliability.
5The Polskis point out that users of Cold-Eeze were instructed to inhale through the nose
slowly and deeply, which, they argue, makes Dr. Jafeks theory more plausible. But Quigley
argues in response that inhaling deeply makes it less likely that Cold-Eeze reaches the olfactory
epithelium, as it sucks the Cold-Eeze quickly past the opening to the olfactory epithelium, down
the throat, and into the lungs. The dispute between the parties again points to the need for
testing of Dr. Jafeks theory.
Needless to say, because Dr. Jafeks theory has not been tested at all, it has never been
subjected to peer review and publication, nor has it been generally accepted in the scientific
community, nor does it have a known or potential rate of error. Instead, Dr. Jafek simply
speculates that, because there is a straight pathway from the nostril to the olfactory epithelium,
and because Cold-Eeze travels in a straight line when squirted, Cold-Eeze is capable of reaching
the almost . . . inaccessible olfactory epithelium. This problematic theory has not been
subjected to any of the rigors of the scientific method, and the Court concludes that it is too
speculative to be presented to a jury.5
Because all of Dr. Jafeks opinions rely on his theory that Cold-Eeze reaches the
olfactory epithelium and because the Court has excluded as unreliable Dr. Jafeks opinion
that Cold-Eeze, when used as directed, comes into contact with the olfactory epithelium the
Courts ruling necessarily requires the exclusion of the remainder of Dr. Jafeks causation
testimony. As discussed below, that testimony must also be excluded for additional reasons.
2. Cold-Eeze is toxic to the olfactory epithelium
Most of the evidence on which Dr. Jafek relies in expressing the opinion that the zinc in
Cold-Eeze causes anosmia is derived from studies of zinc sulfate. The active ingredient in Cold-
Eeze, however, is zinc gluconate. This difference is potentially important, because [e]ven
minor deviations in molecular structure can radically change a particular substances properties
and propensities. Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 990 (8th Cir. 2001); see
also Sorensen ex rel. Dunbar v. Shaklee Corp., 31 F.3d 638, 646 n.12 (8th Cir. 1994)
([m]olecules with minor structural differences can produce very different biological effects
(quoting Joseph Sanders, From Science to Evidence: The Testimony on Causation in the
Bendectin Cases, 46 Stanford L. Rev. 1, 19 (Nov. 1993))).
In the 1930s, Dr. Edwin Schultz and other scientists researching the efficacy of intranasal
zinc in preventing polio theorized that one of the ways that zinc may prevent entry of the polio
virus is through some union of the zinc ion with the protoplasm of the olfactory endings, a zinc
proteinate being formed . . . . Edwin W. Schultz, Future of Chemoprophylaxis as a Measure for
the Practical Control of Poliomyelitis, 13 J. Peds. 38, 40 (1938) (Reed Aff. Ex. B, Apr. 18,
2007). Using that theory as a starting point, Dr. Jafek conducted an experiment, using egg
albumin, that demonstrated that zinc gluconate and zinc sulfate have similar protein-precipitation
properties. See Hans v. Matrixx Initiatives, Inc., No. 04-0540, slip op. at 8 (W.D. Ky. Sept. 29,
2006) (Swayze Aff. Ex. OO) (discussing Dr. Jafeks protein-precipitation experiment). The
Schultz article on which Dr. Jafek relies, however, notes that there is no absolute correlation . . .
between the power to precipitate egg white in solution and protective power . . . . Schultz,
supra at 40. In other words, the actions of these chemical compounds in the laboratory do not
necessarily correlate to their actions in the human body.
Dr. Jafek also cites authority for the proposition that zinc sulfate and zinc gluconate are
similarly soluble. This authority, however, indicates that zinc gluconate is less soluble than zinc
sulfate. See George Eby, Preventing Anosmia from Intranasal Zinc Administration (Reed Aff.
Ex. D at D8, Apr. 18, 2007).
6Chelation is the process of binding a metal ion to a chemical compound to form a ring.
