Motion For Judgment On Pleadings Delarosa V Boiron

Case 8:10-cv-01569-JST -CW Document 27
Filed 01/21/11 Page 1 of 4 Page ID #:324
Gary A. Pemberton, Bar No. 126159 1 John Mark Jennings, Bar No. 192641 SHULMAN HODGES & BASTIAN LLP 2 26632 Towne Centre Drive, Suite 300 Foothill Ranch, California 92610-2808 3 Telephone: (949) 340-3400 Facsimile: (949) 340-3000 4 Email: GPemberton@shbllp.com JJennings@shbllp.com 5 PATTON BOGGS LLP 6 Christina Guerola Sarchio (pro hac vice) 2550 M Street, N.W. 7 Washington, DC 20037-1350 Telephone: (202) 457-6000 8 Facsimile: (202) 457-6315 Email: CSarchio@PattonBoggs.com 9 Attorneys for Defendant Boiron, Inc. 10 11 12 13 14 GINA DELAROSA, individually and ) on behalf of all others similarly ) situated, ) 15 ) ) 16 Plaintiff, ) vs. ) 17 ) BOIRON, INC., a corporation of ) 18 unknown origin; and JOHN DOES 1 ) ) 19 20, ) Defendants. ) 20 ) ) 21 ) ) 22 ) ) 23 ) ) 24 ) 25 26 27 28
SHULMAN HODGES & BASTIAN LLP 26632 Towne Centre Drive Suite 300 Foothill Ranch, CA 92610 4280-000\G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Notice.doc
UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA Case No. 8:10-cv-01569 JST (CWx) Honorable Josephine S. Tucker Courtroom 10-A DEFENDANT BOIRON, INC.S NOTICE OF MOTION AND MOTION FOR JUDGMENT ON THE PLEADINGS [Fed. Rule Civ. Proc. 12(c)] [Memorandum of Points and Authorities, Request for Judicial Notice and Proposed Order and Judgment filed and lodged concurrently herewith] Date: February 28, 2011 Time: 10:00 a.m. Courtroom: 10-A
PLEASE TAKE NOTICE that on February 28, 2011, at 10:00 a.m., or as
2 thereafter as the matter may be heard, in Courtroom 10-A of the above-entitled 3 Court, located at 411 W. Fourth Street, Santa Ana, California 92701, Defendant 4 Boiron, Inc. (Boiron) will move the Court pursuant to Federal Rule of Civil 5 Procedure 12(c) for judgment on the pleadings as to the claims set forth in the 6 Complaint of Plaintiff Gina Delarosa (Delarosa). 7 Boiron makes this motion on the grounds that it is entitled to judgment as a
8 matter of law pursuant to Federal Rule of Civil Procedure 12(c) because Delarosas 9 claims are preempted by federal law and otherwise fail to state a claim upon which 10 relief may be granted. Accordingly, Boiron respectfully requests that this Court 11 grant judgment on the pleadings as to the claims of relief in Delarosas complaint. 12 This Motion will be based on this Notice of Motion and Motion, the
13 accompanying Memorandum of Points and Authorities, Request for Judicial 14 Notice and proposed Order and Judgment filed and lodged concurrently herewith, 15 the pleadings and other materials filed herein, and on such other and further oral 16 and documentary evidence as may be presented at the hearing on this Motion or of 17 which the Court may take judicial notice. 18 This Motion is made following the conference of counsel pursuant to L.R. 7-
19 3 which took place on December 20, 2010. 20 21 22 23 24 25 26 27 28

