A-1-CA-36565 | Omnilex

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Court of Appeals of New Mexico
Filed 12/30/2019 2:40 PM

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IN THE COURT OF APPEALS OF THE STATE OF NEW MEXICO

Court of Appeals of New Mexico
Opinion Number: Filed 12/30/2019 2:40 P]

Filing Date: December 30, 2019 A. [>
a ad
No. A-1-CA-36565 Mark Reynolds

MICHAEL BRIAN MCDONALD, PH.D,

Plaintiff-Appellee,

Vv.

ZIMMER INC., and ZIMMER
HOLDINGS INC.,

Defendants-Appellants,
and

LAMORRIS RICHARD HERRIN, JR.
and RK ORTHOPEDICS, LLC,

Defendants.

APPEAL FROM THE DISTRICT COURT OF BERNALILLO COUNTY
Nan G. Nash, District Judge

McGinn, Montoya, Love & Curry P.A.
Randi McGinn

Katie Curry

Albuquerque, NM

Kerry Kiernan, P.C.
Kerry Kiernan
Albuquerque, NM

for Appellee

UM B&B WN

CO WAAN

Rodey, Dickason, Sloan, Akin & Robb, P.A.
Nelson Franse

Krystle A. Thomas

Edward Ricco

Albuquerque, NM

Faegre Baker Daniels LLP
Michael J. Kanute
Chicago, IL

Bruce Jones

Minneapolis, MN

for Appellants

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OPINION

VANZI, Judge.

{1}. Zimmer Inc. and Zimmer Holdings Inc. (collectively, Defendants) appeal the
district court’s finding of strict liability for a design defect in the hip prosthetic
implanted in Brian McDonald (Plaintiff). Following a bench trial, the district court
concluded that the design of the prosthetic was unreasonably dangerous, in that it
shed excessive metal debris, causing poisoning and death of the soft tissue in
Plaintiff's hip joint, requiring Plaintiff to have additional hip surgeries and ongoing
(potentially lifelong) antibiotic treatment. Defendants argue on appeal that (1) the
district court erred in its findings and conclusions concerning a design defect; and
(2) the hip prosthetic is an unavoidably unsafe product, for which adequate warnings
were given, such that Defendants are not subject to strict liability, pursuant to
comment k to the Restatement (Second) of Torts § 402A (1965). Defendants seek
judgment as a matter of law, or a new trial. For the reasons set forth below, we affirm
the district court.

BACKGROUND

I. Procedural History
{2} Plaintiff filed a lawsuit against Defendants, and co-defendants Lamorris
Richard Herrin, Jr., and RK Orthopedics, LLC, on May 9, 2013. The complaint arose

from Plaintiff's injuries in connection with the failure of his hip implant, a prosthetic

device designed and manufactured by Defendants. The claims tried before the
district court in December 2016, in a bench trial, sounded in strict liability (design
defect and failure to warn), negligence, breach of express and implied warranties,
and punitive damages. The district court found Defendants strictly liable for a design
defect in the prosthetic device, and dismissed all other claims, including those
against co-defendants Herrin and RK Orthopedics.!

II. Facts Presented at Trial

A. Plaintiff’s Hip Surgeries

3} In 2010 Plaintiff was diagnosed with severe osteoarthritis with flattening of
the femoral head, osteophyte formation, and cystic formation. Plaintiff consulted
with orthopedic surgeon Joshua Carothers, M.D., and elected to have total hip
replacement surgery.” Dr. Carothers had originally planned to use a single-modular
prosthetic device for Plaintiffs hip replacement—a Zimmer brand “M/L Taper with
VerSys head.” “Single-modular” describes a device with a fixed or solid neck-stem?
component (the component anchored to the femur) coupled with an artificial head
(replacing the “ball” of the natural hip joint). Zimmer’s device, which included a

titanium alloy neck-stem component, and a cobalt-chromium alloy (CoCr) head

'The co-defendants were dismissed pursuant to a motion under Rule 1-041(B)
NMRA, granted by the district court following the bench trial.

Also known as “total hip arthroplasty.”

3Also called a “monoblock taper.”

component, was (at the time) considered the “gold standard” in total hip
replacement. However, during the surgery in June 2010, Dr. Carothers had to make
certain adjustments to accommodate Plaintiff's anatomy, and decided to use a dual-
modular device instead: the Zimmer brand “M/L Taper Hip Prosthesis with Kinectiv
Technology” (MLTK).* The MLTK is a “dual-modular” device because the neck
and stem components of the prosthetic are separate and can be adjusted, both in
relationship to the head and to one another, to account for variations in joint
configuration (e.g., leg length, offset, and version, which refers to the forward or
backward rotation of the hip joint). In Plaintiff's case, these options allowed Dr.
Carothers to choose an anteverted neck (one with a forward rotation) for Plaintiff's
implant. Like the traditional M/L Taper, the MLTK’s neck and stem are made of
titanium alloy. The MLTK can be used with either a CoCr head (such as the VerSys)
or a ceramic head. Dr. Carothers used the CoCr head.

{4} Plaintiff initially recovered well, but by early May 2011, Plaintiff was
experiencing hip pain, groin pain, and loss of flexibility. Dr. Carothers commenced
an established series of tests to determine the cause of Plaintiff’s pain, which

showed, inter alia, that Plaintiff had elevated levels of C-reactive protein (indicating

‘Dr. Carothers noted in his testimony that, at the time, Presbyterian Hospital
(where Plaintiffs surgery was performed) had a sole-source contract with
Defendants, and therefore Dr. Carothers was restricted to using a Zimmer product
for Plaintiffs total hip replacement.

tissue necrosis, or tissue death), and a pseudotumor” forming in the hip joint. Plaintiff
then saw Christopher Beauchamp, M.D., at the Mayo Clinic in Phoenix, Arizona, on
September 2, 2011, where Dr. Beauchamp diagnosed Plaintiff with an adverse
reaction to metal debris, associated with the MLTK implant, and scheduled Plaintiff
for revision surgery. Dr. Beauchamp ordered a blood serum test, which revealed
slightly elevated chromium levels, and significantly elevated (tenfold the normal
level) cobalt levels. Dr. Beauchamp performed a revision surgery on Plaintiff's right
hip joint on October 4, 2011, during which he discovered corrosion® and metal debris
at the taper junction of Plaintiff's MLTK prosthetic, as well as burnishing on the
neck component at the second (neck-stem) junction, necrotic (dead) tissue, and
turbid (cloudy) joint fluid. Dr. Beauchamp’s pre-operative and post-operative

diagnoses were failed total hip replacement secondary to adverse reaction to metal

°A pseudotumor is metal-related pathology consisting of a large fluid
collection in the joint.

