Petition for Writ of Certiorari — Pharmavite LLC, Petitioner v. Noah Bradach

No. _________

================================================================

In The

Supreme Court of the United States

-----------------------------------------------------------------PHARMAVITE LLC,

Petitioner,

v.

NOAH BRADACH, on behalf of himself

and all others similarly situated,

Respondent.

-----------------------------------------------------------------On Petition For A Writ Of Certiorari

To The United States Court Of Appeals

For The Ninth Circuit

-----------------------------------------------------------------PETITION FOR WRIT OF CERTIORARI

-----------------------------------------------------------------DANIEL J. CONNOLLY

FAEGRE BAKER DANIELS LLP

2220 Wells Fargo Center

90 South Seventh Street

Minneapolis, MN 55402-3901

(612) 940-9453

Daniel.Connolly@FaegreBD.com

Counsel of Record for Petitioner

================================================================

COCKLE LEGAL BRIEFS (800) 225-6964

WWW.COCKLELEGALBRIEFS.COM

i

QUESTIONS PRESENTED

1.

Is it a violation of the Supremacy Clause, U.S.

CONST. art. VI, cl. 2, for a federal court to certify a class

that includes class members asserting state law claims

that are expressly preempted by federal statute, where

the question of preemption cannot be determined for

the class as a whole?

2.

Is it a violation of the Supremacy Clause, U.S.

CONST. art. VI, cl. 2, for a federal court to certify a class

that includes class members asserting state law false

labeling claims that are expressly preempted by federal statute, if the federal court does not require individual inquiry into the interpretation of or reliance on

the challenged label to determine whether each member’s claim is preempted?

3.

To avoid violating the Supremacy Clause, U.S.

CONST. art. VI, cl. 2, is it necessary to require inquiry

into individual class members’ interpretation of or reliance on a label statement alleged to be false under

state law to determine whether each class member’s

claims are expressly preempted by federal statute,

even if the causation/reliance element of the state

claims may be determined on a class-wide basis, without individual inquiry into each class member’s reliance on the challenged label?

ii

PARTIES TO THE PROCEEDING

AND RULE 29.6 STATEMENT

The Petitioner is Pharmavite LLC, who was Defendant-Appellee below. Pharmavite LLC is owned

100% by Otsuka America, Inc. Otsuka America, Inc. is

owned 100% by Otsuka Pharmaceutical Co., Ltd.,

which is owned 100% by Otsuka Holdings Co., Ltd., a

public company.

The Respondent is Noah Bradach, who was Plaintiff-Appellant below. Noah Bradach is an individual,

and asserts claims on behalf of himself and others similarly situated.

iii

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ................................

i

PARTIES TO THE PROCEEDING AND RULE

29.6 STATEMENT............................................

ii

OPINIONS BELOW.............................................

1

JURISDICTION ...................................................

1

STATUTORY AND REGULATORY PROVISIONS AT ISSUE .............................................

2

STATEMENT OF THE CASE..............................

6

REASONS FOR GRANTING THE PETITION ... 11

A.

The Supremacy Clause precludes state

law claims that are preempted by federal

law ............................................................. 12

B.

The Supremacy Clause of the U.S. Constitution does not permit individuals to recover on preempted claims merely because

they are absent class members ................. 14

C.

Class certification should not be permitted in federal court where the issue of

preemption cannot be determined on a

class-wide basis ......................................... 17

CONCLUSION..................................................... 21

APPENDIX

Appendix A

Opinion, U.S. Court of Appeals for the Ninth Circuit Entered May 17, 2018................................ App.1

iv

TABLE OF CONTENTS – Continued

Page

Appendix B

Order re Renewed Motion for Class Certification, U.S. District Court, Central District of

California, Entered July 6, 2016 ...................... App.9

Appendix C

Order re Plaintiff’s Response to Order to Show

Cause, U.S. District Court, Central District of

California, Entered August 25, 2016 .............. App.27

Appendix D

Order re Pharmavite LLC’s Motion for Judgment on the Pleadings, U.S. District Court,

Central District of California, Entered December 22, 2015............................................... App.35

Appendix E

Order denying Petitions for Rehearing, U.S.

Court of Appeals for the Ninth Circuit Entered July 10, 2018 .......................................... App.46

v

TABLE OF AUTHORITIES

Page

FEDERAL CASES

Amchem Prods., Inc. v. Windsor, 521 U.S. 591

(1997) .......................................................................17

Cima v. WellPoint Health Networks, Inc., 250

F.R.D. 374 (S.D. Ill. 2008) ........................................20

Gallagher v. Bayer AG, 2015 WL 1056480 (N.D.