SHULMAN HODGES & BASTIAN LLP 26632 Towne Centre Drive Suite 300 Foothill Ranch, CA 92610 4280-000\G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Notice.doc
SHULMAN HODGES & BASTIAN LLP Dated: January 21, 2011 By: /s/ Gary A. Pemberton Gary A. Pemberton John Mark Jennings
PATTON BOGGS LLP Dated: January 21, 2011 By: /s/ Christina Guerola Sarchio Christina Guerola Sarchio (pro hac vice) Attorneys for Defendant Boiron, Inc.
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PROOF OF SERVICE STATE OF CALIFORNIA, COUNTY OF ORANGE
I am employed in the City of Foothill Ranch, County of Orange, State of 4 California. I am over the age of 18 years and not a party to the within action. My business address is 26632 Towne Centre Drive, Suite 300, Foothill Ranch, 5 California 92610. 6 On January 21, 2011, I served the documents named below on the parties in this Action as follows: 7 DEFENDANT BOIRON, INC.S NOTICE DOCUMENT(S) SERVED: OF MOTION AND MOTION FOR 8 JUDGMENT ON THE PLEADINGS 9 TO BE SERVED BY THE COURT VIA NOTICE OF ELECTRONIC 10 [ x] FILING (NEF) Pursuant to controlling General Order(s) the foregoing 11 document(s) will be served by the court via NEF and hyperlink to the document. On January 21, 2011 I checked the CM/ECF docket for this case and determined 12 that the following person(s) are on the Electronic Mail Notice List to receive NEF transmission at the email address(es) indicated below: 13 Ryan M Ferrell 14 rferrell@calljensen.com 15 Scott J Ferrell sferrell@trialnewport.com,lberger@trialnewport.com 16 Christina Guerola Sarchio 17 csarchio@pattonboggs.com 18 19 20 21 22 23 24 25 26 27 28
SHULMAN HODGES & BASTIAN LLP 26632 Towne Centre Drive Suite 300 Foothill Ranch, CA 92610 4280-000G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Notice.doc
[ x]
(FEDERAL) I declare that I am employed in the office of a member of the bar of this court, at whose direction this service was made. I declare under penalty of perjury that the foregoing is true and correct.
Executed on January 21, 2011, at Foothill Ranch, California. /s/ Tovia Lenz Tovia Lenz
SERVICE LIST
2 Counsel for Defendant Boiron, Inc. 3 Christina Guerola Sarchio (Via First Class Mail) Co-Chair, Government Investigations & 4 Litigation Practice Group Patton Boggs, LLP 5 2550 M Street, NW Washington, DC 20037-1350 6 Direct: (202) 457-7527 Fax: (202) 457-6315 7 Main: (202) 457-6000 csarchio@pattonboggs.com 8 Counsel for Plaintiff Gina Delarosa: 9 Newport Trial Group 10 Scott J. Ferrell, Esq. Ryan M. Ferrell, Esq. 11 610 Newport Center Drive, Suite 700 Newport Beach, CA 92660 12 Tel: (949) 706-6464 Fax: (949) 706-6469 13 rferrell@calljensen.com sferrell@trialnewport.com,lberger@trialnewport.com 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
SHULMAN HODGES & BASTIAN LLP 26632 Towne Centre Drive Suite 300 Foothill Ranch, CA 92610 4280-000G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Notice.doc
Case 8:10-cv-01569-JST -CW Document 27-1 #:328
Filed 01/21/11 Page 1 of 24 Page ID
1 Gary A. Pemberton, Bar No. 126159 John Mark Jennings, Bar No. 192641 2 SHULMAN HODGES & BASTIAN LLP 26632 Towne Centre Drive, Suite 300 3 Foothill Ranch, California 92610-2808 Telephone: (949) 340-3400 4 Facsimile: (949) 340-3000 Email: GPemberton@shbllp.com 5 JJennings@shbllp.com 6 PATTON BOGGS LLP Christina Guerola Sarchio (pro hac vice) 7 2550 M Street, N.W. Washington, DC 20037-1350 8 Telephone: (202) 457-6000 Facsimile: (202) 457-6315 9 Email: CSarchio@PattonBoggs.com 10 Attorneys for Defendant Boiron, Inc. 11 12 13 14 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA Case No. 8:10-cv-01569 JST (CWx) Honorable Josephine S. Tucker Courtroom 10-A DEFENDANT BOIRON, INC.S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF ITS MOTION FOR JUDGMENT ON THE PLEADINGS [Fed. Rule Civ. Proc. 12(c)] [Notice of Motion and Motion, Request for Judicial Notice and Proposed Order and Judgment filed and lodged concurrently herewith] Date: February 28, 2011 Time: 10:00 a.m. Courtroom: 10-A
GINA DELAROSA, individually and ) ) 15 on behalf of all others similarly situated, ) ) 16 ) Plaintiff, ) 17 vs. ) ) 18 BOIRON, INC., a corporation of ) unknown origin; and JOHN DOES 1 ) 19 20, ) ) 20 Defendants. ) ) 21 ) ) 22 ) ) 23 ) ) 24 ) ) 25 ) ) 26 27 28
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SHULMAN HODGES & BASTIAN LLP 26632 Towne Centre Drive Suite 300 Foothill Ranch, CA 92610
I. II. III.
TABLE OF CONTENTS INTRODUCTION ........................................................................................... 1 STANDARD OF REVIEW ............................................................................ 4 ARGUMENT .................................................................................................. 5 A. FEDERAL LAW PREEMPTS PLAINTIFFS CLAIMS .................... 5 1. 2. 3. B. Federal Mandate Expressly Prohibits Plaintiffs Claims ........... 8 Plaintiff Improperly Seeks to Frustrate Federal Objectives ................................................................................. 10 Complaints About the Effectiveness of Homeopathic Drugs Are Better Addressed By the FDA ................................ 12
BOIRON IS ENTITLED TO JUDGMENT ON THE PLEADINGS BECAUSE PLAINTIFF FAILS TO STATE A CLAIM UPON WHICH RELIEF CAN BE GRANTED ................... 13 1. 2. 3. Safe Habor Provisions Preclude Plaintiffs Consumer Protection Claims...................................................................... 14 Plaintiff Fails To State Fraud With Particularity...................... 15 Plaintiffs Failure to Comply With CLRAs Notice Requirements Precludes Her Claim for Damages .................... 16
IV.
CONCLUSION ............................................................................................. 17
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1 2 CASES
TABLE OF AUTHORITIES
3 American Home Prod. Corp. v. Johnson & Johnson, 672 F. Supp. 135 (S.D.N.Y. 1987) ..................................................................... 12 4 Ashcroft v. Iqbal, 5 129 S. Ct. 1937, 173 L.Ed. 2d 868 (2009) ......................................................... 15 6 Astoria Fed. Sav. & Loan Ass'n v. Solimino, 501 U.S. 104, 111 S. Ct. 2166, 115 L. Ed. 2d 96 (1991) ................................... 5 7 Bell Atl. Corp. v. Twombly, 8 550 U.S. 544, 127 S. Ct. 1955, 167 L.Ed. 2d 929 (2007) .................................... 5 9 Bly-Magee v. California, 236 F.3d 1014 (9th Cir. 2001) ............................................................................ 15 10 California Grocers Ass'n, Inc. v. Bank of America Nat'l Trust & Sav. 11 Assn., 22 Cal. App. 4th 205, 27 Cal. Rptr. 2d 396 (1994) ........................................... 12 12 Capital Cities Cable, Inc. v. Crisp, 13 467 U.S. 691, 104 S. Ct. 2693, 81 L.Ed. 2d 580 (1984) .................................... 10 14 Carter v. Novartis, 582 F. Supp. 2d 1271 (C.D. Cal. 2008) ............................................................ 8, 9 15 Cel-Tech Commcns, Inc. v. Los Angeles Cellular, 16 20 Cal. 4th 163, 83 Cal. Rptr. 2d 548 (1999) ..................................................... 14 17 Decker v. GlenFed, Inc., 42 F.3d 1541 (9th Cir. 1994) .............................................................................. 15 18 Diaz v. Kay-Dix Ranch, 19 9 Cal. App. 3d 588, 88 Cal. Rptr. 433 (1970) .................................................... 12 20 Dowhal v. Smithkline Beecham Consumer Healthcare, 32 Cal. 4th 910, 12 Cal. Rptr. 3d 262 (2004) ..................................................... 11 21 Dworkin v. Hustler Magazine, Inc., 22 867 F.2d 1188 (9th Cir.1989) .............................................................................. 5 23 Geier v. Am. Honda Motor Co., 529 U.S. 861, 120 S. Ct. 1913, 146 L.Ed. 2d 914 (2000) .................................. 10 24 Gerber v. Bayer Corp., 25 2008 U.S. Dist. LEXIS 12174 (N.D. Cal. Feb. 6, 2008)(White, J.)................... 16 26 Gil v. Bank of Am., N.A., 138 Cal. App. 4th 1371, 42 Cal. Rptr. 3d 310 (2006) ........................................ 15 27 Heliotrope Gen., Inc. v. Ford Motor Co., 28 189 F.3d 971 (9th Cir.1999) ................................................................................. 4 SHULMAN HODGES & ii BASTIAN LLP