Corrosion is a reduction-oxidation reaction at the surface of a metal. It may
occur where two metals with differing electro-potentials are in contact with one
another, and the more active metal (i.e., the metal that more readily loses electrons)
oxidizes, or corrodes. This is known as galvanic corrosion. Corrosion may also occur
through micro-motion or fretting—that is, wear to a metal surface induced by
rubbing (on metal or another surface). With fretting corrosion (also known as
tribocorrosion), surface wear removes the metal’s natural oxide coating and exposes
it to a new chemical environment. In the junction of a modular hip prosthetic, wear
is created by the micro-motion of one component against the other, and small
volumes of joint fluid exchanged within the junction facilitate the corrosive reaction,
carrying oxides and metal ions outside of the joint, and generally altering the electro-
chemical environment around and within the joint. This phenomenon has been
described as mechanically-assisted crevice corrosion.

debris caused by the CoCr head on the hip prosthetic articulating with the titanium
trunnion (the top of the neck, where it couples with the head). Such adverse reaction
is also known as metallosis or adverse local tissue reaction.

5} Dr. Beauchamp revised the hip by exchanging the CoCr head for a ceramic
head; he also replaced the Kinectiv neck component and the polyethylene liner
(which rests between the head and the cup). Dr. Beauchamp was unable to remove
all of the necrotic tissue around Plaintiff's right hip, because removing too much
tissue leaves a patient at risk for joint dislocation; however, retaining necrotic tissue
poses a risk of infection, given the lack of blood circulation to the dead tissue. In
fact, Plaintiff developed an infection following this revision surgery, requiring a
second revision surgery, performed by Dr. Carothers. Dr. Carothers performed an
irrigation and debridement for the infection and replaced the Kinectiv neck and
polyethylene liner. He also replaced the ceramic head from the first revision surgery
with a new ceramic head.’ Plaintiff has required and may permanently require
antibiotic therapy due to his continued risk for infection. It is probable that Plaintiff
will require a third, more complicated revision surgery in the future to eradicate the

infection.

"Dr. Carothers testified that, for Plaintiff's primary surgery, he believed the
benefits of using the MLTK with the CoCr head outweighed the risks, but at the
time, he did not know that the MLTK with CoCr head presented a risk of metallosis.

B. Development of the MLTK

6} Single-modular hip prostheses have been widely used since the early 1980s,
but dual-modular prostheses were not developed until approximately twenty years
later. Indeed, when Defendants launched the development of the MLTK in 2001
(through a project known as “G2”), it was a new design and a “new frontier” for
Defendants. Defendants employed multiple engineers and approximately twenty
consulting surgeons on the design team. The MLTK was intended to be minimally
invasive, to offer a wider range of adjustments to surgeons, and to provide greater
flexibility within the joint. Defendants designed the titanium neck and stem
components to be used with either a CoCr or a ceramic head component. The MLTK
offers a total of sixty possible configurations.

(7 Hip implants fail for a variety of reasons, including but not limited to
dislocation, fracture, loosening, infection, and metallosis. Some degree of corrosion
occurs in all modular hip implants. Although there is no consensus as to why some
patients with a corroding implant develop metallosis, while others do not, it is well
understood that more corrosion/metal debris increases the risk of developing
metallosis. Defendants were aware the particular characteristics of the MLTK would
increase the risk of micro-motion, and therefore corrosion and liberated metal debris
from junctions of the prosthetic. Specifically, the MLTK features (1) two modular

junctions, and therefore an additional location where corrosion may occur; (2) a

junction between two dissimilar metals (known to generally pose a higher risk of
corrosion than junctions between similar metals); (3) a neck that is thinner in two
planes and more flexible® than a traditional neck (increasing the likelihood of fretting
corrosion); and (4) optional adjustments in length and version that may increase the
bending moment’ in the neck (further increasing the likelihood of fretting corrosion).
{8} Accordingly, one of the design goals for the MLTK was to minimize corrosion
at the head-neck and neck-stem junctions, with the goal that the metal debris released
by the device would be within “known acceptable levels.” However, no reasonable
level for wear debris was, in fact, known. Defendants elected to define “known
acceptable level[s]” through a “clinically proven” predicate device: the traditional
M/L taper with a CoCr (VerSys) head, and six-inch tapered titanium neck (a single-
modular device). This device, according to Defendants’ research report on the
MLTK, had a “long clinical history of exhibiting some debris generation without
adverse clinical effects.” Defendants therefore designed a test (known as an

accelerated corrosion fatigue test!°) that would quantify the “worst case” metal

8The MLTK neck is in the top third of flexibility among hip prosthetic necks.

°The “moment” is the product of force times distance. In the neck of the
MLTK, for instance, the longer the neck, the greater the moment. A greater moment
induces greater bending (and consequently, greater micro-motion in the junction).

Accelerated corrosion fatigue testing is calculated to mimic and accelerate
the corrosive conditions in the human body, to measure a prosthetic’s loss of debris
under such conditions and to ascertain the fatigue strength of the components.
Fatigue strength refers to resistance to cracking or fracture under corrosion stress. In
this case, such testing entailed immersing the relevant prosthetic components in a

debris released by the predicate device, which was determined to be 5.62 milligrams.
Defendants reasoned that, if the debris generated by the “worst case” orientation of
the MLTK in a similar environment was below 5.62 milligrams, the MLTK would,
like the predicate device, avoid adverse clinical effects.!'

93 At trial Defendants explained that they ran corrosion fatigue testing on the
two MLTK junctions “separately,” in order to isolate and measure the worst-case
metal debris generated at the head-neck, and neck-stem junctions, respectively. In
effect, the Defendants tested the entire MLTK device with a ceramic head, but never
tested the entire device with CoCr head. Defendants’ explicit rationale for this was
that utilization of the ceramic head would minimize the debris generated at the head-
neck junction, thus allowing Defendants to isolate the debris generated at the neck-
stem junction. Defendants then separately tested the head-neck junction using a
CoCr head and titanium neck, but did not use the Kinectiv neck, instead using a

titanium neck of similar geometry (a 12/14 Taper) anchored in bone cement.

solution with a PH slightly more acidic than the human body, at a temperature
somewhat higher than the temperature of the human body, and subjecting the
components to loads analogous to the weight borne by the joint over a period of
approximately five years.

"Defendants initially ran corrosion fatigue testing on a design featuring a
CoCr neck, as CoCr is an alloy superior in strength to titanium. However, this
combination generated too much metal debris, and was therefore abandoned in favor
of a design that replaced the CoCr neck with a titanium neck. This change in
materials extended the time-frame of the G-2 project (from three to five years) and
resulted in additional costs for Defendants.

