Opposition Brief — Johnson & Johnson, et al., Petitioners v. California

No. 22-447

In the Supreme Court of the United States

JOHNSON & JOHNSON, et al.,

Petitioners,

v.

STATE OF CALIFORNIA,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE C ALIFORNIA COURT OF A PPEAL, F OURTH DISTRICT

BRIEF IN OPPOSITION

ROB BONTA

Attorney General of California

MICHAEL J. MONGAN

Solicitor General

NICKLAS A. AKERS

Senior Assistant

Attorney General

January 17, 2023

SAMUEL T. HARBOURT*

Deputy Solicitor General

JON F. WORM

TINA CHAROENPONG

Supervising Deputy

Attorneys General

ADELINA ACUÑA

MONICA J. ZI

GABRIEL SCHAEFFER

DANIEL OSBORN

Deputy Attorneys General

STATE OF CALIFORNIA

DEPARTMENT OF JUSTICE

455 Golden Gate Avenue

Suite 11000

San Francisco, CA 94102-7004

(415) 510-3919

Samuel.Harbourt@doj.ca.gov

*Counsel of Record

i

QUESTION PRESENTED

Following a nine-week bench trial, a state trial

court found that, over the course of a nearly 20-year

period, petitioners repeatedly disseminated false and

misleading statements marketing their medical products to both patients and doctors. The question presented is:

Whether petitioners lacked fair notice, for purposes of the Due Process Clause, that the trial court

could treat each of their false or misleading communications as a separate violation under state statutes

prohibiting “any . . . untrue or misleading” advertising. Cal. Bus. & Prof. Code §§ 17200, 17500.

ii

TABLE OF CONTENTS

Page

Statement ....................................................................... 1

Argument ...................................................................... 11

Conclusion .................................................................... 22

iii

TABLE OF AUTHORITIES

Page

CASES

A.B. Small Co. v. Am. Sugar Ref. Co.

267 U.S. 233 (1925) ................................................ 19

Adams v. Robertson

520 U.S. 83 (1997) .................................................. 12

Ashland Specialty Co. v. Steager

139 S. Ct. 2714 (2019) ............................................ 12

Cameron v. Johnson

390 U.S. 611 (1968) ................................................ 16

Dep’t of Legal Affs. v. Rogers

329 So. 2d 257 (Fla. 1976) ..................................... 19

Fowler v. Sec. & Exch. Comm’n

142 S. Ct. 590 (2021) .............................................. 12

G & M Realty L.P. v. Castillo

141 S. Ct. 363 (2020) .............................................. 12

Giaccio v. Pennsylvania

382 U.S. 399 (1966) ................................................ 16

Gormley v. Gonzalez

84 Cal. App. 5th 72 (2022) ..................................... 13

Gosselin World Wide Moving v. U.S. ex

rel. Bunk

574 U.S. 819 (2014) ................................................ 12

iv

TABLE OF AUTHORITIES

(continued)

Page

Johnson & Johnson v. Ingham

141 S. Ct. 2716 (2021) ............................................ 12

Kaiser v. Johnson & Johnson

947 F.3d 996 (7th Cir. 2020) ................................... 8

Lent v. Cal. Coastal Comm’n

142 S. Ct. 1109 (2022) ............................................ 12

M & N Fin. Corp. v. Dep’t of Fair Emp.

& Hous.

142 S. Ct. 2714 (2022) ............................................ 12

Manuel v. City of Joliet

137 S. Ct. 911 (2017) .............................................. 18

Medtronic, Inc. v. Lohr

518 U.S. 470 (1996) .................................................. 8

Monsanto Co. v. Pilliod

142 S. Ct. 2870 (2022) ............................................ 12

Mother & Unborn Baby Care of

N. Tex., Inc. v. State

749 S.W.2d 533 (Tex. App. 1988) .......................... 19

Ortho-McNeil-Janssen Pharms., Inc. v.

S.C. ex rel. Wilson

577 U.S. 1093 (2016) .............................................. 12

People v. Dollar Rent-A-Car Sys., Inc.

211 Cal. App. 3d 119 (1989) ............................13, 16

v

TABLE OF AUTHORITIES

(continued)

Page

People v. JTH Tax, Inc.

212 Cal. App. 4th 1219 (2013) .........................15, 16

People v. Morse

21 Cal. App. 4th 259 (1993) .................. 9, 13, 15, 16

People v. Overstock.com, Inc.

12 Cal. App. 5th 1064 (2017) ................................. 15

People v. Superior Court (Olson)

96 Cal. App. 3d 181 (1979) .................................... 15

People v. Toomey

157 Cal. App. 3d 1 (1984) ...................................... 15

People v. Witzerman

29 Cal. App. 3d 169 (1972) .................................... 15

Scott v. Ass’n for Childbirth at Home, Int’l

88 Ill. 2d 279 (1981) ............................................... 19

Sessions v. Dimaya

138 S. Ct. 1204 (2018) ............................................ 17

State ex rel. Nixon v. Telco Directory Publ’g

863 S.W.2d 596 (Mo. 1993) .................................... 19

State v. Ralph Williams’ Nw. Chrysler

Plymouth, Inc.

