Pharmaceutical Research & Manufacturers of America v. County of Alameda

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PHARMACEUTICAL RESEARCH AND No. 13-16833

MANUFACTURERS OF AMERICA;

GENERIC PHARMACEUTICAL D.C. No.

ASSOCIATION; BIOTECHNOLOGY 3:12-cv-06203-

INDUSTRY ORGANIZATION, RS

Plaintiffs-Appellants,

v. OPINION

COUNTY OF ALAMEDA; ALAMEDA

COUNTY DEPARTMENT OF

ENVIRONMENTAL HEALTH,

Defendants-Appellees.

Appeal from the United States District Court

for the Northern District of California

Richard Seeborg, District Judge, Presiding

Argued and Submitted

July 11, 2014—San Francisco, California

Filed September 30, 2014

Before: N. Randy Smith and Morgan Christen, Circuit

Judges, and Lawrence L. Piersol, Senior District Judge.*

Opinion by Judge N.R. Smith

*

The Honorable Lawrence L. Piersol, Senior District Judge for the U.S.

District Court for the District of South Dakota, sitting by designation.

2 PRMA V. COUNTY OF ALAMEDA

SUMMARY**

Civil Rights/Commerce Clause

The panel affirmed the district court’s summary judgment

and held that Alameda County’s Safe Drug Disposal

Ordinance was constitutional under the Commerce Clause.

The Safe Drug Disposal Ordinance requires any

prescription drug producer who either sells, offers for sale, or

distributes brand name and generic drugs in Alameda County,

to collect and safely dispose of the County’s unwanted

prescription drugs, no matter which manufacturer made the

drug in question.

Plaintiffs, non-profit trade organizations representing the

manufacturers and distributors of pharmaceutical products,

alleged that the Ordinance violates the dormant Commerce

Clause by requiring interstate drug manufacturers to conduct

and pay for Alameda County’s drug disposal program.

The panel first held that the Ordinance neither

discriminates against nor directly regulates interstate

commerce. The panel determined that the Ordinance does not

discriminate on its face and in effect because it applies to all

manufacturers that make their drugs available in Alameda

County—without respect to the geographic location of the

manufacturer. The panel further determined that the

Ordinance does not directly regulate interstate commerce

**

This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

PRMA V. COUNTY OF ALAMEDA 3

because it does not control conduct beyond the boundaries of

the County.

Applying the balancing test set forth in See Pike v. Bruce

Church, Inc., 397 U.S. 137, 142 (1970), the panel could not

say that the Ordinance substantially burdens interstate

commerce, given that plaintiffs provided no evidence that the

Ordinance will affect the interstate flow of goods. The panel

then noted that the Ordinance’s environmental, health, and

safety benefits were not contested for purposes of the cross-

motions for summary judgment and that the Supreme Court

is reluctant to invalidate regulations that touch upon safety.

COUNSEL

Michael Anthony Carvin (argued), Christian G. Vergonis, and

Richard M. Re, Jones Day, Washington, D.C.; Craig Stewart,

Jones Day, San Francisco, California, for Plaintiffs-

Appellants.

Arthur J. Shartsis (argued), Mary Jo Shartsis, and John J.

Stein, Shartsis Friese LLP, San Francisco, California, for

Defendants-Appellees.

Kate Comerford Todd and Tyler R. Green, National Chamber

Litigation Center, Inc., Washington, D.C.; Fred A Rowley, Jr.

and Ellen M. Richmond, Munger, Tolles & Olson LLP, Los

Angeles, California, for Amicus Curiae Chamber of

Commerce of the United States of America.

Richard A Samp and Cory L. Andrews, Washington Legal

Foundation, Washington, D.C., for Amicus Curiae.

4 PRMA V. COUNTY OF ALAMEDA

Orry P. Korb, County Counsel, Danny Y. Chou, Assistant

County Counsel, Greta S. Hansen, Lead Deputy County

Counsel, Marlene M. Dehlinger, Litigation Fellow, Office of

the County Counsel, County of Santa Clara, San Jose,

California, for Amici Curiae California State Association of

Counties and League of California Cities.

Sarah C. Tallman, Natural Resources Defense Council,

Chicago, Illinois; Nancy S. Marks, Natural Resources

Defense Council, New York, New York, for Amicus Curiae

Natural Resources Defense Council.