26632 Towne Centre Drive Suite 300 Foothill Ranch, CA 92610 4280-000\G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Memo.doc
1 Hobby Indus. Ass'n of Am. v. Younger, 101 Cal. App. 3d 358, 161 Cal. Rptr. 601 (1980) .............................................. 14 2 Kanter v. Warner Lambert Co., 3 99 Cal. App. 4th 780, 122 Cal. Rptr. 2d 72 (2002). ......................................... 8, 9 4 Kearns v. Ford Motor Co., 567 F.3d 1120 (9th Cir. 2009) ............................................................................ 16 5 Laster v. T-Mobile, 6 407 F. Supp. 2d 1181 (S.D. Cal. 2005) .............................................................. 16 7 Mack v. South Bay Beer Distributors, 798 F.2d 1279 (9th Cir. 1986) .............................................................................. 5 8 Mills v. Warner Lambert Co., 9 581 F. Supp. 2d 772 (E.D. Tex. 2008) ................................................................. 8 10 National Council Against Health Fraud, Inc. v. King Bio Pharm., Inc., 107 Cal. App. 4th 1336, 133 Cal. Rptr. 2d 207 (2003) .................................. 6, 11 11 Outboard Marine Corp. v. Superior Court, 12 52 Cal. App. 3d 30, 124 Cal. Rptr. 852 (1975) .................................................. 16 13 Ove v. Gwinn, 264 F.3d 817 (9th Cir. 2001) ................................................................................ 5 14 Scharringhausen v. U.S., 15 No. 06-CV-2167 JLS (CAB), 2008 WL 686691 (S.D. Cal. Mar. 13, 2008) ............................................................................................................... 4 16 Swanson v. St. John's Reg'l Med. Ctr., 17 97 Cal. App. 4th 245, 118 Cal. Rptr. 2d 325 (2002) .......................................... 14 18 Udall v. Tollman, 380 U.S. 1, 85 S. Ct. 792, 13 L.Ed. 2d 616 (1965) ............................................ 12 19 United States v. Article of Drug Ova II, 20 414 F. Supp. 660 (D.N.J. 1975).......................................................................... 13 21 Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097 (9th Cir. 2003) ............................................................................ 15 22 Williston Basin Interstate Pipe-line Co. v. An Exclusive Gas Storage 23 Leasehold And Easement In The Cloverly Subterranean Geological Formation, 24 524 F.3d 1090 (9th Cir. 2008) .............................................................................. 5 25 STATUTES 26 21 C.F.R. 10.85(e) (2010)....................................................................................... 7 27 21 C.F.R. 201.10 (2010) ......................................................................................... 7 28 21 C.F.R. 201.5 (2010) ........................................................................................... 7 SHULMAN HODGES & iii BASTIAN LLP
1 21 C.F.R. 201.61(b) (2010) .................................................................................... 7 2 21 C.F.R. 201.62 (2010) ......................................................................................... 7 3 21 C.F.R. 201.66(c)(4) (2010) ................................................................................ 7 4 21 C.F.R. 211 (2010) .............................................................................................. 7 5 21 U.S.C. 321(g)(1) ................................................................................................ 6 6 21 U.S.C. 351(a)(2)(B) ........................................................................................... 7 7 21 U.S.C. 351(b) ..................................................................................................... 6 8 21 U.S.C. 352(f)(1) ................................................................................................. 7 9 21 U.S.C. 379r .................................................................................................... 8, 9 10 21 U.S.C. 301 et seq. ............................................................................................ 6 11 Cal. Bus. & Prof. Code 17200 .............................................................................. 13 12 Cal. Bus. & Prof. Code 17500 .............................................................................. 14 13 Cal. Civ. Code 1770.............................................................................................. 13 14 Cal. Civ. Code 1770(a)(7) .................................................................................... 13 15 Cal. Civ. Code 1780(a) ......................................................................................... 13 16 Cal. Civ. Code 1782............................................................................................... 16 17 Cal. Health & Safety Code 109875 ........................................................................ 6 18 Cal. Health & Safety Code 11014 .......................................................................... 6 19 Cal. Health & Safety Code 111235 ........................................................................ 6 20 RULES 21 Fed. R. Civ. P. 12(c) .................................................................................................. 4 22 Fed. R. Evid. 201 ....................................................................................................... 5 23 OTHER AUTHORITIES 24 California Consumer Legal Remedies Act .............................................................. 13 25 California Sherman Food and Drug Act .................................................................... 6 26 Compliance Policy Guide 400.400 ...................................................................... 7, 12 27 Food and Drug Administration Modernization Act of 1997 ..................................... 8 28 Homeopathic Pharmacopeia of the United States ..................................................... 6 SHULMAN HODGES & iv BASTIAN LLP
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MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANTS MOTION FOR JUDGMENT ON THE PLEADINGS Defendant Boiron, Inc. (Boiron) respectfully submits this Memorandum of
4 Points and Authorities in support of its Motion for Judgment on the Pleadings, 5 pursuant to Federal Rule of Civil Procedure 12(c), on the ground that the 6 Complaint fails to state a claim upon which relief can be granted. Moreover, given 7 that the Complaint is a veiled attempt to fundamentally alter the marketing and sale 8 of homeopathic drugs in the United States, the regulation of which Congress 9 expressly delegated to the United States Food and Drug Administration (FDA), 10 Plaintiffs claims are preempted by federal law. 11 I. 12 INTRODUCTION Boiron is part of an international company founded in 1932 in Lyon, France
13 that has been manufacturing and distributing homeopathic drugs for over 80 years. 14 Boiron has been selling Childrens Coldcalm, a homeopathic drug for children 3 15 years of age and older that provides multi-symptom cold relief, in the U.S. since 16 2008. Boiron does not advertise Childrens Coldcalm on television, radio or in the 17 print media; nor does Boiron sell directly to the consuming public. 18 The label on Childrens Coldcalm, which conforms to federal labeling