Cal. Mar. 10, 2015) ..................................................13

Gawry v. Countrywide Home Loans, Inc., 640

F. Supp. 2d 942 (E.D. Ohio 2009) ............................20

Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1 (1824)..... 12, 14

Law v. General Motors Corp., 114 F.3d 908 (9th

Cir. 1997) .................................................................12

Lazaroff v. Blue Cross & Blue Shield of Conn.,

Inc., 1989 U.S. Dist. LEXIS 19175, 1989 WL

235958 (D.Conn. Jan. 11, 1989) ..............................20

Morales v. Trans World Airlines, Inc., 504 U.S.

374, 119 L. Ed. 2d 157, 112 S. Ct. 2031 (1992).......12

Sellers v. Rushmore Loan Mgmt. Servs., LLC,

2017 U.S. Dist. LEXIS 203736 (M.D. Fla. Dec.

12, 2017) ..................................................................19

Tait v. BSH Home Appliances Corp., 289 F.R.D.

466 (C.D. Cal. Dec. 20, 2012)...................................17

Turek v. General Mills, Inc., 662 F.3d 423 (7th

Cir. 2011) .................................................................13

Ward v. United Airlines, Inc., 2016 U.S. Dist.

LEXIS 38896 (N.D. Cal. Mar. 23, 2016) ............ 17, 18

vi

TABLE OF AUTHORITIES – Continued

Page

STATE CASES

In re Tobacco II Cases, 41 Cal. 4th 1257 63

Cal.Rptr.3d 418, 163 P.3d 106 (2007) .....................16

In re Tobacco II Cases, 46 Cal. 4th 298

(2009) ........................................................... 10, 15, 16

Kasky v. Nike, Inc., 27 Cal. 4th 939 (2002), as

modified (May 22, 2002) ................................... 10, 14

U.S. CONSTITUTION

U.S. CONST. art. VI, cl. 2 .......................................... 2, 11

FEDERAL STATUTES

21 U.S.C. §§ 301-399 ............................................. 2, 4, 7

21 U.S.C. § 321(ff ) .........................................................3

21 U.S.C. § 343 ...................................................... 2, 3, 7

21 U.S.C. § 343(r)(6) .................................................. 4, 7

21 U.S.C. § 343(r)(6)(A) .................................................7

21 U.S.C. § 343(r)(6)(C) .................................................8

21 U.S.C. § 343-1(a)(2) ..................................................2

21 U.S.C. § 343-1(a)(5) ..................................................7

28 U.S.C. § 1254(1) ........................................................2

FEDERAL REGULATIONS

21 C.F.R. § 101.1(c)(4) ............................................... 3, 7

21 C.F.R. § 101.93 .........................................................4

vii

TABLE OF AUTHORITIES – Continued

Page

21 C.F.R. § 101.93(f ) .....................................................7

21 C.F.R. § 101.93(g)(2) .................................................7

65 FR 1000 ....................................................................8

FEDERAL RULES

FED. R. CIV. PROC. 23 ............................................ 15, 17

FED. R. CIV. PROC. 23(a) ................................................5

FED. R. CIV. PROC. 23(b)(3) ..................................... 5, 17

STATE STATUTES

Cal. Bus. Prof. Code §§ 17200 et seq. ............................6

Cal. Civ. Code §§ 1750 et seq.........................................6

1

OPINIONS BELOW

The U.S. District Court for the Central District of

California denied class certification by unpublished order entered on July 6, 2016. (Attached hereto as Appendix B).

The district court also dismissed Noah Bradach’s

individual claims as preempted by unpublished order

dated August 25, 2016. Although not the subject of this

Petition, because this order is cited herein, it is attached hereto as Appendix C.

In a decision that also is not the subject of this Petition (but is cited herein), the district court denied a

motion for judgment on the pleadings on December 22,

2015. (Attached hereto as Appendix D).

The Ninth Circuit Court of Appeals reversed and

remanded the class certification order and the order

dismissing Bradach’s individual claims in an unpublished opinion entered on May 17, 2018. (Attached

hereto as Appendix A).

The unpublished Order of the Ninth Circuit Court

of Appeals denying the timely Petitions for Panel Rehearing and for Rehearing En Banc was entered on

July 10, 2018. (Attached hereto as Appendix E).

