Timothy Hall, Et Al. V. Hemelt, Et Al. 09-CV-01899-Verified Shareholder

Total Page:16

File Type:pdf, Size:1020Kb

Timothy Hall, Et Al. V. Hemelt, Et Al. 09-CV-01899-Verified Shareholder Case 2:09-cv-01899-SRB Document 1 Filed 09/11/09 Page 1 of 19 1 Eric L. Zagar Robin Winchester 2 BARROWAY TOPAZ KESSLER MELTZER & CHECK, LLP 3 280 King of Prussia Road 4 Radnor, PA 19087 Telephone: (610) 667-7706 5 Fax: (610) 667-7056 [email protected] 6 [email protected] 7 Robert D. Mitchell, 011922 Julie M. Beauregard, 023093 Sarah K. Deutsch, 026229 8 MITCHELL & ASSOCIATES 9 A Professional Corporation Viad Corporate Center, Suite 1715 1850 North Central Avenue 10 Phoenix, Arizona 85004 Telephone (602) 468-1411 11 Fax (602) 468-1311 [email protected] 12 [email protected] [email protected] 13 www.mitchell-attorneys.com 14 Counsel for Plaintiff 15 UNITED STATES DISTRICT COURT 16 DISTRICT OF ARIZONA 17 TIMOTHY HALL, Derivatively on Behalf of ) 18 Nominal Defendant MATRIXX INITIATIVES, ) INC., ) 19 Plaintiff, ) Case No. 20 v. ) ) 21 WILLIAM J. HEMELT, SAMUEL C. ) COWLEY, CARL J. JOHNSON, L. WHITE) VERIFIED SHAREHOLDER 22 MATTHEWS, III, MICHAEL A. ZEHER,) DERIVATIVE COMPLAINT 23 WILLIAM C. EGAN, LORI H. BUSH, and ) JOHN M. CLAYTON, ) 24 Defendants, ) 25 ) and ) JURY TRIAL DEMANDED 26 ) MATRIXX INITIATIVES, INC., ) 27 ) 28 Nominal Defendant. ) ) Case 2:09-cv-01899-SRB Document 1 Filed 09/11/09 Page 2 of 19 1 Plaintiff Timothy Hall (“Plaintiff”), by the undersigned attorneys, submits this 2 Verified Shareholder Derivative Complaint (the “Complaint”) against the defendants named 3 herein, and alleges upon personal knowledge with respect to himself, and upon information 4 and belief based upon, inter alia, a review of public filings, press releases and reports, and an 5 investigation undertaken by Plaintiff’s counsel, as to all other allegations herein, as follows: 6 NATURE OF THE ACTION 7 1. This is a shareholder’s derivative action brought for the benefit of nominal 8 defendant Matrixx Initiatives, Inc. (“Matrixx” or the “Company”) against certain members of 9 Matrixx’s Board of Directors (the “Board”) and certain of its executive officers seeking to 10 remedy defendants’ breaches of fiduciary duties. 11 2. The Individual Defendants (as defined herein breached their fiduciary duties 12 by, among other things, (1) misrepresenting the safety of the Company’s Zicam Cold 13 Remedy Products (The Zicam Cold Remedy Products refer to Zicam Cold Remedy Nasal 14 Gel; Zicam Cold Remedy swabs; and Zicam Cold Remedy, Kids Size) and failing to warn 15 consumers and shareholders that the Zicam Cold Remedy Products could result in anosmia 16 (loss of smell) despite their actual knowledge of the problem; and (2) failing to disclose to 17 the United States Food and Drug Administration (“FDA”), despite the Company’s obligation 18 to do so, the existence of numerous reports of serious adverse events relating to the loss of 19 smell associated with the use of Zicam Cold Remedy Products. 20 3. Specifically, for several years the Individual Defendants were aware that 21 Matrixx had received hundreds of serious adverse events reports from consumers concerning 22 the loss of smell caused by the Company’s Zicam Cold Remedy Products. The Individual 23 Defendants, acting on behalf of the Company, knowingly failed to report these adverse 24 events to the FDA despite the Company’s obligation to do so. The Individual Defendants, 25 acting on behalf of the Company, knowingly failed to comply with FDA regulations despite 26 their repeated assurances of the Company’s compliance. 27 4. The failure of the Individual Defendants to report the serious adverse events to 28 the FDA created the false impression that the Zicam Cold Remedy Products were safe and - 1 - Case 2:09-cv-01899-SRB Document 1 Filed 09/11/09 Page 3 of 19 1 effective remedies for consumers. By failing to report the serious adverse events associated 2 with the Zicam Cold Remedy Products, the Individual Defendants caused the true risks 3 associated with the use of these products to be concealed from the public and the Company’s 4 shareholders. 5 5. Finally, on June 16, 2009, the FDA recalled the Zicam Cold Remedy Products 6 and told consumers to stop using them because of the risk of permanent damage to the sense 7 of smell. In a warning letter from the FDA to the Company on the same date (“FDA 8 Warning Letter”), the FDA stated that the agency was aware that Matrixx had received more 9 than 800 reports related to loss of sense of smell associated with the Zicam Cold Remedy 10 Products that were not submitted to the FDA as required by law. 11 6. As a result of the FDA advisory regarding the Zicam Cold Remedy Products, 12 the FDA Warning Letter, and the revelation of the existence of more than 800 serious 13 adverse incidents in the Company’s possession that went unreported to the FDA, Matrixx’s 14 stock price plummeted $13.46 to close on June 16, 2009 at $5.78, a one day drop of nearly 15 70%. 