Case:0-cv-00-WHA Document Filed0/0/ Page of Michael D. Nelson Red Cedar Court Danville, CA 0 Telephone ( Plaintiff pro se IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA 0 MICHAEL D. NELSON vs. MATRIXX INITIATIVES, INC., A DELAWARE CORPORATION, Plaintiff, DEFENDANT ZICAM L.L.C., AN ARIZONA LIMITED LIABILITY COMPANY, Defendants PLAINTIFF, Michael D Nelson, hereby alleges: No. C0-00-WHA FIRST AMENDED COMPLAINT PLAINTIFF REQUESTS A JURY TRIAL 0 GENERAL ALLEGATIONS. Plaintiff is a resident of the County of Contra Costa, State of California.. The plaintiff has information and belief and therefore alleges that Defendant Matrixx Initiatives, Inc. is a Delaware Corporation, having a principal office and place of business at E Anderson Drive, Scottsdale, AZ and conducts business in the State of California, hereinafter referred to as Defendant MATRIXX.. The plaintiff has information and belief and therefore alleges that Defendant Zicam LLC is an Arizona Limited Liability Company, having a principal office and place of business at E First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 Anderson Drive, Scottsdale, AZ, hereinafter referred to as Defendant ZICAM. The Defendant ZICAM has only one owner/member and that is Defendant MATRIXX. The Defendant ZICAM conducts business in and throughout the State of California.. The plaintiff has information and belief and therefore alleges that at all times mentioned herein, Defendant ZICAM and Defendant MATRIXX, and each of them, were acting as an agent, servant or employee of each other Defendant and were acting within the course and scope of said agency and/or employment.. The plaintiff has information and belief and therefore alleges that at all times mentioned herein, Defendant ZICAM and Defendant MATRIXX and each of them with full knowledge and advice expressly and impliedly ratified the acts of each other Defendant in all respects and adopted as his or her own acts the acts of the other Defendants, and each of them, as set forth in detail hereinafter.. Defendant MATRIXX is engaged in the development, manufacture and marketing of over the counter pharmaceuticals, including Zicam Cold Remedy Nasal Gel Spray and Zicam Cold Remedy Gel Swabs, the two products hereinafter collectively referred to as Zicam Cold Remedy Nasal Gel.. Defendant ZICAM is a wholly owned subsidiary of MATRIXX and produces, markets and sells Zicam Cold Remedy Nasal Gel.. Zicam Cold Remedy Nasal Gel is packaged in various manners and with various delivery systems, all of which are developed, manufactured and marketed by or with the express consent of each other defendant.. Zicam Cold Remedy Nasal Gel contains divalent ionized zinc in the form of zinc gluconate, which is listed on the product s active ingredients under the trade name of zincum gluconium x. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 0. Zicam Cold Remedy Nasal Gel is not an approved drug as that term is defined in 0 of the Federal Food, Drug and Cosmetic Act, Chapter, Stat. 00, USC... Zicam Cold Remedy Nasal Gel, hereinafter also referred to as the product, is not and never has been approved for safety and/or efficacy by the United Stated Food and Drug Administration. Zicam Cold Remedy s labeling has never been approved by the United States Food and Drug Administration.. Defendant MATRIXX, as the successor corporation to Gumtech International, Inc., is liable for any design defects and/or negligence of Gumtech International, Inc. under the doctrine of successor liability.. Defendant ZICAM as the successor to Gel Tech, LLC, is liable for any design defects and/or negligence of Gel Tech, LLC under the doctrine of successor liability. Sometime during 00 Michael Nelson purchased Zicam Cold Remedy Gel Swabs and used such swabs in December 00.. In December 00, the Plaintiff Michael Nelson used the Zicam Cold Remedy Nasal Swabs in a manner reasonably foreseeable by the defendants.. Sometime during 00, Michael Nelson purchased a bottle of Zicam Cold Remedy Nasal Gel Spray from a Longs Drug Store located at 0 Camino Tassajara, Danville, California.. In December 00, the Plaintiff Michael Nelson used the Zicam Cold Remedy Nasal Gel Spray in a manner reasonably foreseeable by the defendants.. Plaintiff Michael Nelson was over the age of at the time of the purchase and use of Zicam Cold Remedy Nasal Gel. 0. After applying the Zicam Cold Remedy Nasal Gel Spray to both nostrils in December 00, Plaintiff Michael Nelson felt an intense stinging and/or burning sensation in his nose. