Posted on April 22, 2011 at 4:49 pm by Lyle Denniston
The Supreme Court holds one hour of oral argument on Tuesday on the scope of constitutional protection for the modern phenomenon of “data-mining,” the creation of usable information out of masses of stored computer entries.Â The case is Sorrell, et al., v. IMS Health, et al. (10-779). Â Arguing for the state of Vermont, defending a law that limits the commercial use of such data, will be an assistant state attorney general, Bridget C. Asay of Montpelier.Â Supporting such regulatory efforts, for the federal government, will be Deputy U.S. Solicitor General Edwin S. Kneedler, with ten minutes of time.Â Speaking for data-mining companies and pharmaceutical manufacturers will be Thomas C. Goldstein of Goldstein, Howe & Russell in Washington, D.C.Â (Disclosure: the Goldstein, Howe & Russell firm is the sponsor of this blog; the author of this post operates independently of the law practice.)
It is a reality of the Information Age that a vast amount of information of a very personal nature is gathered and stored in computer data banks, and it is a reality that many Americans are worried about the potential for public disclosure of such private data.Â But it also a reality that “mining” such data can turn it into highly useful information to guide a vast array of private decisions and government actions — in some ways, creating the information database that makes a complex modern society actually able to function.Â And the potential conflict among these realities is mirrored in a constitutional conflict: privacy versus expression, the right to be let alone versus the right to gather and use information freely.
Those are rather grand themes, but they do loom in the background as the Supreme Court takes up a dispute that involves one of the most acute fears of Americans in the age of high-tech information gathering: how much privacy do they have in the records containing their medical profiles?Â In particular, the case of Sorrell, et al., v. IMS Health, et al. (10-779), tests how far the government can go to restrict the commercial use of information gathered about the billions of drug prescriptions that doctors write every year, and whether, specifically,Â the state of Vermont has chosen a workable (and constitutional) means to shield the privacy of medical patients’ drug records and the privacy of the doctors who wrote those prescriptions.
There is, in the written briefs before the Court in this case, an energetic secondary debate about modern information technology.Â It is this: even if steps are taken to try to ensure that the identity of individual patients or doctors will not be exposed through the “mining” of their computerized Rx data, is any such system hacker-proof, or does assured privacy never really exist?Â The Court may well have to take that debate into account in the constitutional calculus.
A separate constitutional theme also looms over this case: assuming that data-mining does have First Amendment protection, as a form of commercial publishing, does it get the highest level of insulation from government regulation, or is some middling level sufficient, on the theory that it is, after all, “commercial speech,” traditionally less protected than, say, political speech?Â The Court may not need to reconsider that traditional view to decide the case, but a challenge to it — a plea for first-tier protection for commercial speech –Â is there to ponder.
Although there is a good deal of complexity to the case before the Justices, there are two simple things about it: first, drugstores and other dispensers of prescription drugs must, by law, keep records of all such prescriptions, and, second, drug manufacturers want that data for use in advising doctors on what drugs to prescribe — including the manufacturers’ own brand-name products.Â Â The constitutional dispute here, much over-simplified, grows out of Vermont’s attempt to keep the former from facilitating the latter, on the belief that doing so will check rising drug prices and protect patient or doctor privacy.
In 2007, Vermont’s legislature passed a law to restrict the commercial use of data gathered from drug dispensers about the prescribing of brand-name drugs for patients.Â Its aim, the legislature specified, was to protect the privacy of doctors and the information about patients’ prescriptions, to reduce health care costs by encouraging prescription of generic drugs, and to protect public health.Â The lawmakers also said that the law would help ensure that doctors got unbiased information about the drugs they might prescribe.
Unabashedly, the legislature explicitly said that it was seeking to interfere with the customary method of marketing drugs — the process of “detailing” in which agents of the drug manufacturers visit doctors directly to talk with them about which drugs to prescribe.Â The lawmakers regarded that process as one-sided, and expressed concern that public health might be at risk if doctors were writing prescriptions based on promotions rather than for objective medical reasons.Â So, the law barred dispensers from selling the information for use in marketing drugs, and it barred drug manufacturers from using the data for such purposes.
