RIKOS v. BAYER HEALTHCARE, LLC
OPINION. Signed by Judge John Michael Vazquez on 04/17/2017. (ek)
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
IN RE: BAYER PHILLIPS COLON HEALTH
PROBIOTICS SALES PRACTICES
Civil Action No. 11-03017
John Michael Vazguez, U.S.D.J.
This matter comes before the Court on Defendant Bayer Healthcare LLC’s (“Bayer” or
“Defendant”) motion for summary judgment.
Also pending before the Court is
Plaintiffs Troy Yuncker and Dino Rikos’ (collectively “Plaintiffs”) motions for class certification
(D.E. 143) and motion to strike portions of Defendant’s expert’s opinion (D.E. 165). Plaintiffs
allege that Bayer made false and misleading claims regarding one of its dietary supplements. The
Court considered the written submissions of the parties’ and considered the motion without oral
argument pursuant to Federal Rule of Civil Procedure 78(b) and Local Civil Rule 78.1(b). For the
reasons that follow, Bayer’s motion for summary judgment is granted. Because the Court grants
Bayer’s motion, Plaintiffs’ pending motions (D.E. 143, 165) are denied as moot.
Bayer’s brief in support of its motion for summary judgment will be referred to as “Def. Br.”
Plaintiffs opposition brief will be known as “P1. Opp.” Bayer’s reply brief will be referred to as
The facts of this matter are derived from the record, and they are reviewed in the light
most favorable to the non-moving party, Plaintiff. See Tolan v. Cotton, 134 S. Ct. 1861, 1866
(2014) (noting that in motion for summary judgment “a court must view the evidence in the light
most favorable to the opposing party” (internal quotation marks omitted)).
A. The Dietary Supplement
Plaintiffs filed this action on their own behalf and on behalf of all others similarly situated
who purchased Phillips’ Colon Health (“PCH”), a probiotic dietary supplement sold by Bayer.
Defendants Statement of Material F acts not in Dispute (“DSOF”) ¶ 1 •2 The supplement is provided
to Bayer from another company, Wakunaga of America Co., Ltd.3 (“Wakunaga”). Plaintiffs allege
that Bayer made “false and misleading” representations in the marketing of PCH. Id. PCH’s
product label stated as follows:
3 strains of good bacteria to promote
OVERALL DIGESTIVE HEALTH
Helps Defend Against Occasional:
GAS AND BLOATING
Plaintiffs allege that these “statements are false and misleading and reasonably likely to
deceive the average consumer.” Id. At all relevant times, the PCH label contained the statement
The Court cites to Bayer’s Statement of Material F acts not in Dispute only when Plaintiffs have
admitted that such facts are undisputed.
The parties do not make clear the actual corporate name of Wakunaga in their moving papers or
the Complaint. The Court derives the name Wakunaga of America Co., Ltd. from the exhibits
that the parties submitted.
that “[t]his product is not intended to diagnose, treat, cure, or prevent any disease.” DSOF
The disclaimer was required by law.
A probiotic is defined by the World Health Organization as “[l]ive microorganisms which,
when administered in adequate amounts, confer a health benefit on the host.” D.E. 145-7 at 8.
Probiotics are commonly used to “prevent overgrowth of potential pathogens in the gastrointestinal
Id. Probiotics can lead to better “host defense and nutritional benefits by increasing
indigenous beneficial bacteria and decreasing harmful bacteria.” Id.
There are many other
benefits of probiotics and scientists are just beginning to understand all of the functions they
perform in the overall health of human beings. Declaration of Dr. Stefano Guandalini, M.D.
(“Guandalini Dec.”) ¶ 14 (D.E. 160-3). Bacteria are categorized by their genus, species, and strain.
P1. Opp. at 5. The genus, species, and strain for the three PCH bacteria are (1) Lactobacilttts
(genus) gasseri (species) KS-13 (strain); (2) Bzfidobacteriitm bUidum G9-1; and (3)
BJIdodbacterittm ion gum MM-2. Id. The parties do not dispute that PCH is regulated as a dietary
supplement, as opposed to a drug.
Pursuant to the Dietary Supplement Health & Education Act of 1994 (“DSHEA”), the
approval process for dietary supplements is less onerous than that required for drugs. The DSHEA
permits the label on dietary supplements “to bear, among other types of statements, a statement
that describes the role of a nutrient or dietary ingredient intended to affect the structure or function
in humans or that characterizes the documented mechanism by which a nutrient or dietary
ingredient acts to maintain such structure or function.” Stanley v. Bayer Healthcare LLC, No. 11862, 2012 WL 1132920, at *7 (S.D. Cal. Apr. 3, 2012) (internal quotation marks omitted). These
statements, known as “structure/function claims, are not required to be pre-approved by the FDA.”
Id. Drugs, however, are held to a higher standard requiring pre-approval from the Food and Drug
Administration, 21 U.S.C. §sS 33 1(d), 355(a), and generally “must be supported by randomized,
placebo-controlled, double-blind clinical trials,” United States v. Bayer Coip., No. 07-01, 2015
WL 5822595, at *3 (D.N.J. Sept. 24, 2015) (the “FTC Opinion”) (citing 21 C.F.R.
Dietary supplements need not meet these requirements. Id.
§ 3 14.126).
Instead, “the only substantiation
requirement is that claims must be ‘truthful and not misleading,” id. (quoting 21 U.S.C.
343(r)(6)(B)), and a statement “prominently displayed and in boldface type” which says, “This
statement has not been evaluated by the Food and Drug Administration. This product is not
intended to diagnose, treat, cure, or prevent any disease,” 21 U.S.C.
the supplement is not marketed as a drug
§ 343(r)(6)(C). “As long as
i.e., it is not claimed to diagnose, mitigate, treat, cure,
or prevent a specific disease or class of diseases,
it is not regulated like a drug.” FTC Opinion,
at *3 (internal quotation marks and citations omitted).
C. Plaintiffs Troy Yuncker and Dino Rikos
Plaintiff Troy Yuncker alleges that he purchased one package of 30-count PCH in May
2011 at a Waigreens store in Chicago, Illinois based on “the digestive health representations” on
the package. Id.
¶ 7. Yuncker was shopping for a probiotic because he “was having bad gas and
digestive problems” due to consuming fast food. Id.
¶ 11. In particular, Yuncker testified that he
had been suffering from “gastrointestinal problems,” which he later identified as acid reflux, for
at least ten years prior to using PCH. Id.
¶ 12. Yuncker consumed one pill of PCH per day for a
period of nine days and then stopped taking the supplement. Id.
¶ 13-14. Yuncker believed that
PCH was ineffective because his “gas and constipation [had not] changed.” Deposition of Troy
Yuncker (“Yuncker Dep.”) at 85:3-7.
