United States: Artificial Intelligence Is No Threat To PMA Preemption

Last Updated: June 10 2019
Article by James Beck

A week or so ago, Bloomberg Law published (behind a pay wall) an article entitled "Medical Device Makers May Risk Liability Following FDA Effort." The Bloomberg article relied upon the same FDA initiative regarding artificial intelligence/machine learning ("AI/ML") in medical devices that we covered here, in a guest post. Our guest post raised preemption as one issue to consider:

As product liability litigators, concerns about the proposed framework's effects on preemption and duty to warn/learned intermediary doctrine are on our radar screens. For example, will regulation of SaMD self-modification be "rigorous" enough to support preemption?

The Bloomberg article, on the other hand, pushed the view that the FDA's regulation was creating sort of a preemption "grey area," and that it's "unclear" whether the FDA regulation would be "rigorous enough." We even read, "if algorithmic changes expand a device's scope beyond that for which it was approved, preemption becomes an 'open question.'"

That's about as far as "fair use" lets us sample the Bloomberg piece, so we've decided to examine the subject in a bit more detail. First of all, as long as the FDA chooses to regulate a medical device featuring AI/ML as requiring pre-market approval ("PMA") – and the Supreme Court continues to follow Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) – there will be preemption. We suppose that, should the still rather vague concept of "focused review" mutate into an entirely new form of FDA pre-market device review (one not currently provided by the Medical Device Amendments to the FDCA), either the Agency in the first instance or the courts would have to decide whether that new, neither-fish-nor-fowl process was preemptive. But as long as the FDA includes its approach to AI/ML medical devices within the rubric of the PMA framework, Riegel preemption will apply.

Assuming the FDA continues to use the framework, for AI/ML medical devices, tort claimants relying on state law are not permitted to second-guess the FDA's decision to regulate a device as requiring PMA versus any other regulatory path to marketing. Plaintiffs may not relitigate the sufficiency of FDA attention given to particular PMA devices:

The thrust of [plaintiffs'] argument is that the FDA could not have granted premarket approval to the [device] because it did not have sufficient data to do so.

However, the sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval. Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review. The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466, 471-72 (D. Mass. 2012). State-law claims are "preempted [where they] require[] a fact finder to make a determination under state law that federal law leaves exclusively to the FDA." Zimmerman v. Novartis Pharmaceuticals Corp., 889 F. Supp.2d 757, 777 (D. Md. 2012). At least since Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was decided not quite 20 years ago, and up until, like, now, we know of no case in which a plaintiff was allowed to second-guess an FDA decision whether to require PMA for a medical device, as opposed to §510(k) "substantial equivalence" – or vice versa. See McNeil-Williams v. Depuy Orthopaedics, Inc., 2019 WL 2179217, at *6 (E.D.N.C. May 20, 2019) (denying, as preempted by Buckman, "discovery regarding whether defendants, 'submissions to the FDA were timely, truthful and complete'") (this is the "now").

Thus the idea floated in the Bloomberg article that the FDA not requiring a separate PMA for every algorithm alteration created by AI/ML could affect preemption doesn't hold water. Assuming the FDA chooses to regulate such changes through a PMA approach evaluating rates and direction of change, and that decision holds up under federal administrative law as within the Agency's discretionary authority, preemption will bar state tort claimants from second-guessing the FDA's supposed lack of "rigor" in the context of the Agency's PMA evaluation.

[I]t is inappropriate for a jury to second-guess FDA's scientific judgment on such a matter that is within FDA's particular expertise. FDA determines the scope of a device, including . . . the appropriate regulatory pathway for the device. FDA subsequently determines whether the device meets the PMA approval standard. The agency makes a reasoned and deliberate decision as to the correct pathway of regulation and whether to approve the device. Juries lack the scientific knowledge and technical expertise necessary to make such judgments. [T]he prospect of hundreds of individual juries determining the propriety of particular device approvals, or the appropriate standards to apply to those approvals, is the antithesis of the orderly scheme Congress put in place and charged the FDA with implementing.

Blunt v. Medtronic, Inc., 738 N.W.2d 143, 151 (Wis. App. 2007) (quoting Horn v. Thoratec Corp., 376 F.3d 163, 178 (3d Cir. 2004)), aff'd, 760 N.W.2d 396 (Wis. 2009). See In re Orthopedic Bone Screw Products Liability Litigation, 264 F.3d 344, 364 (3d Cir. 2001) ("[b]ecause substantial equivalence determinations as well as the manner in which those decisions get made are functions committed to the discretion of the FDA, we will not second guess their outcomes."); Schering Corp. v. FDA, 51 F.3d 390, 399 (3rd Cir. 1995) ("[FDA's] judgments as to what is required to ascertain the safety and efficacy of drugs fall squarely within the ambit of the FDA's expertise and merit deference from us."); Center for Science in the Public Interest v. FDA, 74 F. Supp. 3d 295, 305 (D.D.C. 2014) (refusing to reevaluate "FDA's unique − and authoritative − position to view its projects as a whole, estimate the prospects for each, and allocate its resources in the optimal way"). See also Our recent post on Merck Sharp & Dohme Corp. v. Albrecht, ___ S. Ct. ___, 2019 WL 2166393 (U.S. May 20, 2019), about who should be deciding FDA-related issues that affect preemption.

The other approach suggested in the Bloomberg article questioned preemption in a situation where "algorithmic changes expand[ed] a device's scope beyond that for which it was approved." That argument is belied by the plethora of off-label use cases that we've covered on the Blog over the years, many of which we summarized here. To summarize our summary, the teaching of the great majority of the off-label use cases is that, preemption depends on pre-market approval of the "device" itself," not a device's potentially many "intended uses," a regulatory term that can change over time. The FDA approves "devices" not "uses." So once PMA is obtained, preemption exists under Riegel, regardless of which particular "use" or "intended use" a device is put to in any given case.

That's the same concept identified in the Bloomberg piece, only instead of a manufacturer's alleged "off-label promotion" changing a device's "intended use," the purported change is a consequence of incremental changes causes by AI/ML. Again, that is for the FDA, not private state-law litigants to decide. The FDA's ultimate regulation of AI/ML medical devices will no doubt superintend the evolutionary process of machine learning by establishing boundaries beyond which substantial evolution of a self-teaching device will require an additional PMA. Indeed, that's exactly what we read the FDA's discussion paper as doing:

For example, an app that was used to flag skin moles as potentially cancerous (and recommend a visit to a doctor) could morph into a program that could definitively diagnose melanoma (without a trip to the doctor). Such a change in the possible use for a life-threatening condition would necessitate pre-market approval ("PMA").

Thus, the FDA will decide when evolutionary changes to a medical device caused by AI/ML will – and equally importantly, will not – require a new PMA. As far as private plaintiffs attempting to second-guess an FDA decision not to require another PMA at any particular time, that takes us back to the first argument, since these type of decisions may not be collaterally attacked via state-law litigation.

Thus, upon further reflection, we don't think that anything in the FDA's currently envisioned approach to AI/ML medical devices portends any weakening of PMA preemption. What the FDA says is a PMA device will be treated as a PMA device in product liability litigation, particularly including preemption. If the FDA ever clears an AI/ML device under §510(k) as "substantially equivalent," then the device will have whatever preemption protection that process is interpreted as providing. Plaintiffs cannot now, and will not in the future, be able to second the FDA's decision how, or when, to require PMA.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions