Case3:14-cv WHO Document59 Filed04/13/15 Page1 of 12

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1 Case:-cv-00-WHO Document Filed0// Page of 0 Jonathan F. Cohn (admitted pro hac vice) jcohn@sidley.com Cara R. Viglucci López (admitted pro hac vice) cvigluccilopez@sidley.com Paul J. Ray (admitted pro hac vice) paul.ray@sidley.com 0 K Street, N.W. Washington, D.C. 00 Telephone: ().000 Facsimile: (). Eugene A. Schoon (admitted pro hac vice) eschoon@sidley.com One South Dearborn Chicago, IL 00 Telephone: (). Facsimile: ().0 Ryan Sandrock (SBN ) rsandrock@sidley.com California Street, Suite 00 San Francisco, CA 0 Telephone: ().0 Facsimile: ().00 Attorneys for Defendants Bayer AG, Bayer Corporation, and Bayer HealthCare LLC COLLEEN GALLAGHER, ILANA FARAR, ANDREA LOPEZ, JOANN CORDARO, and ROSANNE COSGROVE, on behalf of themselves and all others similarly situated, v. Plaintiffs, BAYER AG, BAYER CORPORATION, and BAYER HEALTHCARE LLC, Defendants. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION Case No. -cv-00-who NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT; [PROPOSED] ORDER [Fed. R. Civ. P. (b), (b)(), ()(b)()] Second Amended Complaint Filed: March 0, Date: June, Time: :00 PM Place: Courtroom Judge: William H. Orrick MOTION TO DISMISS CASE NO. -00-WHO

2 Case:-cv-00-WHO Document Filed0// Page of 0 NOTICE OF MOTION AND MOTION TO PLAINTIFFS AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on June,, at :00 P.M., in Courtroom of the aboveentitled court, located at 0 Golden Gate Avenue, San Francisco, California 0, Defendants Bayer AG, Bayer Corporation, and Bayer HealthCare LLC will and hereby do move pursuant to Fed. R. Civ. P. (b)() and (b)() to dismiss the Second Amended Complaint for lack of subject matter jurisdiction and for failure to state a claim upon which relief may be granted. The motion is based on this notice of motion, the memorandum of points and authorities attached hereto, the previous briefing, and the Court s Order on Defendants Motion to Dismiss, and all other papers and pleadings on file hereon, and the argument of counsel at the hearing of this motion. The motion specifically is based on the grounds that: () Plaintiffs do not adequately plead that Defendants proper structure/function claims should be interpreted as disease claims; and () Plaintiffs pleadings do not support their allegations that Defendants claims are false. Dated: April, By: /s/ Jonathan F. Cohn Attorney of Record for Defendants Bayer AG, Bayer Corporation, and Bayer HealthCare LLC (i) MOTION TO DISMISS CASE NO. -00-WHO

3 Case:-cv-00-WHO Document Filed0// Page of TABLE OF CONTENTS 0 Page TABLE OF AUTHORITIES... iii INTRODUCTION AND SUMMARY OF ARGUMENT... ARGUMENT... I. Plaintiffs Do Not Link Structure/Function Claims to Disease... A. Heart Health... B. Immunity... II. Plaintiffs Studies Do Not Support Their Attempt to Plead Actual Falsity... A. Heart Health... B. Immunity... CONCLUSION... (ii) MOTION TO DISMISS CASE NO. -00-WHO

4 Case:-cv-00-WHO Document Filed0// Page of 0 CASES TABLE OF AUTHORITIES Eckler v. Wal-Mart Stores, Inc., No. -cv-, WL (S.D. Cal. Nov., )... Kardovich v. Pfizer, No. -CR- (RRM) (VVP), WL 0 (E.D.N.Y. Mar., )...,,, Padilla v. Costco, No. C (JWH), WL 0 (N.D. Ill. June, )... RULE Fed. R. Civ. P. (b)... OTHER AUTHORITIES R.M. Douglas et al., Vitamin C for Preventing and Treating the Common Cold, Cochrane Database Sys. Rev. CD0000 (0)... Salah Gariballa, Vitamin and Mineral Supplements for Preventing Infections in Older People, B.M.J. 0-0 (Aug. 0)... J.M. Graat et al., Effect of Daily Vitamin E and Multivitamin-mineral Supplementation on Acute Respiratory Tract Infections in Elderly Persons: A Randomized Controlled Trial, JAMA - (Aug. 0)... Alice H. Lichtenstein et al., Am. Heart Ass n Nutrition Comm., Diet and Lifestyle Recommendations Revision 0: A Scientific Statement, Circulation (0)... B.A. Liu et al., Effect of Multivitamin and Mineral Supplementation on Episodes of Infection in Nursing Home Residents, J. Am. Geriatr. Soc. - (Jan. 0)... Nat l Heart, Lung and Blood Institute, Health Topics, Coronary Heart Disease Risk Factors, (last visited April, )... Nat l Inst. Of Health, Health Professional Fact Sheet: Vitamin B, B-Health Professional/ (last visited Dec., )... Nat l Inst. Of Health, Health Professional Fact Sheet: Vitamin C, Professional/ (last visited Dec., )..., Page (iii) MOTION TO DISMISS CASE NO. -00-WHO