Plaintiff Dino Rikos purchased PCH six to seven times over a six-month period in 2010 at
“various retail drug store chains” in California and Illinois. DSOF
¶ 16. Rikos claims to have
chosen PCH based on the “digestive health representations” on the label. Id.
¶ 17. In particular,
Rikos purchased PCH to combat chronic diarrhea, gas, and bloating that he suffered subsequent to
a diagnosis of colon and rectal cancer, chemotherapy, radiation, and colon resection surgery. Id.
¶ 20. Rikos believed that PCH “wasn’t doing anything” to cure his symptoms, and as a result,
decide to file suit against Bayer for false advertising. Deposition of Dino Rikos (“Rikos Dep.”)
48:18 to 49:6.
D. The Scientific Studies
There are three scientific studies that both Plaintiffs and Defendant claim play a significant
role in the outcome of this motion. Each study was a double-blind, placebo randomized controlled
trial (“RCT”).4 RCTs are known in the scientific community as the “gold standard” for scientific
Mttltins v. Premier Nutrition Corp., 178 F. Supp. 3d 867, $82 (N.D. Cal. 2016)
(“Randomized clinical trials are ‘the gold standard for determining the relationship of an agent to
a health outcome.” (quoting Federal Judicial Center, Reference Manual on ScientUic Evidence
555 (3d ed. 2011))).
An RCT is defined as
[am experimental study to assess the effects of a particular variable
(e.g., a drug or treatment) in which subjects are assigned randomly
to an experimental, placebo, or control group. The experimental
group receives the drug or procedure; the placebo group’s
medication is disguised to resemble the drug being investigated.
The control group receives nothing. Laboratory tests or clinical
evaluations are performed on the groups (usually using the double
blind technique) to determine the effects of the drug procedure.
Taber ‘s Cyclopedic Medical Dictionaiy 1847-48 (20th ed. 2006).
The first RCT was conducted with approval from the Research Ethics Board of the
Canadian College of Naturopathic Medicine in March 2010 and approval from the Natural Health
Product’s Directorate in May 2010 (the “Canada I Study”). Declaration of James F. Cecchi
(“Cecchi Dec.”), Ex. 55 (D.E. 145-27). The purpose of the study was “to investigate the effects
of an investigational Probiotic on Irritable Bowel Syndrome.” Id. The study used the same threestrain bacteria that make up Bayer’s PCH. Id. at Ex. 54. The results of the Canada I Study
indicated that the active group5 and placebo group both experienced “significant improvements”
in Irritable Bowel Syndrome (“lBS”).6 Id. at Ex. 54. The study found that “the greatest difference
in effect between active and placebo groups [was] seen in the [d]iarrhea subtype.” Id. The greatest
effect regardless of whether the participant was in the active or placebo group was seen in the
constipation subtype. Id. However, despite these positive trends, the Canada I Study concluded
that the “difference between the groups is not statistically significant” and the “sample size
amongst the subtypes is not large enough to draw a definite conclusion.” Id.
The second RCT took place in 2013 and “was performed to test the effect of [PCH] on the
severe sufferers of [IBS].” Id., Ex. 58 (the “Canada II Study”). The analysis of the Canada II
Study was conducted by the Centre for Quantitative Analysis and Decision Support at Carleton
University. Id. The study concluded that the use of PCH on severe lBS participants did not “reveal
a statistically significant treatment effect.” Id. at 2. The Canada II Study acknowledged that the
differences in improvement between the active and placebo groups “were nearly significant,” but
ultimately found that “the large placebo effect and high fluctuating nature of lBS on a day-to-day
The “active group” designates the participants that took the three bacteria strains.
is a “chronic, reoccurring gastrointestinal disorder. characterized by abdominal pain,
bowel dysfunction and bloating in the absence of any structure abnormalities.” Cecchi Dec., Ex.
basis make it very difficult to control for the uncertainty of the data.” Id. at 2. In sum, the study
found that “there is simply not enough evidence to conclude that [PCH] is effective against lBS
[or that it] provides a practically significant improvement in the average participant’s quality of
life.” Id. at 20-21.
The third RCT, known as the “Florida Study,” was conducted by researchers at the
University of Florida and published in 2015. Id., Ex. 59. The Florida Study used the same threestrain bacteria contained in PCH. Id. at 1. The objective of the study was to determine “whether
older adults who consumed a probiotic mixture would have a greater proportion of circulating
CD4+ lymphocytes, altered cytokine production, and a shifi in intestinal microbiota toward a
healthier microbial community.” Id. The study consisted of 32 healthy adults between the ages
of 65 and 80. Id. at 5. It was designed not to detect changes in clinical symptoms, but in
“biomarkers.” Id. at 1. Biomarkers are defined as a “detectable cellular or molecular indicator of
exposure, health effects, or susceptibility, which can be used to measure the absorbed,
metabolized, or biologically effective dose of a substance, the response to the substance including
susceptibility and resistance, idiosyncratic reactions, and other factors or conditions.” Stedman ‘s
Medical Dictionary 221 (28th ed. 2006).
The Florida Study concluded that the probiotic mixture “maintained CD4+ lymphocytes
and produced a less inflammatory cytokine profile in healthy older adults.” D.E. 145, Ex. 59 at
9. The study found that the “changes may have been due to changes in the microbial communities,
which more closely resemble those observed in healthy younger populations.” Id. While the
Florida Study concluded that “healthy older adults may benefit from ingesting this probiotic mix,”
it suggested that “future studies should explore inflammatory changes and health-related outcomes
in an at-risk population.” Id.
E. Plaintiffs’ Expert
Plaintiffs’ expert Dr. Stefano Guandalini, M.D. is a Professor of Pediatrics and Director of
the Division of Gastroenterology, Hepatology and Nutrition of the Department of Pediatrics at the
University of Chicago. Guandalini Dec.
1. Dr. Guandalini has engaged in extensive clinical
research testing probiotics, authored more than 200 peer-reviewed publications, and presented
more than 300 invited lectures. Id.
In his deposition, Dr. Guandalini opined that PCH “has been clinically proven to be
ineffective” for people with 13$. Deposition of Dr. Stefano Guandalini, M.D. (“Guandalini Dep.”)
at 69:14-16; 176:13-18. Dr. Guandalini explained that for a claim about a dietary supplement,
such as PCH, to be true it must be supported by “competent and reliable scientific evidence,” which
requires “well conducted clinical trials.” Id. at 68:17-21; 150:2-12. Dr. Guandalini defined “wellconducted clinical trial” to mean, among other things, that the study should not be initiated by the
industry, possibly be conducted “in a multi-center fashion, be double blind and placebo controlled,
consist of a sufficient number of sufficient participants to reach statistically significant results, be
carefully analyzed, and be subject to.peer review. Id. at 137:6 to 138:1; see also id. at 161:4-8
(stating that an RCT would be required to state that a product “helps promote digestion”). Dr.
