Search results for: off-label promotion

This post is from the non-Reed Smith side of the blog only.

Having to report on a negative InFuse decision happens about as often as meteorologists correctly predict snowstorms.  Boy did they get it wrong for New Jersey and Pennsylvania this week.  Talk about deflated snowfall expectations.  Speaking personally for a minute, this non-skiing, non-snowboarding, warm-weather-loving blogger was not disappointed at this turn of events. And, we actually feel a little sorry for weather forecasters whose sole job it is to predict the often unpredictable, but who are held to exacting standards.  Next time a blizzard is predicted, people will mock the forecast, go to work, get stuck in ten inches of snow, slip and slide the whole way home, and then complain that the warning wasn’t strong enough.  Meteorologists really can’t win.

Defendants in the InFuse litigation, however, usually do. But like meteorologists who occasionally hit it right on, sometimes an InFuse judge gets it wrong.  When that judge is confined by having to apply Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010), the result isn’t completely shocking. Disappointing, but not shocking.

The basic allegations in Garross v. Medtronic, Inc., 2015 U.S. Dist LEXIS 6675 (E.D. Wis. Jan. 21, 2015) are like those in all of the other InFuse cases.  The InFuse bone fusion system is a Class III, pre-market approved medical device.  As such, plaintiff’s claims should only survive if they can squeeze through the “narrow gap” left after application of express and implied preemption.  Notably, the Garross court called it only “a gap,” id. at *7, suggesting a more spacious opening then we believe is supported by the case law.Continue Reading Deflated PMA Preemption: Off-label Promotion and Failure to Report Keep InFuse Case Alive

Here’s the second case that was sent to us by our readers.  It is a favorable decision on one of our many pet peeves, off-label promotion, In re Celexa & Lexapro Marketing & Sales Practices Litigation, 2014 WL 3908126 (D. Mass. Aug. 8, 2014).  On this one, the congratulations belong to Debevoise for winning it, and our thanks to J. Robert Abraham for being so kind as to send us a copy of the decision.

In C&L (the official title is too much of a mouthful) the defendant was sued under the California unfair competition statute (“UCL”) for “restitution” of co-payment the plaintiffs paid for Celexa.  The case was initially brought as a class action (most UCL cases these days are), but certification had been denied earlier because of the predominance of individualized issues.  Among other things, C&L demonstrates the correctness of that determination, since the reliance facts were quite peculiar.

Other than the peculiar UCL damages (personal injury is not recoverable), C&L reads like a learned intermediary rule warning causation case and applies largely the same principles.

Continue Reading Interesting Cases Sent By Users (Part II) Off-Label Promotion

Until recently it’s simply been accepted that the FDA administratively banned off-label promotion – no ifs, ands, or buts.  Bexis’ book used to read:  “It is illegal, however, for a manufacturer of a prescription medical product to promote an off-label use.”  §4.01[4] at p. 4.01-45.  We sort of took that much, at least, for granted – even though we vociferously dissented, on First Amendment grounds, from this “ban” applying to truthful promotion, as we’ve done in most of our posts under our “First Amendment” blog topic.

Not so fast.

As Einstein demonstrated, sometimes even the most seemingly established propositions are questionable.

In fact, as we learned in Caronia, the FDA’s path to prosecution of off-label promotion is anything but direct and certain.  United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012).  In actuality, “[t]he FDCA and its accompanying regulations do not expressly prohibit the ‘promotion’ or ‘marketing’ of drugs for
off-label use.”  Id. (emphasis added).  Indeed, for all the frequency with which “promotion” gets bandied about, there isn’t even a definition of the term “promote” or “promotion” in either the FDCA or in FDA regulations.  Rather, the Agency seems to be hiding the ball with regulatory statements – notably in the investigational drug context – that “[t]his provision [barring but not defining “promotion”] is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.”  21 C.F.R. §312.7(a).

That’s a load of malarkey.  Barring “full exchange of scientific information” is precisely what the FDA’s been doing with its off-label promotion stance for decades.Continue Reading Just How “Illegal” Is Off-Label Promotion?