Defendants added together the metal debris released in each test,!? which totaled 4.4
milligrams. Because this total was less than the 5.62 milligrams released by the
predicate device, Defendants determined that the debris generated by the MLTK in
vivo would be within “known acceptable levels.”

10} Nothing prevented Defendants from performing corrosion fatigue testing on
the entire MLTK device with a CoCr head. Spectrum Accelerated Corrosion Fatigue
(SACF) testing, which would have applied side loads in a variable manner more
similar to a patient’s use of his or her joint, was also considered by the G2 design
team in 2006, but Defendants elected not to pursue it. Although the best evaluation
of a device would include clinical information, in addition to laboratory testing, and
one of Defendants’ consulting surgeons, Joshua Jacobs, M.D., proposed clinical
studies in 2003 (and 2011, after the device had been marketed), Defendants never
conducted one prior to launching the MLTK. Again, evidence showed that
Defendants deemed a clinical study unnecessary, reasoning that the clinical
predicate device used in the corrosion fatigue testing provided sufficient information
regarding the device’s risk of corrosion in patients. Ultimately, the MLTK,
configured with the CoCr head or the ceramic head, passed Defendants’ testing for

fatigue strength and stability.

"Defendants actually tested five different constructs for the neck-stem
junction and averaged them.

C. Marketing and Use of the MLTK

4113. The MLTK was cleared for marketing by the Food and Drug Administration
(FDA) on January 24, 2007. The MLTK is a “Class IIT” medical device—meaning
one that either “presents a potential unreasonable risk of illness or injury” or which
is “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[.]” 21 U.S.C. § 360c(a)(1)(C) (2018). Although such devices are ordinarily
required to undergo a rigorous premarket approval process, the Medical Device
Amendments Act of 1976, Pub. L. No. 94-295, 90 Stat. 539 (the Act), permitted
devices that are “substantially equivalent” to devices already on the market to avoid
the premarket approval process. See 21 U.S.C. § 360e(b)(1)(B) (2018). Courts have
observed that this truncated route (known as the “510k process,” under a prior
version of the Act) is “focused on equivalence, not safety.” Medtronic, Inc. v. Lohr,
518 U.S. 470, 493 (1996) (emphasis, internal quotation marks, and citation omitted).
Whereas the premarket review process (which requires 1,200 hours to complete) is
a federal safety review, the on-average 20-hour review process for devices marketed
under 510k “requires little information, rarely elicits a negative response from the
FDA, and gets processed very quickly.” Jd. at 479 (internal quotation marks and

citation omitted).

{12} Manufacturers are required to internally track adverse events in connection
with medical devices and to report them to the FDA; these are made public through
the Manufacturer and User Facility Device Experience (MAUDE) database.
However, because such data is primarily controlled by the manufacturers, and
because not all doctors report adverse events to manufacturers, statistical data from
MAUDE may not be used to justify or prove a device’s safety. At trial, evidence was
presented that, per Defendants’ internal reporting, 47 MLTK devices were revised
due to metallosis between July 9, 2009 and June 20, 2016. It is unknown whether,
or how many of these devices were configured in the same manner as Plaintiff's,
because Defendants do not track reported revisions with sufficient detail to ascertain
this information. Dividing this number by the number of devices sold worldwide
through 2016 (148,470), .032 MLTK devices were revised due to metallosis, for
every thousand sold.'? The traditional M/L Taper (the predicate device in testing for
the MLTK) had a lower metallosis revision rate (.025 per thousand) during the same
period.

{13} At trial, evidence was also presented regarding the MLTK’s performance as

reported through independent registries in Australia and the United Kingdom

Units sold does not reflect the units actually implanted in a patient, further
limiting the usefulness of this data.

(UK).'4 It appears that the MLTK had a significantly higher overall revision rate,!°
and a nine-times higher rate of revision due to metal-related pathology, compared to
all other hip implant systems being used in Australia as of 2013. In the UK, the
revision rate between 2006 and 2016 was 23 for 1,074 MLTK units implanted, for a
revision rate of only .021, but the number of MLTKs sold in the UK has also dropped
precipitously since 2012; zero were sold in 2016. No explanation for this was offered
in evidence at trial.!®

143 In 2010 Dr. Jacobs submitted a research proposal to study fretting corrosion
in the MLTK. The proposal sought to utilize corrosion fatigue and other wear testing
of the entire device (both junctions) with a CoCr head, in multiple configurations.
The rationale for this was that, “presently, the amount of metal released from newer

dually modular head-neck total arthroplasty components is not well characterized

and thus the biological impact of this is not known.” Dr. Jacobs explained that

'4George Kantor, M.D., retained by Plaintiff as an expert in orthopedic
surgery, explained that the registry data is problematic in terms of relying on it to
communicate reasons for revision of a given prosthetic device, because the data is
limited in specificity, and the causes of implant failure are complex. For instance,
revisions reported as caused by loosening of the prosthetic, fracture, infection, and
osteolysis (bone loss), may have been caused by metallosis or metal-related
pathology, but not reported as such. Dr. Kantor felt that this data’s best function,
then, is as a “canary in the mine-shaft.”

'5Dr. Kantor testified that, per National Institutes of Health consensus on hip
prosthetic performance, the five-year revision rate for survival should be 2.0; per the
Australian data; the MLTK’s rate was 5.1 at five years.

'6Tt appears that fewer than one-third of the MLTKs implanted in the UK used
cobalt-chromium heads.

fretting corrosion in modular junctions “appears to be a major or primary source of
metal released in vivo in total joint arthroplasty patients” and that “[t]he issue of
metal release from modular prosthetic devices is becoming increasingly urgent due
to an increasing prevalence of implant modularity associated with new Kinectiv joint
replacement surgery techniques.” Defendants’ lead engineer in the design of the
MLTK, Steven Meulink, met with Dr. Jacobs, and agreed with his concerns, but
Defendants did not fund the proposed research because they “did not have funding
for the project at [the] time.”

15} Dr. Jacobs then reported on ten cases in which head-neck taper corrosion was
“observed at the time of revision[,]” and in which adverse local tissue reactions were
observed in a subset of several patients, leading Defendants to conduct a Quality
Investigation Report (QIR-12014) in 2011. QIR-12014 noted a substantial rise in
“corrosion complaint rates” in the past five years, among which the majority had
“in-vivo times of less than four years.” Moreover, the highest number of complaints
were regarding CoCr heads on MLTK devices or CoCr heads on a fixed CoCr stem
(the VerSys Beaded Full Coat Stem).