Dr. Jafek also bases his opinion about the similarity of zinc sulfate and zinc gluconate on
the fact that Cold-Eeze is designed to deliver unchelated zinc ion into the nose.6 For support,
he points to the patent cited on Cold-Eeze packaging. But that patent specifically discourages
the use of gluconate because it is a compound capable of chelating zinc, thus rendering zincgluconate
nasal sprays only marginally effective[.] See Reed Aff. Ex. D at D1, Apr. 18, 2007
(U.S. Patent No. 5,622,724, at 4-6).
Finally, Dr. Jafek cites what he calls epidemiologic studies of zinc gluconate to support
his opinions. But the only published study Dr. Jafek cites an article that he himself
published in the American Journal of Rhinology is not an epidemiological study at all.
Rather, the article is simply a case report detailing the symptoms of a number of users of zincgluconate
nasal sprays.
As numerous courts have observed, case studies, standing alone, are no substitute for true
toxicological or epidemiological data. See Glastetter, 252 F.3d at 989-90; Rider v. Sandoz
Pharms. Corp., 295 F.3d 1194, 1199 (11th Cir. 2002). This case illustrates why. The Polskis
lawyer, when questioned at oral argument about various problems with Dr. Jafeks testimony,
sometimes resorted to answering, in essence, What are the chances that both Sheryl and
Howard would lose their senses of smell at the same time? It had to be the Cold-Eeze. The
problem with this reasoning is that it confuses coincidence with causation. It is true that Sheryl
and Howard both lost their senses of smell after using Cold-Eeze. But it is also true that
thousands of others including all of the subjects of the CRL study used Cold-Eeze without
losing their senses of smell. Determining whether Cold-Eeze causes anosmia obviously must
involve much more than toting up case studies.
Rather than rely on unreliable case studies, Quigley commissioned a randomized, doubleblind
trial before putting Cold-Eeze on the market. That study showed no correlation between
the use of Cold-Eeze and anosmia. Indeed, not one participant in the study suffered a loss of
smell, even though nearly all of them experienced the burning and stinging described by the
Polskis. Dr. Jafek does not counter this study with anything resembling an epidemiological
study documenting the incidence of anosmia in users of zinc-gluconate nasal sprays in
comparison with the general population. The Court therefore concludes that Dr. Jafek lacks a
reliable basis for his opinion that the zinc gluconate in Cold-Eeze is toxic to the olfactory
3. Cold-Eeze delivers a toxic amount of zinc to the olfactory epithelium
For the Polskis to recover, they must establish not merely that zinc gluconate in some
amount is toxic to the olfactory epithelium; they must also establish what amount of zinc
gluconate must reach the olfactory epithelium in order to damage the sense of smell. The Polskis
must then establish not just that some of the zinc gluconate in the Cold-Eeze spray came into
contact with their olfactory epithelia, but that enough zinc gluconate reached their olfactory
epithelia to damage the sense of smell.
Dr. Jafek opines that Cold-Eeze delivers a toxic amount of zinc gluconate to the olfactory
epithelium on the basis of a study in which researchers determined the Lowest Observable Effect
Level (LOEL) of zinc sulfate on the olfactory tissue of mice. See Lea Frimann Hansen et al.,
Effects of Intranasal ZnSO4 Irrigation on Olfactory and Trigeminal Cues, 55 Physiology &
Behavior 699 (1994) (Swayze Aff. Ex. P, Sept. 15, 2006 [Docket No. 111]). Dr. Jafek calculated
that Cold-Eeze delivers eighty-three times that LOEL of zinc in each dose. As discussed above,
Dr. Jafek lacks a reliable basis to opine that zinc sulfate and zinc gluconate have similar biologic
effects. Putting that aside, the mouse study still does not provide a reliable basis for Dr. Jafeks
One of the central tenets of toxicology is that toxic responses in laboratory animals can
be useful predictors of toxic responses in humans. See Bernard D. Goldstein and Mary Sue
Henifin, Reference Guide on Toxicology, in Reference Manual on Scientific Evidence 401, 403
(Federal Judicial Center 2d ed. 2000). This is especially true of research conducted on
mammals. Id. at 410, 419-20. Nevertheless, when an expert relies on animal studies to establish
human toxicity levels, the court must ensure that the studies are sufficiently similar to the facts
alleged in the litigation so as to provide a reliable basis for the experts opinions. See Gen. Elec.
