The opinion of the court was delivered by: Hon. Anthony J. BattagliaU.S. District Judge
ORDER: (1) DENYING PLAINTIFFS' MOTION TO EXCLUDE DR. BLUMBERG'S EXPERT TESTIMONY, (Doc. Nos. 141); (2) DENYING DEFENDANTS' MOTION TO EXCLUDE MILMAN'S EXPERT TESTIMONY, (Doc. No. 142); (3) GRANTING DEFENDANTS' ) MOTION TO EXCLUDE DR. ) MARONICK'S EXPERT ) TESTIMONY, (Doc. No. 155); ) ) (4) GRANTING DEFENDANTS' ) MOTION FOR SUMMARY ) JUDGMENT, (Doc. No. 172); AND ) (5) DENYING AS MOOT ) DEFENDANTS' MOTION TO EXCLUDE MR. ELMORE'S ) EXPERT TESTIMONY, (Doc. No. ) 157), DEFENDANTS' MOTION TO ) STRIKE MR. ELMORE'S ) SUPPLEMENTAL REPORT, (Doc. ) No. 161), PLAINTIFFS' MOTION ) TO EXCLUDE DR. DHAR'S ) EXPERT TESTIMONY, (Doc. No. ) 162), AND PLAINTIFFS' MOTION ) TO EXCLUDE DR. HUGHES' EXPERT TESTIMONY, (Doc. No. ) 156).
Presently before the Court are Plaintiffs' motions to exclude Defendants' expert testimony and opinions, (Doc. Nos. 141, 156 & 162), Defendants' motions to exclude Plaintiffs' expert testimony and opinions, (Doc. Nos. 142, 155 & 157), Defendants' motion to strike the supplemental report of Plaintiffs' expert, (Doc. No. 161), and Defendants' motion for summary judgment, (Doc. No. 172). All matters were fully briefed.*fn1 On March 7, 2013, the Court heard oral argument on Defendants' motion to exclude Mr. Elmore's expert opinions and testimony, Defendants' motion to strike Mr. Elmore's supplemental report, and Defendants' motion for summary judgment.*fn2 Timothy Gordon Blood and Thomas Joseph O'Readon II appeared on behalf of Plaintiffs, and Julie LeMaye Hussy, Shirli Fabbri Weiss, and Ryan T. Hansen appeared on behalf of Defendants. (Doc. No. 226.)
For the reasons set forth below, the Court DENIES Plaintiffs' motion to exclude the expert testimony and opinions of Jeffrey B. Blumberg ("Dr. Blumberg"), (Doc. No. 141); DENIES Defendants' motion to exclude the expert testimony and opinions of Harry A. Milman ("Dr. Milman"), (Doc. No. 142); GRANTS Defendants' motion to exclude the expert testimony and opinions of Thomas J. Maronick ("Dr. Maronick"), (Doc. No. 155); GRANTS Defendants' motion for summary judgment, (Doc. No. 172); and DENIES AS MOOT Plaintiffs' motion to exclude the expert testimony and opinions of James W. Hughes ("Dr. Hughes"), (Doc. No. 156), Defendants' motion to exclude the expert testimony and opinions of Ravi Dhar ("Dr. Dhar"), (Doc. No. 162), Defendants' motion to exclude the expert testimony and opinions of David R. Elmore, Jr. ("Mr. Elmore"), (Doc. No. 157), and Defendants' motion to strike Mr. Elmore's supplemental report, (Doc. No. 161). The Clerk of Court is instructed to enter judgment and close the
This is a consumer class action brought by Plaintiffs David Johns ("Johns") and Marc Bordman ("Bordman") on behalf of themselves and a class of similarly situated California consumers (collectively, "Plaintiffs"). The Second Amended Class Action Complaint ("Second Amended Complaint") alleges that Defendants Bayer Corporation and Bayer Healthcare, LLC (collectively, "Bayer" or "Defendants") violated the Consumer Legal Remedies Act ("CLRA"), Cal. Civ. Code § 1750 et seq., and California's Unfair Competition Law ("UCL"), Cal. Bus. & Prof. Code § 17200 et seq., by making false and deceptive advertising claims regarding prostate health benefits in two of Bayer's men's One-A-Day ("OAD") vitamin products-OAD Men's Health Formula ("OAD Men's Health") and OAD Men's 50 Advantage ("OAD Men's 50 Advantage") (collectively, "Vitamin Products" or "Products"). (Doc. No. 22, SAC ¶¶ 74 & 83.) Specifically, Plaintiffs contend that despite mounting scientific evidence that the ingredients in the Vitamin Products do not support prostate health and do not reduce the risk of prostate cancer, Bayer marketed the Products as having such benefits, thereby engaging in deceptive marketing practices to capitalize on the growing awareness of prostate health concerns among men. (Id. at ¶¶ 43, 45, 48, 49 & 74.) As a result, Plaintiffs allege Bayer gained an unfair advantage over other vitamin manufacturers who did not engage in similar deceptive advertising practices. (Id.)
The Challenged Prostate Statements
Plaintiffs challenge two representations made by Bayer: (1) representations that the Products support overall prostate health ("Prostate Health Claim"); and (2) representations that emerging research suggests selenium may reduce the risk of prostate cancer ("Prostate Cancer Claim") (collectively, "Prostate Claims").*fn3 (Id. at ¶¶ 2 & 12-19; Doc. No. 172, Ackerman Decl., Exs. A-G, I & K.) Both Prostate Claims were made with respect to OAD Men's Health, whereas only the Prostate Health Claim was made with respect to OAD Men's 50 Advantage. (SAC ¶¶ 17-19; Doc. No. 172 at 3.)
A. Prostate Claims Made with Respect to OAD Men's Health
Bayer first launched a men's gender-specific multivitamin in 1994. (Doc. No. 172, Ackerman Decl. ¶¶ 2 & 3.) At this time, Bayer began to advertise and market the multivitamin as specifically formulated for men, with representations relating to heart health and metabolism. (Id.) In 2002, Bayer reformulated and re-branded the men's gender-specific multivitamin to include representations that the product supports eye health, heart health, increases energy, helps lower blood pressure, and supports prostate health. (Doc. No. 172, Ackerman Decl. ¶ 5, Ex. A; Doc. No. 212, Blood Decl., Ex. 17.) This new product was labeled OAD Men's Health, and was one of many sub-brands within Bayer's OAD multivitamin line. (Id.)