19 requirements for homeopathic drugs, provides: (1) a clear indication that the 20 product is homeopathic; (2) directions for use; (3) an ingredient list specifying 21 dilutions and an indication for use for each ingredient; and (4) a general description 22 stating the product is for multi-symptom cold relief. Class Action Complaint 23 (Compl.) Ex. 1 and 2: 24 /// 25 /// 26 /// 27 /// 28 ///
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 On August 31, 2010, Plaintiff Gina Delarosa (Plaintiff) filed suit1 against 18 Boiron claiming vaguely that the Childrens Coldcalm label is false and 19 misleading. Despite the fact that Childrens Coldcalm is intended for children, the 20 adult Plaintiff claims to have consumed Childrens Coldcalm as directed, but it 21 did not work as advertised nor did Plaintiff experience any of the promised 22 benefits. Compl. at 8, 31. Notwithstanding the fact that Childrens Coldcalm 23 has only been sold since 2008, Plaintiff seeks monetary damages for a putative 24
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Plaintiff initially filed suit in the Superior Court of California, County of Orange, Delarosa vs. Boiron USA, Inc. and Does 1-20, No. 30-2010-00404262-CU-MTCMX. Defendant removed the action to the U.S. District Court for the Central District of California on federal diversity grounds on October 14, 2010. Boiron filed its Answer to the Complaint with this Court on October 21, 2010. The Parties agreed to a Stipulation Striking Defendant Boiron USA, Inc. and Interlineating Defendant Boiron, Inc. which the Court approved on November 8, 2010. 3
1 class of California purchasers of the product for the past 4 years. Plaintiff further 2 demands Boiron cease sales of Childrens Coldcalm under the current label. 3 Plaintiff, however, spends little time specifying how the statements on the
4 label are purportedly fraudulent, as required under both Rule 9(b) and Twombly. 5 Rather, Plaintiff launches an assault upon homeopathy and homeopathic drug 6 preparation, nearly all of which is unrelated to Childrens Coldcalm. Compl. at 7 11-20. For instance, Plaintiff does not complain that Childrens Coldcalm fails to 8 comply with federal labeling requirements; she instead argues that the label 9 nonetheless misleads consumers because 1) the FDA has never deemed the [sic] 10 Childrens Coldcalm as effective against any ailment or condition; 2) Defendants 11 treatments have never been proven effective, nor can they since the tablets contain 12 none of its purported active ingredients; and 3) serial dilutions, such as those 13 claimed by Defendant, render the ingredients non-existent. Compl. at 21. 14 These criticisms, even if deemed true for purposes of this motion, not only
15 fall short of establishing any colorable state law claim against Boiron, but are also 16 nothing more than an impermissible collateral attack on the decisions of the expert 17 federal agency charged expressly by Congress with regulating the marketing and 18 sale of homeopathic drugs. Because the Complaint seeks to impose requirements 19 on the labeling of homeopathic drugs different from what the federal government 20 requires, Plaintiffs claims are preempted. Accordingly, this Court should dismiss 21 the Complaint with prejudice. 22 II. 23 STANDARD OF REVIEW After the pleadings are closed[,] ... a party may move for judgment on the Fed. R. Civ. P. 12(c). A Rule 12(c) motion attacks the legal
24 pleadings.
25 sufficiency of the claims alleged in the complaint. Scharringhausen v. U.S., No. 26 06-CV-2167 JLS (CAB), 2008 WL 686691, at *2 (S.D. Cal. Mar. 13, 2008). Such 27 a motion is properly granted when, taking all the allegations in the pleadings as 28 true, the moving party is entitled to judgment as a matter of law. Heliotrope Gen.,
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1 Inc. v. Ford Motor Co., 189 F.3d 971, 978-79 (9th Cir.1999)(citation omitted). A 2 12(c) motion is functionally identical to a Rule 12(b) motion to dismiss, as a 3 result the same standard of review applicable to a Rule 12(b) motion applies to its 4 Rule 12(c) analog[.] Dworkin v. Hustler Magazine, Inc., 867 F.2d 1188, 1192 5 (9th Cir.1989). 6 To survive a motion to dismiss for failure to state a claim, the plaintiff must
7 allege enough facts to state a claim to relief that is plausible on its face. Williston 8 Basin Interstate Pipe-line Co. v. An Exclusive Gas Storage Leasehold And 9 Easement In The Cloverly Subterranean Geological Formation, 524 F.3d 1090, 10 1096 (9th Cir. 2008) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 11 1955, 167 L. Ed. 2d 929 (2007)). [A] plaintiff's obligation to provide the
12 grounds' of his entitle[ment] to relief requires more than labels and conclusions, 13 and a formulaic recitation of the elements of a cause of action will not do. 14 Twombly, 550 U.S. at 555 (citation omitted). While factual allegations are taken as 15 true and construed in the light most favorable to the non-moving party, 16 conclusory allegations of law and unwarranted inferences are insufficient to 17 defeat a motion to dismiss.2 Ove v. Gwinn, 264 F.3d 817, 821 (9th Cir. 2001) 18 (citations omitted). 19 III. 20 21 ARGUMENT A. FEDERAL LAW PREEMPTS PLAINTIFFS CLAIMS
Homeopathy is a Congressionally-recognized tradition of medicine that has
22 been used by millions of people in the United States and throughout the world for 23 24 25 26 27 28
A fact is properly subject to judicial notice, if it is one not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned. Fed. R. Evid. 201. Accordingly, a court may consider matters of public record on a motion for judgment on the pleadings without transforming it into one for summary judgment. See Mack v. South Bay Beer Distributors, 798 F.2d 1279, 1282 (9th Cir. 1986), abrogated on other grounds by Astoria Fed. Sav. & Loan Ass'n v. Solimino, 501 U.S. 104, 111, 111 S. Ct. 2166, 115 L. Ed. 2d 96 (1991). 5
1 more than 200 years.3
Homeopathy involves the use of carefully diluted
2 preparations (homeopathic drugs) for symptomatic relief of conditions. Because 3 homeopathic drugs are produced from natural sources, including plant, mineral, 4 and animal matter, they have wide appeal as a safe alternative to allopathic drugs. 5 With a full understanding of the nature of homeopathy as a long-established
6 and familiar discipline, Congress officially sanctioned the sale of homeopathic 7 drugs in the United States in 1938 with the enactment of the federal Food, Drug, 8 and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., wherein Congress adopted 9 the Homeopathic Pharmacopeia of the United States (HPUS) as an official 10 compendium.4 See 21 U.S.C. 321(g)(1). The HPUS includes a compilation of 11 standards for source, composition, and preparation of homeopathic drugs. The 12 Homeopathic Pharmacopeia Convention, a non-governmental, non-profit scientific 13 organization composed of experts5 in the fields of medicine, biology, botany, 14 chemistry, and pharmacy, who publishes HPUS, determines which homeopathic 15 drugs should be listed in the HPUS based on evidence of its prior or known uses as 16 a homeopathic drug. See generally, National Council Against Health Fraud, Inc. 17 v. King Bio Pharm., Inc., 107 Cal. App. 4th 1336, 1341 133 Cal. Rptr. 2d 207 18 (2003). 19 In 1988, the FDA confirmed its position on marketing homeopathic drugs
20 when it issued a Compliance Policy Guide (CPG) entitled Conditions Under 21 22 23 24 25 26 27