5 Case:-cv-00-WHO Document Filed0// Page of 0 Nat l Inst. Of Health, Health Professional Fact Sheet: Vitamin E, E-Health Professional/ (last visited Dec., )..., Nat l Inst. Of Health, Health Professional Fact Sheet: Selenium, Professional/ (last visited Dec., )..., Stephen J. Oppenheimer, Iron and Its Relation to Immunity and Infectious Disease, J. Nutrition S (Feb. 0)... Madeline Simasek et al., Treatment of the Common Cold, Am. Family Physician (0)... Audrey I. Stephen et al., A Systematic Review of Multivitamin and Multimineral Supplementation for Infection, () J. Human Nutrition & Dietetics (June 0)... Donald V. Veverka et al., Use of Zinc Supplements to Reduce Upper Respiratory Infections in United States Air Force Academy Cadets, Complementary Therapies in Clin. Practice (May 0)... (iv) MOTION TO DISMISS CASE NO. -00-WHO

6 Case:-cv-00-WHO Document Filed0// Page of 0 INTRODUCTION AND SUMMARY OF ARGUMENT Plaintiffs third bite at the apple fares no better than the first two. This Court articulated requirements for Plaintiffs to replead their heart health and immunity claims, but the Second Amended Complaint ( SAC ) fails to meet these requirements. See Order Granting in Part and Denying in Part Motion to Dismiss ( Order ) (Docket No. ). Accordingly, the Court should dismiss the SAC with prejudice with respect to these claims. The Court s Order explained that Plaintiffs heart and immunity claims were preempted as structure/function claims expressly approved by the FDA, and gave Plaintiffs two paths to try to salvage these claims. Order at. Plaintiffs could either: () plead facts showing that [these claims] ha[ve] been linked by virtue of specifically identified packaging or marketing to treatment or prevention of disease, or () explicitly plead with support to scientific evidence that Bayer s support heart health and support immunity claims are false as structure/function claims. Id. at, - (emphasis added). The SAC does neither. First, the SAC fails to identify any packaging or marketing linking Bayer s claims to the treatment or prevention of disease. Second, although Plaintiffs assert that the support[s] heart health and support[s] immunity claims are false, see, e.g., SAC at,, 0,,,, 0, they cite no scientific studies to support those specific... claims, Order at. Like the First Amended Complaint ( FAC ), Plaintiffs cite only articles regarding the prevention or treatment of disease. The Court did not dismiss Plaintiffs challenge to Bayer s claim that One A Day multivitamins help support physical energy after Plaintiffs conceded in their brief that Bayer made a structurefunction claim. See Order at, Memorandum of Law in Opposition to Defendants Motion to Dismiss (Docket No. 0) at -, n.. However, in the SAC, Plaintiffs once again misconstrue Bayer s claim and contend that Bayer claimed that consumers will experience increased energy,. There is a critical difference between a supports energy claim and an increased energy claim. See Kardovich v. Pfizer, Case No. -CR- (RRM) (VVP), WL 0, at * (E.D.N.Y. Mar., ) (distinguishing between improving and supporting function: [The multivitamin] makes no claim that it improves immune function. As its packaging says, it claims to support normal immune function. (emphasis added)). Defendants respectfully request this Court to clarify that Plaintiffs can proceed only on a challenge to Bayer s actual claim ( support physical energy ), not on the claim Bayer never made ( experience increased energy ). () MOTION TO DISMISS CASE NO. -00-WHO

