Court Opinion

ID: 4398497
Source: CourtListenerOpinion
Date Created: 2019-05-20 12:02:28.309426+00
Date Added: 2024-06-11T12:19:42.684155
License: Public Domain

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           RAYMOND C. FERRARI v. JOHNSON
              AND JOHNSON, INC., ET AL.
                     (AC 41170)
                     Alvord, Sheldon and Pellegrino, Js.

                                   Syllabus

The plaintiff brought this product liability action against the defendants,
    alleging that the defendants’ product, a spinal system, was defective
    and that it caused him to sustain injuries. The plaintiff’s surgeon, P, had
    used various components of the spinal system, which included titanium
    rods, in the fusion of the plaintiff’s spine during a spinal surgery. There-
    after, the plaintiff underwent a second surgery that revealed a fracture
    of one of the titanium rods. The plaintiff claimed, inter alia, that the
    spinal system contained a design defect and that the written warnings
    in the product insert were not adequate when combined with the input
    and influence of the defendants’ product representative, R, who had
    had discussions with P prior to the plaintiff’s first surgery that were in
    the nature of technical assistance. The defendants filed a motion for
    summary judgment in which they claimed, inter alia, that because the
    plaintiff had failed to disclose an expert witness, he could not establish
    that the product was defective, and that his failure to warn claim was
    barred by the learned intermediary doctrine. The trial court granted
    the motion for summary judgment and rendered judgment thereon,
    determining, inter alia, that under the modified consumer expectation
    test, the plaintiff could not, as a matter of law, maintain a breach of
    warranty or strict liability design claim against the defendants without
    expert testimony. Held:
1. The trial court properly rendered summary judgment for the defendants
    as to the plaintiff’s design defect and breach of warranty claims, as the
    plaintiff could not prove, without the use of expert testimony, that the
    defendants’ product was defective or that its alleged defect caused his
    injury: because the ordinary consumer expectation test was inapplicable,
    as this was not a res ipsa type case or one in which the injury was so
    bizarre or unusual that the jury would not need expert testimony, the
    modified consumer expectation test applied, and, therefore, the court
    correctly held that expert testimony was required to prove the product’s
    defect; moreover, expert testimony was required to establish that the
    alleged defect caused the plaintiff’s injury, as the spinal system at issue
    is a complex product that includes titanium rods that are implanted
    into a patient’s spine and components that consist of fifteen screws,
    two rods and two transverse transconnectors.
2. The trial court properly rendered summary judgment for the defendants
    as to the plaintiff’s failure to warn claim on the basis of the learned
    intermediary doctrine; the plaintiff, who acknowledged that the defen-
    dants’ product was accompanied by adequate warnings in the product
    insert, did not present any evidence that R said or did anything inconsis-
    tent with the product’s warnings, and, thus, failed to provide a sufficient
    evidentiary foundation to demonstrate the existence of a genuine issue
    of material fact.
           Argued January 17—officially released May 21, 2019

                             Procedural History

   Action to recover damages for personal injuries sus-
tained as a result of an allegedly defective product man-
ufactured and sold by the defendants, and for other
relief, brought to the Superior Court in the judicial dis-
trict of Hartford, where the court, Noble, J., granted the
defendants’ motion for summary judgment and ren-
dered judgment thereon, from which the plaintiff
appealed to this court. Affirmed.
   Andrew W. Skolnick, for the appellant (plaintiff).
  W. Kennedy Simpson, pro hac vice, with whom was
Christopher J. Lynch, for the appellees (defendants).
                          Opinion

   ALVORD, J. The plaintiff, Raymond C. Ferrari,
appeals from the summary judgment rendered by the
trial court in favor of the defendants, Johnson & John-
son, Inc., and Synthes, Inc. The plaintiff claims that the
court erred by holding that (1) he cannot prove that the
defendants’ product was defective, or that the product’s
alleged defect caused the plaintiff’s injury, without the
use of expert testimony, and (2) the learned intermedi-
ary doctrine barred the plaintiff’s failure to warn claim.
We affirm the judgment of the trial court.
