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Western States Medical Center, a Nevada Corporation Women's International Pharmacy, a Wisconsin Corporation Health Pharmacy, a Wisconsin Corporation Apothecure, a Texas Corporation College Pharmacy, a Colorado Corporation Lakeside Pharmacy, a Tennessee Corporation Wedgewood Village Pharmacy, a New Jersey Corporation v. Donna E. Shalala, in Her Official Capacity as Secretary, United States Department of Health and Human Services Jane E. Henney, M.D., in Her Official Capacity as Commissioner

Citations: 238 F.3d 1090; 2001 Daily Journal DAR 1391; 2001 Cal. Daily Op. Serv. 1073; 2001 U.S. App. LEXIS 1555Docket: 99-17424

Court: Court of Appeals for the Ninth Circuit; February 5, 2001; Federal Appellate Court

Narrative Opinion Summary

The case revolves around a group of licensed pharmacies challenging the constitutionality of specific sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which restrict the advertising of compounded drugs. The pharmacies argue that these restrictions infringe upon their First Amendment rights. The district court ruled in favor of the plaintiffs, applying the Central Hudson test to determine that the government failed to adequately justify the restrictions as they did not directly advance a substantial government interest, nor were they narrowly tailored. The court found that alternative, less restrictive measures could achieve the government's aims without infringing on free speech rights. On appeal, the Ninth Circuit Court is tasked with reviewing this decision de novo. The court also addressed the issue of severability, concluding that the unconstitutional provisions could not be severed from the FDAMA, rendering the entire section invalid. The ruling underscores the importance of protecting commercial speech and the necessity for the government to substantiate its regulatory interests with compelling evidence.

Legal Issues Addressed

Alternative Means of Regulation

Application: The court pointed out that less intrusive alternatives to the speech restrictions existed, which the government did not adequately consider.

Reasoning: Alternatives, such as disclaimers on compounded drugs or a comprehensive FDA safety review, exist that would be less intrusive to pharmacists' free speech rights.

Central Hudson Test for Commercial Speech

Application: The court applied the Central Hudson test, finding that the government failed to show that the speech restrictions directly advanced its interests or were narrowly tailored.

Reasoning: The government failed to show that the speech restrictions directly advanced its asserted interests or that they were narrowly tailored.

First Amendment and Commercial Speech

Application: The district court determined that the restrictions on advertising compounded drugs imposed by the FDAMA violated the First Amendment because they did not satisfy the Central Hudson test.

Reasoning: The district court granted summary judgment in favor of the Plaintiffs, determining that the restrictions did not satisfy the Central Hudson test for permissible government regulation of commercial speech.

Government Interest in Restricting Commercial Speech

Application: The court concluded that the government's asserted substantial interests were not sufficiently supported by evidence to justify the speech restrictions.

Reasoning: The government failed to meet this burden, lacking sufficient evidence to demonstrate a substantial interest in preventing widespread drug compounding.

Severability of Unconstitutional Provisions

Application: The court held that sections 353a(a) and (c) of the FDAMA were not severable from the rest of the statute, rendering the entire section invalid.

Reasoning: Since these provisions cannot be severed from the broader section 353a, the entire section is deemed invalid.