------------------------------------------------------------------

JURISDICTION

The Ninth Circuit Court of Appeals filed its opinion reversing the district court’s denial of class

2

certification on May 17, 2018 (Appendix A), and on

July 10, 2018, filed its opinion denying the timely Petitions for Rehearing En Banc and Panel Rehearing

(Appendix E).

This Court has jurisdiction under 28 U.S.C.

§ 1254(1) to review the Ninth Circuit’s decision on a

writ of certiorari.

------------------------------------------------------------------

STATUTORY AND REGULATORY

PROVISIONS AT ISSUE

1. The Supremacy Clause of the U.S. Constitution, U.S. CONST. art. VI, cl. 2, provides:

This Constitution, and the laws of the United

States which shall be made in pursuance

thereof; and all treaties made, or which shall

be made, under the authority of the United

States, shall be the supreme law of the land;

and the judges in every state shall be bound

thereby, anything in the Constitution or laws

of any State to the contrary notwithstanding.

2. The preemption clause of the Nutrition Labeling and Education Act, 21 U.S.C. § 343 (2012), which

amended the Food, Drug, and Cosmetic Act 21 U.S.C.

§§ 301–399, provides in pertinent part (at 21 U.S.C.

§ 343–1(a)(2)):

National uniform nutrition labeling.

*

*

*

3

. . . [N]o State or political subdivision of a

State may directly or indirectly establish under any authority or continue in effect as to

any food1 in interstate commerce—

*

*

*

(2) any requirement for the labeling of food

of the type required by [21 U.S.C.] section

343(c), 343(e), 343(i)(2), 343(w), or 343(x) . . .

that is not identical to the requirement of

such section. . . .

3. The regulations thereunder,

§ 100.1(c)(4), provide in relevant part:

21

C.F.R.

“[N]ot identical to” . . . means that the State

requirement directly or indirectly imposes obligations or contains provisions concerning

the . . . labeling of food . . . that:

(i) Are not imposed by or contained in the

applicable provision (including any implementing regulation) of [21 U.S.C. § 343]; or

(ii) Differ from those specifically imposed by

or contained in the applicable provision (including any implementing regulation) of [21

U.S.C. § 343].

4. The structure/function provisions of the Nutrition Labeling and Education Act, 21 U.S.C. § 343

(2012), which amended the Food, Drug, and Cosmetic

1

The Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(ff ), provides that “a dietary supplement shall be deemed to be a food

within the meaning of this Act.”

4

Act, 21 U.S.C. §§ 301–399, provide in pertinent part (at

21 U.S.C. § 343(r)(6)):

(6) For purposes of paragraph (r)(1)(B), a

statement for a dietary supplement may be

made if—

(A) the statement . . . describes the role

of a nutrient or dietary ingredient intended to affect the structure or function

in humans, . . .

(B) the manufacturer of the dietary supplement has substantiation that such

statement is truthful and not misleading,

and

(C) the statement contains, prominently

displayed and in boldface type, the

following: “This statement has not been

evaluated by the Food and Drug Administration. This product is not intended to

diagnose, treat, cure, or prevent any disease.”

A statement under this subparagraph may not claim to diagnose,

mitigate, treat, cure, or prevent a

specific disease or class of diseases. . . .

5. The regulations

§ 101.93, provide:

thereunder,

21

C.F.R.

Sec. 101.93 Certain types of statements for dietary supplements.

*

*

*

5

(f ) Permitted structure/function statements.

Dietary supplement labels or labeling may . . .

bear statements that describe the role of a nutrient or dietary ingredient intended to affect

the structure or function in humans . . . provided that such statements are not disease

claims under paragraph (g) of this section. If

the label or labeling of a product marketed as

a dietary supplement bears a disease claim as

defined in paragraph (g) of this section, the

product will be subject to regulation as a drug

unless the claim is an authorized health claim

for which the product qualifies.

(g)

Disease claims. . . .

(2) FDA will find that a statement about

a product claims to diagnose, mitigate,

treat, cure, or prevent disease (other than

a classical nutrient deficiency disease)

under 21 U.S.C. 343(r)(6) if it meets one

or more of the criteria listed below. These

criteria are not intended to classify as disease claims statements that refer to the

ability of a product to maintain healthy

structure or function, unless the statement implies disease prevention or treatment. . . .