4163 Soon thereafter, in 2012, Paul J. Diwelius, M.D., another of Defendants’
consulting surgeons for the MLTK, published a short-term study on a large cohort
of patients, some of whom received a traditional M/L Taper implant, and some of

whom received the MLTK implant, with the aim of understanding whether the

advantages of the MLTK outweigh its disadvantages. He concluded that the
advantages of the MLTK’s modular neck configuration did not translate to better
outcomes, and that the benefits of using the MLTK over the M/L Taper did not
outweigh the risks. In a group of three patients with the MLTK components, he
observed corrosion and adverse local tissue reactions at the junction of the CoCr
head and titanium neck. He also noted the risk of corrosion at the titantum neck-stem
junction. Dr. Diwelius “now almost exclusively uses nonmodular stems and ceramic
femoral heads to decrease the possibility of corrosion.” Dr. Beauchamp, who
performed Plaintiff's first revision surgery, no longer uses the Zimmer CoCr head
in his total hip arthroplasty practice. He has switched to ceramic heads, to “eliminate
cobalt-chromium from the equation,” and reduce the risks to his patients. Indeed,
Dr. Beauchamp testified that the Mayo Clinic in Arizona has largely shifted to use
of ceramic heads, only, to avoid the metal debris generated by CoCr heads. Dr.
Kantor testified that he has performed approximately 5,000 hip surgeries, and that
he never uses dual-modular implants in his primary procedures. Moreover, although
the prevalence of metallosis is not yet well understood, Dr. Kantor sees cases of
metallosis on a monthly basis.

417} In a 2016 article, Dr. Jacobs recommended, to prevent adverse local tissue
reactions, minimizing the micro-motion of modular junctions, and “optimizing

material selection,” noting that “many surgeons have abandoned CoCr heads

entirely” in favor of ceramic heads. Dr. Jacobs also noted that serum cobalt levels
differentially elevated over chromium levels have become a “hallmark” diagnosis
for adverse local tissue reaction. At trial, Dr. Jacobs testified that he has never seen
a case of adverse local tissue reaction in a patient with a ceramic head component
and is only aware of a case report or two documenting such a reaction in a patient
with a ceramic head on a CoCr stem (not a titanium stem, used in the MLTK).
Although Dr. Jacobs testified that ceramic heads present risks—including a risk of
fracture—he felt that these risks are exceedingly low. Dr. Jacobs was also aware that
ceramic head technology was available in 2010 (when Plaintiff received his primary
MLTK implant).

183} Finally, Jeremy Gilbert, Ph.D., a biomedical engineering expert retained by
Defendants, authored a 2016 study investigating the material loss associated with
use of a ceramic head, versus a CoCr head, on a group of modular hip prosthetics
including the MLTK. Dr. Gilbert found that use of the ceramic head resulted in
reduction of material loss by an order of magnitude (a factor of ten), and that the
study’s findings “support the hypothesis that the use of ceramic heads mitigates
metallic material loss from taper junctions.” At trial, Dr. Gilbert acknowledged that
the use of ceramic heads should eliminate the release of cobalt-chromium entirely.
He also testified that a “constant” in patients who develop adverse local tissue

reactions is the presence of modular junctions, where at least one component in those

junctions is fabricated from cobalt alloy. A 2015 study by Brian J. McGrory, M.D.,
noted that, while minimal titanium corrosion still occurs with the use of a ceramic
head, it does not seem to cause metallosis.

{19} In 2010, 90 percent of the femoral heads sold by Zimmer were CoCr, and ten
percent were ceramic. By the time of trial in 2016, 50 percent of the femoral heads
sold by Zimmer were CoCr, and 50 percent were ceramic.

D. Risk of Injury

20} Plaintiff's expert biomechanical engineer, Albert Burstein, Ph.D., testified
that earlier generations of single-modular hip implants did not generate fretting
corrosion/metal debris at toxic levels in meaningful clinical quantities. However, the
MLTK introduced a risk of fretting corrosion well beyond that seen in earlier
devices. According to Dr. Burstein, Defendants did not perform adequate testing
with respect to the risk of corrosion in the MLTK. Specifically, Dr. Burstein opined,
Defendants failed to test the cobalt-chromium head on the full Kinectiv device, even
though the Kinectiv neck-stem is more flexible than a titanium neck anchored in
bone cement, and greater flexibility is known to increase micro-motion, and
therefore corrosion. Furthermore, Defendants’ test of the neck-stem junction did not
include a CoCr head, nor the multiple geometric configurations available to surgeons
(such as the anteverted orientation of Plaintiff's implant), despite the fact that the

version of the neck (in addition to the length) is known to impact fretting corrosion.

Defendants’ failure to adequately test resulted in the marketing of an unreasonably
dangerous and defective device—one that, when used with a CoCr head, in the
configuration seen in Plaintiff's implant, allowed the liberation of excessive, toxic
quantities of cobalt debris.'”

21} Dr. Gilbert testified that, in his opinion, the MLTK as configured in Plaintiff
is not unreasonably dangerous. In his view, Defendants effectively tested the worst-
case configurations of the MLTK, and separate testing of each junction was
appropriate under a principle of mechanical engineering known as “Saint Venant’s
[p]rinciple,” such that motion at one of the MLTK junctions should not affect motion
at the other. However, Dr. Gilbert later conceded that corrosion at one location
affects other locations of corrosion, under principles of electrochemistry, as he had
previously testified when presenting to the FDA. Dr. Gilbert stated that the corrosion
observed on Plaintiff's device was moderate. However, when asked at trial: “If a
device is throwing off or creating so much metal debris and corrosion that it causes
metallosis or adverse local tissue reaction, that is not an acceptable risk of harm, is

it?” Dr. Gilbert responded, “No, it’s not.”

'7Dr. Burstein noted that Plaintiff's configuration was a more “extreme” case
within the system of sixty possible configurations of the MLTK. He explained that,
in order to predict performance, an adequate number of configurations at certain
extremes need to be tested (and, in the case of the MLTK, they were not).

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III. Findings and Conclusions on Strict Liability for Design Defect

{22} Based on the evidence presented at trial, the district court found (in relevant
part) that “Plaintiff developed metallosis around his implant and his implant failed
due to the corrosion caused by the cobalt chromium femoral head articulating with
the titanium trunnion.” The district court reasoned that “[a]lthough a small amount
of non-toxic corrosion or metal debris may occur with a hip implant, an implant that
causes an excessive amount of corrosion or metal debris sufficient to cause toxic
metal poisoning creates an unreasonable risk of injury.” It further found that the
MLTK device, when configured with a CoCr head, as in Plaintiff's case, may
generate metal debris sufficient to cause toxic metal poisoning. Accordingly, the

MLTK, as configured in Plaintiff's case, was defective.

