Hood v. Matrixx Initiatives, Inc.
| Decision Date | 10 February 2011 |
| Docket Number | No. 4D09-1994.,4D09-1994. |
| Citation | 50 So.3d 1166 |
| Parties | Michael HOOD and Teri Hood, his wife, Appellants, v. MATRIXX INITIATIVES, INC., a Delaware corporation, f/k/a Gumtech International Inc., a foreign corporation, and ZICAM, LLC, a limited liability corporation, f/k/a Gel Tech, LLC, an Arizona limited liability company, Publix Super Markets, Inc., a Florida corporation, and Botanical Laboratories, Inc., Appellees. |
| Court | Florida District Court of Appeals |
Keith Chasin of Law Office of Keith Chasin, Miami, for appellants.
Alan J. Lazarus of Drinker Biddle & Reath, L.L.P., San Francisco, California, and Mercer K. Clarke, Karen H. Curtis and Matthew Cordis of Clarke Silverglate & Campbell, P.A., Miami, for appellees.
Michael Hood and his wife, Teri Hood, appeal the summary final judgment entered in this product liability action in favor of Matrixx Initiatives, Inc., Zicam, LLC (collectively referred to as "Matrixx"), Publix Super Markets, Inc. (Publix), and Botanical Laboratories, Inc. (Botanical). We reverse the summary judgment because we find that the relevant issue—whether the Hoods' expert, Dr. Bruce Jafek, should be allowed to testify that Mr. Hood's use of Zicam gel caused him to lose his sense of smell—is controlled by the standards set forth in the Florida Supreme Court's decision in Marsh v. Valyou, 977 So.2d 543 (Fla.2007). Applying Marsh, we find that the trial court erred in refusing to allow Dr. Jafek to testify on the issue of causation.
The present action arises out of Michael Hood's claim that he sustained personal injuries as the result of his use of Zicam nasal gel, a homeopathic over-the-counter cold remedy that the Hoods purchased at a Publix grocery store. In particular, Mr. Hood alleged that in November of 2000, he used Zicam to prevent a possible cold. Zicam is used by squirting a gel-like substance, which contains zinc gluconate, into the nose. Mr. Hood alleged that as a result of the application of Zicam gel in his nose, he developed anosmia, otherwise known as the loss of the sense of smell.
The Hoods brought this action against several defendants that were involved in the development, manufacturing, marketing, or retail sale of Zicam nasal gel—Matrixx, Publix and Botanical. Mr. Hood asserted various claims, including strict products liability, negligence, and breach of warranty. In addition, his wife, Teri, brought a claim for loss of consortium.
By way of background, it is generally accepted that there are multiple possible causes of persistent loss of smell, such as upper respiratory infections, sinonasal disease, and head trauma. In an effort to prove the element of causation, the plaintiffs presented the opinion of Dr. Bruce Jafek, a professor of otolaryngology at the University of Colorado, School of Medicine. Dr. Jafek conducted an independent medical examination on Mr. Hood in December 2005. Dr. Jafek subsequently prepared a medical report which described Mr. Hood's medical history, discussed the results of the medical examination, reviewed medical and scientific literature, and set forth Dr. Jafek's opinions regarding the cause of Mr. Hood's anosmia. The plaintiffs also presented excerpts of Dr.Jafek's deposition testimony in other Zicam cases, as well as medical case study articles regarding anosmia after the use of zinc gluconate. See Bruce W. Jafek et al., Anosmia after Intranasal Zinc Gluconate Use, 18 Am. J. Rhinol. 137 (2004); T.H. Alexander & T.M. Davidson, Intranasal Zinc and Anosmia: The Zinc-Induced Anosmia Syndrome, 116 Laryngoscope (Vol. 2) 217-20 (Feb.2006).
According to Dr. Jafek's written report, Mr. Hood used Zicam because he thought he might be getting a cold. Mr. Hood squirted Zicam into each nostril, sniffed, and experienced an immediate burning sensation, lasting several hours. Soon after using Zicam, Mr. Hood noticed a loss of smell, and when it did not return, he consulted several doctors. He was evaluated with both CT and MRI testing, both of which were normal, thus excluding trauma as a possible cause of his anosmia. Dr. Jafek performed an examination of Mr. Hood's olfactory groove, which he reports showed "apparent scarring of the mucosa (olfactory epithelium) of the olfactory cleft...." Having reviewed the patient data, Dr. Jafek concluded that Mr. Hood's allergies, medications, past history, social history, family history, and other medical history were not contributing factors to his anosmia.
In his report, Dr. Jafek further opined that: (1) Zicam nasal gel, when used according to the directions contained in the package, reaches the olfactory epithelium (smell tissue) in humans; (2) the active ingredient in Zicam, zinc gluconate, is toxic to the olfactory epithelium; (3) Zicam nasal gel is toxic to the olfactory epithelium in the amounts delivered with the pump; (4) Zicam toxicity to the olfactory epithelium is permanent in some cases; and (5) the acute nature and strong temporal association of Mr. Hood's loss, accompanied by burning pain (a recognized sign of injury), strongly supports that the application of Zicam was the cause of Mr. Hood's loss of smell, as opposed to the other "several hundred causes of loss of smell described in the literature."