   The following undisputed facts and procedural his-
tory are relevant to our resolution of this appeal. On
August 17, 2012, the plaintiff underwent spinal surgery
at Hartford Hospital. The procedure included a postero-
lateral fusion, in which the plaintiff’s surgeon, Dr. Paul
Schwartz, implanted various components of the defen-
dants’ product, the Synthes Matrix spinal system (prod-
uct). This system included stabilizing titanium rods that
were used in the fusion of the plaintiff’s spine. The
plaintiff’s surgery required a junction of the new tita-
nium hardware with a previously placed steel construct.
On April 4, 2013, the plaintiff underwent a second sur-
gery, which revealed a fracture of the left titanium rod
at the junction of the new titanium instrumentation
with the old steel construct.
   On April 7, 2016, the plaintiff served a four count
complaint on the defendants. The first two counts
alleged product defect claims pursuant to the Connecti-
cut Product Liability Act, General Statutes § 52-572m
et seq. Specifically, the plaintiff set forth claims involv-
ing (1) a failure to warn defect1 and (2) a design defect.2
The third and fourth counts alleged breaches of express
and implied warranties.
  The deadline for the plaintiff to disclose any expert
witnesses was January 15, 2017, pursuant to the parties’
mutually agreed on scheduling order. The plaintiff failed
to disclose any expert witnesses.3
   On April 17, 2017, the defendants filed a motion for
summary judgment, arguing that (1) the plaintiff had
failed to disclose an expert witness, (2) the plaintiff
could not establish that the product was defective, (3)
comment (k) to § 402A of the Restatement (Second)
of Torts barred the plaintiff’s claims, (4) the learned
intermediary doctrine barred the plaintiff’s claims, and
(5) the plaintiff could not establish causation. On July
10, 2017, the plaintiff filed an objection to the defen-
dants’ motion for summary judgment, claiming that a
product defect can be inferred from the evidence with-
out expert testimony and that genuine issues of material
fact existed as to whether there were adequate warn-
ings. A hearing on the defendants’ motion for summary
judgment was held on July 31, 2017.
November 28, 2017, granting the defendants’ motion for
summary judgment. This appeal followed. Additional
facts and procedural history will be set forth as nec-
essary.
   Before addressing the plaintiff’s claims, we set forth
the applicable standard of review of a trial court’s ruling
on a motion for summary judgment. ‘‘Practice Book
§ [17-49] provides that summary judgment shall be ren-
dered forthwith if the pleadings, affidavits and any other
proof submitted show that there is no genuine issue as
to any material fact and that the moving party is entitled
to judgment as a matter of law. . . . In deciding a
motion for summary judgment, the trial court must view
the evidence in the light most favorable to the nonmov-
ing party. . . . The party seeking summary judgment
has the burden of showing the absence of any genuine
issue [of] material facts which, under applicable princi-
ples of substantive law, entitle him to a judgment as
a matter of law.’’ (Internal quotation marks omitted.)
DiMiceli v. Cheshire, 162 Conn. App. 216, 221–22, 131
A.3d 771 (2016).
   ‘‘Once the moving party has met its burden [of pro-
duction] . . . the opposing party must present evi-
dence that demonstrates the existence of some disputed
factual issue. . . . [I]t [is] incumbent [on] the party
opposing summary judgment to establish a factual pred-
icate from which it can be determined, as a matter of
law, that a genuine issue of material fact exists. . . .
The presence . . . of an alleged adverse claim is not
sufficient to defeat a motion for summary judgment.’’
(Citation omitted; internal quotation marks omitted.)
Episcopal Church in the Diocese of Connecticut v.
Gauss, 302 Conn. 408, 422, 28 A.3d 302 (2011), cert.
denied, 567 U.S. 924, 132 S. Ct. 2773, 183 L. Ed. 2d 653
(2012). ‘‘Our review of the decision to grant a motion
for summary judgment is plenary. . . . We therefore
must decide whether the court’s conclusions were
legally and logically correct and find support in the
record.’’ (Internal quotation marks omitted.) DiMiceli
v. Cheshire, supra, 162 Conn. App. 222.