Co. v. Joiner, 522 U.S. 136, 144-45 (1997).
In Joiner, the expert opined that PCBs caused the plaintiffs cancer based in part on a
study in which researchers injected PCBs directly into the abdomens of infant mice, who then
developed alveologenic adenomas. Id. No other studies had demonstrated that PCBs lead to
cancer in any other species. Id. Unlike the mice in the study, the plaintiff in Joiner developed
small-cell carcinomas (a different type of cancer) after mainly external skin contact with much
lower levels of the toxin than were used in the study. Id. at 139, 144. The Supreme Court held
that the experts causation opinion was unreliable because there was too great an analytical gap
between the data and the opinion proffered. Id. at 146.
Here, in contrast to Joiner, Dr. Jafek based his toxicity opinion on the assumption that
humans were exposed to much more zinc than the mice. Dr. Jafeks opinion also assumes the
same route of exposure (direct contact) with the same type of tissue (olfactory epithelium)
causing the same type of damage (loss of smell). Moreover, Dr. Jafek draws his conclusions
against a backdrop of research supporting the general toxicity of zinc sulfate to the olfactory
epithelia of humans and other animals; there is no doubt that some amount of zinc sulfate applied
to the olfactory epithelia of humans and other animals damages the sense of smell (at least
temporarily). Finally, Dr. Jafek offers a basis for concluding that the LOEL in mice is relevant
to the toxicity level in humans: He points out that the olfactory epithelium of a mouse is
approximately the same size as that of a human. At least in theory, then, there is not too great
an analytical gap between the data and the opinion proffered in this case.
Nevertheless, there is a problem with the methodology Dr. Jafek uses to arrive at his
conclusion: The Court has already ruled that Dr. Jafeks opinion that any Cold-Eeze and thus
any zinc comes into contact with the olfactory epithelium is not sufficiently reliable to be
admitted under Rule 702. For the same reasons, Dr. Jafeks opinion as to how much zinc reaches
the olfactory epithelium must also be excluded. The fact of the matter is that Dr. Jafek has no
idea how much zinc reaches the olfactory epithelium of a typical user of Cold-Eeze. He merely
assumes without supporting data or even supporting explanation that every bit of the zinc
in a dose of Cold-Eeze reaches the olfactory epithelium.
To determine the LOEL of zinc in mice, the researchers anesthetized the mice, laid them
head downward, inserted a hypodermic needle through the mouth into the nasal cavity, flushed a
zinc-sulfate solution through the needle, and left the mice in a head-downward position for ten
minutes. This method is, of course, nothing like the method by which Cold-Eeze users introduce
zinc into their noses. Dr. Jafeks assumption that all of the zinc in a dose of Cold-Eeze reaches
an almost . . . inaccessible part of the nose is facially untenable. There is thus no basis to
compare the level of zinc sulfate that reached the olfactory epithelia of the mice in the study
relied on by Dr. Jafek with the level of zinc gluconate that reached the Polskis olfactory
epithelia when they sprayed Cold-Eeze in their noses. Dr. Jafeks opinion that Cold-Eeze
delivers a toxic amount of zinc to the olfactory epithelium is therefore inadmissible.
4. The damage Cold-Eeze causes is permanent in some cases
Dr. Jafek opines that Cold-Eeze can cause permanent anosmia largely based on anecdotal
evidence of the persistence of anosmia in a few of the participants in the 1930s polio studies.
These anecdotes appear in letters and historical accounts of the campaign against polio. See
Edwin W. Schultz and Louis P. Gebhardt, Letter to the Editor, The Use of Zinc Sulfate Solution
for the Prevention of Poliomyelitis in Man, 110 J. Am. Med. Assoc. 2024 (June 11, 1938)
(What is especially important is that recently we have learned of several cases in adults in
whom the sense of smell has not yet returned after a period of more than six months); Roland
H. Berg, Polio and its Problems 42 (1948) (It was many months later [that] Dr. Schultz began
receiving complaints from physicians that many of their patients had suffered a complete and
evidently permanent loss of smell) (Swayze Aff. Ex. P, Sept. 15, 2006 [Docket No. 111]). Such
reports, however, are of little scientific value and are not a sufficient basis for concluding that
Cold-Eeze can cause permanent damage (especially given that these studies involved zinc sulfate
rather than zinc gluconate).