6. Federal Rule of Civil Procedure Rule 23(b)(3)

provides, in pertinent part:

(b) TYPES OF CLASS ACTIONS. A class action

may be maintained if Rule 23(a) is satisfied

and if:

*

*

*

6

(3) the court finds that the questions of

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

only individual members, and that a class

action is superior to other available methods for fairly and efficiently adjudicating

the controversy. . . .

------------------------------------------------------------------

STATEMENT OF THE CASE

Wanting to protect himself from heart disease,

plaintiff Noah Bradach alleges he purchased NatureMade® brand vitamin E, which is manufactured and

sold by defendant Pharmavite LLC (“Pharmavite”).

Bradach claims that he bought the vitamin in reliance

upon one of the several statements on the product’s label—“Helps Maintain a Healthy Heart”—which Bradach interpreted to mean “prevents heart disease.”

Shortly after making his purchase, Bradach’s attorney

(from a different case in which Bradach was the named

plaintiff in a putative class action) informed Bradach

that vitamin E purportedly does not prevent heart disease. Bradach, accordingly, filed a putative class action

alleging that Pharmavite violated two California statutes—the Consumer Legal Remedies Act, California

Civil Code §§ 1750 et seq. (“CLRA”), and the Unfair

Competition Law, California Business and Professions

Code §§ 17200 et seq. (“UCL”)—by including the allegedly false statement on its vitamin E labels.

Pharmavite’s vitamin labels are subject to the

comprehensive requirements of the Food, Drug and

7

Cosmetic Act, 21 U.S.C. §§ 301–399 (“FDCA”), as

amended by the Nutrition Labeling and Education Act,

21 U.S.C. § 343 (“NLEA”), as well as the regulations issued thereunder by the federal Food and Drug Administration (“FDA”). The NLEA expressly preempts state

laws that impose labeling requirements different from

or in addition to the requirements set forth in the

FDCA/NLEA and the implementing regulations. 21

U.S.C. § 343–1(a)(5); see also 21 C.F.R. § 100.1(c)(4).

The NLEA and governing regulations distinguish

between two types of statements, or claims, on vitamin

labels: “disease” claims and “structure/function”

claims. A disease claim is one that explicitly or implicitly claims to mitigate, treat, cure, or prevent disease.

21 U.S.C. § 343(r)(6); 21 C.F.R. § 101.93(g)(2). A structure/function claim is one that does not claim to mitigate, treat, cure, or prevent disease, but instead

describes the ways in which a nutrient or dietary ingredient affects the structure or the function of the human body or a part thereof. 21 U.S.C. § 343(r)(6)(A); 21

C.F.R. § 101.93(f ). By definition, disease claims and

structure/function claims are mutually exclusive; a label claim can be one or the other, but not both.

“Helps maintain a healthy heart” is a structure/

function claim, as Bradach and Pharmavite both agree.

As such, it does not imply that vitamin E can prevent,

treat, cure, or mitigate heart disease. The FDA, in its

guidance for manufacturers, offers similar statements

as examples of structure/function claims, including:

“helps maintain cardiovascular function and a healthy

8

circulatory system.” 65 FR 1000 at 1012.2 Manufacturers may include structure/function claims on vitamin

labels so long as the manufacturer has substantiation

that the vitamin provides a benefit to the function or

the structure of the body part or system at issue. 21

U.S.C. § 343(r)(6)(C). Pharmavite has substantiation

that vitamin E benefits the function and structure of

the heart.3 It thus included the structure/function

claim “helps maintain a healthy heart” on its vitamin

E labels.4

In a decision not appealed, the U.S. District Court

for the Central District of California held in this case

that, in light of the NLEA’s express preemption of state

laws’ imposition of labeling requirements different

2

Another FDA example of a structure/function claim is:

“supports the cardiovascular system by inhibiting leukotriene

and thromboxane synthesis, substances associated with platelet

aggregation.” 65 FR 1000 at 1030.

3

Among other things, as Pharmavite’s experts explained in

their reports filed with the district court, vitamin E is an antioxidant that protects the heart from damage by free radicals; reduces

inflammation (essential to the maintenance of the arteries that

carry blood to the heart); inhibits an enzyme involved in cell

growth and differentiation (a process important to the functioning

of vascular smooth muscle cells); helps suppress genes that cause

blood cell components to bind to the wall of blood vessels; modulates enzymes that promote blood vessel expansion; and modulates other enzymes in a manner that discourages blood platelets

from aggregating in clumps.