82 Wash. 2d 265 (1973).......................................... 19

United States v. Williams

553 U.S. 285 (2008) ..........................................17, 19

vi

TABLE OF AUTHORITIES

(continued)

Page

Village of Hoffman Estates v. Flipside,

Hoffman Estates Inc.

455 U.S. 489 (1982) ................................................ 18

STATUTES

Cal. Bus. & Prof. Code

§ 17200 ................................................ i, 3, 11, 13, 20

§ 17500 ................................................ i, 3, 11, 13, 20

OTHER AUTHORITIES

Hamilton, The Ancient Maxim Caveat

Emptor, 40 Yale L.J. 1133 (1931) ......................... 21

Hess, History and Present Status of the

“Truth-in-Advertising” Movement,

101 Annals Am. Acad. Pol. & Soc.

Sci. 211 (1922) ........................................................ 21

Petty, The Historic Development of

Modern U.S. Advertising Regulation,

7 J. of Hist. Rsch. in Marketing 524

(2015) ....................................................................... 21

Pridgen & Alderman, Consumer Protection

and the Law (2022-2023 ed.) ................................. 20

Shapiro et al., Supreme Court Practice

(11th ed. 2019) ............................................13, 14, 18

1

STATEMENT

This case arises from a state court judgment holding petitioners responsible for taking “active, willful

measures for nearly twenty years to suppress information and conceal serious risk and complication

information from physicians and patients” about

certain medical devices manufactured and sold by

petitioners. Pet. App. 126a. Unless otherwise noted,

the information in this Statement comes from the trial

court’s extensive findings of fact, see id. at 113a-543a,

or the California Court of Appeal’s description of those

findings, see id. at 1a-103a.

1. Petitioner Johnson & Johnson and its subsidiaries, petitioners Ethicon, Inc., and Ethicon US, LLC,

have long “manufactured, marketed, and sold pelvic

mesh products intended to treat two conditions that

can affect women—stress urinary incontinence (SUI)

and pelvic organ prolapse (POP).” Pet. App. 4a. SUI

is a condition experienced by approximately one-third

of women. Id. at 5a. It is “characterized by urine leakage during everyday activities such as laughing,

coughing, sneezing, or exercising.” Id. at 4a-5a. POP

is a “disorder whereby the muscles and tissue in the

pelvis weaken and cause pelvic organs to prolapse (i.e.,

descend) into, and sometimes outside of, the vagina.”

Id. at 5a.

There are “a range of surgical and non-surgical

treatment options available for both SUI and POP.”

Pet. App. 118a. For example, “patients can perform

pelvic floor exercises known as kegel exercises to

strengthen the muscles around the urethra.” Id. at 5a.

“They can also insert a device called a pessary into the

vagina to stop urine leakage.” Id. In addition, POP

can be treated “through the use of a pessary or a

hormone estrogen cream” or “through a native tissue

2

repair whereby sutures are inserted to support the top

of the vagina.” Id.

In the late 1990s, petitioners began manufacturing

and marketing pelvic mesh as an alternative to the

approaches discussed above. Pet. App. 4a-6a. When a

patient opts for pelvic mesh, a doctor must surgically

implant a synthetic material (polypropylene) into the

patient’s pelvis. Id. at 6a; see id. at 116a-120a. “When

the mesh functions as intended, it elicits an acute

inflammatory response that causes scar tissue to grow

through the mesh’s pores and incorporates the mesh

into the patient’s body.” Id. at 6a. The goal of the

procedure is to help prevent urine leakage or provide

additional support for the pelvic organs. Id.

“[F]rom the time [that petitioners] launched” their

mesh products, they were aware of serious risks of “severe, long-term complications.” Pet. App. 119a; see id.

at 12a-14a, 119a-120a. According to a number of physicians and medical experts—including petitioners’

own medical directors—those complications can include “chronic pain, dyspareunia [genital pain associated with sexual activity], decreased sexual function,

partner pain (hispareunia), mesh exposure through

the surface of the vagina, mesh erosion into another

organ, distortion and shortening of the vagina, urinary problems, and urinary and bladder infections.”

Id. at 13a; see id. at 141a, 142a-143a (table collecting

the many risks and complications that “the company

knew about . . . since the time of launch”). Petitioners

were also aware that there is often “no exit strategy”:

“when severe complications arise, some patients may

need to undergo multiple invasive surgeries to

attempt to remove the mesh, and even with removal

the complications may never be fully resolved.” Id. at

3

182a; see id. at 249a (discussing “the ‘essential irreversibility’ of mesh complications”). 1

In light of those and other risks, the FDA took an

escalating series of actions to protect patients. In 2011,

for example, the FDA released a public health notification stating that “serious complications associated

with surgical mesh for POP repair are not rare.” Pet.

App. 133a (internal quotation marks omitted). In

2012, the FDA “issued orders requiring [petitioners]

to conduct” additional studies on the risks of complications from several of their mesh products. Id. at

134a-135a. And in 2019, “the FDA banned all transvaginal POP mesh devices from the United States

market because the FDA found that their safety and

effectiveness had not been established.” Id. at 137a.

2. In 2016, following an extensive, multi-year

investigation, California’s Attorney General sued petitioners in state court for misleading patients and

doctors about the risks of their mesh products. Pet.

