1 

RECOMMENDED FOR FULL-TEXT PUBLICATION 

Pursuant to Sixth Circuit I.O.P. 32.1(b) 

File Name: 15a0199p.06 

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT 

_________________ 

DINO RIKOS et al., 

Plaintiffs-Appellees, 

v. 

THE PROCTER & GAMBLE COMPANY, 

Defendant-Appellant. 

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No. 14-4088 

Appeal from the United States District Court 

for the Southern District of Ohio at Cincinnati. 

No. 1:11-cv-00226—Timothy S. Black, District Judge. 

Argued: June 16, 2015 

Decided and Filed: August 20, 2015 

Before: MOORE and COOK, Circuit Judges; COHN, District Judge.*

_________________ 

COUNSEL 

ARGUED: Brian J. Murray, JONES DAY, Chicago, Illinois, for Appellant. Timothy G. Blood, 

BLOOD HURST & O’REARDON, San Diego, California, for Appellees. ON BRIEF: Brian J. 

Murray, JONES DAY, Chicago, Illinois, D. Jeffrey Ireland, FARUKI IRELAND & COX P.L.L., 

Cincinnati, Ohio, Joanne Lichtman, BAKER & HOSTETLER LLP, Cleveland, Ohio, Chad A. 

Readler, Rachel Bloomekatz, JONES DAY, Columbus, Ohio, for Appellant. Timothy G. Blood, 

Leslie E. Hurst, Thomas J. O’Reardon II, BLOOD HURST & O’REARDON, San Diego, 

California, for Appellees. 

 MOORE, J., delivered the opinion of the court in which COHN, D.J., joined. COHN, 

D.J. (pg. 37), delivered a separate concurring opinion. COOK, J. (pp. 38–40), delivered a 

separate dissenting opinion. 

 *

The Honorable Avern Cohn, United States District Judge for the Eastern District of Michigan, sitting by 

designation. 

>
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 2

_________________ 

OPINION

_________________ 

KAREN NELSON MOORE, Circuit Judge. The named plaintiffs-appellees (“Plaintiffs”) 

are three individuals who purchased Align, Procter & Gamble’s (“P&G”) probiotic nutritional 

supplement, and found that the product did not work as advertised—that is, it did not promote 

their digestive health. Plaintiffs subsequently brought suit, alleging violations by P&G of 

various state unfair or deceptive practices statutes because it has not been proven scientifically 

that Align promotes digestive health for anyone. On June 19, 2014, the district court certified 

five single-state classes from California, Illinois, Florida, New Hampshire, and North Carolina 

under Federal Rule of Civil Procedure 23(b)(3) comprised of “[a]ll consumers who purchased 

Align . . . from March 1, 2009, until the date notice is first provided to the Class.” On appeal, 

P&G contends that the district court abused its discretion in granting Plaintiffs’ motion for class 

certification. For the reasons set forth below, we AFFIRM the district court’s judgment granting 

class certification to Plaintiffs. 

I. BACKGROUND

A. Facts

Align contains a patented probiotic strain, Bifidobacterium infantis 35624 (“Bifantis”), 

which it developed in the 1990s and early 2000s in partnership with Alimentary Health, a 

company based in Ireland. Sealed App. at 497. According to the World Health Organization, 

probiotics are “live microorganisms . . . which when administered in adequate amounts confer a 

health benefit to the host.” R. 108-8 (Komanduri Decl. ¶ 12) (Page ID #1596). “While there is a 

consensus within the medical and scientific communities that utilizing bacteria as a therapeutic 

measure in human disease is promising, current knowledge of the use of bacteria for these 

purposes remains fairly primitive.” Id. ¶ 13 (Page ID #1596). Although a limited number of 

probiotics have been approved as prescription treatments for pouchitis and infectious diarrhea, 

the overall “[m]edical understanding of probiotics in humans is still in its infancy.” Id. ¶¶ 13–14 

(Page ID #1596–97). 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 3

Align is not a prescription probiotic. Instead, it is marketed to the general public as a 

supplement that “naturally helps build and support a healthy digestive system, maintain digestive 

balance, and fortify your digestive system with healthy bacteria.” Appellant Br. at 12 

(alterations omitted). In addition, unlike some other non-prescription probiotics, Align is not 

included as an add-on ingredient to another consumer product (e.g., yogurt), but is rather sold in 

a capsule that is “filled with bacteria and [otherwise] inert ingredients.” R. 140 (Dist. Ct. Order 

at 30) (Page ID #6444). 

P&G began selling Align in various test markets in October 2005, with sales 

representatives dropping off samples to doctors’ offices in St. Louis, Boston, and Chicago. 

Sealed App. at 410. P&G was also able to sell a limited amount of product online, although 

“physician-driven sales outpaced internet-driven sales by about 2:1.” Id. One of the initial 

hurdles faced by P&G was convincing consumers of the product’s value, particularly given 

Align’s premium price point. See id. at 535 (company document noting that “[v]alue is a trial 

barrier due to the premium price point of $29.99. Probiotics on shelf at major retailers range 

from $9.99-$29.99. Of note, other probiotics detailed through physicians cost upwards of $45”) 

(emphasis added). After a successful rollout across multiple markets, P&G launched Align 

nationwide in 2009, promoting Align through a comprehensive advertising campaign, which 

included in-person physician visits, television and print advertisements, in-store displays, and 

product packaging. Appellant Br. at 11–12. 

B. Procedural History

Dino Rikos, Tracey Burns, and Leo Jarzembrowski, the named plaintiffs-appellees, are 

residents of Illinois, Florida, and New Hampshire, respectively. From 2009 to 2011, Rikos, 

Burns, and Jarzembrowski were “exposed to and saw Procter & Gamble’s claims by reading the 

Align label.” R. 85 (Second Amended Class Action Compl. ¶¶ 10–12) (Page ID #963–64). In 

reliance on P&G’s claims of Align’s effectiveness, they proceeded to purchase Align at various 

stores in California, Illinois, North Carolina, Florida, and New Hampshire. 

In their complaint, Plaintiffs allege that they “suffered injury in fact and lost money as a 

result of the unfair competition described [t]herein” after finding that Align did not provide them 

with the digestive benefits that it promised to provide. Id. Plaintiffs initially filed suit in the 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 4

United States District Court for the Southern District of California, but the case was eventually 

transferred to the Southern District of Ohio. R. 25 (S.D. Cal. Dist. Ct. Order at 4) (Page ID 

#374). In January 2014, Plaintiffs filed a motion and memorandum in support of class 

certification. Sealed App. at 15–63. In their motion, Plaintiffs requested that the district court 

certify the following five single-state classes and appoint them as class representatives: 

California Class (Represented by Plaintiff Dino Rikos): All consumers who 

purchased Align in California from March 1, 2009, until the date notice is first 

provided to the Class. 

Illinois Class (Represented by Plaintiff Dino Rikos): All consumers who 

purchased Align in Illinois from March 1, 2009, until the date notice is first 

provided to the Class. 

Florida Class (Represented by Plaintiff Tracey Burns): All consumers who 

purchased Align in Florida from March 1, 2009, until the date notice is first 

provided to the Class. 

New Hampshire Class (Represented by Plaintiff Leo Jarzenbowski [sic]): All 

consumers who purchased Align in New Hampshire from March 1, 2009, until the 

date notice is first provided to the Class. 

North Carolina Class (Represented by Plaintiff Tracey Burns): All consumers 

who purchased Align in North Carolina from March 1, 2009, until the date notice 

is first provided to the Class. 

Excluded from each of the Classes are the defendant, its officers, directors, and 

employees, and those who purchased Align for the purpose of resale. 

Id. at 16.

After hearing oral argument from both sides, the district court issued an order granting 

Plaintiffs’ motion for class certification. In its order, the district court made clear that it was not 

attempting to provide a ruling on the merits of the case (i.e., whether or not Align promotes 

digestive health), but was instead reviewing only whether Plaintiffs had presented sufficient 

evidence to satisfy Federal Rule of Civil Procedure 23. R. 140 (Dist. Ct. Order at 5–6) (Page ID 

#6419–20). It then determined that class certification was proper. Id. at 1, 38 (Page ID #6415, 

6452). P&G has timely appealed. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 5

II. ANALYSIS

A. Standard of Review

 “Class certification is appropriate if the [district] court finds, after conducting a ‘rigorous 

analysis,’ that the requirements of Rule 23 have been met.” In re Whirlpool Corp. FrontLoading Washer Prods. Liab. Litig., 722 F.3d 838, 851 (6th Cir. 2013) (quoting Walmart Stores, 

Inc. v. Dukes, 131 S. Ct. 2541, 2551 (2011)). Nonetheless, we have noted that “[t]he district 

court maintains substantial discretion in determining whether to certify a class, as it possesses the 

inherent power to manage and control its own pending litigation.” Beattie v. CenturyTel, Inc., 

511 F.3d 554, 559 (6th Cir. 2007) (internal quotation marks omitted). We review the district 

court’s decision to grant or deny class certification under an abuse-of-discretion standard. Id. 

“An abuse of discretion occurs when we are left with the definite and firm conviction that the 

[district] court . . . committed a clear error of judgment in the conclusion it reached upon a 

weighing of the relevant factors or where it improperly applies the law or uses an erroneous legal 

standard.” United States v. Haywood, 280 F.3d 715, 720 (6th Cir. 2002) (alterations in original) 

(internal quotation marks omitted). 

B. Rule 23(a)1

1. Plaintiffs Have Sufficiently Demonstrated Commonality 

Federal Rule of Civil Procedure 23(a)(2) states that “[o]ne or more members of a class 

may sue or be sued as representative parties on behalf of all members only if . . . there are 

questions of law or fact common to the class.” “Commonality requires the plaintiff to 

demonstrate that the class members have suffered the same injury.” Dukes, 131 S. Ct. at 2551 

(internal quotation marks omitted).

P&G contends that, like the plaintiffs in Dukes, Plaintiffs here have failed sufficiently to 

demonstrate commonality. According to P&G, Dukes requires that named plaintiffs present 

evidence proving that class members suffered an actual common injury to establish 

commonality. Appellant Br. at 25–26. P&G argues that Plaintiffs here have presented only 

 1

P&G has not challenged on appeal two other requirements of Federal Rule of Civil Procedure 23(a), 

numerosity and adequacy of representation.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 6

anecdotal evidence that Align does not work for them—Plaintiffs have “presented no evidence 

that the reported consumer benefits [of Align to all purchasers] were due solely to the placebo 

effect.” Id. at 29. Instead, P&G claims that “consumer satisfaction—and repeat purchasing—is 

probative of Align’s benefits to consumers.” Id. In addition, P&G notes that at least some 

studies appear to conclude that Align is effective in promoting digestive health.2

P&G misconstrues Plaintiffs’ burden at the class-certification stage. Whether the district 

court properly certified the class turns on whether Plaintiffs have shown, for purposes of Rule 

23(a)(2), that they can prove—not that have already shown—that all members of the class have 

suffered the “same injury.” Dukes, 131 S. Ct. at 2551. The Supreme Court in Dukes did not 

hold that named class plaintiffs must prove at the class-certification stage that all or most class 

members were in fact injured to meet this requirement. Rather, the Court held that named 

plaintiffs must show that their claims “depend upon a common contention” that is “of such a 

nature that it is capable of classwide resolution—which means that determination of its truth or 

falsity will resolve an issue that is central to the validity of each one of the claims in one stroke.” 

Id. (emphases added). In other words, named plaintiffs must show that there is a common 

question that will yield a common answer for the class (to be resolved later at the merits stage), 

and that that common answer relates to the actual theory of liability in the case. 