4

Pharmavite at all times has also included the following

statement on all of the NatureMade vitamin E labels, as required

by 21 U.S.C. § 343(r)(6)(C): “This statement has not been evaluated by the Food and Drug Administration. This product is not

intended to diagnose, treat, cure, or prevent any disease.” 21

U.S.C. § 343(r)(6)(C).

9

from or in addition to the requirements of the

FDCA/NLEA and implementing regulations, because

“helps maintain a healthy heart” is a structure/function claim and not a disease claim, it can violate the

CLRA and UCL only if “helps maintain a healthy

heart” is false as a structure/function claim—i.e., if vitamin E does not help maintain the function or structure of the heart, regardless of whether vitamin E can

prevent heart disease. (Appendix D at pp. App.40–

App.41). The district court held that using a “disease

claim characterization” of the challenged label claim

“helps maintain a healthy heart” in a CLRA or UCL

claim “would effectively impart requirements onto the

structure/function claim that are inconsistent with the

FDCA’s provisions,” and “Plaintiffs’ state law claims

would be preempted under the NLEA’s express

preemption provision.” (Id.).

Following this decision, Bradach moved under

Rule 23 of the Federal Rules of Civil Procedure for an

order certifying a nationwide and/or California class of

NatureMade vitamin E consumers asserting claims

under the CLRA and UCL. The district court denied

Bradach’s motion on the ground, inter alia, that

“[w]hether a given consumer has non-preempted false

structure/function claims will depend on how the consumer interpreted ‘Helps Maintain a Healthy Heart’

when the consumer purchased the supplements,”

which will require “an individualized inquiry into each

consumer’s interpretation” of the label “to determine

whether each consumer has non-preempted claims.

Such individualized inquiries would predominate over

10

any other issues common to the class.” (Appendix B at

p. App.20). “As both Bradach and the class must advance non-preempted false structure/function claims

for such claims to survive, each class member’s interpretation of “Helps Maintain a Healthy Heart”—including Bradach’s—matters in determining the

viability of his or her claims.” (Id. at p. App.15).

The Ninth Circuit reversed, holding that “the district court’s conclusion that it would need to inquire

into the motives of each individual class member” to

determine if each was asserting a claim expressly

preempted by federal statute “was premised on an error of law.” (Appendix A at p. App.6). Relying on a decision by the California Supreme Court which

considered only non-preempted claims (because the

preempted claims were stripped out of the case before

the decision was rendered), the Ninth Circuit stated

that California courts allow the causation element of

CLRA and UCL claims to be satisfied for the entire

class by showing that “members of the public are likely

to be deceived”; to prove causation, individual inquiries

are not required to determine whether each class

member relied on the challenged statement in making

his or her purchase. (Appendix A at pp. App.6–App.7,

citing Kasky v. Nike, Inc., 27 Cal. 4th 939, 951 (2002),

as modified (May 22, 2002), and In re Tobacco II Cases,

46 Cal. 4th 298, 312 (2009)). Accordingly, and even

though the Tobacco II decision was made after the

preempted claims were stripped out of the case (and

the Kasky decision did not involve preempted claims),

the Ninth Circuit extrapolated that no similar inquiry

11

should be required to determine whether any individual class member is asserting a claim expressly

preempted by federal statute in violation of the Supremacy Clause of the U.S. Constitution. (Appendix A

at pp. App.6–App.7).5

------------------------------------------------------------------

REASONS FOR GRANTING THE PETITION

In light of the growing number of false labeling

class actions that have been filed in recent years, the

Court’s review is warranted to settle the important

question of federal law: is it a violation of the Supremacy Clause, U.S. CONST. art. VI, cl. 2, for a federal court

to certify a class that includes class members asserting

state law claims that are expressly preempted by federal statute, where the question of preemption cannot

be determined for the class as a whole?

5

In a decision not appealed here, the Ninth Circuit also reversed the district court’s dismissal of Bradach’s personal claims.

(Appendix A at pp. App.4–App.5). The district court dismissed

Bradach’s claims based on his discovery responses and testimony

that he purchased NatureMade vitamin E because he believed the

challenged label statement meant that the vitamin E would prevent heart disease. (Appendix C). Bradach testified that he bought

the vitamin E for this purpose and this purpose only, and that he

would not have bought the vitamin E if he had known that it

would not prevent heart disease. Citing no evidence, the Ninth

Circuit concluded that Bradach had “mixed motives” in buying

the vitamin E: he believed it would prevent heart disease and also

believed that it would help maintain his healthy heart in ways

unrelated to heart disease. (Appendix A at pp. App.4–App.5).

