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The briefing is complete on Amarin’s motion for preliminary injunction.  The parties and several amici have all weighed in, and the court will hear oral argument tomorrow.

To this point, there has been significant back and forth between the FDA and Amarin.  Here is some of it.  The FDA argued that it mooted much of Amarin’s preliminary injunction request by sending its June 5 letter to Amarin.  We all saw that argument coming. Even though Amarin never asked for an FDA response to its proposed off-label promotion, it got one anyway.  In the June 5 letter, the FDA said that it “does not have concerns with much of the information [that Amarin] proposed to communicate.”  The FDA’s decision to send this unsolicited response appeared litigation driven and, unsurprisingly, it led off the FDA’s response brief:

The June 5 Letter makes clear that FDA does not object to Amarin’s distribution of summaries and reprints of the ANCHOR trial and journal article reprints, if Amarin takes the reasonable steps outlined in the Letter and ensures that such dissemination is truthful and non-misleading. June 5 Letter at 10.  Assuming Amarin takes those steps, then for all but one of the communications proposed in the Complaint, FDA would not rely on such communications in an enforcement action against Amarin.

(FDA Br. at 15.)Continue Reading The Court Will Hear Oral Argument Tomorrow Morning on Amarin’s First Amendment Challenge to FDA Off-Label Regulation

Last month, Amarin Pharma, Inc. filed a complaint in the Southern District of New York asserting that the FDA could not apply its regulations to prohibit or criminally prosecute Amarin’s proposed communication of truthful, non-misleading information as to off-label uses of Vascepa, a drug that the FDA had approved to treat very high, but not high, triglyceride levels.  Amarin claimed that such regulation would violate its First Amendment commercial speech rights.  We blogged about it here.

Since then, Amarin has moved for a preliminary injunction.  The content of Amarin’s supporting brief is both unsurprising and convincing.  It laid out the truthful, non-misleading statements that it wanted to provide to healthcare providers:

  • Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.
  • The ANCHOR trial demonstrates that Vascepa® lowers triglyceride levels in patients with high (≥ 200 mg/dL and <500 mg/dL) triglyceride levels not controlled by diet and statin therapy.
  • In the ANCHOR trial, Vascepa® 4g/day significantly reduced TG, non-HDL-C, Apo B, VLDL-C, TC  and HDL-C levels from baseline relative to placebo in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy.  The reduction in TG observed with Vascepa® was not associated with elevations in LDL-C relative to placebo.

It also wanted to hand health care providers the results of its ANCHOR clinical trial as well as other peer-reviewed articles on clinical trials addressing the connection between EPA (Vascepa’s active ingredient) and coronary risk.  It proposed to caution health care providers that (i) the FDA had not approved Vascepa to reduce coronary risk or to treat mixed dyslipidemia and high triglycerides, (ii) Amarin was conducting an ongoing cardiovascular outcome study, and (iii) the costs of Vascepa may not be reimbursed by government programs.Continue Reading The FDA Sends Amarin a Letter In Their First Amendment Court Battle

This post come from the non-Reed Smith part of the blog.

In Otis-Wisher v. Medtronic, Inc., 2015 U.S. App. LEXIS 9565 (2d Cir. June 9, 2015), an Infuse device decision, the Second Circuit offered its thoughts on the viability of parallel violation claims based on allegedly misleading off-label promotion.  In short, they are not…

“We’ve seen this movie before.”  That is something people say when they encounter something that seems simultaneously dreadful and predictable.  That is how we felt upon reading the latest dismal opinion out of the Drake Botox litigation in Vermont federal court.  We’ve blogged about this case several times before, bemoaning the blundering approach taken…

That didn’t take long. Last Monday, we recommended a recent Journal of Law and the Biosciences article proposing a new model under which the FDA could regulate drug promotion consistent with the First Amendment.  Three days later, an Irish drug company, Amarin, sued the FDA in the Southern District of New York seeking a declaration that the FDA’s off-label regulations, as applied by the FDA, violate the First Amendment.  Amarin Pharma, Inc. v. FDA, 1:2015cv03588, (SDNY May 7, 2015).  Amarin also seeks a declaration that the FDA is violating the Due Process clause of the Fifth Amendment by failing to provide clarity on its position regarding off-label promotion, particularly since the Second Circuit issued its Caronia decision.  Here’s the complaint.