App. 114a-115a. The State alleged that petitioners

violated two California statutes prohibiting “any . . .

untrue or misleading” advertising. 2 In an “extremely

e.g., Pet. App. 246a (describing patients with such

severe pain during sex that it “‘caused . . . partner[s] to leave,’”

“‘essentially ruin[ing] [their] life of intimacy’”); id. at 244a-245a

(similar); id. at 246a (patients “suffering urinary dysfunction

caused by mesh to the point where they are forced to ‘intermittently self-catheterize . . . throughout the day in order to empty

[their] bladder[s],’” forcing them to “stay close to the bathroom at

all times”) (internal quotation marks omitted); id. (patients with

pain so “irreversible and severe” that “they ended up in wheelchairs”) (internal quotation marks omitted).

1 See also,

2 The first statute bars “any . . . untrue or misleading advertis-

ing.” Cal. Bus. & Prof. Code § 17200. The second prohibits the

dissemination of “any statement . . . which is untrue or misleading” for marketing purposes. Id. § 17500.

4

thorough, 128-page statement of decision,” based on

testimony and evidence admitted during a nine-week

bench trial, id. at 11a, the trial court agreed with the

State and imposed civil penalties for petitioners’ “willful,” years-long “campaign of deceptive marketing,” id.

at 250a.

The trial court based its liability findings on three

principal forms of communications disseminated by

petitioners from 2008 (the earliest date petitioners

could be held liable under the relevant statutes of limitations) through 2017:

First, petitioners included “packets of information”

called “instructions for use” (or “IFUs”) with their

mesh devices. Pet. App. 9a. Those packets contained

information that doctors “read and rel[ied] on . . .

when counseling and treating patients,” id. at 18a, including “clinical performance results . . . and adverse

reactions associated with the device,” id. at 9a. Among

many false or misleading statements in the IFUs—

each described in detail on pages 159a through 185a

of the petition appendix—petitioners disclosed certain

relatively minor risks while omitting any reference to

“some of the most significant risks,” including “lifelong/chronic pain,” “lifelong/chronic dyspareunia,”

“pain to partner,” and “the need for mesh removal

which may not resolve the complications from mesh.”

Id. at 167a. As the trial court explained, “[b]y only

disclosing an incomplete list of risks. . . tell[ing] half

the story—the benign half ”—petitioners misled doctors about “the whole picture of possible mesh risks.”

Id. (emphasis omitted).

Second, petitioners targeted doctors with a variety

of other “marketing communications,” Pet. App. 10a,

including both “written communications” (such as

product brochures and advertisements in medical

5

journals) and “oral communications” (such as conference presentations and sales pitches during meals between doctors and sales representatives), id. at 65a.

The trial court found these communications to be unlawful for many of the same reasons that the IFUs

were “deceptive and misleading.” Id. at 186a; see id.

at 185a-190a. One “doctor-directed marketing material,” for example, trumpeted the results of several

questionable studies funded by petitioners, “advertis[ing] a 97% overall success rate . . . and negligible

complications rates without disclosing any of the dangerous properties or the serious long-term risks

caused by the mesh.” Id. at 189a n.25; see also id. at

66a (referring to the trial court’s “23-page violations

appendix cataloguing the precise manner by which

each and every written or online marketing communication was likely to deceive doctors”).

Third, petitioners “directed deceptive marketing

straight to the consumer,” promising patients that pelvic mesh offered “a quick, easy cure.” Pet. App. 191a.

A number of petitioners’ advertisements, for example,

marketed mesh surgery as a “minimally invasive 30minute procedure” “providing significant lifestyle

benefits to women by restoring their ability to have a

fulfilling sex life and to engage in physical activity.”

Id. (internal quotation marks omitted). At the same

time, such advertisements often “misstated, downplayed, and omitted the known risks.” Id. at 192a.

One brochure considered by the court featured Olympic speed skater Bonnie Blair, suggesting that pelvic

mesh surgery would enable patients to live an “athletic” lifestyle. Id. at 198a; see id. at 121a. The brochure directed patients to what it called a “‘complete

description of risks’”—a list that “in reality disclosed

none of mesh’s most serious complications.” Id. at

198a, 245a; see also id. at 198a-199a (testimony from

6

patient explaining how the Blair advertisement

“piqued her interest” in a “medical procedure [that] . . .

[she] wasn’t otherwise looking for,” ultimately leading

her to suffer “chronic pain and dyspareunia that cost

her the ability to work, [engage in] physical activity

and [have a] sex life”).

To count the total number of violations, the trial

court looked to evidence “quantif[ying] instances of

circulation or dissemination” of each type of marketing communication discussed above. Pet. App. 221a.

In particular, the court “credit[ed] . . . [the] methodology . . . and calculations” of expert forensic accountant

Travis Armstrong, who used data provided by petitioners during discovery to calculate the total number

of violations. Id. at 224a; see id. at 223a-242a. In crediting Armstrong’s calculations, the court emphasized

that he produced an “undercount[],” id. at 247a n.62—

a “conservative[]” “lower-bound of the number of violations,” id. at 224a, 236a-237a—because “for certain

gaps of time, [petitioners] did not have internal company data necessary for . . . calculat[ing] the number

of deceptive IFUs and marketing communications that

[they] disseminated,” id. at 87a n.17; see id. at 223a224a, 263a.