                             I
  The plaintiff first claims that the trial court erred
by holding that he cannot prove that the defendants’
product was defective, or that the product’s alleged
defect caused the plaintiff’s injury, without the use of
expert testimony. In response, the defendants argue
that expert testimony was required for the plaintiff to
prevail on his claims, as a matter of law. We agree with
the defendants.
  The following additional facts and procedural history
are relevant to our resolution of this claim. The defen-
dants submitted numerous exhibits in support of their
motion for summary judgment, including Dr. Schwartz’
notes, the transcript of Dr. Schwartz’ deposition, and
a copy of the product insert that contained warnings
with respect to the use of the defendants’ product.
   The product’s insert explained that nonunion4 could
result from the product’s use. The insert provided in
relevant part: ‘‘These devices can break when subjected
to the increased loading associated with delayed union
or nonunion. Internal fixation appliances are load-shar-
ing devices which hold a fracture in alignment until
healing occurs. If healing is delayed, or does not occur,
the implant could eventually break due to metal fatigue.
Loads produced by weight-bearing and activity levels
will dictate the longevity of the implant. The patient
should understand that stress on an implant can involve
more than weight-bearing. In the absence of solid bony
union, the weight of the limb alone, muscular forces
associated with moving a limb, or repeated stresses of
apparent relatively small magnitude, can result in the
failure of the implant.’’ (Emphasis omitted.)
   In its memorandum of decision, the trial court con-
cluded that, without expert testimony to establish the
existence of a defect and the element of causation, the
plaintiff could not, as a matter of law, maintain a breach
of warranty claim or a strict liability design defect claim
against the defendants. The court concluded that, under
the modified consumer expectation test,5 the plaintiff
could not prove that the defendants’ product was defec-
tive without the use of expert testimony. With respect
to causation, the trial court determined that the product
was of a complex design, and that ‘‘[e]xpert testimony is
thus essential, because the claims will raise and address
complex and highly technical concepts and questions,
which are clearly beyond the everyday experiences of
the ordinary consumer.’’
   We begin by setting forth the applicable standard
of review and relevant legal principles that guide our
analysis. ‘‘Our Supreme Court has described the essen-
tial elements of a strict products liability claim as fol-
lows: (1) the defendant was engaged in the business of
selling the product; (2) the product was in a defective
condition unreasonably dangerous to the consumer or
user; (3) the defect caused the injury for which compen-
sation was sought; (4) the defect existed at the time of
the sale; and (5) the product was expected to and did
reach the consumer without substantial change in the
condition.’’ (Emphasis omitted; internal quotation
marks omitted.) Theodore v. Lifeline Systems Co., 173
Conn. App. 291, 308, 163 A.3d 654 (2017).
  The plaintiff first argues that, with respect to whether
the product was in a defective condition and was unrea-
sonably dangerous to the consumer or user, the ordi-
nary consumer expectation test was applicable and,
therefore, he was not required to provide expert testi-
mony to prove the product’s defect.6 We disagree.
  Under the ordinary consumer expectation test, ‘‘[t]o
be considered unreasonably dangerous, the article sold
must be dangerous to an extent beyond that which
would be contemplated by the ordinary consumer who
purchases it, with the ordinary knowledge common to
the community as to its characteristics.’’ (Internal quo-
tation marks omitted.) Izzarelli v. R.J. Reynolds
Tobacco Co., 321 Conn. 172, 185, 136 A.3d 1232 (2016).
‘‘Expert testimony on product design is not needed to
prove the product’s defect . . . .’’ Id., 203.
   In Izzarelli, however, our Supreme Court held that
the modified consumer expectation test is our primary
strict product liability test. Id., 194. The court explained
the limited circumstances in which the ordinary con-
sumer expectation test applied: ‘‘The ordinary con-
sumer expectation test is reserved for cases in which
the product failed to meet the ordinary consumer’s min-
imum safety expectations, such as res ipsa type cases.’’