16 7. As a result of the Individual Defendants’ breach of their fiduciary duties, the 17 Company has sustained significant damages, as alleged herein. 18 JURISDICTION AND VENUE 19 8. This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332 in that 20 Plaintiff and Defendants are citizens of different states and the amount in controversy 21 exceeds $75,000.00, exclusive of interest and costs. This action is not a collusive one to 22 confer jurisdiction on a court of the United States of America which it would not otherwise 23 have. 24 9. Venue is proper in this District pursuant to 28 U.S.C. § 1391(a) and (c) in that a 25 substantial part of the events or omissions giving rise to the claim occurred in this District, 26 and defendants have received substantial compensation in this district by engaging in 27 numerous activities and conducting business here, which had an effect in this district. 28 - 2 - Case 2:09-cv-01899-SRB Document 1 Filed 09/11/09 Page 4 of 19 1 PARTIES 2 10. Plaintiff, a citizen of Nevada, is a shareholder of Matrixx, was a shareholder of 3 nominal defendant Matrixx at the time of the wrongdoing alleged herein and has been a 4 shareholder of Matrixx continuously since that time. 5 11. Nominal defendant Matrixx is a Delaware corporation with its principal 6 executive offices located at 8515 East Anderson Drive, Scottsdale, Arizona 85255. 7 According to its public filings, Matrixx develops, produces, markets and sells over-the- 8 counter healthcare products. 9 12. Defendant William J. Hemelt (“Hemelt” ), a citizen of Arizona, has served as 10 the Company’s Acting President, Chief Operating Officer and Chief Financial Officer since 11 October 2008. 12 13. Defendant Samuel C. Cowley (“Cowley”), a citizen of Arizona, has served as a 13 director of Matrixx since July 2005 and as the Company’s Executive Vice President, 14 Business Development, General Counsel and Secretary since May 2008. 15 14. Defendant Carl J. Johnson (“Johnson”), a citizen of Arizona, served as a 16 director of Matrixx and as the Company’s President and Chief Executive Officer from July 17 2001 until his retirement on October 31, 2008. 18 15. Defendants Hemelt, Cowley, and Johnson are referred to herein as the “Officer 19 Defendants.” 20 16. Defendant L. White Matthews, III (“Matthews”), a citizen of Wyoming, has 21 served as a director of Matrixx since March 2003. 22 17. Defendant Michael A. Zeher (“Zeher”), a citizen of New York, has served as a 23 director of Matrixx since September 2000. 24 18. Defendant William C. Egan (“Egan”), a citizen of New Jersey, has served as a 25 director of Matrixx since August 2001. 26 19. Defendant Lori H. Bush (“Bush”), a citizen of California, has served as a 27 director of Matrixx since October 2004. 28 - 3 - Case 2:09-cv-01899-SRB Document 1 Filed 09/11/09 Page 5 of 19 1 20. Defendant John M. Clayton (“Clayton”), a citizen of Tennessee, has served as 2 a director of Matrixx since October 2005. 3 21. Defendants Matthews, Zeher, Egan, Bush, and Clayton will be referred to as 4 the “Director Defendants.” 5 22. Collectively, the Officer Defendants and Director Defendants will be referred 6 to herein as the “Individual Defendants.” 7 DUTIES OF THE INDIVIDUAL DEFENDANTS 8 23. By reason of their positions as officers, directors, and/or fiduciaries of Matrixx 9 and because of their ability to control the business and corporate affairs of Matrixx, the 10 Individual Defendants owed Matrixx and its shareholders fiduciary obligations of good faith, 11 loyalty, and candor, and were and are required to use their utmost ability to control and 12 manage Matrixx in a fair, just, honest, and equitable manner. The Individual Defendants 13 were and are required to act in furtherance of the best interests of Matrixx and its 14 shareholders so as to benefit all shareholders equally and not in furtherance of their personal 15 interest or benefit. Each director and officer of the Company owes to Matrixx and its 16 shareholders the fiduciary duty to exercise good faith and diligence in the administration of 17 the affairs of the Company and in the use and preservation of its property and assets, and the 18 highest obligations of fair dealing. 19 24. The Individual Defendants, because of their positions of control and authority 20 as directors and/or officers of Matrixx, were able to and did, directly and/or indirectly, 21 exercise control over the wrongful acts complained of herein, as well as the contents of the 22 various public statements issued by the Company.
