Search caronia

The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  A couple of anonymous, obviously plaintiff-side, comments to our “breaking news” Amarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside.  Both comments raised the same issue:  what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?

One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over.  The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.”  Id. at 277.  See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action).  Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:

The publication here was not a ‘commercial’ advertisement. . . .  That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . .  To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.

376 U.S. at 266 (citations and quotation marks omitted).Continue Reading When They Don’t Have Anything, They’ll Try Anything

Today we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use.

First, we’ve mentioned Pacira Pharmaceuticals v. FDA before as the latest First Amendment follow-up action to Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  What we have for you now are the two industry-side amicus briefs filed in support of Pacira’s First Amendment motion against the FDA.  This one was filed by PhRMA, and this one was filed by something called the Medical Information Working Group, which is a consortium consisting of Amgen, Bayer, Boehringer, Lilly, Genentech, GSK, J&J, Novartis, Novo Nordisk, Pfizer, and Sanofi.  Impressive lineup.  And to think we can remember when nobody was willing to take on the FDA about truthful off-label promotion for fear of retaliation….  What a difference a few wins make.

We’ve read through the two amicus briefs and we heartily recommend them to anyone interested in bringing the FDA’s reign of (t)error in this area to long-overdue end.  Briefly, the MIWG brief makes the following points:  (1) the FDA’s ban is an “ambiguous tangle of regulations, nonbinding guidance documents, and severe enforcement practices”; (2) pharmaceutical promotion is First Amendment protected speech under Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011); (3) truthful off-label promotion provides valuable information to physicians and patients alike; (4) what FDA claims is “misbranding” is the same information it has pledged in other contexts to “work hard to address”; (5) Pacira’s speech is really on-label promotion that the FDA has attempted to suppress through an improperly crabbed reading of the drug’s intended use; (6) off-label use is legal, common-place, medically valuable, and sometimes the medical standard of care; (7) more truthful speech about off-label use is better than less; (8) the FDA’s ban unconstitutionally discriminates on the basis of both speaker and content; (9) the basis for the FDA’s ban is unconstitutionally vague and ambiguous; (10) FDA’s “safe harbors” are arbitrary and constitutionally inadequate; (11) the FDA has taken inconsistent positions on what off-label promotion is allowed; (12) the FDA has never even defined “promotion”; (13) the FDA’s vagueness and contradictory policies chills protected speech − truthful pharmaceutical promotion; and (14) because of this chilling effect there is both standing and justiciability.Continue Reading First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Here are a couple of non-litigation related matters that we thought our readers need to know about.

First, the FDA.  We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and devices 21 C.F.R. §801.4) both contain the following potentially disturbing language:

[I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

This language has the potential, if the FDA wanted to, to allow the prosecution of a drug or device manufacturer for an “adulterated”/”misbranded” product (for not having “adequate labeling”), merely because that manufacturer KNEW ABOUT off-label use of its products – forget promotion (truthful or otherwise). Fortunately, the FDA generally has not read this language literally.  Instead it requires prior agency approval of warnings about risks peculiar to off-label uses (we discussed that here).Continue Reading The FDA Tiptoes – and Congress Splashes Into – the 21st Century

The FDA may be in for a lot of this.  In the wake of Amarin’s preliminary injunction win, another pharmaceutical company has brought a First Amendment challenge to the FDA’s restriction of off-label promotion.  Last year, the FDA issued a warning letter claiming that Pacira Pharmaceuticals, Inc. had engaged in false and misleading promotion and…

Today’s guest post is a first for this blog in two ways, first, our guest poster is anonymous.  Second, our guest post is from an in-house source.  The two are, of course, related.  While it is important to us as lawyers that our clients not be charged with anything we say on our blog, that goes double (or triple) for someone actually working in-house.  So you won’t know exactly who to credit, or blame, for what follows.

What follows is our in-house source’s thoughts on the recent Amarin First Amendment victory over the FDA.

