United States: The Titanic Is Sinking: Caronia, Amarin And Now Pacira V FDA

Last Updated: September 11 2015
Article by Michael A. Walsh and Katherine McGahey

In 2011, the US Supreme Court decided Sorrell v US, holding that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment." This one phrase stated matter-of-factly what was unthinkable a generation earlier. Sorrell was a watershed event for how the Supreme Court views the First Amendment in the context of FDA-regulated industry.

In 2012 the Second Circuit decided US v Caronia. In reversing Caronia's conviction, the Second Circuit ruled that the FDA's enforcement of the Food Drug and Cosmetic Act (FDCA) violated Caronia's First Amendment rights, stating: "We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug." (See our discussion of Caronia here). Some commentators were outraged at the implications of Caronia and foretold undoing the work attributed to Frances Oldham Kelsey and a return to the horrors of products marketed without adequate warnings. Though the world today is very different than the world of Kelsey, the FDA Titanic nonetheless holds on to old arguments, while failing to meet new challenges.

As demonstrated in Sorrell and Caronia, it takes unusual facts for a case involving the FDCA and the First Amendment to reach a federal courthouse. Amarin sued the FDA in May of 2015, seeking to expand its approved drug claims to include claims being asserted by dietary supplement manufacturers for the same product. The court in Amarin flatly rejected the position the FDA has been touting for decades— that it was not prosecuting speech but conduct that is evidence of intent. The court went on to hold that "the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment." (Slip Opinion at 48). The court further rejected the government's attempt to rewrite the holding in Caronia: "Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based." (Id. at 49)

Pacira v. FDA: Declaring The Truth False And Punishing It.

Pacira v US, 15-cv-7055-RA, (SDNY filed on Sept. 9, 2015) adds no new constitutional analysis, but what it does bring is unique facts boasting: "Pacira's case is even stronger, for while the speech at issue in Amarin and Caronia concerned "off-label" drug uses, the speech Pacira desires to engage in concerns on-label information about use of EXPAREL for its FDA-approved indication." (Brief at 1). Pacira's drug EXPAREL was indicated for general surgical use because "[a]s recognized by FDA's historical practice and regulatory guidance ... the safety and effectiveness of EXPAREL in these two well-established pain models provide a clear scientific and medical rationale for concluding that the drug's clinical benefits are generalizable to other surgical sites." (Brief at 2). The FDA-approved label did not limit the types of surgeries to those in the underlying studies. But, through its criminal enforcement power, three years after approval, FDA sought to rewrite the label to limit the indications to the two surgeries studied.

On September 22, 2014, the Company received a Warning Letter from FDA's Office of Prescription Drug Promotion objecting to the company's promotional materials and asserting a violation of the criminal provisions of the FDCA. In the FDA's defense, the Warning Letter (here) states that the clinical trial section of the label states "EXPAREL has not been demonstrated to be safe and effective in other procedures."

In response, the company tried to meet with the FDA to work out how to comply with the FDA's demands due to the fact that the indications section of the labeling did not limit the product to the surgeries studied. More importantly, the product was effective and the incidence of adverse events was low (one third of one tenth percent), but the FDA stonewalled. Given the threat of criminal sanctions, the company relented and did what the FDA demanded and refrained from disseminating truthful FDA-approved information to physicians. The FDA subsequently issued a "Close Out Letter" and Pacira continues to refrain from engaging in conduct that the FDA is barred by the First Amendment from prohibiting.

Not Commercial Speech

Pacira correctly observes that the FDA's interpretation of the regulations broadly defines the term "labeling" to include any utterance (and non-utterance) that supports the FDA's conclusion and the "FDA's interpretation of 'false or misleading' does not hinge on whether information is true." (Brief at 10). One difference in Pacira, unlike Amarin, the manufacturer is not conceding that the speech at issue is commercial speech. This is no minor technicality because where the manufacturer does not concede that the speech at issue is commercial speech and suggests that heightened scrutiny applies. The burden on the government to justify its restriction on speech is much greater when the manufacturer does not concede that intermediate scrutiny for commercial speech applies.

The FDA and Science Fiction

Pacira complains that FDA tramples the First Amendment, imposing two impermissible distinct speaker- and content-based restrictions on Pacira's ability to speak about EXPAREL. The issue for the court is whether the FDA's threatened enforcement of Pacira for discussing the use of EXPAREL in general surgeries and prohibiting statements about the drug's effectiveness runs afoul of the constraints of the First Amendment. Moreover, the FDA's position in its Warning Letter suggests that the FDA may be changing the rules to suit its purpose raising significant due process concerns. For the FDA to prevail, the court may need to agree with the FDA that "as a categorical matter . . . all claims regarding efficacy or comparative claims are false or misleading unless supported by two clinical trials, as FDA purports to do." (Brief at 9).

Before the regulatory ship sinks entirely, FDA might consider following through with what it said it would do: hold public hearings and get the reasoned voice of industry, the public, and even the public interest groups to provide guidance on what has become a public health imperative to provide more, not less, truthful scientific and medical information to the medical community and the public concerning approved products.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Michael A. Walsh
Katherine McGahey
In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.