Amicus Curiae Brief — Bristol-Myers Squibb Co., et al., Petitioners v. Clare E. Connors, Attorney General of Hawaii

No. 20-1149

In the Supreme Court of the United States

BRISTOL-MYERS SQUIBB CO., ET AL., PETITIONERS

v.

CLARE E. CONNORS, ATTORNEY GENERAL OF HAWAII

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

BRIEF OF THE PHARMACEUTICAL RESEARCH AND

MANUFACTURERS OF AMERICA AND THE CHAMBER OF

COMMERCE OF THE UNITED STATES OF AMERICA AS

AMICI CURIAE IN SUPPORT OF PETITIONERS

JAMES C. STANSEL

MELISSA B. KIMMEL

PHARMACEUTICAL RESEARCH

AND MANUFACTURERS

OF AMERICA

950 F Street, NW

Suite 300

Washington, DC 20004

DOUGLAS HALLWARD-DRIEMEIER

Counsel of Record

CHIMSO OKOJI

ROPES & GRAY LLP

2099 Pennsylvania Avenue, NW

Washington, DC 20006

(202) 508-4600

Douglas.Hallward-Driemeier

@ropesgray.com

TARA S. MORRISSEY

JENNIFER B. DICKEY

U.S. CHAMBER LITIGATION

CENTER

1615 H Street, NW

Washington, DC 20062

SAMUEL POKROSS

ROPES & GRAY LLP

Prudential Tower

800 Boylston St.

Boston, MA 02199

TABLE OF CONTENTS

Page

Interest of amici curiae .................................................... 1

Summary of the argument .............................................. 3

Argument:

I.

The court of appeals’ opinion erodes a

defendant’s right to obtain federal judicial

review of important questions of federal law,

including federal constitutional rights ................. 4

II. There is an urgent need for this Court’s review,

in light of the increasing prevalence of largely

unsupervised enforcement cases being brought

by private lawyers in the name of states ........... 16

Conclusion........................................................................ 21

(I)

II

TABLE OF AUTHORITIES

Page(s)

Cases:

American Bankers Mgmt. Co. v. Heryford, 885

F.3d 629 (9th Cir. 2018)......................................... 19

Bouie v. City of Columbia, 378 U.S. 347 (1964) ........ 9

Buckman Co. v. Plaintiffs’ Legal Comm., 531

U.S. 341 (2001)........................................................ 15

City of Oakland v. BP PLC, 960 F.3d 570 (9th

Cir. 2020), amended by 969 F.3d 895 (9th Cir.

2020)......................................................................... 18

City of Seattle v. Monsanto Co., 387 F. Supp. 3d

1141 (W.D. Wash. 2019) ........................................ 17

Commonwealth v. Janssen Pharms., Inc., 8 A.3d

267 (Pa. 2010).......................................................... 19

Consol Buchanan Mining Co. v. Sec’y of Lab.,

841 F.3d 642 (4th Cir. 2016).................................. 10

County of Santa Clara v. Superior Court, 235

P.3d 21 (Cal. 2010), cert. denied, 131 S. Ct. 920

(2011) ....................................................................... 17

Effler v. Purdue Pharma L.P., 614 S.W.3d 681

(Tenn. 2020) ............................................................ 18

England v. La. State Bd. of Med. Exam’rs, 375

U.S. 411 (1964)...................................................... 4, 5

Expressions Hair Design v. Schneiderman, 137

S. Ct. 1144 (2017) ................................................... 14

Exxon Mobil Corp. v. Allapattah Servs., Inc.,

545 U.S. 546 (2005)................................................. 11

III

Cases—Continued:

Page(s)

Green v. Mansour, 474 U.S. 64 (1985) ........................ 5

Huffman v. Pursue, Ltd., 420 U.S. 592 (1975) ........ 14

Hughes Aircraft Co. v. United States ex rel.

Schumer, 520 U.S. 939 (1997)................................. 8

Johnson v. Mississippi, 421 U.S. 213 (1975)............ 11

Knick v. Township of Scott, 139 S. Ct. 2162

(2019) ....................................................................... 11

Liparota v. United States, 471 U.S. 419 (1985) ......... 9

Michigan v. Harvey, 494 U.S. 344 (1990) ................... 9

Middlesex Cnty. Ethics Comm. v. Garden

State Bar Ass’n, 457 U.S. 423 (1982)..................... 7

National Ass’n of Wheat Growers v. Becerra,

No. 17-cv-2401, 2020 WL 3412732 (E.D. Cal.

June 22, 2020) ......................................................... 14

Nessel v. 3M Co., No. 20-03366-NZ (Mich. Cir.

Ct. for 17th Jud. Cir. Jan. 14, 2020) ..................... 17

Nike, Inc. v. Kasky, 539 U.S. 654 (2003) .................. 19

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

No. CV-12-1058 (Ark. Mar. 20, 2014) .................. 20

Paypal, Inc. v. Consumer Fin. Prot. Bureau,

No. 1:19-cv-03700, 2020 WL 7773392

(D.D.C. Dec. 30, 2020) ........................................... 13

Pennhurst State Sch. & Hosp. v. Halderman,

465 U.S. 89 (1984)..................................................... 5

Pharmaceutical Rsch. & Mfrs. of Am. v.