7 Case:-cv-00-WHO Document Filed0// Page of 0 ARGUMENT I. Plaintiffs Do Not Link Structure/Function Claims to Disease. As this Court held: Any state law claim that would impose a labeling requirement that is in addition to or in conflict with the FDA s requirements for structure/function claims is preempted. Order at (citing cases). The FDA has explicitly characterized statements like supports heart health and supports immunity as structure/function claims. Id. at -. The Court allowed Plaintiffs to amend their pleadings to show that supports heart health and supports immunity have been linked by virtue of specifically identified packaging or marketing to treatment or prevention of disease. Id. at (emphasis added). But Plaintiffs have failed to make this showing. A. Heart Health Plaintiffs do not point to any specific language on the packaging, websites, or in advertisements of the Supplements that would take the supports heart health language and move it towards a disease claim. Id. at 0. Instead, like the FAC, the SAC includes images of Women s and Men s One A Day packaging that say nothing about the heart except Support[s] Hearth Health. See SAC at, Illustration, and, Illustration ( Formulated to Support... Heart Health and With Heart Health Support ). Plaintiffs assert that Bayer uses television advertisements to link its One A Day heart health Claims with cardiovascular diseases, but the only example Plaintiffs provide is for One A Day Men s 0+. See SAC at. It is the same screen image Plaintiffs included in the FAC, and it simply states, Supports heart and eye health. See id., Illustration. Plaintiffs nonetheless allege: [T]elevision advertisements for One A Day Men s 0+ state that the product is a complete multivitamin designed for men s health concerns as we age. During the commercial, the claim [s]upports heart and eye health appears prominently on the The Order clearly summarized the governing law. In the interest of economy and brevity, Defendants will reference the Order for the relevant law and will not re-argue legal issues or re-cite supporting case law already addressed by this Court. Defendants hereby incorporate their arguments from the prior briefing to dismiss Plaintiffs complaint. Furthermore, even if Defendants did make disease claims (and they did not), those claims have not been proven actually false, for the reasons stated in Defendants earlier filings. See Motion to Dismiss (Docket No. ) at -. () MOTION TO DISMISS CASE NO. -00-WHO

8 Case:-cv-00-WHO Document Filed0// Page of 0 screen while a voice-over mentions that the Supplement is designed for men s health concerns as we age. As most Americans know, as you get older, your risk for CHD [Coronary Heart Disease] and heart attack rises. The juxtaposition of the heart health Claim and the voice-over leads a consumer to believe that taking Bayer One A Day Men s 0+ will support heart health. Id. (emphasis added) (footnotes omitted). But the italicized sentence on CHD and heart attacks is not from any Bayer advertisement. Bayer never spoke or used those words. The quote is from a National Heart, Lung and Blood Institute ( NHLBI ) webpage titled Who Is at Risk for Heart Disease? Nat l Heart, Lung and Blood Institute, Health Topics, Coronary Heart Disease Risk Factors, (last visited April, ). Placing this NHLBI language next to Bayer s language, Plaintiffs create the illusion that the One A Day advertisement contained that wording. But no One A Day advertisement contained that wording or anything like it. Bayer never made any disease claim. In any event, Plaintiffs have no standing to challenge this advertisement, which pertains only to the Men s 0+ product. Order at 0, n.0 ( the plaintiffs in this suit only purchased the One A Day Women s Supplement, and there is no evidence that the Women s Supplement s advertising contained any [relevant] representation ). Finally, Plaintiffs contend that they commissioned a consumer protection survey in March, which supposedly showed that many of Bayer s consumers will interpret supports heart health as a disease-prevention claim. SAC at -. Plaintiffs have not published the survey, provided it to Defendants, or filed it with the Court. Moreover, regardless of whether consumers understand the distinction between structure-function claims and disease claims, the legal distinction exists, the FDA has spoken, and so has this Court. See Order at 0. Claims which the FDA has determined are structure-function claims do not become disease claims (subject Even if the Court were to consider the unproduced survey relevant, and it is not, plaintiffs do not provide the actual studies on which these assertions are based, and thus, these unsupported statements do nothing to support the plausibility of plaintiffs claim or the particularity standard required under Rule (b). Kardovich, WL 0, at * (citing Padilla v. Costco, No. C (JWH), WL 0, at * (N.D. Ill. June, ) (failure to identify, discuss, or attach scientific studies that demonstrate how representations were fraudulent does not satisfy Rule (b))). () MOTION TO DISMISS CASE NO. -00-WHO

