FDA - The First Amendment Closes In

The DC Circuit today held 2-1 that the FDA's proposed graphic labeling for cigarettes is unconstitutional under the First Amendment.  R.J. Reynolds Co. v. FDA, No 11-5332, slip op. (D.C. Cir. Aug. 24, 2012).  While it's a much different analysis than restrictions on truthful off-label promotion, the FDA's regulation fell under the Central Hudson test usually applied to commercial speech.  Slip op. at 28-30.  We think that the court's discussion of the second Central Hudson prong - the "direct advancement" test - id. at 24- has some relevance to the Agency's off-label speech prohibition.  The court required proof of "direct cause" to satisfy that prong, and we doubt that the FDA has any more evidence of such cause to support its off-label ban than it did for its graphic warnings.  The agency's characterization of data as "suggestive" was only another way of saying it was "mere speculation and conjecture."  Id. at 26.

Nor can the FDA define for itself the "effectiveness" of its speech restrictions:

Allowing FDA to define “effectiveness” however it sees fit would not only render Central Hudson’s “substantial interest” requirement a complete nullity, but it would also eviscerate the requirement that any restriction “directly advance” that interest.

  Slip op. at 29.  And there, at the end, lurks Sorrell:  “[t]hat the [government] finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.”  Slip op. at 30 (quoting Sorrell, 131 S.Ct. at 2671).

Off-label use is probably more prevalent than smoking these days. The most plausible argument for the FDA is that discouraging off-label promotion encourages submission of such uses to the Agency. That doesn't seem to have worked much, if at all. "FDA cannot get around the First Amendment by pleading incompetence or futility." Slip op. at 28-29.

Ouch.  The First Amendment is coming.

Stolen Valor and Off-Label Promotion

Earlier this month, Paul Clement, a really smart guy who used to be Solicitor General of the United States, came to Philadelphia to present an overview of the Supreme Court’s last term.  According to the Legal Intelligencer’s (that’s our local Philly legal newspaper) article about the event, he suggested that the Supreme Court’s “stolen valor” case, United States v. Alvarez, 132 S.Ct. 2537 (2012), would be of use to folks, like us, who are interested in First Amendment protection of truthful promotion of off-label use.  According to the Legal:

Lawyers representing pharmaceutical companies in litigation over off-label marketing may want to read up on the U.S. Supreme Court's decision in the so-called “Stolen Valor” case, former U.S. Solicitor General Paul Clement said. . . .  The Stolen Valor case, United States v. Alvarez, was a “great illustration of how pro-First Amendment this court is,” Clement said. . . . “This case is useful in off-label marketing cases and fraud prosecution,” Clement said.  He noted that the government has settled these types of cases for high-dollar figures and there are a number of lawsuits against pharmaceutical companies regarding off-label marketing.  But Clement said the [C]ourt’s willingness to give “breathing space” to speech may benefit the drug companies.

Legal Intelligencer, “Clement, Prolific in High Court Arguments, Reviews Latest Term” (para 1-7) (July 18, 2012).

Since one could say that we’re interested in that subject, we decided to take him up on it.

There aren’t that many facts necessary to understand Alvarez − just two, actually.  (1) Congress passed the “Stolen Valor” Act, 18 U.S.C. §704, making it a crime for anyone to “falsely represent[] himself or herself . . . to have been awarded any decoration or medal authorized by Congress for the Armed Forces of the United States.”  Alvarez, 132 S. Ct. at 2543.  (2) The appellant falsely represented himself as having been awarded the Congressional Medal of Honor in a town hall meeting.  Id. at 2542.

First impression:  Alvarez is about admittedly “false” speech.  Anything the Court holds concerning First Amendment protection of false speech will be a fortiori (legal Latin for “that goes double for”) where truthful off-label promotion is involved.

Now, figuring out the Court’s “holding” will be a little difficult.  There’s no majority opinion.  Justice Kennedy wrote the lead opinion in Alvarez joined by only three other members of the Court (Roberts, C.J., Ginsberg, and Sotomayor).  There’s a concurring opinion written by Justice Breyer, joined by Justice Kagan.  That makes six justices voting to hold the Stolen Valor act unconstitutional under the First Amendment.

The lead opinion starts out well.  “[T]he First Amendment means that government has no power to restrict expression because of its message, its ideas, its subject matter, or its content.”  132 S. Ct. at 2543 (we’ll only say “citations and quotation marks omitted” once, since quotations abound − consider yourself warned).  That’s useful and certainly not limited to false speech.  “[T]his Court has rejected as ‘startling and dangerous’ a free-floating test for First Amendment coverage based on an ad hoc balancing of relative social costs and benefits.”  Id. at 2544.  Ditto.

Next, the plurality listed the “long familiar” exceptions that allow “content-based restrictions” on speech: those being, incitement of “imminent lawless action”; obscenity; defamation; “speech integral to criminal conduct”; “fighting words”; child pornography; fraud; “true threats”; and “speech presenting some grave and imminent threat the government has the power to prevent.”  Id.

Second impression:  Notably lacking from Alvarez’s list of exceptions allowing content-based restriction is “commercial speech.”  Instead, the seminal commercial speech case, Virginia Board v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976), is listed as a “fraud” case.  That’s particularly interesting because of the application in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), of a more robust First Amendment test than previously used in commercial speech cases.  The negative implication is that commercial speech − other than “fraud” − cannot be subjected to “content-based restrictions.”  That’s good for those of us who support truthful off-label promotion.

There is no “general exception” to the First Amendment allowing the government to ban “false statements”  anywhere at any time.  Alvarez, 132 S. Ct. at 2544.  “[F]alse statements are inevitable if there is to be an open and vigorous expression of views in public and private conversation.”  Id.  Even in the context of fraud (where the opinion put Virginia Board), falsity alone was not determinative:

The Court has never endorsed the categorical rule the Government advances:  that false statements receive no First Amendment protection. . . .  Even when considering . . . fraud, moreover, the Court has been careful to instruct that falsity alone may not suffice to bring the speech outside the First Amendment.  The statement must be a knowing or reckless falsehood.

Id. at 2545.

Third impression:  Wow!  Under this standard, the False Claims Act, particularly as it has been construed in the First Circuit, may well be unconstitutional as applied, since the “false statements” it purportedly punishes aren’t limited to “knowing or reckless falsehood.”  Alvarez certainly would seem to have application to off-label promotion cases where the supposedly “false” claims aren’t really false and definitely aren’t intentional.

Well, maybe not.  The Court doesn’t discuss the False Claims Act, but it does discuss a general statute criminalizing false statements made to government officials:

The federal statute prohibiting false statements to Government officials punishes “whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government . . . makes any materially false, fictitious, or fraudulent statement or representation.”  Section 1001’s prohibition on false statements made to Government officials, in communications concerning official matters, does not lead to the broader proposition that false statements are unprotected when made to any person, at any time, in any context.

Alvarez, 132 S. Ct. at 2546.  We’re not specialists in false claims, but our impression in reading qui tam cases involving off-label promotion, is that these cases tend to be brought on a whole lot less than “materially false, fictitious, or fraudulent statement[s]” made directly to the government.  We’ll leave it at that.  The Alvarez plurality seems to us to require, as a matter of constitutional law, a much higher standard of falsity than is generally asserted by current relators in False Claims litigation.

The plurality in Alvarez goes on to state that “[s]ome false speech may be prohibited even if analogous true speech could not be.”  132 S. Ct. at 2546.  That’s generally where we’ve been with off-label promotion.  We don’t have a problem with willfully false off-label promotion being prohibited.  But where off-label promotion is in fact true, then there doesn’t seem to be any basis, particularly under current First Amendment jurisprudence, for banning it.  The only justification has been the lesser protection of “commercial” speech, and in Alvarez, the plurality appears to be equating the “commercial speech” exception with “fraud.”

The Stolen Valor Act, admirable as its intent was, was thus toast under the First Amendment:

The Act by its plain terms applies to a false statement made at any time, in any place, to any person. . . .  [T]he sweeping, quite unprecedented reach of the statute puts it in conflict with the First Amendment. . . .  The statute seeks to control and suppress all false statements on this one subject in almost limitless times and settings.  And it does so entirely without regard to whether the lie was made for the purpose of material gain. . . .  Permitting the government to decree this speech to be a criminal offense, whether shouted from the rooftops or made in a barely audible whisper, would endorse government authority to compile a list of subjects about which false statements are punishable.  That governmental power has no clear limiting principle.

Alvarez, 132 S. Ct. at 2547 (citations − including to George Orwell’s 1984 − omitted) (we had to mention that one).

Fourth impression:  Imagine the Court’s reaction if the same prohibition were extended to true statements.  That’s the FDA’s off-label promotion ban.  The only countervailing factor, as we’ve noted is the Court’s comment about “the purpose of material gain.”  Would the prospect of “material gain” be enough for the Court to wave through the FDA’s off-label promotion ban “at any time, in any place, to any person”?  Perhaps, but we rather doubt it.

Even as a limited prohibition, the Stolen Valor Act was subject to “exacting scrutiny.”  Id. at 2548.  The government’s purpose was a valid one:  fostering “esprit de corps” in the military to “reinforce[] the pride and national resolve that the military relies upon to fulfill its mission.”  Id.  There’s national security wrapped in the flag − can’t get more bedrock than that.  But was a ban “actually necessary”?  Id. at 2549.  The plurality said no.  There was no evidence that such false statements taint “public perception” of military honors.  Id.  Nor could the government show “why counterspeech would not suffice to achieve its interest.”  Id.

