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Pharmaceutical Research & Manufacturers of America v. County of Alameda

United States Court of Appeals, Ninth Circuit

September 30, 2014

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; GENERIC PHARMACEUTICAL ASSOCIATION; BIOTECHNOLOGY INDUSTRY ORGANIZATION, Plaintiffs-Appellants,
v.
COUNTY OF ALAMEDA; ALAMEDA COUNTY DEPARTMENT OF ENVIRONMENTAL HEALTH, Defendants-Appellees

Argued and Submitted, San Francisco, California: July 11, 2014.

Page 1038

Appeal from the United States District Court for the Northern District of California. D.C. No. 3:12-cv-06203-RS. Richard Seeborg, District Judge, Presiding.

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 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, 90 S.Ct. 844, 25 L.Ed.2d 174 (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.

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.

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.

Before: N. Randy Smith and Morgan Christen, Circuit Judges, and Lawrence L. Piersol, Senior District Judge.[*] Opinion by Judge N.R. Smith.

OPINION

Page 1039

N.R. SMITH, Circuit Judge:

The Supreme Court " has adopted what amounts to a two-tiered approach to analyzing state economic regulation under the

Page 1040

Commerce Clause." Brown-Forman Distillers Corp. v. N.Y. State Liquor Auth., 476 U.S. 573, 578-79, 106 S.Ct. 2080, 90 L.Ed.2d 552 (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 has] ...

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