David, No. 2:17-cv-02573, 2021 WL 22473

(E.D. Cal. Jan. 4, 2021) .......................................... 20

IV

Cases—Continued:

Page(s)

Sorrell v. IMS Health Inc., 564 U.S. 552

(2011) ........................................................... 11, 12, 20

Sprint Commc’ns Inc. v. Jacobs, 571 U.S. 69

(2013) .............................................................. passim

State v. Actavis Pharma, Inc., 167 A.3d 1277

(N.H. 2017), cert. denied, 138 S. Ct. 1261

(2018) ....................................................................... 18

State ex rel. Discover Fin. Servs., Inc. v. Nibert,

744 S.E.2d 625 (W. Va. 2013) ............................... 19

State ex rel. Hunter v. Purdue Pharma L.P.,

No. CJ-2017-816, 2019 WL 9241510 (Okla.

Dist. Ct. Nov. 15, 2019) ......................................... 20

United Mine Workers of Am. v. Gibbs, 383 U.S.

715 (1966) ................................................................ 11

United States v. Harriss, 347 U.S. 612 (1954) ......... 10

Wyeth v. Levine, 555 U.S. 555 (2009) ........................ 15

Young v. United States ex rel. Vuitton et Fils

S.A., 481 U.S. 787 (1987) ......................................... 9

Ex parte Young, 209 U.S. 123 (1908) .................. 3, 4, 5

Younger v. Harris, 401 U.S. 37 (1971) ............. passim

Constitutional provisions and statutes:

U.S. Cont. Amend. I ........................................... passim

21 U.S.C. 352(a) ........................................................... 15

21 U.S.C. 337(a) ............................................................ 15

Tennessee Drug Dealer Liability Act, Tenn.

Code Ann. § 29-38-101 to -116 .............................. 18

V

Miscellaneous:

Richard O. Faulk & John S. Gray, Alchemy in

the Courtroom? The Transmutation of

Public Nuisance Litigation, 2007 Mich. St. L.

Rev. 941 (2007) ....................................................... 17

Ariel Gilreath, Greenville County Schools to File

Lawsuit Against Juul, Maker of ECigarettes, Greenville News (Dec. 10, 2020),

https://tinyurl.com/2npnxa36 ............................... 17

Glenn N. Levine et al., 2016 ACC/AHA

Guideline Focused Update on Duration of

Dual Antiplatelet Therapy in Patients with

Coronary Artery Disease, 68 J. Am. Coll.

Cardiology 1082 (2016) .......................................... 13

Yukio Ozaki et al., CVIT Expert Consensus

Document on Primary Percutaneous

Coronary Intervention (PCI) for Acute

Myocardial Infarction (AMI) in 2018, 33

Cardiovascular Intervention & Therapeutics

178 (2018) ................................................................ 12

Martin H. Redish, Private Contingent Fee

Lawyers and Public Power: Constitutional

and Political Implications, 18 Sup. Ct. Econ.

Rev. 77 (2010) ......................................................... 17

In the Supreme Court of the United States

NO. 20-1149

BRISTOL-MYERS SQUIBB CO., ET AL., PETITIONERS

v.

CLARE E. CONNORS, ATTORNEY GENERAL OF HAWAII

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

BRIEF OF THE PHARMACEUTICAL RESEARCH AND

MANUFACTURERS OF AMERICA AND THE CHAMBER OF

COMMERCE OF THE UNITED STATES OF AMERICA AS

AMICI CURIAE IN SUPPORT OF PETITIONERS

INTEREST OF AMICI CURIAE 1

The Pharmaceutical Research and Manufacturers of

America (PhRMA) is a voluntary, non-profit association

that represents the nation’s leading biopharmaceutical

and biotechnology companies. PhRMA’s mission is to

advocate for public policies that encourage the discovery

of life-saving and life-enhancing medicines. PhRMA’s

members invest billions of dollars each year to research

1

Pursuant to Rule 37.2(a), counsel for all parties received

timely notice of amici’s intent to file this brief, and consented in

writing. No counsel for any party authored this brief in any part,

and no person or entity other than amici, amici’s members, or amici’s

counsel made a monetary contribution to fund its preparation or

submission.

(1)

2

and develop new drugs, more than 500 of which have

been approved by the U.S. Food and Drug Administration (FDA) since 2000.

The Chamber of Commerce of the United States of

America (Chamber) is the world’s largest business federation. It represents approximately 300,000 direct

members and indirectly represents the interests of more

than 3 million companies and professional organizations

of every size, in every industry sector, and from every

region of the country. An important function of the

Chamber is to represent the interests of its members in

matters before Congress, the Executive Branch, and the

courts. To that end, the Chamber regularly files amicus

curiae briefs in cases that raise issues of concern to the

nation’s business community. The Chamber has an interest in ensuring that its members are afforded a neutral federal tribunal in which to vindicate federal rights

that are impinged by state governmental entities.