Finally, the trial court imposed a per-violation civil

penalty of $1,250, half of the $2,500 maximum penalty

authorized by the governing statutes. Pet. App. 243a.

The court held that this amount was appropriate in

light of petitioners’ “serious, knowing, and willful misconduct over a period of close to twenty years.” Id.

The court stressed, among other things, that “[i]nternal communications presented at trial show[ed] that

[petitioners] intentionally concealed and misrepresented risk information” to increase sales of their

7

mesh products. Id. at 247a; see, e.g., id. at 248a (marketing director’s refusal to provide patients with more

information because “it would be ‘dig[ging] her own

grave’ to reveal to customers that mesh might ever

need to be removed”). In the court’s view, this deceptive conduct was “particularly egregious” because it

involved “selling a permanent implant with no exit

strategy while hiding its risks.” Id. at 249a; see id.

(“patients . . . were deprived of the ability to make an

informed decision in the first place [and] will not get a

second chance”).

3. The California Court of Appeal affirmed in part

and reversed in part, largely upholding the trial

court’s judgment while reducing the total penalty

award. Pet. App. 1a-103a.

The appellate court first addressed—and rejected—a number of petitioners’ state-law challenges

to the trial court’s liability findings. The court disagreed, for example, with petitioners’ contention that

their IFUs were unlikely to deceive doctors because

doctors were “already aware of the risks.” Pet. App.

32a; see id. at 48a-62a. Reviewing “substantial evidence” in the record, id. at 48a, the court held that the

trial court properly found (among other things) that

doctors regularly “read and rely on IFUs,” id.; that

doctors “expect IFUs to list the full range of complications associated with medical devices,” id. at 49a; that

the relevant IFUs “did not list the full range of complications,” id.; and that “many practicing doctors went

to medical school or completed their residency

programs before [petitioners] released [their] pelvic

mesh products,” making the doctors unfamiliar with

the risks of those products, id. at 51a; see id. at 55a

(emphasizing that the “trial court strongly discredited”

testimony from petitioners’ witnesses suggesting that

8

“doctors . . . are familiar with the range and severity

of pelvic mesh complications”).

The court also rejected petitioners’ argument that

they were entitled to a statutory safe-harbor defense

because “the FDA authorized, or at a minimum

permitted, certain IFUs and marketing communications.” Pet. App. 72a. As a former FDA Commissioner

explained at trial, the FDA merely conducted a “limited review” to determine whether petitioners’ devices

were substantially equivalent to devices already on

the market. Id. at 76a; see id. at 75a-77a. The FDA

“even instructed” petitioners that its review “did not

mean that the FDA had made a determination that

[petitioners’] devices complied” with applicable

federal safety standards. Id. at 77a (alterations omitted). 3

As to the penalty award, the court reduced the total

award by about $42 million, concluding that there was

insufficient evidence to support liability for one subcategory of violations. Pet. App. 69a. While “there

was evidence showing that [petitioners] trained [their]

sales representatives to convey uniform marketing

The FDA process that petitioners referenced below—and

continue to discuss before this Court, e.g., Pet. 8-9—is “referred

to as section ‘510(k) approval.’” Pet. App. 75a. As Judge Sykes

recently explained in one of a number of other cases filed against

petitioners for misconduct related to their production and marketing of pelvic mesh, see id. at 56a-62a (collecting cases), “[m]ost

medical devices enter the market” through this process, which

often has “nothing to do with product safety,” Kaiser v. Johnson

& Johnson, 947 F.3d 996, 1004 (7th Cir. 2020). Indeed, “the FDA

has promulgated a disclaimer that § 510(k) clearance ‘does not in

any way denote official approval of [a] device”—and it is “unlawful for a device manufacturer to make such a representation.” Id.

at 1005; see generally Medtronic, Inc. v. Lohr, 518 U.S. 470, 492493 (1996) (discussing the 510(k) process).

3

9

messages,” id. at 67a—as well as evidence showing

that such training “promoted the disclosure of misleading information,” id. at 68a; see, e.g., id. at 216a217a—the appellate court was “unable to find evidence in the record” demonstrating that “every single

one of [petitioners’] thousands of oral communications

with doctors included false or misleading statements,”

id. at 66a, 67a-68a. The court thus struck from the

aggregate violation figure the approximately 33,500

violations based on petitioners’ oral communications

to doctors. Id. at 69a.

The court upheld the penalty award in all other

respects. As relevant here, it concluded that the trial

court properly “counted each deceptive IFU and marketing communication as a separate violation.” Pet.

App. 87a. The appellate court invoked California precedent approving the same “per-communication methodology.” Id. at 88a; see id. at 89a-93a (citing People v.

Morse, 21 Cal. App. 4th 259, 272-274 (1993)). It also

emphasized that petitioners’ communications were

“highly-targeted” (Pet. App. 92a): they were “explicitly written” and disseminated in carefully chosen mediums to reach or appeal to “patients who were suffering from SUI or POP,” or to “doctors who were

considering whether to implant [petitioners’] device[s]

or were preparing to do so.” Id. at 91a.

The court next rejected petitioners’ contention that

there was insufficient evidence to support the total

number of violations found by the trial court. Pet. App.