In or around November 2006, some of the packaging for OAD Men's Health also included the following representation: "Complete Multivitamin Plus More† for Men -Did you know that prostate cancer is the most frequently diagnosed cancer in men and that emerging research suggests Selenium may reduce the risk of prostate cancer? One A Day® Men's Health Formula is a complete multivitamin plus key nutrients including Selenium to support a healthy prostate." (SAC ¶ 16; Doc. No. 172, Ackerman Decl., Ex. F, G, I & K; Doc. No. 212, Blood Decl., Ex. 17.) This representation was located on the back of the product package, and was highlighted, bolded, and italicized. (Id.) The images below depict examples of OAD Men's Health product packaging during the Class Period. (SAC ¶¶ 15, 17; Doc. No. 212, Blood Decl., Ex. 17.)
In addition to the Prostate Claims located on OAD Men's Health product packaging, Bayer ran multiple television advertisements that communicated the same or similar messages. (SAC ¶¶ 17 & 18; Doc. No. 212, Blood Decl., Exs. 5, 9, 15 & 16.) For example, one commercial, commonly referred to as the "Mustang" commercial, made the following representations through both dialog and visual depictions:
[Editor's Note: Image not available]
Did you know one in three men will face prostate issues? One in three, really? That's why One-A-Day Men's is a complete multivitamin . . . with Lycopene, which . . . Harvard studies suggest may help prostate health. (Doc. No. 212, Blood Decl., Ex. 15.)Another television commercial, commonly referred to as the "Striking Out Prostate Cancer" commercial, also communicated the Prostate Health Claim, which Plaintiffs allege was aired by Bayer a "a fully integrated marketing plan that aim[ed] at 'Manning Up' the brand and communicat[ing Bayer's] prostate health message." (Doc. No. 212, Blood Decl., Ex. G, Nunziata Depo. at 17:12-24 & 43-45.) The Prostate Cancer Claim, which first appeared on OAD Men's Health product packaging in or around November 2006, never appeared in television advertisements, and was only made on the product packaging.
B. Prostate Claims Made with Respect to OAD Men's 50 Advantage
Bayer first launched OAD Men's 50 Advantage in or around May 2007. (Doc. No. 172, Ackerman Decl. ¶ 12; Doc. No. 212, Blood Decl., Ex. 18.) OAD Men's 50 Advantage included the Prostate Health Claim, as well as representations relating to memory and concentration, heart health, healthy blood pressure, and eye health.*fn4 (Id.) The product packaging for OAD Men's 50 Advantage never included the Prostate Cancer Claim, or any other representation relating to prostate cancer. (Doc. No. 172, Ackerman Decl., Exs. H, J & L.) The images below depict examples of OAD Men's 50 Advantage product packaging during the Class Period. (SAC ¶¶ 15 & 17; Doc. No. 212, Blood Decl., Ex. 17.)
[Editor's Note: Image not available]
C. Purchase of the Men's Vitamin Products
Plaintiff Johns allegedly purchased OAD Men's Health in July 2009 for the retail price of approximately $8.00 a bottle. (SAC ¶¶ 6 & 50; Doc. No. 73, Syverson Decl., Ex. 52, Johns Depo. at 11.) Plaintiff Johns read the representations on the product packaging for OAD Men's Health, and contends he purchased the product for various reasons, including the Prostate Health Claim. (Doc. No. 73, Syverson Decl., Ex. 52, Johns Depo. at 22-25.) Plaintiff Bordman allegedly purchased several bottles of OAD Men's 50 Advantage in 2008, each time paying the full retail price. (SAC ¶¶ 50 & 54; Doc. No. 73, Syverson Decl., Ex. 53, Bordman Depo.) In addition to the representations made on the Products' packaging, both Plaintiffs allege they have seen and heard television commercials advertising and marketing the Prostate Claims, and that they relied on such representations when deciding to purchase the Products. (SAC ¶¶ 51 & 55; Doc. No. 73, Syverson Decl., Ex. 52, Johns Depo., Ex. 53, Bordman Depo.)
Plaintiffs originally brought this action on September 3, 2009,
alleging: (1) violations of the UCL; and (2) unjust enrichment. (Doc.
No. 1.) Plaintiffs filed a First Amended Complaint ("FAC") as a matter
of right on October 16, 2009, thereby adding a cause of action under
the CLRA. (Doc. No. 10.) On October 30, 2009, Bayer filed a motion to
dismiss and a motion to strike portions of the FAC. (Doc. Nos. 13 &
14.) On February 9, 2010, the Court granted in part and denied in part
Bayer's motion to strike, and granted Bayer's motion to
dismiss.*fn5 (Doc. No. 21.) Specifically, the Court
granted Bayer's motion to strike paragraphs of the FAC that amounted
to "borrowed allegations" from a prior FTC action involving Bayer,
denied Bayer's motion to strike paragraphs of the FAC seeking
disgorgement, and granted Bayer's motion to dismiss.*fn6
(Id.) Plaintiffs filed the operative Second Amended Complaint
("SAC") on March 11, 2010. (Doc. No.
22.) Thereafter, on March 29, 2010, Bayer filed a motion to dismiss
and a motion to strike portions of the SAC. (Doc. Nos. 23 & 24.) On
June 24, 2010, the Court granted in part and denied in part Bayer's
motion to strike (striking ¶ 42), and denied Bayer's
motion to dismiss. (Doc. No. 35.) Bayer filed an answer to the SAC on
August 10, 2010 and discovery commenced shortly thereafter. (Doc. No.
On August 17, 2011, Plaintiffs filed a motion to certify the class. (Doc. No. 73.) On February 3, 2012, the Court granted the motion, certifying a class of all persons who purchased the Vitamin Products in the state of California from the date the Vitamin Products were first sold in California with the Prostate Claims until May 31, 2010 ("Class Period"). (Doc. No. 105 at 2:21-23.) Therefore, the relevant Class Period with respect to OAD Men's Health is June 2002 to May 31, 2010 ("Men's Health Class Period"), and the relevant Class Period with respect to OAD Men's 50 Advantage is August 2007 to May 31, 2010 ("Men's 50 Advantage Class Period"). (Doc. No. 172, Ackerman Decl. ¶¶ 4, 5, 10, 11 & 16; Doc. No. 212, Blood Decl., Ex. 17.) Presently before the Court are the parties respective Daubert motions, (Doc. Nos. 141, 142, 155, 156, 157 & 162), Bayer's motion to strike Mr. Elmore's supplemental report, (Doc. No. 161), and Bayer's motion for summary judgment, (Doc. No. 172).