(Emphasis in original.) Id. ‘‘In other words, the ordinary
consumer expectation test would be appropriate when
the incident causing injury is so bizarre or unusual that
the jury would not need expert testimony to conclude
that the product failed to meet the consumer’s expecta-
tions.’’ Id., 191; see Potter v. Chicago Pneumatic Tool
Co., 241 Conn. 199, 222, 694 A.2d 1319 (1997) (The court
emphasized that it would ‘‘not require a plaintiff to
present evidence relating to the product’s risks and
utility in every case. . . . There are certain kinds of
accidents—even where fairly complex machinery is
involved—[that] are so bizarre that the average juror,
upon hearing the particulars, might reasonably think:
Whatever the user may have expected from that con-
traption, it certainly wasn’t that.’’ [Emphasis added;
internal quotation marks omitted.]).
   The present case does not arise in any of the limited
circumstances in which the ordinary consumer expec-
tation test is applicable. This is not a ‘‘res ipsa type
case’’ or a case in which the ‘‘injury is so bizarre or
unusual that the jury would not need expert testimony
. . . .’’7 Izzarelli v. R.J. Reynolds Tobacco Co., supra,
321 Conn. 191.
    Accordingly, the modified consumer expectation test
applies in the present case. ‘‘Under the modified con-
sumer expectation test, the jury would weigh the prod-
uct’s risks and utility and then inquire, in light of those
factors, whether a reasonable consumer would con-
sider the product design unreasonably dangerous.’’
(Internal quotation marks omitted.) Id., 190. Therefore,
‘‘[t]o establish the defect, the plaintiff’s case required
expert testimony on [the product] design and manufac-
ture, as well as the feasibility of an alternative design.’’
Id., 203–204; see White v. Mazda Motor of America, Inc.,
139 Conn. App. 39, 49, 54 A.3d 643 (2012) (‘‘[a]lthough
it is true that an ordinary consumer may, under certain
circumstances, be able to form expectations as to the
safety of a product . . . [our courts] nonetheless con-
sistently have held that expert testimony is required
when the question involved goes beyond the field of
the ordinary knowledge and experience of judges or
jurors’’ [citation omitted; internal quotation marks omit-
ted]), aff’d, 313 Conn. 610, 99 A.3d 654 (2014). Thus,
the trial court correctly held that expert testimony was
required to prove the product’s defect in the present
case.
   The plaintiff also argues that expert testimony was
not required to prove that the alleged defect caused the
injury for which compensation was sought. Specifically,
he argues that expert testimony was not required to
prove causation because ‘‘[t]here is no dispute that the
defendants’ product failed.’’ We disagree.
   ‘‘Proof that a defect in the product caused the injury
in controversy is a prerequisite to recovery for product-
caused injury in every products liability case, whether
the action is grounded on negligence, breach of war-
ranty, strict liability in tort . . . or a combination of
such theories.’’ (Internal quotation marks omitted.) The-
odore v. Lifeline Systems Co., supra, 173 Conn. App.
308. ‘‘When the causation issue involved goes beyond
the field of ordinary knowledge and experience of
judges and jurors, expert testimony is required.’’ (Inter-
nal quotation marks omitted.) Id., 311.
   The product at issue in the present case is a complex
product: a spinal system which includes stabilizing tita-
nium rods that are implanted into the patient’s spine.
The implanted product components consist of fifteen
screws, two rods, and two transverse transconnectors.8
Accordingly, we agree with the trial court’s determina-
tion that expert testimony was required to establish cau-
sation.
   For the foregoing reasons, we conclude that the trial
court properly rendered summary judgment in favor of
the defendants, with respect to the plaintiff’s design
defect and breach of warranty claims, because the plain-
tiff could not prove that the defendants’ product was
defective, or that the product’s alleged defect caused
the plaintiff’s injury, without the use of expert tes-
timony.
                            II
   The plaintiff next claims that genuine issues of mate-
rial fact remained with respect to his failure to warn
claim and, therefore, the learned intermediary doctrine
did not bar this claim. Specifically, the plaintiff argues
that, although the written warnings contained in the
product insert were adequate, ‘‘[t]he factual circum-
stances of this case make the application of the learned
intermediary doctrine inappropriate. The warnings
were not adequate when combined with the input and
influence of [the] defendants’ product representative.’’