Since Dukes, the Supreme Court has made clear that “Rule 23 grants courts no license to 

engage in free-ranging merits inquiries at the certification stage. Merits questions may be 

considered to the extent—but only to the extent—that they are relevant to determining whether 

the Rule 23 prerequisites for class certification are satisfied.” Amgen Inc. v. Conn. Ret. Plans 

& Trust Funds, 133 S. Ct. 1184, 1194–95 (2013) (emphasis added); see also In re Whirlpool, 

722 F.3d at 851–52 (“[D]istrict courts may not turn the class certification proceedings into a 

dress rehearsal for the trial on the merits.” (internal quotation marks omitted)); Gooch v. Life 

Investors Ins. Co. of Am., 672 F.3d 402, 417 (6th Cir. 2012) (explaining that although 

“conformance with Rule 23(a) . . . must be checked through rigorous analysis, . . . it is not 

always necessary . . . to probe behind the pleadings before coming to rest on the certification 

 2

Although not relevant to the commonality inquiry, Plaintiffs point to flaws in the scientific studies relied 

upon by P&G that Plaintiffs claim mean that it has not been proven with proper scientific analysis that Align works 

for anyone who takes it. See, e.g., Sealed App. at 42–44.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 7

question, because sometimes there may be no disputed factual and legal issues that strongly 

influence the wisdom of class treatment” (internal quotation marks omitted)). 

A brief overview of the class claims in Dukes illustrates the Supreme Court’s more 

limited holding than what P&G claims. The named plaintiffs were “three current or former WalMart employees who allege[d] that the company discriminated against them on the basis of their 

sex by denying them equal pay or promotions, in violation of Title VII of the Civil Rights Act of 

1964.” Dukes, 131 S. Ct. at 2547. They sought to have a class certified of “[a]ll women 

employed at any Wal-Mart domestic retail store at any time since December 26, 1998, who have 

been or may be subjected to Wal–Mart’s challenged pay and management track promotions 

policies and practices.” Id. at 2549 (internal quotation marks omitted). Significantly, “[t]hese 

plaintiffs . . . [did] not allege that Wal–Mart ha[d] any express corporate policy against the 

advancement of women.” Id. at 2548. Rather, plaintiffs “claim[ed] that the discrimination to 

which they have been subjected [was] common to all [of] Wal–Mart’s female employees” 

because “a strong and uniform ‘corporate culture’ permits bias against women to infect, perhaps 

subconsciously, the discretionary decisionmaking of each one of Wal–Mart’s thousands of 

managers—thereby making every woman at the company the victim of one common 

discriminatory practice.” Id.

The Supreme Court rejected this theory, finding that the plaintiffs had failed to 

demonstrate that “there are questions of law or fact common to the class.” Fed. R. Civ. P. 

23(a)(2). After reviewing the details of Wal-Mart’s discretionary promotion policy, the Court 

noted that, “[i]n such a company, demonstrating the invalidity of one manager’s use of discretion 

will do nothing to demonstrate the invalidity of another’s.” Dukes, 131 S. Ct. at 2554. Thus, 

“[a] party seeking to certify a nationwide class will be unable to show that all the employees’ 

Title VII claims will in fact depend on the answers to common questions.” Id. The plaintiffs, 

the Court noted, had presented no evidence that managers at Wal-Mart had exercised their 

discretion in the same way—i.e., that they had used it to discriminate against women. It would 

have been possible for some managers to discriminate in favor of women, for others to 

discriminate against women, and for still others not to discriminate at all. Id.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 8

Here, in contrast, Plaintiffs have identified a common question—whether Align is “snake 

oil” and thus does not yield benefits to anyone, Appellee Br. at 7—that will yield a common 

answer for the entire class and that, if true, will make P&G liable to the entire class. The district 

court conducted a sufficient analysis of the record evidence in finding commonality here. It 

concluded that no individual would purchase Align but-for its digestive health benefits, which 

P&G promoted through an extensive advertising campaign. If Align does not provide any such 

benefits, then every class member was injured in the sense that he or she spent money on a 

product that does not work as advertised. No more investigation into the merits (i.e., whether 

Align actually works) is needed for purposes of satisfying Rule 23(a)(2)’s commonality 

requirement.3 Thus, although P&G argues that some class members were not injured because 

they kept buying Align—a sign that Align works, says P&G—that is not the right way to think 

about “injury” in the false-advertising context. The false-advertising laws at issue punish 

companies that sell products using advertising that misleads the reasonable consumer. See, e.g., 

Williams v. Gerber Prods. Co., 552 F.3d 934, 938 (9th Cir. 2008) (“Appellants’ claims under 

these California statutes [the Unfair Competition Law and the Consumer Legal Remedies Act] 

are governed by the ‘reasonable consumer’ test. . . . Under the reasonable consumer standard, 

Appellants must show that members of the public are likely to be deceived.” (internal quotation 

marks omitted)). Whether consumers were satisfied with the product is irrelevant. See, e.g., 

McCrary v. Elations Co., LLC, No. EDCV 13-00242 JGB, 2014 WL 1779243, at *14 (C.D. Cal. 

Jan. 13, 2014) (“Defendant’s concern that some putative class members were happy with 

Elations and thus were uninjured is unpersuasive. The requirement of concrete injury is satisfied 

when the Plaintiffs and class members . . . suffer an economic loss caused by the defendant, 

namely the purchase of defendant’s product containing misrepresentations.” (alteration and 

 3

Neither FTC v. Pantron I Corporation, 33 F.3d 1088 (9th Cir. 1994), nor In re Whirlpool support P&G’s 

argument that the district court did not sufficiently consider the merits of the case to grant class certification. 

Pantron was not a class action, and thus the decision cited conducts a full merits analysis. The evidence we noted 

that the district court properly considered in In re Whirlpool related to whether there was in fact a common question 

capable of a common answer. Specifically, we highlighted evidence that confirmed that mold the class claimed was 

due to design defects in Whirlpool products occurred “despite variations in consumer laundry habits.” 722 F.3d at 

854. Such evidence was critical to disproving Whirlpool’s claim that “proof of proximate cause must be determined 

individually for each plaintiff in the class,” i.e., that the class’s common question would not yield a common answer. 

Id. Significantly, however, we did not examine whether the named plaintiffs had presented evidence that the alleged 

design defects in Whirlpool products had in fact proximately caused the mold of which they complained. That issue 

went solely to the merits of the case. Similarly, the evidence P&G has presented here that it claims the district court 

insufficiently examined goes solely to the merits of the case, not to whether Plaintiffs’ common question will yield a 

common answer.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 9

internal quotation marks omitted)). In fact, courts have held that it is misleading to state that a 

product is effective when that effectiveness rests solely on a placebo effect. See, e.g., FTC v. 

Pantron I Corporation, 33 F.3d 1088, 1100–01 (9th Cir. 1994). 

P&G has failed to identify a single false-advertising case where a federal court has denied 

class certification because of a lack of commonality. See, e.g., In re Scotts EZ Seed Litig., 

304 F.R.D. 397, 405 (S.D.N.Y. 2015) (“A common question with respect to the first theory of 

liability is whether EZ Seed grows grass. If plaintiffs can prove EZ Seed ‘does not grow at all’ 

and thus is worthless, plaintiffs will be entitled to relief.”); Ries v. Ariz. Beverages USA LLC, 

287 F.R.D. 523, 537 (N.D. Cal. 2012) (“By definition, all class members were exposed to such 

representations and purchased AriZona products, creating a common core of salient facts. 

Courts routinely find commonality in false advertising cases that are materially indistinguishable 

from the matter at bar.” (emphasis added) (internal quotation marks and citation omitted)); see 

also Suchanek v. Sturm Foods, Inc., 764 F.3d 750, 756 (7th Cir. 2014) (distinguishing Dukes 

from consumer false-advertising class actions by noting that “[w]here the same conduct or 

practice by the same defendant gives rise to the same kind of claims from all class members, 

there is a common question. . . . In this case, the plaintiffs’ claims and those of the class they 

would like to represent all derive from a single course of conduct by Sturm: the marketing and 

packaging of GSC”). 

In addition, as Plaintiffs point out, every court has, when presented with the opportunity, 

found commonality sufficient to satisfy Rule 23(a)(2) where plaintiffs have alleged that 

probiotics are ineffective. See, e.g., Johnson v. Gen. Mills, Inc., 278 F.R.D. 548, 551 (C.D. Cal. 

2012) (“Mr. Johnson has presented sufficient facts to show that all of the class members’ claims 

have at their heart a common contention: Defendants made a material misrepresentation 

regarding the digestive health benefits of YoPlus that violated the UCL and the CLRA. The 

class members all assert they were misled by a common advertising campaign that had little to 

no variation.”); Wiener v. Dannon Co., 255 F.R.D. 658, 664–65 (C.D. Cal. 2009) (“The proposed 

class members clearly share common legal issues regarding Dannon’s alleged deception and 

misrepresentations in its advertising and promotion of the Products.”). 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 10

In Fitzpatrick v. General Mills, Inc., 635 F.3d 1279 (11th Cir. 2011), for instance, 

plaintiff Julie Fitzpatrick brought suit under the Florida Deceptive and Unfair Trade Practices 

Act (“FDUTPA”) against General Mills, alleging that the company had made “false and 

misleading claims that YoPlus provides digestive health benefits that other yogurt products do 

not.” Id. at 1281. “YoPlus is ordinary yogurt supplemented with probiotic bacteria, inulin, and 

vitamins A and D. The mixture of probiotic bacteria and inulin in YoPlus allegedly provides 

habitual consumers with digestive health benefits by aiding in the promotion of digestive health.” 

Id. Fitzpatrick moved to certify a class of “all persons who purchased YoPlus in the State of 

Florida.” Id. The district court granted Fitzpatrick’s motion. Fitzpatrick v. Gen. Mills, Inc., 

263 F.R.D. 687 (S.D. Fla. 2010). On the issue of commonality, the district court explained 

“[w]hether General Mills’ claim that Yo–Plus aids in the promotion of digestive health is 

‘deceptive’ is a mixed question of law and fact common to every class member seeking damages 

under the FDUTPA.” Id. at 696. The district court continued that “[e]ven though a few 

consumers likely purchased Yo–Plus for reasons unrelated to Yo–Plus’ purported digestive 

health benefits, . . . the Court is convinced that a significant number of Yo–Plus consumers 

purchased Yo–Plus because of its purported digestive health benefit, which is, as General Mills’ 

marketing documents plainly state, Yo–Plus’ primary distinguishing feature.” Id.at 696–97. The 

Eleventh Circuit did not discuss the commonality requirement on appeal. Fitzpatrick, 635 F.3d 

at 1282. It did note, however, that “[t]he district court’s analysis . . . [was] sound and in accord 

with federal and state law.” Id. at 1283.4

As the preceding false-advertising cases make clear, the district court correctly found that 

Plaintiffs have demonstrated that their claims share a common question—whether Align is 

“snake oil” and thus does not yield benefits to anyone. Appellee Br. at 7. That common 

question will yield a common answer for the entire class that goes to the heart of whether P&G 

will be found liable under the relevant false-advertising laws. That is all Dukes requires. 