Summary judgment is proper where the pleadings and materials demonstrate "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). A genuine dispute as to a material fact is a question a trier of fact must answer to determine the rights of the parties under the applicable substantive law. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986) (stating that a material fact is one that is relevant to an element of a claim or defense and whose existence might affect the outcome of the suit). Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. The court must review the record as a whole and draw all reasonable inferences in favor of the non-moving party. Hernandez v. Spacelabs Med. Inc., 343 F.3d 1107, 1112 (9th Cir. 2003). However, unsupported conjecture or conclusory statements are insufficient to defeat summary judgment. Id.; Surrell v. Cal. Water Serv. Co., 518 F.3d 1097, 1103 (9th Cir. 2008).
The moving party has the initial burden of demonstrating that summary judgment is proper. See Adickes v. S.H. Kress & Co., 398 U.S. 144, 152 (1970). The burden then shifts to the opposing party to provide admissible evidence beyond the pleadings to show that summary judgment is not appropriate. See Celotex, 477 U.S. at 322, 324. To avoid summary judgment, the opposing party cannot rest solely on conclusory allegations of fact or law. See Berg v. Kincheloe, 794 F.2d 457, 459 (9th Cir. 1986). Instead, the non-movant must designate which specific facts show that there is a genuine issue for trial. See Anderson, 477 U.S. at 256. The opposing party's evidence is to be believed, and all justifiable inferences are to be drawn in their favor. See id.
Motions To Exclude Expert Testimony Plaintiffs and Bayer each identified three experts to assist the trier of fact. Plaintiffs designated Mr. Elmore to calculate damages under the UCL and CLRA, Dr. Maronick to opine on Bayer's marketing research and promotion of the Vitamin Products before and during the Class Period, and Dr. Milman to evaluate the truth, falsity, and/or deceptive nature of the Prostate Claims in light of the scientific research available during the Class Period. To rebut Plaintiffs' experts and independently contest the viability of Plaintiffs' claims, Bayer designated Dr. Hughes to evaluate Mr. Elmore's findings, Dr. Dhar to evaluate Dr. Maronick's findings, and Dr. Blumberg to evaluate Dr. Milman's findings and opine on the scientific substantiation for the Prostate Claims during the Class Period. The parties now move to exclude the testimony and opinions of each parties' respective experts. Plaintiffs move to exclude the testimony and opinions of Dr. Hughes, Dr. Dhar, and Dr. Blumberg, (Doc. Nos. 156, 162 & 141); and Bayer moves to exclude the testimony and opinions of Mr. Elmore, Dr. Maronick, and Dr. Milman, (Doc. 157, 155 & 142). Bayer also moves to strike Elmore's supplemental expert report as untimely. (Doc. No. 161.)
Because the parties' exhaustive challenges under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed. 2d 469 (1993) will necessarily impact the evidence the Court may properly consider in adjudicating Bayer's pending motion for summary judgment, the Court first addresses the parties' respective evidentiary challenges and then considers the parties' substantive arguments under the UCL and CLRA. However, because the Court finds Plaintiffs' claims are based on "lack of substantiation" rather than proof of falsity or deception, and summary judgment in favor of Bayer is warranted on this ground alone, the Court need not address whether Plaintiffs have proffered a valid measure of damages under the UCL and CLRA. Therefore, the Court DENIES AS MOOT the parties' respective motions to exclude the testimony and opinions of Dr. Hughes and Mr. Elmore, and DENIES AS MOOT Bayer's motion to strike Mr. Elmore's supplemental report. Likewise, because the Court finds Dr. Maronick's testimony and opinions will not aid the trier of fact, and therefore must be excluded, Plaintiffs' corresponding motion to exclude Dr. Dhar's testimony-Bayer's rebuttal expert-is also DENIED AS MOOT. Accordingly, the Court only addresses the merits of the parties' respective motions to exclude the expert testimony and opinions of Dr. Milman, Dr. Blumberg, and Dr. Maronick.
Rule 702 governs the admissibility of expert testimony. Pursuant to Rule 702:
[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.
Fed. R. Evid. 702. "The party offering the expert bears the burden of establishing that Rule 702 is satisfied." Sundance Image Tech., Inc. v. Cone Editions Press, Ltd., No. CV 02--2258 JM (AJB), 2007 WL 935703, at *4 (S.D. Cal. Mar. 7, 2007) (citing Allison v. McGhan Med. Corp., 184 F.3d 1300, 1306 (11th Cir. 1999) (in turn citing Daubert, 509 U.S. at 592 n.10, 113 S.Ct. 2786)); see also Walker v. Contra Costa Cnty., No. C 03--3723 TEH, 2006 WL 3371438, *1 (N.D. Cal. Nov. 21, 2006) (citing Bourjaily v. United States, 483 U.S. 171, 172 (1987)).
Prior to admitting expert testimony, the trial court must make "a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue." Daubert, 509 U.S. at 592-93. The trial court acts as a "gatekeeper" by making a preliminary determination of whether the expert's proposed testimony is not only relevant but reliable. Elsayed Mukhtar v. Cal. State Univ. Hayward, 299 F.3d 1053, 1063 (9th Cir. 2002), amended by 319 F.3d 1073 (9th Cir. 2003). This two-step assessment requires consideration of whether: (1) the reasoning or methodology underlying the testimony is scientifically valid (the reliability prong); and (2) whether the reasoning or methodology properly can be applied to the facts in issue (the relevancy prong). Daubert, 509 U.S. at 592-93; Kennedy v. Collagen Corp., 161 F.3d 1226, 1228 (9th Cir. 1998).
