Pharmaceutical Research and Ma, et al v. County of Alameda, et al
Filing
FILED OPINION (N. RANDY SMITH, MORGAN B. CHRISTEN and LAWRENCE L. PIERSOL) AFFIRMED. Judge: NRS Authoring. FILED AND ENTERED JUDGMENT. [9258675]
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FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
PHARMACEUTICAL RESEARCH AND
MANUFACTURERS OF AMERICA;
GENERIC PHARMACEUTICAL
ASSOCIATION; BIOTECHNOLOGY
INDUSTRY ORGANIZATION,
Plaintiffs-Appellants,
No. 13-16833
D.C. No.
3:12-cv-06203RS
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.
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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.
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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 crossmotions 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 PlaintiffsAppellants.
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.
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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 twotiered 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
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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
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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
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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.,
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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 instate 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).
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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)).
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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
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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
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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.
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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
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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.
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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
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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.
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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.
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