Supreme Court to Hear Prescription Privacy Case - Sorrell v. IMS Health, Inc.

Supreme Court to Hear Prescription Privacy Case - Sorrell v. IMS Health, Inc.

Contact:

Sean Fiil-Flynn, sflynn@wcl.american.edu  (202)294-5749

Meredith Jacob, mjacob@wcl.american.edu  (202)640-1701

Program on Information Justice & Intellectual Property

American University, Washington College of Law 

For background about prescription privacy and the IMS Health litigation in New Hampshire, Maine, and Vermont, please see the complete site here.

Introduction

Tuesday, April 26, 2011, the United States Supreme Court will hear oral arguments in Sorrell v. IMS Health, Inc, et al.  The case focuses of the ability of states to protect the confidentiality of health care date, specifically the ability of states to restrict the use of physician-identifiable data for the purpose of pharmaceutical marketing.  American University, Washington College of Law’s Program on Information Justice & Intellectual Property’s Sean Flynn and Meredith Jacob had previously filed an amicus curiae  brief in this case.  The brief, filed on behalf of AARP and the National Legislative Association on Prescription Drug Prices, argued that the Supreme Court should not limit this valuable tool for protecting medical privacy and controlling prescription drug prices.  This case raises central questions about the interplay of privacy protections and the First Amendment, and will set the stage for upcoming decisions about consumer privacy, consent, and the sale of data.

Background

This case involves incredibly important information privacy concerns. The Supreme Court has repeatedly held that there is a “Constitutional interest” of governments in protecting the privacy of information transmitted to commercial entities through commerce. The interest here could not be more weighty. This case deals with the confidentiality of prescription records that contain intimate details about the medicines we take. The respondents purchase prescription records from pharmacies to track individual patients and their race, weight, gender, medical condition, prescription history and a host of other identifiers and link that information to doctor identities. They use this information in complex databases to target marketing at convincing doctors to switch patient prescriptions to more profitable drugs. This practice is illegal in all of Europe and much of Canada because of the robust information privacy protections in those countries that ban companies from trading identifying information without the identified people’s consent. The companies in this case argue that similar privacy protections are unconstitutional in the U.S. because it invades there commercial speech rights. 

Is Sale and Use of Data for Marketing First Amendment Speech?

There is no commercial speech interest here. This case involves consumer surveillance not commercial speech. Only the latter is protected by the First Amendment. The commercial speech doctrine serves consumer interests in being fully informed of products and services on the market by providing limited protection from government regulation of advertisements and other speech to consumers describing their products and proposing commercial transactions. Pharmaceutical companies engage in commercial speech when they advertise their products through media and in-person sales calls to doctors. The commercial speech doctrine does not, however, extend protection to every use of information by private firms to target their marketing efforts. The respondents are not communicating with potential buyers when they monitor the prescribing practices of physicians, and therefore this practice is not accorded protection under the First Amendment.

Even if Viewed as First-Amendment Protected Speech, States can Regulate the Sale and Use of Prescriber-Identifiable Data

Even if the trade in prescription records was deemed to be speech, there are overwhelming societal justifications for its regulation. When governments require the disclosure of personally identifying information, such as that required on prescription records, privacy interests demand that governments ensure that the information is safeguarded from unwarranted disclosure. In addition, an abundance of social science evidence demonstrates that undue influence of pharmaceutical marketing over the prescribing choices of physicians and other health professionals compromises a central value of our health system – that medical decisions be based on evidence, not on personal relationships, marketing influence or the hope for pecuniary reward. Permitting pharmaceutical marketers to track prescribing choices and use that information to tailor commercial messages and target gifts and enticements exaggerates undue influence of pharmaceutical companies in our health system that raises health care costs, promotes irrational drug selection, threatens professional integrity, compromises patient privacy and increases the prevalence of harassing marketing practices. States have an overriding interest in combating these social ills.

Safeguarding the confidentiality of prescription records from commercial marketing purpose is a serious public policy issue. At least 14 states have introduced statutes restricting the sale of physician identifiable prescription data.

States Interests Served by the Protection of Prescription Confidentiality

Giving pharmaceutical companies access to the specific prescribing history of doctors involving every one of their patients is invasive and damaging to the doctor patient relationship. 

Access to prescribing history undermines the effectiveness of the FDA in regulating pharmaceutical marketing messages.  As we’ve seen in a number of off-label marketing and marketing fraud cases, pharmaceutical marketing is constantly pushing the boundaries of truthful promotion of their products. 

The availability of this data creates an immediate and inescapable conflict of interest for sales representatives.  On one hand they are held out as source of medical information, yet on the other, they are paid based on the increase in prescriptions among the physicians they market to.

Expensive brand name medicines are aggressively marketed before there is a sufficient safety record.  FDA approval is a starting point, not an end point.  This sort of aggressive marketing fuels the overuse of the newest medicines, such as the rapid adoption of Vioxx, before the risks are fully understood.

Prescribing decisions should be made based on the best interest of the patient and nothing else.  This marketing data is gathered without consent from patients of physicians, and then used to skew prescribing decisions for non-medical reasons.

2d Circuit Decision Calls in to Question Other Privacy Protections

If the Supreme Court finds that these laws violate the First Amendment, then there can be few limits on the re-disclosure of private data.  Do-not-Call lists, the Driver Privacy Protection Act, laws limiting the sale of information about video rental choices -- all would be called into question were this law overturned. President Obama just signed S3386, the ‘‘Restore Online Shoppers’ Confidence Act’’ to prevent “data pass” where one online merchant passes billing data to another to facilitate aggressive marketing and streamlined purchase of add-ons a consumer had not intentionally purchased.  Under the logic of the Respondents, this law would violate the 1st amendment, because it restricts the transmission of data from one holder to a third party.

Increasingly, all transactions we conduct generate data, and storage of our data takes place online.  It would be a dire mistake to find that any intermediate holder of that information has a first amendment right to sell it to the highest bidder.

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