A district court has broad latitude in deciding how to measure reliability and in making the ultimate reliability determination. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 142 (1999) ("Kumho Tire"). In essence, the court must determine whether the expert's work product amounts to "good science." Daubert v. Merrell Dow Pharms.,, 43 F.3d 1311, 1315 (9th Cir. 1995) ("Daubert II") (quoting Daubert, 509 U.S. at 593) (internal citations omitted). In Daubert, the Supreme Court outlined factors relevant to the reliability prong, including: (1) whether the theory can be and has been tested; (2) whether it has been subjected to peer review; (3) the known or potential rate of error; and (4) whether the theory or methodology employed is generally accepted in the relevant scientific community. Daubert, 509 U.S. at 593-94. As later confirmed in Kumho Tire: "Daubert's list of specific factors neither necessarily nor exclusively applies to all experts or in every case. Rather the law grants a district court the same broad latitude when it decides how to determine reliability as [the court] enjoys in respect to its ultimate reliability determination." Kumho Tire, 526 U.S. at 141-42.
Under the relevancy or "fit" prong, the testimony must be "relevant to the task at hand, . . . i.e., that it logically advances a material aspect of the proposing party's case." Daubert II, 43 F.3d at 1315 (quoting Daubert, 509 U.S. at 597). Relevancy requires opinions that would assist the trier of fact in reaching a conclusion necessary to the case. See Kennedy, 161 F.3d at 1230. In general, the Daubert analysis focuses on the principles and methodology underlying an expert's testimony, not on the expert's ultimate conclusions. Daubert, 509 U.S. at 595. However, the Supreme Court has cautioned that "conclusions and methodology are not entirely distinct from one another." Gen. Elec. v. Joiner, 522 U.S. 136, 146 (1997). As such, "[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered." Id.
B. Bayer's Motion to Exclude Plaintiffs' Science Expert Dr. Milman
Dr. Milman was retained by Plaintiffs to offer an expert opinion regarding the scientific substantiation for the Prostate Claims during the Class Period. Specifically, Dr. Milman was asked to opine on: (1) whether selenium, lycopene, zinc, and vitamin E promotes prostate health; and (2) whether selenium supplementation reduces the risk of prostate cancer. (Doc. No. 196 at 3:24-28.) Dr. Milman's report offers the following five opinions:
(1) In my professional opinion, and within a reasonable degree of scientific certainty, there is no credible scientific evidence that supports Bayer's advertising claims that lycopene supplementationsupports a healthy prostate.
(2) In my professional opinion, and within a reasonable degree of scientific certainty, scientific evidence available in 2002 about the effect of selenium supplementation in humans was limited, inadequate and insufficient to support advertising health claims begun at the time by Bayer that selenium in One-a-Day Men's Health Formula supports a healthy prostate.
(3) In my professional opinion, and within a reasonable degree of scientific certainty, scientific evidence available in 2006 about the effect of selenium supplementation in humans remained limited, inadequate and insufficient to support advertising health claims by Bayer that selenium in One-a-Day Men's Health Formula and in One-a-Day Men's 50 Advantage supports a healthy prostate and that selenium in One-a-Day Men's Health Formula also may reduce the risk of prostate and other forms of cancer.
(4) In my professional opinion, and within a reasonable degree of scientific certainty, convincing scientific evidence published between 2006 and the summer of 2009 showed that selenium supplementation has no effect on the incidence of prostate and other forms of cancer. In addition, available scientific evidence does not support the health claims made by Bayer that selenium in One-a-Day Men's Health Formula and in One-a-Day Men's 50 Advantage supports a healthy prostate, and that selenium in One-a-Day Men's Health Formula also may reduce the risk of prostate and other forms of cancer.
(5) In my professional opinion, and within a reasonable degree of scientific certainty, selenium supplementation in One-a-Day Men's Health Formula and in One-a-Day Men's 50 Advantage potentially may be toxic to human health if consumed in large amounts.
(Doc. No. 142, Weiss Decl., Ex. A at 10, 21, 30-31, 35 & 38.)
Bayer seeks to exclude Dr. Milman's expert testimony on the following grounds:
(1) Dr. Milman is not qualified to testify in the area of nutritional science because he is a toxicologist; (2) Dr. Milman's third and fourth opinions are preempted under federal law; (3) Dr. Milman's first, second, and third opinions are irrelevant because they are based on "lack of substantiation;" (4) Dr. Milman's testimony is based on unsound methodology because he did not review the actual Product labels before forming his opinions; (5) Dr. Milman's analysis is flawed because he failed to address the impact of zinc and vitamin E; (6) Dr. Milman's standard requiring "definitive proof" has no basis in the scientific community and is thus unreliable; and (7) Dr. Milman's fifth opinion, which states that the Products "potentially may be toxic," is irrelevant because it assumes an overdose contrary to package instructions. The Court first addresses Dr. Milman's qualifications and then addresses Bayer's remaining substantive objections.
1. Dr. Milman's Qualifications
First, Bayer argues Dr. Milman is not qualified to render an opinion in the area of nutritional science because he is a toxicologist and has no experience or expertise in nutritional research. As a result, Bayer contends Dr. Milman's qualifications in the area of toxicology do not automatically render him qualified to offer an expert opinion regarding the nutritional benefits of zinc, vitamin E, lycopene, and selenium, and more importantly, the nutrients' corresponding effects on the human body.*fn7 (Doc. No. 142 at 4-8.)
Although Bayer makes a valiant effort to disqualify Dr. Milman based on his qualifications, the Court finds there is substantial overlap in the foundational principles underlying the fields of toxicology, pharmacology, and nutritional science, and Dr. Milman's ample education and experience in these fields render him qualified to offer an expert opinion.*fn8 See also United States v. Chang, 207 F.3d 1169, 1172 (9th Cir. 2000) ("To qualify as an expert, a witness must have knowledge, skill, experience, training or education, relevant to such evidence or fact in issue."); Casey v. Ohio Med. Prods., 877 F. Supp. 1380, 1383 (N.D. Cal. 1995) ("The fact that [an expert] is not an expert [in a specific field] does not, in view of [the expert's] other medical experience, [automatically] disqualify him."). For example, Dr. Milman holds a Bachelor of Science (B.S.) in pharmacy from Columbia University, a Master of Science (M.S.) in pharmaceutics from St. John's University, and a Doctorate (Ph.D.) in pharmacology from George Washington University. (Doc. No. 142, Weiss Decl., Ex. A, Milman Report at 5.) Moreover, Dr. Milman has over forty (40) years of experience and training in toxicology, pharmacology, pharmacy, and carcinogensis, including: ten (10) years of experience as a research pharmacist and pharmacologist/toxicologist at the United States National Institute of Health; eighteen (18) years of experience as a Senior Toxicologist and Senior Science Advisor at the United States Environmental Protection Agency; thirteen (13) years of experience as Chief Pharmacist at a community pharmacy; and six (6) years of experience as a pharmacy intern. (Id. at 6.) Finally, Dr. Milman has published five (5) books on toxicology and carcinogensis; published seventy (70) articles and abstracts in toxicology, pharmacology, and carcinogensis peer reviewed scientific journals; is a member of several toxicology and pharmacology professional organizations; and has attended, organized, and presented at numerous workshops and conferences on toxicology, pharmacology, pharmacy, and carcinogensis. (Id. at 6-7 & 64-73.)