Dr. Jafek cited one article that catalogued the evidence of persistent anosmia following
the use of zinc sulfate to prevent polio. See F.F. Tisdale et al., Persistent Anosmia Following
Zinc Sulfate Nasal Spraying, 13 J. Peds. 60-62 (1938) (Swayze Aff. Ex. P, Sept. 15, 2006
[Docket No. 111]). The individuals discussed were not part of a formal polio study; instead, they
had requested, and received, applications of zinc nasal sprays from private otolaryngologists in
the hope that this experimental treatment would protect them from polio. Id. The authors of the
article collected anecdotal reports from these private otolaryngologists about patients with
persistent anosmia. Although the otolaryngologists reported the number of sprayings per patient,
there is almost no other pertinent data. There is no description of the method used to apply the
zinc, no information about the contents of the zinc solution, no description of the test used to
determine the patients level of smell function, and no way of knowing how soon after the
application the patients first noticed a disturbance in their smell function. There is also no
discussion of the otolaryngologists attempts, or lack thereof, to determine other possible causes
of the loss of smell. This is not surprising, as these patients were not participating in a controlled
study. It is thus not possible to tell whether the patients loss of smell function was the result of
something other than the zinc (such as physical damage from the application of the zinc or the
use of anesthesia or some other additive).
Indeed, given the dearth of information in the article, it is not possible to tell for certain
whether these patients loss of smell was the result of the use of zinc or was merely a
coincidental loss that followed some time later. Essentially, the article amounts to a tabulation
of people who were treated with zinc in some way and, months later, reported disturbances of
some kind in their ability to smell. Such a collection of anecdotal case studies is not reliable
scientific evidence that the zinc gluconate sprayed into the nose with a Cold-Eeze bottle can
cause permanent anosmia. The Court therefore concludes that Dr. Jafek lacks a reliable basis to
opine that Cold-Eeze can cause permanent anosmia.
5. Cold-Eeze caused the Polskis loss of smell
Even if Dr. Jafek could testify that Cold-Eeze can cause permanent anosmia in some
people, he would still need a reliable basis for concluding that the Polskis anosmia was caused
by Cold-Eeze, and not by another cause (such as a virus). In eliminating alternative causes of
the Polskis loss of smell, Dr. Jafek cites the burning pain that the Polskis experienced and the
acute nature of their loss of smell.
Dr. Jafek did not examine the Polskis until two years after the onset of their anosmia.
Moreover, Dr. Jafek never reviewed the Polskis medical records; instead, he relied solely on the
Polskis recitation of their medical histories. Perhaps as a result, Dr. Jafeks description of the
acute nature of their injuries does not match the Polskis descriptions. Neither Howard nor
Sheryl connected a specific instance of using Cold-Eeze to the loss of their senses of taste and
smell. Howard testified that his sense of taste was normal while he was in California using
Cold-Eeze, and that he did not notice a loss of taste until about a week after he returned home,
when he was beyond the cold. H. Polski Dep. 68, 75. Similarly, Sheryl first noticed a
problem with her senses of taste and smell in January 2004, after recovering from her cold, and
she could not recall whether she had any trouble with her senses of taste and smell when in
California working her way through her second bottle of Cold-Eeze. S. Polski Dep. 53-54.