Recommended publications
  • Section 4: Business Institute of Bill of Rights Law at the William & Mary Law School
    College of William & Mary Law School William & Mary Law School Scholarship Repository Supreme Court Preview Conferences, Events, and Lectures 2010 Section 4: Business Institute of Bill of Rights Law at the William & Mary Law School Repository Citation Institute of Bill of Rights Law at the William & Mary Law School, "Section 4: Business" (2010). Supreme Court Preview. 198. https://scholarship.law.wm.edu/preview/198 Copyright c 2010 by the authors. This article is brought to you by the William & Mary Law School Scholarship Repository. https://scholarship.law.wm.edu/preview IV. Business In This Section: New Case: 09-152 Bruesewitz v. Wyeth, Inc. p. 107 Synopsis and Questions Presented p. 107 "SUPREME COURT ACCEPTS APPEAL OVER VACCINE SAFETY" p. 120 Bill Mears "3RD CIRCUIT: KIDS HURT BY VACCINES CAN'T PURSUE DESIGN DEFECT p. 122 CLAIMS" Shannon P. Duffy "VACCINE COURT FINDS No LINK TO AUTISM" p. 125 CN.com "SUIT SAYS MT. LEBANON GIRL SUFFERED SEVERE BRAIN DAMAGE" p. 128 Brian Bowling New Case: 09-329 Chase Bank USA, N.A. V. McCoy p. 130 Synopsis and Questions Presented p. 130 "SUPREME COURT TO HEAR JPMORGAN APPEAL IN CARD CASE" p. 141 James Vicini 7TH CIRCUIT RULES BANK CAN RAISE INTEREST RATE WITHOUT NOTICE p. 142 David Ziemer "BANK OF AMERICA WINS CREDIT CARD FEE LAWSUIT" p. 145 Jonathan Stempel "CREDIT CARD COMPANIES ADD TO ECONOMIC WOES" p. 146 Jann Swanson "CONSUMERS ARE DEALT A NEW HAND IN CREDIT CARDS" p. 148 Ron Lieber New Case: 08-1423 Costco Wholesale Corp. v. Omega, S.A. p. 150 Synopsis and Questions Presented p.
    [Show full text]
  • Zinc Toxicity in Odora Cells
    Zinc Toxicity in Odora Cells A thesis submitted to the University of Cincinnati Division of Graduate Studies in partial fulfillment of the requirements for the degree of Master of Science in the Department of Environmental Health of the College of Medicine by Heidi Hsieh A.B. Harvard University August 2011 Committee: Mary Beth Genter, Ph.D. (Chair) Hassane Amlal, Ph.D. Abstract Zinc has been touted as a panacea for the common cold. However, there has been some controversy over whether Zicam, an intranasal zinc gluconate gel purported to fight colds, causes anosmia, or the loss of the sense of smell. Historical evidence has shown that zinc sulfate solutions can cause anosmia in humans along with significant damage to the olfactory epithelium in rodents. However, more recent work has claimed to show that zinc gluconate is less toxic than zinc sulfate. Using an in vitro system to compare the toxicity of zinc sulfate and zinc gluconate on immature and mature rat olfactory sensory neurons, it was found that the toxicity of both zinc salts was similar with zinc sulfate being slightly more toxic than zinc gluconate and occurred at significantly lower concentrations than that found in Zicam nasal gel, which strengthens the epidemiological link between intranasal zinc exposure and anosmia. Mechanistic studies disproved the hypothesis that zinc toxicity was caused by inhibition of the HVCN1 proton channel which would have led to acidosis and apoptotic cell death. It was found that these immature rat olfactory sensory neurons are able to maintain their intracellular pH through a + + - - Na /H exchanger, specifically NHE1, and a Cl /HCO3 exchanger.
