We’ve been interested in IMS Health, Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010), since literally the day after the Second Circuit decided that case. Our interest is not as much in the particular facts of the case, which involves data mining and prescribing statistics (although this is interesting in its own right), as in the context that those statistics are used.
The State of Vermont imposed the restrictions at issue in Sorrell – and did so rather explicitly – to interfere with their use by drug companies in promoting their drugs to prescribing physicians. Thus, as we said in our original post, part and parcel of the Sorrell decision has to be a holding that pharmaceutical promotion is protected commercial speech: “Hello the Supreme Court getting another chance to review governmental speech restrictions on pharmaceutical detailing.” Since truthful promotion of off-label use is also pharmaceutical promotion, a finding of First Amendment commercial speech protection in Sorrell necessarily implicates the off-label use question. We mentioned that in our initial post, too: “Can the off-label promotion ban be far behind?”
Well, as we thought it might, the Supreme Court accepted an appeal in Sorrell. The Court held oral argument in Sorrell yesterday, and we have to say, we think that the First Amendment question of pharmaceutical detailing as a form of protected corporate speech came through looking pretty good. Here’s a link to the transcript, so you don’t just have to take our word for it.
Here’s a brief Justice-by-Justice breakdown of what we thought was interesting, with transcript page numbers:
(14-15) The state wants to lower health care costs by censoring drugmakers. (15) Restrictions disproportionately burden one class of speakers. (17-18) Why is the state making judgments about what commercial speech is effective? (27) It’s problematic to let the state choose the uses of speech, particularly when the state is financially interested. (28) What if the statute only prohibited use of the information for criticizing the state of Vermont? (38-39) Statute allows the information to be sold to journalist for public dissemination, so it doesn’t do much for privacy. (59) Does your argument turn on all the exceptions and the state’s counter-detailing? (59-60) How would you write a statute to protect a physician’s privacy? (62) How is this different from selling tax returns? (65-66) How do you explain the legislative finding about an imbalance in the marketplace of ideas?
(4, 6) The law picks out one use of the information and restricts it. (5) Its “obvious” purpose is to impede pharmaceutical marketing. (7) The prescribing information is public, not private, knowledge. (7-8, 11, 31) The same thing could be achieved (without a restriction on speech) by doctors saying that they’re not interested in sales pitches. (11) How is privacy benefitted when the data can be given away, but not sold? (12) There is no legitimate privacy purpose. (16-17) The law restricts “effective” speech. (19-20) Are you changing your rationale from what you argued below? (24-25) The statute doesn’t protect a physician’s privacy. (30) Can the state bar petition gatherers from only approaching people who have previously consented to being approached? (43) This isn’t a case about false advertising.
(9) The data could be sold to universities. (16) Aren’t you favoring one commercial interest over another by restricting speech? (19) Are you changing your rationale from what you argued below? (29) Are you saying the state can prohibit the most effective form of speech? (52) What if the statute prohibited selling the information to anybody at all? (61) How much does improper legislative intent factor into the First Amendment analysis?
Silence, as always, was golden.
(14) Vermont is also trying to promote generics over other drugs, so doesn’t that contravene precedent that the state cannot restrict one speaker so other speakers can be better heard? (31) Who owns a physician’s prescribing records? (49-50) How is this different from HIPAA?
(40-42) Could the FTC issue a general rule banning certain pharmaceutical detailing practices as false and misleading, including use if data mining? (41) Nobody says the First Amendment doesn’t apply. (42) Why can’t Vermont regulate false and misleading practices? (44) How is this different from false advertising? (51) Could the government collect and keep confidential information about the use of products? (58) Are you questioning restrictions on selling by regulated industries?
(8) The statute would allow Vermont to use the same information in run a “counter-detailing” program – that is, to debunk drugmakers’ claims – should it choose to do that. (18-19, 20-21) Are you changing your rationale from what you argued below? (26) Does the statute protect a doctor who doesn’t want the information given to anyone?
(12-13, 46) Isn’t having an opt-out option a less restrictive alternative to the current restrictions on speech? (49) Why is this not just a consumer statute about control over information? (54) Are what you saying is that the government cannot try to stop the spread of information? (55) Are you hinging your argument on viewpoint discrimination?
(21) How are you (Vermont) interpreting the statute now?
Reading through the transcript, we don’t really see any votes for the proposition that pharmaceutical detailing isn’t protected commercial speech. Even the justices whom we’ve found least congenial to pharmaceutical interests in other cases had problems with the discriminatory manner in which this statute operates (and was intended to operate), the existence of less restrictive alternatives, and the State of Vermont’s positional flip flops.
Whether any of this will ultimately translate into success on the issue of off-label promotion, we don’t know, but we don’t think there’s much sympathy on this Court for a state deciding to restrict the dissemination of information to promote viewpoint-related discrimination against drug detailing by pharmaceutical companies.
We don’t think there’s a lot to be said for the Vermont’s statute at issue in Sorrell. There seem to be a solid six or seven votes to declare it unconstitutional, and the Court could even be unanimous on that point. To us, the more interesting aspect is how broadly or narrowly it will be struck down.