Fifth impression:  We’ve argued, in the context of commercial speech, that disclaimers would suffice to prevent anyone from having the false impression that off-label promotion involved something that the FDA had evaluated.  Here’s the same First Amendment point − even in the context of banning concededly false speech.  In either case, “[t]he remedy . . . is speech that is true.”  Alvarez, 132 S. Ct. at 2550.  “Truth needs neither handcuffs nor a badge for its vindication.”  Id. at 2551.  We’d say the same goes double for FDA approval.

That’s the plurality.  To make a majority, at least in Alvarez, required Justice Breyer’s concurrence.  We note that, in Sorrell − also authored by Justice Kennedy, all of the dissenters found truthful pharmaceutical promotion First Amendment protected (although neither of the concurring justices here in Alvarez did).

Justice Breyer would find the Stolen Valor Act unconstitutional under “intermediate scrutiny” − that’s the same level scrutiny that is (or used to be) applied to commercial speech.

The dangers of suppressing valuable ideas are lower where, as here, the regulations concern false statements about easily verifiable facts that do not concern such subject matter.  Such false factual statements are less likely than are true factual statements to make a valuable contribution to the marketplace of ideas.

Alvarez, 132 S. Ct. at 2552 (emphasis added).

Sixth impression:  After having said this, Justice Breyer will have trouble finding an administrative justification for banning truthful off-label promotion − but he could certainly try.  What’s more likely to “make a valuable contribution to the marketplace of ideas”; lying about being awarded a military medal or truthful information about uses of drugs/devices that could save people’s lives?  We know which way we’d vote.
Justice Breyer then recites “value” that can be found even in false statements.  Id. at 2553.  Moreover, “the threat of criminal prosecution for making a false statement can inhibit the speaker from making true statements, thereby ‘chilling’ a kind of speech that lies at the First Amendment’s heart.”  Id.  Imagine how much more “chilling” he might find an absolute ban on undisputedly truthful speech.  That’s the old a fortiori again.

Other prohibitions of false statements, Justice Breyer believes, are properly limited in scope.  In particular, there’s fraud.  “Fraud statutes, for example, typically require proof of a misrepresentation that is material, upon which the victim relied, and which caused actual injury.”  Id. at 2554.  None of those limiting features is found in the FDA’s ban on truthful off-label promotion.  It doesn’t matter if the off-label promotion changes anyone’s mind or if it causes any harm to anyone.

The Stolen Valor Act “lacks any such limiting features.”  Id. at 2555.  Even if construed to prohibit only deliberate falsehood, it still applies in any context, public or private − just as the FDA’s prohibition applies to private conversations between sales reps and doctors.  See, e.g., United States v. Caronia, 576 F. Supp.2d 385 (E.D.N.Y. 2008) (prosecuting private conversation with a physician from which no prescription resulted from truthful off-label promotion − because the physician was also a government informant).  “[T]he risk of censorious selectivity by prosecutors is also high.”  Alvarez, 132 S. Ct. at 2555.  See Caronia, supra.  And how much of the FDA’s information about off-label promotion comes from competitors motivated (selectively) by commercial reasons?  We’d say a lot.

Finally, Justice Breyer embraces the concept of “less burdensome” alternatives − such as the truth.  “I would also note, like the plurality, that in this area more accurate information will normally counteract the lie.”  Alvarez, 132 S. Ct. at 2556.  Less restrictive alternatives were available, so the prohibition on false statements failed intermediate scrutiny.  Id.

Final impression:  While there’s a lot about Alvarez that’s distinguishable from a First Amendment case involving truthful off-label promotion, most of those distinguishing factors cut in favor of more, not less, constitutional protection of truthful speech, particularly if the particular off-label statements were made in an innocuous context, such as a private presentation to a skilled audience (a trained physician) that includes some scientific papers and other core First Amendment protected speech, and involve intrinsically valuable information that could save lives or promote health.

In short, the illustrious Mr. Clement is in all probability correct in his observation − at least on this subject.

New First Amendment Article

While we’re still sitting around waiting for the Second Circuit to decide Caronia, we though we’d pass along a new article on the First Amendment and the FDA’s restrictions on off-label use.  It’s by Kyle Thompson, a law student at BU, and it’s titled “The Changing Landscape of the Commercial Speech Doctrine and FDA Advertising Regulation: Off-Label Marketing in the Wake of Sorrell v. IMS.”  We got it through SSRN for free, although we did have to register. We hope we’re not overstepping our bounds somehow, but here’s a link to the article.


We found it, frankly, because it cited a couple of Bexis’ articles on the subject.  But you can put that aside, since what he wrote is pretty old.  The Thompson piece also cites and to some degree synthesizes a flood of more recent scholarship (see article at fn.7) that’s been written since Bexis left writing law review articles to law professors and decided to take up blogging instead (to the relief of both professors and bloggers).

Anyway, we don’t want to spoil your reading enjoyment by giving everything away, so we’ll just hit the highlights:  (1) an interesting discussion (using Botox as an example) of the government’s campaign to monetize the FDA’s questionable prohibition truthful promotion of off-label use; (2) a good, detailed discussion of the Sorrell case, which introduced academe to the off-label use issue; (3) some critical analysis of non-speech alternatives to the FDA’s current regime; and what was probably the most interesting to us (4) an analysis of what the more general opinion − Citizens United v. Federal Election Commission, 130 S. Ct. 876 (2010) − could bring to the table. That’s the good stuff.

Conversely, we were disappointed in one aspect, or non-aspect, of the Thompson article.  We were hoping, especially in the Citizens United context, for a discussion of fully-protected scientific speech, as opposed to just promotion of off-label use as commercial speech.  We see scientific speech as the closest analogy to the political speech at issue in Citizens United, although we’re still somewhat skeptical of exactly how relevant Citizens United is to the entire off-label use issue.

Anyway, if you’re into the First Amendment’s impact on off-label use promotional restrictions, you’ll probably enjoy the new article.

More Inspiration from the Courts on Commercial Speech

When most of us think of the First Amendment, commercial speech is probably not what springs to mind.  A business talking about its products doesn’t fit our classic perception of free speech.  It will never equal the “I Have a Dream” speech or stir inspiration in your soul.  But it’s important.  It really is.  The Supreme Court says so:

Advertising, though entirely commercial, may often carry information of import to significant issues of the day.  And commercial speech serves to inform the public of the availability, nature, and prices of products and services, and thus performs an indispensable role in the allocation of resources in a free enterprise system.  In short, such speech serves individual and societal interests in assuring informed and reliable decision-making.

Bates v. State Bar, 433 U.S. 350, 364 (1977). 

And, generally, the worth of the information that is put into the commercial marketplace should be determined by the speakers and the audience hearing it, not the government:

The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented.

Edenfield v. Fane, 507 U.S. 761, 767 (1993).  This means that the government should not quiet commercial speech simply for paternalistic reasons: “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996).

Given its importance, we have discussed the FDA and its regulation of commercial speech often, and we recently saw yet another interesting opinion in this area, Fleminger, Inc. v. U.S. Dep’t of Health & Human Servs., No. 3:10cv855 (VLB), 2012 U.S. Dist. LEXIS 22892 (D. Conn. Feb. 23, 2102).  The Fleminger case involved green tea.  Its maker petitioned the FDA for authorization to make a “health claim,” which is a claim that relates nutrients in the product with a positive health effect.  Here, the particular health claim was that the green tea may reduce the risk of breast and prostate cancers.  Id. at *25.  

Generally, the FDA will allow such a health claim if there is (i) “significant scientific agreement” supporting the claim or (ii) “credible evidence” (a lower level of evidence) supporting the claim, but then only if the claim is accompanied by an appropriate disclaimer on the lower level of the scientific evidence.  The FDA calls this second category “qualified” health claims and readily admits that it arose from court rulings against the FDA in First Amendment cases.  See, e.g., Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053832.htm). 

Fleminger involved a “qualified health claim.”  It was “qualified” because the FDA found that the scientific evidence supporting it was “the lowest level” that could still allow such a claim.  Id. at *26-28.  Hardly a ringing endorsement from the FDA, but this is where the First Amendment steps in.  The FDA can’t stop a company from making such a claim since it has sufficient supporting evidence.  The FDA, instead, can require the company to include an appropriate disclaimer, but only one that doesn’t violate the company’s First Amendment rights. 

The controversy in Fleminger did not involve the company’s health claim – that “Green tea may reduce the risk of breast and prostate cancers.”  That is good.  The FDA has recognized that the First Amendment does not allow it to simply strike down a health claim that has some support.  The controversy in Flemering, instead, involved the disclaimer.  The company wanted:

“The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.” 

Id. at *34-35.  The FDA believed that this disclaimer overstated the scientific evidence.  It wanted:

“FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” 

Id. at *33-34.  The company balked and took the issue to court on First Amendment grounds. 