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The background information provided in this section about homeopathic medicine can be found in FDA Compliance Policy Guide 7132.15, Conditions Under Which Homeopathic Drugs May Be Marketed (Sec. 400.400) (First issued May 31, 1988, revised March 1995). See Request for Judicial Notice (RJN) The California Sherman Food and Drug Act also recognizes the HPUS as an official compendium and notes that a product labeled and offered for sale as a homeopathic drug, [ ] shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States . Cal. Health & Safety Code 11014, 109875, and 111235. The Convention works closely with the FDA and other homeopathic organizations. See 21 U.S.C. 351(b). 6
1 Which Homeopathic Drugs May Be Marketed.6 See CPG 400.400 (formerly CPG 2 7132.15), attached to RJN. The CPG describes the Agencys regulatory approach 3 toward homeopathic drugs, including a description of the regulatory requirements 4 that apply to both homeopathic drugs and other nonprescription, over-the-counter 5 (OTC) drugs. Id. (This document provides guidance on the regulation of OTC 6 and prescription homeopathic drugs and delineates those conditions under which 7 homeopathic drugs may ordinarily be marketed in the U.S.). For example, the 8 CPG requires homeopathic drug manufacturers to register with the FDA, list their 9 drug products with the Agency, and meet certain legal standards for strength, 10 purity, and packaging, like other drug manufacturers. See 21 U.S.C. 352(f)(1), 11 21 U.S.C. 351(a)(2)(B), 21 C.F.R. 211 (2010). 12 Of relevance here, the FDA also significantly regulates the labels on
13 homeopathic drugs. Specifically, the FDA requires a homeopathic label to contain: 14 (1) adequate directions for use[,] 21 C.F.R. 201.5 (2010); (2) a statement of 15 ingredients, id. 201.10 (2010); (3) the dilution, id. 201.62 (2010); and (4) at 16 least one major OTC indication for use (i.e., medical problem to be treated). See 17 21 C.F.R. 201.61(b) (2010) (the indications for use shall be included in the 18 directions for use of the drug, as required by [21 U.S.C. 352(f)(1)] of the act and 19 by the regulations in this part.), and 21 C.F.R. 201.66(c)(4) (2010) (an OTC 20 drug container or wrapper must contain the heading Use or Uses, followed by 21 the indications for the specific drug product.). Most importantly, therefore, FDA 22 requires homeopathic drug companies to include an indication for use statement 23 (i.e. statement indicating what the drug is effective for) on an OTC homeopathic 24 drug label. 25
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A CPG constitutes a formal FDA advisory opinion, which FDA is obligated to follow unless or until it is amended or revoked. See 21 C.F.R. 10.85(e) (2010). Notably, when FDA issued the CPG, fifty years after Congress officially recognized homeopathic drugs in the FDCA, the agency was clearly aware of how homeopathic efficacy claims included on product labels were developed and supported. 7
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Federal Mandate Expressly Prohibits Plaintiffs Claims
Congress expressly preempted the regulation of nonprescription or OTC
3 drugs when it amended the FDCA via the Food and Drug Administration 4 Modernization Act of 1997, which included the National Uniformity for 5 Nonprescription Drugs clause. 21 U.S.C. 379r. Under this preemption clause, 6 Congress precluded any State or political subdivision of any State from 7 establishing any requirement: (1) that relates to the regulation of an OTC drug; and 8 (2) that is different from or in addition to, or that is otherwise not identical with, a 9 requirement under the FDCA. See 21 U.S.C. 379r(a); Carter v. Novartis, 582 F. 10 Supp. 2d 1271, 1279 (C.D. Cal. 2008) (citations omitted).7 Accordingly, courts in 11 California and elsewhere have routinely dismissed as preempted challenges to 12 statements made on drug labels such as that here. See generally, Carter, 582 F. 13 Supp. 2d at 1271; Mills v. Warner Lambert Co., 581 F. Supp. 2d 772 (E.D. Tex. 14 2008); Kanter v. Warner Lambert Co., 99 Cal. App. 4th 780, 122 Cal. Rptr. 2d 72 15 (2002). 16 For example, in Kanter, the California Court of Appeals rejected fraud and
17 other putative class action claims premised on the accuracy of federally-approved 18 labels for lice treatment medications. Id. at 796. Plaintiff argued that the labels 19 were false because head lice had developed a resistance to the insecticides in the 20 products, rendering them ineffective. Id. at 788. The court analyzed the relevant 21 regulations applicable to the labeling of defendants OTC product to determine if 22 those laws had preemptive effect. Id. at 792. The court determined that even 23 though the FDA does not require individual OTC drug labels to be submitted for 24 approval, the FDA sets forth explicit and detailed federal requirements regarding 25 the contents of these labels. Id. at 795. Accordingly, challenges to those labels 26
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Congress further provided that any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug shall be deemed a state requirement under this section. See id. (citing 21 U.S.C. 379r(a)(1)). 8
1 were preempted. Id. at 797. The court further affirmed the dismissal of all 2 California state claims as preempted finding that, while each of plaintiffs legal 3 theories, including false advertising, unfair competition, and violations of the 4 CLRA, may differ, each is bottomed on the assertion that this approved label is no 5 longer accurate or adequate and that the label should be changed or the product 6 banned, which falls within FDAs jurisdiction. Id. at 796. 7 More recently, this jurisdiction broadened Congress OTC drug preemption
8 clause. Carter, 582 F. Supp. 2d at 1271. In Carter, a putative class challenged the 9 indications for use statement on the labels of childrens OTC cough and cold 10 medicines arguing not only that childrens cough and cold medicines were 11 ineffective and contrary to their label, but also affirmatively unsafe based on FDA 12 and other findings. Id. at 1276. Plaintiffs raised several arguments against
13 preemption contending that their California state claims fell outside the bounds of 14 FDA regulation. Id. at 1282. The court found, however, that the touchstone of 15 preemption under 379r is the effect that a finding of liability on a particular claim 16 would have on the Defendants. Id. at 1283 (emphasis in original). In granting 17 the motion to dismiss, the court elaborated that the FDCA and preemption 18 precedent suggest that virtually any state requirement that relates to the regulation 19 of nonprescription drugs can be preempted, regardless of the common law theory 20 under which it is brought. Id. at 1282. See also Green v. BDI Pharmaceuticals, 21 803 So. 2d 68, 74, 2001 La. App. LEXIS 2390 (La. App. 2 Cir. 2001)(A plain 22 reading of 21 U.S.C. 379r shows a clear intent to override any State labeling 23 requirements). 24 Here, each of Plaintiffs grievances against Childrens Coldcalm directly
25 assaults the federal framework that governs homeopathic drugs and regulates their 26 labels. For example, Plaintiff asserts in a conclusory manner that the homeopathic 27 ingredients in Childrens Coldcalm are diluted to the point to render them 28 ineffective, and that this practice runs contrary to dose-response relationship
9
1 established by pharmacology. Id. at 17-20. As an initial matter, none of the 2 drug products regulated by the FDA, including homeopathic drugs, are subject to 3 any statutory dose-response prerequisites. More to the point, even if, as Plaintiff 4 alleges, the practice of dilution runs contrary to practices established by 5 pharmacology, Congress recognized and accepted the practice of dilution in the 6 manufacture of homeopathic drugs when it adopted the HPUS as an official 7 compendium. Thus, to preclude Boiron from being able to market its product 8 under the current label based on others practices would run counter to FDAs 9 directives and Congress intent. 10 Plaintiff also argues that homeopathic drugs are not held to the same
11 rigorous standard as other drugs. This can and has lead [sic] to serious confusion. 12 Id. at 12. Once again, it is the FDA, pursuant to Congressional mandate, who 13 determines the appropriate standards to apply to homeopathic drugs. Thus, any 14 grievance about those standards and any risk of confusion that may result is better 15 directed to the federal agency that promulgated them, not this Court. 16 17 2. Plaintiff Improperly Seeks to Frustrate Federal Objectives
Notwithstanding that federal law expressly preempts any challenges to labels
18 that conform to FDAs requirements, the doctrine of implied preemption further 19 precludes Plaintiffs claims. Implied preemption applies when compliance with 20 both state and federal law is impossible, or when the state law stands as an obstacle 21 to the accomplishment and execution of the full purposes and objectives of 22 Congress. Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 698-99, 104 S. Ct. 23 2693, 81 L.Ed. 2d 580 (1984) (citation omitted); see also Mills, 581 F. Supp. 2d at 24 790 (noting claims were preempted because defendants could either market their 25 products in compliance with the FDA requirements, or they can refrain from 26 marketing their products in order to comply with the requirements (and avoid the 27 liability) imposed by Plaintiffs lawsuit. They cannot do both.). 28
Such obstacles exist where state law presents difference; irreconcilability; 10