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0. Since using the Zicam Cold Remedy Nasal Gel Spray in December 00, Plaintiff Michael Nelson has lost his sense of smell.. Plaintiff, Michael Nelson s loss of his sense of smell ( anosmia has continued to the date of this complaint.. That despite medical consultations and treatments, Michael Nelson s sense of smell has yet to return.. Mr. Michael Nelson has been informed that the sense of smell is in all likelihood permanent, total and irreversible.. As a result of the total, irreversible loss of smell, Mr. Michael Nelson s ability to taste has been severely diminished and is likewise permanent, total and irreversible.. The product Zicam Cold Remedy Nasal Gel, when used as reasonably anticipated by the defendants, caused a permanent, total and irreversible loss of one or more vital bodily functions of Plaintiff Michael Nelson, namely, his ability to smell and taste.. Plaintiff Michael Nelson did not alter the product or its packaging at any time.. Plaintiff Michael Nelson was not aware that the use of the product created an unreasonable risk of personal injury. Plaintiff further did not voluntarily expose himself to any known, unreasonable risk of harm in using this product, as he was not aware, prior to his use of it that it posed an unreasonable risk of personal injury.. At the time of the product s manufacture and distribution, the defendants had actual knowledge that the product was defective and that there was a substantial likelihood that the defect would cause the injury; Defendant Matrixx and Defendant ZICAM further willfully disregarded that knowledge in the manufacture and/or distribution of this product. FIRST CAUSE OF ACTION DEFECTIVE PRODUCT - DESIGN First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 0. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference.. Defendant MATRIXX and Defendant ZICAM, and their predecessor entities owed a duty to Plaintiff, Michael Nelson, and all others similarly situated, to use due care and caution in the design of its Zicam Cold Remedy Nasal Gel to avoid unreasonable risks of injury during reasonably foreseeable uses of the product.. The Defendant MATRIXX and Defendant ZICAM breached their duty through acts and/or omissions which include, but are not necessarily limited to, the following: a. by designing a product intended to and instructing its users to apply Zicam Cold Remedy Nasal Gel intranasally; b. by failing to engage in proper and adequate testing of this product and its effects on the sense of smell; c. by failing to conduct an adequate investigation into the historical and scientific evidence that relates intranasal zinc application to anosmia or smell loss; and d. by otherwise failing to design the product in accordance with prevailing industry and scientific standards in a manner that would have eliminated unreasonable risks of injury during reasonably foreseeable uses.. The Zicam Cold Remedy Nasal Gel has no reasonable usefulness.. At the time Defendant MATRIXX and Defendant ZICAM designed the product, the severity of injury to users was foreseeable to Defendants. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0. As a direct and proximate result of Defendant MATRIXX s and Defendant ZICAM s breach of the aforementioned duties described above, the Plaintiff, Michael Nelson, suffered complete, total, permanent and irreversible loss of his sense of smell. As a direct and proximate result of Defendant MATRIXX s and Defendant ZICAM s breached the aforementioned duties described above, the Plaintiff, Michael Nelson, suffered a permanent and irreversible severely diminished sense of taste.. Plaintiff, Michael Nelson, has suffered damages which are continuing in nature and include, but are not necessarily limited to, the following: a. Permanent and irreversible loss of the sense of smell; b. Permanent and irreversible diminution of the sense of taste; c. The need to undergo several fruitless medical procedures and treatments; d. Mental and emotional distress; e. Mortification and humiliation; f. Physical pain and suffering; g. Medical expenses, both past and future; h. Loss of enjoyment of everyday activities and severely diminished quality of life given the fact that two of his five senses are gone forever; i. Increased susceptibility to risks generally avoidable by a person with an intact sense of smell and/or taste; and j. Other damages not specifically identified above. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against all Defendants in whatever amount sufficient to compensation the plaintiff, together with all other damages, costs and interest that he may be entitled. SECOND CAUSE OF ACTION First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 DEFECTIVE PRODUCT FAIURE TO WARN. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference.. The Defendant MATRIXX and Defendant ZICAM breached their duty through acts and/or omissions which include, but are not necessarily limited to, the following: a. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the Zicam Cold Remedy Nasal Gel can and does cause loss of smell; b. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the Zicam Cold Remedy Nasal Gel can and does cause significant reduction in the sense of taste; c. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the Zicam Cold Remedy Nasal Gel was not an approved drug as that term is defined in 0 of the Federal Food, Drug and Cosmetic Act, Chapter, Stat. 00, USC. d. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that Zicam Cold Remedy Nasal Gel is not and never has been approved for safety and/or efficacy by the United Stated Food and Drug Administration. e. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that Zicam Cold Remedy Nasal Gel labeling has never been approved by the United States Food and Drug Administration. f. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that Zicam Cold Remedy Nasal Gel was misbranded because it does not provide adequate warnings regarding the risk of loss of smell or reduction in the sense of taste associated with the use of the product. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 g. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the Defendants refused to follow their expert consultants recommendations that a warning be placed on the Zicam Cold Remedy Nasal Gel product that it could cause anosmia or reduced smell loss associated with its use. h. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants did not perform any testing on the safety of Zicam Cold Remedy Nasal Gel or the adverse affects of Zicam Cold Remedy Nasal Gel on the sense of smell or taste. i. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants did not perform any testing on the safety of Zicam Cold Remedy Nasal Gel or the adverse affects of Zicam Cold Remedy Nasal Gel on the sense of smell and taste after it was advised to do so by its consultants. j. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants did not perform any animal testing on the safety of Zicam Cold Remedy Nasal Gel or the adverse affects of Zicam Cold Remedy Nasal Gel on the sense of smell and taste after it was advised to do so by its consultants. k. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants received complaints of smell loss from using Zicam Cold Remedy Nasal Gel immediately after it was introduced into the market in. l. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants received thousands of complaints of smell loss from using Zicam Cold Remedy Nasal Gel by the time plaintiff purchased and used Zicam Cold Remedy Nasal Gel Spray in 00. m. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the clinical studies performed by the defendants were seriously flawed in that the defendants did not test for or know if any of the test subjects had a cold. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 n. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the clinical studies performed by the defendants were seriously flawed in that when one of the defendants consultant s tested for the rhinovirus in the test subjects contrary to the study protocol set forth by the defendants, it was determined that % of the test subjects tested negative for the rhinovirus. o. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that clinical studies performed by others where the cold virus was introduced into the test subjects and confirmed that the test subjects came down with a cold showed no improvement or reduction of symptoms or duration of the cold when the Zicam Cold Remedy Nasal Gel was used. p. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the clinical studies performed by the defendants were seriously biased because of business relations between the defendants and/or the defendant s employees and the clinical labs doing the clinical testing. q. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants actively concealed relevant information regarding flaws in the clinical studies by entering into agreements with third parties to not disclose to the public seriously flawed clinical studies. r. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants actively concealed relevant information regarding flaws in the clinical studies by entering into agreements with third parties to not disclose to the public seriously biased clinical studies. s. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that scientific studies on clinical trials advocating the benefits of Zicam Cold Remedy Nasal Gel were written by or materially edited by the defendants or the defendants public relations firm without disclosing the involvement of the defendants in those studies. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page0 of 0 0 t. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that scientific studies on clinical trials advocating that the use of Zicam Cold Remedy Nasal Gel will not reach the olfactory clef were written by the defendants, and the defendants selected the author to publish the article in a professional journal under his name, even after the author selected by the defendants stated he was not qualified, and then selected other co-authors to participate in the article without disclosing the aforesaid facts to the journal publisher or the public. u. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the best mode of using the product as set forth in US Patents,00, and,, was to apply the product directly to the nasal cavity which was contrary to the instructions that the product be put only into the nostrils and that the user should not sniff. v. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants were aware that prior to the sale and distribution of Zicam Cold Remedy Nasal Gel, that zinc sulfate had caused anomsia in children. w. by failing to warn users of the Zicam Cold Remedy Nasal Gel, including the plaintiff herein, that the defendants learned that zinc gluconate was more toxic to cells than zinc sulfate. x. by failing to warn users of Zicam Cold Remedy Nasal Gel, including the plaintiff herein, of other problems, defects, and side effects that the Plaintiff is presently unaware, and when the Plaintiff becomes aware of these other problems, defects, and side effects the Plaintiff will move this court for permission to amend the complaint accordingly. 0. THAT had the warnings set forth in paragraph aforesaid, or any of them, been made, the Plaintiff would not have purchased the Zicam Cold Remedy Nasal Gel product.. THAT had the warnings set forth in paragraph aforesaid, or any of them, been made, the Plaintiff would not have used the Zicam Cold Remedy Nasal Gel product.. THAT had the warnings set forth in paragraph aforesaid, or any of them, been made, the Plaintiff would not have been injured as set forth here. First Amended Complaint 0 Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0. As a direct and proximate result of Defendant MATRIXX s and Defendant ZICAM s failure to warn the public and the plaintiff herein, as set forth above, the Plaintiff, Michael Nelson, suffered complete, total, permanent and irreversible loss of his sense of smell.. As a direct and proximate result of Defendant MATRIXX s and Defendant ZICAM s failure to warn the public and the plaintiff herein, as set forth above, the Plaintiff, Michael Nelson, suffered a permanent and irreversible severely diminished sense of taste.. Plaintiff, Michael Nelson, has suffered damages as set forth hereinbefore. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against the Defendants and each of them in an amount to fully compensate him for his damages, together with all other damages, costs and interest that he may be entitled. THIRD SEPARTE AND FURTHER CAUSE OF ACTION DEFECTIVE PRODUCT MANUFACTURE. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference.. Defendant MATRIXX and Defendant ZICAM and their predecessor entities owed a duty to Plaintiff, Michael Nelson, and all others similarly situated, to use due care and caution in the manufacture of its Zicam Cold Remedy Nasal Gel to avoid unreasonable risks of injury during reasonably foreseeable uses of the product.. Using the product as directed on its packaging is a reasonably foreseeable use of the product.. Defendant MATRIXX and Defendant ZICAM breached their duty through acts and/or omissions which include, but are not necessarily limited to, the following: a. By manufacturing a product intended to and instructing its users to apply Zicam Cold Remedy Nasal Gel intranasally; First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 b. By failing to use proper and adequate manufacturing methods and procedures to make Zicam Cold Remedy Nasal Gel safe for use. c. By failing to adopt adequate and proper manufacturing methods and procedures to make Zicam Cold Remedy Nasal Gel safe for use. d. By failing to test for and eliminate impurities in the manufacture of Zicam Cold Remedy Nasal Gel so that the product would be safe for use. e. By failing to test for and implement instructions on the appropriate shelf life of the Zicam Cold Remedy Nasal Gel so that the product would be safe for use. f. By otherwise failing to manufacture the product in accordance with prevailing industry and scientific standards in a manner that would have eliminated unreasonable risks of injury during reasonably foreseeable uses. 0. At the time Defendant MATRIXX and Defendant ZICAM manufactured the product, the severity of injury to users was foreseeable to Defendants.. As a direct and proximate result of Defendant MATRIXX s and Defendant ZICAM s breach of the aforementioned duties described above, the Plaintiff, Michael Nelson, suffered complete, total, permanent and irreversible loss of his sense of smell.. As a direct and proximate result of Defendant MATRIXX s and Defendant ZICAM s, breached the aforementioned duties described above, the Plaintiff, Michael Nelson, suffered a permanent and irreversible severely diminished sense of taste.. Plaintiff, Michael Nelson, has suffered damages as set forth hereinbefore. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against the Defendants and each of them in an amount to fully compensate him for his damages, together with all other damages, costs and interest that he may be entitled. FOURTH SEPARTE AND FURTHER CAUSE OF ACTION First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 FRUAD INTENTIONAL MISREPRESENTATION. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference.. The Defendant MATRIXX and Defendant ZICAM made the following representations of material facts to the general public, including the plaintiff herein: a. that Zicam Cold Remedy Nasal Gel was safe to use. b. that Zicam Cold Remedy Nasal Gel was an effective cold remedy. c. that Zicam Cold Remedy Nasal Gel was a homeopathic cold remedy. d. that Zicam Cold Remedy Nasal Gel was safe, fast acting and without any apparent side effects. e. that Zicam Cold Remedy Nasal Gel gets the user over a cold faster. f. that Zicam Cold Remedy Nasal Gel reduces the severity of cold symptoms. g. that Zicam Cold Remedy Nasal Gel doesn t temporarily suppress the symptoms it reduces the severity and duration of the cold. h. that Zicam Cold Remedy Nasal Gel reduces the duration of the common cold by % to % when taken at the onset of symptoms. i. that Zicam Cold Remedy Nasal Gel reduces the duration of the cold symptoms from days to an average of. days. k. that Zicam Cold Remedy Nasal Gel reduces common cold symptoms of sore throat, stuffy nose, sneezing, coughing and congestion.. The representations as set forth in paragraph are false and were false at the time they were made.. The Defendant MATRIXX and Defendant ZICAM knew that the representations set forth in paragraph were false at the time they were made.. The Defendant MATRIXX and Defendant ZICAM made the representations set forth in paragraph to the general public, including the plaintiff herein, for the purpose of inducing the First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 members of the general public, including the plaintiffs herein, to purchase Zicam Cold Remedy Nasal Gel and to use the product.. The plaintiff herein, relied on the representations set forth in paragraph, purchased the Zicam Cold Remedy Nasal Gel and used the product. 0. THAT had the plaintiff knew of the falsity of the representations aforesaid, or any of them, the Plaintiff would not have purchased the Zicam Cold Remedy Nasal Gel product, would not have used the Zicam Cold Remedy Nasal Gel product, and would not have been injured as set forth here.. As a direct and proximate result of intentional misrepresentations set forth above the Plaintiff, Michael Nelson, suffered complete, total, permanent and irreversible loss of his sense of smell.. As a direct and proximate result of intentional misrepresentations set forth above, the Plaintiff, Michael Nelson, suffered a permanent and irreversible severely diminished sense of taste.. Plaintiff, Michael Nelson, has suffered damages as set forth hereinbefore. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against all Defendants in whatever amount sufficient to compensation the plaintiff, together with all other damages, costs and interest that he may be entitled. FIFTH SEPARTE AND FURTHER CAUSE OF ACTION FRUAD FALSE PROMISE. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference.. The Defendant MATRIXX and Defendant ZICAM made the following promises to the general public, including the plaintiff herein: a. that Zicam Cold Remedy Nasal Gel was safe to use. b. that Zicam Cold Remedy Nasal Gel was an effective cold remedy. c. that Zicam Cold Remedy Nasal Gel gets the user over a cold faster. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 d. that Zicam Cold Remedy Nasal Gel reduces the severity of cold symptoms.. The promises as set forth in paragraph are false and were false at the time they were made.. The Defendant MATRIXX and Defendant ZICAM knew that the promises set forth in paragraph were false at the time they were made.. The Defendant MATRIXX and Defendant ZICAM made the promises to the general public, including the plaintiff herein, for the purpose of inducing the members of the general public, including the plaintiffs herein, to purchase Zicam Cold Remedy Nasal Gel and to use the product.. The plaintiff herein, relied on the promises set forth in paragraph, purchased the Zicam Cold Remedy Nasal Gel and used the product. 