PhRMA and the Chamber have a strong interest in

this case because their members are increasingly the

targets of suits by private counsel purporting to act in

the name of the state. In addition, PhRMA and the

Chamber have a substantial interest in ensuring that the

courts fully protect companies’ federal rights, including

important First Amendment interests regarding scientific information in the healthcare context.

Amici therefore respectfully urge this Court to

grant the petition for a writ of certiorari and reverse the

ruling of the court of appeals.

3

SUMMARY OF THE ARGUMENT

This Court has repeatedly recognized that federal

courts have a “virtually unflagging” obligation to exercise the jurisdiction Congress has conferred, Sprint

Commc’ns Inc. v. Jacobs, 571 U.S. 69, 77 (2013) (quoting

Colorado River Water Conservation Dist. v. United

States, 424 U.S. 800, 817 (1976)), including with respect

to challenges to conduct by state actors that would subvert federally protected rights, see Ex parte Young, 209

U.S. 123, 160 (1908). In the decision below, the Ninth

Circuit adopted just the type of broad view of abstention

under Younger v. Harris, 401 U.S. 37 (1971), that this

Court rejected in Sprint. If allowed to stand, the decision will undermine critical federal oversight of state

conduct that implicates important federal interests, including by infringing federally protected constitutional

rights. The court of appeals’ opinion would permit private counsel, purportedly acting on behalf of state enforcement authorities, to violate defendants’ federal

rights with little or no federal judicial oversight—such

as, in this case, by imposing staggering liability on

speech that is protected by the First Amendment.

The instant case demonstrates the risks of a broad

application of Younger abstention. Here, private attorneys, with no regulatory authority or expertise, used the

name of the state to convince a state court to dictate the

content of scientific speech, and to do so in a way that

contradicts the expert judgment of federal regulators.

Without question, had a state agency issued a regulation

purporting to require petitioners to make scientifically

unsubstantiated statements about their products, petitioners would have had a right to a federal forum in

which to challenge that mandate. The fact that the state

4

chose instead to impose a similar mandate through litigation by self-interested counsel should not make the

state’s conduct any less subject to federal review. Yet

the court of appeals’ opinion does just that—providing a

contingency-fee lawyer with greater immunity from federal judicial scrutiny for compelled speech than state officials proceeding by regulation would enjoy. The ruling

below will only exacerbate the increasing trend in which

state attorneys general lend their names to creative private lawyers who bring actions “on behalf of” a state,

with little to no oversight by those state actors with true

regulatory expertise and authority.

Review is necessary to reaffirm the “primacy of the

federal judiciary in deciding questions of federal law,”

England v. La. State Bd. of Med. Exam’rs, 375 U.S. 411,

415-416 (1964), and the duty of federal courts to decide

cases within their jurisdiction, Sprint, 571 U.S. at 77.

This Court should grant the writ and reverse, in order

to ensure that parties with valid federal claims against

state actors have access to a federal forum.

ARGUMENT

I.

THE COURT OF APPEALS’ OPINION ERODES A DEFENDANT’ S R IGHT T O O BTAIN F EDERAL J UDICIAL

REVIEW OF IMPORTANT QUESTIONS OF FEDERAL

LAW, INCLUDING FEDERAL CONSTITUTIONAL

RIGHTS

In Ex parte Young, this Court established that federal courts are available to hear challenges to conduct by

state actors that would subvert a party’s federal rights.

209 U.S. 123, 160 (1908). Since then, this Court’s decisions have repeatedly emphasized that the Ex parte

Young doctrine rests on the need to “vindicat[e] federal

5

rights” and to “hold state officials responsible to the supreme authority of the United States.” Pennhurst State

Sch. & Hosp. v. Halderman, 465 U.S. 89, 105 (1984) (citation omitted); see also Green v. Mansour, 474 U.S. 64,

68 (1985) (explaining that Ex parte Young furthers the

federal interest in vindicating federal law). The Ninth

Circuit, in adopting an expansive conception of abstention under Younger v. Harris, 401 U.S. 37 (1971), declined to fulfill its “virtually unflagging” obligation to

vindicate federal rights and decide questions of federal

law, despite this Court’s clear direction in Sprint Communications Inc. v. Jacobs that “only exceptional circumstances * * * justify a federal court’s refusal to decide a case in deference to the States.” 571 U.S. 69, 7778 (2013) (quoting Colorado River Water Conservation

Dist. v. United States, 424 U.S. 800, 817 (1976), New Orleans Pub. Serv., Inc. v. Council of City of New Orleans,

491 U.S. 350, 368 (1989)). As the Court has recognized,

“[t]here are fundamental objections to any conclusion

that a litigant who has properly invoked the jurisdiction

of a Federal District Court to consider federal constitutional claims can be compelled, without his consent and

through no fault of his own, to accept instead a state

court’s determination of those claims.” England v. La.