DISCUSSION

I. Standard of Review

23} We review de novo the district court’s application of law to the facts. TPL,
Inc. v. N.M. Taxation & Revenue Dep’t, 2003-NMSC-007, § 10, 133 N.M. 447, 64
P.3d 474. Moreover, where a district court enters conclusions of law following a
bench trial, those conclusions must find support in one or more findings of fact.
Chavez v. S.E.D. Labs., 2000-NMSC-034, § 19, 129 N.M. 794, 14 P.3d 532 (Chavez
II). “Findings are sufficient if, taken together and construed in support of the

judgment, they justify that judgment.” Jd We review a district court’s factual

findings as we would the verdict of a jury—for substantial evidence. See Bustos v.
Hyundai Motor Co., 2010-NMCA-090, § 27, 149 N.M. 1, 243 P.3d 440; see also

Giant Cab, Inc. v. CT Towing, Inc., 2019-NMCA-072, ] 6, P.3d 18

“Substantial evidence is such relevant evidence as a reasonable mind might accept
as adequate to support a conclusion.” Clovis Nat’l Bank v. Harmon, 1984-NMSC-
119, § 7, 102 N.M. 166, 692 P.2d 1315 (internal quotation marks and citation
omitted). Moreover, “we resolve all disputed facts in favor of the successful party,
indulge all reasonable inferences in support of a verdict, and disregard all evidence
and inferences to the contrary.” Jd. { 7 (noting also that we do not re-weigh the
evidence).

II. Analysis

243 Defendants’ first argument on appeal is that the district court effectively held
Defendants “absolutely liable” for Plaintiff's injuries, both through misapplication
of the law, and because there were insufficient findings or evidence of a design
defect in the hip prosthetic. Defendants specifically assert that, in its assessment of

risk of injury, the district court failed to make sufficient findings under the seven

'8Defendants assert that “[w]hether the evidence presented at trial is sufficient
to support the trial court’s decision” is a question of law subject to de novo review.
This is incorrect. The case cited by Defendants for this proposition, Couch v. Astec
Indus., Inc., 2002-NMCA-084, Jf 56-57, 132 N.M. 631, 53 P.3d 398, is addressed
to the standard of review for entry of a directed verdict, not entry of a judgment
following trial.

factors required by Brooks v. Beech Aircraft Corp., 1995-NMSC-043, § 32 n.2, 120
N.M. 372, 902 P.2d 54 (citing UJI 13-1407 NMRA, comm. cmt.). Defendants also
suggest that the findings, such as they are, were not supported by sufficient
evidence.!”

5} Defendants’ second argument on appeal is that the district court should have
found strict liability inapplicable to Plaintiff's claims under comment k to the
Restatement (Second) of Torts Section 402A, pursuant to which “unavoidably
unsafe products” are exempt from strict liability, provided (as here) the product was
properly prepared and marketed and adequate warnings were given. We address each
argument in turn.

A. The District Court Did Not Err in Finding a Design Defect

26} Defendants first contend that the district court identified no defect in the
MLTK, and instead erroneously “based its conclusion that the MLTK was defective
in design on its finding that the implant was ‘unreasonably dangerous.’ ” However,
this is precisely what is required under New Mexico law. “[A]n unreasonable risk of

injury resulting from a condition of the product or from a manner of its use... makes

the product defective.” UJI 13-1406 NMRA; see Rudisaile v. Hawk Aviation, Inc.,

''Throughout Defendants’ briefs, it is unclear whether they are challenging
the district court’s factual findings, or the evidence in support of those findings, or
both. We have endeavored to address both contentions where it appears they are
raised, but the overlapping nature of the arguments has made our review more
difficult.

1979-NMSC-015, 4 11, 92 N.M. 575, 592 P.2d 175 (noting that “[c]ourts have

+ 99

generally equated ‘defective’ with ‘unreasonably dangerous’ ”), abrogated on other
grounds by Livingston v. Begay, 1982-NMSC-121, J 24, 98 N.M. 712, 652 P.2d 734.
An unreasonable risk of injury is “a risk which a reasonably prudent person having
full knowledge of the risk would find unacceptable. This means that a product does
not present an unreasonable risk of injury simply because it is possible to be harmed
by it.” UJI 13-1407; see id, comm. cmt. (further explaining that “a product is
defective if it is unreasonably dangerous as marketed. It is unreasonably dangerous
if a reasonable person would conclude that the magnitude of the scientifically
perceivable danger as it is proved to be at the time of the trial outweighed the benefit
of the way the product was so designed and marketed” (alteration, internal quotation
marks, and citation omitted)). In determining whether a product design poses an
unreasonable risk of injury, the fact-finder conducts a risk-benefit analysis, and
considers “the ability to eliminate the risk without seriously impairing the usefulness
of the product or making it unduly expensive.” UJI 13-1407.

27} While a “defect” may be considered a separate element of the cause of action
in the sense that an unreasonable danger must result “from a condition of the product
or from a manner of its use,” the concept is broad. See Brooks, 1995-NMSC-043,

4 31 (‘Our ‘unreasonable-risk-of-injury’ test [has] allowed for proof and argument

under any rational theory of defect.”); id. J 32 (holding that UJI 13-1406 and 13-

1407 “adequately define ‘defect’ ” by focusing the fact-finder’s attention to evidence
of the relative risks and benefits of a product’s design); see also Rudisaile, 1979-
NMSC-015, 4 11 (relying on other state court holdings that “[i]f a product is
unreasonably dangerous, it is necessarily defective[,]” and that separate proof of
defectiveness and unreasonable danger is not required (internal quotation marks and
citation omitted)). The cases cited by Defendants do not offer any meaningful
alternative definition of “defect.” For instance, in Tenney v. Seven-Up Co., 1978-
NMCA-090, § 7, 92 N.M. 158, 584 P.2d 205, we noted that a defect was an element
of proof in a strict liability case, but held that the product in that case was defective
only in the sense that it was unfit for its intended purpose, and not unreasonably
dangerous. We emphasized that strict liability is only imposed where “the product
involves a risk of death or serious personal injury or substantial damage.” Id. | 6.
Similarly, Trujillo v. Berry, 1987-NMCA-072, § 12, 106 N.M. 86, 738 P.2d 1331,
only states that a defective product is an element of a products liability claim. In
Pacific Indemnity Co. v. Therm-O-Disc, Inc., 476 F. Supp. 2d 1216, 1229 (D.N.M.
2006) (applying New Mexico law), the federal district court held that “the mere fact
that a failure or accident occurred is insufficient to support a strict products liability
claim[,]” and that [t]here must be evidence of a defect[,]” but did not offer any

definition of “defect.”