Therefore, based on the above, and a through review of Milman's Curriculum Vitae, the Court finds Dr. Milman qualified to offer an expert opinion regarding the falsity or deceptive nature of the Prostate Claims during the Class Period.*fn9 See Fed. R. Evid. 702(stating that a witness may offer an expert opinion only if he or she draws on some special "knowledge, skill, experience, training or education to formulate that opinion").
2. Bayer's Substantive Objections to Dr. Milman's Opinions and Testimony
Bayer's remaining six objections, which are based on preemption, lack of substantiation, unsound methodology, or relevancy, each go to the weight rather than the admissibility of Dr. Milman's testimony. See United States v. Prime, 431 F.3d 1147, 1153 (9th Cir. 2005); Kennedy,161 F.3d at 1230-31 ("In arriving at a conclusion, the factfinder may be confronted with opposing experts, additional tests, experiments, and publications, all of which may increase or lessen the value of the expert's testimony. But their presence should not preclude the admission of the expert's testimony-they go to the weight, not the admissibility.").
For example, Bayer's second objection contends Dr. Milman's third and fourth opinions regarding selenium supplementation and a reduction in the risk of prostate cancer are preempted under federal law. (Doc. No. 172, Def.s' RJN, Ex. B, 2003 FDA Decision Letter at 34-35.)*fn10 Specifically, Bayer contends the 2003 FDA Decision Letter, which approved a "qualified health claim" regarding selenium and the reduction in the risk of certain forms of cancers, preempts Dr. Milman's testimony and warrants exclusion of his opinions under Rule 702.*fn11 Bayer relies on the following language, which was approved by the FDA in 2003:
Claim 1: Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancers. However, the FDA has determined that this evidence is limited and not conclusive. . at 34.) Although Bayer is correct that any allegations based on language exactly replicating "Claim One" are preempted under federal law, Bayer is incorrect to infer that all of Plaintiffs' allegations, including allegations not based on the exact language of the qualified health claim, are also preempted. Thus, as further explained below, because the FDA did not issue a "qualified" or "unqualified" claim specifically linking selenium to a reduction in the risk of prostate cancer, Bayer's representations exceeding the scope of the qualified claim are not immune under federal law. Cf. Reid v. Johnson & Johnson, et. , 11CV1310, 2012 WL 4108114, at *6 (S.D. Cal. Sept. 18, 2012) (finding plaintiff's claims preempted by federal law because defendant used the exact language authorized by the FDA). Accordingly, Bayer's second objection is overruled.
Bayer's third objection contends Dr. Milman's first, second, and third opinions must be excluded because they are based on an improper belief that Bayer must provide scientific substantiation for the Prostate Claims as a result of the instant lawsuit. Although Bayer's assertion of the law is correct, which Plaintiffs do not dispute, such arguments are nonetheless an improper means to exclude expert testimony. See United States v. 87.98 Acres of Land More or Less in the Cnty. of Merced, 530 F.3d 899, 904-05 (9th Cir. 2008). Under Rule 702, the district judge is a "gatekeeper, not a factfinder." United States v. Sandoval-Mendoza, 472 F.3d 645, 654 (9th Cir. 2006). Thus, if the expert meets the reliability and relevancy threshold established by Rule 702, and explained in Daubert, the expert may testify and the factfinder determines how much weight to give the testimony, and whether the testimony satisfies the respective parties' burden of proof. See Primiano v. Cook, 598 F.3d 558, 564-65 (9th Cir. 2010). Therefore, because Dr. Milman's testimony is highly relevant to the ultimate determination of whether Plaintiffs will be able to prove that the Prostate Claims were in fact false or deceptive, Bayer's arguments for exclusion are an improper means to seeks summary judgment under Rule 702. See Norris v. Baxter Healthcare Corp., 397 F.3d 878, 884 n.2 (10th Cir. 2005) (stating that under the relevance prong of Daubert the district court need only ensure that the proposed expert testimony logically advances a material aspect of the case); Guidroz-Brault v. Miss. Pac. R. Co., 254 F.3d 825, 830 (9th Cir. 2001) (finding locomotive engineer's testimony on the appropriate lookout procedure relevant because it was a key issue in the case). Accordingly, Bayer's third objection is overruled.