1 inconsistency; violation; curtailment; interference or the like with federal law. 2 Geier v. Am. Honda Motor Co., 529 U.S. 861, 873, 120 S. Ct. 1913, 146 L.Ed. 2d 3 914 (2000) (citation omitted)(State tort claims seeking to impose regulations that a 4 federal agency rejected in favor of a broader proposal that gave manufacturers 5 more options were impliedly preempted because they stood as an obstacle to the 6 accomplishment of the federal agencys objective); see also Dowhal v. Smithkline 7 Beecham Consumer Healthcare, 32 Cal. 4th 910, 929, 12 Cal. Rptr. 3d 262 8 (2004)(federal policy on the warning requirements of an OTC drug set forth in an 9 FDA letter impliedly preempted a case involving state-law requirements that 10 sought to provide greater warnings on the label). 11 In National Council Against Health Fraud, Inc. v. King Bio Pharm., Inc.,
12 Plaintiff unsuccessfully challenged a homeopathic drugs label and advertising on 13 the grounds that the products were not effective as claimed. 107 Cal. App. 4th at 14 1347-48. In dismissing plaintiffs public policy argument for the need to require a 15 defendant to affirmatively substantiate its homeopathic drug claims, the court 16 explained that: 17 18 19 20 21 22 23 24 25 26 27 28
The [FDCA] recognizes as official the remedies and standards of the Homeopathic Pharmacopeia. . . . The FDA permits homeopathic remedies included in the Homeopathic Pharmacopeia to be marketed. King Bios products are included in the Homeopathic Pharmacopeia and otherwise comply with FDA regulations. Thus, prior to the
marketing of a product by King Bio, the general efficacy and safety of the remedy has been substantiated to the extent required by federal law. 107 Cal. App. 4th at 1348 (emphasis added). Here, as an initial matter, Congress included numerous provisions in the FDCA governing homeopathic drugs, including adoption of the HPUS as an 11
1 official compendium.
Plaintiff does not contend Boirons products are not
2 included in the HPUS or otherwise fail to meet those standards. Moreover, the 3 FDA considered what regulations to impose on the marketing and sale of 4 homeopathic drugs when it issued the CPG in 1988, which it revised in 1995. CPG 5 400.400. Again, Plaintiff does not argue Childrens Coldcalm violated those Thus, to find legal fault with the way homeopathic drugs are
6 requirements.
7 marketed and labeled even though a homeopathic drug manufacturer conforms to 8 federal requirements, not only impedes on FDAs jurisdiction, but further 9 undermines Congress wish that the American public have access to this safe and 10 natural alternative to allopathic medicine. Accordingly, Plaintiffs claims cannot 11 stand. 12 13 14 3. Complaints About the Effectiveness of Homeopathic Drugs Are Better Addressed By the FDA If this Court believes Plaintiffs claims are neither expressly nor impliedly
15 preempted, the Court nonetheless should exercise judicial restraint and abstain 16 from hearing the case in deference to the governments enforcement powers. The 17 idea behind abstention is that the courts should ordinarily give great deference to 18 the interpretation given the statute by the officers or agency charged with its 19 administration. Udall v. Tollman, 380 U.S. 1, 16, 85 S. Ct. 792, 13 L.Ed. 2d 616 20 (1965); see generally, Diaz v. Kay-Dix Ranch 9 Cal. App. 3d 588, 599, 88 Cal. 21 Rptr. 433 (1970). 22 Federal and California state agencies are recognized as having both the
23 responsibility and the expertise to address the type of allegation brought by 24 Plaintiff, namely, that homeopathic drugs lack any the therapeutic benefits. These 25 agencies plainly have better sources of gathering information and addressing its 26 value than do courts in isolated cases. California Grocers Ass'n, Inc. v. Bank of 27 America Nat'l Trust & Sav. Assn., 22 Cal. App. 4th 205, 218 27 Cal. Rptr. 2d 396 28 (1994)(internal citation and quotation marks omitted); see also American Home
12
1 Prod. Corp. v. Johnson & Johnson, 672 F. Supp. 135, 145-46 (S.D.N.Y. 1987) 2 (because public interest is best served by leaving OTC drug labeling regulation and 3 enforcement to expert regulatory function of FDA, private attorney general 4 action for injunction and compensation against manufacturer of drug product under 5 state unfair competition laws or federal Lanham Act is precluded). 6 This Court should therefore not permit Plaintiff to bypass the relevant
7 agencies and effectively supplant their authority by bringing a civil action. See, 8 e.g., United States v. Article of Drug Ova II, 414 F. Supp. 660, 661-62 (D.N.J. 9 1975); Thompson Medical Co. v. F.T.C., 791 F.2d 189, 194 (D.C. Cir. 1986)(FTC 10 determination of false advertising claims based upon asserted ineffectiveness of 11 one drug (Aspercreme) required extensive evidentiary hearing, a record in excess 12 of 6500 pages, a 127-page opinion of an ALJ and a 56-page FTC opinion, before it 13 reached the judicial branch). 14 15 16 17 B. BOIRON IS ENTITLED TO JUDGMENT ON THE
PLEADINGS BECAUSE PLAINTIFF FAILS TO STATE A CLAIM UPON WHICH RELIEF CAN BE GRANTED Alleging breach of the California Consumer Legal Remedies Act8