Guandalini stated that the reason he believes “well-conducted clinical trials” are necessary is
because doing so is “good clinical practice.” Id. at 140:9-19. According to Dr. Guandalini, the
testing required to determine the efficacy of a product is the same whether the product is classified
as a drug or a dietary supplement. Id. at 6 1:6-10. Dr. Guandalini also testified that he did not
“have enough authority to express a judgment on” the difference between the Food and Drug
Administration’s regulations on drugs compared to dietary supplements. Id. at 62:24 to 63:5.
To support his conclusion that PCH is ineffective, Dr. Guandalini relied on two RCTs, the
Canada I Study and the Florida Study.7 Id. at 69:10-11; 164:3-7. Dr. Guandalini explained that
these were the only two studies on which he based his opinion to conclude that PCH’s claims of
“defend[ing] against occasional constipation, diarrhea, gas, and bloating” are false. Id. at 164:37. However, Dr. Guandalini recognized some limitations in the results of the Canada I and Florida
Studies. In regard to the Canada I Study, Dr. Guandalini noted that the study’s results were limited
to showing that PCH did not cause a statistically significant improvement in adults with symptoms
of IBS, as opposed to less severe gastrointestinal issues or general health maintenance. Id. at
163:22 to 164:9. Dr. Guandalini agreed that PCH’s effect on lBS symptoms and its effect on
overall digestive health are distinct inquiries:
Q. Okay. Now, whether a therapy shows significant changes in lBS
symptom severity does not necessarily tell us whether or not a
therapy supports overall digestive health in a healthy population,
A. Yeah, right.
Id. at 165:10-14. Additionally, as to the Florida Study, Dr. Guandalini explained that its results of
PCH’s ineffectiveness were limited to the particular patient population of “70 years and older.”
Id. at 158:9-14.
Dr. Guandalini was asked whether he believed that PCH effectively promoted overall
digestive health in adults who do not have IBS, to which he provided inconsistent responses. first,
he opined that there was sound scientific evidence that PCH is ineffective for adults with lBS.
while leaving open the possibility that PCH could be effective for someone without IBS:
In his deposition, Dr. Guandalini said he relied only on these two studies. Guandalini Dep. at
69:10-11; 164:3-7. It appears, however, that Dr. Guandalini subsequently considered the Canada
II study as it was discussed in his declaration submitted in connection with this motion. See D.E.
Q. Okay. So then your opinion leaves open the possibility that PCH
may work for someone without IBS, right?
A. Well, yeah.
Q. You are not opining that PCH is incapable of helping to promote
overall digestive health, you just don’t how one way or the other?
A. I don’t know.
Id. at 175:18-21; 177:2-5. Then Dr. Guandalini clarified that he would “be surprised if [PCH
promoted overall digestive health] considering the small amount of bacteria contained in the
preparation.” Id. at 177:2-9.
Next, Dr. Guandalini stated that he believed that PCH was
“incapable of protecting against” symptoms of occasional constipation, diarrhea, gas, and bloating.
Id. at 178:7-23. The colloquy took place as follows:
Q. Okay. Let’s go back. My original question was, you are not
opining that PCH is incapable of helping to defend against
occasional constipation, diarrhea, gas, and bloating?
A. In my opinion, it is incapable of protecting against those
symptoms as well, based on the fact that is was so clearly negative
in the population of lBS sufferers, which, once again, are a
population closely resembling, overlapping those that the claims are
made for. I hope I made myself clear. So the strong evidence of
lack of efficacy, clinical proven ineffective to treat patients with
irritable bowel syndrome, on that I stand firm. I want to add, in
addition, my opinion is that given this proof of inefficiency, it’s
extremely likely that we’ll also not be able to protect from the
occasional onset of symptoms. I really see no evidence to support
Id. Finally, Dr. Guandalini was asked:
Q. Can you completely rule out that PCH provides health benefits
to some people?
A. No, I cannot.
Q. Okay. In fact, there’s no study finding that PCH has no benefits
for anyone, correct?
A. There is no study yes. I’m not aware of any study showing
that there is a complete lack of health benefit.
Id. at 180:23 to 181:7.
F. Defendant’s Expert
Defendant’s Expert, Dr. Daniel I. Merenstein, M.D. is a tenured associate professor at
Georgetown University where he focuses his research on probiotics and sinusitis and also teaches
in both the undergraduate and medical schools.
Declaration of Daniel J. Merenstein, M.D.
(“Merenstein Dec.”) ¶J 1, 3, 5. (D.E. 157-9). In the past six years, Dr. Merenstein was the principal
investigator on seven probiotic clinical trials. Id.
¶ 6. Dr. Merenstein also works as a family
physician with specialties in pediatrics and infectious and gastrointestinal diseases. Id.
Dr. Merenstein opined that PCH helps alleviate diarrhea, constipation, gas, and bloating.
Deposition of Daniel J. Merenstein, M.D (“Merenstein Dep.”) 180:13 to 182:19. (D.E. 160-1). In
particular, Dr. Merenstein “believe[s] that PCH can effectively help individuals who are generally
healthy but suffer from occasional constipation, diarrhea, gas, and bloating.” Merenstein Dec.
50. However, Dr. Merenstein acknowledged that although PCH promotes overall digestive health
for some users, it may not do so for all people. Dr. Merenstein explained his position as follows:
Q. Does Phillips Colon Health promote overall digestive health for
A. No. We talked about that I think in the last hour, that there is
nothing out there that does it for everyone. People can exercise
and have a heart attack. People can get a flu vaccine and get
the flu. And people can take Phillips Colon Health and have
Okay. Does PCH promote overall digestive health at least for
A. Oh, yes, no question about it.
Q. Okay. And, similarly, does PCH help defend against
occasional constipation, diarrhea, gas, and bloating for
everyone that uses it?
A. No, it does not for everyone.
Q. But it does for some users, correct?
A. It does for some users.
Id. at 337:7 to 338:2.
Dr. Merenstein was asked for his opinion regarding the results of the Canada I, Canada II,
and Florida Studies. Dr. Merenstein described the two Canada Studies as “null studies.” Id. at
237:5-11. Dr. Merenstein found them to be “null studies” because they did not support the theory
that PCH had a different effect on the active participants when compared to those who took the
placebo. Id. at 237:18-21. Dr. Merenstein opined that although the two Canada Studies did not
demonstrate that PCH “helps defend against occasional diarrhea, constipation, gas, or bloating,”
Id. at 237:5-11; 239:19 to 240:4, the testing in these studies was targeting PCH’s effect on
participants with lBS as opposed to its effect on digestive health outcomes, Id. at 23 7:22 to 23 8:4.