Kamala D. Harris, Attorney General of California, Sally

Magnani, Senior Assistant Attorney General, Janill L.

Richards, Supervising Deputy Attorney General, Dennis L.

Beck Jr. and M. Elaine Meckenstock, Deputy Attorneys

General, State of California Department of Justice, Office of

the Attorney General, San Francisco, California, for Amicus

Curiae Attorney General Kamala D. Harris.

OPINION

N.R. SMITH, Circuit Judge:

The Supreme Court “has adopted what amounts to a two-

tiered approach to analyzing state economic regulation under

the Commerce Clause.” Brown-Forman Distillers Corp. v.

N.Y. State Liquor Auth., 476 U.S. 573, 578–79 (1986).

[1] When a state statute directly regulates or

discriminates against interstate commerce, or

when its effect is to favor in-state economic

interests over out-of-state interests, [the Court

PRMA V. COUNTY OF ALAMEDA 5

has] generally struck down the statute without

further inquiry.

[2] When, however, a statute has only indirect

effects on interstate commerce and regulates

evenhandedly, [the Court has] examined

whether the State’s interest is legitimate and

whether the burden on interstate commerce

clearly exceeds the local benefits.

Id. at 579 (citations omitted). Because the Alameda County

Safe Drug Disposal Ordinance (the “Ordinance”) passes

constitutional muster under this two-tiered approach, we

affirm the district court.

FACTS

The facts are not in dispute. Alameda County

(“Alameda”) passed the Ordinance in July of 2012. The

Ordinance requires that prescription drug manufacturers, who

either sell, offer for sale, or distribute “Covered Drugs” in

Alameda, operate and finance a “Product Stewardship

Program.” The term “Covered Drug” includes “all drugs in

21 U.S.C. § 321(g)(1) of the Federal Food, Drug and

Cosmetic Act . . . including both brand name and Generic

Drugs.” To operate and finance a Product Stewardship

Program, the manufacturers must provide for the collection,

transportation, and disposal of any unwanted Covered

Drug—no matter which manufacturer made the drug in

question.

Facially, the Ordinance applies equally to both

manufacturers located within Alameda and manufacturers

located outside the county. While some manufacturers have

6 PRMA V. COUNTY OF ALAMEDA

their corporate offices or principal places of business in

Alameda, all prescription drugs currently sold arrive in

Alameda via inter-county or interstate commerce; even drugs

manufactured in Alameda are shipped to other counties for

packaging and then shipped back into Alameda. Alameda

estimates that its total 2010 prescription drug retail sales were

approximately $965 million and neither party asserts that

sales have declined since then.

Pursuant to the Ordinance, manufacturers must set up

disposal kiosk sites throughout Alameda. The kiosks will

consist of disposal bins located in areas “convenient and

adequate to serve the [disposal] needs of Alameda County

residents.” Manufacturers must also promote the stewardship

program to the public via “educational and outreach

materials.” After collection, the prescription drugs must be

destroyed at medical waste facilities.

The manufacturers are free to individually operate

separate product stewardship programs or to jointly operate

a program with one or more other manufacturers. If

manufacturers choose to operate a program jointly, the

Ordinance requires that the program’s costs be spread fairly

and reasonably among the manufacturers. The manufacturers

may run the stewardship program themselves, or they may

pay a third-party to operate the stewardship program on their

behalf. Assuming the manufacturers jointly operated a

stewardship program, the start-up costs would approximate

$1,100,000. Around $200,000 of the start-up costs consists

of reimbursement to Alameda for the county’s costs to

administer the Ordinance. While Plaintiffs estimate the

subsequent annual costs to maintain the stewardship program

to be around $1,200,000, Alameda estimates annual

maintenance costs of only $330,000. However, both parties

PRMA V. COUNTY OF ALAMEDA 7

agreed this difference in estimates was immaterial for

summary judgment purposes. Alameda estimates an annual

cost of $200,000 per year to oversee the stewardship program

and the Ordinance requires the manufacturers to reimburse

Alameda for this cost. Using these numbers, Alameda

estimates a total annual cost to each manufacturer between

$5,300 and $12,000. Under the Ordinance, manufacturers

may not implement a point-of-sale “tax” or fee to recoup the

stewardship program’s administrative costs.