The Fleminger opinion detailed the history of decisional law on the FDA’s regulation of commercial speech and, if interested, you should read the entirety of the opinion.  We will limit our discussion, however, to the court’s consideration of whether the FDA’s rejection of the company’s disclaimer and imposition of its own disclaimer was a “reasonable fit” with the government’s interest in preventing confusion about health claims and advancing the public health.     

First, the court addressed the company’s proposed disclaimer – “FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.”  The court struck this down as misleading and inaccurate, basing its decision on its deference to the FDA’s finding that there was “very little scientific evidence” to support the company’s health claim.  Id. at *50-62.  The court considered the FDA’s ranking of the evidence to be very different from the company’s claim that it was “credible . . . although . . . limited.”  What is interesting, though, is that the FDA’s own guidelines define a “qualified health claim” as one that is supported by “credible but limited evidence.”   Id. at *57.  That language is very familiar.  It’s almost the same language that the company used in its disclaimer.  So how can the company’s disclaimer be inaccurate if it essentially tracks the description of qualified health claims found in the FDA guidelines? 

Well, the court found a difference between consumers' everyday understanding of the word “credible” and its unique and technical meaning within the FDA guidelines.  The court determined that a member of the public reading a disclaimer was more likely to understand “credible” to mean “offering reasonable grounds for being believed,” which is how Webster's dictionary defines it, than to mean the lowest level of evidence, which is how it applied under the FDA guidelines in this case.  Id. at *53-54, 57-58.  This reasoning didn't help the company.  But it could help the defense in other products and device cases.  We've seen plaintiffs' counsel try to use technical terms from FDA regulations and guidelines, such as "adulterated" or "misbranded," to create a false or overly negative impression with a jury.  The reasoning of the Fleminger court, however, can possibly be used to block such efforts or get a curative instruction from the judge. 

Next, the court addressed the FDA’s proposed disclaimer and upheld the portion stating that “very little scientific evidence” supported the company’s health claim.  Id. at *67-70.  This was sheer deference to the FDA’s findings.  This ruling, however, is not surprising.  The history of this case reveals that the FDA contoured the language of its proposed disclaimers to the case law as it developed.  The FDA has been chastened over the years by previous losses in First Amendment litigation.  The FDA has finally reacted and adjusted.  “[T]he First Amendment requires that the FDA allow Fleminger’s claim,” but the FDA can require “the addition of short, succinct and accurate disclaimers as to the level of scientific support of the proposed health claim.”  Id. at *68-69.  Here, the FDA provided the court with the details of its analysis and findings on the level of scientific evidence and proposed a short, succinct clause to describe those findings.

But the court did not uphold the FDA’s entire disclaimer.  The court struck down the FDA’s proposed language that “FDA does not agree that green tea may reduce that risk.”  That is not a disclaimer.  It’s an explicit announcement of the FDA’s own opinion that was to be inserted into the Company’s speech immediately after the company’s health claim.  It would have had the impermissible  “effect of negating any relationship between green tea and the reduction of breast or prostate cancer and therefore effectively swallow[ed] the entire claim.”  Id. at *71.  In essence, it was a way around the prohibitions of the First Amendment, and the court properly did not allow it.

The story ended fairly well.  The company was allowed to exercise its First Amendment rights and state its health claim about green tea, and the FDA was not allowed to inject its own opinion into that claim.  It’s probably not inspirational or moving.  But it’s another step in what has become a very interesting area of the law. 

This New England v. New York Thing is Getting Old

Let’s get this out straightaway: it is gruesomely hard to come up with a Super Bowl theme for a post on drug and device litigation. It’s even harder for anyone in Philadelphia to come up with anything nice to say about New York or Boston. Philadelphia used to be the second-biggest English-speaking city in the world. But the Erie Canal and other factors propelled NYC past us, and we’re still smarting over the indignity. We probably harbor even harsher feelings for Beantown. Applying any objective measure, Philly trumps Boston (more history, better climate, closer to, um, New York). Nevertheless, denizens of “The Hub” carry around an unbearably smug Brahmin attitude while we cheesesteak-eaters are all-too-quick to poor-mouth our fair city. Let’s remember that Benjamin Franklin was born in Boston, but fled Red Sox Nation for greener pastures – Philly – where he became our most entertaining and randy Founding Father. Let’s also remember that the Patriots (the footballers, not the heroes of 1776) racked up their greatest victories while cheating – ever hear of Cameragate?

Yesterday’s New York-New England Super Bowl presented your average Philadelphian with a bitter choice. Manhattan chowder or New England? Bah – snapper soup tastes better than either. The Ramones or Aerosmith? Those guys are all dead or look like it. Today, The Roots rule. Melville or Emerson? Turgid transcendentalism is a literary snooze-fest, and why does it take 600 pages to get from “Call me Fishmeal” to the "devious-cruising Rachel" who "found another orphan"? (Sounds like a description of an ordinary Saturday night in an Alphabet City club, doesn't it?) Give us the legal fiction of former Dechert-ite Lisa Scottoline anytime.

Anyway, we spent too much time yesterday straining to come up with a Super Bowl angle for today’s post. Why not just pop open a Yuengling, forget that there ever was a disappointment called the Iggles, and enjoy the unofficial National Holiday? But we’re legal geeks, so we cannot help but compare Boston and New York in legal terms. Both have had some Pro Bowl jurists. Oliver Wendell Holmes was on the Massachusetts bench, and New York had Cardozo. But the glory that was Boston and the grandeur that was New York are no more. Now Boston is home to frivolous qui tam cases, and we tremble at the prospect of another social engineering magnum opus from E.D.N.Y.

So we’re setting up a new competition between New York and New England. There are a couple of cases where lower courts fumbled some pretty basic and important DDL concepts, and now it’s up to the First and Second Circuits to go under the hood and, after further review, reverse the calls on the field. To switch to another sport for a moment, we feel like Ted Knight in Caddyshack, grimacing and sputtering, “Well – we’re waiting!”

In New York there was the Caronia case, which we blogged about here and some other places. The constitutionality of the FDA’s prohibition against truthful off-label promotion is at issue. Since the Second Circuit favorably decided the Sorrell first amendment decision, later affirmed by the U.S. Supreme Court, we were optimistic that Caronia would be reversed. We are still optimistic, but are also increasingly impatient.

In New England there was the Bartlett case, which we blogged about here and several other places. Bartlett produced a couple of decent rulings, and then it produced some monstrous ones, followed by a $21 million verdict. It made our bottom ten list in 2010 mostly because the court permitted a design defect claim against an FDA-approved prescription drug, even where the plaintiff does not show an alternative design. The court also allowed failure-to-warn evidence that had no proper place in the case. The court apparently regretted the plaintiff counsel’s grotesquely unfair conduct, but did not do anything about it. In other words, the plaintiff’s counsel got away with it.

Football is fine, but it isn’t ultimately how we judge a city. We’re more likely to don a big foam finger or slip on a beer-tube helmet to honor whichever appellate court is first to tackle and reverse one of these rotten decisions.

* * * * * * *

While we are on the subject of keeping score, we thought we’d step back and take a look at what has happened in Aredia/Zometa trials. We've written about motion practice in Aredia/Zometa cases here, among other places. Last Tuesday, Joe Hollingsworth reported on a defense verdict in the Kyle case that was returned in just over two hours after a three week long federal Zometa trial in the Western District of Kentucky. That was pretty good. Then the next day, in Brodie v. Novartis Pharms. Corp., the jury found in favor of Novartis following a one and a half week trial in the Eastern District of Missouri. In Brodie, plaintiff Sharon Brodie alleged that her deceased husband, John Brodie (not the 49er quarterback), developed osteonecrosis of the jaw (“ONJ”) as a result of his use of Novartis’s cancer drug Zometa. The prescribing oncologist testified that he had been aware of the risk of ONJ as a result of a “Dear Doctor “letter. That was the third federal defense verdict in a row for Novartis and the second defense verdict in just two days in litigation arising out of the consolidated federal MDL pending in the Middle District of Tennessee, In re Aredia and Zometa Prods. Liab. Litig. (The fourth case is on appeal in the Fourth Circuit.) And in the only case arising from the New Jersey state court consolidated Aredia/Zometa litigation to be tried, Bessemer v. Novartis Pharms. Corp., the jury also found for Novartis. A number of Zometa trials are set for the remainder of 2012, including a trial arising out of the New Jersey consolidated litigation that’s scheduled to begin in March. We are cheering for Joe to keep running up the score.

First Amendment Smorgasbord

While we’re all waiting for the Second Circuit to decide the Caronia case – and, we hope, hold that the FDA’s prohibiting the truthful promotion of off-label use violates the First Amendment – we’d like to pass along some light reading.  The current issue of Health Matrix, published by the Case Western Reserve Law School, is mostly a symposium on commercial speech and public health.   It contains six articles that provide a variety of viewpoints on the First Amendment and health-related communications generally, and off-label use in particular.