In other words, Dr. Merenstein believed that each of the Canada Studies “tell us nothing about the
cause and effect between probiotic use and helping to promote overall digestive health (as opposed
to IBS), which is what the PCH label claims.” Merenstein Dec.
¶ 55. As to the Florida Study, Dr.
Merenstein stated that it “support[ed] Bayer’s claims as part of the totality of scientific evidence.
and proved PCH to be beneficial for the maintenance of gut homeostasis.” Merenstein Dec.
G. Procedural History
Plaintiffs filed a six-count Amended Complaint against Bayer alleging the following causes
of action: (1) violation of the New Jersey Consumer fraud Act (on behalf of Plaintiffs Rikos,
Yuncker and all class members), (2) violation of the Consumers Legal Remedies Act
Civil Code Section 1750 et seq. (on behalf of Plaintiff Rikos and the California subclass), (3)
unlawful business acts and practices in violation of California Business & Professions Code
Section 17200, et seq. (on behalf of Plaintiff Rikos and the California subclass), (4) violation of
Illinois’ Consumer Fraud Act, 815 ILCS 505/1, et seq. (on behalf of Plaintiffs Rikos, Yuncker,
and the Illinois subclass), (5) breach of implied warranty of merchantability,8 (6) unjust enrichment
(on behalf of Plaintiffs Rikos, Yuncker, and all class members). D.E. 94.
Defendant filed a motion to dismiss the complaint, which the Court granted in part and
denied in part. D.E. 114. The Court denied the motion as to Counts Two through Six, but
dismissed Plaintiffs’ claim under the New Jersey Consumer Fraud Act. Id. Then, after discovery,
Bayer moved for summary judgment on the remaining counts, which Plaintiffs oppose.
III. LAW AND ANALYSIS
A. Standard of Review
A moving party is entitled to summary judgment where “the movant shows that 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. 5 6(a). A fact is “material” when a dispute over that fact “might affect the outcome
of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
Importantly, “[f]actual disputes that are irrelevant or unnecessary will not be counted.” Id. A
material fact raises a “genuine” dispute “if the evidence is such that a reasonable jury could return
a verdict for the non-moving party.” Williams
Borough of W. Chester, $91 F.2d 458, 459 (3d
In Plaintiffs opposition brief, they clarified that they are not seeking certification of this claim.
Cir. 1989) (quoting Liberty Lobby, 477 U.S. at 248). “Where the record taken as a whole could
not lead a reasonable trier of fact to find for the non-moving party, there is no genuine issue for
trial.” Matsushita Elec. Indits. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (internal
quotation marks omitted). “When analyzing the sufficiency of the evidence, the court must view
the facts and any reasonable inferences drawn therefrom in the light most favorable to the party
opposing summary judgment.” Inter Vest, Inc. v. Bloomberg, L.P., 340 F.3d 144, 159-60 (3d Cir.
2003) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 456 (1992)).
Summary judgment is appropriate “against a party who fails to make a showing sufficient
to establish the existence of an element essential to that party’s case, and on which that party will
bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Under those
circumstances, “there can be ‘no genuine issue as to any material fact,’ since a complete failure of
proof concerning an essential element of the nonmoving party’s case necessarily renders all other
facts immaterial.” Id. at 322-23. However, to withstand a motion for summary judgment, the
nonmoving party need only “come forward with evidence which, if believed, would support a
finding in its favor.” In re Bressman, 327 f.3d 229, 237 (3d Cir. 2003).
B. The Federal Trade Commission Opinion
In September 2015, Judge Linares issued an opinion relevant to the issues arising in this
case. See United States v. Bayer Corp., No. 07-01, 2015 WL 5822595 (D.N.J. Sept. 24, 2015) (the
“FTC Opinion”). In particular, the FTC Opinion analyzed (1) the different regulatory standards
applicable to a dietary supplement as opposed to a drug, (2) the type of scientific evidence
necessary to demonstrate that a dietary supplement, such as PCH, is “truthful and not misleading,”
and (3) the significance of the Canada I and Florida Studies.
In the FTC Opinion, Judge Linares addressed whether the United States of America (the
“Government”) had demonstrated by clear and convincing evidence that Bayer violated a consent
decree thereby warranting a finding of contempt. Id. at *1. The consent decree, which had been
entered into in 2007, applied to all of Bayer’s dietary supplements. The consent decree provided
that Bayer was barred “from making any representation, directly or by implication, concerning the
need for or benefits to be derived from consumption of such [dietary supplements], unless, at the
time such representation is made, [Bayer] possesses and relies upon a reasonable basis consisting
of competent and reliable scientific evidence to substantiate the representation.” Id. At issue was
whether Bayer possessed adequate substantiation for its claims that PCH “prornote[s] overall
digestive health” and that it “helps defend against occasional constipation, diarrhea, gas, and
bloating.” Id. at *2, 5.
Judge Linares first recognized the regulatory differences between a dietary supplement and
a drug. He explained that drugs are held to a higher standard requiring pre-approval from the FDA
and usually must be supported randomized, placebo controlled, double-blind clinical trials, while
dietary supplements do not. Id. at *3• Judge Linares determined that Bayer did not market PCH
as a drug because it never made claims that PCH treats, prevents, or cures any diseases. The court
noted that “[e]very package of PCH and every advertisement contains a disclaimer that that PCH
is ‘not intended to diagnose, treat, cure or prevent any disease.” Id. at *12. Additionally, there
was no evidence that the language on PCH’s packages and advertisements would expressly or
impliedly make a consumer believe PCH was making a disease claim. Id. at * 13. Therefore, the
court concluded that substantiation of PCH was evaluated by the lower standard used for dietary
In order for a supplement to be “truthful and not misleading,” Judge Linares noted that the
FTC requires “competent and reliable scientific evidence,” which is defined as: “tests, analyses,
research, studies, or other evidence based on the expertise of professionals in the relevant area,
that have been conducted and evaluated in an objective manner by persons qualified to do so, using
procedures generally accepted in the profession to yield accurate and reliable results.” Id. (quoting
PX—1 Dieta,’y Sttpplements: An Advertising Guide for Indttstry at 3). The FTC makes clear that
RCTs are not required to meet the standard of “competent and reliable scientific evidence.” Id.