Plaintiffs, non-profit trade organizations representing the

manufacturers and distributors of pharmaceutical products,

claim that the Ordinance violates the dormant Commerce

Clause by requiring interstate drug manufacturers to conduct

and pay for Alameda County’s drug disposal program. The

district court disagreed and granted Defendants’ motion for

summary judgment.

STANDARD OF REVIEW

“We review de novo the district court’s grant of summary

judgment.” Smith v. Clark Cnty. Sch. Dist., 727 F.3d 950, 954

(9th Cir. 2013).

DISCUSSION

The Commerce Clause dictates that “Congress shall have

Power . . . [t]o regulate Commerce . . . among the several

States.” U.S. Const. art. I, § 8, cl 3. “Though phrased as a

grant of regulatory power to Congress, the Clause has long

been understood to have a ‘negative’ aspect that denies the

States the power unjustifiably to discriminate against or

burden the interstate flow of articles of commerce.” Or.

Waste Sys., Inc. v. Dep’t of Envtl. Quality of State of Or.,

8 PRMA V. COUNTY OF ALAMEDA

511 U.S. 93, 98 (1994). “The modern law of what has come

to be called the dormant Commerce Clause is driven by

concern about economic protectionism that is, regulatory

measures designed to benefit in-state economic interests by

burdening out-of-state competitors.” Dep’t of Revenue of Ky.

v. Davis, 553 U.S. 328, 337–38 (2008) (internal quotation

marks omitted). We analyze dormant Commerce Clause

claims using the Supreme Court’s two-tiered approach. See

Brown-Forman, 476 U.S. at 578–79.

I.

The first tier asks whether the Ordinance “either

discriminates against or directly regulates interstate

commerce.” Greater L.A. Agency on Deafness, Inc. v. Cable

News Network, Inc., 742 F.3d 414, 432 (9th Cir. 2014). If the

Ordinance does either of these things, “it violates the

Commerce Clause per se, and we must strike it down without

further inquiry.” NCAA v. Miller, 10 F.3d 633, 638 (9th Cir.

1993). The Ordinance does neither.

A. Discrimination

A statute is discriminatory if it “impose[s] commercial

barriers or discriminates against an article of commerce by

reason of its origin or destination out of State.” C & A

Carbone, Inc. v. Town of Clarkstown, N.Y., 511 U.S. 383, 390

(1994). “Conversely, a statute that treats all private

companies exactly the same does not discriminate against

interstate commerce. This is so even when only out-of-state

businesses are burdened because there are no comparable in-

state businesses.” Assoc. des Eleveurs de Canards et d’Oies

du Quebec v. Harris, 729 F.3d 937, 948 (9th Cir. 2013)

(internal quotation marks, alteration, and citation omitted).

PRMA V. COUNTY OF ALAMEDA 9

The Ordinance, both on its face and in effect, applies to

all manufacturers that make their drugs available in Alameda

County—without respect to the geographic location of the

manufacturer. Even if one of the manufacturers represented

by Plaintiffs were to close all of its production facilities, open

a single production facility in Alameda County, and limit the

sale of its products to intra-county commerce, the Ordinance

would still apply to that manufacturer. In other words, the

Ordinance does not discriminate, because it “treat[s] all

private companies exactly the same.” See United Haulers

Ass’n, Inc. v. Oneida-Herkimer Solid Waste Mgmt. Auth.,

550 U.S. 330, 342 (2007).1

Plaintiffs argue that the Ordinance is discriminatory,

because “the real world effect of the Ordinance is

indistinguishable from a tariff.” The Commerce Clause

forbids the use of tariffs “[b]ecause of their distorting effects

on the geography of production.” W. Lynn Creamery, Inc. v.

Healy, 512 U.S. 186, 193 (1994). The evil of a tariff is that

it “artificially encourag[es] in-state production even when the

same goods could be produced at lower cost in other States.”

Id. Tariff-like statutes similarly provide distinct advantages

to in-state entities over out-of-state entities, so courts

routinely strike them down. “[C]ases of this kind are legion.”

Id. at 194 (collecting cases).