One of Dr. Jafek's foundational opinions on causation is that Zicam nasal gel, when used as directed, can reach the olfactory epithelium (i.e., tissue containing nerve cells that detect smell). Through personal observations, Dr. Jafek noted that the Zicam nasal pump could squirt gel into the air at a distance of four to ten feet, routinely reaching the ceiling. He further noted that Zicam gel, when pumped, travels in a straight stream, according to his personal observation. Dr. Jafek asserted that the pathway from the nasal sill (the outer opening of the nose) to the cribiform plate (the site of the olfactory epithelium) is straight in most patients, as shown in a 1930s polio study. Dr. Jafek relied upon a 1937 article entitled "The Chemical Prophylaxis for Poliomyelitis," which studied whether the intranasal application of zinc sulfate could protect children from the polio virus. See Max M. Peet et al., The Chemical Prophylaxis for Poliomyelitis, 108 J. Am. Med. Ass'n 2184 (1937). In Dr. Jafek's opinion, there was no visible obstruction or significant septal deviation in Mr. Hood's nose.
Another of Dr. Jafek's foundational opinions is that zinc gluconate is toxic to the olfactory epithelium. Dr. Jafek's conclusion in this regard is founded in large part on polio studies of the 1930s and 40s, animal experiments, and his own protein-precipitation experiment. In the polio studies, polio researchers applied a zinc sulfate solution directly to the olfactory epithelium, attempting to prevent the entry of the polio virus. The polio studies demonstrated that zinc sulfate is toxic to the olfactory epithelium. However, the active ingredient of Zicam is zinc gluconate.Dr. Jafek concluded that zinc gluconate produces analogous effects to zinc sulfate, reasoning that: (1) zinc gluconate releases zinc ions when dissolved in water, (2) zinc sulfate and zinc gluconate had similar solubility, (3) zinc sulfate does not react with water to form sulfuric acid, which indicates that it is the zinc ion (rather than sulfuric acid) causing the toxicity, (4) animal studies, in particular a study on fish, showed that it was the release of zinc ions from the zinc sulfate that is toxic to olfactory tissue, as sodium sulfate was not toxic to the olfactory tissue, (5) zinc ions are "the standard method" to produce the loss of smell in animals, and (6) Dr. Jafek's own protein-precipitation experiment showed that zinc gluconate produces analogous effects to other zinc salts, "implying analogous pharmacodynamic mechanisms in the production of loss of smell."
Dr. Jafek further opined that zinc gluconate is toxic to the olfactory epithelium in the amounts delivered with the pump. Dr. Jafek based this opinion on an animal study regarding the toxicity of zinc sulfate to the olfactory epithelium in mice. Dr. Jafek's report noted that the olfactory epithelium of a mouse is approximately the same size as that of a human. Dr. Jafek asserted that the recommended human dose of zinc gluconate in Zicam is 17 1/2 times the LOEL (least observable effect level) for olfactory damage in mice.
The defendants moved to exclude the testimony of Plaintiffs' sole causation expert, Dr. Jafek, and for summary judgment. The defendants contended that Dr. Jafek's expert opinion testimony that Zicam nasal gel reached Mr. Hood's olfactory epithelium failed to meet the standards set forth in Frye v. United States, 293 F. 1013 (D.C.Cir.1923), because this opinion had not been generally accepted by the relevant scientific community, and further contended that his opinion concerning the toxicity of zinc gluconate was new and novel and not based on scientific principles.
The Hoods opposed the defendants' motion, arguing that Dr. Jafek's medical opinion, based on a "differential diagnosis," was a "pure opinion" that was not subject to Frye and was admissible under Marsh. Second, they argued that even if Frye applied, Dr. Jafek's opinion satisfied Frye, as it was based upon a differential diagnosis as well as studies dating back to the 1930s linking zinc to anosmia.
At an October 2008 hearing on defendants' motion to exclude Dr. Jafek's testimony, the defendants presented multiple expert reports and studies in support of their motion to exclude the expert report and testimony of Dr. Jafek.1 The defendants also relied upon a number of federal opinions excluding Dr. Jafek's causation testimony as unreliable under the federal standard set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). See, e.g., Polski v. Quigley Corp., 538 F.3d 836, 841 (8th Cir.2008) (...
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The "pure opinion" exception to the Florida Frye standard.
...expert testimony in federal courts is clear. Hood v. Matrixx The Fourth DCA's application of Marsh in Hood v. Matrixx Initiatives, Inc., 50 So. 3d 1166 (Fla. 4th DCA 2011), is instructive because Hood notes the inconsistency of admissibility as it surrenders to applying Marsh: "While we rec......