State Bd. of Med. Exam’rs, 375 U.S. 411, 415 (1964). In

the decision below, the court of appeals contravened this

established precedent by permitting private, self-interested counsel, acting in the name of the state, to violate

petitioners’ federal rights without meaningful federal

review.

As discussed below, see pp. 6-15, infra, this case well

demonstrates the dangers of the Ninth Circuit’s overbroad application of Younger abstention. Not only did

the court of appeals abstain from vindicating petitioners’

6

federal rights, but it ignored other federal interests, including those of FDA. The court’s decision allows private attorneys to dictate the content of scientific speech

in a way that contradicts the expert judgment of federal

regulators and violates federal law.

A. The court of appeals misapplied this Court’s precedent regarding Younger abstention, and thus foreclosed a federal judicial forum to vindicate a defendant’s

federal constitutional rights. In Sprint, the Court offered a forceful reminder of the long-standing principle

that “federal courts ordinarily should entertain and resolve on the merits an action within the scope of a jurisdictional grant, and should not ‘refus[e] to decide a case

in deference to the States.’ ” 571 U.S. at 72 (quoting New

Orleans Pub. Serv., 491 U.S. at 368). This is because federal courts have an “obligation to hear and decide a

case,” and “[p]arallel state-court proceedings do not detract from that obligation.” Id. at 77 (quoting Colorado

River Water Conservation Dist., 424 U.S. at 817). The

Court in Sprint reaffirmed that, pursuant to Younger

and its progeny, only three “exceptional circumstances *

* * justify a federal court’s refusal to decide a case in deference to the States”: (1) intrusion into ongoing state

criminal prosecutions, (2) interference with certain

“quasi-criminal” civil enforcement proceedings, and (3)

state civil proceedings involving orders in furtherance of

state courts’ judicial function. Id. at 77-78.

As relevant here, the Court in Sprint provided that

the only “civil enforcement proceedings” that come

within Younger’s scope are those “ ‘akin to a criminal

prosecution’ in ‘important respects.’ ” Sprint, 571 U.S. at

73, 79 (citations omitted). Further, the Court provided

7

criteria to determine whether particular proceedings

were sufficiently akin to criminal prosecution:

Such enforcement actions are characteristically initiated to sanction the federal plaintiffs,

i.e., the party challenging the state action, for

some wrongful act. In cases of this genre, a

state actor is routinely a party to the state proceeding and often initiates the action. Investigations are commonly involved, often culminating in the filing of a formal complaint or

charges.

Id. at 79-80 (citations omitted).

Instead of examining these factors, the court below

summarily decreed that “[w]hat matters for Younger abstention is whether the state proceeding falls within the

general class of quasi-criminal enforcement actions—not

whether the proceeding satisfies specific factual criteria.” Pet. App. 7a. As detailed in the Petition, that approach is contrary to that of every court of appeals to

consider whether to abstain in favor of ongoing civil enforcement proceedings since the Sprint decision. Moreover, the court’s approach effectively would resuscitate

the broad-based exceptions based on Middlesex County

Ethics Committee v. Garden State Bar Association, 457

U.S. 423 (1982), that the Court repudiated in Sprint.

The court below failed to apply the factors set forth

in Sprint, and in so doing, improperly denied federal review of petitioners’ claim that the state is infringing

their federal rights. The underlying case exemplifies

what the Court sought to avoid by reiterating the narrow and exceptional grounds for Younger abstention.

Applying the factors, it is evident that Hawai`i did not

8

“initiate” the Unfair or Deceptive Acts or Practices

(UDAP) action in the traditional sense; rather, private

counsel developed the claims prior to approaching the

attorney general to bring the action on behalf of the

state. This alone could serve as a sufficient reason to find

Younger abstention inapplicable. While the court of appeals “s[aw] no reason why the application of Younger

should turn on the State’s choice of lawyers,” Pet. App.

5a, a state actor’s blessing of a suit conceived by private

attorneys seeking a personal payday is a far cry from a

considered determination by a state official, based on

thorough investigation by the state, to initiate an enforcement action, and does not warrant the “exceptional” step of declining to exercise jurisdiction under

Younger.

This Court has previously recognized the import of

the disparate incentives motivating private counsel. In

Hughes Aircraft Co. v. United States ex rel. Schumer,

the Court held, in the context of the False Claims Act,

that expanding the class of persons authorized to initiate

suit to include private persons acting as qui tam relators

was “not insignificant,” and amounted to “a new cause of

action, not just an increased likelihood that an existing

cause of action will be pursued.” 520 U.S. 939, 949-950

(1997). As the Court explained, “[a]s a class of plaintiffs,

qui tam relators are different in kind than the Government. They are motivated primarily by prospects of

monetary reward rather than the public good.” Id. at 949

(emphasis added). Just as the monetary incentives rendered qui tam relators different in kind, here, the private lawyers hired by the state pursuant to contingencyfee arrangements are different in kind for purposes of

assessing whether Younger abstention is appropriate.

