                 This opinion is subject to revision before final
                      publication in the Pacific Reporter

                                 2019 UT 56

                                    IN THE
       SUPREME COURT OF THE STATE OF UTAH

            DALE BURNINGHAM and LANA BURNINGHAM,
                      Plaintiffs-Appellants,
                                       v.
              WRIGHT MEDICAL TECHNOLOGY, INC. and
                  WRIGHT MEDICAL GROUP, INC.,
                      Defendants-Appellees.

                             No. 20180143
                        Filed September 5, 2019

                     On Certification from the
         United States District Court for the District of Utah
                   The Honorable Jill N. Parrish
                        Case No. 2:17-CV-92

                                 Attorneys: 1
       Brian C. Stewart, Salt Lake City, George E. McLaughlin,
        Thomas R. Leemon, Denver, for plaintiffs-appellants
   Elisabeth M. McOmber, Salt Lake City, Dana J. Ash, Robert M.
       Palumbos, Sean K. Burke, Ryan J. O’Neil, Philadelphia,
                     for defendants-appellees


   1 Amici Curiae attorneys are:
   Brent E. Johnson, Nathan Archibald, Salt Lake City, Daniel B.
Rogers, Miami, Victor E. Schwartz, Washington D.C., for amici
Advanced Medical Technology Association, Amercian Tort Reform
Association, BioUtah, Chamber of Commerce of the United States of
America,     National    Association    of    Manufacturers,  and
Pharmaceutical Research and Manufacturers of America
   Jessica A. Andrew, Lance Andrew, Salt Lake City, Jeffrey R.
White, Washington D.C., for amici The Utah Association for Justice
and The American Association for Justice
   John A. Anderson, Lauren E.H. DiFrancesco, Salt Lake City, for
amici The International Association of Defense Counsel
   Michael J. Schefer, Salt Lake City, for amici Washington Legal
Foundation
                  BURNINGHAM v. WRIGHT MEDICAL
                         Opinion of the Court


JUSTICE PETERSEN authored the opinion of the Court, in which
        CHIEF JUSTICE DURRANT, ASSOCIATE CHIEF JUSTICE LEE,
            JUSTICE HIMONAS, and JUSTICE PEARCE joined.


   JUSTICE PETERSEN, opinion of the Court:
                         INTRODUCTION
    ¶1 The federal district court certified four questions to us
related to a case before it involving artificial hip implants. Plaintiff
Dale Burningham had artificial hips surgically implanted in both
sides of his body. He alleges that parts of both hips have failed,
necessitating several surgeries to address problems with the
equipment. Defendants Wright Medical Technology, Inc. and Wright
Medical Group, Inc. (collectively, Wright Medical) manufactured the
equipment at issue. Burningham and his wife sued Wright Medical
in federal court under various theories of liability, including strict
liability for design defects.
    ¶2 The federal court asks us to resolve whether and to what
extent implanted medical devices should be immune from strict
liability design defect claims under Utah law because they are
“unavoidably unsafe”—meaning they are “incapable of being made
safe for their intended and ordinary use,” but their marketing and
use is justified because of the benefit they provide. RESTATEMENT
(SECOND) OF TORTS § 402A cmt. k (A.L.I. 1965). While some
implanted medical devices might very well be unavoidably unsafe,
we conclude that under current federal regulations, this question
should be treated as an affirmative defense and determined by the
factfinder on a case-by-case basis with regard to devices that enter
the market through the 510(k) process. For devices that go through
the more rigorous premarket approval process, the United States
Supreme Court has held that federal law preempts any state law tort
claims, so we do not opine on whether such devices might be
unavoidably unsafe as a matter of law because they are already
exempt from design defect claims.
                          BACKGROUND
   ¶3 Burningham received hip implants in both of his hips. Over
time, parts of the implants failed, and Burningham underwent
several revision surgeries. He and his wife sued Wright Medical in
federal district court, alleging that the implanted hip devices injured
Burningham. The Burninghams claimed that there were defects in