 

Here are some brief descriptions to whet your appetite:

• Beales, “Health Related Claims, the Market for Information, & the First Amendment,” 21 Health Matrix 7 (2011).  A former FTC consumer regulator, argues for surprising limited regulation of commercial speech.  More information is better than less, and regulation should be viewed skeptically lest it backfire.
• Noah, “Truth or Consequences?:  Commercial Free Speech vs. Public Health Promotion (at the FDA),” 21 Health Matrix 31 (2011). We could read Lars Noah all day on any number of topics (his recent article on Conte liability is a gem).  Well, here’s sixty more pages.  He thinks the FDA’s on the path to perdition, and that regulation of off-label promotion needs to be a lot more nuanced than the Agency’s current meat axe approach.
• Gilhooley, “Commercial Speech, Drugs, Promotion & A Tailored Advertisement Moratorium,” 21 Health Matrix 97 (2011).  She doesn’t like DTC advertising, so she would be happy to see Congress shut it down.  Back-handedly, she seems to admit that she has a lousy legal hand at the moment, so she wants the Court to back away from its decision in Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
• Masoudi & Pruitt, “The Food & Drug Administration v. The First Amendment:  A Survey of Recent FDA Enforcement,” 21 Health Matrix 111 (2011).  Masoudi worked in the belly of the beast, but seems to have thought better of it.  The article posits that the FDA’s enforcement posture is both substantively unconstitutional and chills free speech.  It takes one to know one.
• Conko, “Hidden Truth:  The Perils and Protection of Off-Label Drug & Medical Device Promotion,” 21 Health Matrix 149 (2011). This one’s probably closest to our views, since it: (a) recognizes the health benefits of off-label use and (b) emphasizes less restrictive alternatives to the FDA’s flat ban.
• Yosifon, “Discourse Norms as Default Rules:  Structuring Corporate Speech to Multiple Stakeholders,” 21 Health Matrix 189 (2011).  The other side will like this, since he views corporate speech as a “problem,” and somehow consumers become “stakeholders” just by existing.  This view can’t really be reconciled with the last 30 years of First Amendment jurisprudence, so Yosifon doesn’t much bother to try.

Enjoy.

FDA Takes It On The Chin Again In First Amendment Case

This opinion involves cigarette warnings, so we have to be careful, since Dechert represents tobacco companies.  We recommend that our readers interested in First Amendment issues take a look at R.J. Reynolds Tobacco Co. v. FDA, No. 11-1482 (RJL), slip op. (D.D.C. Nov. 7, 2011), with an eye towards the court's analysis of "compelled commercial speech."  Although the facts are (we hope) extreme, the court's discussion of the Zauderer "purely factual and uncontroversial information" test for compelled speech leaves us with some interesting hypotheticals to consider.  Remember, after New York Times v. Sullivan, private tort claims are on par with other forms of governmental restrictions on speech for purposes of the First Amendment.  Query whether plainitiffs demanding warnings about supposed causal relationships that are anything but "uncontroversial" might be running afoul of the First Amendment.  Or query further whether the FDA's regulations, which at some points appear to require warning changes based on less than an established causal relationship (more about that here) might also be subject to First Amendment challenge.

We're not in a position to answer these questions.  But we think they're worth asking.

You Heard It Here First

Yesterday's Wall Street Journal has an interesting article about the FDA's off-label promotion ban being "in some jeopardy" after the Supreme Court's Sorrell decision, and pointing to the Caronia case, to be decided "within weeks," as the leading example of possible First Amendment scrutiny.  Well, you heard it here first.  We pointed out this implication of Sorrell back in June, the day that the Supreme Court decided the case.  We've been following Caronia even longer. Glad to see the mainstream media waking up, that the government ability to monetize (to the tune of over $8 billion, according to the article) its First Amendment violations may be drawing to a long-overdue close.

First Amendment Toolkit

Thursday is normally the day for our longer and meatier posts.  However, the crush of business at the moment really is a crush.  So we’re putting up something today that, frankly, doesn’t require as much work.  Yesterday we provided our opinions about the latest First Amendment briefing in the Caronia off-label promotion case.  We remarked that we were gratified that the industry itself – instead of just interest groups (kudos to the Washington Legal Foundation for engaging in a fairly lonely battle on this issue for years), criminal defendants, and miscellaneous bloggers like us – appeared to be getting into the game.


Our desire to see more First Amendment challenges to the FDA’s suppression of truthful commercial speech in this area is tempered by a countervailing concern not to see any newcomers screw up the law.  Large companies with correspondingly large cases and large legal budgets, we don’t worry about much, but many FDA regulated entities whose free speech rights are being chilled by the threat of FDA enforcement aren’t so big.

So we’ve decided to do our bit to help by collecting the best First Amendment/off-label use litigation references that we know about and offering the here.  That's our toolkit.

First, some cases.  For anyone even thinking about an FDA-related First Amendment challenge, the Supreme Court’s decisions in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), are absolutely required reading.  The relevant test, at least up until Sorrell, was stated in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557, 566 (1980).

There are too many lower court opinions to cite them all, but a good place to start is with WLF v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998), partially mooted, 202 F.3d 331 (D.C. Cir. 2000), and WLF v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999), which are really part of the same case.  Not as closely on point, but from an appellate court is, Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).  In the same category as Pearson we’d put Alliance for Natural Health U.S. v. Sebelius, 714 F. Supp.2d 48 (D.D.C. 2010).  The District of Columbia federal courts are a frequent forum for litigating FDA issues, and they’ve been pretty friendly to the First Amendment so far.

There’s also a helpful discussion of the issue in United States v. Caputo, 517 F.3d 935 (7th Cir. 2008), but it’s dictum.

It’s not all sweetness and light though, as the district court decision being appealed in Caronia demonstrates, United States v. Caronia, 576 F. Supp.2d 385 (E.D.N.Y. 2008).

And finally, it has nothing to do with the First Amendment, but Richardson v. Miller, 44 S.W.3d 1 (Tenn. App. 2000), has what we’d describe as the most thorough discussion of off-label use by a court in a non-regulatory context.

Second, some briefs.  Here are some briefs that not only make the right legal arguments, but collect a lot of the relevant factual material needed to support a serious First Amendment challenge.  Perhaps the best of the bunch – at least those we know of – is the preliminary injunction brief filed by Allergan in its regrettably settled litigation against the FDA.   It’s what one would expect from an actual party to litigation backed by the resources of an AmLaw top 50 firm.  With the industry coming on board, we're hoping to see more.

Then there are sophisticated amicus briefs.  Most recent, of course, is the Medical Information Working Group amicus brief in Caronia that we discussed yesterday. The WLF’s amicuss brief at an earlier stage in Caronia is also quite comprehensive and useful.  A bunch of groups signed on to support Allergan in its litigation; their brief compiles lots of useful regulatory and medical sources about off-label use. The amicus brief that Bexis filed in Caputo on behalf of WLF ain’t too shabby either.

Third, some law review articles.  The newest thing we know of is, LaSalle, “A Prescription For Change:  Citizens United’s Implications For Regulation Of Off-Label Promotion Of Prescription Pharmaceuticals,” 19 J. L. & Pol’y 867 (2011), although we caution that the legal approach it recommends pushes the envelope somewhat.  We were consulted by the author, so we have a pre-publication copy online here.

A couple of fairly recent treatments, heavy on the regulatory side, are Gentry, “Criminalizing Knowledge:  The Perverse Implications of the Intended Use Regulations for Off-Label Promotion Prosecutions,” 64 Food & Drug L.J. 441 (2009) (the author sent us a link, here), and Leghorn, et al., “The First Amendment & FDA Restrictions on Off-Label Uses:  The Call for a New Approach,” 63 Food & Drug L.J. 391 (2008).

We’re also partial to Hall & Sobotka, “Inconsistent Government Policies:  Why FDA Off-Label Regulation Cannot Survive First Amendment Review under Greater New Orleans,” 62 Food & Drug L.J. 263 (2007) (available here), especially since Professor Hall loaned it to Bexis in pre-publication form for use in his in his Caputo brief.

For more about policy and less about law, check out:  Osborn, “Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific & Medical Information,” 10 Yale J. Health & Pol. L. & Ethics 299 (2010), Dresser & Frader, “Off-Label Prescribing: A Call For Heightened Professional & Government Oversight,” 37 J.L. Med. & Ethics 476 (Fall 2009), and Fritch, “Speak No Evil, Hear No Evil, Harm the Patient?:  Why the FDA Needs to Seek More, Rather Than Less, Speech From Drug Manufacturers On Off-Label Drug Treatments,” 9 Mich. St. U. J. Med & L. 315 (2005).

Another good, if old, place to look is Smith, “Avoiding Awkward Alchemy in the Off Label Drug Context and Beyond:  Fully-Protected Independent Research Should Not Transmogrify into Mere Commercial Speech Just Because Product Manufacturers Distribute It,” 34 Wake Forest L.R. 963 (1999).

Finally, they’re a little long in the tooth right now, but back before he started blogging, Bexis wrote law review articles.  Blackwell & Beck, “Drug Manufacturers’ First Amendment Right to Advertise & Promote Their Products for Off-Label Use:  Avoiding a Pyrrhic Victory,” 58 Food & Drug L.J. 439 (2003), has a good discussion of the issues, especially alternatives to the FDA's speech ban, and also some things to watch out for in bringing these sorts of actions.  His even older article (the first law review article ever that really discussed off-label use in depth), Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions,” 53 Food & Drug L.J. 71 (1998) (available here), isn't First Amendment-centric, but is still a decent source for general information on off-label use and the regulatory scheme.  Debunking has also been cited a lot, so it can be a fruitful springboard for finding more recent stuff.