 4

The Eleventh Circuit ultimately vacated the district court’s decision and remanded the case to the district 

court, but for a reason unrelated to its commonality findings. The district court’s “class definition limit[ed] the class 

to those who purchased YoPlus ‘to obtain its claimed digestive health benefit,’ which takes into account individual 

reliance on the digestive health claims.” 635 F.3d at 1283. However, the Eleventh Circuit found that proof of 

individual reliance is unnecessary under the relevant law in Florida (a claim evaluated in more detail below), and 

thus the district court’s “analysis would lead one to believe that the class [sh]ould be defined as ‘all persons who 

purchased YoPlus in the State of Florida.’” Id. n.1.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 11

2. Plaintiffs’ Claims Are Typical Of The Class

Federal Rule of Civil Procedure 23(a)(3) requires plaintiffs to show that “the claims or 

defenses of the representative parties are typical of the claims or defenses of the class.” As the 

Supreme Court made clear in Dukes, “[t]he commonality and typicality requirements of Rule 

23(a) tend to merge.” 131 S. Ct. at 2551 n.5 (alteration in original) (internal quotation marks 

omitted); see also Charles Alan Wright, Arthur R. Miller & Mary Kay Kane, 7A Federal Practice 

and Procedure § 1764 (3d ed. 2005) (“Thus, many courts have found typicality if the claims or 

defenses of the representatives and the members of the class stem from a single event or a 

unitary course of conduct, or if they are based on the same legal or remedial theory. Of course, 

when this is true the typicality standard is closely related to the test for the common-question 

prerequisite in subdivision (a)(2).” (footnotes omitted)). Indeed, in challenging the district 

court’s finding of typicality, P&G largely repeats its arguments against commonality. Appellant 

Br. at 30–32. 

P&G does appear to make a slight variation of its consumer-satisfaction argument by 

contending that “many of the unnamed class members have no interest in pursuing restitution, 

nor in crippling the product. Indeed, this lawsuit may be antithetical to their interests.” Id. at 31. 

The district court considered and rejected this argument in its order granting class certification. 

See R. 140 (Dist. Ct. Order at 19) (Page ID #6433) (“Defendant advertised to all that the 

proprietary probiotic bacteria in Align provides proven digestive health benefits. The question is 

not whether each class member was satisfied with the product, but rather whether the purchaser 

received the product that was advertised.”). The district court’s conclusion is consistent with 

those of other district courts who have reviewed similar arguments. See, e.g., Johnson, 

278 F.R.D. at 552 (“Both Mr. Johnson’s and the fourth generation purchasers’ claims center on 

the assertion that in deciding to purchase YoPlus they relied to their detriment on the allegedly 

false digestive health message communicated by Defendants. Mr. Johnson’s claims are, 

therefore, ‘reasonably co-extensive’ with those of the fourth generation purchasers, and he 

satisfies the typicality requirement.”). Consistent with its findings on commonality, the district 

court did not abuse its discretion in finding that “the claims or defenses of the representative 

parties are typical of the claims or defenses of the class.” Fed. R. Civ. P. 23(a)(3). 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 12

C. Rule 23(b)(3): Plaintiffs Have Demonstrated That Common Questions Will 

Predominate Over Individualized Inquiries In Assessing the Merits of Their 

Claims 

“[E]ach class meeting [the] prerequisites [of Rule 23(a)] must also pass at least one of the 

tests set forth in Rule 23(b).” Sprague v. Gen. Motors Corp., 133 F.3d 388, 397 (6th Cir. 1998) 

(en banc). Plaintiffs have sought certification under Federal Rule of Civil Procedure 23(b)(3), 

which states that a class action may be maintained only if “the court finds that the questions of 

law or fact common to class members predominate over any questions affecting only individual 

members.”5

P&G contends that the district court erred in four separate but related ways. First, it 

alleges that some individuals were not actually exposed to P&G’s marketing campaign—that 

some individuals purchased Align upon receiving advice from a family member, friend, or 

physician. Second, it claims that, under the state laws at issue, individual issues of causation and 

reliance predominate over the common questions that allegedly affect all members of the class. 

Third, P&G claims that Align does actually work for many purchasing it, and thus Plaintiffs 

cannot prove injury on a classwide basis. Finally and relatedly, P&G claims that Plaintiffs’ 

damages model is inconsistent with their theory of liability and that individual calculation of 

damages will be necessary. 

1. Actual Exposure

According to P&G, “significant numbers of consumers became aware of and purchased 

Align based on sources of information unrelated to the advertising at issue,” and thus individual 

proof that class members purchased Align because of its advertising will be necessary, thereby 

defeating predominance. Appellant Br. at 40. P&G contends that “[d]octors do not simply 

recommend Align based on P&G’s professional marketing. Doctors make independent decisions 

based on their review of the science, experience, and expertise.” Appellant Reply Br. at 25. In 

support of its point, P&G relies on Minkler v. Kramer Laboratories, Inc., No. 12-9421, 2013 WL 

 5

P&G has not challenged on appeal the district court’s holding that the other element of Rule 23(b)(3) is 

met, “that a class action is superior to other available methods for fairly and efficiently adjudicating the 

controversy.” Fed. R. Civ. P. 23(b)(3). 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 13

3185552, at *4 (C.D. Cal. Mar. 1, 2013), and In re American Medical Systems, Inc., 75 F.3d 

1069, 1085 (6th Cir. 1996). 

These cases are, however, readily distinguishable from the case at hand. In In re 

American Medical Systems, we made clear that our decision to vacate the district court’s 

conditional certification order was based “on the extraordinary facts of [the] case.” 75 F.3d at 

1074. In that case, the plaintiff brought suit over alleged defects in a number of different 

prosthetic devices, although the plaintiff had problems only with one of the ten types of 

prosthetics manufactured by American Medical Systems. We determined class certification to 

be inappropriate because we held that the claims at issue—strict liability; fraudulent 

misrepresentation; negligent testing, design, and manufacture; and failure to warn—would 

“differ depending upon the model and the year [the prosthetic] was issued.” Id. at 1081. 

“Proof[] . . . will also vary from plaintiff to plaintiff because complications with an AMS device 

may be due to a variety of factors, including surgical error, improper use of the device, 

anatomical incompatibility, infection, device malfunction, or psychological problems.” Id. 

Thus, on the issue of predominance, we noted that, “[a]s this case illustrates, the products are 

different, each plaintiff has a unique complaint, and each receives different information and 

assurances from his treating physician. Given the absence of evidence that common issues 

predominate, certification was improper.” Id. at 1085. 

Minkler—an unpublished district court decision from a court outside of the Sixth 

Circuit—involved a plaintiff seeking certification of a class consisting of “[a]ll persons 

domiciled or residing in the State of California who ha[d] purchased a Fungi–Nail anti-fungal 

product.” 2013 WL 3185552, at *1. The plaintiff purchased Fungi-Nail in order to treat some 

discoloration of his toenail, which he believed was a nail fungus. Id. In finding class 

certification inappropriate, the district court did note that some members of the proposed class 

purchased Fungi-Nail based “on the recommendations of physicians or pharmacists, and the 

appearance of the products’ packaging would not have been important to their purchasing 

decision.” Id. at *4. Yet the district court also noted that “Fungi–Nail is marketed for use as a 

treatment for ringworm, athlete’s foot and other conditions that can appear in places other than 

‘on nails.’” Id. It was not, in other words, necessarily even marketed for treatment of the 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 14

plaintiff’s condition, and “Defendants [even] raise[d] significant doubts as to whether Plaintiff 

actually ha[d] a fungal infection.” Id. 

The facts in this case paint a far different picture. Unlike the plaintiff in American 

Medical Systems, Plaintiffs here do not take aim at a panoply of P&G products. They focus their 

attention on Align. Plaintiffs all purchased Align because it allegedly promoted digestive health. 

That is the only reason to buy Align. In addition, Plaintiffs here have produced evidence 

showing that P&G undertook a comprehensive marketing strategy with a uniform core message, 

even if its packaging has changed somewhat over time: buy Align because it will help promote 

your digestive health. See Sealed App. at 253–55. That marketing campaign focused on 

physician recommendations, with many sales representatives dropping off samples in various 

doctors’ offices over a multi-year period. Id. at 255. 

The district court’s decision to certify the proposed class is also in accord with the 

decision of courts in other consumer-products class action cases. In Johnson, for instance, the 

plaintiff—like Plaintiffs here—“presented evidence demonstrating that Defendants marketing 

campaign was prominent and not limited to statements made on the YoPlus packaging.” 

278 F.R.D. at 551 (emphasis added). The Johnson court made clear that the form of presentation 

was irrelevant: “Regardless of how the message was communicated, the claims brought by Mr. 

Johnson on behalf of the class under the UCL and the CLRA center around a common question: 

Did Defendants state a false claim of a digestive health benefit that a reasonable person would 

have been deceived by, for purposes of the UCL, or would have attached importance to, for 

purposes of the CLRA?” Id. Likewise, in Wiener, defendant Dannon “contend[ed] that a classwide inference of proof is not appropriate in this case, because purchasers were not uniformly 

exposed to Dannon’s advertising claims and the materiality of the misrepresentation is an issue 

unique to each purchaser, as Dannon’s consumer surveys show that purchasers bought the 

Products for different reasons.” 255 F.R.D. at 668. Echoing the language in Johnson, the district 

court held that “[r]egardless of whether every class member was exposed to Dannon’s television, 

print, and internet advertisements, the record clearly establishes that Dannon’s alleged 

misrepresentations regarding the clinically proven health benefits of the Products are 

prominently displayed on all of the Products’ packaging, a fact that Dannon has never 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 15

contested.” Id. at 669. “Because, by definition, every member of the class must have bought one 

of the Products and, thus, seen the packaging, Plaintiffs have succeeded in showing that the 

alleged misrepresentations were made to all class members.” Id.; see also In re ConAgra Foods, 

Inc., No. CV 11-05379 MMM, 2015 WL 1062756, at *46 (C.D. Cal. Feb. 23, 2015) (noting that 

“it is undisputed that ConAgra made the same alleged misrepresentation on each bottle of 

Wesson Oils purchased by class members” in finding predominance on the issue of 

causation/reliance). 

 The facts at issue in Johnson and Wiener are identical to the ones at issue here. 

Regardless of how customers first heard about Align—whether through P&G’s direct advertising 

campaign, through a physician who had learned about Align through a P&G sales representative, 

or through a friend or family member who had used Align—they nonetheless decided to 

purchase the product only for its purported health benefits. Although P&G contends that a 

doctor could recommend Align based on “her independent judgment,” that argument is belied by 

the fact that P&G developed Bifantis, the probiotic behind Align, and P&G, in turn, developed 

the marketing campaign to promote Align. In light of this point, the Johnson and Wiener 

decisions, and the differences between the facts at issue here and the facts in American Medical 

Systems and Minkler, the district court did not abuse its discretion in rejecting P&G’s contention 

that certain class members did not rely on P&G advertising in making their decision to buy 

Align. 

2. State Laws 

On a related point, P&G also claims that Plaintiffs cannot prove reliance and causation, 

which P&G claims are required by the false-advertising laws at issue, on a classwide basis. 

Appellant Br. at 41. We examine each of these false-advertising laws below. We conclude that, 

under each of the five laws, Plaintiffs can prove causation and/or reliance on a classwide basis 

provided that (1) the alleged misrepresentation that Align promotes digestive health is material 

or likely to deceive a reasonable consumer, and (2) P&G made that misrepresentation in a 

generally uniform way to the entire class. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 16

a. California

Rikos seeks “certification of claims arising under Cal. Bus. & Prof. Code § 17200 

(California’s Unfair Competition Law or ‘UCL’), Cal. Civ. Code § 1750 (California’s 

Consumers Legal Remedies Act or ‘CLRA’), and breach of express warranty.” Sealed App. at 

19–20. None of these causes of action require individualized proof of reliance or causation such 

that classwide proof will never suffice. 