We disagree.
  The following additional facts and procedural history
are relevant to our resolution of this claim. As pre-
viously noted, the plaintiff’s surgery required a junction
of the new titanium hardware with a previously placed
steel construct. In addition, the plaintiff alleges that he
weighed 267 pounds at the time of his first surgery.
   The product was sold with a package insert con-
taining several warnings about the risk of product fail-
ure and breakage. Specifically, the warnings provided
that ‘‘factors such as the patient’s weight . . . have an
effect on the stresses to which the implant is subjected,
and therefore on the life of the implant.’’ The warnings
additionally provided that ‘‘[d]issimilar metals in con-
tact with each other can accelerate the corrosion pro-
cess due to galvanic corrosion effects,’’ and warn
against ‘‘[m]ixing titanium . . . with stainless implant
components . . . for metallurgical, mechanical and
functional reasons.’’
   In his complaint, with respect to his failure to warn
claim, the plaintiff alleged that the defendants’ pro-
ducts were sold ‘‘without proper or adequate warnings,
labels and instructions regarding use in patients of the
plaintiff’s size and history of prior spinal fusions and
instrumentalities,’’ and ‘‘without proper or adequate
warnings, labels and instructions regarding the junc-
tion of titanium hardware to stainless steel hardware
. . . .’’
   In the plaintiff’s objection to the defendants’ motion
for summary judgment, he argued that ‘‘[t]he warnings
were not adequate when combined with the input and
influence of the defendant’s product representative.’’
The plaintiff claimed that, prior to his first surgery, ‘‘Dr.
Schwartz had discussions and consultations with Mike
Rogers, who was and still is the defendants’ local sales
representative. Those discussions were in the nature
of technical assistance, including the product to be used
in the surgery and the properties thereof, including the
size and type.’’
   Similarly, at the hearing on the defendants’ motion
for summary judgment, the plaintiff’s counsel argued:
‘‘[Dr. Schwartz] testified that ultimately it was his deci-
sion. My argument, Your Honor . . . is that he was
nonetheless influenced; and the warnings were muted
by virtue of the defendants’ agent’s involvement. And
for that, that is a question of fact as to what extent he
was influenced, to what extent the warnings were
muted and weakened, and that is something that the
trier of fact should decide.’’
  In its memorandum of decision, the trial court con-
cluded: ‘‘There is no testimony or other evidence that
shows that the consultant had any impact on Dr.
Schwartz’ decisions regarding the plaintiff’s surgery.
Accordingly, there is no question of fact that the learned
intermediary doctrine bars the plaintiff’s failure to
warn claim.’’
   We begin by setting forth the applicable standard
of review and relevant legal principles that guide our
analysis. A product may be defective because of inade-
quate warnings or instructions. See Hurley v. Heart
Physicians, P.C., 278 Conn. 305, 315, 898 A.2d 777
(2006); Giglio v. Connecticut Light & Power Co., 180
Conn. 230, 236, 429 A.2d 486 (1980) (‘‘the failure to warn
. . . is, of itself, a defect’’).
  ‘‘According to the Restatement (Second) of Torts,
certain products, by their very nature, cannot be made
safe. See 2 Restatement (Second), [Torts § 402A, com-
ment (k) (1965)]. Prescription drugs generally fall
within the classification of unavoidably unsafe prod-
ucts. . . .
   ‘‘Comment (k) to § 402A of the Restatement (Second)
of Torts provides that some products are incapable of
being made safe for their intended and ordinary use.
Nevertheless, certain unavoidably unsafe products pro-
vide such benefits to society that their use is fully justi-
fied, notwithstanding the unavoidab[ly] high degree of
risk which they involve. Such a product, properly pre-
pared, and accompanied by proper directions and warn-
ing, is not defective, nor is it unreasonably dangerous.
. . . [Id.] Comment (k) provides that a manufacturer
of an unavoidably unsafe product should not . . . be
held to strict liability for unfortunate consequences
attending their use, merely because [it] has undertaken
to supply the public with an apparently useful and desir-
able product, attended with a known but apparently
reasonable risk. . . .