1

The fact that the Ordinance exempts local pharmacies does not change

the outcome, because no “actual or prospective competition” exists

between the pharmacies and the manufacturers. See Gen. Motors Corp.

v. Tracy, 519 U.S. 278, 298, 299–300 (1997) (“Conceptually, of course,

any notion of discrimination assumes comparison of substantially similar

entities.” (footnote omitted)).

10 PRMA V. COUNTY OF ALAMEDA

However, unlike any of these statutes, an ordinance that

applies across-the-board provides no geographic advantages.

This holds true even where the ordinance only affects

interstate commerce due to an absence of intrastate

businesses. See Assoc. des Eleveurs, 729 F.3d at 948. Given

that the Ordinance applies across the board, it does not

discriminate at all, let alone in the same way as a tariff.

Plaintiffs also argue that the Ordinance discriminates

against interstate commerce by shifting costs to counties and

states outside of Alameda. As the Supreme Court has

observed,

[o]ur dormant Commerce Clause cases often

find discrimination when a State shifts costs

of regulation to other States, because when

“the burden of state regulation falls on the

interests outside of the state, it is unlikely to

be alleviated by the operation of those

political restraints normally exerted when

interests within the state are affected.”

United Haulers, 550 U.S. at 345 (quoting S. Pac. Co. v. Ariz.

ex rel. Sullivan, 325 U.S. 761, 767 n.2 (1945)). In United

Haulers, the Supreme Court upheld a statute and noted that

it “bears mentioning” that the cost of the ordinances “is likely

to fall upon the very people who voted for the laws.” Id. It

concluded that “[t]here [was] no reason to step in and hand

local businesses a victory they could not obtain through the

political process.” Id.

Plaintiffs’ political-restraints argument fails because, like

in United Haulers, the Ordinance affects “interests within the

[county].” Id. Even though all of the pharmaceutical drugs

PRMA V. COUNTY OF ALAMEDA 11

travel in interstate commerce before being sold in Alameda,

three of Plaintiffs’ members have their corporate headquarters

or principal place of business in Alameda and two of

Plaintiffs’ members have facilities in Alameda that

manufacture prescription drugs for commercial distribution.

Moreover, the cost of running the disposal program has

not been entirely shifted outside of the county. Plaintiffs

assert that the manufacturers will cover the cost of the

Ordinance by raising the price of their drugs. This will result

in higher prices for everyone outside of Alameda, but it will

also result in higher prices for residents of Alameda. Given

these facts, we are satisfied that the burden imposed by the

Ordinance was sufficiently subjected to “those political

restraints normally exerted when interests within the state are

affected.” Id.

B. The Ordinance does not directly regulate

interstate commerce.

“[A] statute violates the dormant Commerce Clause per

se when it directly regulates interstate commerce.” Assoc.

des Eleveurs, 729 F.3d at 949 (internal quotation marks

omitted). “Direct regulation occurs when a state law directly

affects transactions that take place across state lines or

entirely outside of the state’s borders.” S.D. Myers, Inc. v.

City and Cnty. of S.F., 253 F.3d 461, 467 (9th Cir. 2001)

(internal quotation marks omitted). “The critical inquiry is

12 PRMA V. COUNTY OF ALAMEDA

whether the practical effect of the regulation is to control

conduct beyond the boundaries of the State.”2 Healy v. Beer

Institute, Inc., 491 U.S. 324, 336 (1989).

Two stipulations of the parties reveal that the Ordinance

does not “control conduct beyond the boundaries of the

[county],” see id.:

8. Any person, manufacturer, or distributor

that does not sell, offer for sale, or distribute

prescription drugs in Alameda County is not

required to undertake any action under the

Ordinance.

9. Nothing in the Ordinance requires that

[manufacturers] implement stewardship plans

in any location or jurisdiction outside of

Alameda County.

Unable to quarrel with these facts, Plaintiffs essentially assert

four arguments as to how the Ordinance directly regulates

interstate commerce.

First, Plaintiffs argue that the Ordinance “cannot be an

exercise of the police power with an ‘incidental’ effect on

interstate commerce, but is necessarily an effort to directly

regulate and burden [interstate commerce].” The problem

2

Under Assoc. des Eleveurs, the test articulated in Healy may not apply

to the Ordinance at all. See Assoc. des Eleveurs, 729 F.3d at 951 (“Healy

[does not apply] to a statute that does not dictate the price of a product and

does not ‘t[ie] the price of its in-state products to out-of-state prices.’”