************

We are witnessing a strange chapter in the hegemony of FDA control over drug promotion.  For while the OIG and DOJ continue to make good use of their Swiss army knife of an Anti-Kickback Statute, the FDA has been taking body blows from First Amendment litigators.  First, the Supreme Court’s Sorrell decision, Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), protecting promotional communications as commercial speech; next, the Second Circuit in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), vacating a misbranding conviction on First Amendment grounds; and finally, the Southern District of New York in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015), declaring that a manufacturer may legally engage in off-label promotional communications.

Any doubts that this may indeed be a watershed event should be assuaged by the FDA’s public relations campaign to marginalize Caronia and the agency’s anxious efforts to moot the Amarin case or controversy before decision.Continue Reading Guest Post – Game of Thrones, the FDA Under Attack, An In-House View of Amarin

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion.  Both of them raised the same suggestion:  “Does the logic of this opinion permit a generic manufacturer to include truthful warnings about the risks of a drug on its labeling when such truthful warnings do not appear on the labeling of the branded drug?”

Not much later, we saw the same point raised by a plaintiff-side lawyer in this story in 360:

“I think this decision has huge implications for the preemption doctrine,” Lou Bograd of the Center for Constitutional Litigation PC said.

“If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products,” he said.

Needless to say, we don’t think that’s true.  Moreover, if plaintiffs try for what amounts to an Amarin-based Hail Mary pass, it may even create a jurisdictional advantage for our side.Continue Reading Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

Now that Amarin has successfully won a preliminary injunction in its First Amendment challenge to the FDA’s regulation of off-label marketing (we blogged about Amarin’s victory here and you can access the decision here), an important question arises: What will the FDA do?  The FDA is faced with a resounding defeat, its second in the Second Circuit.  In fact, Amarin got everything it asked for.  The court ordered that Amarin may discuss off-label uses of its drug, Vascepa, for the treatment of persistently high triglycerides outside the confines of the FDA’s proposed prohibitions.  For instance, Amarin can affirmatively discuss the science concerning such off-label use with doctors.  It no longer has to await a doctor’s unsolicited request for such information.  Amarin’s communications to doctors are no longer required to come from only its medical affairs department.  Its sales reps can present summaries of the science to doctors and discuss off-label use.  Amarin can now also make statements about the state of the science surrounding Vascepa’s off-label use that the FDA previously reserved only for nutritional supplement manufacturers.  The only restriction on any of this speech is that Amarin’s statements must be truthful and non-misleading.  And, to boot, the court held that all of Amarin’s proposed communications, as mildly modified by the court, are truthful and non-misleading.

But the problems for the FDA are broader.  It lost its battle to read the Caronia decision out of the law books.  The FDA argued that Caronia addressed only outright bans on off-label promotion, and that the FDA never does that:

[T]he outcome in Caronia is not controlling.  Caronia did not involve speech that was shown at trial to be potentially false or misleading and did not involve the use of speech as evidence of intent.  Instead, it involved the constitutionality of a ‘complete and criminal ban on off-label promotion.’  703 F.3d at 167.

(FDA Br. at 25.)  This argument has always seemed strained.  It’s as if the FDA was arguing that the regulatory regime at issue in Caronia was entirely different from what the FDA does today.  Yet no one who follows the FDA in this arena has seen this sea-change in the FDA’s approach.  The argument seemed like nothing more than that—argument.  The Amarin court didn’t accept it. Caronia controlled, and the FDA’s attempt to prohibit truthful, non-misleading speech concerning off-label use had to give way to the First Amendment.Continue Reading The Amarin Win and the Next Big Question: What Will the FDA Do?

Here’s a copy of today’s 71-page decision in Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015), in which the court granted a First Amendment-related injunction against the FDA’s prohibition against all off-label promotion, regardless of truth.  First, the court found standing to sue, because the FDA had threatened the company with enforcement action.  “Here, 10 days before Amarin filed suit, the FDA had expressly threatened . . . to bring a misbranding action against it for promoting [the drug] off-label.”  Id. at 40.  That was sufficient “chilling effect” to support litigation.  Id.  Significantly, the court had earlier recognized another possible adverse consequence – that of privately prosecuted False Claims Act litigation also asserting illegal off-label promotion.  Id. at 13.