92a n.18. While petitioners “complain[ed] [that] the

forensic accountant’s calculations were inflated

because he extrapolated one salesperson’s history to

the entire sales staff and failed to account for brochures that were ordered but not distributed,” the

appellate court pointed out that petitioners failed to

10

provide data in their discovery responses that would

have enabled more precise calculations. Id. “Additionally,” the court noted, petitioners “never suggested

a method to discount the expert’s calculation,” in “either the trial court or on appeal.” Id. For those reasons, and because the calculation of violations “was

likely an undercount” in any event, id. at 87a, the

court upheld the trial court’s calculation, id. at 92a.

Finally, the court rejected petitioners’ due process

challenge to the penalty award. Pet. App. 97a-99a.

Petitioners argued that they “lacked fair notice” that

the trial court might impose an aggregate award exceeding $300 million because, according to petitioners,

that amount was larger than awards upheld in prior

“reported decision[s]” involving the same statutes. Id.

at 97a. As the appellate court explained, however, the

relevant California statutes “expressly define the

maximum amounts a violator can be punished per

violation—$2,500.” Id. at 98a. And nothing in the

statutory text or any prior appellate decisions

suggested that the awards in prior cases “somehow

[established] the outer limit of penalties that may be

properly imposed.” Id. (internal quotation marks

omitted). 4

Petitioners sought review before the California Supreme Court, arguing (among other things) that it

should “resolve a conflict” among intermediate state

4 The appellate court also rejected petitioners’ argument that the

trial court violated the federal Due Process Clause by applying

“unprecedented” standards in determining whether a communication qualified as deceptive. Pet. App. 97a; see, e.g., id. (explaining that, contrary to petitioners’ assertion, the trial court never

“requir[ed] [petitioners] to warn consumers of all risks associated

with its products regardless of consumers’ existing knowledge”).

11

appellate courts “over the proper standard for identifying distinct violations” under the State’s false advertising laws. Pet. for Rev. 27; see id. at 27-37. The

petition was denied. Pet. App. 544a.

ARGUMENT

As the trial court found, for “nearly twenty years,”

petitioners took “active, willful measures . . . [to]

conceal serious risk and complication information

from physicians and patients.” Pet. App. 126a; see id.

at 113a-543a. Petitioners now ask this Court to grant

plenary review and hold that they lacked fair notice

that each of their deceptive communications could be

treated as a distinct violation of state statutes barring

“any . . . untrue or misleading” advertising. Cal. Bus.

& Prof. Code §§ 17200, 17500. That argument does

not implicate any division of authority among state or

federal appellate courts. And there is no need here for

the Court to evaluate “the degree of fair notice scrutiny applicable to different types of laws,” Pet. 18,

because petitioners’ argument would fail under any of

the standards of scrutiny identified in the petition.

Nor is this case an appropriate vehicle for addressing

the legal and policy concerns raised by petitioners (see

id. at 29-39) about other States’ “unfair and deceptive

acts and practices” statutes.

1. Petitioners’ principal argument is that they

“lacked fair notice of how the California courts would

count statutory violations” for purposes of determining the appropriate civil penalty under state false advertising laws. Pet. 24; see id. at 22-29. This Court

has repeatedly denied petitions raising context-specific constitutional challenges to civil penalty awards

12

and damages judgments. 5 It should do the same here.

Petitioners do not contend that the decision below

creates or deepens any conflict among state or federal

appellate courts. Moreover, the particular fair-notice

argument that petitioners seek to present in this

Court was not properly preserved below; is intertwined with questions of state law; and lacks merit.

To be preserved for review in this Court, federal

issues must be “either addressed by, or properly presented to, the state court that rendered the decision”

below. Adams v. Robertson, 520 U.S. 83, 86 (1997).

Here, the California Court of Appeal addressed and

rejected petitioners’ various state-law challenges to

the trial court’s calculation of statutory violations. Supra pp. 9-10. It also addressed petitioners’ contentions

that their federal due process rights were violated

because they lacked adequate notice that aggregate

penalties could exceed $300 million, supra p. 10, or

that the trial court would apply certain standards in

determining whether a particular communication

qualified as “deceptive,” supra p. 10, n.4. But the appellate court did not address—and petitioners did not

properly preserve—the separate due process argument that they now seek to present in this Court: that

5 See, e.g., M & N Fin. Corp. v. Dep’t of Fair Emp. & Hous., 142

S. Ct. 2714 (2022) (No. 21-1285); Monsanto Co. v. Pilliod, 142 S.

Ct. 2870 (2022) (No. 21-1272); Lent v. Cal. Coastal Comm’n, 142

S. Ct. 1109 (2022) (No. 21-563); Fowler v. Sec. & Exch. Comm’n,

142 S. Ct. 590 (2021) (No. 21-591); Johnson & Johnson v. Ingham,

141 S. Ct. 2716 (2021) (No. 20-1223); G & M Realty L.P. v. Castillo, 141 S. Ct. 363 (2020) (No. 20-66); Ashland Specialty Co. v.

Steager, 139 S. Ct. 2714 (2019) (No. 18-1053); Ortho-McNeilJanssen Pharms., Inc. v. S.C. ex rel. Wilson, 577 U.S. 1093 (2016)

(No. 15-600); Gosselin World Wide Moving v. U.S. ex rel. Bunk,

574 U.S. 819 (2014) (No. 13-1399).

13

California’s false advertising statutes failed to provide

sufficient notice that each of petitioners’ deceptive

communications could be treated as a distinct “statutory violation[].” Pet. 24. 6

Even setting aside that defect, petitioners’ new due

process argument would not warrant review because

it lacks merit and is inextricably bound-up in case-specific facts and state-law issues.