“Instead, competent and reliable scientific evidence is a flexible standard, and there is no fixed
formula for the number or type of studies required.” Id. In short, dietary supplements are evaluated
by looking to the “totality of the evidence.” Id. at *4 The court noted that the FTC’s requirement
of “competent and reliable scientific evidence,” was the same level of proof required by the consent
decree for Bayer to substantiate its claims regarding PCH. Id. at *3•
Judge Linares also discussed many of the studies Bayer relied upon to substantiate its
claims about PCH. Two of those studies were the Canada I and Florida Studies. The court
explained that the Florida Study “showed a positive impact in its primary outcome” and that PCH
“was proven to be beneficial for maintenance of gut horneostasis” such as “digestive health and
the absence of symptoms like constipation, diarrhea, gas and bloating.”
Id. at *9 (internal
quotation marks omitted). As to the Canada I Study, Judge Linares found that it was a “primarily
neutral study but showed results that trended positive for digestive health benefits.” Id. (internal
quotation marks omitted). The court noted that “the study was underpowered meaning there were
not enough people to show a statistically significant benefit,” but that Bayer’s substantiation of
PCH was not undercut “because many successful products, including FDA-approved drugs have
neutral studies.” Id.
Judge Linares concluded that the Government had failed to prove by clear and convincing
evidence that Bayer had violated the consent decree. Id. at *19. One of the primary deficiencies
in the Government’s case concerned its expert evidence vis-ã-vis the standards applicable to
dietary supplements. The Government’s expert opined that to meet the competent and reliable
standard. Bayer needed to subject PCH to a double-blind, placebo controlled RCT. Id. at *9 The
Government’s expert admitted that “his study design did not distinguish between drugs or
supplements.” Id. Significantly, the Government’s expert was not familiar with the regulations
for dietary supplements nor was he familiar with FTC guidance concerning the “substantiation
necessary for dietary supplement claims.” Id. at *10.
Judge Linares concluded that Bayer did not violate the consent decree by failing to rely
upon RCTs to support its claims about PCH. Id. at *14. Judge Linares explained that, contrary to
the opinion of the Government’s expert, proof of “competent and reliable scientific evidence” does
not require RCTs pursuant to the regulations and FTC guidance. Id. Moreover, nothing in the
consent decree required Bayer to conduct RCTs to support its claims concerning PCH. Id. at * 16.
Judge Linares also ruled that the Government’s expert’s opinion failed to satisfy the Government’s
burden. Id. at *1516. The court criticized the Government’s expert for “not paying attention to
the law or regulations about the difference between dietary supplements and drugs’ in formulating
his opinion.” Id. at *16. Judge Linares explained that the Government’s expert opinion that an
RCT was necessary was “directly contrary” to the legal requirement as well as contrary to FTC
guidance. Id. Judge Linares further concluded that Bayer possessed and relied upon competent
and reliable scientific evidence in support its claims about PCH. Id. at *1819. Bayer’s medical
lead for PCH “reviewed and relied upon [relevant] scientific studies in the public domain.” Id. at
The FTC Opinion is not dispositive in the current matter. There, the standard was different,
specifically, the Government had to prove by clear and convincing evidence that Bayer violated
the consent decree by making false and misleading claims concerning PCH. Here, the burden of
proof is preponderance of the evidence. Moreover, the issue is whether there is a genuine issue of
material fact to preclude summary judgment. However, the FTC Opinion is instructive. Like the
Government’s expert in the FTC Opinion, Plaintiffs’ expert testified that a double-blind, placebo
controlled RCT was necessary.
Not only does this testimony misstate the correct legal
requirements for dietary supplements, it also confuses the burden of proof. Plaintiffs must prove
that Defendant’s claims concerning PCH are false and misleading. Significantly, Plaintiffs did not
conduct their own double-blind, placebo controlled RCT to support their position. In addition,
like the Government’s expert in the FTC Opinion, it does not appear that Plaintiffs’ expert was
aware of the different legal standards that govern dietary supplements as opposed to drugs.
C. California and Illinois Consumer Protection Statutes
Plaintiffs allege causes of action under the Consumers Legal Remedies Act, California
§ 1750, et seq. (“CLRA”), false or deceptive advertising in violation of California
Business and Professions Code, Cal. Bus. & Prof. Code
§ 17200 et seq. (“UCL”), and violation of
the Illinois Consumer Fraud Act, 815 ILCS 505/1, et seq. (“ICFA”).
California’s CLRA generally prohibits “unfair methods of competition and unfair or
deceptive acts or practices.” Cal Civ. Code
§ 1770. California’s UCL prohibits any “unlawful,
unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading
advertising.” Cal. Bus. & Prof. Code
§ 17200. In evaluating a claim under the CLRA and UCL,
the court must determine whether a reasonable consumer is likely to be deceived by the defendant’s
Williams v. Gerber Prod. Co., 552 F.3d 934, 938 (9th Cir. 2008). When
alleging false advertising under the UCL and CLRA, “the plaintiff ‘bears the burden of proving
the defendant’s advertising claim is false or misleading.” Stanley, 2012 WL 1132920, at *3
(quoting Nat’! Council Against Health Frattd, Inc. v. King Bio Pharms., Inc., 107 Cal. App. 4th
1336, 1342 (2003)). Importantly, a plaintiff must put forth affirmative evidence offalsity “and
caimot prevail by arguing that the defendant’s claims are itnstthstantiated and therefore
misleading.” Mttllins, 178 F. Supp. 3d at 892 (emphasis added); see also Alottdi v. Intramedic
Research Grp., LLC, 2015 WL 4148381, at *4 (N.D. Cal. July 9, 2015) (dismissing UCL and
CLRA claims averring that defendant failed “to provide adequate substantiation” that its
advertising claims were true); Stanley, 2012 WL 1132920, at *3 (“Private individuals may not
bring an action demanding substantiation for advertising claims.
only prosecuting authorities
may require an advertiser to substantiate its advertising claims.”).
The third consumer protection statute at issue, the ICFA, “protects consumers against
‘unfair or deceptive
acts or practices,’
‘misrepresentation or the concealment, suppression or omission of any material fact.” Wigod v.
Wells Fargo Bank, NA., 673 F.3d 547, 574 (7th Cir. 2012) (quoting 815 ILCS 505/2). The
elements of a claim under the ICFA are “(1) a deceptive or unfair act or practice by the defendant;
(2) the defendant’s intent that the plaintiff rely on the deceptive or unfair practice; and (3) the
unfair or deceptive practice occurred during a course of conduct involving trade or commerce.”
Siegel v. Shell Oil Co.. 612 F.3d 932, 934 (7th Cir. 2010). Similar to the UCL and CLRA, to
demonstrate a deceptive act or practice under the ICFA, the plaintiff has the burden to show that
the defendant’s alleged misrepresentations were actually false. Baldwin v. Star Sd., Inc., 78 F.