9 Case:-cv-00-WHO Document Filed0// Page of 0 to different statues and regulations) just because some consumers construe them to relate to diseases. B. Immunity Plaintiffs argument on immunity is similarly flawed. Plaintiffs claim that the marketing and context in which Bayer makes its immunity Claim link this Claim to the concept of getting sick less often, but Plaintiffs cite nothing to support this conclusory assertion. SAC at ; see also Order at (holding that the Court is not required to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences ) (internal quotations marks and citation omitted). The SAC identifies no specific packaging or marketing materials regarding immunity, except for ones that use the structure-function claims: support[s] immunity and immunity support. SAC at 0,, Illustration. Plaintiffs also cite their own survey, but as discussed, purported consumer perceptions do not eliminate the FDA-recognized distinction between structure-function claims and disease claims. II. Plaintiffs Studies Do Not Support Their Attempt to Plead Actual Falsity. Plaintiffs likewise fail to explicitly plead with support to scientific evidence that Bayer s support heart health and support immunity claims are false as structure/function claims. Order at -. Instead, Plaintiffs cite articles discussing scientific evidence on the ingredients impact on diseases. Simply put, these studies concerning specific medical conditions in no way correlate to, let alone contradict as plaintiffs allege, the unrelated claims made by [the product] about its health benefits. Kardovich, WL 0, at *. A. Heart Health Plaintiffs assert that [s]cientists have examined whether supplements with these vitamins support heart health, and studies have shown that they do not. SAC at. Plaintiffs largely cite the same materials they cited in the FAC, including certain National Institute of Health ( NIH ) Factsheets. See id, 0. Each cited Factsheet contains a subsection titled Cardiovascular disease or Coronary heart disease which summarizes scientific information regarding the ingredient and its effect on or relationship to cardiovascular disease. See Nat l Inst. of Health, Office of Dietary Supplements, Health Professional Factsheet: Vitamin B; Nat l Inst. of Health, () MOTION TO DISMISS CASE NO. -00-WHO

10 Case:-cv-00-WHO Document Filed0// Page0 of 0 Office of Dietary Supplements, Health Professional Factsheet: Vitamin E; Nat l Inst. of Health, Office of Dietary Supplements, Health Professional Factsheet: Vitamin C. None shows that Bayer s structure-function claims are false. Plaintiffs also cite an American Heart Association Nutrition Committee publication on diet and lifestyle recommendations. SAC at, 0. The first sentence of the abstract states that [i]mproving diet and lifestyle is a critical component of the American Heart Association s strategy for cardiovascular disease reduction in the general population. American Heart Association Nutrition Committee, A.H. Lichtenstein et al., Diet and lifestyle recommendations revision 0: a scientific statement from the American Heart Association Nutrition Committee, CIRCULATION - (0) ( AHA ) (emphasis added). The entire publication focuses on strategies to reduce the incidence of cardiovascular disease. Plaintiffs do not cite any materials that dispute One A Day s actual structure/function claim. [T]he results of studies on particular diseases or conditions do not lend facial plausibility to far more general health benefit claims. Kardovich, WL 0, at * (relying on Eckler v. Wal-Mart Stores, Inc., No. -cv-, WL, at * (S.D. Cal. Nov., )). If anything, the cited materials confirm that One A Day s ingredients help support heart health. See B Factsheet ( Vitamin B also plays a role in... maintaining normal levels of homocysteine... [and] is involved in... hemoglobin formation. ); see also Motion to Dismiss (Docket No. ) (MTD) at -. B. Immunity Plaintiffs immunity allegations also rely on articles and studies dealing with disease. In At and of the SAC, Plaintiffs cite: Nat l Inst. of Health, Office of Dietary Supplements, Health Professional Factsheet: Vitamin C ( regular intakes of vitamin C at doses of at least 0 mg/day do not reduce the incidence of the common cold in the general population ) ( vitamin C supplementation, usually in combination with other micronutrients, does not affect cancer risk ); J.M. Graat et al., Effect of Daily Vitamin E and Multivitamin-mineral Supplementation on Acute Respiratory Tract Infections in Elderly Persons: A Randomized Controlled Trial, JAMA - (Aug. 0); B.A. Liu et al., Effect of Multivitamin and Mineral Supplementation on Episodes of Infection in Nursing Home Residents, J. Am. Geriatr. Soc. - (Jan. 0); Salah Gariballa, Vitamin and Mineral Supplements for Preventing Infections in Older People, B.M.J. 0-0 (Aug. 0); Donald V. Veverka et al., Use of Zinc Supplements to Reduce Upper Respiratory Infections in United States Air Force Academy Cadets, Complementary Therapies in Clin. Practice - (May 0); Nat l Inst. of Health, Office of Dietary Supplements, Health () MOTION TO DISMISS CASE NO. -00-WHO