In In re Tobacco II Cases, 207 P.3d 20 (Cal. 2009), the California Supreme Court held 

that, “[t]o state a claim under . . . the UCL . . . based on false advertising or promotional 

practices, it is necessary only to show that members of the public are likely to be deceived.” Id. 

at 29 (internal quotation marks omitted). “[T]he UCL’s focus [is] on the defendant’s conduct . . . 

in service of the statute’s larger purpose of protecting the general public against unscrupulous 

business practices.” Id. at 30. Thus “relief under the UCL is available without individualized 

proof of deception, reliance and injury” for absent class members. Id. at 35. Plaintiffs thus need 

not show that every purchaser of Align in California relied on the product’s advertising. Courts 

have qualified, however, that if the defendant made disparate misrepresentations to the class, 

then there still may be issues of predominance. Stearns v. Ticketmaster Corp., 655 F.3d 1013, 

1020 (9th Cir. 2011) (“We do not, of course, suggest that predominance would be shown in 

every California UCL case. For example, it might well be that there was no cohesion among the 

members because they were exposed to quite disparate information from various representatives 

of the defendant. See, e.g., . . . Kaldenbach v. Mut. of Omaha Life Ins. Co., 178 Cal. App. 4th 

830, 849–50 (2009).”). 

It is true that, “[u]nlike the UCL, . . . plaintiffs in a CLRA action [must] show not only 

that a defendant’s conduct was deceptive but that the deception caused them harm.” Mass. Mut. 

Life Ins. Co. v. Superior Court, 97 Cal. App. 4th 1282, 1292 (Cal. Ct. App. 2002). However, 

“[c]ausation as to each class member is commonly proved more likely than not by materiality. 

That showing will undoubtedly be conclusive as to most of the class.” Id. (internal quotation 

marks omitted). Thus, “plaintiffs satisfy their burden of showing causation as to each by 

showing materiality as to all. . . . ‘[I]f the trial court finds material misrepresentations were made 

to the class members, at least an inference of reliance would arise as to the entire class.’” Id. at 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 17

1292–93 (quoting Vasquez v. Superior Court, 484 P.2d 964, 973 (Cal. 1971)). Materiality is 

measured by an objective standard: “[m]ateriality of the alleged misrepresentation generally is 

judged by a reasonable man standard. In other words, a misrepresentation is deemed material if 

a reasonable man would attach importance to its existence or nonexistence in determining his 

choice of action in the transaction in question.” In re Steroid Hormone Prod. Cases, 181 Cal. 

App. 4th 145, 157 (Cal. Ct. App. 2010), as modified on denial of reh’g (Feb. 8, 2010) (internal 

quotation marks omitted); see also Stearns, 655 F.3d at 1022–23; In re ConAgra Foods, 

2015 WL 1062756, at *34. 

Finally, proof of individualized reliance or causation is not necessary under California 

law to establish breach of an express warranty. Under California law, “[a]n express warranty is a 

term of the parties’ contract.” In re ConAgra Foods, 2015 WL 1062756, at *35. “Product 

advertisements, brochures, or packaging can serve to create part of an express warranty.” 

Rosales v. FitFlop USA, LLC, 882 F. Supp. 2d 1168, 1178 (S.D. Cal. 2012). “[T]o prevail on a 

breach of express warranty claim, the plaintiff must prove (1) the seller’s statements constitute 

an affirmation of fact or promise or a description of the goods; (2) the statement was part of the 

basis of the bargain; and (3) the warranty was breached.” Weinstat v. Dentsply Int’l, Inc., 

180 Cal. App. 4th 1213, 1227 (Cal. Ct. App. 2010) (internal quotation marks omitted). “Proof of 

reliance on specific promises or representations is not required.”6

 In re ConAgra Foods, 

2015 WL 1062756, at *35 (and citing cases); see also Weinstat, 180 Cal. App. 4th at 1227 (“The 

lower court ruling rests on the incorrect legal assumption that a breach of express warranty claim 

requires proof of prior reliance. While the tort of fraud turns on inducement, as we explain, 

breach of express warranty arises in the context of contract formation in which reliance plays no 

role.”); Rosales, 882 F. Supp. 2d at 1178 (“Product advertisements, brochures, or packaging can 

serve to create part of an express warranty. While this does not require that plaintiff relied on the 

individual advertisements, it does require that plaintiff was actually exposed to the advertising.”). 

 6

The case cited by P&G that states that reliance is required cites a decision that predates California’s 

Uniform Commercial Code (“UCC”). Williams v. Beechnut Nutrition Corp., 185 Cal. App. 3d 135, 142 (Cal. Ct. 

App. 1986) (“In order to plead a cause of action for breach of express warranty, one must allege the exact terms of 

the warranty, plaintiff’s reasonable reliance thereon, and a breach of that warranty which proximately causes 

plaintiff injury. (See Burr v. Sherwin Williams Co. (1954) 42 Cal. 2d 682 . . . .”)). Section 2313 of California’s 

UCC governs breach of express warranty claims. Weinstat, 180 Cal. App. 4th at 1227. However, as the Weinstat

court explained, although “[p]re-Uniform Commercial Code law governing express warranties required the 

purchaser to prove reliance on specific promises made by the seller,” a close analysis of the text and official 

comments to the UCC reveals that “[t]he Uniform Commercial Code . . . does not require such proof.” Id.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 18

However, “class treatment of breach of express warranty claims is only appropriate if plaintiffs 

can demonstrate that the alleged misrepresentation would have been material to a reasonable 

consumer.” In re ConAgra Foods, 2015 WL 1062756, at *36. 

b. Illinois

Rikos also seeks “certification of claims arising under the Illinois Consumer Fraud and 

Deceptive Business Practices Act (‘ICFA’).” Sealed App. at 20. A claim under the ICFA 

requires: “(1) a deceptive act or practice by the defendant, (2) the defendant’s intent that the 

plaintiff rely on the deception, (3) the occurrence of the deception in a course of conduct 

involving trade or commerce, and (4) actual damage to the plaintiff that is (5) a result of the 

deception.” De Bouse v. Bayer AG, 922 N.E.2d 309, 313 (Ill. 2009). When the deceptive act 

alleged is a misrepresentation, that misrepresentation must be “material” and “is established by 

applying a reasonable person standard.” In re ConAgra Foods, 2015 WL 1062756, at *45.

Reliance is not required to establish an ICFA claim. Id. (citing cases). However, to establish the 

last two elements of an ICFA claim, plaintiffs must show “that the allegedly deceptive act 

‘proximately caused any damages’ suffered by the plaintiff.” Id. (quoting De Bouse, 922 N.E.2d 

at 313); see also Clark v. Experian Info. Solutions, Inc., 256 F. App’x 818, 821 (7th Cir. 2007) 

(“We concluded that ‘a private cause of action under the ICFA requires a showing of proximate 

causation.’” (quoting Oshana v. Coca–Cola Co., 472 F.3d 506, 514–15 (7th Cir. 2006))). As 

part of proving proximate causation, a plaintiff must “receive, directly or indirectly, 

communication or advertising from the defendant.” De Bouse, 922 N.E.2d at 316. 

It is true that courts have denied class certification of ICFA claims on the grounds that 

individual issues of proving proximate causation predominate over common issues. See, e.g., 

Siegel v. Shell Oil Co., 612 F.3d 932, 935–36 (7th Cir. 2010) (holding that individualized 

inquiries regarding “why a particular plaintiff purchased a particular brand of [the product]” 

were necessary to establish harm to each class member under the ICFA and, thus, common 

issues could not predominate); In re Glaceau Vitaminwater Mktg. & Sales Practice Litig., No. 

11-CV-00925 DLI RML, 2013 WL 3490349, at *8 (E.D.N.Y. July 10, 2013) (citing other cases); 

Oshana v. Coca-Cola Co., 225 F.R.D. 575, 586 (N.D. Ill. 2005) (“To establish proximate 

causation, each individual must provide evidence of his or her knowledge of the deceptive acts 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 19

and purported misstatements. This showing requires an individual analysis of the extent to 

which Coca-Cola’s marketing played a role in each class member’s decision to purchase fountain 

diet Coke.” (citations omitted)). 

As Plaintiffs note, ICFA claims do not necessarily require individualized proof of 

causation such that class certification is never proper. Appellee Br. at 40 n.5. Rather, “where the 

representation being challenged was made to all putative class members, Illinois courts have 

concluded that causation is susceptible of classwide proof and that individualized inquiries 

concerning causation do not predominate if plaintiffs are able to adduce sufficient evidence that 

the representation was material.” In re ConAgra Foods, 2015 WL 1062756, at *46 (and citing 

cases); see also In re Glaceau Vitaminwater Mktg. & Sales Practice Litig., 2013 WL 3490349, at 

*9 (“Illinois courts have certified classes asserting violations of the ICFA, where the defendant 

engaged in ‘uniform’ conduct toward the class, and the successful adjudication of the named 

plaintiff’s claims would establish a right to recovery for all class members.”); S37 Mgmt., Inc. v. 

Advance Refrigeration Co., 961 N.E.2d 6, 16 (Ill. App. Ct. 2011) (“The defendant argues that 

individual issues regarding deception and damages preclude class certification in this case. 

However, just as we found in P.J.’s Concrete, where a defendant is alleged to have acted 

wrongfully in the same manner toward the entire class, the trial court may properly find common 

questions of law or fact that predominate over questions affecting only individual members.”). 

c. Florida

Burns seeks “certification of claims arising under the Florida Deceptive and Unfair Trade 

Practices Act, Fla. Stat. §501.201 et seq. (‘FDUTPA’)”. Sealed App. at 20. “A claim under 

FDUTPA has three elements: (1) a deceptive or unfair practice; (2) causation; and (3) actual 

damages.” Siever v. BWGaskets, Inc., 669 F. Supp. 2d 1286, 1292 (M.D. Fla. 2009). The 

Florida Supreme Court has not addressed whether reliance and/or causation requires 

individualized proof. Like Illinois, Florida courts of appeals and federal courts interpreting 

Florida law have reached somewhat diverging conclusions. In re Sears, Roebuck & Co. Tools 

Mktg. & Sales Practices Litig., No. 05 C 4742, 2012 WL 1015806, at *7–9 (N.D. Ill. Mar. 22, 

2012) (noting this tension in the case law applying the FDUTPA). 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 20

Many courts have held that the FDUTPA does not require proof of actual, individualized 

reliance; rather, it requires only a showing that the practice was likely to deceive a reasonable 

consumer. In re ConAgra Foods, 2015 WL 1062756, at *42 (“Claims under the FDUTPA are 

governed by a ‘reasonable consumer’ standard, obviating the need for proof of individual 

reliance by putative class members.”); Office of the Att’y Gen. v. Wyndham Int’l, Inc., 869 So. 2d 

592, 598 (Fla. Dist. Ct. App. 2004) (“When addressing a deceptive or unfair trade practice claim, 

the issue is not whether the plaintiff actually relied on the alleged practice, but whether the 

practice was likely to deceive a consumer acting reasonably in the same circumstances. . . . 

[U]nlike fraud, a party asserting a deceptive trade practice claim need not show actual reliance 

on the representation or omission at issue.”); Davis v. Powertel, Inc., 776 So. 2d 971, 973–74 

(Fla. Dist. Ct. App. 2000) (“A party asserting a deceptive trade practice claim need not show 

actual reliance on the representation or omission at issue. . . . [T]he question is not whether the 

plaintiff actually relied on the alleged deceptive trade practice, but whether the practice was 

likely to deceive a consumer acting reasonably in the same circumstances.”); Latman v. Costa 

Cruise Lines, N.V., 758 So. 2d 699, 703 (Fla. Dist. Ct. App. 2000) (“[M]embers of a class 

proceeding under the [FDUTPA] need not individually prove reliance on the alleged 

misrepresentations. It is sufficient if the class can establish that a reasonable person would have 

relied on the representations.” (internal quotation marks omitted)). In Fitzpatrick, 635 F.3d at 

1283, the Eleventh Circuit affirmed the “legal analysis of the district court,” which included the 

district court’s conclusion that the FDUTPA’s “causation requirement is resolved based on how 

an objective reasonable person would behave under the circumstances.” Fitzpatrick, 263 F.R.D. 

at 695. 