The governing

statutes expressly prohibit the dissemination of

“any . . . untrue or misleading” advertisements. Cal.

Bus. & Prof. Code §§ 17200, 17500 (emphasis added).

Consistent with that language, California courts have

previously adopted a “per-communication methodology” for counting violations, Pet. App. 88a, treating

each “marketing communication[] that contained a

false or misleading statement” as a separate violation,

id. at 91a; see id. at 90a (citing People v. Morse, 21 Cal.

App. 4th 259, 272-274 (1993)); see also People v. Dollar

Rent-A-Car Sys., Inc., 211 Cal. App. 3d 119, 131-132

(1989). Anyone reading the statutes and relevant

precedent (cf. Pet. 25) would reasonably conclude that

6 Petitioners devoted about three pages of their opening brief in

the Court of Appeal to arguments involving the federal Due Process and Excessive Fines Clauses. C.A. Opening Br. 69-71. The

due process argument now advanced by petitioners appears

nowhere in those pages. See id. While petitioners hinted at the

new argument in one sentence on page 53 of their appellate reply

brief, that was not sufficient to preserve it. See Gormley v. Gonzalez, 84 Cal. App. 5th 72, 82 (2022) (“arguments raised for the

first time in a reply will not be considered”). Nor did petitioners

remedy their failure to preserve the argument when they later

devoted one paragraph to it in their petition for review before the

California Supreme Court. See Pet. for Rev. 39; see generally

Shapiro et al., Supreme Court Practice § 3.18(b ), p. 3-59 (11th ed.

2019) (“Where a federal question is initially raised in a petition . . . filed in the highest state court, . . . the jurisdiction of the

Supreme Court cannot attach.”).

14

each false or misleading advertisement could be

deemed a violation.

Petitioners principally respond by arguing that

“the California courts” have disagreed on the proper

violation-counting method, “depriv[ing] businesses of

fair notice of how violations will be assessed.” Pet. 26.

But even if petitioners were right about disagreement

in the relevant state case law, but see infra pp. 14-16,

that would not provide a basis for this Court’s intervention. This Court is “reluctant to grant review of

cases turning on state statutes or constitutions where

state decisions on the issues are . . . in confusion.”

Shapiro et al., Supreme Court Practice § 4.10, p. 4-32

(11th ed. 2019). Responsibility for resolving tension in

the decisions of intermediate state appellate courts

“rests with the highest state court,” not this one. Id.

And here, the California Supreme Court considered

and denied petitioners’ request for it to address a purported “conflict in the Courts of Appeal” over the

proper method of calculating violations under the

State’s false advertising laws. Pet. for Rev. 33; see supra pp. 10-11.

That denial was for good reason: petitioners are

not correct that the relevant state precedent, “up until

now,” required trial courts to employ violation-counting methods other than the per-communication approach applied below. Pet. 25. In all but one of the

state decisions invoked by petitioners, see id. at 25-26,

state intermediate appellate courts merely affirmed

trial courts’ discretion to adopt alternative, more lenient violation-counting approaches. Those decisions

did not prohibit trial courts from counting “additional

violations” under a per-communication approach. E.g.,

15

Morse, 21 Cal. App. 4th at 274 n.26 (rejecting a reading of the case law similar to the one advanced by petitioners before this Court). 7

Petitioners cite only one decision rejecting a percommunication approach, but it is inapplicable to the

circumstances here. See Pet. App. 90a-91a. In People

v. Superior Court (Olson), 96 Cal. App. 3d 181, 185

(1979), the defendant published a false advertisement

in several newspapers with a circulation greater than

one million, thereby authorizing aggregate penalties

“in excess of two and a half billion dollars” under a percommunication approach, id. at 197. In the court’s

view, the defendant’s conduct was not sufficiently culpable to justify such a large award under the “the due

process prohibition against ‘oppressive’ or ‘unreasonable’ statutory penalties.” Id. at 198. The court thus

construed the relevant statute to require a different

method for counting violations when the per-communication approach would authorize an unconstitutionally excessive award. Id.; see Morse, 21 Cal. App. 4th

at 273-274. Here, “unlike . . . in Olson,” petitioners

disseminated numerous distinct types of deceptive

7 See also People v. Overstock.com, Inc., 12 Cal. App. 5th 1064,

1087 (2017) (affirming trial court’s decision to assess penalties

based on “the number of days” that the defendant’s misrepresentations appeared online, without addressing whether the court

could have instead applied a per-communication approach); People v. JTH Tax, Inc., 212 Cal. App. 4th 1219, 1255 (2013) (affirming decision to base aggregate violations on estimated readership

or viewership of misleading print and television advertisements,

without addressing whether the trial court could have instead

used total “circulation numbers”); see id. at 1252-1255; People v.

Toomey, 157 Cal. App. 3d 1, 22 (1984) (affirming calculation

based on estimate of sales triggered by misleading communications, without addressing whether the trial court could have

instead applied a per-communication approach); People v. Witzerman, 29 Cal. App. 3d 169, 180 (1972) (similar).