Amarin’s drug, Vascepa, was approved by the FDA a few years ago for the treatment of very high triglyceride levels.  Its active ingredient is EPA, an omega-3 fatty acid. Since then, Amarin has sought an additional indication for Vascepa – the treatment of high (not very high – there’s a difference) triglyceride levels.  To get this new indication, Amarin conducted a clinical trial called ANCHOR. ANCHOR’s results showed that Vascepa in fact lowered high triglyceride levels.  But Amarin ran into a problem.  After ANCHOR began, a number of studies were published that to some extent called into question the link between lowering triglycerides and improving heart health.  Since then, the FDA has seemingly taken a different view of the importance of establishing only that a drug lowers triglycerides.  The FDA (after convening an advisory panel) did not approve Vascepa for its additional indication.  Amarin, feeling that Vascepa had shown its effectiveness at lowering triglycerides, appealed administratively, a number of times.  It lost.  Trying another approach, Amarin asked the FDA to allow it to include ANCHOR’s efficacy results in Vascepa’s label, along with a disclaimer that use of the drug has not been shown to reduce cardiovascular risk.  The FDA denied that as well.Continue Reading Amarin v. FDA Focuses the Spotlight on the First Amendment and the FDA’s Regulation of Off-Label Promotion

Friction between the First Amendment and the FDA’s  attempts to regulate off-label drug promotion has existed for decades.  It has sparked an ever growing body of case law that often finds the FDA overreaching.  One of the more recent examples is the Second Circuit’s decision in Caronia, which vacated a criminal conviction that had…

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents.  We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals.

This time our meanderings have led us into False Claims Act (“FCA”) litigation, and not for the first time.  That’s not surprising since when the First Amendment ultimately takes down the FDA’s ban on truthful off-label promotion, the vehicle is likely to be an FCA case.  The FDA can control its own prosecutions and make sure falsity is always alleged, but it can’t control FCA relators, who if they can get away with it, will avoid alleging anything – such as falsity – that might be difficult to prove.

We have two recent off-label FCA developments to share with you.

Keeping “False” in a False Claim

The first new decision is really recent, like from a couple of days ago.  In United States ex rel. Garcia v. Novartis AG, ___ F. Supp.3d ___, 2015 WL 1206122 (not on yet), C.A. Nos. 06-10465-WGY, et al., slip op. (D. Mass. March 17, 2015), the court dismissed three FCA complaints with prejudice (including one that had been hanging around since pi-day 2006) for a number of reasons – including failure to allege anything false about purported off-label promotion.  The Garcia opinion is 63 pages long.  We only care about pages 44-56, dealing with the relators’ complaints’ failure to plead their false claims with particularity under Fed. R. Civ. P. 9(b).Continue Reading Notes From The Off-Label Underground

“Our rural ancestors, with little blest,
Patient of labor when the end was rest,
Indulged the day that housed their annual grain,
With feasts, and off’rings, and a thankful strain.”

― Alexander Pope, Imitations of Horace

Today isn’t officially a holiday, but the preparations for Thanksgiving make it terribly difficult to put in a productive…

Today’s post is really three different posts on three unrelated subjects.  None of them very long (at least by DDLaw Blog standards), but we think that each will be of interest to at least some our readers.

On Generic Plaintiffs’ Preemption “Win” in New Jersey

This piece is from the non-Dechert side of the blog.

Plaintiffs alleging failure to warn of the risks of a generic drug scored a “win” of sorts in In re Reglan Litigation, 2014 WL 5840281 (N.J. Super. App. Div. Nov. 12, 2014).  The court held, in an unpublished decision, that “failure-to-update” claims survived the otherwise comprehensive impossibility preemption that applies to generic drugs:

[T]he trial court correctly determined that plaintiffs’ claims based on the Generic Defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.  The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve . . . .  Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law.

Id. at *4. As the Appellate Division points out, non-preemption of “duty to update” is the majority view.

We may not like it, but we’re not losing much sleep about it.

Why?Continue Reading Short Subjects

We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber).  We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.

The biggest conceptual problem is that there are two fundamentally different kinds of warnings.  Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t.  Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).  Most step-by-step directions also fall in this category.

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about.  Rather, with prescription-only products, most of the relevant risks arise whenever the product is used.  A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product.  The only way to avoid the risk is not to use the product at all.  All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place.  For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.Continue Reading Who Heeds The Heeding Presumption?

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