Supp. 3d 724, 738 (N.D. Ill. 2015) (concluding that plaintiff failed to state a claim under the ICFA
when he failed to allege “how [dJefendant’s alleged misrepresentations were false”); see also
Spectorv. Mondelëzlnt7, Inc., 17$ F. Supp. 3d 657, 665 (N.D. Ill. 2016) (“Plaintiffs unsupported,
conclusory allegation here regarding the falsity of the [defendant’s] representation does not suffice
to state a cause of action under the ICFA.”).
Thus, Plaintiffs’ claims under the CLRA, UCL, and ICFA depend on whether they have
presented proof of falsity regarding Bayer’s claims that PCH “promotes overall digestive health”
and “helps defend against occasional constipation, diarrhea, gas, and bloating.” Merely proving
that the claims are unsubstantiated is insufficient. Two cases from the Southern and Northern
Districts of California illustrate the necessary level of proof to defeat summary judgment in a claim
for false advertising.
In Mttllins, the court addressed claims under the UCL and CLRA alleging that the
defendant made false or misleading representations in selling its product “Joint Juice.” 17$ F.
Supp. 3d at 875. Joint Juice was a liquid dietary supplement that was marketed to remedy pain
and stiffness in arthritic joints, but according to the plaintiff, was actually nothing more than “snake
oil.” Id. The active ingredients in Joint Juice were glucosarnine hydrochloride (“glucosamine”)
and chondroitin sulfate (“chondroitin”).
The court in Mttllins concluded that the plaintiff “advanced evidence which directly
supports the contention that certain of [the defendant’s] representations are false or misleading.”
Id. at 876. The plaintiff presented evidence of Joint Juice’s inefficacy through numerous RCTs in
the form of randomized double-blind, placebo-controlled studies. Id. at 882-84. The plaintiff also
produced meta-analyses9 clinical treatment protocols, and bioavailability studies in support of her
theory. Id. at 884-887. Among various types of medical evidence, meta-analyses are “considered
“Meta-analyses pool the results of clinical trials to arrive at a single figure to represent the
totality of the studies reviewed.” Mitilins, 17$ F. Supp. 3d at $84 (internal quotation marks
the strongest.” Id. at 884 (citation omitted). Clinical treatment protocols look to see if medical
guidelines recommend using a particular substance to treat a condition or its symptoms. Id. at 885.
No clinical treatment protocol recommended either glucosamine or chondroitin for plaintiff’s
condition. Id. The bioavailability studies showed that active ingredients in Joint Juice never
reached the targeted joint cartilage and, even if they did, the amount was too small to have any
meaningful effect on the joints. Id. at 886-87.
The district judge in Mttllins acknowledged that the defendant’s expert advanced some
evidence, such as in vitro and preclinical animal studies, to refute the plaintiffs position, but that
many of the sources relied upon by the defendant’s expert could be deemed unreliable. Id. at 895.
F or example, the defendant’s expert failed “to take into consideration the hierarchy of scientific
evidence, which places meta-analyses and randomized clinical trials at the top” and also relied on
certain studies “characterized by poor design” or industry bias. Id. The Multins court found that
due to the competent evidence presented by the plaintiff, and because the plaintiff “offered
principled, supported critiques of the studies [the defendant’s experti used to form his opinions,
and a jury may reasonably adopt those same views, [the plaintiff] may be able to convince a jury
that [the defendant’s] claims are literally false.” Id. at 896. Therefore, the district court denied
the defendant’s motion for summary judgment.
In Stanley, the Southern District of California addressed claims under the CLRJ& and UCL,
which alleged that Bayer made false and misleading statements regarding PCH, the same product
at issue in the instant matter. 2012 WL 1132920, at *1.2. The plaintiff alleged that Bayer violated
the CLRA and UCL by stating, among other things, that PCH “promote[s] overall digestive health”
and “helps defend against occasional constipation, diarrhea, gas, and bloating.” Id. at *5
The plaintiffs experts believed that these statements were false and misleading due to a
lack of substantiation. Id. at *5 One of the plaintiffs experts opined that “a majority of data
generated in peer reviewed, double[-]blind, placebo controlled studies, relating to probiotics,
largely suggests that probiotics have little effect on human digestive or immune health.” Id. at *5
(internal quotation marks omitted). The Stanley court noted, however, that none of the plaintiffs
experts actually opined that the claims about PCH were false or explained how the contested
statements might mislead a reasonable consumer. Id. Instead, the plaintiffs experts repeatedly
asserted that the statements were false or misleading due to a lack of substantiation. Id. for
example, one expert was asked whether he could “rule out that probiotics do work for some
people,” to which he responded, “it’s inconclusive.” Id. at *6. Additionally, the plaintiffs experts
were not aware of the different regulations for drugs and dietary supplements. Id. at *7• To the
contrary, one expert opined that “he believe[d] [d]efendant should have the same support for its
PCH claims as drug companies must have for their drug claims, i.e. proof of efficacy in placebocontrolled double-blind human studies.” Id.
The district court held that the plaintiff had not met her burden in demonstrating that
Bayer’s statements about PCH were actually false or misleading. Id. In granting Bayer’s motion
for summary judgment, the court in Stanley concluded by noting that the plaintiff “cannot create a
genuine issue of material fact regarding whether Defendant met the level of substantiation required
under federal law by presenting opinions from experts who are not aware of the relevant regulatory
Here, Plaintiffs failed to meet their burden of proof of showing that PCH’s claims of
promoting “overall digestive health” and “defend[ing] against occasional constipation, diarrhea,
gas, and bloating” are actually false. Although Plaintiffs argue that they have shown actual falsity,
their expert’s opinion is actually one of lack of substantiation. Plaintiffs’ proofs are deficient for
First, like the plaintiffs experts in Stanley and the Government’s expert in the FTC
Opinion, Dr. Guandalini does not recognize the difference in proof required to substantiate a
dietary supplement as compared to a drug. As noted, drugs require pre-approval from the FDA
and generally “must be supported by randomized, placebo controlled, double-blind clinical trials.”
FTC Opinion, at *3 Dietary supplements, in comparison, require only that the statements made
regarding their properties are “truthful and not misleading.” 21 U.S.C.
§ 343(r)(6)(B). To be
“truthful and not misleading,” the statements must be supported by “competent and reliable
scientific evidence.” FTC Opinion, at *3• Importantly, RCTs may be used to satisfy this standard,
but they are not required. Id.