When a dispenser fills a doctor’s prescription, the data includes the doctor’s name and address, the name, dosage and quantity of the drug, the date and place where the prescription was filled, and the patient’s age and gender — but not patient name and address.Â The information is stored in computerized records, and dispensers sell that information to a number of buyers, including data-mining companies, which call themselves publishers because they aggregate the data and republish it, showing the prescription-writing patterns of individual doctors.Â The sales to those companies are a strong revenue source for drugstores.
The analyzed and published data are sold by the “mining” firms to pharmaceutical manufacturers, who then make use of it in “detailing.”Â Â But the data also has other uses as well: tracking the progression of diseases, aiding law enforcement, conducting clinical trials, and post-marketing surveillance.
For doctors whose prescription patterns are revealed by the data, Vermont’s law offers an opt-in approach.Â Doctors may choose to allow the use of their prescription data for marketing purposes, so they have a veto power over the mining companies’ access to the data in their records for use in marketing.Â Thus, the law is expressly aimed only at marketing, which it defines as any effort to influence sales or market shares of a given brand-name drug, or to influence how and what a doctor prescribes.Â Â The law allows a wide array of other recipients of the data — including insurance companiesÂ and medical research institutions, as well as law enforcement authorities — to get the data, without restricting their use of it.
The law was challenged in federal court by three data-mining companies, IMS Health Inc., Verispan LLC, and Source Healthcare Analytics, Inc., and by the trade group for drug manufacturers, the Pharmaceutical Research and Manufacturers of America.Â A federal District judge upheld the law, but the Second Circuit Court struck it down under the First Amendment, concluding that Vermont had moved directly to curb the commercial message of the mining companies and the drug manufacturers.Â Â With the numerous exceptions that the law allows to its ban on use of the data, the Circuit Court said, the state law does not achieve its goal of protecting the privacy of the prescription process or of doctors’ medical practice.
There was no attempt here, the appeals court concluded, to control how doctors prescribe drugs, and no attempt directly to regulate the drug companies’ “detailing” system.Â The veto power given individual doctors, to the use of their data, did not salvage the law, the Circuit Court found, since the law was a categorical ban on free speech involving a specified form of information — marketing.Â The Second Circuit said it would not follow the First Circuit Court’s lead in upholding similar laws in New Hampshire and Maine.
Petition for Certiorari
Although the Supreme Court in June 2009 had refused to hear the data-mining companies’ constitutional challenge to the First Circuit’s ruling upholding the New Hampshire law, that was before there was a conflict among the federal appeals courts.Â Â With the Second Circuit striking down the Vermont law in November 2010, officials of that state filed a petition for review in December, urging the Justices to rule on a single question: whether a law restricting access to prescription drug files and giving doctors a right to consent to the use of their prescription patterns violated the First Amendment protection of free speech.Â Quickly, the data-mining companies and the drug manufacturers’ association told the Court that they agreed it should hear the case and settle the conflict, even though, of course, they contended that the Second Circuit had been right in striking down the Vermont statute.
State officials, in their petition, sought to broaden the scope of the constitutional controversy, arguing that the Second Circuit approach had called into question the constitutionality of “numerous federal and state laws that protect information privacy by restricting access to or use of private information.”Â Â Moreover, it contended, the lower courts had split on the issue just at a time when there had been a spreading practice of “commercial data-mining.”Â That, it said, is a “burgeoning business,” and it “makes it increasingly difficult for any person to limit the dissemination of personal information in an age in which such information is routinely maintained and transferred through electronic means.”
The use of electronic medical records “is rapidly expanding, and more and more Americans are relying on private companies to maintain the privacy of their personal health information,” the state petition said.Â The Second Circuit, it argued, had frustrated that effort.Â Â The petition put special emphasis on the fact that the records involved could reveal actual treatment decisions for patients, and on the fact that government has mandated that these records be kept.Â Â “If governments cannot restrict the confidentiality of information in this context, then it is difficult to conceive how any data privacy law would survive constitutional scrutiny,” the petition contended.
The data-mining companies and the manufacturers’ association argued in response that the Vermont legislature had chosen up favorites among the many entities that make use of the prescription files at issue, choosing to stifle the communications only of the drug companies and the data publishers. Insurance companies and academics, they noted, can freely use the material, and do so for commercial purposes, without running afoul of the state law.Â “If the First Amendment means anything,” the data companies argued, “it means that the government cannot so significantly disfavor the one side in a debate that it disfavors.”