0. THAT had the plaintiff knew of the falsity of the promises aforesaid, or any of them, the Plaintiff would not have purchased the Zicam Cold Remedy Nasal Gel product, would not have used the Zicam Cold Remedy Nasal Gel product, and would not have been injured as set forth here.. As a direct and proximate result of false promises set forth above the Plaintiff, Michael Nelson, suffered complete, total, permanent and irreversible loss of his sense of smell.. As a direct and proximate result of the false promises set forth above, the Plaintiff, Michael Nelson, suffered a permanent and irreversible severely diminished sense of taste.. Plaintiff, Michael Nelson, has suffered damages as set forth hereinbefore. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against all Defendants in whatever amount sufficient to compensation the plaintiff, together with all other damages, costs and interest that he may be entitled. FIFTH SEPARTE AND FURTHER CAUSE OF ACTION FRUAD CONCEALMENT. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0. The Defendant MATRIXX and Defendant ZICAM concealed the following material facts from to the general public, including the plaintiff herein: a. that Zicam Cold Remedy Nasal Gel, when used in a reasonably anticipated manner causes loss of smell; b. that Zicam Cold Remedy Nasal Gel, when used in a reasonably anticipated manner causes significant loss of taste; c. that Zicam Cold Remedy Nasal Gel was never submitted to the Federal Food & Drug Administration for approval. d. that Zicam Cold Remedy Nasal Gel was never approved by the Federal Food & Drug Administration. e. that Zicam Cold Remedy Nasal Gel does not reduce the duration of the common cold. f. that Zicam Cold Remedy Nasal Gel does not reduce the symptoms of the common cold. g. that Zicam Cold Remedy Nasal Gel is not and never has been approved for safety and/or efficacy by the United Stated Food and Drug Administration h. that the defendant s expert consultants had recommended that a warning be placed on the Zicam Cold Remedy Nasal Gel product that it could cause anosmia or reduced smell loss associated with its use. i. that the defendants did not perform any testing on the safety of Zicam Cold Remedy Nasal Gel or the adverse affects of Zicam Cold Remedy Nasal Gel on the sense of smell or taste. j. that the defendants received complaints of smell loss from using Zicam Cold Remedy Nasal Gel immediately after it was introduced into the market in. k. that the defendants received thousands of complaints of smell loss from using Zicam Cold Remedy Nasal Gel by the time plaintiff purchased and used Zicam Cold Remedy Nasal Gel in 00. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 l. that the clinical studies performed by the defendants were seriously flawed in that the defendants did not test for or know if any of the test subjects had a cold. m. that the clinical studies performed by the defendants were seriously flawed in that when one of the defendants consultant s tested for the rhinovirus in the test subjects contrary to the study protocol set forth by the defendants, it was determined that % of the tests subjects tested negative for the rhinovirus. n. that the clinical studies performed by others where the cold virus was introduced into the test subjects and confirmed that the test subjects came down with a cold showed no improvement or reduction of symptoms or duration of the cold when the Zicam Cold Remedy Nasal Gel was used. o. that t the clinical studies performed by the defendants were seriously biased because of business relations between the defendants and/or the defendant s employees and the clinical labs doing the clinical testing. p. that the defendants entering into agreements with third parties to not disclose to the public seriously flawed clinical studies. q. that the defendants entering into agreements with third parties to not disclose to the public seriously biased clinical studies. r. that the scientific studies on clinical trials advocating the benefits of Zicam Cold Remedy Nasal Gel were written by or materially edited by the defendants or the defendants public relations firm without disclosing the involvement of the defendants in those studies. s. that the scientific studies on clinical trials advocating the that use of Zicam Cold Remedy Nasal Gel will not reach the olfactory clef were written by the defendants, and the defendants selected the author to publish the article in a professional journal under his name, even after the author selected by the defendants stated he was not qualified, and then selected other co-authors to participate in the article without disclosing the aforesaid facts to the journal publisher or the public. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0 t. that the instructions that the Zicam Cold Remedy Nasal Gel product be put only into the nostrils and that the user should not sniff was contrary to the disclosures of the best mode of using the product as set forth in US Patents,00, and,,. u. that the defendants were aware of published studies that prior to the sale and distribution of Zicam Cold Remedy Nasal Gel, that zinc sulfate had caused anomsia in children. v. that the defendants learned that Zinc gluconate was more toxic to cells than zinc sulfate during the prosecution of US Patents,, and,00, before the United States Patent Office.. THAT had the concealed facts set forth in paragraph, or any of them, been disclosed to the Plaintiff, he would not have purchased the Zicam Cold Remedy Nasal Gel product, would not have used the Zicam Cold Remedy Nasal Gel product, and would not have been injured as set forth here.. The Defendant MATRIXX and Defendant ZICAM knew the concealed facts at the time they marketed the Zicam Cold Remedy Nasal Gel to the general public, including the plaintiff herein.. The Defendant MATRIXX and Defendant ZICAM concealed the material facts from the general public, including the plaintiff herein, for the purpose of inducing the members of the general public, including the plaintiffs herein, to purchase Zicam Cold Remedy Nasal Gel and to use the product.. The plaintiff herein relied on the representations that the Zicam Cold Remedy Nasal Gel was safe and effectively reduces cold symptoms and purchased the Zicam Cold Remedy Nasal Gel and used the product. 0. As a direct and proximate result of non disclosure of the concealed facts as set forth above the Plaintiff, Michael Nelson, suffered complete, total, permanent and irreversible loss of his sense of smell. First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of 0 0. As a direct and proximate result of the non disclosure of the concealed facts as set forth above, the Plaintiff, Michael Nelson, suffered a permanent and irreversible severely diminished sense of taste.. Plaintiff, Michael Nelson, has suffered damages as set forth hereinbefore. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against all Defendants in whatever amount sufficient to compensation the plaintiff, together with all other damages, costs and interest that he may be entitled. SIXTH SEPARTE AND FURTHER CAUSE OF ACTION NEGLIGENCE. The Plaintiff herein realleges and incorporates by reference paragraphs through as set forth above and incorporates each and every paragraph herein by reference.. Defendant MATTRIX and Defendant ZICAM and their predecessor entities owed a duty to Plaintiff, Michael Nelson, and all others similarly situated, to use due care and caution in the design, manufacture, and sale of its Zicam Cold Remedy Nasal Gel to avoid unreasonable risks of injury during reasonably foreseeable uses of the product.. Defendant MATTRIX and Defendant ZICAM and their predecessor entities were negligent in the design, manufacture, and sale of its Zicam Cold Remedy Nasal Gel.. As a direct and proximate result of the negligence of the Defendant MATTRIX and Defendant ZICAM and their predecessor entities, the Plaintiff, Michael Nelson was injured as hereinbefore alleged. WHEREFORE, the Plaintiff, Michael Nelson, respectfully requests that this Honorable Court grant him judgment against Defendant MATTRIX and Defendant ZICAM in whatever amount above he is found to be entitled, together with all other damages, costs and interest that he may be entitled. END First Amended Complaint Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page0 of 0 P R A Y E R Plaintiff prays judgment against the Defendants as follows:. For damages in an amount to compensate the plaintiff for his loss of smell and reduced loss of taste in an amount in excess of that required to qualify for diversity jurisdiction ;. For punitive damages in amount sufficient to deter this conduct and set as an example for others not to act in the way the defendants did herein;. For medical expenses incurred;. For future medical expenses to be incurred;. Increased susceptibility to risks generally avoidable by a person with an intact sense of smell and/or taste;. For special damages according to proof;. For interest;. For costs of suit;. For treble damages under Civil Code Section ; and 0. For such other and further relief as this Honorable Court may deem just and proper. 0 Dated //0 /s/ Michael D Nelson Michael D. Nelson Plaintiff Pro se First Amended Complaint 0 Case No. C0-00-WHA
Case:0-cv-00-WHA Document Filed0/0/ Page of CERTIFICATE OF SERVICE I hereby certify that on April, 0, the Plaintiff s First Amended Complaint was electronically transmitted to the Clerk of the Court using the CM/ECF System, which will send notification of such filing and transmittal of a Notice of Electronic Filing to all CM/ECF registrants. /s/ Michael D Nelson 0 0 First Amended Complaint Case No. C0-00-WHA