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US District Court : EVIDENCE | expert's testimony excluded under Daubert; complaint dismissedUNITED STATES DISTRICT COURTDISTRICT OF MINNESOTA HOWARD J. POLSKI and SHERYL L. POLSKI, Plaintiffs, v. THE QUIGLEY CORPORATION, Defendant. Case No. 04-CV-4199 (PJS/JJG) MEMORANDUM OPINION AND ORDER GRANTING DEFENDANT’S MOTION FOR SUMMARY JUDGMENT 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. -2- judgment on all of the Polskis’ claims. For the reasons described below, Quigley’s motions are granted and the Polskis’ claims are dismissed with prejudice.1 I. BACKGROUND 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 2–4 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. -3- 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 Year’s 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 Sheryl’s 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 simplicity’s sake, the Court will refer to the damage allegedly caused by Cold-Eeze simply as anosmia. -4- 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. II. ANALYSIS A. Quigley’s 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. Jafek’s 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: -5- 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 expert’s testimony is reliable. Olson v. Ford Motor Co., 481 F.3d 619, 626 (8th Cir. 2007). In determining whether an expert’s 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 publication; (3) whether the theory or technique has a known or potential error rate and standards controlling the technique’s operation; and (4) whether the theory or technique is generally accepted in the scientific community. 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 -6- 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. Jafek’s 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 -7- 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]; Stedman’s 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. Jafek’s opinions for the reasons stated in Benkwith, 467 F. Supp. 2d at 1325; Wyatt v. Matrixx Initiatives, Inc., No. 4- -8- 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 consumer’s 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. Jafek’s 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 Zicam’s viscosity leaves this court stumped.”). -9- 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. Jafek’s 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. Jafek’s 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. Jafek’s theory. This is no small matter. Dr. Jafek’s 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. Jafek’s failure to test his theory — particularly given his theory’s 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 theory’s 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. Jafek’s 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. Jafek’s theory. -10- Needless to say, because Dr. Jafek’s 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. Jafek’s opinions rely on his theory that Cold-Eeze reaches the olfactory epithelium — and because the Court has excluded as unreliable Dr. Jafek’s opinion that Cold-Eeze, when used as directed, comes into contact with the olfactory epithelium — the Court’s ruling necessarily requires the exclusion of the remainder of Dr. Jafek’s 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 substance’s properties and propensities.” Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 990 (8th Cir. 2001); see -11- 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. Jafek’s 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). 6“Chelation” is the process of binding a metal ion to a chemical compound to form a ring. -12- 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. Jafek’s 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 -13- 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 epithelium. 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 & -14- 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. Jafek’s opinion. 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 expert’s opinions. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 144-45 (1997). In Joiner, the expert opined that PCBs caused the plaintiff’s 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 expert’s causation opinion was unreliable because there was “too great an analytical gap between the data and the opinion proffered.” Id. at 146. -15- 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. Jafek’s 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. Jafek’s 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. Jafek’s 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 -16- minutes. This method is, of course, nothing like the method by which Cold-Eeze users introduce zinc into their noses. Dr. Jafek’s 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. Jafek’s 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). -17- 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 -18- 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. Jafek’s 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 -19- 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); O’Hanlon 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. Jafek’s 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. Jafek’s 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 Minnesota’s consumer-fraud statute by marketing Cold-Eeze as “safe and effective.” Under Minnesota’s 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 Quigley’s allegedly unlawful conduct. See Group Health Plan, Inc. v. Philip Morris Inc., 621 N.W.2d 2, 4, 13 (Minn. 2001). -20- B. Quigley’s 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. Quigley’s motion for summary judgment is therefore granted. ORDER Based on the foregoing, and on all of the files, records, and proceedings herein, IT IS HEREBY ORDERED THAT: 1. Defendant’s motion in limine to preclude the report and testimony of Bruce W. Jafek, MD [Docket No. 116] is GRANTED. -21- 2. Defendant’s motion for summary judgment [Docket No. 108] is GRANTED. 3. Defendant’s motion in limine to preclude the report and testimony of Miriam R. Linschoten, Ph.D. [Docket No. 119] is DENIED WITHOUT PREJUDICE as moot. 4. Defendant’s motion to sever [Docket No. 153] is DENIED WITHOUT PREJUDICE as moot. 5. Plaintiffs’ first amended complaint [Docket No. 31] is DISMISSED WITH PREJUDICE AND ON THE MERITS. LET JUDGMENT BE ENTERED ACCORDINGLY. Dated: September 5 , 2007 s/Patrick J. Schiltz Patrick J. Schiltz United States District Judge |
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Michael E. Douglas, Attorney at Law, Saint Paul MN. All Rights
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