The drug companies used their brief to claim credit for developing many life-saving and life-enhancing medicines, based on highly expensive research that they have undertaken. and defended the practice of “detailing” as a primary means by which the information about new drugs and treatment options gets out to doctors.Â The data-mining companies defended their publishing efforts, and insisted that the law simply does not protect doctors’ privacy because the prescription data is so widely distributed.
Still, because they argued that the issues at stake were of “surpassing importance,” they joined Vermont in asking the Court to accept the case for review.Â The Court granted review on January 7.
A central theme of the merits brief filed by Vermont officials, and of the Justice Department’s brief in support, is that this is a case about access to non-public information, and the First Amendment does not give the data-mining companies or the drug manufacturers any right of access to that information.Â An obvious effort to defuse the free speech claims on the other side, these merits briefs borrow from Supreme Court precedents on the government’s authority to restrict the uses of private information that the government has required someone to produce.
“Pharmacies have the prescription information,” the state’s brief said, “only by virtue of government regulation.Â They do not have an unfettered right to sell or use it for purposes unrelated to the patient’s care.Â Nor do [the data companies and the drug makers] have a right to buy these health care records.”Â Thus, it went on, there is no First Amendment right to be recognized.
The Justice Department, in its amicus brief on that side of the case, echoed that theme: “If the information were in the state’s possession, it could deny access without any constitutional difficulty….To be sure, the information here is in private hands rather than the government’s possession, but it came into those hands as a result of the pharmacies’ participation in a closed regulatory system for the safe dispensing of prescription drugs….In these circumstances, it should not matter whether federal and state law require the information to reside with the government itself or with a set of highly regulated private entities.”
Addressing the claims that the law operates as a direct restraint on specific commercial utterances, the state argued that the law does not restrict at all what the drug companies may do in marketing their drugs to doctors, or curb the information they provide.Â It simply handed doctors a veto power to protect only their own prescription information from dissemination without their consent, the state contended.
Both the state and the Justice Department also contended that, if the state law is viewed as a restriction on speech, it should be judged only according to a middle-level of First Amendment scrutiny, especially since the information is generated only as a result of a government mandate.
The data-mining companies and the drug manufacturers’ association, in their separate merits briefs, sought to put the emphasis not on their original access to the information, but on the restraints that they insisted the state law seeks to impose directly on the commercial messages that they communicate with the information once they have it.Â As the drug companies put it: “The First Amendment has never tolerated laws based on blatant animus towards a speaker and its views.”Â Vermont has chosen to favor makers of cheaper generic drugs, and uses that favoritism as the basis for actually banning some communication by the makers of brand-name drugs, the association contended.
“Here, the discrimination is all the more offensive to the First Amendment,” the association argued, “because the law seeks to restrict a massive swath of truthful, beneficial, and FDA-regulated speech concerning whether drugs can save or improve human life in an area marked by scientific and medical complexity and rapid technological evolution.”Â Moreover, the trade group asserted, Vermont has acted “on the assumption that highly sophisticated and trained physicians are not well-equipped to decide what is in the best interests of their patients.”
The data-mining companies’ merits brief sought to mount an attack on the customary view that commercial speech is entitled to lesser protection under the First Amendment.Â First, the brief contended, what the companies do with the data is not solicitation of a commercial transaction at all, but the communication to doctors who would benefit from more information about available drugs and treatment options.Â Â Second, the brief contended, if the message here is treated as commercial speech, under the Court’s prior precedents, then those rulings should be overturned “and the Court should hold that all such attempts to insulate individuals from important and truthful information are subject to strict scrutiny under the First Amendment.”Â Â But, in any event, it added, this law cannot survive even a more tolerant level of scrutiny.
The state of Vermont has drawn the support of 35 other states and the District of Columbia, as amici, arguing that the Second Circuit was right, and that a multitude of state laws that seek to protect against “unauthorized use of personal information for marketing purposes” would be jeopardized if Vermont’s law does not survive. That brief also contended that the data-mining companies and the drug companies should be thwarted in the effort to get the Court to “narrow or abandon the commercial speech doctrine,” because such a result would threaten a wide array of consumer-protection efforts “in areas far beyond the data-mining restriction at issue here.”