Bayer's fourth and fifth objections contend that Dr. Milman's testimony must be excluded because he did not review actual product labels before forming his opinions, and thus ignored zinc and vitamin E, two of the nutrients the Prostate Claims are based on. However, as stated above, neither of these contentions warrant exclusion under Rule
See United States v. Chischilly, 30 F.3d 1144, 1154 (9th Cir. 1994) ("The impact of imperfectly conducted laboratory procedures might therefore be approached more properly as an issue not going to the admissibility, but to the weight of the . . . evidence."). Whether Dr. Milman rendered an opinion regarding zinc and vitamin E does not render his entire testimony irrelevant, To the contrary, whether or not Plaintiffs will be able to meet their burden of proof, through the presentation of evidence and expert testimony, makes Dr. Milman's testimony highly relevant. Moreover, to the extent Bayer argues Dr. Milman never viewed actual product labels, such contentions and possible flaws in Dr. Milman's testimony can be addressed through the presentation of contrary evidence and vigorous cross-examination. See Primiano, 598 F.3d at 564 (stating that "shaky but admissible evidence is to be attacked by cross-examination, contrary evidence, and attention to the burden of proof, not by exclusion"); Daubert, 509 U.S. at 596 ("Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence."); Prime, 431 F.3d at 1153. Accordingly, Bayer's fourth and fifth objections are each overruled.*fn12
Bayer's remaining two objections are also easily dispatched. First, Bayer contends Dr. Milman's testimony is unreliable because he demands application of a "definitive proof" standard that has no basis in the scientific community. However, contrary to Bayer's contentions, Dr. Milman's report does not assert that definitive proof from a well-controlled randomized clinical trial ("RCT") is required in this case, but does, as does Dr. Blumberg (Bayer's science expert), recognize the importance of RCTs in the area of nutritional science. Thus, although Bayer may disagree with Dr. Milman's ultimate conclusions, these findings are properly attacked through rigorous cross-examination and the presentation of contrary evidence, not exclusion. See Primiano, 598
F.3d at 564. Moreover, Bayer contends that Dr. Milman's fifth opinion regarding the potential toxicity of the Products is irrelevant because it assumes an overdose of selenium contrary to the dosage specified on the Products' packaging. Although the Court is cognizant that Dr. Milman admits that the Products present no risk of selenosis or Type 2 diabetes when taken as directed, (Doc. No. 142, Weiss Decl., Ex. B., Milman Depo. at 26:21-27:9, 27:19-24 & 43:21-44:3), the Court finds Dr. Milman's underlying opinion is relevant to whether selenium promotes "prostate health," and is based on reliable scientific research. (Doc. No. 142, Weiss Decl., Ex. A, Milman Report at 38-41.) Thus, whether, and to what extent, the factfinder will give weight to Dr. Milman's toxicity conclusion-in light of the Product packaging and his deposition testimony-is not a basis for exclusion under Rule 702. See Kennedy, 161 F.3d at 1230-31. Accordingly, Bayer's sixth and seventh objections are each overruled.
Therefore, the Court finds each of Bayer's objections go to the weight rather than the admissibility of Dr. Milman's testimony. See Prime, 431 F.3d at 1153 (9th Cir. 2005) (stating that the proper inquiry focuses "solely on principles and methodology, not on the conclusions that they generate") (internal quotations omitted); Daubert, 509 U.S. at 595 ( finding that "[a]s long as the process is generally reliable, any potential error can be brought to the attention of the jury through cross-examination and the testimony of other experts"). Accordingly, Bayer's motion to exclude the testimony and opinions of Dr. Milman is DENIED, and the Court will consider such evidence when adjudicating Bayer's pending motion for summary judgment. See Lust By & Through Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594, 598 (9th Cir. 1996).
C. Plaintiffs' Motion to Exclude Bayer's Science Expert Dr. Blumberg
Dr. Blumberg was retained by Bayer to review the scientific evidence supporting the Prostate Claims during the Class Period. Specifically, Dr. Blumberg was asked to: (1) review and opine on the scientific substantiation for Bayer's representation that zinc, vitamin E, lycopene, and selenium "support prostate health;" (2) review and opine on the scientific substantiation for Bayer's representation that "emerging research suggests [that] Selenium may reduce the risk of prostate cancer;" (3) evaluate and explain the bioavailability and effectiveness of different forms of selenium and lycopene, including sodium selenate and synthetic lycopene, both of which were included in the Vitamin Products and tested in the supporting scientific research; and (4) review and rebut certain statements made by Plaintiffs' science expert Dr. Milman. (Doc. No. 141, Syverson Decl., Ex. A, Blumberg Report at 2-3.) Dr. Blumberg's report offers ten opinions. The first opinion is a broad assertion regarding the scientific support for the Prostate Claims during the Class Period, opinions two through six refer to Dr. Blumberg's findings regarding selenium, and the final four opinions relate to Dr. Blumberg's finding regarding lycopene, zinc, and vitamin E. Specifically, Dr. Blumberg concludes that:
(1) At all times during what I understand to be the class period . . . scientific evidence existed, and still exists to support the statement that each of the Vitamin Products as formulated "Supports Prostate Health" as Bayer indicated on the packaging for One-A-Day Men's Health Formula® and One-A-Day Men's 50 Advantage®, respectively. I am further aware that several other multivitamin products currently and previously on the market have made and continue to use the structure function claim for prostate health support based on the ingredients selenium, lycopene, zinc, and/or vitamin E.
(2) At all times during the proposed class period, scientific evidence existed and still exists showing that selenium intake can reduce the risk of prostate cancer. As with almost all nutrient supplements, the effect of selenium in specific men can be influenced by many variables, including inherent and environmental factors such as nutrigenomics and lifestyle, respectively, plasma selenium concentrations, and prostate specific antigen (PSA) levels. Men having a baseline level of plasma selenium (prior to selenium supplementation) at <123.2 ng/ml="" are="" most="" likely="" to="" benefit="" from="" a="" nutritional="" supplement="" that="" includes="" selenium.="" in="" addition,="" evidence="" from="" some="" clinical="" trials="" indicates="" that="" men="" within="" a="" normal="" range="" of="" psa="" ng/ml="" can="" benefit="" from="" a="" nutritional="" supplement="" that="" includes="">123.2>
(3) In my opinion, the totality of nutritional and biomedical research indicates that selenium is an essential dietary mineral which plays a beneficial role in reducing the risk of prostate cancer in men and in supporting general prostate health. My opinion is based on my review of the body of clinical trials, observational studies, and supportive basic research addressing the relationship between selenium and prostate health.
(4) Sodium selenate is a naturally occurring inorganic form of the mineral selenium found in soil and alkaline water and used by plants to synthesize selenomethione. Sodium selenate is the form of selenium used in both the One-A-Day Men's Health Formula® and One-A-Day Men's 50 Advantage® multivitamins. Sodium selenate is readily bioavailable, a process describing the absorption of a nutrient into blood and its distribution to body tissues. Indeed, all forms of selenium, organic as well as inorganic forms, such as sodium selenate, are readily absorbed from the small intestine. Overall, absorption of all forms of selenium ranges from 70 to 95%, but varies according to the source and the selenium status of the individual (Finley 2006). Regardless of its dietary form, selenium is stored and accumulates over time in body tissues.