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the Profemur® Modular Neck implanted in Burningham’s left hip,
and the metal-on-metal Conserve® components implanted in his
right and left hips. Some of the Burninghams’ claims rested on a
theory of strict liability for design defect.
    ¶4 Wright Medical filed a motion to dismiss, arguing that the
“unavoidably unsafe” doctrine, which Utah has adopted, should
immunize its hip implant devices from strict liability design defect
claims. Wright Medical supported its argument with Utah case law
extending the unavoidably unsafe doctrine to categorically
immunize prescription drugs from such claims. See Grundberg v.
Upjohn Co., 813 P.2d 89, 99 (Utah 1991). Burningham responded that
while Utah has held that all prescription drugs are deemed
unavoidably unsafe as a matter of law, no Utah appellate court has
similarly applied the unavoidably unsafe exception to implanted
medical devices.
    ¶5 Confronted with these issues, the federal district court
determined that there was no controlling Utah law on this issue. We
appreciate the federal court’s recognition that “resolution of these
questions will have a significant impact on the bounds of strict
liability for design defect claims brought under Utah law.” 2 The
federal court ultimately certified the following questions to us:
       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


   2  Notably, Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991), was
also the result of certified questions from the federal court.



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                          Opinion of the Court

           devices were cleared for market through the
           FDA’s premarket approval process as opposed to
           the § 510(k) clearance process?
                       STANDARD OF REVIEW
   ¶6 “A certified question from the federal district court does not
present us with a decision to affirm or reverse a lower court’s
decision; as such, traditional standards of review do not apply. On
certification, we answer the legal questions presented without
resolving the underlying dispute.” Egbert v. Nissan N. Am., Inc., 2007
UT 64, ¶ 7, 167 P.3d 1058 (citations omitted) (internal quotation
marks omitted). We have jurisdiction to answer certified questions
pursuant to Utah Code section 78A-3-102(1).
                               ANALYSIS
               I. STRICT PRODUCTS LIABILITY AND THE
                  UNAVOIDABLY UNSAFE EXCEPTION
    ¶7 Plaintiffs’ causes of action against Wright Medical include
strict liability design defect claims. Wright Medical argues that its
hip implants should be categorically immune from such claims
based on the “unavoidably unsafe doctrine,” an exception to strict
products liability.
    ¶8 We have adopted section 402A of the Restatement (Second)
of Torts, which imposes liability upon “[o]ne who sells any product
in a defective condition unreasonably dangerous to the user or
consumer, or to his [or her] property.” RESTATEMENT (SECOND) OF
TORTS § 402A(1) (A.L.I. 1965); see also Ernest W. Hahn, Inc. v. Armco
Steel Co., 601 P.2d 152, 158 (Utah 1979). This liability is strict in that it
applies whether or not “the seller has exercised all possible care in
the preparation and sale of his [or her] product.” RESTATEMENT
(SECOND) OF TORTS § 402A(2)(a). Comment g defines a “[d]efective
condition” as a condition “not contemplated by the ultimate
consumer, which will be unreasonably dangerous to [that
consumer].” Id. § 402A cmt. g; see also Dowland v. Lyman Prods. for
Shooters, 642 P.2d 380, 381 n.2 (Utah 1982) (applying comment g).
   ¶9 The unavoidably unsafe doctrine is an exception to strict
products liability. Comment k of section 402A describes a category of
products that are incapable of being made entirely safe, but when
they are “properly prepared, and accompanied by proper directions
and warning, [are] not defective, nor . . . unreasonably dangerous.”
Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991) (alterations in



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original) (citation omitted) (internal quotation marks omitted).
Comment k provides in its entirety:
      k. Unavoidably unsafe products. There are some
      products which, in the present state of human
      knowledge, are quite incapable of being made safe for
      their intended and ordinary use. These are especially
      common in the field of drugs. An outstanding
      example is the vaccine for the Pasteur treatment of
      rabies, which not uncommonly leads to very serious
      and damaging consequences when it is injected. Since
      the disease itself invariably leads to a dreadful death,
      both the marketing and the use of the vaccine are
      fully justified, notwithstanding the unavoidable high
      degree of risk which they involve. Such a product,
      properly prepared, and accompanied by proper
      directions and warning, is not defective, nor is it
      unreasonably dangerous. The same is true of many
      other drugs, vaccines, and the like, many of which for
      this very reason cannot legally be sold except to
      physicians, or under the prescription of a physician. It
      is also true in particular of many new or experimental
      drugs as to which, because of lack of time and
      opportunity for sufficient medical experience, there
      can be no assurance of safety, or perhaps even of
      purity of ingredients, but such experience as there is
      justifies the marketing and use of the drug
      notwithstanding a medically recognizable risk. The
      seller of such products, again with the qualification
      that they are properly prepared and marketed, and
      proper warning is given, where the situation calls for
      it, is not to be held to strict liability for unfortunate
      consequences attending their use, merely because he
      has undertaken to supply the public with an
      apparently useful and desirable product, attended
      with a known but apparently reasonable risk.
RESTATEMENT (SECOND) OF TORTS § 402A cmt. k.
   ¶10 Almost thirty years ago, in Grundberg, 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.” 813 P.2d at 95. In that case we extended comment k
beyond its borders to categorically immunize all prescription drugs
from strict liability design defect claims. Id. at 99. We held that “a

