> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Amarin Settlement Leaves Questions Unanswered: Attorneys - URL: https://www.fdaweb.com/amarin-settlement-leaves-questions-unanswered-attorneys/ - Published: 2016-03-10T12:00:00.000Z - Updated: 2026-09-15T02:42:39.000Z - Author: David McFarland - Tags: Drugs, FDA Policy/General, #legacy-id-D5135030 > While the [proposed settlement](https://www.fdaweb.com/amarin-proposes-vascepa-case-settlement/) between Amarin Pharma and FDA over off-label promotion of the company’s Vascepa will end that litigation when approved by the court, there remain questions about whether and how FDA and the Justice Department will pursue misbranding cases involving off-label promotion, according to an online [analysis](http://www.lexology.com/library/detail.aspx?g=0eeeab3c-edc1-4249-92ac-b479ba289ecd&utm%5Fsource=Lexology+Daily+Newsfeed&utm%5Fmedium=HTML+email+-+Body+-+General+section&utm%5Fcampaign=Lexology+subscriber+daily+feed&utm%5Fcontent=Lexology+Daily+Newsfeed+2016-03-10&utm%5Fterm=) by six Skadden Arps attorneys. They write that the proposed settlement “appears to reflect a broad concession by FDA that *Caronia* precludes the agency from pursuing criminal misbranding charges based solely on truthful, non-misleading speech. At the same time, the settlement order’s precise language, pursuant to which FDA ‘agrees to be bound’ by the *Amarin* court’s conclusion that under *Caronia*, truthful and non-misleading speech ‘may not form the basis of a prosecution for misbranding,’ leaves some latitude for FDA to argue that *Caronia* and *Amarin* do not apply to future cases that **(1)** involve false or misleading speech, **(2)** involve conduct rather than speech, or **(3)** arise outside of the Second Circuit. > > The attorneys say that all three of those conditions applied in a recent unsuccessful FDA prosecution of Vascular Solutions, Inc., and **Howard Root** in a Texas federal court. The government said the company and Root sold Vari-Lase laser ablation devices used to treat varicose veins without FDA approval and conspired to defraud the U.S. by concealing the activity. The government said that the company and Root engaged in a campaign to promote the Vari-Lase devices for ablation of perforator veins when they were only approved for use in superficial veins. It also said the campaign continued after FDA failed to clear a specific 510(k) covering device use in perforator veins and after a clinical trial failed to establish that the device was safe and effective for the use. > > The post says that the court rejected efforts by the company and Root to have the charges dismissed under *Caronia* and *Amarin* because the government alleged that their speech was false and misleading. It also ruled that the government had indicated that it would use evidence of conduct, rather than speech, to establish the defendants’ intent to promote the device off-label. Ultimately, however, the company and Root were acquitted on all charges, the post says. > > “The government’s willingness to pursue this prosecution, and its efforts to distinguish *Caronia* and *Amarin* in doing so, suggest that FDA and DoJ harbored a continued belief that a conduct rather than speech-based off-label prosecution might succeed,” the attorneys conclude. “For this reason, a broad reading of the *Amarin* settlement may be overly optimistic. *Caronia* and *Amarin*, combined with the government’s statements in *Vascular Solutions*, suggest that it is unlikely that FDA and DoJ will choose, even outside the Second Circuit, to prosecute cases involving truthful, non-misleading speech or conduct. The *Amarin* settlement order, however, leaves the door open for the government to pursue off-label cases based on objectively false or misleading speech, as it sought to do in *Vascular Solutions*. In this regard, the unsuccessful *Vascular Solutions* prosecution may have an equally important impact on the government’s future exercise of its enforcement discretion relating to off-label cases.” > > A second [analysis](http://www.lexology.com/library/detail.aspx?g=4a2f1b47-cd20-4e7a-89cc-6eecd4798dfa&ref=fdaweb.com) by six Hogan Lovells attorneys calls attention to the settlement proposal’s “novel procedure through which Amarin can seek feedback from FDA regarding proposed communications about Vascepa.” That procedure includes specific time frames for each side and the potential to take unresolved issues back to the court for determination. The settlement also includes a dispute resolution process with time frames to be used if the parties can’t resolve any other dispute on matters arising under the settlement. > > “These unusual judicial resolution procedures,” the analysis says, suggest that the parties may anticipate the possibility of substantial disagreements in the future about what constitutes truthful and non-misleading speech; moreover, they could render the Southern District of New York an active participant in defining the scope of permissible communications about Vascepa going forward. Importantly, the court has not yet accepted this proposed settlement, so it remains to be seen whether it will agree to be ‘on call’ in the continuing implementation of this settlement.” > > The attorneys say that for companies considering *Amarin*\-like communications, the settlement is a reminder that they may submit proposed communications to the agency for comment. “Although the settlement’s novel feedback procedure, with specified timelines and an option for judicial resolution, is available to Amarin only,” they write, “it is interesting to consider whether FDA may adopt this type of mechanism as a feature of its policy, moving forward, regarding promotional communications about unapproved uses of approved drugs, or if it might consider other mechanisms floated by external groups recently, such as a third-party expert panel to review and provide comments on such communications.” > > Finally, three Foley & Lardner attorneys [say](http://www.lexology.com/library/detail.aspx?g=cf79158b-6e55-4b1a-b72c-c73742a1e2da&ref=fdaweb.com) the settlement “by no means signals an end to litigation over restraints on off-label promotion.” They cite the Pacira Pharmaceuticals suit against FDA in response to a Warning Letter claiming that the company’s Exparel was being promoted for new uses for which it lacked approval, and the fact that FDA settled the claims and rescinded the letter. “FDA’s resolution of Amarin’s and Pacira’s claims may generate other preemptive ‘me too’ litigation by pharmaceutical companies seeking to engage in truthful off-label promotion of drugs,” they write. “The larger questions of when and how FDA and/or the Justice Department will file misbranding cases involving off-label promotion in light of *Caronia* remain largely unanswered.”