(quoting Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 669

(2003)). Assuming Healy does apply, the Ordinance withstands its

scrutiny.

PRMA V. COUNTY OF ALAMEDA 13

with Plaintiffs’ argument—aside from the fact that Plaintiffs

cite not a single case to support this theory—is that it

conflates the “direct regulation” doctrine and the second-tier,

Pike balancing test, which asks whether the “State’s interest

is legitimate,” Brown-Forman, 476 U.S. at 578–79.

Moreover, direct regulation of interstate commerce is more

than the absence of a legitimate statutory purpose. Even

assuming the State has no legitimate interest whatsoever in

passing the Ordinance, it does not automatically follow that

the Ordinance directly regulates interstate commerce.

Second, Plaintiffs argue that the Ordinance directly

regulates interstate commerce, because “it regulates

[manufacturers] whose only connection to Alameda is such

interstate commerce.” However, there is nothing unusual or

unconstitutional per se about a state or county regulating the

in-state conduct of an out-of-state entity when the out-of-state

entity chooses to engage the state or county through interstate

commerce. Cf. Assoc. des Eleveurs, 729 F.3d at 948–49 (“A

statute is not invalid merely because it affects in some way

the flow of commerce between the States.” (internal quotation

marks omitted)). For example, in Assoc. des Eleveurs, this

court upheld a California statute that prohibited the sale of

products that were the result of force feeding birds. Id. at

941–42. It did not matter that the practical effect of the

statute was to regulate the conduct of farmers and producers

that were “non-California entities” who chose to engage

California through interstate commerce. Id. at 942, 950–51.

Plaintiffs suggest that the Ordinance is different, because

it imposes an affirmative obligation. However, neither the

Supreme Court nor this court has drawn such a distinction.

See Pharm. Research, 538 U.S. at 668–69 (rejecting a

dormant commerce clause challenge to a Maine regulation

14 PRMA V. COUNTY OF ALAMEDA

that required drug manufacturers to enter into a rebate

agreement with the state in order to compensate pharmacists

for selling cheaper drugs); Greater L.A. Agency, 742 F.3d at

419, 432–33 (rejecting a dormant commerce clause challenge

to a statute that “compell[ed] [CNN] to caption videos posted

on its web site”).

Third, Plaintiffs argue that the Ordinance directly

regulates interstate commerce, because it “shift[s] the costs of

Alameda’s disposal responsibility and local government

program from the County’s consumers and taxpayers to the

interstate market.” This rationale applies when determining

whether a statute discriminates against, rather than directly

regulates, interstate commerce.3 United Haulers, 550 U.S. at

345. Accordingly, we addressed this argument above.

Fourth, Plaintiffs invite the panel to apply dormant

Commerce Clause tax cases to the Ordinance. Specifically,

Plaintiffs ask the panel to apply the “nexus” and “fairly

apportioned” requirements. Plaintiffs cite no case, and we

can find none, in which a court has applied the nexus and

fairly apportioned requirements outside of the tax context.

We decline the invitation to break this new legal ground.

3

Plaintiffs try to make this an argument about direct regulation by

asserting that “this Court has squarely stated that a law has an

impermissible ‘direct burden’ on interstate commerce if, under the law, the

locality ‘would be able to shift the tax burden to out-of-state . . .

producers.’” See Nat’l Meat Ass’n v. Deukmejian, 743 F.2d 656, 661 (9th

Cir. 1984). But that statement did not come from the court. The court

was quoting the state’s economic expert, who made the statement in

support of upholding a state statute. 743 F.2d at 661. The only thing “this

Court . . . squarely stated” concerning that quotation is that it “is not

controlling.” Id.

PRMA V. COUNTY OF ALAMEDA 15

II.

The second tier of a dormant commerce clause analysis

has come to be known as the Pike balancing test. See Pike v.