Dr. Guandalini testified that in order for Bayer’s statements about PCH to be true, they
must be supported by double-blind, placebo controlled “well conducted clinical trials,” which he
equates to RCTs. Guandalini Dep. at 6$: 17-21; 150:2-12; 161:4-8. Dr. Guandalini believes RCTs
are necessary because they are “good clinical practice.” Id. at 140:12-19. However, RCTs are not
required for a dietary supplement. Further to the point, Dr. Guandalini testified that his opinion
about a product’s efficacy would not change regardless of whether it is a drug or a dietary
supplement. Id. at 61:6-10. In his words, “[e]ither a compound works or it doesn’t.” Id. Dr.
Guandalini candidly admitted that he did not have enough knowledge “to express a judgment” on
the different types of regulations and requirements for drugs versus dietary supplements. Id. at
62:24 to 63:2. Dr. Guandalini was asked whether he was aware that in the FTC Opinion, the Court
“already found that dietary supplements do not need to be supported by randomized, placebo
controlled, double blind control trials.” Id. at 147:21 to 148:10. Dr. Guandalini responded that he
was “not aware and frankly [doesn’t] care.” Id.
Dr. Guandalini’s lack of awareness and/or misunderstanding of the applicable legal
standard required to prove that a statement about a dietary supplement is “true and not misleading”
undercuts Plaintiffs’ argument that “[t]his is not a lack of substantiation case because Plaintiffs
present evidence that PCH does not work as advertised.” P1.
Opp. at 26.
Dr. Guandalini’s opinion
is nothing more than a lack-of-substantiation theory. In essence, Plaintiffs’ expert opines that
absent an RCT showing PCH’s efficacy, Bayer’s claims that PCH promotes digestive health are
false. This lack-of-substantiation theory is not the legal standard. Without understanding the
proper legal requirements to demonstrate whether Bayer’s statements about PCH are false and
misleading, Dr. Guandalini cannot offer an informed opinion as to whether that standard has been
met. See Stanley, 2012 WL 1132920 at *7 (“Plaintiff cannot create a genuine issue of material
fact regarding whether Defendant met the level of substantiation required under federal law by
presenting opinions from experts who are not aware of the relevant regulatory standards.”).
Certainly, using RCTs to substantiate PCH may be a reliable scientific method to show its efficacy
(or lack thereof), but such studies are not required as a matter of law. See FTC Opinion, at *3
Second, Dr. Guandalini’s interpretation of the Canada I & II and Florida Studies does not
prove actual falsity. The purpose of the Canada Studies was to determine the effect of PCH on
people who have lBS and severe lBS. The studies were not designed to test whether PCH
“promote[s] overall digestive health” and “helps defend against occasional constipation, diarrhea,
gas, and bloating.” DSOF
(emphasis added). The difference in the symptoms of those with
lBS and the syn-iptoms that PCH purports to defend against are materially different in terms of
severity. lBS is a “chronic,
gastrointestinal disorder... characterized by abdominal
pain, bowel dysfunction and bloating in the absence of any structure abnormalities.” Cecchi Dec.,
Ex. 54 (emphasis added). These “chronic” and “reoccurring” symptoms are far more severe than
the occasional constipation, diarrhea, gas and bloating that PCH claims to defend against.
In fact, Dr. Guandalini admitted that “whether a therapy shows significant changes in lBS
symptom severity does not necessarily tell us whether or not a therapy supports overall digestive
health in a healthy population.” Guandalini Dep. 165:10-14. Dr. Guandalini implied multiple
times that PCH could potentially be effective for someone without 13$:
Q. So then your opinion leaves open the possibility that PCH may
work for someone without IBS, correct?
A. Well, yeah.
Id. at 175:18-21.
Q. But for people who do not [have 13$] we do not have proof that
the claims are false, correct?
A. Neither that they are correct, yes, that’s correct, but neither do we
have proof that the statement is true.
Id. at 176:8-12.
Q. You are not opining that PCH is incapable of helping to promote
overall digestive health, you just don’t know one way or the other?
A. I don’t know.
Id. at 177:2-5. In short, Dr. Guandalini did not offer a definitive opinion as to whether PCH’s
claims that it promotes overall digestive health and helps defend against occasional constipation,
diarrhea, gas, and bloating were actually false.
Dr. Guandalini attempted to backtrack from his equivocal answers by claiming PCH is
ineffective in treating occasional digestive problems. Dr. Guandalini stated that he “would be
surprised” if PCH promoted overall digestive health “considering the small amount of bacteria
contained in the preparation.” Id. at 177:7-10. He also explained that because lBS sufferers are a
population closely resembling those with occasional constipation, diarrhea, gas, and bloating that
“it’s extremely likely that [PCH will] also not be able to protect from the occasional onset of
symptoms” and that “(he] really see[s] no evidence to support that.” Id. at 178:11-23 (emphasis
Yet, even Dr. Guandalini’s modified opinion is nothing more than a theory of lack of
substantiation. At worse, it is pure speculation in light of the fact that he never clinically tested
his views, and, at best, it is an educated guess. However, either is insufficient to carry Plaintiffs’
burden of showing that the PCH’s statements are actually false or misleading. Dr. Guandalini
stated that he saw “no evidence to support” the statement that PCH helps promote digestive health.
As discussed above, the question is not whether there is sufficient evidence to support PCH’s
claims, but rather whether Plaintiffs have presented proof that PCH’s claims are in fact false or
misleading. Moreover, Dr. Guandalini’s testimony that “he would be surprised” if PCH was
effective is a far cry from the scientific proof necessary to show actual falsity.
Dr. Guandalini’s attempt to extrapolate the results of the lBS Canada Studies to those with
occasional symptoms of constipation. diarrhea, gas, and bloating is unavailing. The Canada I
Study concluded that it was conducted with too small of a sample size to draw a definite
conclusion. Yet, there were indications of affirmative results for general digestive health. Cecchi
Dec., Ex. 55; see also FTC Opinion at *9 (noting that Canada I Study was “primarily a neutral
study but showed results that trended positive for digestive health benefits
[except that] the
study was underpowered meaning there were not enough people to show a statistically significant
benefit” (internal quotation marks omitted)).
Dr. Guandalini offers no explanation why
extrapolating from an inconclusive study about lBS to draw a conclusion about a different
population demonstrates that PCH’s claims are false. As to the Canada II Study, Dr. Guandalini
similarly does not provide a basis as to why a single study that did not conclude PCH improved
the quality of life for those with “severe” lBS is indicative of PCH’s efficacy in those with
occasional digestive problems. For those reasons, the Canada Studies do not demonstrate that
Bayer’s claims about PCH fail to meet the standard of “truthful and not misleading.”
