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In re Zicam Cold Remedy Mktg., Sales, Practices, & Prods. Liab. Litig.

United States District Court for the District of Arizona

February 23, 2011, Decided; February 24, 2011, Filed

No. 09-md-2096-PHX-FJM

Opinion

ORDER

We have before us defendants' "Motion for a  [*46] Ruling to Exclude The Expert Reports and Testimony of Plaintiffs' General Causation Experts Ashim Mitra, Ph.D., Greg Davis, M.D. and Steven Pike, M.D." (doc. 1061), plaintiffs' response (doc. 1230), and defendants' reply (doc. 1274). Plaintiffs have proffered the opinions of Dr. Greg Davis, Dr. Ashim Mitra, and Dr. Steven Pike as general causation experts. Defendants move to exclude the opinions and testimony of all three causation experts.

We also have defendants' "Motion to Exclude Expert Report and Testimony of Plaintiffs' Expert Jay Sirois" (doc. 1063), plaintiffs' response (doc. 1227), and defendants' reply (doc. 1275).

I. MDL Background

A. Zicam intranasal products

Zicam Cold Remedy Nasal Gel (Zicam) is a homeopathic (treatment with small amounts of a drug that is believed to produce symptoms similar to those of the disease being treated) cold product marketed by defendants Matrixx Initiatives, Inc. (Matrixx) and Zicam LLC. It is a viscous gel that is applied to the nose with either a spray pump or a swab resembling a q-tip. This litigation concerns three "intranasal" products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. The  [*47] active ingredient in the products is zinc gluconate, at a level of 1.58% concentration. Each dose or swab contains 130-140 microliters of gel, or about .0274 teaspoons. The amount of zinc in each dose is .231% of the gel, or 260-280 micrograms of zinc. See Motion to Exclude Causation Experts at 6.1 The package instructions on the pump products direct the user to place the applicator tip one-eighth of an inch past the nasal opening, angle the nozzle slightly outward, pump the applicator once in each nostril, and not to "sniff up" the gel, in order to avoid irritation. The swab directions instruct the user to dab the gel from the swab just inside the nasal opening.

The anatomy of the nasal cavity is complex. See Dalby Report at 7 (doc. 1066-1); Mitra Report at 6 (doc. 1067-7). The cavity is divided into right and left halves by the nasal septum, and is lined by tissue called mucosa. Cilia line the mucosa and carry the mucous through the cavity. The parts of the mucosal lining that contain sensory cells that detect smell are called olfactory epithelium ("OE"). The bones that curve into the nasal passageway on each side of the cavity are  [*48] called turbinates. They are identified as inferior (lower), middle, and superior (upper) turbinates. Above the superior turbinate is the olfactory region, or olfactory cleft, a portion of the ceiling of the nasal cavity densely covered by olfactory receptors.

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2011 U.S. Dist. LEXIS 20356 *; 2011 WL 798898

IN RE: Zicam Cold Remedy Marketing, Sales Practices, and Products Liability Litigation. THIS DOCUMENT RELATES TO: All Personal Injury Actions.

Subsequent History: Motion granted by, in part, Motion denied by, in part, Dismissed by In re Zicam Cold Remedy Mktg., Sales Practices & Prods. Liab. Litig., 2011 U.S. Dist. LEXIS 19620 (D. Ariz., Feb. 24, 2011)

Reconsideration denied by In re Zicam Cold Remedy Mktg., 2011 U.S. Dist. LEXIS 28908 (D. Ariz., Mar. 17, 2011)

Prior History: In re Zicam Cold Remedy Mktg., 2010 U.S. Dist. LEXIS 131285 (D. Ariz., Nov. 29, 2010)

CORE TERMS

zinc, anosmia, causation, olfactory, nasal, motion to exclude, toxicity, reliable, studies, Deposition, scientific, gluconate, gel, researchers, labeling, defendants', cleft, diffusion, tissue, Cold, Swabs, Toxicology, intranasal, biologic, smell, in vitro, Pharmaceutical, methodology, nose, products