(283 Here, it was virtually undisputed that significant corrosion and metal debris
generated by the MLTK, as configured with a CoCr head, was a substantial cause of
Plaintiffs serious injury (i.e., metallosis) and failed implant. The question for the
district court was, then, whether the MLTK so configured posed an unreasonable
risk of metallosis, taking into account the relative risks and benefits of its design.
See UJI 13-1406, -1407. The district court found that the MLTK’s dual modularity
and flexible neck, its multiple possible configurations, and its CoCr-titanium head-
neck junction, offers a number of benefits, but also a risk of corrosion greater than
the risk posed by earlier, single-modular designs. The court further found that,
although patients respond differently to corrosion, greater corrosion increases the
associated risks, such as metallosis. Consistent with the foregoing, the court cited
evidence that the MLTK configured with a CoCr head poses a greater risk of
metallosis than other devices. Defendants’ own consulting expert biomechanical
engineer, Dr. Gilbert, testified that it was not an acceptable risk of harm for a device
to generate metal debris sufficient to cause metallosis. Dr. Beauchamp, who
performed Plaintiff's revision surgery at the Mayo Clinic, agreed that a safely-
designed hip prosthetic should not generate metal debris sufficient to cause
metallosis. The MLTK, including as configured with a ceramic head, had passed
Defendants’ internal product testing/design goals for strength, corrosion fatigue and

junction stability. The court found that Defendants’ own alternative design—the

MLTK with a ceramic head—was being used by Defendants’ own consulting
surgeon and others to avoid the risk of metallosis posed by the CoCr head. The above
findings were sufficient to support the district court’s conclusion that the MLTK
with a CoCr head, as configured in Plaintiff, presented an unreasonable risk of
metallosis, rendering it defective.

29} Defendants argue that, even if the district court made a broad connection
between the MLTK and an unreasonable risk of injury, it did not adequately connect
any particular feature of the MLTK with the mechanism of injury or the degree of
risk, and therefore erred in finding a design defect. Defendants cite, inter alia, Bustos,
2010-NMCA-090, § 23, for the proposition that a design defect, and the risk posed
thereby, must be precisely described and quantified. In that case, the “steep rake of
[the] support pillar for the car roof” was identified by expert testimony as the defect
that created the unreasonable risk of injury. That expert based his opinion on the
damage to and measurements of the vehicle at issue, and a calculation that filling the
support pillar with foam would add 10-20 percent structural strength. Jd. Here, by
contrast, no expert quantified the amount of corrosion necessary to cause metallosis,
and thus no expert could quantify the “excessive” corrosion allegedly caused by the
MLTK in Plaintiff, nor did any expert describe whether all, or only some of

configurations of the MLTK with a CoCr head were defective.

30} To the extent Defendants argue that the district court misapplied the law by
failing to require adequate quantification of the risks posed by the MLTK, the
defendants in Bustos, an enhanced injury case,”° also argued that the plaintiffs were
required to show the unreasonableness of the risk through precise data: namely that,
but for the defective design, the roof would have crushed only to a certain number
of inches. Id. § 30. We disagreed, as testimony in the record reflected various ways
that the strength of the roof could have been improved without undue cost (including
but not limited to altering the rake of the support pillar), and the expert opined that,
as a result of the failure to undertake any of these improvements, the roof did not
provide adequate survival space in a slow rollover accident. Id. {§ 30-32. Thus, there
was evidence from which a jury could reasonably infer that the roof could and should
have been designed not to crush to a level “way below what would be considered
necessary to provide rollover protection[.]” Jd. ¢ 32. Similarly, here, the findings
supported the district court’s reasonable inference that the MLTK could and should
have been designed to minimize corrosion and metal debris to levels that do not

cause metallosis.

°Bustos requires a plaintiff in an enhanced injury case to present evidence as
to the degree of enhancement, and in that sense requires some quantification of the
properties affecting risk. 2010-NMCA-090, 9{ 35-46. We agree with Plaintiff that
this does not equate to a requirement that risks be precisely quantified in every
design defect case.

31} We further note the following: Defendants elected to market the MLTK
without a precise understanding of what degree of corrosion or volume of metal
debris presents a risk of metallosis. The district court concluded that Defendants’
testing was inadequate to measure the quantity of corrosion and debris liberated by
the MLTK with a CoCr head. Defendants identify no law that would require Plaintiff
to conduct the research and clinical trials omitted by Defendants in order to establish
a precise quantification of the risks posed by the MLTK. Indeed, we read the district
court’s findings regarding the inadequacies of Defendants’ testing of the MLTK as
an explanation for the presence of an unreasonable risk that could have been better
understood and earlier identified, but was not.

32} To the extent Defendants argue that there was insufficient evidence to support
the district court’s findings,”'! Defendants’ brief overlooks significant portions of the
evidentiary record—including key testimony from Dr. Gilbert (Defendants’ own
consulting expert), Dr. Jacobs, Mr. Meulink, Dr. Beauchamp, Dr. Kantor and
exhibits such as research articles and Zimmer’s own internal data. Defendants focus
almost exclusively on Dr. Burstein’s testimony, and the language of the findings
themselves, rather than on the sufficiency of the entire record under the applicable

legal standards. Under our appellate rules, “[a] contention that a verdict, judgment,

*\Tn their reply brief, Defendants state that they do not focus “primarily” on
the sufficiency of the evidence, which is of little assistance.

or finding of fact is not supported by substantial evidence shall be deemed waived
unless the summary of proceedings includes the substance of the evidence bearing
on the proposition[.]” Rule 12-318(A)(3) NMRA. This rule is intended to ensure that
we are fully apprised of the fact-finder’s view of the facts and its disposition of the
issues, particularly given that we “resolve all disputed facts in favor of the successful
party, indulge all reasonable inferences in support of a verdict, and disregard all
evidence and inferences to the contrary.” Harmon, 1984-NMSC-119, 4 7; see
Martinez v. Sw. Landfills, Inc., 1993-NMCA-020, J 15, 115 N.M. 181, 848 P.2d
1108 (stating that the purpose of Rule 12-318 is to ensure that the appellate court is
fully apprised of the “fact finder’s view of the facts and it’s disposition of the
issues”). The district court’s findings are binding on Defendants, who failed to set
forth the substance of the evidence (favorable or unfavorable) bearing on those
findings. See Maloof v. San Juan Cty. Valuation Protests Bd., 1992-NMCA-127,
4 19, 114 N.M. 755, 845 P.2d 849; see also Chavez v. S.E.D. Labs., 2000-NMCA-
034, | 26, 128 N.M. 768, 999 P.2d 412 (Chavez I), aff'd in part, rev'd in part on
other grounds by Chavez IT, 2000-NMSC-034, § 24.

