United States: What If We Win? Off-Label Promotion & Product Liability

Last Updated: March 20 2017
Article by James Beck

Since the nomination of Dr. Scott Gottlieb to head the FDA, we've seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We don't think we can add a lot to those descriptions of Dr. Gottlieb's views, so we won't try. We will, of course, be very pleased if the FDA ends its unconstitutional ban on truthful off-label promotion before ultimately being forced to by the courts.

We've also read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled "Off-Label Promotion Could Mean More Drug Company Liability." Although apparently written before the Gottlieb nomination, this article consists largely of the interviews with two avatars of the other side of the "v.": fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we've tangled before over off-label issues. Needless to say, we disagree with the "more liability" spin they put on any would-be FDA retreat on off-label promotion.

Here's why – and we apologize to all of you who can't read the article we're responding to, but it's behind a paywall, and Michael Bloomberg didn't get to be a billionaire by giving things away that he could charge for (that's what we do).

The first contention is that, once truthful off-label promotion is legal, "drug companies would lose the protection afforded by preemption." We don't think that's grounds for "more liability." First of all, "drug companies" – at least those making innovative branded drugs, don't have much of a preemption defense. The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of "clear evidence" that the FDA would have rejected the label change in question. There are other possible preemption grounds concerning design defect claims (which we've advocated here), but off-label promotion doesn't involve design. So, while there may be liability issues raised concerning specific instances of off-label promotion, we don't see any basis for calling it "more" liability than already exists for on-label promotion. Most branded drug warnings don't have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label. The FDA, however, can order a drug's label to contain statements (usually warnings) about an off-label use. 21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of "required by" the FDA). That's important because, as we discussed in more detail here, only the FDA can do this. Drug companies are not allowed to discuss off-label uses in their labels whenever they want. Without the FDA telling them to, that is a form of misbranding.

Should truthful off-label promotion become legal, it may be expected that the FDA would react by ordering more warnings about those uses to appear on drug/device labeling. That's actually good for preemption, in a number of ways.

First, with the FDA picking the language it wants, an order to put "X" in the label about a particular off-label risk is (to our defense-oriented way of thinking) "clear evidence" under Levine that the FDA doesn't want some plaintiff-advocated statement "Y" on that same label. Once the FDA itself is in the business of imposing precise wording, the agency's actions pretty much preclude other statements about the same risk.

Second, there's also preemption by way of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), to deal with. We've already discussed the "independence principle" that these cases articulate for the application of impossibility preemption. The cases on our preemption cheat sheet demonstrate that this principle is in no way limited to generic drugs (heck, it's been applied to airplanes). Thus, in a truthful off-label promotion case, plaintiffs shouldn't even be able to argue that an additional warning about the use at issue should appear on the label, because (as just discussed) any such change would have to come from the FDA.

Third, physicians put medical devices as well as drugs to off-label use. In addition to items (1) and (2), an FDA order that a Class II device manufacturer should put specific language about a specific off-label use of a specific device should constitute a "device specific" requirement justifying preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Since Lohr currently precludes most arguments concerning express preemption (invoking a since-abolished presumption against preemption), this would be yet another way that preemption would be greater, not less, in some cases involving legal off-label promotion.

The Bloomberg article then discusses the big First Amendment win for our side in Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015), with the Amarin subsequent settlement somehow "bring[ing] more liability exposure." Exactly how Amarin would increase liability isn't explained, in the article, and we frankly don't see it. Here's a copy of the Amarin settlement agreement. The most significant aspect of the settlement in the liability context is found in paragraph 5 – providing for an FDA pre-clearance mechanism for off-label promotion:

Amarin may submit to FDA under the preclearance procedure described in this paragraph up to two proposed communications per calendar year about the off-label use of [the drug] before communicating them in promotion to doctors to determine if FDA has concerns with Amarin's proposed communications. If FDA has concerns with a proposed communication that Amarin submits to FDA under this paragraph, FDA will contact Amarin with its specific concerns or objections within 60 calendar days.

To the extent that that the Amarin settlement were to become a model for a future legal off-label promotion regime, this kind of arrangement isn't likely to increase liability either.