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                        Opinion of the Court

drug approved by the [FDA], properly prepared, compounded,
packaged, and distributed, cannot as a matter of law be ‘defective’ in
the absence of proof of inaccurate, incomplete, misleading, or
fraudulent information furnished by the manufacturer in connection
with FDA approval.” Id. at 90.
    ¶11 At the time, we recognized this was an extension of
comment k. Id. We noted that “[e]ven in the case of a clearly alleged
design defect, . . . comment k is unclear on the scope of its
protection.” Id. at 92. But we chose to apply comment k categorically
to prescription drugs for policy reasons, noting we were not “bound
by the specific language of comment k and may adopt and apply its
fundamental policy without restricting ourselves to what we
perceive to be its literal interpretation.” Id. at 95. Our reasons for
deeming all prescription drugs to be unavoidably unsafe as a matter
of law included their “unique nature and value, the elaborate
regulatory system overseen by the FDA, the difficulties of relying on
individual lawsuits as a forum in which to review a prescription
drug’s design, and . . . significant public policy considerations.” Id.
    ¶12 Here, we are asked how we will apply comment k to
implanted medical devices. Essentially, the question before us is
whether we will treat all implanted medical devices as unavoidably
unsafe as a matter of law, as we did with prescription drugs in
Grundberg, or whether we will conclude comment k should apply
differently to these devices.
    ¶13 Wright Medical argues that because “medical devices
present the same unique risks and benefits as prescription drugs,
while also being subject to premarket and post-market scrutiny from
the [FDA] and physician oversight, the court should apply the same
categorical protection of the unavoidably unsafe doctrine to
implanted medical devices that it applies to prescription drugs.” The
Burninghams disagree, noting that it was the FDA’s rigorous review
process that convinced us all prescription drugs should receive
comment k protection, and arguing that the FDA does not
necessarily subject all medical devices to the same thorough
screening.
               II. FDA OVERSIGHT OF IMPLANTED
                         MEDICAL DEVICES
    ¶14 Because the extent of the FDA’s oversight is significant to
this analysis, we address the FDA’s regulation of medical devices.
Before implanted medical devices like the ones made by Wright
Medical may be marketed in the United States, the FDA categorizes


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each device into one of three categories: Class I, II, or III, graded by
their potential for causing serious injury. 3 See 21 U.S.C. § 360c(a)(1).
    ¶15 Class I devices are those that pose no unreasonable risk of
illness or injury and are subject to only general control regulations.4
See id. § 360c(a)(1)(A). Class II devices are slightly more sophisticated
devices that are regulated by special controls “necessary to provide
adequate assurance of safety and effectiveness.” 5 Id. § 360c(a)(1)(B).
    ¶16 Unlike Class I and Class II devices, which present lesser
risks, Class III devices include those that “present[] a potential
unreasonable risk of illness or injury.” Id. § 360c(a)(1)(C)(ii)(II). These
are devices “purported or represented to be for a use in supporting
or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health.” 6 Id.
§ 360c(a)(1)(C)(ii)(I).
   ¶17 Because of the risk involved, all new Class III devices must
undergo a process to provide “reasonable assurance” that the
devices are effective and safe for medical use before they reach the
market. Id. § 360c(a)(1)(C)(ii)(II). There are three methods of
obtaining market approval for Class III devices. See id. § 360e.
   ¶18 The most rigorous is the premarket approval (PMA)
process, which requires manufacturers to provide the FDA with
comprehensive information about the device, including “full reports
of all information, published or known to or which should
reasonably be known to the applicant, concerning investigations
which have been made to show whether or not [the] device is safe
and effective.” Id. § 360e(c)(1)(A). The PMA process is focused on

   3 These classifications were introduced in 1976 when Congress
enacted the Medical Device Amendments (MDA), amending the
Federal Food, Drug, and Cosmetic Act.
   4 “Examples of Class I devices include stethoscopes, tongue
depressors and ice packs.” Sasha B. Rieders, Note, State Law Tort
Claims and the FDA: Proposing A Consumer-Oriented Prescription in
Medical Device Cases, 25 CARDOZO L. REV. 1159, 1162 n.14 (2004).
   5  Examples of Class II devices include oxygen masks,
contraceptive devices, and tampons. Rieders, supra note 3, at 1162
n.14.
   6Examples of Class III devices include pacemakers and prosthetic
implants. Rieders, supra note 3, at 1162 n.16.