A number of briefs from groups specializing in electronic commerce are in the case as amici in Vermont’s support, arguing about the risks of public disclosure of private information through massive data banks, and arguing that attempts to use electronic methods to shield privacy have been shown increasingly to be unable to do so.Â The Electronic Privacy Information Center, for example, praised the development of electronic databases to improving health care, but warned that “without proper safeguards, these databases pose a serious threat to privacy.”Â The transition to centralized depositories of such private information, it added, may lead to disclosure of this kind of data to outsiders.Â That brief also argued that there are significant shortcomings in the cryptographic techniques the data miners use to shield private information about prescriptions.
A number of briefs from medical organizations made it clear that there is at least a substantial segment of the community of doctors and hospitals that is strongly resistant to the drug companies’ “detailing” operations, arguing, among other points, that it interferes with the doctor-patient relationship.
On the other side, the drug-mining companies and the drug trade group drew a varied group of organizations in support as amici, ranging from news organizations that increasingly make use of data-mining in their journalism, to medical research and academic organizations that see major potential in widening the distribution of data, to the U.S. Chamber of Commerce and major trade groups of advertisers seeing in the case a threat to targeted advertising, to former Cabinet health secretaries encouraging wider dissemination of the information in “statistically robust databases,” and to conservative legal advocacy organizations urging the Court to use the case as a way to enhance the free speech rights of the business community in general.
The news organizations’ brief contended that, “in today’s 21st Century information-driven democracy,” gathering and publishing computer-generated data “is a centerpiece of freedom of speech,” and to give it a lesser degree of First Amendment protection would ignore how important that development is to traditional news publishers.Â One of the groups joining in that brief, the non-traditional, online-based investigative entity known as ProPublica, is cited for its efforts to “compile thousands of records in order to track the financial ties between doctors and drug companies,” raising serious ethical questions.Â Much of ProPublica’s efforts, the brief noted, has shown up in traditional newspapers.
Both sides in the case have made energetic efforts to promote their very different visions of what this case is all about, at its core, and that will complicate the Court’s task from the outset.Â Is this a case about access to non-public information, or is it a case about censorship of a disfavored message?Â Starting from either basic perspective, the Court might be led quickly to a nearly inevitable result.Â If this is only an access case, the First Amendment claims of the data miners and the drug companies would seem to be seriously weakened.Â But if it is a censorship case, the First Amendment claims would appear to be at their strongest — even if the message is treated as only a commercial one.
However distasteful some in the medical community find the drug companies’ “detailing” process to be, the problem for Vermont may be that it has chosen a rather blunt instrument to squelch that message.Â The legislative history behind the enactment suggests quite strongly that, even though the lawmakers did not flatly ban drug “detailers” from showing up in Vermont doctors’ offices, that was what they were really striving for.Â But, for the Court to get to this legislative history, it may have to be persuaded first that this is, indeed, a censorship case.Â If it is an access case, there is no persuasive argument that the data miners or the drug makers have some right to it: what prescription forms say is simply not information that is traditionally open to public examination.
Perhaps the biggest challenge for the data miners and the drug companies will be to get the Justices to see the social utility in data-mining as a mode of expression deserving of some First Amendment protection, and perhaps even some heightened protection. Â Given the widespread angst over leaks from computer databases, and the risks of identity theft, the spectacle of huge banks of stored personal data being raked through for salable information might strike some Justices as something less than elevated social discourse.Â Â There are reasons why commercial speech has not yet been brought into the First Amendment’s full embrace, and that, of course, helps explain why the challengers to Vermont’s law have gone to such efforts to persuade the Court that they are not conveying a commercial message at all, but are engaged in the spread of new medical knowledge in the interest of improving health care in America.
The Court has shown some reluctance, when introduced for the first time to new modes of communication, to say too much too soon, lest they develop constitutional doctrine that can be so quickly outdated by another innovation in information technology.Â It may be doubtful, therefore, that the decision that ultimately emerges in this case will say much about data-mining in general, and where it stands in First Amendment rank.