Law Commons^™

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Scholarly Works

In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.

Collective Corporate Knowledge, The Federal False Claims Act, And The Future Of Federal Health Programs, Sam F. Halabi

Faculty Publications

While recent U.S. Supreme Court decisions have drawn focus to whether what corporations “say” is protected by the First Amendment or what they “believe” is protected by the federal Religious Freedom Restoration Act, the more relevant inquiry for a wide range of statutory and regulatory regimes is what corporations “know.” At the core of that question is what guides information relevant for legal compliance (including product safety, employee welfare, and material risks considered by investors) from its source to any given point in the firm, including decision-makers. This Article analyzes the federal False Claims Act as an underexploited resource in …

Informed Consent And The First Amendment, Wendy K. Mariner, George J. Annas

Faculty Scholarship

For more than two decades, states have been adding to the things that physicians must say and do to obtain “informed consent” — and thereby testing the constitutional limits of states' power to regulate medical practice. In 1992, the Supreme Court upheld states' authority to require physicians to provide truthful information that might encourage a woman to reconsider her decision to have an abortion, finding that such a requirement did not place an “undue burden” on the woman.

Reforming The Law Of Reputation, Frank A. Pasquale

Faculty Scholarship

Unfair and deceptive practices of controllers and processors of data have adversely affected many citizens. New threats to individuals’ reputations have seriously undermined the efficacy of extant regulation concerning health privacy, credit reporting, and expungement. The common thread is automated, algorithmic arrangements of information, which could render data properly removed or obscured in one records system, nevertheless highly visible or dominant in other, more important ones.

As policymakers reform the law of reputation, they should closely consult European approaches to what is now called the “right to be forgotten.” Health privacy law, credit reporting, and criminal conviction expungement need to …

The Prudential Third Party Standing Of Family-Owned Corporations, Matthew I. Hall, Benjamin Means

Scholarly Works

On November 26, 2013, the Supreme Court agreed to decide whether for-profit corporations or their shareholders have standing to challenge federal regulations that implement the Patient Protection and Affordable Care Act (ACA). At issue in the two cases consolidated for appeal, Hobby Lobby and Conestoga Wood Specialties, are regulations mandating that employers with fifty or more employees offer health insurance that includes coverage for all contraceptives approved by the Food and Drug Administration (FDA). The plaintiffs assert that providing certain types of contraceptive care would be contrary to their religious beliefs and allege, therefore, that the mandate violates the Religious …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

William H. Sorrell, Attorney General Of Vermont, Et Al. V. Ims Health Inc., Et Al. - Amicus Brief In Support Of Petitioners, Kevin Outterson, David Orentlicher, Christopher T. Robertson, Frank A. Pasquale

Faculty Scholarship

On April 26, 2011, the US Supreme Court will hear oral arguments in the Vermont data mining case, Sorrell v. IMS Health Inc. Respondents claim this is the most important commercial speech case in a decade. Petitioner (the State of Vermont) argues this is the most important medical privacy case since Whalen v. Roe.

The is an amicus brief supporting Vermont, written by law professors and submitted on behalf of the New England Journal of Medicine

Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson

Faculty Scholarship

In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.