  ‘‘A manufacturer of an unavoidably unsafe product
can avoid strict liability if the product is properly pre-
pared, and accompanied by proper directions and warn-
ing . . . . [Id.] Generally, a manufacturer’s duty to
warn of dangers associated with its products pertains
only to known dangers and runs to the ultimate user
or consumer of those products. . . . The learned inter-
mediary doctrine, which is supported by comment (k)
to § 402A of the Restatement (Second) of Torts, is an
exception to this general rule. . . .
  ‘‘The learned intermediary doctrine provides that ade-
quate warnings to prescribing physicians obviate the
need for manufacturers of prescription products to
warn ultimate consumers directly. The doctrine is based
on the principle that prescribing physicians act as
learned intermediaries between a manufacturer and
consumer and, therefore, stand in the best position to
evaluate a patient’s needs and assess [the] risks and
benefits of a particular course of treatment.’’ (Citations
omitted; emphasis omitted; internal quotation marks
omitted.) Breen v. Synthes-Stratec, Inc., 108 Conn. App.
105, 110–12, 947 A.2d 383 (2008). In Breen, this court
concluded that, under Connecticut law, the learned
intermediary doctrine is properly applied to cases
involving prescription implantable medical devices.
Id., 109.
   The plaintiff admits that the defendants’ product was
accompanied by adequate warnings in the product
insert. What the plaintiff claims is at issue, however,
is whether, notwithstanding the written warnings, the
defendants’ product representative, by his oral commu-
nications to Dr. Schwartz, nullified the written warnings
in the insert and rendered the warnings inadequate.
   In Hurley v. Heart Physicians, P.C., supra, 278 Conn.
305, our Supreme Court considered a similar argument.
In Hurley, the plaintiffs appealed from the trial court’s
summary judgment rendered, on the basis of the learned
intermediary doctrine, in favor of the defendant manu-
facturer on the plaintiffs’ failure to warn product liabil-
ity claims. Id., 307–308. Similar to the plaintiff in the
present case, the plaintiff parents in Hurley and their
fourteen year old daughter who used the pacemaker at
issue, admitted that the product was accompanied by
adequate warnings in the product’s manual. Id., 321.
The plaintiffs’ claim before the trial court was based
on the assertion that the defendant’s product represen-
tative had made statements to the daughter’s treating
physician that nullified the warnings that had been con-
tained in the product’s manual. Id., 307. The plaintiffs
presented evidence from which a jury could have found
that the defendant’s sales consultant had made recom-
mendations and taken actions in a manner inconsistent
with the product’s warnings.9 The court concluded that
‘‘whether [the defendant’s product representative’s]
actions were in derogation of the warnings in the techni-
cal manual was an issue of material fact sufficient to
defeat the defendant’s motion for summary judgment’’;
id., 323–24; and reversed the judgment of the trial court
as to the plaintiffs’ product liability claims.10 Id., 326.
   In the present case, however, the plaintiff failed to
provide a sufficient evidentiary foundation to demon-
strate the existence of a genuine issue of material fact.
In Hurley, our Supreme Court noted: ‘‘If there exists an
undisputed record demonstrating that [the defendant’s
product representative] did nothing inconsistent with
the manual, then we would agree with the defendant
that the trial court properly rendered judgment in its
favor based on the learned intermediary doctrine.’’
(Emphasis in original.) Id., 321. The plaintiff in the pre-
sent case did not present any evidence that the defen-
dants’ representative said or did anything inconsistent
with the product’s warnings.11 Accordingly, the trial
court properly rendered summary judgment in favor of
the defendants on the basis of the learned intermediary
doctrine with respect to the plaintiff’s failure to warn
claim.
     The judgment is affirmed.
     In this opinion the other judges concurred.
 1
     The plaintiff alleged that the defendants’ product was sold ‘‘without
proper or adequate warnings, labels and instructions regarding use in
patients of the plaintiff’s size and history of prior spinal fusions and instru-
mentalities,’’ and ‘‘without proper or adequate warnings, labels and instruc-
tions regarding the junction of titanium hardware to stainless steel
hardware.’’
