U.S. Supreme Court Strikes Down Vermont’s Prescription Drug Data Mining Ban Law
Last Friday, the United States Supreme Court struck down the Vermont Prescription Confidentiality Law allowing prescriber-identifying information to be sold and disclosed by pharmacies and pharmaceutical manufacturers for marketing purposes. You can retrieve a copy of the U.S. Supreme Court’s full opinion here. A fantastic history of the case as well as various Amicus Briefs filed for and against Sorrell vs. IMS are posted on Vermont Office of Attorney General’s website. The case was argued on April 26, 2011, and you can listen to the oral arguments in front of the Justices here. Many have been anxiously awaiting the Court’s decision, which promised to have a profound affect either way on how deidentified information is collected and used for various purposes, including healthcare research and quality improvement, as well as for marketing.
Justice Kennedy, writing for the 6-3 majority, held that the Vermont law was an unconstitutional content-based restriction on First-Amendment protected expression. The majority asserted that speech restraint of this kind must be subject to strict judicial scrutiny. Kennedy concludes that the Vermont law fails this test because, in seeking to advance its goal of lowering health care costs and promoting public health, it restrict “certain expression by certain speakers.”
Justice Breyer, in his dissent, argued that the Vermont law only modestly affects expression, by depriving “pharmaceutical and data-mining companies of data… that could help pharmaceutical companies create better sales messages.”
The dissenting justices contend that these messages are commercial speech, and that government regulation of commercial speech has not been subjected to the heightened judicial scrutiny employed by the majority. In this light, Justice Breyer concludes that the statute permissibly regulates commercial activity. The Court’s dissent also raised concerns over long-term precedential trouble created by the majority’s decision. Justice Breyer states that, “at best the court opens a Pandora’s Box of First Amendment challenges to many ordinary regulatory practices that may only incidentally affect a commercial message… [and] at worst, it reawakens Lochner’s pre-New Deal threat of substituting judicial for democratic decision-making where ordinary economic regulation is at issue.”
For some, the Court’s decision is a huge disappointment, but others will undoubtedly welcome the Court’s decision as the correct outcome. In my previous post about this case, I included the in depth analysis of Sorrell vs. IMS prepared by the Centers for Democracy and Technology (CDT). There, CDT pointed out, among other things, that:
The first thing to recognize about the data at issue is that it contains doctorsʼ names but it does not contain patient names. The data is [‘]patient de-identified[‘] pursuant to standards established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HIPAA already prohibits the use of patient-identified data for marketing to patients or to doctors. Vermont went one step further and said that even patient de-identified data cannot be used to market drugs to doctors.
CDT also pointed out it its analysis:
[i]f the Supreme Court were to accept some of the privacy claims, it could do damage to privacy by discouraging use of de-identified data. And claims that doctors have a privacy right in their drug prescribing practices could upset a host of policy goals associated with improving the efficiency and safety of the health care system.
Finally, the CDT memo points out:
The behavior of physicians and other health care professionals is routinely scrutinized by federal and state regulators, accrediting organizations, licensing boards, and health care plans, among others. A broadly recognized privacy interest in prescriber-identifiable data could have implications for multiple important issues, including quality measurement and public reporting, as well as comparative effectiveness research, which are critical to reform of our health care system. If the Court were to agree that prescriberrecords need to be protected like corporate “tradesecrets” or that there is no role for outside review of physician decision making, important reform activities that depend on access to and use of prescriber identified data could be impaired or prohibited.
Clearly, the U.S. Supreme Court agreed.