18 (CLRA)(First Claim), common law fraud (Second Claim), and violations of 19 the Californias Unfair Competition Law9 and Californias False Advertising 20 21 22 23 24 25 26 27 The CLRA prohibits unfair methods of competition and unfair or deceptive acts or practices. Cal. Civ. Code 1770. An action may be brought under the CLRA pursuant to 1780(a), which provides that [any] consumer who suffers any damage as a result of the use or employment by any person of a method, act, or practice declared to be unlawful by Section 1770 may bring an action against such person.... Cal. Civ. Code 1780(a) (emphasis added). The statute proscribes a variety of conduct, including a prohibition again [r]epresenting that goods or services are of a particular standard, quality, or grade, or that goods are of a particular style or model, if they are of another. Id. at 1770(a)(7).
9 8
The UCL proscribes any unlawful, unfair or fraudulent business act or practice.... Cal. Bus. & Prof. Code 17200. 28
13
1 Law10 (collectively, Third Claim), Plaintiff purports to seek all available legal 2 and equitable statutory remedies, including restitution, damages, statutory 3 penalties, attorneys fees, costs, and interest. See Compl. at 36, 41, 42, 46, and 4 Prayer for Relief. Plaintiff further seeks injunctive relief whereby consumers 5 would be deprived of this safe and natural drug until Boiron changes the Childrens 6 Coldcalm label. Plaintiff, however, fails to satisfy the threshold requirements 7 needed to proceed with her Complaint. 8 9 10 1. Safe Habor Provisions Preclude Plaintiffs Consumer Protection Claims Boirons compliance with federally-imposed requirements for labeling
11 homeopathic drugs provides a safe harbor to shield it from liability under the 12 CLRA, UCL, and FAL. As the California Supreme Court stated in Cel-Tech 13 Commcns, Inc. v. Los Angeles Cellular, [c]ourts may not simply impose their 14 own notions of the day as to what is fair or unfair. 20 Cal. 4th 163, 182, 83 Cal. 15 Rptr. 2d 548 (1999). When the Legislature has permitted certain conduct or 16 considered a situation and concluded no action should lie, courts may not override 17 that determination. When legislation provides a safe harbor, plaintiffs may not 18 use the general unfair competition law to assault that harbor. Id. 19 Courts have not hesitated to reject claims contending unfair or fraudulent
20 business practices similar to what is alleged here on safe harbor grounds. See, 21 e.g., Swanson v. St. John's Reg'l Med. Ctr., 97 Cal. App. 4th 245, 248, 118 Cal. 22 Rptr. 2d 325 (2002)(holding that defendant's filing of liens pursuant to Hospital 23 Lien Act precluded UCL action as a matter of law; [i]t is settled that a business 24 practice does not violate the UCL if it is permitted by law); Hobby Indus. Ass'n of 25 Am. v. Younger, 101 Cal. App. 3d 358, 370, 161 Cal. Rptr. 601 (1980)(Although 26 the Supreme Court has construed the orbit of the unfair competition statutes The FAL prohibits advertising which is untrue or misleading, and which is known, or which by the exercise of reasonable care should be known, to be untrue 28 or misleading. Cal. Bus. & Prof. Code 17500. SHULMAN HODGES & 14 BASTIAN LLP
27
10
1 expansively, it cannot be said that this embracing purview also encompasses 2 business practices which the Legislature has expressly declared to be lawful in 3 other legislation.)(Citations omitted). 4 Thus, where, as here, the business practice complained of has been explicitly
5 sanctioned or required by federal regulations, it cannot serve as a basis for liability. 6 The very statements that Plaintiff alleges give rise to liability for unfair or 7 deceptive practices the ingredients and indications for use are required on OTC 8 labels for homeopathic drugs. As such, Boirons compliance with federal labeling 9 requirements is not actionable under Californias consumer protection statutes and 10 those claims must be dismissed. 11 12 2. Plaintiff Fails To State Fraud With Particularity
Plaintiff never identifies a single statement on the Childrens Coldcalm label
13 that is or could be false or misleading. Instead, it appears that Plaintiff contends 14 any and every statement Boiron made about its product must be false, based solely 15 on Plaintiffs belief that homeopathic drugs simply do not work. Pursuant to Rule 16 9(b), however, Plaintiff is required to allege circumstances constituting the alleged 17 fraud that are specific enough to give defendants notice of the particular 18 misconduct . . . so that they can defend against the charge and not just deny that 19 they have done anything wrong. Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 20 1106 (9th Cir. 2003) (quoting Bly-Magee v. California, 236 F.3d 1014, 1019 (9th 21 Cir. 2001)). Moreover, an unadorned, the-defendant-unlawfully-harmed-me
22 accusation will not suffice. Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949, 173 L.Ed. 2d 23 868 (2009). 24 Thus, Plaintiff must allege the who, what, when, where, and how of the
25 misconduct charged. Vess, 317 F.3d at 1106; Decker v. GlenFed, Inc., 42 F.3d 26 1541, 1548 (9th Cir. 1994)). Plaintiff is further required to plead the five elements 27 required for her California common law fraud court: (1) misrepresentation, (2) 28 knowledge of its falsity, (3) intent to defraud, (4) justifiable reliance, and (5)
15
1 resulting damage. Gil v. Bank of Am., N.A., 138 Cal. App. 4th 1371, 42 Cal. Rptr. 2 3d 310 (2006). 3 Plaintiff, however, fails to meet these pleading requirements. Indeed, while
4 Plaintiff makes conclusory assertions that Boiron made misrepresentations about 5 Childrens Coldcam knowing they were false, she neglects to address the intent, 6 reliance or injury elements required. Thus, as Plaintiff does not satisfy the