    2
      The plaintiff alleged that the defendants’ product was ‘‘designed, fabri-
cated, manufactured, tested, distributed, marketed and/or sold without ade-
quate or proper precautions to prevent the failure and fracture of
components once installed in patients,’’ and that the defendants’ product
was ‘‘in [a] dangerous and defective condition at the time [it] left [Johnson &
Johnson, Inc.’s] possession and control and [was] placed into the stream
of commerce by [the defendants] with the expectation that [it] would reach
users and consumers . . . without substantial change in [its] condition.’’
    The trial court noted that ‘‘[t]he plaintiff does not clearly allege what
product defect existed but rather recites various possibilities in his allega-
tions . . . . The plaintiff’s complaint is most clearly construed to allege a
design defect.’’ (Citation omitted.) The plaintiff does not claim otherwise
on appeal. Therefore, like the trial court, we construe the plaintiff’s complaint
to allege strict liability failure to warn and design defect claims, and a breach
of warranty claim.
    3
      Moreover, the plaintiff did not request permission to file an untimely
disclosure of an expert. Rather, the plaintiff was of the view, as he is on
appeal, that an expert was not needed for him to prevail.
    4
      At his deposition, Dr. Schwartz acknowledged that nonunion, also
referred to as pseudoarthrosis, is the failure of a patient’s bones to heal or
fuse. He stated that nonunion is the primary reason that hardware either
breaks or loosens. In their memorandum of law in support of their motion
for summary judgment, the defendants stated that their expert, Dr. Nicholas
Theodore, a neurosurgeon, would opine that the most likely cause of the
breakage of the defendants’ product, in this case, was chronic pseudoarthro-
sis, which was exacerbated by the plaintiff’s smoking.
    5
      ‘‘Under the modified consumer expectation test, the jury would weigh
the product’s risks and utility and then inquire, in light of those factors,
whether a reasonable consumer would consider the product design unrea-
sonably dangerous.’’ (Internal quotation marks omitted.) Izzarelli v. R.J.
Reynolds Tobacco Co., 321 Conn. 172, 190, 136 A.3d 1232 (2016). Therefore,
‘‘[t]o establish the defect, [a] plaintiff’s case require[s] expert testimony on
[the product] design and manufacture, as well as the feasibility of an alterna-
tive design.’’ Id., 203–204.
    In its memorandum of decision, the trial court refers to the modified
consumer expectation test as the risk-utility test. Courts use these terms
interchangeably. See id.
    6
      Although the plaintiff argues that the ordinary consumer expectation
test applies to the circumstances of the present case, he also appears to
set forth an argument, on appeal, under the malfunction theory as a basis
for establishing strict liability. In his brief to this court, the plaintiff argues:
‘‘Design defects can be inferred from circumstantial evidence. Under appro-
priate circumstances, the evidence of malfunction is sufficient evidence of
a defect.’’
    ‘‘A product liability claim under the malfunction theory is distinct from
an ordinary product liability claim.’’ White v. Mazda Motor of America, Inc.,
313 Conn. 610, 622, 99 A.3d 1079 (2014). ‘‘The malfunction theory allows a
plaintiff in a product liability action to rely on circumstantial evidence to
support an inference that an unspecified defect attributable to a product
seller was the most likely cause of a product malfunction when other possible
causes of the malfunction are absent. . . . This theory does not fall squarely
within either the ordinary or modified consumer expectation test, but to
some extent overlaps with both tests.’’ (Citation omitted; emphasis added;
internal quotation marks omitted.) Izzarelli v. R.J. Reynolds Tobacco Co.,
supra, 321 Conn. 194–95 n.12.