The third and final RCT, the Florida Study, also does not show that the PCH claims are
false or misleading. In the FTC Opinion, Judge Linares found that the Florida Study “showed a
positive impact in its primary outcome” and that PCH “was proven to be beneficial for
maintenance of gut homeostasis” such as “digestive health and the absence of symptoms like
constipation, diarrhea, gas and bloating.” FTC Opinion, at *9• But even assuming that the Florida
Study showed that PCH was ineffective, its results nonetheless do not prove that Bayer’s claims
about PCH are in fact false. The Florida Study was limited to adults between the age of 65 to $0.
Therefore, the study provides no basis to conclude that Bayer’s claims about PCH are untrue for
people who fall outside this age range.’°
Lastly, Plaintiffs’ reliance on In re Neitrontin Marketing & Sates Practices Litigation, 712
F.3d 21(1st Cir. 2013) is misplaced. In that case, the first Circuit held that where “numerous
[double-blind randomized controlled trials] indicate that a drug is ineffective, that provides
powerful scientific evidence of inefficacy.” Id. at 49. Here, the only RCTs are the three studies
discussed above. The Canada Studies tested PCH’s effectiveness on individuals with lBS and
Plaintiffs also cite a report from the European Food Safety Authority (“EF$A”) which found
there is no evidence that “PCH ingredients support respiratory tract defenses or resulted in a
decrease in duration or severity of the common cold.” P1. Opp. at 12. Plaintiffs present no legal
argument regarding the significance, if any, of this report to the claims at issue concerning overall
digestive health. This matter concerns digestive health. The common cold and the respiratory
tract are not the issue.
severe lBS and the Florida Study was limited to people aged 65-80. Plaintiffs have not directed
the Court to an RCT where PCH’s claims were tested on people younger than 65 and shown to be
ineffective. Nor have Plaintiffs pointed to an RCT in which PCH was proven ineffective vis-à-vis
Bayer’s claims, i.e. promoting overall digestive health and providing relief from occasional
symptoms. Therefore, In re Neuron tin Marketing & Sales Practices Litigation is inapposite.
This matter is very similar to Stan 1ev, not only because the same product is involved but
also due to the nature of Plaintiffs’ proofs. Moreover, Plaintiffs’ case suffers from many of the
same infirmities found by Judge Linares in the FTC Opinion. Plaintiffs’ expert is incorrect as to
the medical evidence necessary for a dietary supplement.
Furthermore, and unlike Mullins,
Plaintiffs have presented no meta-analyses or bioavailability studies.
Plaintiffs also argue that Bayer’s internal documents indicate that Bayer marketed PCH
toward women aged 35 or older who suffer from lBS and that Bayer anticipated that 15% of its
customers would use PCH for lBS. PL. Opp. at 4. In Mullins, the court explained that evidence
of targeting a specific group of consumers maybe considered to show that a dietary supplement’s
implied claims are false or misleading, but it may not be used to substantiate the falsity of general
178 F. Supp. 3d at 896. There, the plaintiff hired an expert to analyze the
defendant’s marketing materials, advertisements, marketing research, and customer surveys to
determine why consumers purchased Joint Juice. Id. at 8 80-82. The plaintiff’s expert concluded
that “the primary appeal and driving reason consumers purchase Joint Juice are joint health and
joint pain” and that “consumers understand [the defendant’s] implied claims about the palliative
and structural benefits of drinking the product.” Id. at 880-8 1 (internal quotation marks omitted).
In other words, the plaintiff in Mttllins presented evidence that the “vast majority of consumers
purchased Joint Juice because they suffered arthritis and joint pain and stiffness”
Joint Juice did not explicitly claim to remedy. Id. at 891.
Here, unlike Mullins, Plaintiffs did not hire an expert to determine whether customers
purchase PCH for a reason other than its explicit general health claims of promoting overall
digestive health and helping to defend against occasional constipation, diarrhea, gas, and bloating.
Instead, Plaintiffs point to Bayer’s internal documents which indicate that Bayer targeted
individuals with lBS and that it believed 15% of its customers would purchase PCH to alleviate
lBS. This evidence is insufficient to overcome summary judgment for two reasons.
First, the fact that Bayer anticipates 15% of its customers will buy PCH to alleviate lBS
symptoms does not prove what motivates those consumers to purchase PCH. More specifically,
it is not clear whether Bayer’s marketing of PCH conveys an implied message that the product
alleviates lBS or whether consumers buy PCH believing that it helps with lBS for some other
unknown reason. Unlike the plaintiff in Mullins, Plaintiffs here did not commission an expert to
determine if PCH conveyed an implied message. Second, and more importantly, Plaintiffs do not
argue that Bayer made any false implied claims about PCH. Therefore, Bayer’s anticipation that
lBS sufferers may purchase PCH, without more, is insufficient to overcome summary judgment.1’
Plaintiffs also argue that Bayer admits in some of its internal documents that PCH “does
nothing.” P1. Opp. at 12. Some examples are from a May 2009 presentation where Bayer stated,
“[t]here is no information about [PCH’s] subspecies and thus the product” and “[t]here is no
clinical support for any of the claims that we make with regard to our specific subspecies.” D.E.
144-32 at 197097. Another example is a May 2011 email where a Bayer representative asks the
Chief Sales Officer from Wakunaga whether there is any additional infonTlation to substantiate
the claims about PCH, to which the Chief Sales Officer replied, “I believe you have everything.”
D.E. 161-1 at 14359. Bayer also acknowledged that there was a “[w]eak scientific base for
[PCH] bacteria strains.” D.E. 150, Ex. 2 at 196802. These statements potentially support a lack
of-substantiation theory, but they fall short of acknowledging that Bayer’s statements about PCH
are actually false or misleading. Therefore, they do not provide a basis for Plaintiffs to overcome
In sum, Plaintiffs failed to present competent evidence to create a genuine issue of material
fact that Bayer’s claims that PCH promotes overall digestive health and helps defend against
occasional constipation, diarrhea, gas, and bloating are actually false or misleading. Therefore,
the Court grants summary judgment in favor of Bayer as to all counts.12
For the reasons set forth above, Bayer’s motion for summary judgment is granted.
Plaintiffs’ motions for class certification and to strike portions of Bayer’s expert’s opinion are
denied as moot. An appropriate Order accompanies this Opinion.
Dated: April 17, 2017
John Michael Vazquei D.J.
Plaintiffs’ claims for breach of the implied warranty of merchantability and unjust enrichment
fail for the same reasons as the consumer protection statutes. See Gaul v. Bayer Healthcare LLC,
No. 12-5110,2013 WL 12181778 (D.N.J. Feb. 11,2013) (dismissingNewJerseyConsumerFraud
Act, unjust enrichment, breach of express warranty, and breach of implied warranty of
merchantability claims because the complaint failed to properly allege that a product was falsely
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