    [Show full text]
  • United States District Court Southern District of New York
    Case 7:15-cv-09843 Document 1 Filed 12/17/15 Page 1 of 32 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK ALAN GULKIS, individually and on behalf of all others similarly situated, Plaintiff, CLASS ACTION COMPLAINT v. ZICAM LLC and MATRIXX INITIATIVES, JURY TRIAL DEMANDED INC. Defendants. Plaintiff Alan Gulkis (“Plaintiff”), by his attorneys, makes the following allegations pursuant to the investigation of his counsel and based upon information and belief, except as to allegations specifically pertaining to himself and his counsel, which are based on personal knowledge. NATURE OF ACTION 1. Defendants Zicam LLC and Matrixx Initiatives, Inc. (collectively “Defendants”) sell fake medicine to consumers seeking treatment for cold symptoms. Double-blind placebo- controlled trials show that Defendants’ “Zicam Pre-Cold Medicine” is nothing more than a placebo. Even though Defendants know that studies show that the “Pre-Cold Medicine” is no different than a placebo, Defendants represent that the “Pre-Cold Medicine” shortens and reduces the severity of cold symptoms, and that the “Pre-Cold Medicine” prevents full cold symptoms from occurring. Defendants have made millions of dollars selling dummy pills to New York residents. 2. Because Defendants’ Pre-Cold Medicine Products are mere placebos, Defendants’ representations that their Products shorten and reduce the severity of the common cold, as well as their representations that the Products stop full cold symptoms are false and misleading. The 1 Case 7:15-cv-09843 Document 1 Filed 12/17/15 Page 2 of 32 Pre-Cold Medicine includes Zicam Pre-Cold RapidMelts Original, Zicam Pre-Cold RapidMelts Ultra, Zicam Pre-Cold Oral Mist, Zicam Pre-Cold Ultra Crystals, Zicam Pre-Cold Lozenges, Zicam Pre-Cold Lozenges Ultra, and Zicam Pre-Cold Chewables (“Pre-Cold Medicine,” “Pre- Cold Products,” or “Products”).
    [Show full text]
  • ZICAM® COLD REMEDY Drug Facts
    ZICAM COLD REMEDY- galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed spray Matrixx Initiatives, Inc. Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective. ---------- ZICAM® COLD REMEDY Drug Facts Active ingredients Galphimia glauca 4x, Luffa operculata 4x, Sabadilla 4x Purpose Reduces duration and severity of the common cold Uses reduces duration of the common cold reduces severity of cold symptoms: dry, scratchy throat runny nose watery eyes sneezing nasal congestion Zicam® Cold Remedy was formulated to shorten the duration of the common cold and may not be effective for flu or allergies. Warnings For nasal use only Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and seek medical help right away. Ask a doctor before use if you have ear, nose, or throat sensitivity susceptibility to nosebleeds When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away. the use of this container by more than one person may spread infection temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur Stop use and ask a doctor if symptoms get worse or last more than 7 days or are accompanied by fever redness or swelling is present new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
    [Show full text]
  • Matrixx Initiatives, Inc. (Exact Name of Registrant As Specified in Its Charter) Delaware 87-0482806 (State Or Other Jurisdiction (I.R.S
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ¥ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2009 or n FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 001-31404 Matrixx Initiatives, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 87-0482806 (State or Other Jurisdiction (I.R.S. Employer of Incorporation or Organization) Identification No.) 8515 E. Anderson Drive Scottsdale, AZ 85255 602-385-8888 (Address of principal executive offices, Registrant’s Telephone Number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on Which Registered Common Stock, $.001 par value Nasdaq Global Select Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes n No ¥ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes n No ¥ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
    [Show full text]