Fourth, to give the other side its due, for the FDA’s official view of off-label promotion, the best place to look is probably the Guidance on Reprint Practices.  Other regulatory materials can be located via the briefs or law review articles already discussed.

Fifth, and finally, if anyone’s interested in our First Amendment musings, they are compiled here.

So you have are the resources, as best as we can supply them. So go forth and litigate. Maybe your case will be the one the Supreme Court ultimately takes.

Caronia, The Latest

The moment we saw the Supreme Court’s First Amendment decision in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), we knew it had implications for the FDA's suppression of truthful commercial speech concerning off-label uses, and we said so.  Not only that, the dissent in Sorrell caught the FDA angle, too.  Id. at 2678. Only the dissenters didn’t like it – we did.


It appears that the first place that the Sorrell rubber is likely to meet the off-label promotion road is in our old friend, the Caronia case, which has been on appeal in the Second Circuit for what seems like forever.  As readers may recall, Caronia was an FDA “sting” where a doctor, wearing a wire, affirmatively sought out off-label promotion, and (through the manufacturer's representative (Caronia)) drew another doctor (Dr. Gleason) who worked for a drug company, into a discussion of an off-label use.  Both the other doctor, and the rep, who facilitated the conversation, were prosecuted.  Nothing false was said, but the government went ahead anyway, and obtained a conviction.

Caronia had already been argued after Sorrell was decided.  The court (we think) on its own motion asked for additional briefing on Sorrell.  Those briefs were filed this past week.  The government’s brief – arguing in favor of criminal suppression of truthful promotion of off-label use – predictably takes the position that Sorrell doesn’t change anything.  Since we like to gripe, we'll spend most of our time on that one.

According to the government, the speech, even if truthful, wasn't itself banned, but was merely used as “evidence of intent.”  U.S. br. at 1.  Sorell was just more of the same, the government argued, simply another application of the Central Hudson test, and the court should ignore the Supreme Court’s references to “heightened" judicial scrutiny:

Read in this context, the Supreme Court’s references to “heightened judicial scrutiny” do not reflect a decision to abandon intermediate scrutiny in favor of a still more demanding level of judicial review. Instead, the term simply means a more rigorous form of judicial review than the rational-basis review employed by the First Circuit and urged by Vermont. The Court’s opinion makes clear that “heightened scrutiny” encompasses not only strict scrutiny, but intermediate scrutiny as well.

U.S. br. at 5.  The Court’s “heightened” scrutiny reference “singles out,” the government claims, Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993), which was a Central Hudson intermediate scrutiny case.  U.S. br. at 5-6.

The only trouble with that last statement is that it’s far less truthful than anything the defendants were prosecuted for in Caronia.  We took a look at Sorrell, and Cincinnati was one of five, count ‘em, five cases cited to support the Court’s “heightened scrutiny” statement.  See Sorrell, 131 S. Ct. at 2664.  The other four, Turner Broadcasting System, Inc. v. FCC, 512 U.S. 622, (1994); United States v. Playboy Entertainment Group, Inc., 529 U.S. 803 (2000); Simon & Schuster, Inc. v. Members of New York State Crime Victims Board, 502 U.S. 105 (1991); and Minneapolis Star & Tribune Co. v. Minnesota Commissioner of Revenue, 460 U.S. 575 (1983), all suffer from the same problem, from the government’s perspective – they don’t even mention Central Hudson.  So, by a Phillies-like 4-1 score, in the actual opinion, strict scrutiny prevailed over intermediate scrutiny.

Next, the government argued that, even if more scrutiny than Central Hudson was required, it still doesn’t matter.

Remember that.  What that means is that, from now on, we're getting the government's position on so-called "strict scrutiny" - which is how restrictions on things such as political/religious speech are evaluated.

The government's positions are positively retro - as in 1984.

Under strict scrutiny, the would-be speech suppressors distinguish between a conviction for “conspiring to promote off-label uses” (supposedly not what happened) and a conviction for “conspiring to distribute [the drug] without adequate directions for use.”  U.S. br. at 6.  That’s a distinction without a difference.  An ancient FDA regulation (substantively unchanged since the 1950s), 21 C.F.R. §201.128, equates one with the other.  Promoting (truthfully or otherwise) off-label automatically changes the “intended use,” and the new “intended use,” since it’s off-label, by definition doesn’t have “adequate directions for use.”   The government's position seems uncomfortably close to an argument that "conspiring" to advocate, say, medicinal marijuana, could be equated, through regulatory hocus-pocus, to selling pot.

Building on its distinction without a difference, the government tries to describe the “adequate directions for use” language as creating some sort of “disclosure statute.”  U.S. br. at 7.  What would the government have these defendants disclose about off-label use?  Somehow, we don’t think there’s any additional “disclosure” that either defendant could have made that would have kept them out of jail – the more they said, the more they would get into trouble.  The only “disclosure” one can make about off-label use (if one works for an FDA-regulated company) is to say nothing.  Disclosure = silence; love = hate.
In another sleight of hand, the government argues that the prohibition is not “content based” for purposes of strict scrutiny because there is no “official hostility to the manufacturer’s message.”  U.S. br. at 8.  That’s contradicted, we suspect, by every Central Hudson brief the government has ever filed on the question of off-label promotion.  Of course there’s “official hostility” to off-label promotion.  It’s the “substantial government interest” that the government claims is advanced under the Central Hudson test.  The FDA is institutionally opposed to off-label promotion because it believes that to allow such speech (truthful or otherwise) reduces the incentive for companies to get new uses approved by the FDA.  The FDA's entire regime is based on “official hostility.”  Off-label promotion strikes at the FDA’s bureaucratic raison d’être.

Then the government inserts the other foot, claiming that its speech suppression isn’t even “speaker-based.”  U.S. br. at 8.  They put the man in jail, didn’t they?  How more speaker-based can you get?  Supposedly the FDA’s regulations aren’t “limited by their terms” to certain speakers, so they can constitutionally be used to convict particular speakers, even under strict scrutiny.  Id.  The government seems to believe that it can suppress speech all it wants if it does so vaguely enough.  Oh, and if it’s not “speaker based,” how come everybody in the universe not affiliated with a regulated entity (even us, if we wanted) can put their uninformed two cents in on this or that off-label use, but only FDA regulated speakers (probably the most knowledgeable) can’t?  That seems pretty “speaker based” - and dumb - to us.

Next, the government offers the following “distinction” from Sorrell:  “The Vermont law restricted the dissemination of information.  In contrast [the federal act] requires it.”  U.S. br. at 9. When we picked our jaws off the floor, we had to laugh.  These defendants were convicted because they opened their mouths, not because they didn't.  Later (in a different section of its brief), the government even states, “the court did instruct the jury that '[t]he manufacturer, its agents, representatives and employees, are not permitted to promote uses for a drug that have not been cleared by the United States Food and Drug and Administration.'” Id. at 12 (emphasis added).  "Not permitted" sure sounds like a "restriction" on "dissemination" to us.  Arguments like this - that the FDA’s total prohibition (outside of certain narrow categories) of off-label promotion is not a “restriction” on “dissemination” - is the kind of stuff that gives lawyers a bad name.

The government next tries to scare the court by demonizing off-label uses.  They are “unapproved,” “unproven,” and “potentially false.”  U.S. br. at 10.  But not actually false, and doctors engage in off-label use every day.  We don’t know about this particular use, but the government – through Medicare/Medicaid – actually pays for a large number of off-label uses.  The promotion of off-label use is no more unsafe or false (and probably less so) than the promotion of various “dietary supplements” we see us every time we turn on, say, the Weather Channel (which we did a lot recently).

Then, after discussing non-First Amendment issues, the government circles back and goes after off-label use again.  We see more scare tactics – using DES (used off-label to prevent miscarriage) as an example of a harmful off-label use.  U.S. br. at 14-15.  But DES was FDA approved without the “breast cancer” risk ever being discovered (it was before the 1962 FDCA amendments, for one thing).  And, as defense lawyers in prescription drug products liability litigation, we’d be remiss if we didn’t point the number of on-label uses for drugs that the other side alleges cause breast cancer or other potentially fatal injuries.

Certainly, there’s “no assurance” that an off-label use is safe or effective.  U.S. br. at 16.  But every drug on the market was originally an off-label use – before it was approved.  That lack of “assurance” doesn’t make any particular use less safe the day before the FDA approves it, than it was the day after.

Then the government states that the “new and qualitatively more reliable” information generated by FDA clinical trials “would never become available” if manufacturers could promote off-label uses.  U.S. br. at 17. That’s not true, either.  The FDA could easily abandon its speech-based prohibitions and simply mandate that off-label uses attaining some specified threshold of frequency must be submitted to the FDA for approval.  Not only would that be more effective, it would suffer from no constitutional deficiencies.

Finally, the government claims the FDA isn’t criminalizing “speech qua speech” because under the law it has to prove something else as well.  U.S. br. at 20.  What’s that something else that's supposedly sufficient to satisfy strict scrutiny?  Introduction into interstate commerce.  Id. Wow, if that’s all it takes to make any speech ban constitutional, I would hate to be a network broadcaster.