If the defendants did not make a generally uniform material misrepresentation to the 

entire class, other courts have held that plaintiffs do need to show individualized causation. The 

sole case cited by P&G, Appellant Br. at 39 n.6, falls into this camp. Miami Auto. Retail, Inc. v. 

Baldwin, 97 So. 3d 846, 857 (Fla. Dist. Ct. App. 2012) (“FDUTPA requires proof of each 

individual plaintiff’s actual (not consequential) damage and defendant’s causation of damage.”). 

However, Miami Automotive Retail did not involve a “uniform representation,” a circumstance in 

which the court noted “individual reliance may not be necessary under FDUTPA.” Id. The 

district court in In re Sears, Roebuck & Co. Tools Marketing & Sales Practices Litigation
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 21

similarly distinguished this latter group of cases requiring proof of individual causation on the 

grounds that, unlike in the Latman and Davis line of cases, these cases did not involve one 

product advertised by a generally uniform theme to all consumers. 2012 WL 1015806, at *10. 

d. New Hampshire

Jarzembrowski seeks “certification of claims arising under the New Hampshire 

Consumer Protection Act, N.H.R.S.A. 358-A et seq. (the ‘New Hampshire CPA’).” Sealed App. 

at 20. Very few New Hampshire cases are on point, but the limited case law indicates that proof 

of individual reliance or causation is not required under the New Hampshire CPA. 

In Mulligan v. Choice Mortgage Corp. USA, a federal district court explained that: 

New Hampshire courts use an objective standard to determine whether acts or 

practices are unfair or deceptive in violation of the CPA. In order to come within 

the CPA, [t]he objectionable conduct must attain a level of rascality that would 

raise an eyebrow of someone inured to the rough and tumble of the world of 

commerce. For such conduct to be actionable, the plaintiff need not show that he 

or she actually relied on the deceptive acts or practices . . . . Rather, a CPA 

plaintiff need only establish a causal link between the conduct at issue and his or 

her injury. 

No. CIV. 96-596-B, 1998 WL 544431, at *11 (D.N.H. Aug. 11, 1998) (internal quotation marks 

and citations omitted); see also Leonard v. Abbott Labs., Inc., No. 10-CV-4676 ADS WDW, 

2012 WL 764199, at *20 (E.D.N.Y. Mar. 5, 2012) (“[T]he New Hampshire statute also does not 

include the elements of reliance or scienter.”). The Mulligan court described the “causal link” as 

requiring that a plaintiff “show[] only that their injuries . . . [were] a consequence of [the 

defendant’s] allegedly unfair and deceptive practices.” 1998 WL 544431, at *12. 

Greater clarity on the proof necessary to establish causation can be found in decisions 

from Massachusetts courts interpreting its analogous consumer fraud statute, to which “the New 

Hampshire Supreme Court frequently looks for guidance.” Id. at *11 n.7. The Massachusetts 

Court of Appeals has held that causation under its consumer fraud statute “is established if the 

deception could reasonably be found to have caused a person to act differently from the way he 

[or she] otherwise would have acted,” and “can also be established by determining whether the 

nondisclosure [or misrepresentation] was of a material fact” because “[m]ateriality . . . is in a 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 22

sense a proxy for causation.” Casavant v. Norwegian Cruise Line, Ltd., 919 N.E.2d 165, 169 

(Mass Ct. App. 2009), aff'd, 952 N.E.2d 908 (2011) (first alteration in original). Materiality is an 

objective inquiry. See id. The sole case cited by P&G, Appellant Br. at 39 n.6, does not 

contradict this case law, because that case interpreted a different statute regarding unfair, 

deceptive, or unreasonable collection practices. Gilroy v. Ameriquest Mortgage Co., 632 F. 

Supp. 2d 132, 137–38 (D.N.H. 2009). 

e. North Carolina

Finally, Burns also seeks certification of claims arising under North Carolina’s Unfair 

and Deceptive Trade Practices Act, N.C. Gen. Stat. §75-1.1 et seq. (“UDTPA”). Sealed App. at 

20. “To state a claim under the UDTPA, a claimant must allege (1) an unfair or deceptive act or 

practice (2) in or affecting commerce (3) which proximately caused injury to the plaintiff or his 

business.” Rahamankhan Tobacco Enters. Pvt. Ltd. v. Evans MacTavish Agricraft, Inc., 989 F. 

Supp. 2d 471, 477 (E.D.N.C. 2013). The North Carolina Supreme Court recently clarified that 

“a claim under section 75–1.1 stemming from an alleged misrepresentation does indeed require a 

plaintiff to demonstrate reliance on the misrepresentation in order to show the necessary 

proximate cause.” Bumpers v. Cmty. Bank of N. Virginia, 747 S.E.2d 220, 226 (N.C. 2013). 

“Actual reliance is demonstrated by evidence [that the] plaintiff acted or refrained from acting in 

a certain manner due to [the] defendant’s representations.” Williams v. United Cmty. Bank, 

724 S.E.2d 543, 549 (N.C. Ct. App. 2012) (internal quotation marks omitted). Plaintiffs base 

their claim under the UDTPA on misrepresentations by P&G regarding Align’s efficacy. R. 85 

(Second Amended Compl. ¶ 113) (Page ID #985). Thus, they must show actual reliance. 

The issue, therefore, is whether North Carolina recognizes any circumstances under 

which classwide proof might suffice to show reliance. In Bumpers, which did not involve the 

issue of class certification, the North Carolina Supreme Court did describe the evidence 

necessary to prove reliance as focused on the mental state of the plaintiff and his/her decisionmaking process, which would seem to be difficult to prove on a classwide basis. Bumpers, 747 

S.E.2d at 227 (“In making this inquiry we examine the mental state of the plaintiff. . . . . In the 

context of a misrepresentation claim brought under section 75–1.1, actual reliance requires that 

the plaintiff have affirmatively incorporated the alleged misrepresentation into his or her 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 23

decision-making process: if it were not for the misrepresentation, the plaintiff would likely have 

avoided the injury altogether.”). No North Carolina decision applying a presumption of reliance 

in class actions like that in California under the CLRA could be identified. The one case cited by 

Plaintiffs doing so, In re Milo’s Dog Treats Consolidated Cases, is a federal district court 

decision and gave no explanation or support for its conclusion that its discussion of reliance 

under California law “is equally applicable to North Carolina’s UDTPA.” 9 F. Supp. 3d 523, 

544 (W.D. Pa. 2014). 

However, the North Carolina Supreme Court has held that reliance can be proved 

circumstantially, not just from direct testimony from the plaintiff. Rowan Cnty. Bd. of Educ. v. 

U.S. Gypsum Co., 428 S.E.2d 648, 661 (N.C. 1992) (“This Court has recognized that proof of 

circumstances from which the jury may reasonably infer the fact is sufficient in proving the 

element of reliance.” (internal quotation marks omitted)). Moreover, the North Carolina Court of 

Appeals has held that a trial court erred in holding that a class action bringing a claim of fraud 

can never be certified because “establishing the elements of fraud requires Plaintiff to make 

individual showings of facts on the element of reliance.” Pitts v. Am. Sec. Ins. Co., 550 S.E.2d 

179, 189 (N.C. Ct. App. 2001) (internal quotation marks omitted), aff’d, 356 N.C. 292 (2002). 

As the court explained, “although individualized showings may be required in actions for fraud, 

this does not in and of itself preclude a finding of the existence of a class” so long as common 

issues predominate. Id. at 190. The court added that “the benefit of allowing consumer fraud 

actions to proceed as class actions must be considered when determining whether the element of 

reliance, an individual issue, renders a class non-existent.” Id. at 189. The court then held that 

common issues predominated. Id. at 190. While its reasoning is sparse, the court appeared to 

focus on the general uniformity in the defendant’s conduct towards the class, but did not spell 

out whether or how it was finding a classwide presumption of reliance or inferring reliance based 

on the identical circumstances faced by the class members. Id.

f. Summary of State Laws

As this survey of the relevant state laws demonstrates, Plaintiffs can prove causation 

and/or reliance on a classwide basis provided that (1) the alleged misrepresentation that Align 

promotes digestive health is material or likely to deceive a reasonable consumer, and (2) P&G 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 24

made that misrepresentation in a generally uniform way to the entire class. As previously 

discussed, both factors are met here. The first factor is met—there is only one reason to buy 

Align, to promote digestive health, and thus the alleged misrepresentation would be material to 

or likely to deceive a reasonable consumer. As to the second factor, P&G undertook a 

comprehensive marketing strategy with a generally uniform core message such that all class 

members were likely exposed to the alleged misrepresentation. At a minimum, all class 

members saw P&G’s advertising on Align’s packaging. 

Although a somewhat closer call, we believe that this classwide proof—that the alleged 

misrepresentation is material and was made in a generally uniform manner to all class 

members—would also suffice in North Carolina to show actual reliance such that individual 

issues would not predominate. The Eleventh Circuit’s discussion in Klay v. Humana, Inc., 

382 F.3d 1241 (11th Cir. 2004), abrogated in part on other grounds by Bridge v. Phoenix Bond 

& Indem. Co., 553 U.S. 639 (2008), is instructive on how classwide circumstantial evidence in 

this case likely satisfies the individual reliance requirement under the UDTPA (although the case 

admittedly did not involve the UDTPA). Physicians brought a class action alleging that various 

HMOs had defrauded them, in part based on misrepresentations that the HMOs would reimburse 

them for medically necessary services plaintiffs provided to the HMOs’ insureds. Id. at 1259. 

The court explained that “while each plaintiff must prove his own reliance in this case, we 

believe that, based on the nature of the misrepresentations at issue, the circumstantial evidence 

that can be used to show reliance is common to the whole class. That is, the same considerations 

could lead a reasonable factfinder to conclude beyond a preponderance of the evidence that each 

individual plaintiff relied on the defendants’ representations.” Id. The court noted that the 

defendant made a uniform representation to class members. Id. And the court explained, “[i]t 

does not strain credulity to conclude that each plaintiff, in entering into contracts with the 

defendants, relied upon the defendants’ representations and assumed they would be paid the 

amounts they were due” because the promise to reimburse was a central reason physicians would 

sign the agreements. Id. Similarly, in this case the alleged misrepresentation that Align 

promotes digestive health is the reason to buy Align. Thus, a jury could “legitimate[ly] infer[] 

[reliance classwide] based on the nature of the alleged misrepresentations at issue.” Id.
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 25

3. Whether Align Actually Works

Echoing its commonality argument, P&G claims that it has put forth unrebutted evidence 

that Align actually works—that it provides digestive health benefits for at least some of its 

consumers—and thus Plaintiffs will not be able to prove injury on a classwide basis. Appellant 

Br. at 33–37. The dissent also focuses on this argument. Even if P&G had not produced such 

proof, P&G argues that scientific evidence might establish that Align “provides benefits for some 

purchasers, but not all—the exact middle ground Plaintiffs ignore,” and thus it would still be 

necessary to determine whether Align works for each individual class member to prove injury, 

such that common issues do not predominate. Appellant Reply Br. at 7. P&G cites several cases 

in which it claims that courts required class plaintiffs to provide some evidence of actual 

classwide injury to establish predominance at the class certification stage. Appellant Br. at 34–

36. 

As an initial matter and as already discussed, Plaintiffs contest whether the studies 

produced by P&G actually demonstrate that Align works for some individuals. Contrary to what 

the dissent claims, Plaintiffs have not tacitly conceded that Align works for individuals with IBS. 