Based on this finding, the Ninth Circuit concluded that “Bradach’s claims were not preempted.” (Id.).

12

Review is warranted to enforce the Supremacy

Clause of the U.S. Constitution and confirm that there

is no exception thereto allowing absent class members

to assert state law claims that are expressly

preempted by federal statute, even where such claims

may not be asserted by named plaintiffs. The Ninth

Circuit decision violates the Supremacy Clause.

A. The Supremacy Clause precludes state law

claims that are preempted by federal law.

The Supremacy Clause of the United States Constitution empowers Congress to enact legislation that

preempts state law. See Gibbons v. Ogden, 22 U.S. (9

Wheat.) 1, 211 (1824) (“In every such case, the act of

Congress, or the treaty, is supreme; and the law of the

State, though enacted in the exercise of powers not

controverted, must yield to it.”); Law v. General Motors

Corp., 114 F.3d 908, 909 (9th Cir. 1997) (“The Supremacy Clause empowers Congress to supplant decentralized, state-by-state regulation with uniform national

rules.”).

Federal law can preempt state law by express statutory command. Morales v. Trans World Airlines, Inc.,

504 U.S. 374, 383, 119 L. Ed. 2d 157, 112 S. Ct. 2031

(1992). In the FDCA and the NLEA, Congress created

a comprehensive scheme for the regulation and oversight of food, vitamin, and supplement products, including the uniform national labeling of such products.

As the Ninth Circuit acknowledged in this case, the

FDCA/NLEA expressly preempts “application of state

13

laws [which] would impose more or inconsistent burdens on manufacturers than the burdens imposed by

the FDCA.” (Appendix A at p. App.3, citing Gallagher

v. Bayer AG, No. 14-cv-04601-WHO, 2015 WL 1056480,

at *3–7 (N.D. Cal. Mar. 10, 2015)).

The Seventh Circuit explained the reason for the

FDCA/NLEA’s uniform labeling rules and express

preemption of differing state rules:

It is easy to see why Congress would not want

to allow states to impose disclosure requirements of their own on packaged food products,

most of which are sold nationwide. Manufacturers might have to print 50 different labels,

driving consumers who buy food products in

more than one state crazy.

Turek v. General Mills, Inc., 662 F.3d 423, 426 (7th Cir.

2011).

Because the FDCA/NLEA and regulations thereunder define and regulate structure/function claims as

mutually exclusive from disease claims, trying to impose disease claim standards on a structure/function

claim under California’s CLRA or UCL—including

by interpreting a structure/function claim to be an

implied-disease-prevention claim and alleging injury

under the CLRA and UCL because the vitamin purportedly does not prevent disease—runs directly afoul

of the FDCA/NLEA’s express preemption provision. As

the district court held, and as the Ninth Circuit did not

dispute, “any legal claim based on a false disease characterization of the [“help maintain a healthy heart”]

14

Statement—i.e., that the Statement is false because

Pharmavite’s vitamin E supplements do not prevent or

cure heart disease—is preempted.” (Appendix C at p.

App.28). This is because a “false disease claim characterization” of the structure/function claim “helps maintain a healthy heart” “would effectively impart

requirements onto the structure/function claim that

are inconsistent with the FDCA’s provisions.” (Appendix D at p. App.41).

B. The Supremacy Clause of the U.S. Constitution does not permit individuals to recover

on preempted claims merely because they

are absent class members.

For nearly 200 years, it has been the law of this

Court that an act of Congress preempting state laws

“is supreme; and the law of the State, though enacted

in the exercise of powers not controverted, must yield

to it.” Gibbons, 22 U.S. at 211. There is no exception to

the Supremacy Clause allowing preempted state law

claims to be asserted by absent class members.

In this case, without regard for the Supremacy

Clause, the Ninth Circuit opined that CLRA and UCL

claims are “ideal for class certification because they

will not require the court to investigate class members’

individual interaction with the product” to prove the

element of causation/reliance. (Appendix A at p.

App.6). Rather, the “standard in actions under both the

CLRA and UCL is whether ‘members of the public

are likely to be deceived.’” (Id., citing Kasky v. Nike,

15

Inc., 27 Cal. 4th 939, 951 (2002), as modified (May 22,

2002)).