7 requirements to proceed with a fraud action or any statutory claims sound[ing] in 8 fraud, which include the CLRA and UCL, her claims must be dismissed. See 9 Kearns v. Ford Motor Co., 567 F.3d 1120, 1125-26 (9th Cir. 2009)(holding that 10 Rule 9(b) applied to a plaintiff's claims under the CLRA and UCL because they 11 were grounded in fraud). 12 13 14 3. Plaintiffs Failure to Comply With CLRAs Notice
Requirements Precludes Her Claim for Damages Plaintiff also failed to comply with the statutory requirements before
15 bringing her CLRA claim. Section 1782 of the California Civil Code provides that 16 a plaintiff shall provide notice of her claims at least thirty days before filing an 17 action for damages under the CLRA. Gerber v. Bayer Corp., 2008 U.S. Dist. 18 LEXIS 12174 (N.D. Cal. Feb. 6, 2008)(White, J.). Courts require strict
19 compliance with this requirement. Outboard Marine Corp. v. Superior Court, 52 20 Cal. App. 3d 30, 124 Cal. Rptr. 852 (1975); Laster v. T-Mobile, 407 F. Supp. 2d 21 1181, 1196 (S.D. Cal. 2005)(Strict adherence to the statutes notice provision is 22 required to accomplish the Acts goals of expeditious remediation before 23 litigation.). 24 Plaintiff, however, has not demonstrated that she satisfied CLRAs notice
25 requirement. Indeed, Boiron alerted Plaintiff of this deficiency in its Answer, yet 26 Plaintiff has not amended the Complaint to provide the necessary proof to support 27 this claim. See Answer 32, Fourteenth Affirmative Defense. Accordingly, the 28 Court should dismiss the CLRA damages claim. Laster, 407 F. Supp. 2d at 1196.
16
1 IV. 2
CONCLUSION For the foregoing reasons, Defendant respectfully requests that the Court
3 grant its Motion for Judgment on the Pleadings as to Plaintiffs First, Second, and 4 Third Claims for Relief with Prejudice. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
SHULMAN HODGES & BASTIAN LLP Dated: January 21, 2011 By: /s/ Gary A. Pemberton Gary A. Pemberton John Mark Jennings
PATTON BOGGS LLP Dated: January 21, 2011 By: /s/ Christina Guerola Sarchio Christina Guerola Sarchio (pro hac vice) Attorneys for Defendant Boiron, Inc.
17
PROOF OF SERVICE
2 STATE OF CALIFORNIA, COUNTY OF ORANGE 3 I am employed in the City of Foothill Ranch, County of Orange, State of California. I am over the age of 18 years and not a party to the within action. My 4 business address is 26632 Towne Centre Drive, Suite 300, Foothill Ranch, California 92610. 5 On January 21, 2011, I served the documents named below on the parties in this 6 Action as follows: 7 DOCUMENT(S) SERVED: 8 9 10 SERVED UPON: 11 [ x] 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
DEFENDANT BOIRON, INC.S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION AND MOTION FOR JUDGMENT ON THE PLEADINGS SEE THE ATTACHED SERVICE LIST
TO BE SERVED BY THE COURT VIA NOTICE OF ELECTRONIC FILING (NEF) Pursuant to controlling General Order(s) the foregoing document(s) will be served by the court via NEF and hyperlink to the document. On January 21, 2011 I checked the CM/ECF docket for this case and determined that the following person(s) are on the Electronic Mail Notice List to receive NEF transmission at the email address(es) indicated below: Ryan M Ferrell rferrell@calljensen.com Scott J Ferrell sferrell@trialnewport.com,lberger@trialnewport.com Christina Guerola Sarchio csarchio@pattonboggs.com
[ x]
(FEDERAL) I declare that I am employed in the office of a member of the bar of this court, at whose direction this service was made. I declare under penalty of perjury that the foregoing is true and correct.
Executed on January 21, 2011, at Foothill Ranch, California. /s/ Tovia Lenz Tovia Lenz
SERVICE LIST
2 Counsel for Defendant Boiron, Inc. 3 Christina Guerola Sarchio Co-Chair, Government Investigations & 4 Litigation Practice Group Patton Boggs, LLP 5 2550 M Street, NW Washington, DC 20037-1350 6 Direct: (202) 457-7527 Fax: (202) 457-6315 7 Main: (202) 457-6000 csarchio@pattonboggs.com 8 Counsel for Plaintiff Gina Delarosa: 9 Newport Trial Group 10 Scott J. Ferrell, Esq. Ryan M. Ferrell, Esq. 11 610 Newport Center Drive, Suite 700 Newport Beach, CA 92660 12 Tel: (949) 706-6464 Fax: (949) 706-6469 13 rferrell@calljensen.com 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Motion For Judgment On Pleadings Delarosa V Boiron

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Case 8:10-cv-01569-JST -CW Document 27

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PLEASE TAKE NOTICE that on February 28, 2011, at 10:00 a.m., or as

19 3 which took place on December 20, 2010. 20 21 22 23 24 25 26 27 28

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PROOF OF SERVICE STATE OF CALIFORNIA, COUNTY OF ORANGE

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Homeopathy is a Congressionally-recognized tradition of medicine that has

4280-000\G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Memo.doc

1 more than 200 years.3

Homeopathy involves the use of carefully diluted

20 when it issued a Compliance Policy Guide (CPG) entitled Conditions Under 21 22 23 24 25 26 27

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4280-000\G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Memo.doc

Federal Mandate Expressly Prohibits Plaintiffs Claims

Congress expressly preempted the regulation of nonprescription or OTC

4280-000\G:\Wp\Cases\A-B\Boiron Inc\Pldgs\Mtn Judgment Pleadings - Memo.doc

Notwithstanding that federal law expressly preempts any challenges to labels

Such obstacles exist where state law presents difference; irreconcilability; 10

Plaintiff does not contend Boirons products are not

Plaintiff never identifies a single statement on the Childrens Coldcalm label

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