16

marketing materials to thousands of consumers over

a nearly 20-year period. Pet. App. 91a; see supra pp. 47. Petitioners do not (and could not) contend that the

total award authorized by the per-communication approach applied below is unconstitutionally excessive.

Petitioners also argue that the State’s false advertising statutes “unequivocally” required the trial court

to quantify and exclude from the aggregate violation

count any misleading communications that went

unread by doctors and patients, such as sales

brochures and other materials that were “thr[own]

away” or “not hand[ed] out or distribute[d]” after petitioners sent them to hospitals or sales representatives.

Pet. 25, 27 (internal quotation marks omitted). But

California courts have consistently rejected such arguments, see, e.g., Morse, 21 Cal. App. 4th at 272-274,

which would allow an advertiser to escape liability for

(among other things) mailing out thousands of

misleading solicitations unless a trial court could

somehow quantify and discount the number treated as

“junk mail” and thrown away before being read, id. at

274 n.25.

Requiring “individualized proof” that

consumers read, viewed, or otherwise received each

deceptive statement would “be ‘so onerous as to undermine the [statutes’] effectiveness . . . as an enforcement tool.’” People v. JTH Tax, Inc., 212 Cal. App. 4th

1219, 1254 (2013); see Dollar Rent-A-Car Sys., 211 Cal.

App. 3d at 131; Pet. App. 40a, 222a.

And even if there were some ambiguity or tension

in the relevant statutes and precedent, that would not

suffice to create a fair notice problem. The Due Process Clause bars enforcement of certain statutes lacking any “ascertainable standard[]” whatsoever. Cameron v. Johnson, 390 U.S. 611, 615 (1968); see, e.g.,

Giaccio v. Pennsylvania, 382 U.S. 399, 403 (1966).

17

“[P]erfect clarity and precise guidance have never

been required.” United States v. Williams, 553 U.S.

285, 304 (2008) (internal quotation marks omitted); cf.

Sessions v. Dimaya, 138 S. Ct. 1204, 1232 (2018) (Gorsuch, J., concurring in part and concurring in the judgment).

Finally, petitioners raise several objections to how

the State’s expert calculated statutory violations. Pet.

26-28; see id. at 26, 27 (criticizing the expert’s “extrapolat[ion] from a single sales representative’s testimony” and “estimate[] . . . of hospital newsletters”).

Those objections relate to state-law evidentiary issues.

As discussed above, supra p. 6, the trial court credited

the expert’s “methodology, extrapolations, estimates

and calculation[s].” Pet. App. 224a. And the Court of

Appeal rejected petitioners’ state-law challenges to

the trial court’s evidentiary findings—in part because

petitioners “never suggested a method to discount the

expert’s calculation.” Id. at 92a n.18; see supra pp. 910. Petitioners’ dissatisfaction with those rulings does

not provide a basis for plenary review in this Court.

2. Petitioners also contend that the Court should

grant certiorari to clarify “what due process strictures

apply to state statutes that . . . [authorize] civil penalties,” Pet. 19, and to address a host of concerns with

unfair and deceptive acts and practices (UDAP) laws

across the country, id. at 29. This case is not a suitable

vehicle for addressing those issues.

a. Whether the fair-notice standard that applies to

statutes with “civil penalties at stake” is characterized

as “robust” or not, Pet. i, petitioners’ due process argument would fail. The relevant statutory text and state

precedent provided ample notice to petitioners that

each of their many deceptive marketing communications violated the law. Supra pp. 13-17. And this

18

Court is generally loathe to grant review of issues that

would have no impact on “the ultimate outcome of the

case.” Supreme Court Practice, supra, § 4.4(f), p. 4-18.

The Court also generally denies certiorari where,

as here, the decision below contains no reasoned

discussion of the relevant issues. Cf. Manuel v. City of

Joliet, 137 S. Ct. 911, 922 (2017) (this Court is “a court

of review, not of first view”) (internal quotation marks

omitted). Because the due process argument that

petitioners now seek to present was not properly

advanced below, supra pp. 12-13 & n.6, the California

Court of Appeal had no occasion to address the appropriate “degree of fair notice scrutiny” when evaluating

that argument, Pet. 18. As for the due process arguments that petitioners did raise below—such as their

contention that they lacked fair notice that the aggregate penalty award might exceed $300 million, supra

p. 10 & n.4—the Court of Appeal agreed with the State

that such arguments failed under any standard of

scrutiny. See Pet. App. 96a-99a; C.A. Respondent’s Br.

66-67. So there was no need for the lower court to consider whether the appropriate form of vagueness scrutiny would be “robust” or comparatively “weak.” Pet.

17, 19.