Bruce Church, Inc., 397 U.S. 137, 142 (1970). Under Pike,

we ask whether “the burden [the Ordinance] imposes on

interstate commerce is ‘clearly excessive in relation to the

putative local benefits.’” See S.D. Myers, Inc., 253 F.3d at

471 (quoting Pike, 397 U.S. at 142). “We have explained that

under Pike, a plaintiff must first show that the statute imposes

a substantial burden before the court will determine whether

the benefits of the challenged laws are illusory.” Assoc. des

Eleveurs, 729 F.3d at 951–52 (internal quotation marks

omitted). The analysis “turn[s] on the interstate flow of

goods.” See Nat. Ass’n of Optometrists & Opticians v.

Harris, 682 F.3d 1144, 1153 (9th Cir. 2012).

A. Substantial Burden

The parties’ briefs provide minimal discussion as to the

burden imposed by the Ordinance. The county compares the

cost of running the disposal program ($530,000–$1,200,000

per year) to the manufacturers’ revenue-stream in Alameda

County (approximately $950 million per year) to conclude

that the burden is minimal. Plaintiffs’ merely state that “the

County cannot dispute that the Ordinance imposes some

burdens on [manufacturers] engaged in interstate commerce.”

Significantly, Plaintiffs provide no evidence that the

Ordinance will interrupt, or even decrease, the “flow of

goods” into or out of Alameda. See id. Further, assuming the

manufacturers comply with the Ordinance, they can continue

to sell pharmaceutical drugs in Alameda. Cf. Assoc. des

Eleveurs, 729 F.3d at 952 (finding Plaintiffs failed to raise

16 PRMA V. COUNTY OF ALAMEDA

serious questions about whether a statute imposed a

substantial burden even though it would “preclude Plaintiffs’

‘more profitable’ method of producing foie gras” (emphasis

added)). Without any evidence that the Ordinance will affect

the interstate flow of goods, we cannot say that the Ordinance

substantially burdens interstate commerce.

B. Local Benefits

According to the joint-stipulation, “Plaintiffs agree that

the Ordinance’s environmental, health, and safety benefits are

not contested for purposes of the cross-motions for summary

judgment.” And “regulations that touch upon safety . . . are

those that the [Supreme] Court has been most reluctant to

invalidate. Indeed, if safety justifications are not illusory, the

Court will not second-guess legislative judgment about their

importance in comparison with related burdens on interstate

commerce.” Kassel v. Consol. Freightways Corp. of Del.,

450 U.S. 662, 670 (1981) (internal quotation marks and

citations omitted).

In an attempt to avoid this “strong presumption of

validity” see id. (internal quotation marks omitted), Plaintiffs

contend that the purpose of the Ordinance is merely to shift

costs away from the county and onto the manufacturers.

Plaintiffs reason that, because Alameda County could run a

drug disposal program that “would achieve precisely the same

effects” as the program mandated by the Ordinance, the

Ordinance “yields no public benefits.” We reject this logic.

PRMA V. COUNTY OF ALAMEDA 17

The fact that the county could run a similar program does

not nullify the program’s benefits.4 For example, in Walsh,

the Supreme Court rejected a dormant Commerce Clause

challenge, despite the fact that Maine could have simply

compensated the pharmacists itself rather than force drug

manufacturers to do so. 538 U.S. at 654. Moreover, even if

the Ordinance did nothing other than save the county money,

that is not equivalent to “no public benefits.” Cf. United

Haulers, 550 U.S. at 346 (“While revenue generation is not

a local interest that can justify discrimination against

interstate commerce, we think it is a cognizable benefit for

purposes of the Pike test.” (internal quotation marks and

citation omitted)).

CONCLUSION

The parties agree that the Alameda County Safe Drug

Disposal Ordinance constitutes a “first-in-the-nation”

ordinance. Opinions vary widely as to whether adoption of

the Ordinance was a good idea. We leave that debate to other

institutions and the public at large. We needed only to review

the Ordinance and determine whether it violates the dormant

Commerce Clause of the United States Constitution. We did;

it does not.

AFFIRMED.

4

To the extent that Plaintiffs argue that the panel must consider less

burdensome alternatives, “case law requir[es] the consideration of less

restrictive alternatives only when heightened scrutiny is required.” Nat.

Ass’n of Optometrists, 682 F.3d at 1157. Because the Ordinance is not

discriminatory and does not directly regulate interstate commerce,

heightened scrutiny is not required. See id.