Plaintiffs point to methodological flaws and problems with the studies on the effectiveness of 

Align for individuals with IBS to question the scientific validity of the studies in their own right, 

in addition to questioning whether those studies can be used to claim Align works for healthy 

individuals. See, e.g., R. 9 (Amended Compl. ¶¶ 36–37) (Page ID #73–74) (for example, noting 

that in one study of women with IBS cited by P&G on its website, “the study tested 

Bifidobacterium infantis 35624 at amounts (referred to as ‘colony-forming units’ or ‘CFUs’) 

different than what is present in Align® probiotic supplement” and “[t]he study authors 

expressly emphasized the variability of results depending on the amount of CFUs”). Although 

P&G and the dissent claim that Plaintiffs’ own expert appeared to concede, in his deposition, that 

Align might have worked for one of his patients having digestive health issues, Dr. Komanduri 

stated later in the deposition that he did not know whether Align was helpful for his patient 

because it actually worked or because of a placebo effect. See R. 133 (Dep. of Srinadh 

Komanduri at 29–30, 58) (Page ID #5748, 5755).
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 26

More fundamentally, however, P&G’s and the dissent’s argument attacks a theory of 

liability that Plaintiffs have not actually presented—that Align is not effective unless it works for 

100% of consumers who take it. Appellant Br. at 32. However, what Plaintiffs actually argue is 

that it has not been shown that Align works for anyone, i.e., that Align is “snake oil.” Appellee 

Br. at 7. Thus, under Plaintiffs’ theory of liability, P&G’s claim that Align works for some 

individuals goes solely to the merits; it has no relevance to the class certification issue. In re 

Scotts EZ Seed Litig., 304 F.R.D. at 408 (“Under plaintiffs’ first theory of liability, nobody was 

able to grow grass using EZ Seed. Plaintiffs will succeed or fail on this theory based on whether 

they are able to prove EZ Seed is worthless. Defendants’ argument that the products worked for 

some individual class members goes to the proof of the merits of plaintiffs’ claims. Any 

argument that challenges the merits of plaintiffs’ allegations about the uniform inefficacy of [EZ 

Seed] has no bearing on the Rule 23 predominance inquiry.” (internal quotation marks and 

citation omitted)); Delarosa v. Boiron, Inc., 275 F.R.D. 582, 594 (C.D. Cal. 2011) (“Defendant’s 

arguments that it can present proof that Coldcalm worked for some individual class members 

goes to the proof of the merits of Plaintiff’s claim, not to the common question as to the overall 

efficacy of the product.”); Fitzpatrick, 263 F.R.D. at 701 (holding that “General Mills’ other 

objection, that Yo–Plus might have worked for some consumers, does not preclude a finding of 

predominance; that question is largely encompassed by the predominant—and, according to 

Plaintiff, binary—issue of whether science supports General Mills’ claim that Yo–Plus aids in 

the promotion of digestive health”). We have an obligation to assess the theory of liability 

Plaintiffs present to us, rather than dismiss it as mere artful pleading, and Plaintiffs’ theory of 

liability—that Align is entirely ineffective—is hardly unprecedented in the consumer fraud 

context as these cases demonstrate. 

Plaintiffs have presented sufficient evidence in the form of testimony from Dr. 

Komanduri that their theory of liability—that Align is worthless—is capable of resolution 

through classwide scientific proof such that common issues predominate. R. 108-8 (Komanduri 

Decl. at 2–4) (Page ID #1596–98). Specifically, Dr. Komanduri attested that whether Align 

works for anyone can be tested by “correctly designed randomized, double-blind and placebo 

controlled clinical trials testing relevant outcomes.” Id. ¶ 15 (Page ID #1597). The studies that 

P&G’s own expert cites and the dissent highlights as allegedly demonstrating that Align in fact 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 27

has been proven to work for some individuals (such as those with IBS) are of a similar kind. R. 

115 (Merenstein Decl. at 12–16) (Page ID #4302–06). At the merits stage, Plaintiffs will have 

the opportunity to put forth their own scientific evidence on Align’s efficacy and to present 

expert testimony more fully contesting the accuracy of these studies and others P&G may 

produce. The key point at the class-certification stage is that this kind of dueling scientific 

evidence will apply classwide such that individual issues will not predominate. In other words, 

assessing this evidence will generate a common answer for the class based on Plaintiffs’ theory 

of liability—whether Align in fact has been proven scientifically to provide digestive health 

benefits for anyone. That common answer, of course, may be that Align does work for some 

subsets of the class. That does not transform this classwide evidence into individualized 

evidence that precludes class certification, however. Neither P&G nor the dissent has articulated 

how evidence that Align might work for some sub-populations actually would necessitate 

individualized mini-trials that should preclude class certification. Rather, the more 

straightforward impact of this evidence is simply that it may prevent Plaintiffs from succeeding 

on the merits. 

The possibility that, at a later point in the litigation, the district court may choose to 

revisit the issue of class certification rather than dismiss the case if assessment of the fully 

developed evidence presented by both parties suggests Align actually works for some subpopulations is hardly as unprecedented or problematic as the dissent suggests. “Federal Rule of 

Civil Procedure 23 provides district courts with broad discretion to determine whether a class 

should be certified, and to revisit that certification throughout the legal proceedings before the 

court.” Armstrong v. Davis, 275 F.3d 849, 871 n.28 (9th Cir. 2001) (emphasis added), 

abrogation on other grounds recognized in Nordstrom v. Ryan, 762 F.3d 903, 911 (9th Cir. 

2014). If later evidence disproves Plaintiffs’ contentions that common issues predominate, “the 

district court may consider at that point whether to modify or decertify the class.” Daffin v. Ford 

Motor Co., 458 F.3d 549, 554 (6th Cir. 2006); see also Gen. Tel. Co. of Sw. v. Falcon, 457 U.S. 

147, 160 (1982) (“Even after a certification order is entered, the judge remains free to modify it 

in the light of subsequent developments in the litigation.”). This possibility, however, is not a 

reason to deny class certification now when Plaintiffs have demonstrated that their current theory 

of liability will be proved or disproved through scientific evidence that applies classwide. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 28

Moreover, the cases P&G cites do not hold that establishing predominance means that 

named plaintiffs must produce actual proof at the class-certification stage of classwide injury, 

here that Align is “snake oil.” On predominance specifically, we emphasized in In re Whirlpool

that “the [Amgen] Court repeatedly emphasized that the predominance inquiry must focus on 

common questions that can be proved through evidence common to the class.” In re Whirlpool, 

722 F.3d at 858 (emphasis added). In other words, named plaintiffs must show that they will be 

able to prove injury through common evidence, not that they have in fact proved that common 

injury. Or, as the Amgen Court expanded, “While Connecticut Retirement certainly must prove 

materiality to prevail on the merits, we hold that such proof is not a prerequisite to class 

certification. Rule 23(b)(3) requires a showing that questions common to the class predominate, 

not that those questions will be answered, on the merits, in favor of the class.” Amgen, 133 S. 

Ct. at 1191. Here, “an inability of the plaintiff class ‘to prove [that Align does not work for 

anyone] would not result in individual questions predominating. Instead, a failure of proof on 

th[is] issue . . . would end the case.’” In re Whirlpool, 722 F.3d at 858 (quoting Amgen, 133 S. 

Ct. at 1191). See also id. at 860 (“To the extent that Comcast Corp. reaffirms the settled rule that 

liability issues relating to injury must be susceptible of proof on a classwide basis to meet the 

predominance standard, . . . that requirement is met in this case.” (emphasis added)). 

The two cases cited by P&G are better characterized as holding that the plaintiffs had not 

demonstrated that the alleged injuries were capable of resolution by classwide proof that would 

predominate over individual issues. Pilgrim v. Universal Health Card, LLC involved a class 

action claiming health care programs were falsely advertised as providing “consumers access to 

a network of healthcare providers that had agreed to lower their prices for members.” 660 F.3d 

943, 945 (6th Cir. 2011). We affirmed the district court’s denial of class certification in part on 

the basis of lack of predominance. Id. at 947–48. Although we noted that there was evidence 

that “the program apparently satisfied some consumers,” id. at 948, our holding actually rested 

on the fact that the “program did not operate the same way in every State and the plaintiffs 

suffered distinct injuries as a result.” Id. at 947–48. As previously discussed, this case involves 

one product with a uniform marketing scheme and message that either does not work for anyone 

or does work at least for some individuals. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 29

Similarly, the decision in Phillips v. Philip Morris Cos., 298 F.R.D. 355 (N.D. Ohio 

2014), denying class certification in a false advertising challenge to Philip Morris’s claim that 

light cigarettes had low tar hinged on the plaintiffs’ inability to prove that a common injury could 

be proved. First, “there [was] no inherent design defect that rendered the product less valuable,” 

and “[t]he potential to realize an injury from the product . . . depend[ed] upon the manner in 

which each consumer used the product and the unique characteristics of each consumer.” Id. at 

368. Second, the court noted that some consumers might have purchased the cigarettes for a 

reason unrelated to the alleged misrepresentation about lower tar and nicotine, such as flavor. Id. 

n.20. Here, however, there is only one reason to buy Align: its digestive health benefits. And 

whether or not Align works as promised for anyone—the issue here—is a scientific question that 

will not turn on the individual behavior of consumers; if Align is shown to work, even for only 

certain individuals, then presumably Plaintiffs lose. 

In the other two cases cited by P&G, the courts denied class certification because there 

was a disconnect between the class’s theory of liability and the class’s damages model, not 

because the named plaintiffs had not conclusively proved injury to the entire class at the classcertification stage, as P&G claims. As discussed in the next subsection, there is no similar 

disconnect here. 

In In re Rail Freight Fuel Surcharge Antitrust Litigation-MDL No. 1869, for example, the 

D.C. Circuit denied class certification because the damages model presented by the plaintiffs 

could not reliably prove classwide injury in fact, i.e., it would “detect[] injury where none could 

exist.” 725 F.3d 244, 252–53 (D.C. Cir. 2013). It was in this context that the D.C. Circuit stated 

that it “do[es] expect the common evidence to show all class members suffered some injury.” Id.

at 252. However, the D.C. Circuit did not alter the normal rule that named plaintiffs need only 

show at the class-certification stage “that they can prove, through common evidence, that all 

class members were in fact injured by the alleged conspiracy,” not that they have in fact proved 

that injury. Id. (emphasis added).

Similarly, in Parko v. Shell Oil Co., the Seventh Circuit held that the district court abused 

its discretion in certifying a class because of a disconnect between the class’s damages model 

and its liability theory. 739 F.3d 1083 (7th Cir. 2014). The class alleged nuisance and related 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 30

torts on the basis of alleged groundwater contamination occurring over a 90-year period. Id. at 

1084. The court, in finding a lack of predominance, did note that the plaintiffs had presented 

nothing more than “unsubstantiated allegation.” Id. at 1086. But the unsubstantiated allegation 

was not whether the groundwater was actually contaminated, as P&G claims, but the plaintiffs’ 

claim that they “intend[ed] to rely on common evidence and a single methodology to prove both 

injury and damages” that was sound and plausible. Id. Thus, the Seventh Circuit reversed class 

certification because the district court had not “investigated the realism of the plaintiffs’ injury 

and damage model in light of the defendants’ counterarguments.” Id. Specifically, the plaintiffs 

proposed to measure damages “by the effect of the groundwater contamination on the value of 

the class members’ properties,” but the defendants pointed out that the plaintiffs did not own the 

groundwater underneath their property and that their water supply did not come from that 

groundwater. Id. at 1084, 1086. Thus, it was not clear how contamination in the groundwater 

could affect property values. Id. at 1086. It was this disconnect between the plaintiffs’ damages 

model and their liability theory that led the Seventh Circuit to deny class certification.7

 Moreover, our holding today is consistent with the Supreme Court’s recent decision in 

Halliburton Co. v. Erica P. John Fund, Inc., 134 S. Ct. 2398 (2014). In that case, the Supreme 

Court held that, at the class-certification stage, defendants in private securities fraud class actions 

must be able to present evidence rebutting a particular presumption of classwide reliance 

available in these kinds of cases. 134 S. Ct. at 2417. The Halliburton Court’s holding is limited 

to allowing rebuttal evidence on issues that affect predominance, not evidence that affects only 

the merits of a case. Id. at 2416. Given Plaintiffs’ theory of liability in this case, the evidence 

that P&G has presented fails this test—it affects only the merits of this case, not predominance. 