11 Case:-cv-00-WHO Document Filed0// Page of 0 addition, the aforementioned Factsheets confirm the ingredients in One A Day are essential to basic immune function. See Nat l Inst. of Health, Office of Dietary Supplements, Health Professional Factsheet: Vitamin B ( Vitamin B is involved in... immune function (for example, it promotes lymphocyte and interleukin- production) ); Nat l Inst. of Health, Office of Dietary Supplements, Health Professional Factsheet: Vitamin C ( [V]itamin C plays an important role in immune function. ); Nat l Inst. of Health, Office of Dietary Supplements, Health Professional Factsheet: Vitamin E ( [v]itamin E is involved in immune function. ); see also MTD at 0-. Because Plaintiffs have failed to explicitly plead with support to scientific evidence that Bayer s support heart health and support immunity claims are false as structure/function claims, Order at -, this Court should dismiss those claims. Professional Factsheet: Selenium (discussing whether selenium prevents [c]ardiovascular disease ); R.M. Douglas et al., Vitamin C for Preventing and Treating the Common Cold, Cochrane Database Sys. Rev. CD0000 (0); Madeline Simasek et al., Treatment of the Common Cold, Am. Family Physician (0); E. Villamor et al., Effects of Vitamin A Supplementation on Immune Responses and Correlation with Clin. Outcomes, Clin. Microbiology Rev. - (July 0) (discussing effect of vitamin A on various diseases); Stephen J. Oppenheimer, Iron and Its Relation to Immunity and Infectious Disease, J. Nutrition S (Feb. 0). At, Plaintiffs cite: Audrey I. Stephen et al., A Systematic Review of Multivitamin and Multimineral Supplementation for Infection, () J. Human Nutrition & Dietetics (June 0) (a meta-analysis of randomized controlled trials found no evidence for a reduction in episodes of infection, the number of days of infection, or antibiotic use in participants supplemented with multivitamins). () MOTION TO DISMISS CASE NO. -00-WHO

12 Case:-cv-00-WHO Document Filed0// Page of CONCLUSION For the foregoing reasons, the motion to dismiss should be granted and the case dismissed with prejudice. Plaintiffs are not entitled to a fourth bite at the apple. 0 Respectfully submitted, Dated: April, By: /s/ Jonathan F. Cohn Attorney of Record for Defendants Bayer AG, Bayer Corporation, and Bayer HealthCare LLC Jonathan F. Cohn (admitted pro hac vice) jcohn@sidley.com Cara R. Viglucci López (admitted pro hac vice) cvigluccilopez@sidley.com Paul J. Ray (admitted pro hac vice) paul.ray@sidley.com 0 K Street, N.W. Washington, D.C. 00 Telephone: ().000 Facsimile: (). Eugene A. Schoon (admitted pro hac vice) eschoon@sidley.com One South Dearborn Chicago, IL 00 Telephone: (). Facsimile: ().0 Ryan Sandrock (SBN ) rsandrock@sidley.com California Street, Suite 00 San Francisco, CA 0 Telephone: ().0 Facsimile: ().00 () MOTION TO DISMISS CASE NO. -00-WHO

13 Case:-cv-00-WHO Document- Filed0// Page of UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION 0 COLLEEN GALLAGHER, ILANA FARAR, ANDREA LOPEZ, JOANN CORDARO, and ROSANNE COSGROVE, on behalf of themselves and all others similarly situated, v. Plaintiffs, BAYER AG, BAYER CORPORATION, and BAYER HEALTHCARE LLC, Defendants. Case No. -cv-00-who [PROPOSED] ORDER GRANTING MOTION TO DISMISS OF BAYER AG, BAYER CORPORATION, AND BAYER HEALTHCARE LLC Having considered the Motion to Dismiss the Second Amended Complaint filed by Bayer AG, Bayer Corporation, and Bayer HealthCare LLC, as well as all the papers and argument provided, the Court GRANTS the motion and orders that Plaintiffs Second Amended Complaint shall be dismissed with prejudice, except for the challenge to Bayer s structure-function claim that One A Day support[s]... physical energy. IT IS SO ORDERED. Date:, The Honorable William H. Orrick United States District Judge PROPOSED ORDER GRANTING MOTION TO DISMISS CASE NO. -00-WHO