However, the fact that state courts have obviated

the need for individual inquiries to prove an element

of a state law claim in situations where no preempted

claims are being asserted by absent class members is

of no relevance to whether absent class members may

assert state law claims that are expressly preempted

by federal statute. The Ninth Circuit’s reversal of the

district court’s order denying class certification failed

to recognize that the Supremacy Clause requires a determination as to whether each class member’s claims

are preempted, which would require individual inquiries into issues of interpretation. All of this is in direct

violation of both the Supremacy Clause of the U.S. Constitution and Rule 23 of the Federal Rules of Civil Procedure.

In holding that individual inquiry is not required

to determine whether class members’ claims are expressly preempted by federal statute, the Ninth Circuit relied on the California Supreme Court’s decision

in In re Tobacco II Cases, 46 Cal. 4th 298, 312 (2009),

that individual class members are not required to

prove reliance in UCL cases. (Appendix A at p. App.6).

In In re Tobacco II Cases, however, the California Supreme Court did not hold—and could not have held

without violating the Supremacy Clause—that absent

class members can assert preempted claims. Preemption was not at issue at that stage of the case.

16

Earlier in the same case, the California Supreme

Court explicitly acknowledged the limitation imposed

by the Supremacy Clause on whether, and to what extent, absent class members could recover under the

UCL. Before the dispute resolved by the 2009 decision

ever got to the Supreme Court, the California Supreme

Court first affirmed summary adjudication of the UCL

claims of those plaintiffs that were preempted by federal law. See In re Tobacco II Cases, 46 Cal. 4th 298,

310, fn.5 (2009) (“allegations within the UCL cause of

action that pertained to defendants’ targeting of minors in advertising were struck as preempted by federal law”), citing In re Tobacco II Cases, 41 Cal. 4th

1257, 1262, 63 Cal.Rptr.3d 418, 163 P.3d 106 (2007); see

also In re Tobacco II Cases, 41 Cal. 4th at 1275–76

(UCL claims could not proceed to the extent preempted

by federal law). Accordingly, in the 2009 decision cited

by the Ninth Circuit, the California Supreme Court did

not have before it the situation presented in this case:

where some, but not all, absent class members want to

recover on claims expressly preempted by federal law.

The California Supreme Court decision in 2009 on

which the Ninth Circuit relied thus did not allow

preempted claims by absent class members, and the

2007 and 2009 decisions by the California Supreme

Court acknowledge that such claims could not proceed.

Because of that, in the 2009 decision (where preempted

claims were no longer in issue), the court did not have

to confront the same issues of predominance, commonality, superiority, and manageability as are present

17

here as a result of the preempted claims by absent

class members.6

C. Class certification should not be permitted

in federal court where the issue of preemption cannot be determined on a class-wide

basis.

Rule 23 of the Federal Rules of Civil Procedure

provides that a class may be certified only where “the

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

members.” Fed.R.Civ.P. 23(b)(3).

Predominance “tests whether proposed classes are

sufficiently cohesive to warrant adjudication by representation.” Amchem Prods., Inc. v. Windsor, 521 U.S.

591, 623 (1997). When, for example, a determination as

to whether class members’ claims are preempted “can

be resolved on a class-wide basis without any individualized inquiries,” there is no bar to class certification.

Ward v. United Airlines, Inc., No. C 15-02309 WHA,

2016 U.S. Dist. LEXIS 38896, at *16 (N.D. Cal. Mar. 23,

2016). Instead, as the Ward court summarized:

The possibility that the putative class may

lose on preemption or constitutional grounds

does not preclude certification of the class. “A

common contention need not be one that will

be answered, on the merits, in favor of the

6

The other case cited by the Ninth Circuit, Tait v. BSH Home

Appliances Corp., 289 F.R.D. 466, 480 (C.D. Cal. Dec. 20, 2012),

similarly did not raise issues of preemption.

18

class. It only must be of such a nature that it

is capable of classwide resolution.”

Ward, 2016 U.S. Dist. LEXIS 38896, at *16 (quoting Alcantar v. Hobart Services, 800 F.3d 1047, 1053 (9th

2015).