In contrast to the Polskis gradual realization that they had lost their senses of taste and
smell, the plaintiffs in most of the other nasal-spray cases in which Dr. Jafek sought to testify
experienced burning pain followed by an immediate loss of smell function. See Sutherland,
No. 04-0129, slip op. at 6 (N.D. Ala. Nov. 7, 2006); OHanlon v. Matrixx Initiatives, Inc.,
No. 04-10391, slip op. at 7 (C.D. Cal. Jan. 3, 2007) (Swayze Aff. Ex. QQ); Hilton v. Matrixx
Initiatives, Inc., No. 04-0519, slip op. at 1 (N.D. Tex. Feb. 20, 2007) (Swayze Aff. Ex. TT
[Docket No. 178]); Wyatt v. Matrixx Initiatives, Inc., No. 04-1230, slip op. at 2 (N.D. Ala. March
30, 2007) (Swayze Aff. Ex. UU [Docket No. 178]). Similarly, Dr. Jafeks case study of anosmic
individuals relies heavily on the immediate loss of the patients sense of smell to establish
causation. See Bruce W. Jafek et al., Anosmia after Intranasal Zinc Gluconate Use, 18 Am J.
Rhinol. 137, 137, 140 (2004) (stating that the most convincing [evidence of causation] was the
immediate, acute, burning pain with the use of the zinc gluconate, followed immediately by
persistent severe hyposmia or anosmia).
At his deposition, Dr. Jafek testified that he discounted the possibility that the Polskis
colds caused their anosmia because a loss of smell due to a virus is slower over time and is
more delayed. Jafek Dep. 124. But the Polskis loss of smell was slow[] and delayed.
Neither Polski appears to have noticed a problem until three or four weeks after first using Cold-
Eeze that is, until after he or she stopped using Cold-Eeze and recovered from his or her cold.
If Dr. Jafeks testimony is accepted, then the Polskis experiences have more in common with
anosmia caused by a virus than with anosmia caused by a toxic agent coming into contact with
the olfactory epithelium. Under his own criteria, therefore, Dr. Jafek had no basis to exclude the
Polskis colds as possible causes of their injuries. His opinion that Cold-Eeze caused their
injuries is therefore unreliable and inadmissible.
7The Polskis allege that Quigley violated Minnesotas consumer-fraud statute by
marketing Cold-Eeze as safe and effective. Under Minnesotas consumer-fraud statute, it is
not necessary to prove damages in order to obtain injunctive relief. See Minn. Stat. 325F.69,
subd. 1. The Polskis seek only damages, however, and therefore they must prove that they were
damaged by Quigleys allegedly unlawful conduct. See Group Health Plan, Inc. v. Philip
Morris Inc., 621 N.W.2d 2, 4, 13 (Minn. 2001).
B. Quigleys Motion for Summary Judgment
Summary judgment is appropriate if the pleadings, depositions, answers to
interrogatories, and admissions on file, together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving party is entitled to a judgment as a
matter of law. Fed. R. Civ. P. 56(c). Rule 56 mandates the entry of summary judgment against
a party who fails to make a showing sufficient to establish an essential element of his claim.
Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).
The Polskis rely entirely on the testimony of Dr. Jafek to establish causation, an essential
element of every one of their claims. See J& W Enters., Inc. v. Econ. Sales, Inc., 486 N.W.2d
179, 181 (Minn. Ct. App. 1992) (in product-liability cases, plaintiffs must show a causal link
between the alleged defect and the injury, regardless of the theory of liability).7 Because the
Court will not permit Dr. Jafek to testify that Cold-Eeze caused the Polskis injuries, the Polskis
will not be able to establish causation at trial. Quigleys motion for summary judgment is
therefore granted.
Based on the foregoing, and on all of the files, records, and proceedings herein, IT IS
1. Defendants motion in limine to preclude the report and testimony of Bruce W.
Jafek, MD [Docket No. 116] is GRANTED.
2. Defendants motion for summary judgment [Docket No. 108] is GRANTED.
3. Defendants motion in limine to preclude the report and testimony of Miriam R.
Linschoten, Ph.D. [Docket No. 119] is DENIED WITHOUT PREJUDICE as
4. Defendants motion to sever [Docket No. 153] is DENIED WITHOUT
PREJUDICE as moot.
5. Plaintiffs first amended complaint [Docket No. 31] is DISMISSED WITH
Dated: September 5 , 2007 s/Patrick J. Schiltz
Patrick J. Schiltz
United States District Judge


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