First, there's both Mensing/Bartlett and "clear evidence" preemption in play. FDA pre-clearance of off-label promotional statements implicates the aforesaid "independence principle" and thus impossibility preemption. It would also provide "clear evidence" that the statement is OK with the FDA. Second, as a practical matter, if off-label promotion follows the Amarin model with FDA pre-clearance (or a litigated court approval if the FDA refuses to allow the particular statements), juries aren't likely to think much of off-label liability claims. If off-label promotion comes with FDA clearance/court approval attached to it, such statements would have a significantly greater "cachet" than many on-label warning defect claims where there isn't the same kind of evidence that the statements at issue received the kind of particularized and detailed scrutiny by either the FDA or a court that is provided by the Amarin model.

The article then, under the heading "no preemption defense," asserts that companies being "less handcuffed" by the FDA "exposes [them] to liability for off-label promotion because they won't be able to use FDA approval as a shield." We're not 100% clear what this means, but the notion that off-label use ipso facto makes preemption evaporate has been raised repeatedly in PMA medical device litigation and, aside from one outlier case, has failed miserably.

"[T]he FDA's "approval process generally contemplates that approved devices will be used in off-label ways." Aaron v. Medtronic, Inc., ___ F. Supp.3d ___ (S.D. Ohio Sept. 22, 2016). The FDCA "preempt[s] any claim that seeks to impose a state law duty that differs from or adds to federal duties, whether those duties concern on- or off-label uses." Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1346 (10th Cir. 2015) (Gorsuch, J.).

[Plaintiffs] are incorrect to argue that the absence of affirmative approval mandates the finding that no federal requirements exist. Federal requirements for off-label use manifestly exist. . . . Furthermore, plaintiffs' argument presumes off-label use to be inherently suspect or substandard, which Congress rejected by enacting 21 U.S.C.A. §396.

Cornett v. Johnson & Johnson, 998 A.2d 543, 561 (N.J. Super. A.D. 2010), aff'd, 48 A.3d 1041 (N.J. 2012). Preemption analysis thus does not depend on how the device is to be used, or promoted to be used. E.g., Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586, 600 (D.N.J. 2015); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015); Arvizu v Medtronic, Inc., 41 F. Supp.3d 783, 790 (D. Ariz. 2014); Martin v. Medtronic, Inc., 32 F. Supp.3d 1026, 1035 (D. Ariz. 2014); Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1218 (W.D. Okla. 2013), aff'd, 784 F.3d 1335 (10th Cir. 2015); Riley v. Cordis Corp., 625 F. Supp.2d 769, 779 (D. Minn. 2009); Cales v. Baptist Healthcare System, Inc., ___ S.W.3d ___, 2017 WL 127731, at *5 (Ky. App. Jan. 13, 2017); Angeles v. Medtronic, Inc., 863 N.W.2d 404, 411 (Minn. App. 2015); McCormick v. Medtronic, Inc., 101 A.3d 467, 490 (Md. App. 2014). But see Ramirez v. Medtronic Inc., 961 F. Supp.2d 977, 991 (D. Ariz. 2013) (the one outlier case we mentioned above).

The conduct plaintiff complains of − how defendants are promoting and marketing to physicians the off-label use of the [product] − is governed by the FDCA. To determine whether said conduct is improper would require reliance on the requirements of the FDCA. Further, even the concept of "off-label use" is a creature of the FDCA, is defined by the FDCA, and is not a part of [state] substantive law.

Caplinger, 921 F. Supp.2d at 1219-20.

Thus, whether preemption is express or implied, claims based on off-label promotion are not some kind of magic formula for making preemption disappear. The same principles still apply. Within the confines of the various preemption regimes applicable to innovator drugs, generic drugs, PMA medical devices, and non-PMA medical devices, we expect plaintiffs to challenge the validity of particular statements made in off-label promotion to the same extent as they can (or cannot) challenge the validity of particular on-label statements. In certain situations there could be liability, but it's simply incorrect to posit that, by the mere fact of off-label promotion, there will be "more" liability than would otherwise exist.