    The plaintiff in the present case, however, did not reference the malfunc-
tion theory in his pleadings, nor did he present any allegations relative to its
elements. ‘‘To properly plead a product liability claim under the malfunction
theory, the plaintiff was required to at least claim in the pleadings that some
unspecified defect caused the plaintiff’s harm and to allege facts tending
to establish the malfunction theory’s two basic elements, namely, that (1)
the incident that caused the plaintiff’s harm was of the kind that ordinarily
does not occur in the absence of a product defect, and (2) any defect most
likely existed at the time the product left the manufacturer’s or seller’s
control and was not the result of the reasonably possible causes not attribut-
able to the manufacturer or seller.’’ (Emphasis added; internal quotation
marks omitted.) White v. Mazda Motor of America, Inc., supra, 313 Conn.
623. ‘‘[T]he plaintiff was not required to plead a separate malfunction theory
count in his complaint, but this does not relieve him of his burden of pleading
facts to raise this theory in his complaint as part of his product liability
claims.’’ Id., 625. Although the plaintiff alleged an unspecified defect, he
failed to allege facts to establish the malfunction theory’s two basic elements.
Because we conclude that the plaintiff did not raise the malfunction theory
in the trial court prior to its rendering summary judgment, we decline to
consider its application on appeal.
   7
     Rather, as the plaintiff concedes, nonunion was a possible cause of the
fracture, apart from any product defect.
   8
     Moreover, the plaintiff’s failure to warn claim involves the risk associated
with the mixing of dissimilar metals. See part II this opinion. This issue also
goes beyond the field of ordinary knowledge and experience of jurors.
   9
     At the product representative’s deposition, he confirmed that he evalu-
ated the defendant’s product, which was the plaintiff’s pacemaker, and
indicated that the battery was low. Hurley v. Heart Physicians, P.C., supra,
278 Conn. 309–10. He told the plaintiff’s physician that the pacemaker’s
battery needed to be replaced as soon as possible. However, he also made
a recommendation that he could lower the pacemaker rate to ‘‘ ‘buy . . .
more time’ ’’ to replace the pacemaker’s battery. Id., 311. In accordance
with what he believed the position of the plaintiff mother to be on the
matter, the product representative chose to adjust the pacemaker down
from sixty paces per minute to forty. Id. The product’s manual, however,
provided that rates below forty paces per minute may be used for ‘‘diagnostic
purposes,’’ and ‘‘the manual [did] not provide that rates below forty paces
per minute safely may be used for diagnostic purposes after the indicator
has signaled the end of battery life.’’ (Emphasis in original.) Id., 323.
   10
      The court explained: ‘‘[A]lthough the manual provides that rates below
forty paces per minute may be used for ‘diagnostic purposes,’ whether the
discussion between [the product representative] and [the physician] and
the adjustment actually made were consistent with that purpose when the
electric replacement indicator on the . . . pacemaker signaled the need for
immediate replacement as in this case, raised disputed factual issues meant
for consideration by a fact finder at trial, not by a court deciding whether
to render summary judgment.’’ (Emphasis in original; footnote omitted.)
Hurley v. Heart Physicians, P.C., supra, 278 Conn. 322–23.
   11
      In support of his claim, the plaintiff points only to the testimony of Dr.
Schwartz. Dr. Schwartz, during his deposition, stated that he consulted with
the defendants’ sales representative before the plaintiff’s surgery, about
screw size and length, and that the defendants’ sales representative was
available to be consulted during the plaintiff’s surgery. This testimony does
not support the plaintiff’s bald assertion that the defendants’ representative
made statements which diluted the product’s warnings. ‘‘Mere statements
of legal conclusions . . . and bald assertions, without more, are insufficient
to raise a genuine issue of material fact capable of defeating summary
judgment.’’ (Internal quotation marks omitted.) CitiMortgage, Inc. v. Cool-
beth, 147 Conn. App. 183, 193, 81 A.3d 1189 (2013), cert. denied, 311 Conn.
925, 86 A.3d 469 (2014).
   Moreover, the plaintiff focuses on Dr. Schwartz’ use of the product despite
the product’s warnings regarding the risks associated with the patient’s
weight and the mixing of dissimilar metals. Dr. Schwartz, however, acknowl-
edged that it was his decision to use the defendants’ product. The plaintiff
does not point to any statements or actions by the defendants’ product
representative that could have diluted the product’s warning.