(5) Selenium as well as other selected nutrients which were present in One-A-Day Men's Health Formula® and One-A-Day Men's 50 Advantage®, when taken as directed, can support men's health in general and "support prostate health" in particular, including potentially reducing the risk of prostate cancer. The evidence for these benefits is derived from human studies, including certain randomized clinical trials and observational studies explained further below. These benefits are also evidenced through basic research using in vitro (test tube) experiments (de Rosa et al. 2012; Gazi et al. 2007; Gundimeda et al. 2008; Liu et al. 2010; Sinha et al. 2011; Xiang et al. 2008) and animal models (Bhattacharyya et al. 2008; Cheng et al. 2011; Holmstrom et al. 2011; Lindshield et al. 2010; Liu et al. 2010; Wang et al. 2008; Waters et al. 2003; Zhang et al. 2011). In vitro and animal model research both provide evidence for the biological plausibility and mechanisms of the anti-cancer actions of selenium and, when corroborated with human studies, can strengthen the available evidence to support a relationship with health outcomes.
(6) In sum, the totality of the available scientific evidence indicates that selenium is an essential nutrient that is readily bioavailable (regardless of its form, e.g., inorganic or organic) and plays a role in supporting prostate health and potentially reducing the risk of cancer of the prostate as well as potentially reducing the risk of BPH (Muecke et al. 2009; Zachara et al. 2005).
(7) Natural and synthetic lycopene are equally bioavailable, and therefore the form of lycopene consumed is irrelevant from a nutritional perspective. The synthetic form of lycopene used in One-A-Day Men's Health Formula® and One-A-Day Men's 50 Advantage® is bioavailable and accumulated and stored by body tissues, including the prostate.
(8) In my opinion, the totality of scientific evidence involving lycopene and prostate health indicates lycopene may decrease the progression of BPH and reduce circulating PSA, thereby promoting prostate health. Lycopene also possesses antioxidant properties that have demonstrated beneficial effects on processes associated with carcinogenesis, which further supports lycopene's role in supporting prostate health and potentially reducing the risk of prostate cancer.
(9) Zinc is essential in controlling and facilitating the physiological function of the prostate gland, including controlling the correct production of prostatic fluid, and is present in abundance in healthy prostate glands and is diminished in diseased prostate glands. In my opinion, zinc plays an important role in maintaining prostate health.
(10) Vitamin E is a potent dietary antioxidant that has been associated with a reduced risk of prostate cancer in observational studies and randomized clinical trials. In my opinion, vitamin E plays an important role in maintaining prostate health. (Doc. No. 141, Syverson Decl., Ex. A, Blumberg Report at 5-7.)
Plaintiffs seek to exclude Dr. Blumberg's testimony and opinions regarding: (1) the scientific substantiation for Bayer's statements that the Vitamin Products support prostate health; (2) the scientific substantiation for Bayer's claims that emerging research suggests that consumption of selenium may reduce the risk of prostate cancer; and (3) the effectiveness of selenium, lycopene, zinc, and vitamin E in reducing the risk of prostate cancer and other prostate related conditions, as well as supporting prostate health in general. (Doc. No. 141 at 1.) Although Plaintiffs' arguments for exclusion vary slightly depending on whether they seek to exclude Dr. Blumberg's testimony regarding selenium, lycopene, zinc, or vitamin E, all of Plaintiffs' arguments essentially conclude that Dr. Blumberg's opinions are based on inconclusive, factually distinguishable, or misleading scientific research.*fn13
In response, Bayer contends Plaintiffs' motion should be denied because: (1) Dr. Blumberg is qualified to offer an expert opinion in the area of nutritional science; (2) Dr. Blumberg offers relevant testimony regarding the scientific substantiation for the Prostate Claims during the Class Period; and (3) Dr. Blumberg's methodology in reaching his conclusions is reliable because he considered the totality of the evidence, including both supportive and non-supportive scientific studies. (Doc. No. 192 at 1-2.) Although not specifically raised or contested by Plaintiffs, the Court first considers Dr. Blumberg's qualifications, and then addresses Plaintiff's arguments for excluding Dr. Blumberg's testimony as it relates to selenium, lycopene, zinc and vitamin E.
1. Dr. Blumberg's Qualifications
As an initial matter, the Court finds Dr. Blumberg qualified to offer expert testimony regarding the scientific substantiation for the Prostate Claims. See Jinro Am. Inc. v. Secure Invs., Inc., 266 F.3d 993, 1004 (9th Cir. 2001)("[C]are must be taken to assure that a proffered witness truly qualifies as an expert, and that such testimony meets the requirements of Rule 702."). For example, Dr. Blumberg holds a Bachelor of Pharmacy (BPharm) from Washington State University and a Doctorate (PhD) in Pharmacology from Vanderbilt University School of Medicine. He is currently a Professor in the Friedman School of Nutritional Science and Policy at Tufts University and a Senior Scientist and Director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutritional Research Center on Aging at Tufts University. (Doc. No. 192 at 4; Doc. No. 141, Syverson Decl., Ex. A, Blumberg Report at 1.) Moreover, Dr. Blumberg received postdoctoral training at the Tennessee Neuropsychiatric Institute and completed a National Institutes of Health post-doctoral fellowship at the University of Calgary in biochemistry. (Id.) Aside from his education, Dr. Blumberg has published over 300 scientific articles, served on countless editorial boards for prominent research journals, is a member of leading nutritional societies and international nutrition policy boards, and has testified before many prominent organizations, including, but not limited to, the Institute of Medicine/National Academy of Science, the Food and Nutrition Board, the Subcommittee on Health and the Environment of the United States House of Representatives, the FDA Conference on Antioxidant Vitamins, and the Dietary Guidelines for Americans 2005 Committee. (Id.) Accordingly, based on his knowledge, experience, and education, the Court finds Dr. Blumberg qualified to offer his expert opinion regarding the scientific substantiation for the Prostate Claims.*fn14
2. Dr. Blumberg's Opinions andTestimony Regarding Selenium
Dr. Blumberg's report includes the following sections to analyze and address the scientific substantiation for Bayer's representations regarding selenium: (1) the relevant history of selenium; (2) selenium intake and its status in the United States; (3) clinical trials involving selenium; (4) observational studies involving selenium; (5) scientific evidence indicating a null effect of selenium on prostate cancer; and (6) the bioavailability and effectiveness of sodium selenate, the form of selenium used by Bayer in the Vitamin Products. (Doc. No. 141, Syverson Decl., Ex. A, Blumberg Report at 9-22.) Based on this information, Dr. Blumberg opines that the totality of the scientific research weighs in favor of finding a beneficial relationship between selenium and a reduction in the risk of prostate cancer. Dr. Blumberg also opines, contrary to Plaintiffs' assertions, that sodium selenate, the form of selenium used in the Vitamin Products, is bioavailable, and thus readily absorbed and distributed into and throughout the human body. (Id. at 21.)