The article, and the questionable statements, keep going. Next comes a claim that the learned intermediary rule is "undercut" by truthful off-label promotion. Again, we don't see how. The promotional statements are still directed to prescribing physicians. We're not aware of any groundswell for direct-to-consumer off-label promotion. As long as the prescriber is the recipient of information about an off-label use, we don't see any weakening of the learned intermediary rule. The law should remain as it has been – "to get around the [learned intermediary] defense, a product liability plaintiff must now show that a different warning would have changed a prescribing physician's decision." (statement in article).

Finally, the article speculates that legal – that is to say, truthful – off-label promotion could somehow limit preemption with respect to generic drugs. We've already dispatched the argument that First Amendment protection makes generic preemption disappear, so here we'll simply reiterate that FDA pre-clearance (the basis for Mensing/Bartlett preemption under the already discussed "independence principle") is would be perfectly constitutional, as a reasonable time, place, and manner regulation, of generic drug free speech as it is of free speech generally, as the Amarin settlement demonstrates.

Otherwise, allegations of off-label use have not prevented broad application of generic preemption. Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1250-51 (N.D. Ala. 2014); Rojas v. Teva Pharmaceuticals USA, Inc., 920 F. Supp.2d 772, 780 (S.D. Tex. 2013); Whitener v. PLIVA, Inc., 2012 WL 1995795, at *4 (E.D. La. June 4, 2012). Kellogg v. Wyeth, 2012 WL 368658, at *4-5 (D. Vt. Feb. 3, 2012). Once the FDA recognizes truthful off-label promotion as legal, there will be even less basis for attacks on generic preemption. After all, the promotional materials would still qualify as "labeling" under the FDA's and the courts' broad definition of that term. E.g., 21 C.F.R. §202.1(1)(2); Holmes v. Hospira, Inc., 2013 WL 12132046, at *10 (C.D. Cal. Jan. 10, 2013) ("FDA's broad definition of labeling" "encompasses nearly every conceivable form of communication with medical professionals").

The FDCA's "sameness" requirement for generic drugs explicitly applies to "labeling." 21 U.S.C. §§355(j)(2)(A)(v), 355(j)(4)(G). "Sameness" would thus extend to off-label promotion of generic drugs. That may create other complications with respect to off-label promotion in generic context, but legalization of truthful off-label promotion shouldn't have any effect on the scope of generic preemption with respect to generic drugs as long as "sameness" is complied with. Moreover, preemption under Buckman would preclude plaintiffs from invoking lack of "sameness" as some sort of cause of action against truthful off-label promotion. Truthful off-label promotion isn't a state law tort, whether it's the "same" as something else or not. "[T]here is no state-law duty to abstain from off-label promotion." Aaron, 2016 WL 5242957, at *12 (applying Buckman).

[T]here is no state law duty to abstain from off-label promotion. Off-label promotion itself exists only as a creation of the FDCA scheme. A state law cause of action cannot rest solely on . . . off-label promotion. . . . [E]ven the concept of 'off-label use' is a creature of the FDCA, is defined by the FDCA."

Martin v. Medtronic, Inc., 32 F. Supp.3d 1026, 1038 (D. Ariz. 2014) (numerous internal citations and quotation marks omitted). Thus, a suit alleging lack of sameness as a tort in the off-label promotion context would assert only a supposed FDCA violation (of sameness), and Buckman is 100% clear that private plaintiffs cannot enforce the FDCA.

In sum, we believe that the Bloomberg article's prediction of "more" liability in the event of the demise of the FDA's ban on truthful off-label promotion is simply the other side's wishful thinking. There will be some liability, just as there now is for on-label statements and promotion, but legalization isn't going to have much effect, if any, on preemption. To the extent legalization has any effect, both precedent (we cite cases; the article doesn't) and common-sense suggests that such effect will be positive from a defense perspective. The biggest thing that legalization will do is eliminate the other side's arguments that defendants are acting illegally despite telling the truth. The demise of "you broke the law" arguments can only be beneficial to the defense.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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.

James Beck
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.