  • Reconciling Their Interests in Regulating Homeopathic Products, 49 J
    UIC Law Review Volume 49 Issue 4 Article 7 Summer 2016 The Food and Drug Administration Versus the Federal Trade Commission: Reconciling Their Interests in Regulating Homeopathic Products, 49 J. Marshall L. Rev. 1193 (2016) Jordannah Bangi Follow this and additional works at: https://repository.law.uic.edu/lawreview Part of the Administrative Law Commons, Antitrust and Trade Regulation Commons, and the Food and Drug Law Commons Recommended Citation Jordannah Bangi, The Food and Drug Administration Versus the Federal Trade Commission: Reconciling Their Interests in Regulating Homeopathic Products, 49 J. Marshall L. Rev. 1193 (2016) https://repository.law.uic.edu/lawreview/vol49/iss4/7 This Comments is brought to you for free and open access by UIC Law Open Access Repository. It has been accepted for inclusion in UIC Law Review by an authorized administrator of UIC Law Open Access Repository. For more information, please contact [email protected]. THE FOOD AND DRUG ADMINISTRATION VERSUS THE FEDERAL TRADE COMMISSION: RECONCILING THEIR INTERESTS IN REGULATING HOMEOPATHIC PRODUCTS JORDANNAH BANGI* I. THE POPULARITY AND GROWING SAFETY CONCERNS FOR HOMEOPATHIC PRODUCTS SPUR FDA AND FTC SCRUTINY ... 1194 II. HOMEOPATHY AND THE CONFLICT BETWEEN THE FDA AND THE FTC’S POLICIES ON REGULATING HOMEOPATHIC PRODUCTS ......................................................................... 1197 A. The Principles and Practice of Homeopathy ................ 1197 1. Basic Principles of Homeopathy ............................ 1197 2. Types of Homeopathic
    [Show full text]
  • Zicam® Cold Remedy Oral Mist™ Drug Facts
    ZICAM COLD REMEDY ORAL MIST- zinc acetate and zinc gluconate spray Matrixx Initiatives, Inc. Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective. ---------- Zicam® Cold Remedy Oral Mist™ Drug Facts Active ingredients Zincum aceticum 2x Zincum gluconicum 1x Purpose Reduces duration and severity of the common cold Uses reduces duration of the common cold helps reduce severity of cold symptoms: sore throat stuffy nose sneezing coughing nasal congestion Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies. Warnings For oral use only Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away. Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
    [Show full text]
  • Siracusano V. Matrixx Initiatives
    FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT JAMES SIRACUSANO, Individually and on behalf of all others similarly situated, Plaintiff-Appellant, No. 06-15677 NECA-IBEW PENSION FUND, D.C. Nos. Claimant-Appellant, CV 04-0886 MHM CV 04-1012 MHM v. OPINION MATRIXX INITIATIVES, INC.; CARL J. JOHNSON; WILLIAM J. HEMELT, Defendants-Appellees. Appeal from the United States District Court for the District of Arizona Mary H. Murguia, District Judge, Presiding Argued and Submitted June 9, 2009—San Francisco, California Filed October 28, 2009 Before: Mary M. Schroeder, A. Wallace Tashima and Carlos T. Bea, Circuit Judges. Opinion by Judge Tashima 14507 14510 SIRACUSANO v. NECA-IBEW PENSION FUND COUNSEL Joseph D. Daley, Coughlin Stoia Geller Rudman & Robbins LLP, San Diego, California, for the plaintiff-appellant. Michael G. Yoder, O’Melveny & Myers LLP, Newport Beach, California, for the defendants-appellees. SIRACUSANO v. NECA-IBEW PENSION FUND 14511 OPINION TASHIMA, Circuit Judge: Matrixx Initiatives, Inc. (“Matrixx”) is a pharmaceutical company that sells cold products through its wholly-owned subsidiary, Zicam, LLC. One of its main products is Zicam Cold Remedy, which comes in several different forms.1 Plaintiffs-Appellants are lead plaintiff, NECA-IBEW Pension Fund, and named plaintiff, James Siracusano, in a class action brought against Matrixx and three Matrixx executives (collec- tively “Appellees”) under the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Appellants alleged that Appellees violated the Securities Exchange Act of 1934 by failing to disclose material information regarding Zicam Cold Remedy — specifically, that Zicam causes a condition called anosmia, which is a loss of the sense of smell, in its users.