9

As for the second Sprint factor, there is no dispute

that the initial “investigation” was also conducted by private lawyers, not the state. This fact confirms that, from

its very origins, the lawsuit diverged in material respects from a criminal proceeding. Prosecutors typically

exercise “considerable discretion in matters such as the

determination of which persons should be targets of investigation, what methods of investigation should be

used, what information will be sought as evidence, [and]

which persons should be charged with what offenses.”

Young v. United States ex rel. Vuitton et Fils S.A., 481

U.S. 787, 807 (1987). In criminal cases, “prosecutorial investigation will have been completed prior to the filing

of the accusatory instrument.” Michigan v. Harvey, 494

U.S. 344, 365 n.9 (1990) (citing ABA Standards for Criminal Justice 3–3.9(a), 11-43 (2d ed. 1980)). Here, by contrast, the state itself conducted no investigation or inquiry with respect to Plavix, further undermining application of Younger’s narrow exception to exercising federal court jurisdiction.

Finally, the alleged “wrongdoing” at issue further

removes this case from the type of “quasi-criminal proceeding” to which Younger abstention applies. By definition, the prosecution of criminal wrongdoing involves

the violation of clear standards of conduct. It is a hallmark of criminal law that “a criminal statute must give

fair warning of the conduct that it makes a crime.” Bouie

v. City of Columbia, 378 U.S. 347, 350-351 (1964); see

also Liparota v. United States, 471 U.S. 419, 427 (1985)

(“[T]he rule of lenity ensures that criminal statutes will

provide fair warning concerning conduct rendered illegal.”); United States v. Harriss, 347 U.S. 612, 617 (1954)

(“The underlying principle is that no man shall be held

criminally responsible for conduct which he could not

10

reasonably understand to be proscribed.”). The same is

true of “quasi-criminal” civil penalties; courts have “long

recognized that parties subject to * * * administrative

sanctions are entitled to . . . clear notice of what conduct

is proscribed by a regulation before being subject to

monetary penalties for a particular violation.” Consol

Buchanan Mining Co. v. Sec’y of Lab., 841 F.3d 642, 648649 (4th Cir. 2016) (citation and internal quotation marks

omitted), as amended (Nov. 23, 2016). If Hawai`i had

provided clear advance notice to petitioners that state

law mandated that their product packaging include scientifically dubious self-criticism of their product, petitioners would have been entitled to bring suit in federal

court to challenge that mandate. See pp. 13-14, infra.

Here, by contrast, petitioners are accused only of violating the highly general provisions of a state proscription

against “unfair or deceptive acts or practices,” which

gave petitioners no notice that they were required to

provide a warning in their labeling regarding a scientific

hypothesis that was the subject of significant scientific

debate. Younger recognizes the state’s important sovereign interest in enforcing its criminal laws against

wrongdoing without undue federal interference. Those

interests are much diminished and the balance shifts in

favor of federal review, however, when the law at issue

is a vague civil standard that can be applied in ways that

raise serious due process and First Amendment issues,

as illustrated by this case.

B. Beyond its failure to follow this Court’s guidance

in Sprint, the Ninth Circuit’s decision also more broadly

runs counter to this Court’s long-standing jurisprudence

stressing the importance of a federal judicial forum to

hear certain federal claims. The Court has stressed that,

“[i]n order to provide a federal forum for plaintiffs who

11

seek to vindicate federal rights, Congress has conferred

on the district courts original jurisdiction in federalquestion cases—civil actions that arise under the Constitution, laws, or treaties of the United States.” Exxon

Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 552

(2005) (citing 28 U.S.C. 1331). And, in order to ensure

that parties can fully avail themselves of that federal forum, the Court construed federal question removal to

encompass as well supplemental jurisdiction over related state claims to allow “federal courts to hear the

whole” case. United Mine Workers of Am. v. Gibbs, 383

U.S. 715, 725 (1966); see also Johnson v. Mississippi, 421

U.S. 213, 219 (1975) (allowing for removal of actions to

federal court when a defendant cannot enforce civil

rights claims in state court); cf. Knick v. Township of

Scott, 139 S. Ct. 2162, 2167 (2019) (reversing precedent

that made the statutory “guarantee of a federal forum

ring[] hollow” where, in practice, plaintiffs were forced

to litigate federal claims in state court). The decision below cuts against this Court’s jurisprudence, foreclosing

federal judicial review of an important claim of federal

law.

1. The decision below would shield from federal review broad categories of state actions that infringe important federal rights, including under the First Amendment, that could otherwise be adjudicated in federal

court. The facts of this case are emblematic. This Court

has stressed that the “First Amendment requires

heightened scrutiny whenever the government creates

‘a regulation of speech because of disagreement with the

message it conveys.’ ” Sorrell v. IMS Health Inc., 564

U.S. 552, 566 (2011) (quoting Ward v. Rock Against Racism, 491 U.S. 781, 791 (1989)). Such protection is especially vital “in the fields of medicine and public health,

12

where information can save lives.” Ibid. As Sorrell and

this case both demonstrate, First Amendment interests

can be undermined by a state’s exercise of authority under the banner of “consumer protection” laws, and a federal forum should be available to vindicate those rights.