{33}, Defendants’ next argument on appeal is that, in reaching its determination that
the MLTK as configured in Plaintiff posed an unreasonable risk of injury, the district
court failed to consider the seven factors set forth in Brooks, 1995-NMSC-043, § 32

n.2, and the committee commentary to UJI 13-1407. But we find no support for the

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12
13
14
15
16
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18
19
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contention that all seven factors must be considered for every design defect claim.
Rather, UJI 13-1407 states in the committee commentary that “{c]Jriteria for
determining whether a risk of injury is unreasonable have not been provided in the
instruction because the committee feels this falls within the unique domain of
advocacy under the circumstances of proof in each case.” The commentary then lists
the seven risk-benefit criteria suggested by Professor John W. Wade in his article
“The Nature of Strict Tort Liability for Products,” 44 Miss. L. J. 825, 837-38 (1973):

(1) the usefulness and desirability of the product... ; (2) the availability

of other and safer products to meet the same need . . . ; (3) the likelihood

of injury and its probable seriousness, i.e., “risk”... ; (4) the

obviousness of the danger . . . ; (5) common knowledge and normal

public expectation of the danger (particularly for established products)

...) (6) the avoidability of injury by care in use of the product (including

the effect of instructions or warnings) . . . [;] and (7) the ability to

eliminate the danger without seriously impairing the usefulness of the

product or making it unduly expensive.
We considered these factors in Bustos, where the defendants argued (citing Brooks)
that the jury was improperly instructed on the plaintiffs’ design defect claim because
the jury should have been required to consider whether there was a showing of a
reasonable alternative design. Bustos, 2010-NMCA-090, 50-51. This Court held
that, “[w]hile a jury is required to make risk-benefit calculations, consideration of
alternative designs is but one of several risk-benefit considerations that a jury may

balance in determining whether a product created an unreasonable risk of injury.”

Id. | 54 (emphasis added). We then referred to the seven risk-benefit considerations

set forth in UJI 13-1407’s committee commentary. See Bustos, 2010-NMCA-090,
454. This Court reasoned that only the seventh factor (the ability to eliminate the
danger without seriously impairing the usefulness of the product or making it unduly
expensive) contains language included in the actual jury instruction as something
the jury “should” consider. /d. Defendants conceded this point at oral argument.

{34} Here, the district court’s conclusions of law included consideration of the
manufacturer’s ability to eliminate the danger without seriously impairing the
usefulness of the product or making it unduly expensive. It is unclear from
Defendants’ brief whether they challenge the sufficiency of the findings on this
point, or the sufficiency of the evidence to support those findings. Again,
Defendants’ argument flatly ignores the district court’s findings concerning the use
of a ceramic head, Defendants’ own alternative component part, in order to avoid
the risk of metallosis. In other words, Defendants already market a design that avoids
the risk of metallosis without impairing the product’s functionality. Such findings
suffice to demonstrate that the district court considered the ability to eliminate the
danger without impairing the usefulness of the product or rendering it unduly
expensive. See Chavez II, 2000-NMSC-034, ¢ 19. To the extent Defendants raise an
argument regarding the sufficiency of the evidence to support these findings,
Defendants’ brief again disregards the majority of the evidentiary record. There was

evidence that use of a ceramic head on the MLTK virtually eliminates the risk of

metallosis; evidence that the MLTK with a ceramic head met Defendants’ internal
strength and stability requirements; and evidence that sales of the ceramic head,
versus the CoCr head, have gone from ten percent to 50 percent of the market share
since 2010. Defendants presented no evidence that any risk of injury from the use of
their alternative design outweigh the benefits of avoiding metallosis. In any event,
we again hold that the district court’s findings are binding on Defendants, who failed
to set forth the substance of the evidence bearing on those findings. See Rule 12-
318(A)(3); Chavez I, 2000-NMCA-034, § 26; Maloof, 1992-NMCA-127, ] 19.

B. Defendants’ Argument Under Comment K Was Not Preserved

{35} Defendants’ second argument on appeal is that the district court should have
found the doctrine of strict liability to be inapplicable to Plaintiff's claims, under
comment k to the Restatement (Second) of Torts, Section 402A. Section 402A
provides that a supplier should not be held strictly liable for the provision of an
unavoidably unsafe product, provided the product was properly prepared and
marketed, and adequate warnings were given.

{36} Specifically, Section 402A comment (1) provides that a seller in the business
of supplying a product “who sells any product in a defective condition unreasonably
dangerous to the user or consumer or to his property is subject to liability for physical
harm thereby caused to the ultimate user or consumer[.]” However, comment k to

this Section provides, in part, as follows:

ODIADNABRWNK

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. . . . 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... 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. . . . 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.

{37}, New Mexico has incorporated the strict liability standards set forth in the
Restatement (Second) of Torts, Section 402A, with some exceptions and
modifications. See, e.g., UJI 13-1406, use note (providing that the instruction is to
be used together with UJI 13-1407 “in every strict products liability case based upon
Restatement (Second) of Torts § 402A”); UJI 13-1406, comm. cmt. (noting that the
language in Section 402A “has less than the universal application which these
instructions are intended to have for strict products liability relating to production
flaw defects, unsafe design or formulation, warning inadequacies, safety options and
products which are unavoidably unsafe, with a risk of harm not justified by
usefulness or desirability of the product”). New Mexico’s “unavoidably unsafe
products” exception is set forth in UJI 13-1419 NMRA, which provides, in part, as

follows:

NO PWN

oO woOn~

There are some products which, even when properly prepared

and labeled, cannot be made safe for their intended and ordinary use.

Because of the nature of ingredients or natural characteristics of the

products, use of these products involves substantial risk of injury, and

some users will necessarily be harmed. Such products are said to be

unavoidably unsafe.

Unless the product unreasonably exposes users to risk of injury,

there is no liability for supplying an unavoidably unsafe product.

Whether users are unreasonably exposed to risk of injury turns upon a

balancing of the dangers and benefits resulting from the product’s use.
The use note of this UJI provide that it “must be given only in cases in which the
generic condition of the product gives rise to the risk of injury, for example, certain
chemicals and drugs. The risk arises from the nature of the product and not from
inadequacies of design, manufacture, or labeling.” UJI 13-1419, use note. The
Committee Commentary, in turn, provides that “[w]hether a risk is reasonable is a
question for the jury, balancing the benefits and hazards of the product.” UJI 13-
1419, comm. cmt.
{38} We must first address whether Defendants preserved for our review their
argument that the MLTK is an unavoidably unsafe product under comment k of
Section 402A and UJI 13-1419. We hold that they did not.
39} In general, an issue is not preserved unless the appellant “fairly invoked a
ruling of the trial court on the same grounds argued in the appellate court.” Benz v.