    [Show full text]
  • Zicam ® Cold Remedy Zinc and Elderberry Lozenge
    ZICAM COLD REMEDY ZINC AND ELDERBERRY LOZENGE- zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top lozenge Church & Dwight Co., Inc. Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective. ---------- Zicam ® Cold Remedy Zinc and Elderberry Lozenge Active ingredients (in each lozenge) Zincum aceticum 2x Zincum gluconicum 2x Sambucus nigra (elderberry) 4x Purpose Active ingredients (in each Purpose tablet) Zincum aceticum 2x Reduces duration of the common cold and helps relieve nasal congestion Zincum gluconicum 2x Sambucus nigra (elderberry) Helps relieve cold 4x symptoms * * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Uses Reduces duration of the common cold and helps relieve nasal congestion ------------------------------------------------------------------------------------------------------ Zicam ® Cold Remedy was not formulated to be effective for flu and allergies. Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If you are allergic or sensitive to zinc, consult a doctor before using. Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
    [Show full text]
  • Zicam® Cold Remedy Medicated Fruit Drops Drug Facts
    ZICAM COLD REMEDY MEDICATED FRUIT DROPS- zinc acetate anhydrous and zinc gluconate bar, chewable Matrixx Initiatives, Inc. Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective. ---------- Zicam® Cold Remedy Medicated Fruit Drops Drug Facts Active ingredients (in each medicated drop) Zincum aceticum 2x Zincum gluconicum 2x Purpose Reduces duration and severity of the common cold Uses reduces duration of the common cold helps reduce severity of cold symptoms: sore throat stuffy nose sneezing coughing nasal congestion Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies. Warnings Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: take one medicated drop at onset of symptoms chew slowly and dissolve completely before swallowing repeat every 2 – 3 hours, not to exceed 5 medicated drops in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take on an empty stomach do not eat or drink for 15 minutes after use.
    [Show full text]
  • Zicam® Cold Remedy Rapidmelts® Citrus
    ZICAM COLD REMEDY RAPIDMELTS CITRUS- zinc acetate anhydrous and zinc gluconate tablet Matrixx Initiatives, Inc. Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective. ---------- ® Zicam® Cold Remedy Rapidmelts Citrus Drug Facts Active ingredients (in each tablet) Zincum aceticum 2x Zincum gluconicum 1x Purpose Reduces duration and severity of the common cold Uses reduces duration of the common cold helps reduce severity of cold symptoms: sore throat stuffy nose sneezing coughing nasal congestion Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies. Warnings Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: take 1 tablet at the onset of symptoms dissolve entire tablet in mouth. Do not chew. Do not swallow whole. repeat every 2–3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take on an empty stomach do not eat or drink for 15 minutes after use.
    [Show full text]
  • Supreme Court of the United States ______
    No. 09-1156 IN THE Supreme Court of the United States __________ MATRIXX INITIATIVES, INC., ET AL., Petitioners, v. JAMES SIRACUSANO AND NECA-IBEW PENSION FUND, Respondents. __________ On Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit __________ BRIEF FOR RESPONDENTS __________ DARREN J. ROBBINS DAVID C. FREDERICK ERIC ALAN ISAACSON Counsel of Record JOSEPH D. DALEY SCOTT H. ANGSTREICH SCOTT H. SAHAM GREGORY G. RAPAWY LUCAS F. OLTS EMILY T.P. ROSEN ROBBINS GELLER RUDMAN KELLOGG, HUBER, HANSEN, & DOWD LLP TODD, EVANS & FIGEL, 655 West Broadway P.L.L.C. Suite 1900 1615 M Street, N.W. San Diego, California 92101 Suite 400 (619) 231-1058 Washington, D.C. 20036 (202) 326-7900 SAMUEL H. RUDMAN ([email protected]) DAVID A. ROSENFELD ROBBINS GELLER RUDMAN & DOWD LLP 58 South Service Road Suite 200 Melville, New York 11747 (631) 367-7100 November 5, 2010 QUESTION PRESENTED Respondents are investors in petitioner Matrixx Initiatives, Inc. who claim that petitioners violated § 10(b) of the Securities Exchange Act of 1934 and Securities and Exchange Commission Rule 10b-5 by misrepresenting and by failing to disclose informa- tion about the safety of their drug products, includ- ing several independent reports by doctors linking intranasal applications of Matrixx’s Zicam products to persistent anosmia (loss of the sense of smell). Contrary to petitioners’ question presented, which asserts that this case concerns “a pharmaceutical company’s nondisclosure of adverse event reports even though the reports are not alleged to be statisti- cally significant,” this case does not involve “adverse event reports” required by the Food and Drug Administration.
    [Show full text]