In the underlying state proceeding, private counsel,

in the name of the State of Hawai`i, brought an action

pursuant to the state’s UDAP statute. The complaint

alleges that petitioners should have warned consumers

that the cardiovascular drug Plavix was less effective for

individuals with a genetic variation more common

among Asians and Pacific Islanders, and should have

urged doctors to consider routine genetic testing for that

variation before prescribing the drug. In 2010, FDA did

require a warning on the labeling stating that Plavix had

“diminished effectiveness” in individuals with the relevant genetic variation, and that tests were available to

identify whether a patient possessed the relevant genetic variation. At the time, leading cardiologists and

medical organizations criticized the warning as premature and unsupported, and subsequent studies by the

companies and independent researchers further undercut the findings of diminished effectiveness in individuals with the genetic variation. In 2016, FDA rescinded

the language from the label referring to the link between

genetic traits and clinical outcomes, and subsequent evidence further indicates that Plavix is effective without

regard to genetics, race, or ethnicity. See, e.g., Yukio

Ozaki et al., CVIT Expert Consensus Document on Primary Percutaneous Coronary Intervention (PCI) for

Acute Myocardial Infarction (AMI) in 2018, 33 Cardiovascular Intervention & Therapeutics 178, 182-183

(2018); see also Glenn N. Levine et al., 2016 ACC/AHA

13

Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery

Disease, 68 J. Am. Coll. Cardiology 1082 (2016).

Against this backdrop, private lawyers proposed,

and the state’s attorney general authorized in 2014, a

suit against petitioners under UDAP for deceptive marketing, alleging that they should have disclosed before

the 2010 labeling revision that Plavix had diminished effectiveness for patients with the relevant genetic variation, particularly for patients of Asian or Pacific Islander

descent. In this fashion, the state seeks to impose liability on petitioners for refusing to make self-critical statements about their product that, petitioners contend, conflict with scientific consensus or, at a minimum, remain a

disputed scientific issue. Pet. 9, 21.

The Ninth Circuit’s opinion shielding this dispute

from federal judicial consideration turns logic on its

head. The decision makes state action that lacks any of

the hallmarks of considered state policy immune from

federal judicial review, while far more formalized and

considered state action would be subject to challenge in

federal court. There is no question that, had a state

agency issued a regulation purporting to require petitioners to make the same scientifically dubious statements about their products as respondent seeks to mandate under UDAP, petitioners would have had a right to

a federal forum in which to challenge that regulatory requirement. Indeed, federal court challenges to state

mandated speech are quite common. See, e.g., Paypal,

Inc. v. Consumer Fin. Prot. Bureau, No. 1:19-cv-03700,

2020 WL 7773392 (D.D.C. Dec. 30, 2020) (challenge to

mandated short-form disclosure of fees for digital wallets); National Ass’n of Wheat Growers v. Becerra, No.

14

17-cv-2401, 2020 WL 3412732 (E.D. Cal. June 22, 2020)

(challenge to mandated warning labels for products that

contain a particular herbicide); see also Expressions

Hair Design v. Schneiderman, 137 S. Ct. 1144 (2017)

(federal challenge to law requiring that price differences

between cash and credit be stated in terms of cash discounts rather than credit card surcharges). The court of

appeals’ decision would afford greater immunity from

federal court supervision to a civil claim asserted by private counsel furthering his own pecuniary interests than

would be afforded to formal state regulations adopted by

state officials charged with acting in the public interest.

Nothing in the Constitution’s federal structure or this

Court’s Younger decision requires that counterintuitive

result.

2. The court of appeals’ holding is particularly misguided on the facts of this case, which arises in a context

of federal supremacy—regulation of the sale and marketing of pharmaceuticals. The motivating constitutional principles behind Younger abstention are “comity

and federalism,” Huffman v. Pursue, Ltd., 420 U.S. 592,

610 (1975), and Younger was predicated on “proper respect for [core] functions” of state sovereignty—enforcement of state criminal law, 401 U.S. at 44. Here,

however, the court of appeals applied Younger abstention to allow the state to encroach upon a core area of

federal responsibility.

The decision below displaces FDA’s expert judgment with that of a private lawyer and single state

judge. FDA has exclusive responsibility for reviewing

and approving drug labeling as well as enforcing the federal prohibition on false or misleading labeling. See 21

U.S.C. 352(a), 337(a); see also Wyeth v. Levine, 555 U.S.