Town Ctr. Land, LLC, 2013-NMCA-111, 4 24, 314 P.3d 688 (internal quotation

marks and citation omitted). Defendants concede that they did not seek a finding that

the MLTK was “unavoidably unsafe,” nor did they otherwise refer to comment k or
UJI 13-1419 in motion practice, at trial, in written closings, or in their requested
findings of fact and conclusions of law. At oral argument, defense counsel identified
only Defendants’ affirmative defenses, set forth in the answer to the complaint, as
explicitly raising comment k of Section 402A or UJI 13-1419. “We require parties
to assert the legal principle upon which their claims are based and to develop the
facts in the trial court primarily for two reasons: (1) to alert the trial court to a claim
of error so that it has an opportunity to correct any mistake, and (2) to give the
opposing party a fair opportunity to respond and show why the court should rule
against the objector.” State v. Gomez, 1997-NMSC-006, 4 29, 122 N.M. 777, 932
P.2d 1. Thus, an affirmative defense is not preserved for our review unless it is
litigated before the district court and a ruling is invoked on the issue. See, e.g.,
Rodriguez ex rel. Rodarte v. Sanchez, 2019-NMCA-065, {J 25-26, 451 P.3d 105
(holding that the defendant’s statute of limitations argument, while raised as an
affirmative defense in the answer, was not litigated before the district court;
therefore, it was not preserved for appellate review).

{40} Defendants argue, in reply, that their proposed findings and conclusions are
predicates for the application of comment k; therefore, Defendants constructively
sought the trial court’s ruling on the issue, preserving their argument. Specifically,

Defendants sought a conclusion of law that the MLTK did not present an

unreasonable risk of harm, and a conclusion that the MLTK was not defectively
designed. Moreover, Defendants proposed, and the district court adopted the
following findings: zero risk of corrosion is unattainable; some corrosion may occur
in any modular implant device; there is no consensus as to why patients react
differently to corrosion; and Defendants’ warnings for the MLTK were adequate.
We hold that, while these points would be relevant to a Section 402A comment k/UJI
13-1419 analysis, they do not amount to a comment k analysis.

{41} UJI 13-1419 (New Mexico’s iteration of comment k) is only applicable where
a product “cannot be made safe” for its intended use, and where the nature of a
product, or its “generic condition . . . gives rise to the risk of injury.” UJI 13-1419,
use note. It is inapplicable where the risk arises “from inadequacies of design[.]” Jd.
Furthermore, New Mexico’s UJI expressly adopts a case-by-case inquiry, as it
contains a caveat that there may be strict liability even for an unavoidably unsafe
product, where the product “unreasonably exposes users to risk of injury[.]” UJI 13-
1419. In other words, even an unavoidably unsafe product may present dangers so
unreasonable that the imposition of strict liability is appropriate. This risk-benefit
determination is a question of fact for the jury (or in this case, the district court). Jd.,
comm. cmt. Other jurisdictions have adopted comment k in a similar manner;
Oklahoma holds (in a case cited by Defendants) that the unavoidably unsafe

exception does not apply unless the product was incapable of being made safer at

the time of its distribution, and its benefits justify its risks. Tansy v. Dacomed Corp.,
890 P.2d 881, 885-86 (Okla. 1994). On appeal, Defendants cite cases holding that
an FDA-approved medical device is covered by comment k and exempt from strict
liability. See, e.g., Gross v. Stryker Corp., 858 F. Supp. 2d 466, 481-82 (W.D. Pa.
2012). However, at least one jurisdiction has addressed the distinction between
drugs/devices approved through the premarket process, and those approved through
the 510k process, holding that the latter are subject to a more rigorous case-by-case
analysis. See, e.g., Burningham v. Wright Med. Tech., Inc., 2019 UT 56, { 39, 448
P.3d 1283 (holding that “when an implanted medical device enters the market
through the 510(k) process .. . 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”).

{423 As the evidence in this case makes clear, a finding that all modular hip
implants present some risk of corrosion is not a finding that all modular hip implants
present an unavoidable risk of metallosis. Indeed, notably, Defendants did not pose
this equivalency to the district court. Defendants proposed no finding that the risk of
metallosis arose from the nature of the MLTK, and not from an inadequacy in design.
Defendants proposed no finding that the MLTK was incapable of being made safe

for its intended use. Defendants ignore the district court’s finding that “[t]he FDA

510(k) process cannot be used as evidence that the MLTK was safe for use[,]” but
their arguments here suggest that they are entitled to the “blanket” exemption
afforded by some jurisdictions to all prescription drugs and medical devices. In sum,
the cited findings and conclusions would not have alerted the district court, or
Plaintiff, that Defendants were seeking a finding that the MLTK was unavoidably
unsafe under comment k and UJI 13-1419, and accordingly, Defendants have failed
1,22

to establish that we can review their comment k argument on appea

CONCLUSION

{43}. For the foregoing reasons, we conclude that the district court properly applied
the law of strict liability for design defect. Moreover, the district court’s findings
supported its conclusion that the MLTK as configured in Plaintiff was defective.
Those findings are binding, given that Defendants failed to set forth the substance
of the evidence bearing on them. Defendants also failed to preserve their argument
under comment k to the Restatement (Second) of Torts Section 402A, and we do not

address it here. Accordingly, we affirm.

22 At oral argument, Defendants referred to our holding in Davila v. Bodelson,
1985-NMCA-072, ff 25-28, 103 N.M. 243, 704 P.2d 1119, for the proposition that
an argument is preserved if there was evidence in the record supporting a theory, and
the theory was tried on implied consent of the parties. But in Davila, the district
court gave an instruction under UJI 13-1419 at trial; the question on appeal was
whether the instruction had been given in error. Davila, 1985-NMCA-072, J 25. The
issue was not, as here, whether the district court’s ruling had been fairly invoked,
such that the court and the plaintiff were able to address the theory presented. See
Gomez, 1997-NMSC-006, § 29. Accordingly, Davila is inapposite.

—

{444 ITISSO ORDERED.

Swan;

(
B
WE CONCUR:
» Whe
J. MILES HANISEE, Chief Judge

JACQUELINE R. MEDINA, Judge

VANZI, Judge

December 30, 2019- Michael Brian McDonald v. Zimmer Inc., No. A-1-CA-36565

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