The Ninth Circuit’s violation of the Supremacy

Clause cannot be rectified by trying to segregate the

preempted from the non-preempted claims. In this

case, the issue of preemption cannot be determined on

a class-wide basis because, as the Ninth Circuit and

district court both recognized, whether a class member’s state law claim is preempted depends on how he

or she understood the “Helps Maintain A Healthy

Heart” statement on the label. That is, in finding that

Bradach had “mixed motives” for buying the NatureMade vitamin E because he purportedly purchased it

(i) to prevent heart disease and (ii) to maintain his

healthy heart, the Ninth Circuit confirmed that a

plaintiff ’s “understanding” of the challenged label

statement and “motive” for buying the product will determine whether the plaintiff ’s state law claim is expressly preempted. The Ninth Circuit opined that

where a plaintiff ’s state claims are “based on mixed

motives” for purchasing the product, the “claims arising in part from non-preempted motives [can] move

forward.” (Appendix A at p. App.5). Conversely, claims

arising solely from preempted motives—i.e., state law

claims premised on characterizing a structure/function

claim as an implied disease prevention claim—are expressly preempted by the NLEA because they impart

requirements inconsistent with the federal statutes

19

and governing regulations. The Ninth Circuit’s holding

that such individualized inquiries are not required to

determine whether claims are preempted because they

are not required to prove an element of the claims is

erroneous.

As the district court correctly found, “an individualized inquiry into each consumer’s interpretation of

‘Helps Maintain a Healthy Heart’ would be required to

determine whether each consumer has non-preempted

claims. Such individualized inquiries would predominate over any other issues common to the class.” (Appendix B at p. App.20).

As numerous district courts have similarly held,

class certification in inappropriate where individual

inquiries would be required to determine whether

class members’ claims are preempted. For example, in

Sellers v. Rushmore Loan Mgmt. Servs., LLC, 2017 U.S.

Dist. LEXIS 203736 (M.D. Fla. Dec. 12, 2017), the court

noted that individualized inquiries had been required

on summary judgment to analyze the viability of the

named plaintiffs’ claims, including whether the claims

were preempted by the Bankruptcy Code. Id. at **9–

10. Thus, the court concluded, “if the Court certified

Plaintiffs’ proposed class, such individualized inquiries

would be required for every class member to determine

whether . . . the Bankruptcy Code precluded and/or

preempted the [claims]. Such a course of action—which

Plaintiffs’ proposed class definition mandates—is the

type of extensive individualized factual inquiry that is

too burdensome to allow class certification.” Id. (footnote omitted).

20

Similarly, in Cima v. WellPoint Health Networks,

Inc., 250 F.R.D. 374, 383–84 (S.D. Ill. 2008), the court

noted that it would be presented with the question

whether the putative class members’ state law claims

“with respect to the group insurance plans in the class

are preempted by federal laws,” and concluded that,

“given that the claims of the proposed class in this case

likely are honeycombed with issues of ERISA preemption, the Court finds that predominance and manageability are not satisfied.”

Likewise, in Gawry v. Countrywide Home Loans,

Inc., 640 F. Supp. 2d 942, 953 (E.D. Ohio 2009), the

court denied class certification in part because the defendant planned to raise as a defense that two federal

bank and loan statutes preempt the claims of the putative class. The court held that it “necessarily will

have to delve into the specific details of each individual

transaction” to determine whether preemption is applicable; this “fact-driven individualized inquiry . . . obviously runs contrary to the class action purpose of

utilizing common evidence to efficiently adjudicate disputes,” and “weighs against class certification.” Id. at

954. See also Lazaroff v. Blue Cross & Blue Shield of

Conn., Inc., 1989 U.S. Dist. LEXIS 19175, **10–11,

1989 WL 235958 (D.Conn. Jan. 11, 1989) (declining to

certify a class where some members “may have claims

that are preempted by ERISA” and others may have

claims that are not preempted).

The Ninth Circuit’s failure to similarly recognize

that the individual inquiry needed to determine

whether putative class members’ claims are

21

preempted renders certification improper under Rule

23(b)(3) demonstrates the need for a definitive and

binding ruling by this Court.

------------------------------------------------------------------

CONCLUSION

For the foregoing reasons, this Court is requested

to issue a writ of certiorari to the Court of Appeals for

the Ninth Circuit.

Respectfully submitted,

DANIEL J. CONNOLLY

FAEGRE BAKER DANIELS LLP

2220 Wells Fargo Center

90 South Seventh Street

Minneapolis, MN 55402-3901

(612) 940-9453

Daniel.Connolly@FaegreBD.com