Even if the evidence P&G presented did affect predominance, however, it is not clear how P&G 

 7

Further evidence that the plaintiffs’ failure to prove that the groundwater was in fact contaminated was 

immaterial to the Seventh Circuit’s decision is found in the case that the Seventh Circuit cites as properly granting 

class certification, Mejdreck v. Lockformer Co., No. 01 C 6107, 2002 WL 1838141 (N.D. Ill. Aug. 12, 2002). 

Parko, 739 F.3d at 1087. As described by the Parko court, in that case “the leakage of the noxious solvent was 

claimed to have contaminated the water supply, as noted by the district court.” Id. (emphasis added). In other 

words, the plaintiffs had not actually proved that the water supply was contaminated for most class members at the 

class-certification stage; rather, they had articulated a coherent theory of injury and damages because they alleged 

that the contaminated water had entered the water supply, and therefore more clearly could affect property values. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 31

alleges the district court violated Halliburton given that P&G was not prevented from putting 

forth this evidence.8

4. Whether Plaintiffs’ Damages Model Is Consistent With Their Liability 

Theory 

Finally and relatedly, P&G claims that Plaintiffs have “failed to provide any viable 

method to determine or award classwide damages, as required by Comcast Corp. v. Behrend, 133 

S. Ct. [1426,] 1433 [(2013)],” because P&G presented evidence that some class members 

benefited from Align, or the scientific evidence could establish Align works for some 

individuals. Appellant Br. at 43–44. 

The premise of this argument suffers from the same problems with P&G’s preceding 

argument. Plaintiffs are claiming that Align works for no one, and if they are correct, all class 

members suffered from the same injury, buying a product that does not work as advertised. If 

Align in fact is proven scientifically to work for some individuals, Plaintiffs will lose on the 

merits. 

Moreover, Plaintiffs’ damages model—a full refund of the purchase price for each class 

member—satisfies Comcast. In that case, the Supreme Court held that courts must conduct a 

“rigorous analysis” to ensure at the class-certification stage that “any model supporting a 

plaintiff’s damages case [is] consistent with its liability case,” i.e., that the model “measure[s] 

only those damages attributable to that theory” of liability. Comcast, 133 S. Ct. at 1433 (internal 

quotation marks omitted). That is the case here. A full refund for each class member is 

appropriate because, as the district court explained, there is no reason to buy Align except for its 

purported digestive benefits—“[i]t is a capsule filled with bacteria and inert ingredients. If, as 

alleged, the bacteria does nothing, then the capsule is worthless.” R. 140 (Dist. Ct. Order at 30) 

 8

P&G also argues in its reply brief that Plaintiffs have at most presented evidence that P&G’s claims about 

Align are unsubstantiated, but false advertising claims require affirmative proof of falsity, not just lack of 

substantiation. Appellant Reply Br. at 16–19. P&G argues that lack of substantiation claims are within the sole 

province of the Federal Trade Commission and other regulatory agencies. Id. at 17. P&G’s argument goes to the 

merits of the case, not to whether class certification is proper. Indeed, all of the cases cited by P&G involve 

discussions of the merits of false advertising claims and do not indicate that this distinction is at all relevant to 

whether a class should be certified. Whether the standard is affirmative proof of falsity or lack of substantiation, the 

evidence necessary to prove this issue will be the same for the entire class such that individual issues will not 

predominate. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 32

(Page ID #6444). Whether purchasers were nevertheless satisfied with Align does not affect the 

propriety of a full-refund damages model. See, e.g., Forcellati v. Hyland’s, Inc., No. CV 12-

1983-GHK MRWX, 2014 WL 1410264, at *9 (C.D. Cal. Apr. 9, 2014) (holding that restitution 

is the appropriate damages model even for satisfied customers if the plaintiffs prove that 

“Defendants’ products are placebos, and that the products’ effectiveness arises solely as a result 

of the placebo effect”) (internal quotation marks omitted). And this analysis is the same for all 

class members: “either 0% or 100% of the proposed class members were defrauded. There is no 

evidence that some proposed class members knew of the alleged falsity of Defendant’s 

advertising yet purchased Align anyway.” R. 140 (Dist. Ct. Op. at 31) (Page ID #6445). Thus, 

Plaintiffs’ damages model measures only damages attributable to its theory of liability, i.e., that 

P&G is liable if it is not proven scientifically that Align helps anyone, and thus satisfies 

Comcast. See, e.g., In re Scotts EZ Seed Litig., 304 F.R.D. at 412 (holding that a “full 

compensatory damages model, under which consumers would receive a full refund for their 

purchases of EZ Seed[,] . . . matches plaintiffs’ first theory of liability—that EZ Seed does not 

grow grass, and is thus valueless,” and therefore “satisfies Comcast because it measures damages 

properly if EZ Seed is valueless” (internal quotation marks omitted)).

In sum, the district court did not abuse its discretion in determining that common issues 

will predominate over individual issues in resolving the key merits issue of this case—whether 

Align promotes digestive health for anyone. 

D. Standing

P&G also contends that the class is overbroad and thus raises Article III standing issues 

because Plaintiffs have failed to produce evidence that most of the class suffered an injury, i.e., 

that Align did not work for them. Appellant Br. at 45–47. This argument again misconstrues the 

basic theory of liability at issue in this case. Under Plaintiffs’ theory of liability, P&G falsely 

advertised to every purchaser of Align. As the district court put it, there is no reason to purchase 

Align except for its promised digestive health benefits. If Align does not work as advertised for 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 33

anyone, then every purchaser was harmed, and a direct line can be drawn from P&G’s 

advertising campaign and the decision to buy Align.9

E. The Proposed Class is Sufficiently Ascertainable

Finally, P&G contends that the proposed class is not ascertainable because “Plaintiffs 

have failed to demonstrate that there is a ‘reliable’ and ‘administratively feasible’ method for 

identifying the class members.” Appellant Br. at 50. Most consumers do not buy Align directly 

from P&G. Instead, they purchase the product from a commercial retailer, either in stores or 

online. This circumstance, P&G contends, makes ascertainability impossible—there is no 

plausible way to verify that any one single individual actually purchased Align. In making this 

point, P&G relies on the Third Circuit’s decision in Carrera v. Bayer Corp., 727 F.3d 300 (3d 

Cir. 2013). 

The district court did not abuse its discretion in holding that the class is sufficiently 

ascertainable. In our circuit, the ascertainability inquiry is guided by Young v. Nationwide 

Mutual Insurance Co., 693 F.3d 532 (6th Cir. 2012). And under Young, Plaintiffs have produced 

evidence sufficient to show that the class is ascertainable. We see no reason to follow Carrera, 

particularly given the strong criticism it has attracted from other courts. See, e.g., Mullins v. 

Direct Digital, LLC, No. 15-1776, 2015 WL 4546159, at *7 (7th Cir. July 28, 2015) (declining to 

follow Carrera because “[t]he Third Circuit’s approach in Carrera, which is at this point the 

high-water mark of its developing ascertainability doctrine, goes much further than the 

established meaning of ascertainability and in our view misreads Rule 23”); In re ConAgra 

Foods, Inc., 302 F.R.D. 537, 566 (C.D. Cal. 2014) (discussing Carrera and noting that 

“ConAgra’s argument would effectively prohibit class actions involving low priced consumer 

goods—the very type of claims that would not be filed individually—thereby upending ‘[t]he 

policy at the very core of the class action mechanism’” (quoting Amchem Prods, Inc. v. Windsor, 

521 U.S. 591, 617 (1997))). Even if Carrera governed, there are a number of factual differences 

that make a finding of ascertainability more appropriate here. 

 9

P&G urges us to enter a circuit split over whether it is sufficient that the named class plaintiff has 

standing, regardless of whether unnamed class members do. Appellant Br. at 48–50. Because reaching this 

argument requires accepting P&G’s inaccurate characterization of Plaintiffs’ theory of liability in this case, we do 

not find it necessary to evaluate this claim. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 34

In Young, the named plaintiffs sued their respective insurance companies, alleging “that 

their insurer charged them a local government tax on their premiums when either the tax was not 

owed or the tax amount owed was less than the insurer billed.” 693 F.3d at 535. The district 

court certified a class of “[a]ll persons in the Commonwealth of Kentucky who purchased 

insurance from or underwritten by [Defendant insurer] . . . and who were charged local 

government taxes on their payment of premiums which were either not owed, or were at rates 

higher than permitted.” Id. at 536 (second alteration in original). On appeal, the insurance 

companies argued “that the class definition [was] not administratively feasible” because the 

plaintiffs’ class description was not “sufficiently definite so that it [would be] administratively 

feasible for the court to determine whether a particular individual is a member.” Id. at 538. 

We rejected this argument. We noted that “[f]or a class to be sufficiently defined, the 

court must be able to resolve the question of whether class members are included or excluded 

from the class by reference to objective criteria.” Id. (internal quotation marks omitted). The 

plaintiffs had presented such a class, because class membership could be determined by 

reviewing factors such as “the location of the insured risk/property” and “the local tax charged 

and collected from the policyholder.” Id. at 539. Unlike the Third Circuit in Carrera, we 

considered—and rejected—the defendants’ claim “that the class properly could [not] be certified 

without . . . 100% accuracy.” Id. Instead, we agreed with the district court’s conclusion that “the 

subclasses can be discerned with reasonable accuracy using Defendants’ electronic records and 

available geocoding software, though the process may require additional, even substantial, 

review of files.” Id. (emphasis added) (internal quotation marks omitted). The court added that 

“[i]t is often the case that class action litigation grows out of systemic failures of administration, 

policy application, or records management that result in small monetary losses to large numbers 

of people. To allow that same systemic failure to defeat class certification would undermine the 

very purpose of class action remedies.” Id. at 540. 

This same reasoning applies to the instant case. The proposed class is defined by 

objective criteria: anyone who purchased Align in California, New Hampshire, Illinois, North 

Carolina, or Florida. As in Young, these single state sub-classes can be determined with 

reasonable—but not perfect—accuracy. Doing so would require substantial review, likely of 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 35

internal P&G data. But as the district court pointed out, such review could be supplemented 

through the use of receipts, affidavits, and a special master to review individual claims. R. 140 

(Dist. Ct. Order at 13–15) (Page ID #6427–29). 

Even if we were to apply Carrera, there are significant factual differences that make this 

class more ascertainable. In Carrera, the plaintiff brought a class action against Bayer 

Corporation, “claiming that Bayer falsely and deceptively advertised its product One–A–Day 

WeightSmart.” 727 F.3d at 304. “Carrera allege[d] [that] Bayer falsely claimed that 

WeightSmart enhanced metabolism by its inclusion of epigallocatechin gallate, a green tea 

extract.” Id. Carrera moved to certify a class consisting of “all persons who purchased 

WeightSmart in Florida,” which the district court granted. Id. In vacating and remanding the 

district court’s order, the Third Circuit held that Carrera’s proposed class was not sufficiently 

ascertainable under the methods proposed by Carrera. Id. at 308–11. 