15

555, 608 (2009) (“The FDA has underscored the importance it places on drug labels by promulgating comprehensive regulations—spanning an entire part of the

Code of Federal Regulations, * * * that set forth drug

manufacturers’ labeling obligations.”). In the drug approval context, the Court has emphasized that, “[w]here

the FDA determines, in accordance with its statutory

mandate, that a drug is on balance ‘safe,’ our conflict preemption cases prohibit any State from countermanding

that determination.” Wyeth, 555 U.S. at 609; see also

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,

348 (2001) (after FDA has struck “a somewhat delicate

balance of statutory objectives” and determined that petitioner submitted a valid application to manufacture a

medical device, a state may not use common law to negate it).

Critically, here, FDA has exercised active supervision of petitioners’ labeling for Plavix, but in a way that

conflicts with the state’s actions under review. FDA has

not found that petitioners’ prior labeling was false or

misleading in any respect, including with regard to petitioners’ pre-2010 labeling. Moreover, FDA’s removal of

the precise language at issue here in 2016 reflects its

judgment that the warning for which the state lawsuit

would impose civil liability and penalties for omitting

was not warranted.

The holding below thus turns the underlying motivation for Younger abstention upside down. Rather

than shielding a core function of state sovereignty from

federal interference, the decision below would shield

from federal review state interference in an area of federal preeminence.

16

II. THERE IS AN URGENT NEED FOR THIS COURT’S

REVIEW, I N LIGHT O F THE INCREASING PREVALENCE O F L ARGELY U NSUPERVISED E NFORCEMENT C ASES B EING B ROUGHT B Y P RIVATE L AWYERS I N T HE N AME O F S TATES

The underlying lawsuit in this case—brought by private counsel on behalf of Hawai`i under the UDAP statute—exemplifies a trend in state regulatory enforcement, and underscores why this Court’s review of the

question presented is urgently needed. State attorneys

general are increasingly opting for contingency-fee arrangements with private counsel to bring public enforcement actions in numerous areas of consumer protection

law. While a state may generally be free to authorize

private counsel to sue on its behalf, that decision remains

an important consideration in determining whether a

particular civil enforcement proceeding is akin to a criminal prosecution that implicates Younger abstention under the Sprint factors. That is particularly so because

private counsel take no oath to uphold the Constitution.

While a given state official’s actions may infringe on constitutional rights, those actions are generally taken in

light of the official’s understanding of the public interest.

Private attorneys seeking personal remuneration

through litigation are not similarly constrained. As a result, it is all the more likely that private counsel will pursue aggressive theories of liability without regard to defendants’ First Amendment or other constitutional

rights.

A. The opinion below warrants review by this Court

as it broadens Younger abstention in a manner that creates a gaping hole in the availability of federal judicial

17

review at a time when such review is critical. An increasing number of state enforcement actions are being

litigated by private counsel. This “new model for statesponsored litigation that combines the prosecutorial

power of the government with private lawyers aggressively pursuing litigation that could generate hundreds

of millions in contingent fees” has become commonplace.

Richard O. Faulk & John S. Gray, Alchemy in the Courtroom? The Transmutation of Public Nuisance Litigation, 2007 Mich. St. L. Rev. 941, 968 (2007); see also Martin H. Redish, Private Contingent Fee Lawyers and

Public Power: Constitutional and Political Implications, 18 Sup. Ct. Econ. Rev. 77, 80 (2010). In recent

years, the number of state enforcement actions litigated

by private attorneys has skyrocketed, and has expanded

into all corners of state consumer protection enforcement. See, e.g., County of Santa Clara v. Superior

Court, 235 P.3d 21, 25 (Cal. 2010) (using private lawyers

to bring tort lawsuits against lead paint manufacturers),

cert. denied, 131 S. Ct. 920 (2011); City of Seattle v. Monsanto Co., 387 F. Supp. 3d 1141, 1165 (W.D. Wash. 2019)

(using private lawyers to bring water-contamination

claims); Nessel v. 3M Co., No. 20-03366-NZ (Mich. Cir.

Ct. for 17th Jud. Cir. Jan. 14, 2020) (using private lawyers to sue manufacturers and users of per- and

polyfluoroalkyl substances for allegedly contaminating

drinking water with carcinogens); Ariel Gilreath, Greenville County Schools to File Lawsuit Against Juul,

Maker of E-Cigarettes, Greenville News (Dec. 10, 2020),

https://tinyurl.com/2npnxa36 (using contingency-fee attorneys to bring claims against the e-cigarette maker

Juul for deceptive and improper marketing); City of

Oakland v. BP PLC, 960 F.3d 570, 573 (9th Cir. 2020)

(using contingency-fee arrangements in climate-change

18

lawsuits against companies in the fossil fuel industry),

amended by 969 F.3d 895 (9th Cir. 2020); State v. Actavis

Pharma, Inc., 167 A.3d 1277, 1279 (N.H. 2017) (hiring

private lawyers to investigate opioid manufacturers and

commence lawsuits on behalf of the state), cert. denied,

138 S. Ct. 1261 (2018).

The proliferation of these lawsuits by private lawyers on behalf of states and localities has resulted in outsourcing public enforcement of state law away from public officials with subject-matter expertise and obligations to serve the public interest. In one particularly

striking example, seven district attorneys in Tennessee

purported to serve as plaintiffs to authorize a state court

suit conceived by contingency-fee lawyers, alleging that

several pharmaceutical companies’ sale and marketing

of prescription opioid medications to DEA-licensed

wholesalers and retail pharmacies (in amounts authorized by DEA) violated the Tennessee Drug Dealer Liability Act (Drug Dealer Act), Tenn. Code Ann. § 29-38101 to -116. See Effler v. Purdue Pharma L.P., 614