Plaintiffs offer five primary objections to Dr. Blumberg's testimony regarding selenium: (1) Dr. Blumberg's reliance on the 1996 and 1998 Nutrition Prevention of Cancer ("NPC") trials are improper and likely to mislead the trier of fact; (2) the results of the NPC trials conflict with the results of the Selenium and Vitamin E Cancer Prevention Trial ("SELECT") and therefore are unreliable; (3) Dr. Blumberg's reliance on observational studies is improper; (4) Dr. Blumberg's reliance on animal and in vitro studies is improper; and (5) Dr. Blumberg fails to proffer reliable testimony that the "totality of the evidence" shows that selenium supports prostate health and/or reduces the risk of prostate cancer.*fn15 (Doc. No. 141 at 7, 9, 10, 12 & 13.) The Court considers each ground for exclusion in turn.
First, Plaintiffs suggest Dr. Blumberg's emphasis on the 1996 and 1998 NPC trials are improper and likely to mislead the trier of fact because the results were equivocal and expressly limited by their authors.*fn16 For example, Plaintiffs assert that the authors of the 1996 NPC trial determined that their results "required confirmation in independent trials of appropriate design before public recommendations regarding selenium supplementation can be made," and that the authors of the 1998 NPC trial conceded that their conclusions "needed confirmation in additional independent trials." (Doc. No. 141 at 7:20-24 & 8:1-2.) Plaintiffs state that Dr. Blumberg was aware of the limited findings and conclusions of the NPC trials, yet elected to disregard such cautionary language in an attempt to bolster his "pre-formed" conclusions. (Doc. No. 141, Syverson Decl., Ex. C, Blumberg Depo. at 161:2-9.) Thus, Plaintiffs argue that because the authors of the NPC trials were unwilling to infer that selenium supplementation reduces the instances of prostate cancer, Dr. Blumberg should be prohibited from making that "leap" for them. (Doc. No. 141 at 8:9-14.)
Although Plaintiffs go to great lengths to highlight the inconclusive
nature of the NPC trials as a means to exclude Dr. Blumberg's
testimony, for the purposes of exclusion under Rule 702, such
objections are misplaced. See Daubert, 509 U.S. at 590 n.9 ("In a case
involving scientific evidence, evidentiary reliability will be based
upon scientific validity."). It is common in scientific literature for
investigators to hedge their claims or
couch their conclusions prefaced with the need for additional
confirmatory research. See In re Denture Cream Prods. Liab. Litig.,
795 F. Supp. 2d 1345, 1362 (S.D. Fla. 2011) ("Scientists tend to hedge
their claims in scientific papers."). Moreover, it is well settled
that there are few if any certainties in science, Daubert, 509 U.S. at
590, and Daubert was not intended to impose an "exacting standard of
causality" beyond the preponderance of the evidence "simply because
scientific issues are involved." In re Ephedra Prods. Liab.
., 393 F. Supp. 2d 181, 190 (S.D.N.Y. 2005); In re Heparin Prods.
Liab. Litig., 803
F. Supp. 2d 712, 743 (N.D. Ohio 2011) (stating that the court "will
not exclude expert testimony on the basis that the evidence supporting
it does not establish causation to a scientific certainty"). Thus,
because the authors of the NPC trials noted that selenium
supplementation was or could be positively correlated with a
significant reduction in prostate cancer, Dr. Blumberg's opinions did
not improperly exceed the NPC authors' conclusions.*fn17
See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d
at 1345 ("Because the authors of the Nations Article themselves do not
conclude there is a causal relationship between the use of Fixodent
and neurological symptoms, it is inappropriate for Plaintiffs' experts
to draw that conclusion for them."). Moreover, the result of the NPC
trials were further confirmed by the Duffield-Lillico study in 2003,
wherein the authors stated that selenium supplemental continues to
support a reduction in the "incidence of prostate cancer.*fn18
(Doc. No. 192, Blumberg Decl., Ex. G,
Duffield-Lillico Study at 16.) Accordingly, this is not the case where a proffered
expert is formulating an opinion based on a study that is directly
contradicted by that study. (Doc. No. 208 at 3:13-15.) As such,
Plaintiffs' objection on this ground is overruled.
Second, Plaintiffs argue Dr. Blumberg's testimony should be excluded because he wholly rejects SELECTs results and conclusions-the largest randomized clinical trial of selenium conducted to date- in addition to other observational studies that do not support his opinion. (Doc. No. 141 at 9.) As such, Plaintiffs contend Dr. Blumberg's conclusions are not based on valid scientific methodology. (Id.) The Court is not persuaded and finds Plaintiffs mischaracterize Dr. Blumberg's opinions and testimony.
In concluding that all of the scientific evidence to date substantiates a positive correlation between selenium supplementation and prostate health, Dr. Blumberg analyzed SELECT, analyzed observational studies agreeing with SELECT, and then identified what he calls "critical limitations" of SELECT. See In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., 524 F. Supp. 2d 1166, 1180 (N.D. Cal. 2007). Thus, contrary to Plaintiffs' allegations, Dr. Blumberg did not wholly disregard SELECT and other observational studies that found a null correlation between selenium and prostate health.*fn19
Instead, as acknowledged by Plaintiffs, Dr. Blumberg recognized the limitations of SELECT and considered whether, in light of SELECTs ultimate conclusions, there was still scientific substantiation for Bayer's representations that selenium promotes prostate health and reduces the risk of prostate cancer.*fn20
Therefore, even though Plaintiffs accurately highlight differences in the scientific findings made by the authors of NPC and SELECT, Plaintiffs are free to cross-examine
Dr. Blumberg on his ultimate conclusions. See In re Heparin Prods. Liab. Litig., 803 F. Supp. 2d at 742 (finding that expert testimony should not be excluded on the basis of "some disagreement in the scientific literature"); see also Daubert,509 U.S. at 596 ("Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence."); Ambrosini v. Labarraque, 101 F.3d 129, 135 (D.C. Cir. 1996) ("The dispositive question is whether the testimony will 'assist the trier of fact to understand the evidence or to determine a fact in issue,' not whether ...