United States: Utah Decision Yields Decidedly Mixed Results

Last Updated: September 12 2019
Article by James Beck

We had been waiting for the Utah Supreme Court's decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court (Utah is one of the few courts allowing district court certification), over a year ago, "[p]ractically no court has . . . treat[ed] prescription drugs and prescription medical devices differently under [Restatement (Second) of Torts §402A] comment k [(1965)]." We presented a 50 state survey indicating that was so – whether the state had adopted an "across-the-board" or a "case-by-case" approach to comment k. Likewise the Third Restatement had treated all prescription medical products identically, even though it used a different test than comment k.

The Utah Supreme Court in Burningham accepted certification of four questions:

  1. Under Utah law, does the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts apply to implanted medical devices?

  2. If the answer to Question 1 is in the affirmative, does the exception apply categorically to all implanted medical devices, or does the exception apply only to some devices on a case-by-case basis?

  3. If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

  4. If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market through the FDA's premarket approval process as opposed to the § 510(k) clearance process?

Burningham v. Wright Medical Technology, Inc., ___ P.3d ___, 2019 WL 4231947, at *2 (Utah Sept. 5, 2019).

Well, last week, Burningham decided to go its own way, not even mentioning the overwhelming precedent to the contrary. In a prescription drug case, Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991), almost "thirty years ago," "this court agreed 'with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect" and "categorically immunize[d] all prescription drugs from strict liability design defect claims." Burningham, 2019 WL 4231947, at *3 (quoting Grundberg, 813 P.3d at 95).

Grundberg had followed Brown v. Superior Court, 751 P.2d 470, 475-83 (Cal. 1988), in applying comment k across the board to abolish prescription drug design defect strict liability. At the time (we were younger and less jaded than now), we had hoped that would become a trend, but it didn't – so we're now counting on preemption instead. But when Burningham was accepted, our greatest fear was that the court would reverse Grundberg. Fortunately, that didn't happen. Instead, Burningham reiterated the "compelling reason" that undergirds Grundberg:

And we are still cognizant of the problems associated with such a[ case-by-case] approach. But we were able to avoid those problems in suits involving prescription drugs only because of the rigorous FDA approval process to which they were subject.

2019 WL 4231947, at *6. So prescription drug design defect cases remain barred by Utah state law. The worst was avoided.

In initially sorting out the four certified questions, Burningham did something that manufacturers of FDA pre-market approved ("PMA") medical devices will like quite a bit. It declined to answer the final question on the basis of federal preemption:

In Riegel v. Medtronic, Inc., the Court held that the MDA preempts state law tort claims involving PMA-approved medical devices. See 552 U.S. 312, 321-25 (2008). . . . The fourth certified question asks whether the unavoidably unsafe exception requires a showing that the implanted medical device was cleared for market through the PMA process rather than the 510(k) process. However, Riegel holds that all state law tort claims, including strict liability design defect claims, involving a PMA-approved device are preempted by the MDA. So, regardless of our conclusion as to whether a PMA-approved device should be deemed unavoidably unsafe as a matter of law, such devices are already immune from strict products liability claims.

So, with regard to question four, we do not opine on whether PMA-approved medical devices are unavoidably unsafe as a matter of law because they are already exempt from all state product liability claims.

2019 WL 4231947, at *5-6 (emphasis added). See Id. at *9 ("PMA-approved medical devices . . . are already exempt from all state products liability claims under [Riegel]"). So the good news for any PMA medical device manufacturer facing a Utah-law suit is that the state's highest court has held, in no uncertain terms, that all state-law claims are preempted. Utah evidently doesn't follow the Riegel dictum that has fooled so many courts into allowing so-called "parallel" violation claims. Utah went its own way.

But that's all the good news out of Burningham. Trading thirty-year-old precedent for an outdated (and almost as old) view of the FDA's §510(k) "substantial equivalence" device clearance procedure, Burningham relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999) (citing Lohr), to denigrate 510(k) clearance as insufficiently rigorous to justify applying Grundberg to such medical devices. 2019 WL 4231947, at *4-5.

To extend our reasoning in Grundberg to the medical device or any other context would require an equally compelling reason, such as a similarly rigorous oversight process.

Based on the applicable regulations, we are not persuaded that 510(k) is such a process. Comment k's premise is that there are some products that are "incapable of being made safe for their intended and ordinary use." Without an FDA evaluation of a medical device's safety, we cannot know whether the device is incapable of being made safe (although it is beneficial), or whether it is "unreasonably dangerous."

Id. at *6 (quoting comment k).

As we laid out in great detail in our "Lohr Has Two Shadows" post, the 510(k) process that Lohr (and cases like Goodlin that parrot Lohr) described no longer exists. Rather, Congress revamped the relevant statutory sections in the Safe Medical Devices Act ("SMDA") to impose the same "reasonable assurance of safety and effectiveness" standard to 510(k) that Lohr (and later Riegel) held would have preemptive effect. 21 U.S.C. §360c(f)(2)(a)(v). But nobody on the bench seems to care. It's almost as if there is a judicial conspiracy of silence in product liability cases with respect to the SMDA.

End of rant.

Be that as it may, in Burningham, the Court used its view of "substantial equivalence" to apply a case-by-case" comment k approach to 510(k) medical devices while retaining the "across-the-board" approach for prescription drugs.

[W]e answer the first certified question conditionally. Although the unavoidably unsafe exception might immunize some implanted medical devices from strict products liability, when such a device enters the market through the 510(k) process, we cannot say that this will always be the case as a matter of law.

2019 WL 4231947, at *7. Therefore some sort of case-by-case approach necessarily applied. "Accordingly, the answer to the second question is that courts applying Utah law should treat this exception as an affirmative defense to be determined by the factfinder on a case-by-case basis." Id.

Burningham tossed defendants some crumbs in exactly what this "affirmative defense" would look like. Plaintiffs had argued that, in addition to proving that the device was unavoidably unsafe, defendants also had to prove that the product was "properly manufactured" and had "adequate warnings." Id. The Utah Supreme Court held that, no, defendants did not have to prove the negative of manufacturing and warning defect claims in order to satisfy comment k. Rather, plaintiffs retained the burden of proof on those other kinds of defects. Grundberg did not "treat proper preparation and adequate warnings as elements of the unavoidably unsafe affirmative defense." Id. at *8.

Rather, these are separate claims a plaintiff must make and prove. If a plaintiff alleges manufacturing flaws or inadequate warnings and the factfinder finds the plaintiff has proved either one by a preponderance of the evidence, then the unavoidably unsafe exception is unavailable to a defendant as an affirmative defense. But if the plaintiff does not raise either claim, or is unable to prove them, the exception is available to the defendant.

Id. That's better than nothing, but experience has taught us that having to prove over and over again to multiple juries what the same defendant already had to prove to the FDA is an expensive and wasteful process, leading to Pyrrhic victories, or worse to lay juries disregarding the FDA's marketing clearances.

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