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                  BURNINGHAM v. WRIGHT MEDICAL
                        Opinion of the Court

evaluating a device’s safety and efficacy. See id. This process “is a
rigorous one.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). After
the manufacturers submit the required information, “the FDA then
reviews [that information], spending an average of 1,200 hours on
each submission.” Id.
    ¶19 In contrast, is a premarket notification process referred to as
the “510(k) process.” 7 The 510(k) process allows a device to be
cleared for market usage when the FDA determines that the device is
“substantially equivalent” to a device already on the market. See
21 U.S.C. § 360e(b)(1)(B). This process allows manufacturers of
devices that are substantially equivalent to devices already on the
market to avoid the otherwise lengthy and costly PMA process. See
id. § 360e(b)(1).
   ¶20 Notably, the FDA has not evaluated devices entering the
market through the 510(k) process for safety and efficacy. The FDA’s
substantial equivalence review is limited in scope, and the FDA
considers “only whether the device is indeed the equivalent of a
preexisting device—regardless of how unsafe or ineffective the
grandfathered device happens to be.” Goodlin v. Medtronic, Inc., 167
F.3d 1367, 1369 n.1 (11th Cir. 1999) (citing Lohr, 518 U.S. at 478–80).
Thus, the FDA does not “approve” devices entering the market
through the substantial equivalence 510(k) process. 21 C.F.R. § 807.97
(“Any representation that creates an impression of official approval
of a device because of complying with the [510(k)] premarket
notification   regulations     is   misleading      and     constitutes
misbranding.”). Instead, the FDA “clears” devices entering the
market through this path. 8




   7 The term “510(k)” refers to the section number in the original
Food, Drug, and Cosmetic Act. See Medtronic, Inc. v. Lohr, 518 U.S.
470, 478 (1996). United States Code section 360e and Code of Federal
Regulations sections 807.81 through 807.100 contain the operative
language of the 510(k) process. See generally 21 U.S.C. § 360e(b);
21 C.F.R. §§ 807.81–807.100.
   8 See 510(k) Clearances, U.S. FOOD & DRUG ADMIN. (Sept. 4, 2018),
https://www.fda.gov/MedicalDevices/ProductsandMedicalProced
ures/DeviceApprovalsandClearances/510kClearances/default.htm
referring to devices entering the market through the 510(k) process
as “510(k) Clearances”).


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    ¶21 The new device does not need to be substantially equivalent
to a device that passed the PMA process; rather, it is sufficient if the
manufacturer can establish that the “marketed device to which a
new device [is] compared . . . is a device that was legally marketed
prior to May 28, 1976” (when the FDA implemented the present
regulatory structure, the Medical Device Amendments (MDA)). Id.
§ 807.92(a)(3). As a result, a device that was grandfathered into legal
marketability in 1976 can serve as the touchstone for future devices
entering the market through the 510(k) process. See id. Additionally,
new devices may receive 510(k) clearance by establishing substantial
equivalence to a “device which has been found to be substantially
equivalent through the 510(k) premarket notification process.” Id.
Thus, the applicable regulations permit an unlimited line of products
marching behind a grandfathered device, none of which has ever
been subjected to the FDA’s scrutiny for safety or efficacy.
   ¶22 Furthermore, the 510(k) process relies on the manufacturer’s
word. 9 The FDA is not involved in investigating the safety of the
product undergoing the process. A finding of substantial
equivalence and satisfaction of the 510(k) process “does not in any
way denote official [FDA] approval of the device.” Id. § 807.97. 10



   9 In the 510(k) process, manufacturers include in their application
the following statement:
        I certify, in my capacity as (position held in
        company), of (company name), that I have conducted
        a reasonable search of all information known or
        otherwise available about the types and causes of
        safety or effectiveness problems that have been
        reported for the (type of device). I further certify that I
        am aware of the types of problems to which the (type
        of device) is susceptible and that, to the best of my
        knowledge, the following summary of the types and
        causes of safety or effectiveness problems about the
        (type of device) is complete and accurate.
21 C.F.R. § 807.94(a).
   10 There is a third process, not implicated here, of gaining market
approval by designating the device as innovative technology and
marketing it under an “investigational device exemption” (IDE). See
id. §§ 812.1–812.150. This method allows manufacturers to market a
device before premarket approval “for the purpose of conducting
                                                           (continued)

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                    BURNINGHAM v. WRIGHT MEDICAL
                          Opinion of the Court

    ¶23 The medical devices at issue in the federal case are Class III
devices. Wright Medical used the 510(k) notification process to bring
its hip implant devices to market, thus avoiding the PMA process.
And the FDA cleared all of the devices at issue through the 510(k)
process.
                    III. THE CERTIFIED QUESTIONS
    ¶24 With this comparison of the PMA and 510(k) processes in
mind, it is important to address the implications for the certified
questions of two cases from the United States Supreme Court
involving federal preemption of state tort claims involving medical
devices. 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). However, the same is not
true for devices that have been cleared through the 510(k) process
because it is focused on equivalence, not on safety or efficacy. See
Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996). Accordingly, the
Court concluded that the 510(k) process was intended to “maintain
the status quo with respect to the marketing of existing medical
devices and their substantial equivalents.” Id. at 494. Maintaining the
status quo “included the possibility that the manufacturer of the
device would have to defend itself against state-law claims of
negligent design.” Id.
    ¶25 These cases affect our resolution of the certified questions.
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. 11 But under



investigations of that device.” Id. § 812.1(a); see also 21 U.S.C.
§ 360j(g) (exempting “devices for investigational use” from the PMA
process requirements). The certified questions do not inquire about
the IDE process, so we do not address products that enter the market
this way.
   11   The parties all agreed with this conclusion at oral argument.



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Lohr, the same is not true for devices that enter the market through
the 510(k) process.
   ¶26 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. But it remains for us to determine whether
510(k)-cleared medical devices, such as Wright Medical’s hip
implants, which are susceptible to state tort claims, are nevertheless
immunized from strict liability design defect claims because they are
unavoidably unsafe as a matter of law. We will now address
questions one through three.
    ¶27 We conclude with regard to the first and second questions
that while a particular 510(k)-cleared medical device might very well
be unavoidably unsafe, this is a fact-intensive question that must be
raised by a defendant as an affirmative defense and determined by
the factfinder on a case-by-case basis. In Grundberg v. Upjohn Co., we
articulated why a case-by-case approach is problematic. 813 P.2d 89,
93–95 (Utah 1991). And we are still cognizant of the problems
associated with such an 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. 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.
    ¶28 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.” RESTATEMENT (SECOND) OF TORTS § 402A
cmt k. (A.L.I. 1965). 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.” See id.
    ¶29 For example, if a medical device is subjected to FDA
scrutiny for safety, and the FDA deems the device to be either unsafe
or capable of being made safer, the FDA will deny the
manufacturer’s application to market the device. See 21 U.S.C.
§ 360e(d)(2). Whereas, if a device enters the market through the
510(k) process, the FDA has not evaluated the device for safety, and
the device has no approval from the FDA in that regard.
Accordingly, we cannot know whether the device is safe, incapable
of being made safe, or unreasonably dangerous.


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                         Opinion of the Court

   ¶30 We join the many courts that have observed the 510(k)
process is concerned primarily with equivalence, not safety.12
Because of the differences between the FDA’s rigorous oversight of
prescription drugs and the 510(k) process for medical devices, we
decline to extend the reasoning in Grundberg to implanted medical
devices that have entered the market through the 510(k) process.
    ¶31 Therefore, we 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. 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.
    ¶32 We now address the third question regarding the proper
analysis to determine whether the exception has been met. The
Burninghams argue in favor of applying the Oklahoma Supreme
Court’s approach in Tansy v. Dacomed Corp., 890 P.2d 881 (Okla.
1994). The Tansy court held that comment k could be raised as an
affirmative defense when a medical device was incapable of being
made safe, but the societal benefit warranted its production. Id. at

   12 See generally Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,
344–46 (2001) (contrasting the PMA process’ safety procedures with
510(k)’s equivalence procedures); Medtronic, Inc. v. Lohr, 518 U.S. 470,
478–80 (1996) (stating that the 510(k) process provides little
protection to the public because it is focused on equivalence, not
safety); Tingey v. Radionics, 193 F. App’x 747, 755 (10th Cir. 2006)
(noting that “the § 510(k) process is focused on equivalence rather
than safety, and therefore ‘provide[s] little protection to the public.’”
(alteration in original) (citation omitted)); Mitchell v. Collagen Corp.,
126 F.3d 902, 905 (7th Cir. 1997) (noting the “stark contrast” between
the PMA process’ safety requirements and the 510(k) process’
equivalence requirements); Reeves v. AcroMed Corp., 44 F.3d 300, 303
(5th Cir. 1995) (contrasting the PMA process’ scrutiny of product
safety with 510(k) process’ focus on determining substantial
equivalence). But see In re DePuy Orthopaedics, Inc., Pinnacle Hip
Implant Prod. Liab. Litig., 888 F.3d 753, 770 (5th Cir. 2018) (“[T]he
[FDA] has clarified, in guidance documents, that ‘principles of safety
and effectiveness underlie the substantial equivalence determination
in every 510(k) review.’” (citation omitted)).



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885. 13 The Burninghams argue that to succeed on this defense under
the Tansy standard, the manufacturer would need to establish that
(1) “the product [was] incapable of being made safe under present
technology,” (2) “the social need for the product warrant[ed] its
production,” and (3) “the product [was] properly manufactured and
contain[ed] adequate warnings.” Id. at 885–86.
   ¶33 While Wright Medical argues that applying comment k to
implanted medical devices on a case-by-case basis would be
unworkable and bad public policy for the reasons we detailed in
Grundberg, it asserts that if we do adopt a case-by-case approach,
then it should be consistent with the Model Utah Jury Instruction
(MUJI) on this issue. After some introductory language to explain
the concept of an “unavoidably unsafe” product to the jury, the
MUJI instruction provides:
        To establish the defense that the [product] was
        unavoidably unsafe, [name of defendant] must prove
        that:
          (1) when the [product] was made, it could not be
              made safe for its intended use even applying
              the best available testing and research; and
           (2) the benefits of the [product] justified its risk.




   13  See also Hill v. Searle Labs., 884 F.2d 1064, 1068 (8th Cir. 1989)
(“We agree with th[e] courts that view comment k as an affirmative
defense.” (citing Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1301
(D. Minn. 1988))); Coursen v. A.H. Robins Co., 764 F.2d 1329, 1338 (9th
Cir. 1985) (upholding a case-by-case application of comment k);
Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290, 1308 (D. Colo. 1984)
(providing that comment k is an affirmative defense); Moss v. Wyeth
Inc., 872 F. Supp. 2d 162, 174 (D. Conn. 2012) (concluding comment k
should provide an affirmative defense); Allen v. G.D. Searle & Co., 708
F. Supp. 1142, 1149 (D. Or. 1989) (applying comment k similarly, but
to prescription drugs); Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273,
1285–86 (Haw. 1992) (holding that a pacemaker did not fall under
comment k because it was “demonstrably capable of being made
safe for its intended use”); Toner v. Lederle Labs., 732 P.2d 297, 308
(Idaho 1987) (concluding that comment k is an affirmative defense to
a claim based on strict liability).



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                  BURNINGHAM v. WRIGHT MEDICAL
                         Opinion of the Court

      If [name of defendant] proves both by a
      preponderance of the evidence, the [product] is not
      defective.
      This defense does not apply to [name of plaintiff]’s
      claims that the [product] was improperly
      manufactured or had inadequate warnings.
MODEL UTAH JURY INSTRS. 2d CV1051.
   ¶34 Both proposed standards treat the unavoidably unsafe
exception as an affirmative defense. And the basic elements of both
are similar. The only substantial difference is that the Burninghams
argue that Tansy requires a defendant to prove that the product was
properly manufactured and had adequate warnings as elements of
the affirmative defense, while Utah’s instruction does not.
    ¶35 Notwithstanding the Burninghams’ characterization,
Oklahoma’s Uniform Jury Instructions suggest that Oklahoma law
does not materially differ from Utah’s on this point. The Oklahoma
instruction reads:
      Against the claim of [Plaintiff] that the [Specify
      Product] was defectively designed, [Defendant] has
      raised the defense that the [Specify Product] was
      unavoidably unsafe. Some products cannot be made
      safe for their intended use, but their benefits are great
      enough to justify their risks of harm. To establish the
      defense that the [Specify Product] was unavoidably
      unsafe, [Defendant] must prove by the greater weight
      of the evidence that:
         1. The benefits of the [Specify Product] justified
            its risks; and
         2. At the time of manufacture and distribution,
            the [Specify Product] could not be made safer
            for its intended use applying the best available
            testing and research.
      [This defense does not apply if [Plaintiff] has proved by the
      greater weight of the evidence that [Specify Product] was
      improperly manufactured or had inadequate warnings.]
OKLA. UNIFORM JURY INSTRS. § 12.11 (emphasis added).
    ¶36 This does not differ materially from Utah law. We made
clear in Grundberg that the unavoidably unsafe exception is
unavailable to manufacturers who improperly manufacture the


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                         Cite as: 2019 UT 56
                        Opinion of the Court

product or who provide inadequate warnings. See Grundberg, 813
P.2d at 90 (“[A] drug approved by the [FDA], properly prepared,
compounded, packaged, and distributed, cannot as a matter of law be
‘defective’ . . . .” (emphasis added)); see also Schaerrer v. Stewart’s
Plaza Pharmacy, Inc., 2003 UT 43, ¶ 17, 79 P.3d 922 (holding that
comment k protects manufacturers from strict liability for defects “if
prepared, distributed, and marketed properly and with appropriate
directions and warnings”).
   ¶37 As we explained in Grundberg:
       As a condition to its application, comment k requires
       that the product be “properly prepared, and
       accompanied by proper directions and warning. . . ”
       There are three types of product defects:
       manufacturing flaws, design defects, and inadequate
       warnings regarding use. See Prosser & Keeton, The
       Law of Torts § 99, at 695–98 (5th ed. 1984); Savina v.
       Sterling Drug, Inc., 247 Kan. 105, 795 P.2d 915, 923
       (1990). By its terms, comment k excepts unavoidably
       unsafe products from strict liability only to the extent
       that the plaintiff alleges a design defect; comment k’s
       immunity from strict liability does not extend to strict
       liability claims based on a manufacturing flaw or an
       inadequate warning. The purpose of comment k is to
       protect from strict liability products that cannot be
       designed more safely. If, however, such products are
       mismanufactured or unaccompanied by adequate
       warnings, the seller may be liable even if the plaintiff
       cannot establish the seller’s negligence. Toner v.
       Lederle Laboratories, 112 Idaho 328, 732 P.2d 297, 305
       (1987). . . . [T]he prerequisite to a comment k
       exemption—that the drug “was properly prepared
       and accompanied by warnings of its dangerous
       propensities”—must be established on a case-by-case
       basis. This limitation on the scope of comment k
       immunity is universally recognized.
813 P.2d at 92.
   ¶38 However, neither Grundberg nor the Oklahoma Uniform
Jury Instruction treat proper preparation and adequate warning as
elements of the unavoidably unsafe affirmative defense. Rather,
these are separate claims a plaintiff must make and prove. If a
plaintiff alleges manufacturing flaws or inadequate warnings and


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                  BURNINGHAM v. WRIGHT MEDICAL
                         Opinion of the Court

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.
    ¶39 Accordingly, when an implanted medical device enters the
market through the 510(k) process, and a manufacturer raises the
affirmative defense that the product is unavoidably unsafe in
response to a design defect claim, the manufacturer must prove by a
preponderance of the evidence that (1) when the product was made,
it could not be made safe for its intended use even applying the best
available testing and research, and (2) the benefits of the product
justified its risk. If the plaintiff has raised an improper
manufacturing or inadequate warning claim, the jury also should be
instructed that this affirmative defense is unavailable if the plaintiff
proves by a preponderance of the evidence either of those claims.
                           CONCLUSION
   ¶40 We first address the fourth certified question to clarify that
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 products liability claims under the United
States Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S.
312 (2008).
   ¶41 We 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.
    ¶42 Regarding the second certified question, the exception does
not apply categorically to all 510(k)-cleared devices. It should be
raised by the defendant as an affirmative defense and determined by
the factfinder on a case-by-case basis.
    ¶43 As to the third certified question regarding the proper
analysis to determine whether the defendant has proven the
exception, we conclude that the MUJI instruction properly explains
Utah law. However, some additional language must be added
explaining that this affirmative defense is unavailable if the plaintiff
alleges and proves by a preponderance of the evidence that the
product was improperly manufactured or contained inadequate
warnings.


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