In any event, petitioners misunderstand this

Court’s fair-notice precedent. Petitioners contend that

the “degree of fair notice scrutiny applicable to” civil

penalty regimes (as opposed to criminal laws) “remains a critical open question” under this Court’s

cases. Pet. 18. While the Court has, at times,

suggested that “the Constitution tolerates” a greater

“degree of vagueness” in civil rather than criminal

statutes, e.g., Village of Hoffman Estates v. Flipside,

Hoffman Estates, Inc., 455 U.S. 489, 498 (1982), the

standard it has applied in both contexts is remarkably

19

similar, compare A.B. Small Co. v. Am. Sugar Ref. Co.,

267 U.S. 233, 238-239 (1925) (asking whether civil

statute prescribed “a rule or standard which was so

vague and indefinite that no one could know what it

was”), with Williams, 553 U.S. at 304 (asking whether

criminal statute provided “person[s] of ordinary intelligence a reasonable opportunity to know what is prohibited”). Similarly, it is not at all clear that the

“‘greater leeway’” afforded to civil statutes in the

decades-old state appellate decisions collected by petitioners (Pet. 19-20) made any difference to the outcome of those cases. The analysis in those decisions

suggests, to the contrary, that the relevant statutory

language was sufficiently clear to withstand even a

“robust” form of vagueness scrutiny. See, e.g, Scott v.

Ass’n for Childbirth at Home, Int’l, 88 Ill. 2d 279, 289

(1981) (rejecting vagueness challenge on the ground

that “words [such] as ‘deception,’ ‘false pretense,’ ‘misrepresentation,’ and ‘fraud’ . . . are words commonly

used and understood by the general public and by

businessmen”). 8

b. Petitioners’ final argument for certiorari is that

the supposed vagueness of UDAP statutes—which

have been adopted by 49 of 50 States—presents a “serious nationwide problem.” Pet. 29; see id. at 29-39.

Of course, the only question on which this Court could

grant plenary review concerns the terms of California’s statutes. And for the reasons explained above,

supra pp. 13-17, California’s prohibition of “any . . .

8 See also State ex rel. Nixon v. Telco Directory Publ’g, 863 S.W.2d

596, 600 (Mo. 1993) (similar); Mother & Unborn Baby Care of N.

Tex., Inc. v. State, 749 S.W.2d 533, 541 (Tex. App. 1988) (similar);

Dep’t of Legal Affs. v. Rogers, 329 So. 2d 257, 264-265 (Fla. 1976)

(similar); State v. Ralph Williams’ Nw. Chrysler Plymouth, Inc.,

82 Wash. 2d 265, 279 (1973) (similar).

20

untrue or misleading” advertising is not impermissibly vague. Cal. Bus. & Prof. Code §§ 17200, 17500.

Nor do California’s false advertising statutes

contain all of the features that petitioners consider

problematic in statutes in other States. Indeed, petitioners repeatedly acknowledge as much. 9 If petitioners have concerns about statutes in other States, they

should raise those concerns with the Legislatures of

those States or litigate them in a case arising from one

of those States. See, e.g., Pet. 32-33, 37 (discussing

litigation arising out of Mississippi, Hawaii, and

South Carolina).

Petitioners are correct that California’s false

advertising statutes are similar to other States’ laws

in that they do not impose all “elements of a tort claim.”

Pet. 33. But that does not make such laws unconstitutionally vague. And there are compelling policy

reasons for a false advertising statute to deviate from

traditional tort principles. “The common law of tort

placed significant barriers in the path of a consumer

who had been misled by a seller,” imposing requirements of scienter and reliance that were “difficult” and

“expensive” for injured purchasers to prove. Pridgen

& Alderman, Consumer Protection and the Law §§ 1:1,

2:11 (2022-2023 ed.); see id. § 2:5. The predictable

See Pet. 35 (noting that “California does not follow th[e]

approach” of allowing the “private plaintiffs’ bar” to “develop the

theories of liability . . . and then litigate the state’s enforcement

action in exchange for a contingency fee”) (internal quotation

marks omitted); id. at 29 (discussing state statutes with “[b]road,

flexible prohibitions of unfair and deceptive practices,” rather

than specific prohibitions of untrue and misleading advertising)

(internal quotation marks omitted); id. at 32 (discussing state

statutes that, unlike those at issue here, authorize penalties of

up to $50,000 per violation).

9

21

result was that “fraudulent advertising was everywhere countenanced,” Hess, History and Present Status of the “Truth-in-Advertising” Movement, 101 Annals Am. Acad. Pol. & Soc. Sci. 211, 211 (1922),

making “purchase . . . a game of chance,” Hamilton,

The Ancient Maxim Caveat Emptor, 40 Yale L.J. 1133,

1187 (1931). To protect consumers, as well as honest

businesses frustrated by their inability to distinguish

themselves from unscrupulous competitors, dozens of

States enacted laws prohibiting “advertising contain[ing] any untrue, deceptive, or misleading . . . representation.” Petty, The Historic Development of Modern U.S. Advertising Regulation, 7 J. of Hist. Rsch. in

Marketing 524, 530 (2015) (internal quotation marks

omitted); see id. at 530-531. Petitioners provide no

sound basis to second-guess that state-level policy consensus—and no legal argument that would justify plenary review by the Court in this case.

22

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted,

ROB B ONTA

Attorney General of California

MICHAEL J. MONGAN

Solicitor General

NICKLAS A. AKERS

Senior Assistant Attorney General

SAMUEL T. HARBOURT

Deputy Solicitor General

JON F. WORM

TINA CHAROENPONG

Supervising Deputy

Attorneys General

ADELINA ACUÑA

MONICA J. ZI

GABRIEL SCHAEFFER

DANIEL O SBORN

Deputy Attorneys General

January 17, 2023