Defendant Caronia also submitted a brief, pursuant to the court’s direction.  Guess what?  We like it better than the government’s brief.  It emphasizes that the government’s parade of horribles simply isn’t implicated where the speech in question is true.  “The “typical” neutral justification for “why commercial speech can be subject to greater governmental regulation than noncommercial speech” is the "concern for fraudulent or misleading statements in commercial transactions.”  Caronia br. at 5.  Sorrell, of course, was all about “truthful” speech.  Id. at 9 (quoting Sorrell, 131 S. Ct. at 2671).

Caronia then argues that the FDA’s suppression of truthful off-label promotion was “content based” and “speaker based” just as was the governmental attempt to restrict on-label detailing in Sorrell.  Any other medical doctor would have been perfectly free to discuss off-label use with a colleague if not affiliated with a drug company.  Caronia br. at 9.  Like the detailers in Sorrell, a company-affiliated physician was within “a narrow class of disfavored speakers.”  Id.  And, like the restriction in Sorrell, it was also viewpoint based.  If either of the defendants had said “don’t do that,” instead of “do that” (assuming that’s what happened), neither would have been criminally prosecuted.  Id. at 9-10.  We’d have hoped that was so obvious it didn’t have to be stated, but apparently it does.  Nobody’s ever been prosecuted either for warning against off-label use (although in the past the FDA has sometimes taken the position, albeit not in court, that warnings are “promotion”) or for simply knowing about it without speaking.

Caronia then equates the banning-too-persuasive speech rationale of Sorrell with off-label promotion, Caronia br. at 10, calling the similarities “striking.”  Id.  We probably wouldn’t go that far, because the FDA bans all off-label promotion, whether it’s persuasive or not, but we do agree fully that what was unconstitutional in Sorrell and the similar problem with the speech ban in Caronia stem from the same root – that pharmaceutical promotion is constitutionally protected speech.  Nor is it just us being biased (which we freely admit to being) – as we mentioned at the beginning of this post, the Sorrell dissenters make the connection, too.  Frankly, we think the off-label ban is worse (as does Caronia, br. at 11), because it’s criminal and because it’s more overtly tied to the content of the information than were the restrictions on use of data in Sorrell.

And this just in - A group called the Medical Information Working Group also filed an amicus brief in Caronia.  We want to get this post done, so as to the substance we'll just say "what they said."  The MIWG brief is, in fact, closer to our First Amendment position than either of the parties' briefs, even Caronia's.  What might be even more significant than the legal argumentsit makes, is the makeup of the MIWG - eleven major pharmaceutical companies.  Finally, the big boys have had enough and are getting into the ring.  Rather than let their rights be determined in appeals of criminal prosecutions selected by the government, we're hoping to see big pharma pick the First Amendment playing fields from here on out.

Anyway, let's not forget that the Supreme Court in Sorrell resolved a First Amendment circuit split – affirming a pro-First Amendment ruling by the Second Circuit.  It’s not lost on us that Caronia is also in the Second Circuit.  We’re hoping that the Second Circuit, having received the Supreme Court’s good-jurisprudence seal of approval in Sorrell, sees fit to build on its First Amendment precedent in this area by reversing the conviction and holding unconstitutional the FDA’s outright suppression of truthful promotion of off-label uses.

Finally, thanks to Rich Samp of WLF and attorneys at Ropes & Gray (representing MIWG) for providing us copies of the Caronia briefing - since PACER inexplicably doesn't include most appellate briefing.

Interesting First Amendment Law Review Note

A recent law review note, Kristie Lasalle, "A Prescription for Change:  Citizens United's Implications for Regulation of Off-Label Promotion of Prescription Pharmaceuticals, 19 J. L. & Pol’y 867 (2011), copy here, puts an interesting twist on the First Amendment arguments against the FDA's ban against truthful promotion of off-label use.  It analogizes between the FDA's vague and discretionarily enforced prohibition and the corporate campaign contribution limitations struck down in Citizens United v. F.E.C., 130 S. Ct. 876 (2010).  While the article was written before the Supreme Court's decision in Sorrell v. IMS Health, Inc., 131 S.Ct. 2653, slip op. (2011), that Sorrell undertook review in a pharmaceutical detailing case that was more rigorous than your usual Central Hudson commercial speech case (something we noted here) provides additional basis for the author's analogy to Citizens United - a non-commercial speech case.

The note also discusses the U.S. v. Caronia case pending in the Second Circuit.  That's the criminal case against a doctor - who happened to be working for a manufacturer - convicted of talking to another doctor (a government informant, as it turns out) truthfully about an off-label use.  We've been following Caronia, most recently here, so we thought we'd see what's up.  Turns out that, after oral argument, the Second Circuit ordered supplemental briefing on the Supreme Court decision in Sorrell (in which the Second Circuit was affirmed).  That order was entered on 7/14/11, and the briefing has yet to be filed.

We mentioned in our own post on Sorrell how that decision implicated the FDA's off-label speech ban.  Evidently the Second Circuit also thinks that it might.

Eventually, the Supreme Court will have to decide the First Amendment issues discussed in the note (and here).  Conceivably Caronia could be that vehicle.

If and when it does, we think that the FDA will lose.

Two More From The Supreme Court

Generic Manufacturers Win Preemption In Mensing

The Court decided 5-4 in favor of generic preemption today in Pliva, Inc. v. Mensing, No. 09–993, slip op.  (U.S. June 23, 2011).  We’d like to talk about Mensing, but it’s a metoclopramide case, and consistent with blog policy we don't comment on cases in which Dechert is involved – so we can’t, at least now.  Sorry, our lips are sealed.

Sorrell – Pharmaceutical Detailing Is First Amendment Protected

In the second interesting opinion of the day, the Court decided Sorrell v. IMS Health, Inc., No. 10-779, slip op. (U.S. June 23, 2011).  Sorrell involved a state statute intended to interfere with pharmaceutical detailing by precluding detailing companies from obtaining access to information (available from pharmacies) about which doctors prescribe what drugs, or even if they got it, from using that information without the prior consent of each and every individual physician.  Slip op. at 2-4.  On top of that, the statute provided for state-financed “counter-detailing” – pushing cheaper, often generic, competing drugs.  Id. at 4-5.  “Data miners,” who gather and sell this information, and pharmaceutical companies challenged the statute as a violation of the First Amendment. 

The 6-3 opinion in Sorrell is a strong reiteration of First Amendment principles, particularly in the commercial speech arena.  Justice Kennedy, the "swing justice" of the current Court, wrote the opinion.  We are aware that, at various times, several of the justices have expressed disagreement with the commercial speech analysis of Central Hudson Gas & Electric Corp. v. Public Servicew Comm’n, 447 U.S. 557 (1980).  Interestingly, Sorrell doesn't strictly adhere to the Central Hudson framework, which will no doubt touch off considerable academic speculation as to that case's continuing viability.  We'll leave that to the First Amendment scholars to chew on.  We're more interested in the prescription drug implications of the case.

In that vein, the point we’re most interested we find right there in the majority opinion’s first paragraph: “Speech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment.”  Sorrell, slip op. at 1.

Initially, the Court found an explicit content-based discrimination against speech, since the statute prohibited use of pharmacy prescriber information only in pharmaceutical detailing.  Slip op. at 6-7.

The statute thus disfavors marketing, that is, speech with a particular content.  More than that, the statute disfavors specific speakers, namely pharmaceutical manufacturers.

Id. at 8.  That’s the first First Amendment no-no, opening the door to heightened judicial scrutiny.  Id. at 7-8.

The Court had no trouble walking through that door.  The state put a heavy thumb on the free speech scale, since the statute alloews it to distribute the same information that it denied pharmaceutical marketers to the statute’s contemplated “counter detailers.”  Slip op. at 8.  “Vermont’s law thus has the effect of preventing detailers – and only detailers – from communicating with physicians in an effective and informative manner.”  Id. at 9.  Thus the statute “goes even beyond mere content discrimination, to actual viewpoint discrimination.”  Id.  That’s an even bigger First Amendment no-no, mandating heightened scrutiny:

Lawmakers may no more silence unwanted speech by burdening its utterance than by censoring its content.  The First Amendment requires heightened scrutiny whenever the government creates a regulation of speech because of disagreement with the message it conveys.

Id. at 10 (citations and quotation marks omitted).  And “commercial speech is no exception.”  Id. at 10-11.

The Court leveled the state’s arguments.  It wasn’t an access to government-controlled information case.  To the contrary, the information that the state was interfering with was already in the private hands of either the pharmacists or the drug manufacturers, and it was their use of information in their own possession that was being restricted.  Slip op. at 12-14.  Nor was the information merely a “commodity” like “beef jerky.” Indeed, in light of what the statute in fact did, the majority had little patience with that argument:

The State has imposed content- and speaker-based restrictions on the availability and use of prescriber-identifying information. So long as they do not engage in marketing, many speakers can obtain and use the information. But detailers cannot. Vermont’s statute could be compared with a law prohibiting trade magazines from purchasing or using ink.

Id. at 15.

The commercial nature of the speech did not insulate the content- and speaker-based prohibitions of the statute from the First Amendment.  “[T]he outcome is the same whether a special commercial speech inquiry or a stricter form of judicial scrutiny is applied.”  Slip op. at 16.  The Court thus left open the possibility (it did not decide the question) that the information in question may be entitled to more than the usual commercial speech protection.  Id.