S.W.3d 681, 684 (Tenn. 2020). Although the district attorneys purported to sue on behalf of the political subdivisions they represented, they neither provided notice

to those subdivisions about the lawsuit nor sought their

consent to sue. See id. at 683, 686, 691. Recognizing that

the district attorneys were “not serving as counsel for

any governmental entities, but as plaintiffs with retained counsel,” the Tennessee Supreme Court held that

the district attorneys lacked standing to sue under the

Drug Dealer Act. Id. at 688-691.

B. This trend heightens the risk that private lawyers, with little to no oversight by state actors, will bring

19

public enforcement actions that interfere with defendants’ federal rights, including their First Amendment

rights.

In recent years, states and localities have hired private counsel to bring actions under state UDAP and

other consumer protection laws challenging allegedly

deceptive or false advertising and marketing. See

American Bankers Mgmt. Co. v. Heryford, 885 F.3d 629,

632 (9th Cir. 2018) (suit against credit card servicing

company); see also Commonwealth v. Janssen Pharms.,

Inc., 8 A.3d 267, 268-269 (Pa. 2010) (suit against pharmaceutical company); State ex rel. Discover Fin. Servs., Inc.

v. Nibert, 744 S.E.2d 625, 629 (W. Va. 2013) (suits against

credit card servicing company and pharmaceutical companies). Given the First Amendment interests at stake,

overreach in these lawsuits raises serious concerns.

While state agencies face “legal and practical checks”

that guide their enforcement discretion toward false and

misleading speech that is particularly egregious and

harmful, private lawyers may press the state to bring

lawsuits to challenge speech based on purely financial,

political, or ideological motives. See, e.g., Nike, Inc. v.

Kasky, 539 U.S. 654, 679-680 (2003) (Breyer, J., dissenting from dismissal of writ of certiorari as improvidently

granted) (arguing that a “private false advertising action

brought on behalf of the State, by one who has suffered

no injury, threatens to impose a serious burden upon

speech”).

The number of legal or regulatory actions by states

that are targeting pharmaceutical manufacturers’

speech has increased dramatically in recent years.

These regulatory efforts have spanned a range of subjects, including attempts to limit manufacturers’ access

20

to information about doctors’ prescribing habits, see

Sorrell, 564 U.S. at 557; novel legal theories to target

pharmaceutical marketing, see, e.g., State ex rel. Hunter

v. Purdue Pharma L.P., No. CJ-2017-816, 2019 WL

9241510, at *4, *12 (Okla. Dist. Ct. Nov. 15, 2019) (applying public nuisance law to defendants’ marketing); Ortho-McNeil-Janssen Pharms. Inc. v. State, No. CV-121058 (Ark. Mar. 20, 2014) (applying Medicaid fraud and

unfair trade practices law to promotion of prescription

medications); and attempts to mandate self-critical

statements concerning drug prices, see, e.g., Pharmaceutical Rsch. & Mfrs. of Am. v. David, No. 2:17-cv02573, 2021 WL 22473, at *6-8 (E.D. Cal. Jan. 4, 2021)

(challenging a 2017 California statute mandating manufacturer statements regarding price increases beyond a

state-specified threshold).

The confluence of these trends—increased targeting

by regulators of speech in the healthcare context and increased outsourcing of enforcement decisions to private,

self-interested attorneys—heightens the risk that such

suits by private counsel in the name of the state will impinge upon the First Amendment rights of pharmaceutical manufacturers and other defendants.

The opinion below increases the likelihood that parties seeking to vindicate their federal constitutional

rights will find the doors of the federal courthouse closed

to them. Before a federal court closes its doors to federal

constitutional claims under Younger abstention, it must

ensure that the underlying action implicates the sovereign interests of the state in enforcing its criminal or

quasi-criminal law against wrongdoing, rather than an

effort by private lawyers to commandeer the state’s reg-

21

ulatory authority for personal gain. The court of appeals’ decision, which fails to engage in that essential inquiry, warrants this Court’s review and correction.

CONCLUSION

For the foregoing reasons, and those stated in the

Petition, the Court should grant the writ.

Respectfully submitted,

DOUGLAS HALLWARD-DRIEMEIER

CHIMSO OKOJI

SAMUEL POKROSS

ROPES & GRAY LLP

JAMES C. STANSEL

MELISSA B. KIMMEL

PHARMACEUTICAL RESEARCH AND

MANUFACTURERS OF AMERICA

TARA S. MORRISSEY

JENNIFER B. DICKEY

U.S. CHAMBER LITIGATION CENTER

MARCH 2021