First, Carrera proposed “using retailer’s records of sales made with loyalty cards . . . , and 

records of online sales.” Id. at 308. The Third Circuit rejected this approach. It noted that 

“there is no evidence that a single purchaser of WeightSmart could be identified using records of 

customer membership cards or records of online sales.” Id. at 309 (emphasis added). Still, the 

court maintained that, “[d]epending on the facts of a case, retailer records may be a perfectly 

acceptable method of proving class membership.” Id. at 308–09. Second, Carrerra proposed 

taking affidavits from various class members, the veracity of which could be assessed by a 

private firm tasked with administering class settlements. The Third Circuit likewise rejected this 

approach. It noted that this method “does not show [that] the affidavits will be reliable,” thereby 

undercutting Bayer’s due-process interests. Id. at 311.10

 10It is worth noting that the Third Circuit subsequently has cautioned against a broad reading of Carrera. 

In Byrd v. Aaron’s Inc., 784 F.3d 154 (3d Cir. 2015), the court discussed the ascertainability requirement in detail. 

The Third Circuit noted that Carrera “only requires the plaintiff to show that class members can be identified.” Id. 

at 164 (quoting Carrera, 727 F.3d at 308 n.2). “Carrera,” in other words, only “stands for the proposition that a 

party cannot merely provide assurances to the district court that it will later meet Rule 23’s requirements.” Id. In 

Byrd, the Third Circuit went on to characterize the defendants’ “reliance on Carrera” as “misplaced.” Id. at 170. 

“In Carrera, we concluded that the plaintiffs’ proposed reliance on affidavits alone, without any objective records to 

identify class members or a method to weed out unreliable affidavits, could not satisfy the ascertainability 

requirement.” Id. (emphasis added). On the other hand, the Byrds—like Plaintiffs in this case—“presented the 

District Court with multiple definitions of class members and simply argued that a form similar to those provided 

could be used to identify household members.” Id.; see also id. (“There will always be some level of inquiry 

required to verify that a person is a member of a class.”). To emphasize the point, the Third Circuit stated that, 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 36

Here, in contrast, there is “evidence that a single purchaser [in the proposed class] . . . 

could be identified using records of customer membership cards or records of online sales.” Id. 

at 309 (emphasis added). P&G’s own documents indicate that more than half of its sales are 

online. Sealed App. at 514. At a minimum, online sales would provide the names and shipping 

addresses of those who purchased Align. In addition, studies conducted by P&G reveal that an 

overwhelming number of customers learned about Align through their physicians. See Sealed 

App. at 160–61 (documenting surveys showing 39% to 80% of all users hearing about Align 

through a physician). Unlike the proposed class in Carrera, P&G could verify that a customer 

purchased Align by, for instance, requesting a signed statement from that customer’s physician. 

Store receipts and affidavits can supplement these methods. 

In sum, the district court did not abuse its discretion in finding the proposed class to be 

sufficiently ascertainable. As the district court pointed out, there is significant evidence that 

Plaintiffs could use traditional models and methods to identify class members. See R. 140 (Dist. 

Ct. Op. at 12–15) (Page ID #6426–29). These methods satisfy Young. 

III CONCLUSION

For the foregoing reasons, we AFFIRM the district court’s judgment granting class 

certification. 

 

 “[c]ertainly, Carrera does not suggest that no level of inquiry as to the identity of class members can ever be 

undertaken. If that were the case, no Rule 23(b)(3) class could ever be certified.” Id. at 171. 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 37

_________________ 

CONCURRENCE

_________________ 

AVERN COHN, District Judge, concurring. I concur in the lead opinion and have this to 

add. As I read Plaintiffs’ false-advertising claims, they are predicated on the proposition that 

Align has no digestive health benefits to anyone, and that there is no reason to purchase Align 

other than for its promised digestive health benefits. On return to the district court, given the 

disagreements between the lead opinion and dissent, I believe the district judge, before 

proceeding further, should consider bifurcation under Fed R. Civ. P. 42(b) the issue of the 

digestive health benefits of Align. If, as Plaintiffs claim, there is no scientific evidence that 

Align promotes digestive heath for anyone, the case can proceed in the regular course. If, on the 

other hand, Plaintiffs’ proofs fail to establish that Align has no digestive health benefits, the case 

should be dismissed. See, e.g., Gillie v. Law Office of Eric A. Jones, LLC, No. 2:13-CV-212, 

2013 WL 6255693 (S.D. Ohio Dec. 4, 2013) (to conserve judicial resources, bifurcating under 

Rule 42(b) issues relating to liability, such as whether defendants are considered “debt 

collectors” under the Fair Debt Collection Practices Act), granting defendants’ motion for 

summary judgment on liability, 37 F. Supp. 3d 928 (S.D. Ohio 2014), vacated and remanded, 

785 F.3d 1091 (6th Cir. 2015); see generally Susan E. Abitanta, Bifurcation of Liability and 

Damages in Rule 23(b)(3) Class Actions: History, Policy, Problems, and a Solution, 36 Sw. L.J. 

743, 744 (1982) (discussing the economic benefits of bifurcation in class actions). 

 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 38

_________________ 

DISSENT

_________________ 

COOK, Circuit Judge, dissenting. Recent Supreme Court precedent clearly holds that 

“plaintiffs wishing to proceed through a class action must actually prove—not simply plead—

that their proposed class satisfies each requirement of Rule 23.” Halliburton Co. v. Erica P. 

John Fund, Inc., 134 S. Ct. 2398, 2412 (2014); see also Comcast Corp. v. Behrend, 133 S. Ct. 

1426, 1432 (2013); Amgen Inc. v. Conn. Ret. Plans & Trust Funds, 133 S. Ct. 1184, 1194 

(2013); Wal-Mart Stores, Inc. v. Dukes, 131 S. Ct. 2541, 2551 (2011). District courts may 

certify a class only where the plaintiff presents “evidentiary proof” sufficient to withstand 

“rigorous analysis” of Rule 23’s requirements. Comcast, 133 S. Ct. at 1432. Nothing about the 

district court’s analysis here was rigorous, and the majority papers over this abuse of discretion 

by claiming that any further inquiry would result in an impermissible “dress rehearsal” for trial. 

More often than not, however, a district court’s “‘rigorous analysis’ will entail some overlap with 

the merits of the plaintiff’s underlying claim.” Dukes, 131 S. Ct. at 2551–52 (quoting Gen. Tel. 

Co. of Sw. v. Falcon, 457 U.S. 147, 614 (1982)). And this case is no exception to that rule. 

Because the majority opinion conflicts with the Supreme Court’s Rule 23 jurisprudence, I 

dissent. 

Plaintiffs proclaim that Align is “snake oil” that produces nothing more than a placebo 

effect. But Plaintiffs offer no proof in support of this argument, and all the available evidence 

tends to show the opposite: that consumers benefit more or less from Align based on their 

individual gastrointestinal health. P&G’s scientific studies and anecdotal evidence tend to show, 

at the very least, that patients suffering from irritable bowel syndrome (IBS) benefit from Align. 

Plaintiffs tacitly acknowledge as much in their amended complaint, challenging the design of 

these studies and arguing that P&G relies on an impermissible string of inferences to conclude 

that Align also benefits “healthy” people. 

Plaintiffs’ attempt to distinguish Align’s impact on IBS sufferers from its effect on the 

general population exposes the flaw in their proposed class definition. At this stage, Plaintiffs 

must demonstrate that they can disprove Align’s efficacy for every member of the class at one 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 39

time. The class certified by the district court includes all consumers who purchased Align, IBS 

patients and “healthy” consumers alike. Because the evidence tends to show that these two 

groups respond differently to Align, Plaintiffs have failed to meet their burden of showing that 

their theory of liability lends itself to common investigation and resolution. See Dukes, 131 S. 

Ct. at 2551 (stating that the benchmark for commonality is a classwide proceeding’s ability to 

generate common answers rather than counsel’s ability to formulate common questions). 

Furthermore, Plaintiffs offer no proof that the benefits associated with Align result solely 

from a placebo effect. Their expert, Dr. Komanduri, expressed no opinion on the question and 

declined to confront any of P&G’s studies directly. He dismissed all these trials as too 

unscientific, although he has yet to study the product himself and acknowledges that the IBS 

symptoms of at least one of his patients improved after taking Align. In lieu of an expert 

opinion, Dr. Komanduri promised to design and conduct a clinical trial that will prove 

definitively whether Align works as advertised, notwithstanding the experts who already 

conclude that it works for at least some consumers. With nothing more than that promise, the 

district court certified a class of millions across five states. In doing so, the court impermissibly 

shifted the burden to P&G, forcing it to disprove the commonality and predominance elements of 

Rule 23. 

To avoid confronting these flaws, the majority quotes Amgen’s admonition that “[m]erits 

questions may be considered to the extent—but only to the extent—that they are relevant to 

determining whether the Rule 23 prerequisites for class certification are satisfied.” 133 S. Ct. at 

1195. But whether Align works similarly for each class member is relevant to certification and 

therefore not beyond the scope of the court’s rigorous analysis. See Dukes, 131 S. Ct. at 2551–

52 (“The class determination generally involves considerations that are enmeshed in the factual 

and legal issues comprising the plaintiff’s cause of action.” (quoting Falcon, 457 U.S. at 160)). 

If Align works to varying degrees—or at all—depending on each member’s unique physiology, 

then the question of Align’s efficacy involves myriad individual inquiries. See Comcast, 133 S. 

Ct. at 1432 (“The party must also satisfy through evidentiary proof at least one of the provisions 

of Rule 23(b).”). This fundamental defect will not disappear by allowing Plaintiffs to define the 

question at an impossibly high level of abstraction. As the case proceeds, the problems with the 
No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 40

district court’s certification order will become painfully clear. Either the court will have to 

whittle down the class definition every time P&G produces a study showing that patients with a 

certain makeup benefit from Align or the court must award judgment to P&G and preclude class 

members with colorable claims from recovery because it defined the class too broadly in the first 

place. 

By discounting the evidence presented at the certification stage, moreover, the majority 

affirms a class definition that includes a clutch of members without standing. E.g., Kohen v. 

Pac. Inv. Mgmt. Co. LLC, 571 F.3d 672, 677 (7th Cir. 2009) (“[A] class should not be certified if 

it is apparent that it contains a great many persons who have suffered no injury at the hands of 

the defendant . . . .” (citations omitted)); Denney v. Deutsche Bank AG, 443 F.3d 253, 264 (2d 

Cir. 2006) (“The class must therefore be defined in such a way that anyone within it would have 

standing.”). The class definition includes all purchasers of Align despite the fact that Plaintiffs 

offer no proof to rebut the studies showing that the product improves digestive health for IBS 

patients. The only evidence before the court shows that IBS patients suffered no injury (because 

Align works as-advertised for them), and therefore Plaintiffs have failed to show a properly 

defined class. See Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992) (“[E]ach element 

must be supported in the same way as any other matter on which the plaintiff bears the burden of 

proof, i.e., with the manner and degree of evidence required at the successive stages of the 

litigation.”). Unless Plaintiffs muster some evidence rebutting the IBS studies, their claim is 

already doomed. 

For these reasons, the Supreme Court requires plaintiffs to affirmatively prove that 

common questions both exist and predominate. Though Plaintiffs artfully frame the question in 

a binary fashion, a rigorous analysis of their evidence shows that resolution of the Plaintiffs’ 

question cannot apply universally to all class members. Plaintiffs offer nothing in support of 

their claim that Align benefits no one. Instead, they nitpick P&G’s competent evidence, trot out 

an expert without any opinion as to the supplement’s efficacy, and promise to conduct the 

definitive trial of Align that accounts for all variables of human physiology. Dukes and its 

progeny teach us that this is insufficient to justify class certification. I must dissent.