On the merits, applying U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), the court held that a pharmaceutical company has a First Amendment-protected right to engage in off-label promotion that is “truthful.”

The Court’s considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.  A fair reading of that decision refutes the FDA’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.

*          *          *          *

The Second Circuit’s thoroughgoing First Amendment analysis in Caronia, which led it to construe the FDCA’s misbranding provisions so as not to reach truthful speech promoting off-label use, further defeats the FDA’s attempt to marginalize the holding in that case as fact-bound.  The Circuit cast the issue as whether a misbranding prosecution that “identified [a defendant’s] speech alone as the proscribed conduct” is constitutionally permissible.  And the Circuit’s ensuing analysis underscored the categorical, rather than case-specific, nature of its holding that it is not.Continue Reading Breaking News − Amarin Hits First Amendment Home Run Off FDA

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much.  We’re gluttons for punishment, however, and this time we were rewarded.  We found a couple of recent law review articles that we think were actually worth the effort.

The first of these comes from our quest for enlightenment regarding 3D printing – which is already making an impact in the medical device market.  Aside from our own prior thoughts, we had not come across anything that we considered a serious analysis of the product liability possibilities when the user (or someone else farther along in the supply chain) also becomes the manufacturer of the product.  That changed with Heidi Nielson, “Manufacturing Consumer Protection for 3-D Printed Products, 57 Ariz.L. Rev. 609 (2015).  This article notes the various ways in which 3D printed products can reach the consumer:  (1) They could be manufactured and sold in the traditional way, with the consumer ordering a 3D printed product from a manufacturer or retailer; (2) a “hobbyist” (casual seller) sells a 3D printed product of his/her own design to a consumer (again, relatively traditional, but raising “deep pocket” concerns); (3) the consumer buys/downloads open source software and produces the product from the consumer’s own 3D printer; (4) the consumer, using acquired software, scans an existing product, creates his/her own printable file and then reprints the product from his/her own 3D printer (which could become typical for replacement parts).  Article, 57 Ariz. L. Rev. at 614-15.  This list already shows some serious thought.

The section on “Liability for Defective 3-D Printed Product” continues with the kind of discussion we’ve been hoping for.  In the first variant, it’s pretty traditional, except to the extent that a seller of 3D printed products claims to sell 3D printing “services” instead of products.  Such sellers “may attempt to contract out of liability for defects and instead hold CAD-file designers responsible.”  Id. at 616.  The article states that “independent designers of products are generally not held strictly liable for defects in their designs, but may be liable for negligence in their designs.”  Id. (citing law review article).  The casual seller problem is also noted.  Id. The bottom line (according to the article) is that small-scale sellers of 3D printed products would be subject to negligence, and larger-scale sellers subject to strict liability.  Id.Continue Reading A Couple of Law Review Articles We Actually Like

Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any accurate information disseminated by an FDA-regulated
manufacturer about an  off-label use.

The first of these articles described the oral argument in Amarin, Inc. v. FDA, a case which we’ve been following closely, here, here, and here.  The Amarin case, which challenges the FDA’s truthful off-label promotion ban under the First Amendment in a Caronia-bound court, saw the FDA in retreat (by letter) before argument, but apparently returning to its old absolutist views at the argument itself.  According to 360:

[The government] advanced an aggressive interpretation of the Caronia decision, arguing that truthful statements alone can still be the basis for enforcement if the government demonstrates that a drug was promoted for unapproved uses that weren’t generally recognized as safe and effective.

Again according to 360’s report, the court appeared torn.  On the one hand, it would be highly unusual to enjoin an FDA prosecution that hasn’t even happened, and there are problems declaring particular medical statements “truthful” when the science is evolving.  On the other hand, the FDA allows exactly the same statements in the context of dietary supplements, and Caronia holds what it holds – which isn’t at all what the government argued.Continue Reading Evening The Score On Off-Label Use Information

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book