Thompson v. Western States Medical Center
535 U.S. 357, 152 L. Ed. 2d 563, 2002 U.S. LEXIS 3035 (2002)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
A restriction on truthful, non-misleading commercial speech is unconstitutional if the government fails to demonstrate that non-speech-related alternatives are insufficient to achieve its substantial interests. The government cannot justify a speech restriction on the paternalistic grounds of preventing the public from making poor decisions with truthful information.
Facts:
- Drug compounding is a traditional practice where a pharmacist combines ingredients to create a medication tailored to an individual patient's needs, based on a doctor's prescription.
- Compounded drugs are exempt from the rigorous and expensive new drug approval process required by the Food and Drug Administration (FDA) for mass-produced pharmaceuticals.
- The FDA became concerned that some pharmacies were manufacturing drugs on a large scale under the guise of compounding, thus bypassing federal safety and efficacy testing requirements.
- In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA) to address this issue.
- Section 127(a) of the FDAMA exempted compounded drugs from standard FDA approval but conditioned this exemption on several restrictions.
- Among the restrictions, the FDAMA prohibited pharmacies from advertising or promoting the compounding of any 'particular drug, class of drug, or type of drug,' although they could advertise their general 'compounding service.'
- Western States Medical Center and other compounding pharmacies had been preparing and distributing promotional materials to inform doctors and patients about the use and effectiveness of specific compounded drugs.
- These pharmacies feared they would be prosecuted under the FDAMA if they continued their advertising practices.
Procedural Posture:
- Western States Medical Center and other pharmacies filed a complaint in the U.S. District Court for the District of Nevada, seeking to enjoin enforcement of the FDAMA's advertising restrictions.
- The District Court granted summary judgment for the pharmacies, holding the speech provisions were unconstitutional restrictions on commercial speech.
- The District Court severed the unconstitutional provisions from the rest of the statute.
- The Government appealed to the U.S. Court of Appeals for the Ninth Circuit.
- The Court of Appeals affirmed the District Court's finding of unconstitutionality but reversed its severability analysis, invalidating the entire relevant section of the FDAMA.
- The Government (Petitioners) petitioned for a writ of certiorari to the U.S. Supreme Court on the constitutional question only, which was granted.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Do the advertising and solicitation restrictions on compounded drugs in the Food and Drug Administration Modernization Act of 1997 violate the First Amendment's Free Speech Clause?
Opinions:
Majority - Justice O’Connor
Yes, the advertising and solicitation restrictions in the FDAMA violate the First Amendment. If the government can achieve its policy goals through non-speech-related regulations, it must do so rather than restricting truthful commercial speech. The government's asserted interests in protecting the drug approval process and ensuring patient access to compounded drugs, while substantial, are not properly served by a speech ban when less restrictive alternatives exist. The law fails the final prong of the Central Hudson test because the government did not demonstrate that the speech restrictions were 'not more extensive than is necessary.' The government could have pursued several non-speech-related alternatives, such as banning the use of commercial-scale manufacturing equipment, prohibiting wholesale distribution of compounded drugs, or capping the volume of compounded drugs a pharmacy can produce. The government cannot justify restricting truthful information on the paternalistic assumption that it must protect people from making bad decisions, a principle rejected in Virginia Bd. of Pharmacy.
Dissenting - Justice Breyer
No, the advertising restrictions do not violate the First Amendment. The majority undervalues the government's substantial interest in protecting public health and safety by ensuring that untested compounded drugs are used only out of medical necessity, not convenience. The ad ban directly advances this interest by helping to ensure that demand for a compounded drug originates from a doctor's individualized medical judgment, rather than from a patient's response to an advertisement. Evidence shows that direct-to-consumer advertising pressures physicians to prescribe drugs they might not otherwise choose. The alternatives proposed by the majority focus on the scale of manufacturing but fail to address the crucial goal of limiting demand to cases of genuine medical need. The Court applies the Central Hudson test too rigidly, transforming a reasonable legislative decision about public health into a constitutional prohibition.
Concurring - Justice Thomas
Yes, the restrictions are unconstitutional. While I agree with the Court's application of the Central Hudson test and its ultimate conclusion, I maintain my view that the Central Hudson test is the wrong framework for analyzing restrictions on truthful commercial speech. The government's asserted interest, which is to be achieved by keeping the recipients of speech 'in the dark,' is illegitimate and cannot justify a restriction on truthful communication.
Analysis:
This decision significantly strengthens the protection for commercial speech under the First Amendment by rigorously applying the final prong of the Central Hudson test. It establishes that the government bears a heavy burden to prove that non-speech-related alternatives are unworkable before it can resort to restricting truthful advertising. The case firmly rejects paternalistic justifications for speech regulations, reinforcing the principle that the government cannot suppress truthful information to 'protect' consumers from themselves. This precedent makes it more difficult for legislatures to use advertising bans as a convenient proxy for regulating underlying economic activity, forcing them to adopt more direct, non-speech-related regulatory measures.
