Far be it from an Alabama law firm to pay undue attention to a federal district court decision in New York. When that distant court issues a lengthy opinion on a trending topic in drug and device litigation, however, we take notice.
That is just what happened last Friday in the hotly-watched case of Amarin Pharma, Inc. v. United States Food & Drug Administration, No. 1:15-cv-3588-PAE, August 7, 2015 (S.D. N.Y. 2015). The decision represents substantial good news for manufacturers, distributors, and retailers of medical devices and pharmaceuticals who wish to market their products for new and innovative uses. While ostensibly about prosecution, the logic of the decision will almost certainly spill over into claims of off-label marketing in civil lawsuits as well.
We live in a golden age of medicine and medical devices. While physicians can no doubt err, and while medicines and devices can be improperly prescribed or used, by and large those products help many patients enjoy a better quality of life. This is especially true when they are recommended by well-informed physicians. While some doctors stay apprised of these trends through journals and conferences, it should be no surprise that some become aware of new applications through company salespeople who not only promote the product for traditional uses but also for more unusual purposes. In the drug and device world, this tactic of suggesting alternative uses is known as “off-label” marketing and promotion, and according to the FDA it is a major no-no.
Think of it like this. A drug or device has an “intended” use, which may be to ease a certain pain, improve joint function, or make surgery more tolerable – to suggest just three out of thousands of possible reasons. If the FDA approves the drug or device as suitable for an intended use, a company is allowed to pitch the product to doctors or even the public for that use. But as you might expect, often drugs and devices turn out to have other helpful uses that are not approved by the FDA. Some smoking cessation drugs initially were approved as anti-depressants, but were discovered to also help smokers quit. Likewise, the drug Terbutaline is approved by the FDA as a short-term asthma medicine, but many obstetricians prescribe it to expectant mothers to reduce the risk of premature labor.
Doctors using or prescribing drugs and devices in “off-label” fashion is perfectly legal, so long as the doctor obtains adequate informed consent and the treatment is in the best interest of the patient. When a drug company or distributor mentions off-label uses to a doctor, however, and those discussions come to light, the FDA has often prosecuted the representative or the company for “misbranding” the drug or device. For years, misbranding prosecutions have typically led to steep fines and apologetic manufacturers.
We have been watching a new trend, however. In recent years, some manufacturers have gotten wise to the threats of the FDA. Some have even challenged the FDA’s approach, which until recently often resulted in a hefty settlement. In 2012, in United States v. Caronia, a pharmaceutical representative was caught promoting a medicine for an off-label use, and he was prosecuted by the FDA. He appealed, however, and the Second U.S. Circuit Court of Appeals reversed his conviction. The Second Circuit explained that the FDA was interpreting any off-label promotional statement as an open-and-shut case of misbranding, when such statements should have simply been one piece of evidence indicating misbranding. In addition, the court noted that Caronia’s speech had been truthful commercial speech, and thus probably protected by the First Amendment. The FDA, perhaps stunned by a key loss, declined the risk of appealing to the U.S. Supreme Court.
Now, just three years after Caronia, a relatively small player in the pharmaceutical market has assumed the role of David to the FDA’s Goliath. Amarin, a New Jersey biopharmaceutical company, currently makes only one drug – an omega-3 fatty acid called Vascepa® – which the FDA has approved to treat individuals with extremely high triglycerides. Amarin claims that Vascepa has proven to be beneficial in a second set of individuals, those whose triglycerides are not quite as high but are persistently above desired levels. Despite a “double-blind placebo-controlled clinical trial” – the gold standard – showing that Vascepa works for this second category, and despite the FDA’s concession that the clinical trial was successful, the FDA has refused to approve this intended use for Vascepa’s labeling. Naturally, then, marketing Vascepa to the “persistently high triglyceride” market would be “off-label,” and thus would be treated by the FDA as misbranding.
In a gutsy move, Amarin sued the FDA. Its complaint in the Southern District of New York sought a declaratory judgment announcing that FDA regulations unconstitutionally violate Amarin’s First Amendment right to truthful, non-misleading, commercial speech. The FDA, for its part, tried to play down the controversy. It filed into court a letter it had sent to Amarin after suit had been filed. The letter opens by saying that the “FDA does not have concerns with much of the information you propose to communicate.” The FDA later states that it is in the process of revising its views and characterizes its view as being in flux due to the “unusual combination of circumstances presented here.” The FDA’s letter, however, stopped short of letting Amarin market Vascepa, and the FDA’s attempt to have its cake and eat it too ultimately bought it no good will.
Amarin’s suit found allies among “Big Pharma,” whose members have seen their share of FDA enforcement actions that they felt were unwarranted. Amicus briefs of two different pharmaceutical and biotechnology companies reserved some of their strongest criticisms for the FDA’s letter, fairly exploding at the duplicity of the FDA’s correspondence – which one brief criticized as “ad hoc,” “litigation-driven,” and a “one-off discretionary exception, applicable to this case and nowhere else,” while the other lambasted the FDA’s “exercise of enforcement discretion on which no other manufacturer may rely.”
Ultimately, the district court granted Amarin the equivalent of a slam dunk. The Court sided with Amarin on virtually every issue and controversy. The Court unpacked the Caronia decision at length, explaining and reiterating the ultimate holding of that case. The end result was a vigorous endorsement of Caronia. The district court made clear that so long as the representations about a medical device or pharmaceutical are truthful and non-misleading, verbal representations about that drug or device to physicians cannot constitute misbranding. The Court only gave the FDA breathing room to prosecute untruthful marketing, misleading marketing, and efforts to promote a product that go beyond speech. In fact, the Court went so far as to say that truthful, non-misleading marketing of a product for an off-label use could never constitute misbranding “no matter how obvious it was that the speaker’s motivation was to promote such off-label use.”
While the FDA could always appeal this order to the Second Circuit, the sheer magnitude of the beatdown administered by the district court, and the fact that circuit court decided Caronia, suggests that would be unlikely and unwise. Thus, barring an unusual development, Amarin will likely remain good law, a lengthy exposition on the contours of Caronia, and a useful decision for pharmaceutical and device lawyers against governmental heavy-handedness. We will continue to monitor the ongoing litigation and post updates as warranted.