In our first-on-the-web quickie analysis of United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), we didn’t have time to do much more than unwrap the Second Circuit’s early Christmas present.  Now that we’ve had a little more opportunity to consider some (but not nearly all) of the implications of Caronia, we offer the following.
First and foremost, whatever anybody else might say, truthful off-label promotion is not all of a sudden “legal in the Second Circuit.”  Caronia was one individual’s successful appeal of a criminal conviction for conspiracy to introduce misbranded drugs in interstate commerce.  It was not a declaratory judgment action.  Neither the FDA nor the Department of Justice has been enjoined from doing anything.  The brave Mr. Caronia’s conviction has simply been vacated and remanded, rather than the action dismissed.  Theoretically, if it could prove falsity, the Agency could even (ignoring such things as the statute of limitations or double jeopardy) prosecute the poor guy again.  What Caronia actually held (as opposed to the court’s reasoning) was this:

[T]he government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.

2012 WL 5992141, at *15.  It did this by construing the FDCA (and with it, the FDA’s regulations) “narrowly” to avoid having to declare them unconstitutional.  That narrowing interpretation required that truth be a defense to a misbranding claim in the context of off-label promotion.

[E]ven if speech can be used as evidence of a drug’s intended use, we decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech.  We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.

Id. (emphasis added).  Although it’s by no means 100% sure, it looks like Caronia’s narrowing interpretation (the court invoked a legal doctrine of construing a statute narrowly to avoid constitutional challenge, id. at *10) carves out a truth exception to the statute itself.  So we’re probably incorrect to speak of a constitutionally mandated truth “defense.”  That would imply that the burden of proving truth is on the defendant.  By construing the statute as exempting “truthful off-label promotion,” it appears that falsity is now an element of off-label-related misbranding, with the burden of proof correspondingly falling on the government.Continue Reading Caronia, Off-Label Promotion, And The First Amendment

If yesterday was the unofficial end of summer, for many of us today is the unofficial start of Fall – in other words, back-to-school day.  Lunches and backpacks packed, pencils sharpened, flip flops traded for sneakers and slick new hair cuts.  In the Philly/New Jersey area it is a soggy first day of school, but you can feel the excitement nonetheless.  The kids are excited to see who is in their class and learn what their friends have been up to all summer.  The parents – well, we all know why we’re excited.  At least until the first major project is due that our child forgot to tell us about and now it’s Sunday night around eight pm and you’re driving around trying to find a store that is still open that sells glue sticks and poster board.  But, let’s not get ahead of ourselves.  Instead, we’ll sit back and wave to our kids as they head for the buses and schoolyards and we’ll bring you a nice piece of news from the District of Oregon.  Well, it’s not all nice and that’s why we decided to post about it today — when we mourn the end of summer but celebrate a new school year.
The case is Teater v. Pfizer, Inc., 2012 U.S. Dist. LEXIS 122848 (D. Ore. Jun. 27, 2012) and it involves alleged off-label promotion of the drug Neurontin.  Plaintiff was prescribed Neurontin for her post-traumatic stress disorder (“PTSD”) which was an off-label use.  Plaintiff alleged that she suffered a whole host of side effects, including depression and attempted suicide.  Id. at *3-4.  Plaintiff’s complaint alleged causes of action for: (1) violations of RICO; (2) fraud; (3) violations of the Oregon Unlawful Trade Practices Act (“UTPA”); (4) unjust enrichment; and (5) products liability (breach of warranty, strict liability and negligence) – all based on allegations of off-label promotion.  Id. at *7.  The court dismissed all but her products liability claims and here is how the court did it.
RICO – no standing.  To sustain a RICO claim, plaintiff has to demonstrate an injury to “a specific business or property interest” and “a concrete financial loss.”  Id. at *8.  Plaintiff Teater alleged that she suffered a business injury when side effects from her use of Neurontin rendered her unable to make payments on business equipment, which was then auctioned off.  Id. at *9-10.  Not so said the court.  “Plaintiff has only pled injuries that derive from the alleged psychological side effects and/or emotional distress caused by her consumption of Neurontin.”  Id. at *11-12.  This is nothing more than standard monetary damages alleged to be the result of side effects of a prescription drug – “hallmark personal injury damages.”  Id. at *11.  Not a RICO injury.Continue Reading No Off-Label Promotion In The Air

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…

With the ink barely dry on the Supreme Court’s recent decision that pharmaceutical detailing is First Amendment protected commercial speech, see Sorrell v. IMS Health Inc., ___ U.S. ___, 2011 WL 2472796, at *8 (U.S. June 23, 2011), the industry is trying again for clarity in the morass that is the FDA’s current regulation…

We blogged before about the Hopper and Bennett cases, in which courts rejected the argument that off-label promotion necessarily generates “false claims” for purposes of the False Claims Act.  Well, we’re pleased to report that the duo has become a trio.  There’s a new opinion, and lo and behold, it dismisses yet another action by…

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