Even under the lesser scrutiny given restrictions on commercial speech, the statute’s impositions upon pharmaceutical detailing failed.

The statute’s purported justifications did not support the restrictions on pharmaceutical detailing.

First, the statute wasn’t a legitimate effort to protect physician privacy.  Only one use of the supposedly private information was proscribed.  The statute did not prohibit disclosure of sensitive information in “only a few narrow and well-justified circumstances,” but rather “made prescriber-identifying information available to an almost limitless audience” – essentially everybody in the world except pharmaceutical detailers.  Slip op. at 18.  Even the physician consent feature operated only to allow speech that the “state opposes,” so the privacy being offered (assuming there was any) was Big Brother privacy, “only on terms favorable to the speech the State prefers.”  Id.  Thus, “limited range of available privacy options instead reflects the State’s impermissible purpose to burden disfavored speech.”  Id. at 19.

Scratch that flattop.

Second, that some doctors were annoyed by pharmaceutical detailing isn't a justification for the discriminatory exercise of state power.  Having to “endure” annoying speech “is a necessary cost of freedom.”  Slip op. at 20.  We could say the same about attorney advertising, or beer commercials.  Everybody - our clients, not just our opponents - has a constitutional right to annoying commercial speech.

We can turn off the TV.  In their offices, like in our homes, physicians can simply tell annoying speakers to go away:

Physicians can, and often do, simply decline to meet with detailers, including detailers who use prescriber-identifying information.  Doctors who wish to forgo detailing altogether are free to give “No Solicitation” or “No Detailing” instructions to their office managers or to receptionists at their places of work.

Id.

That doctors might actually act on the information provided by detailing, even if (the state would say) they do so wrongly, can’t justify the restriction on truthful pharmaceutical-related speech:

The more benign and, many would say, beneficial speech of pharmaceutical marketing is also entitled to the protection of the First Amendment.  If pharmaceutical marketing affects treatment decisions, it does so because doctors find it persuasive. . . .  [T]he fear that speech might persuade provides no lawful basis for quieting it.

Id. at 21.

Scratch another flattop.

Third, the statute couldn’t be justified as a way for the state to save money by inducing physicians to prescribe cheaper drugs.  Speech cannot be inhibited for this reason:

This reasoning is incompatible with the First Amendment. . . .  [T]he State may not seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, non-misleading advertisements that contain impressive endorsements or catchy jingles.  That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.

Slip op. at 22 (emphasis added).  While there are “divergent views regarding detailing and the prescription of brand-name drugs,” “[u]nder the Constitution, resolution of that debate must result from free and uninhibited speech.”  Id.  “The choice between the dangers of suppressing information, and the dangers of its misuse if it is freely available is one that the First Amendment makes for us.”  Id.

Scratch yet another flattop.  It's looking like a First Amendment Battle of Midway out there.

Pharmaceutical detailers have a constitutional right to seek to persuade doctors to use their products, even if the government doesn’t like the result:

The State may not burden the speech of others in order to tilt public debate in a preferred direction.  The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. . . .  [T]he general rule is that the speaker and the audience, not the government, assess the value of the information presented.

Id. at 23-24.  The speech isn’t “false and misleading,” thus “[t]he State’s interest in burdening the speech of detailers instead turns on nothing more than a difference of opinion.”  Id. at 24 (citing, among other cases, Thompson v. Western States Medical Center, 535 U.S. 35, 376 (2002)).  Midway?  Maybe the better analogy would be to the Marianas Turkey Shoot.

FDA, are you listening?

The dissent was.  It observes – and we agree – that “the same First Amendment standards . . . would apply to similar regulatory actions taken by . . . the Federal Government acting, for example, through Food and Drug Administration (FDA) regulation.”  Dissenting slip op. at 6; see id. at 10-11 (discussing off-label use).

First Amendment Looks Strong In Sorrell

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:

Chief Justice Roberts

(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?

Justice Scalia

(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.

Justice Kennedy

(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?

Justice Thomas

Silence, as always, was golden.

Justice Ginsburg

(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?

Justice Breyer

(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?

Justice Alito

(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?

Justice Sotomayor

(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?

Justice Kagan

(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.

On Suing Publishers

Not too long ago a case here in the Eastern District of Pennsylvania, Slater v. Hoffmann-LaRoche Inc., ___ F. Supp.2d ___, 2011 WL 1087240 (E.D. Pa. March 25, 2011), held that an inadequate warning claim against a “monograph publisher” survived the rather loose standard imposed upon fraudulent joinder.

A publisher?

That’s right, or at least that appears to be what this particular defendant, Wolters Kluwer Health, Inc., (“KWH”) does according to its website – it publishes textbooks (including Lippincott), reference products, journals, bibliographic and reference databases, drug information software, point-of-care tools, web-based information systems, online continuing education products, and electronic information.

A publisher can be liable in a product liability suit in Pennsylvania?

That's a new one on us.

Let’s see how Slater purports to accomplish that feat.  First of all, it’s crystal clear under Pennsylvania law that a pharmacist dispensing drugs is not liable for failure to warn about a prescription drug.  Coyle v. Richardson–Merrell, Inc., 584 A.2d 1383, 1386-88 (1991); Makripodis v. Merrell–Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson–Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985) (note: these are all Bendectin cases, and Bexis participated in their defense).  The only way a pharmacist can be liable is for independently screwing up, such as filling a prescription with the wrong drug.

So the plaintiff didn’t sue the pharmacist.

However, pharmacists now include fact sheets – “patient education monographs” about the drugs they dispense. As Slater recognizes, this isn't something that tort law mandates.  In any event, somebody has to prepare and compile this information.  KWH is one of those entities.

KWH is also headquartered in Philadelphia, which (unfortunately for it) makes it a non-diverse potential defendant for plaintiffs looking to keep their cases in the Philadelphia Court of Common Pleas.  Since he couldn't sue the pharmacist, this plaintiff (with lots of others presumably to follow) elected to sue the publisher of the monograph that his pharmacist gave him on the same failure-to-warn grounds that he's suing the drug manufacturer.

The defense response to this sort of thing is to argue “fraudulent joinder” – that is, that no legally recognized claim against the particular defendant exists and it is being sued solely to defeat diversity, and therefore removal of the case to federal court.  The standard for fraudulent joinder is pretty loose:

Joinder is fraudulent where there is no reasonable basis in fact or colorable ground supporting the claim against the joined defendant, or no real intention in good faith to prosecute the action against the defendants or seek a joint judgment.  But, if there is even a possibility that a state court would find that the complaint states a cause of action against any one of the resident defendants, the federal court must find that joinder was proper and remand the case to state court.

Slater, 2011 WL 1087240, at *2 (quoting In re Briscoe, 448 F.3d 201, 217 (3d Cir. 2006)) (emphasis original).

So what did Slater cite for the proposition that a publisher can be sued for the content of what it publishes? Nothing from Pennsylvania, that's for sure – just one case from Massachusetts holding a pharmacist who provided such a list might could be liable under an “assumed duty” rationale if the list was misrepresented as being “complete” when it wasn’t.  Slater, 2011 WL 1087240, at *3 (citing Cottam v. CVS Pharmacy, 764 N.E.2d 814, 823 (Mass. 2002)).  Because Massachusetts allows such a theory, “a Pennsylvania state court could find WKH assumed a duty to plaintiff based on its voluntary provision of monographs.”  2011 WL 1087240, at *3.

We don't think much of that rationale.

For one thing, Slater seems to be adopting a never-before articulated lowest common denominator test – that if any court anywhere in the country has adopted some cockamamie theory, then the fraudulent joinder “possibility” test allows any federal court anywhere else to speculate that any state that has not explicitly rejected the peculiar theory might adopt it.

How about redhibition?  Granted, it's only recognized in Louisiana, but there's no case out there stating flat out that Pennsylvania (or probably most other states) refuse to recognize it.  How about the AMELD?  That's Alabama specific, but no case in Pennsylvania has ever bothered expressly to say "no."

Not only is the rule in Slater bizarre as a matter of common sense, but it's contrary to the Erie doctrine. The Third Circuit has had plenty to say about expansive predictions of state tort law under the Erie, and it sure hasn’t said anything like that.

Instead, it’s held quite the opposite:

Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010):

[W]e have exercised restraint in accordance with the well-established principle that where two competing yet sensible interpretations of state law exist, we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [that state] decides differently.

Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003):

[A] federal court in a diversity case should be reluctant to expand the common law. . . . [T]here has to be a limit somewhere. Our duty here is to predict how the [state] Supreme Court would view this case and we will discharge that duty by holding that it would reject [plaintiff’s] claims.

We could cite lots more precedent for this proposition – and we have – but that’s not even the worst problem with Slater.

The worst problem is that the plaintiff in Slater didn’t sue a pharmacy, he sued a publisher.

They’re not the same.

Suing a publisher for personal injury based upon the substantive content of something it published raises a whole host of other concerns, and these have been addressed by a Pennsylvania court.

In Smith v. Linn, 563 A.2d 123 (Pa. Super. 1989), the plaintiff died, allegedly because of complications brought on by following the so-called “last chance diet.”  The plaintiff’s estate sued the publisher of a book that the plaintiff had bought about the diet, claiming that the book was “false and dangerous.”  Id. at 125.  The Superior Court rejected each of the plaintiff’s theories.  In particular any analogy between a publisher and a drug package insert under Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971), was rejected. “Instructions by a manufacturer which accompany medication or use of certain marketed goods cannot be equated with publication.”  363 A.2d at 126.  In addition:

• Negligence theories (most analogous to Slater, which is also based on negligence) were barred by the First Amendment, as none of the exceptions to protected speech – purely private matters, actual malice, shouting “fire” – were apposite.  Smith, 563 A.2d at 125-26.
• Other sections of the Restatement, §§310-11, 557A, were not intended to apply to publishers, nor did any case law apply them this way.  563 A.2d at 126.
• A book is not a “product” under Restatement §402A for strict liabilty purposes.  563 A.2d at 126-27.

Numerous other courts throughout the country have held, similarly to Smith v. Linn, that the First Amendment precludes publishers (as opposed to, say, product sellers) from being held liable for alleged informational defects in the material they publish.

[T]here is nothing inherent in the role of the publisher or the surrounding legal doctrines to suggest that such a duty [to investigate what they publish] should be imposed on publishers.  Indeed the cases uniformly refuse to impose such a duty.  Were we tempted to create this duty, the gentle tug of the First Amendment and the values embodied therein would remind us of the social costs.

Winter v. G.P. Putnam’s Sons, 938 F.2d 1033, 1036-38 (9th Cir. 1991) (publisher of encyclopedia of mushrooms not liable for erroneous description of mushroom as edible).

Thus, plaintiffs can’t sue the publisher of, say, the Physicians' Desk Reference because the information it contains – obtained from drug manufacturers – might be erroneous:

The material published by PDR is all approved verbatim by the federal Food and Drug Administration, and published by PDR pursuant to 21 C.F.R. §202.1.  In light of that fact, PDR’s own failure to perform independent tests on the products described cannot be deemed “malicious,” does not evince “intent to harm,” and is not “reckless.”  Plaintiff does not claim that Medical Economics did test [the drug] and was aware of its addictive qualities but nonetheless failed to warn its readers of that fact.

Libertelli v. Hoffman-La Roche, Inc., 1981 U.S. Dist. Lexis 11049, at *4-5 (S.D.N.Y. Feb. 23, 1981). Yup, that’s right.  Believe it or not, somebody actually tried suing the PDR.  The First Amendment precluded the suit.  Id. at *7 (“the reasons stated above in connection with publishers’ liability for false advertisements, the First Amendment blocks [plaintiff’s] claim against the publisher”).

There are a lot more cases against various sorts of publishers.  We’ll exclude purely entertainment media (see our rock 'n roll post for some of that) and stick to cases where somebody alleged detrimental reliance of some sort on published information (thus leaving out defamation cases, too).  See Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1110 (9th Cir. 2003) (book and pamphlet publisher entitled to anti-SLAPP dismissal of failure to warn claim); Fowler v. Thomas Nelson Publications, 2009 WL 612385, at *2-3 (E.D. Mich. March 6, 2009) (Bible publisher not liable for Bible’s negative portrayal of homosexuality); Gorran v. Atkins Nutritionals, Inc., 464 F. Supp.2d 315, 326-27 (S.D.N.Y. 2006) (diet book case similar to Smith v. Linn); Ginsburg v. Agora, Inc., 915 F. Supp. 733, 739 (D. Md. 1995) (subscription newsletter publisher not liable for advertisements); Barden v. HarperCollins Publishers, Inc., 863 F. Supp. 41, 45 (D. Mass. 1994) (publisher did not vouch for qualifications of author); Jones v. J.B. Lippincott Co., 694 F. Supp. 1216, 1217 (D. Md. 1988) (predecessor to KWH not liable for failure of treatments described in medical book); First Equity Corp. v. Standard & Poor’s Corp., 690 F. Supp. 256, 258-59 (S.D.N.Y. 1988), aff’d on other grounds, 869 F.2d 175 (2d Cir. 1989) (publisher of corporate records); Pittman v. Dow Jones & Co., 662 F. Supp. 921, 923 (E.D. La. 1987) (newspaper publisher not liable for advertisements), aff’d, 834 F.2d 1171 (5th Cir. 1987); Lewin v. McCreight, 655 F. Supp. 282, 284 & n.2 (E.D. Mich. 1987) (publisher not liable for “defective” formula in book); Demuth Development Corp. v. Merck & Co., 432 F. Supp. 990, 993 (E.D.N.Y. 1977) (drug index publisher protected from liability for allegedly incorrect information); Gutter v. Dow Jones, Inc., 490 N.E.2d 898, 901 (Ohio 1986) (investment newspaper); Walters v. Seventeen Magazine, 241 Cal. Rptr. 101, 103 (App. 1987) (no liability for errors in advertisement); Bailey v. Huggins Diagnostic & Rehabilitation Center, Inc., 952 P.2d 768, 773 (Colo. App. 1997) (book’s allegedly false statements about dental amalgam safety); Birmingham v. Fodor’s Travel Publications, Inc., 833 P.2d 70, 75-76 (Hawai’i 1992) (travel guide not required to warn about dangerous swimming conditions); Alm v. Van Nostrand Reinhold Co., 480 N.E.2d 1263, 1267 (Ill. App. 1985) (“how to” book publisher); Reynolds v. Murphy, 188 S.W.3d 252, 266-67 (Tex. App. 2006) (information in subscription newsletter); Orozco v. Dallas Morning News, Inc., 975 S.W.2d 392, 396 (Tex. App. 1998) (newspaper reporting of criminal activity); Lacoff v. Buena Vista Publishing, Inc., 705 N.Y.S.2d 183, 187-88 (N.Y. Sup. N.Y. Co. 2000) (investment “how to” book); Daniel v. Dow Jones & Co., 520 N.Y.S.2d 334, 339-40 (N.Y. Sup. 1987) (computerized news service not liable for allegedly false story); Walter v. Bauer, 439 N.Y.S.2d 821, 822 (N.Y. Sup. 1981) (book of science experiments not liable for injuries caused by explosion), mod. on other grounds, 451 N.Y.S.2d 533 (App. Div. 1982).

There are, of course, a couple of “hit man” cases that go the other way.  E.g., Rice v. Palladin Enterprises, Inc., 128 F.3d 233 (4th Cir. 1997) (applying Maryland law). But those pretty much prove the general rule stated here – since they escaped dismissal solely due to a First Amendment exception, incitement of criminal activity, id. at 247-49, that has no conceivable relevance to a case like Slater.

Beyond the First Amendment, there is also no precedent suggesting that any Pennsylvania court would apply the “assumed duty” rationale in the manner suggested by Slater. For one thing, an “assumed duty” in Pennsylvania requires an “express” undertaking:

[A] defendant must specifically have undertaken to perform the task that he is charged with having performed negligently, for without the actual assumption of the undertaking there can be no correlative legal duty to perform that undertaking carefully. . . . .  [There is] no support for the proposition that Section 324A gives rise to an implicit or derivative duty that stems from another, related duty undertaken by the defendant.

Reeser v. NGK North American, Inc., ___ A.3d ___, 2011 WL 198457, at *3 (Pa. Super. Jan. 24, 2011) (citation and quotation marks omitted) (emphasis original).  Forseeability is not enough without an express undertaking.  Sheridan v. NGK Metals Corp., 609 F.3d 239, 263 (3d Cir. 2010) (applying Pennsylvania law).

For another thing, Pennsylvania courts have steadfastly refused to impose assumed duties for bare omissions, because the assumed duty theory requires that the defendant have done something that makes a pre-existing risk worse.  The “negligent performance or nonperformance must increase the risk of harm.”  DeJesus v. Liberty Mutual Insurance Co., 223 A.2d 849, 850 (Pa. 1966); see Smithbower v. Southwest Central Rural Electric Cooperative, Inc., 542 A.2d 140, 144 (Pa. Super. 1988) (alleged negligent inspection did not increase risk of electrocution from high tension lines); Evans v. Liberty Mutual Insurance Co., 398 F.2d 665, 677 (3d Cir. 1968) (defendant’s alleged “nonperformance” did not increase pre-existing risk of harm) (applying Pennsylvania law); Midgette v. Wal-Mart Stores, Inc., 317 F. Supp. 2d 550, 561 (E.D. Pa. 2004) (store owner’s actions did not increase risk of violence to plaintiff); Blewit v. Man Roland, Inc., 168 F. Supp. 2d 466, 470 (E.D. Pa. 2001) (failure to inspect did not increase risk of allegedly dangerous machinery).

Nor, of course could the publisher have been liable on the other prong of Restatement §324A – an undertaking to perform a duty owed by another.  The only "assumed" duty would be that of the pharmacist.  But, as already established, in Pennsylvania a pharmacist does not owe a duty to warn a customer about a drug under the Coyle line of cases.

Obviously, we think that it’s a hideous idea for any court even to contemplate the imposition of liability on a publisher simply for errors in medical information it printed, but that somebody else gives out to the public.  The whole premise of the “assumed duty” doctrine is that what the defendant did isn’t legally required.  Thus the end result of the kind of liability postulated in Slater is socially counterproductive and contrary to the public health.  If the law decides to impose liability on voluntarily provided drug information – simply because it didn’t contain more information than it did – then people will stop providing the information.

And that would be a shame.