Fajardo v. Boston Scientific Corp. ( 2022 )

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LESLY FAJARDO ET AL. v. BOSTON
SCIENTIFIC CORPORATION ET AL.
(SC 20455)
Robinson, C. J., and Palmer, D’Auria, Mullins,
Kahn and Ecker, Js.*
Syllabus
Pursuant to this court’s decision in Bifolck v. Philip Morris, Inc. (324 Conn.
402), under the risk-utility test, a product is in a defective condition
that is unreasonably dangerous to the consumer if (1) a reasonable
alternative design that would have avoided or reduced the risk of harm
was available and the absence of that alternative design renders the
product unreasonably dangerous, or (2) the product is a manifestly
unreasonable design in that the risk of harm so clearly exceeds the
product’s utility that a reasonable consumer, informed of those risks
and utility, would not purchase the product.
The plaintiffs, F and F’s husband, sought to recover damages from, among
others, the defendant L, who was F’s gynecologist, L’s medical practice,
and the defendant B Co. for personal injuries that F sustained in connec-
tion with an unsuccessful surgery in which a transvaginal mesh sling
designed by B Co., known as the Obtryx, was implanted in F’s body for
the purpose of treating F’s stress urinary incontinence. During F’s annual
health examination, L diagnosed F with pelvic organ prolapse and recom-
mended that he perform a surgical repair known as a colporrhaphy. L
also recommended that F undergo a sling procedure to rectify her stress
urinary incontinence. Because L did not perform the sling procedure,
he referred F to P, a urologist. P described to F the risks and benefits
of, and alternatives to, the sling procedure, and F gave P her informed
consent to proceed with both the colporrhaphy and the sling procedure.
The procedures were scheduled for the same day but performed consec-
utively. Immediately after L performed the colporrhaphy, P implanted
the Obtryx in F. Thereafter, F continued to experience pain and had
the Obtryx removed. The plaintiffs’ complaint included claims against
L and L’s medical practice, alleging that L had failed to obtain F’s
informed consent to the sling procedure and that L made innocent,
negligent or intentional misrepresentations regarding the risks and bene-
fits of the sling procedure. The complaint also alleged a product liability
claim against B Co. under the Connecticut Product Liability Act (§ 52-
572m et seq.), namely, that the defective design of the Obtryx caused
F’s injuries. Prior to trial, L and L’s medical practice, and the plaintiffs,
filed separate motions for summary judgment in connection with the
informed consent and misrepresentation claims. Specifically, the plain-
tiffs claimed that L had assumed a duty to obtain F’s informed consent
for the sling procedure by discussing and recommending that procedure
to F. The trial court disagreed and, instead, granted the motion for
summary judgment filed by L and L’s medical practice, concluding that
the duty to obtain informed consent rests with the physician performing
the procedure, namely, P. The trial court also rendered summary judg-
ment for L and L’s medical practice on the misrepresentation claims.
The plaintiffs’ product liability claim subsequently was tried to a jury.
The plaintiffs introduced into evidence the testimony of a product design
expert, R, and various medical studies, which referred to a class of mesh
slings known as tension free vaginal tapes (TVTs) that are implanted
in a retropubic fashion, unlike the Obtryx, which is implanted using a
transobturator approach. R testified that all slings made of polypropyl-
ene mesh, including the Obtryx and a certain TVT, are defective and
unreasonably dangerous, that the polypropylene mesh caused a foreign
body reaction in F and contributed to her injuries, and that a surgery
known as the Burch procedure was his preferred method to treat stress
urinary incontinence. He also testified regarding what he considered to
be defects in the Obtryx, specifically, its heat-sealed middle section and
detanged edges, which produce a stiffer mesh. Before the trial court
charged the jury, the plaintiffs e-mailed the court, requesting an instruc-
tion on both prongs of the risk-utility test. The court, however, declined
to instruct the jury as to the reasonable alternative design prong and
instructed the jury only with respect to the second prong regarding
whether the design of the Obtryx was manifestly unreasonable. The jury
returned a verdict for B Co., and the plaintiffs moved to set aside the
verdict on the basis of the court’s failure to give a reasonable alternative
design instruction. The trial court denied that motion and rendered
judgment in accordance with the jury’s verdict, from which the plaintiffs
appealed. Held:
1. The trial court properly rendered summary judgment for L and L’s medical
practice in connection with the plaintiffs’ informed consent claim: this
court previously had concluded, as a matter of law, that the duty to
obtain a patient’s informed consent rests solely with the physician who
is to perform the procedure, and that jurisprudence was consistent
with the rule recognized by most jurisdictions and legal and medical
authorities that, when a physician refers a patient to a specialist for a
consultation and that specialist performs the procedure, the specialist
is solely responsible for educating the patient and obtaining her informed
consent, even when the referring physician discussed the procedure
with, or recommended it to, the patient; in the present case, the implanta-
tion of the Obtryx by P was an entirely separate procedure from the
colporrhaphy performed by L, P was solely responsible for the sling
procedure, even though L suggested it to F and referred her to P, and
the trial court properly relied on the unanimous expert testimony pre-
sented at trial that the physician who performs a procedure, and not
the referring physician, has the duty to obtain the patient’s informed
consent to the procedure; moreover, the plaintiffs’ reliance on the lay
standard of informed consent, which relates to the extent or degree of
disclosure a physician must make to fulfill his duty rather than whether
a physician has a duty to inform, was misplaced because L did not have
a duty to obtain F’s informed consent in the first instance; furthermore,
even if this court were to consider the colporrhaphy and the sling
procedure to be a single procedure, the plaintiffs’ claim would nonethe-
less fail because, when more than one physician provides care to a
patient in relation to a particular medical condition, the patient must
prove by expert testimony which physician, if any, owes the patient a
duty to obtain informed consent, and all the experts testified at trial
that it was the duty of P, not L, to obtain F’s informed consent to the
sling procedure.
2. The trial court properly rendered summary judgment for L and L’s medical
practice in connection with the plaintiffs’ misrepresentation claims: this
court recently held that an innocent misrepresentation claim is not
viable in the context of a urogynecologist’s provision of medical services
because such claims generally are governed by § 552C of the
Restatement (Second) of Torts, which requires that the misrepresenta-
tion occur in a ‘‘sale, rental or exchange transaction with another,’’ and
the plaintiffs’ innocent misrepresentation claim failed as a matter of law
because the only medical services L provided to F, namely, recommend-
ing that F see a specialist and discussing the sling procedure, did not
qualify as a sale, rental or exchange transaction; moreover, the plaintiffs’
negligent and intentional misrepresentation claims also failed because
L could not have negligently or intentionally misled, misinformed or
misrepresented the quality, usefulness, risks or benefits of the Obtryx
in light of the trial court’s findings that L was unaware of what brand
of sling P planned to implant in F and that L never discussed with F
the Obtryx or any other products manufactured by B Co.
3. The plaintiffs could not prevail on their claim that the trial court improperly
declined to instruct the jury on the reasonable alternative design prong
of the risk-utility test:
a. This court assumed, without deciding, that the plaintiffs preserved
their challenge to the trial court’s jury instruction for purposes of this
appeal because, even though the plaintiffs did not take exception to the
instruction until after the jury was instructed and even though their
e-mail request to charge the jury did not comply with the relevant rules
of practice (§§ 16-21 and 16-23) insofar as it neither constituted a written
request nor cited to any supporting evidence in the record, the trial court
nonetheless determined that the plaintiffs timely requested a reasonable
alternative design charge and addressed the claim on the merits.
b. In order to establish that they were entitled to an instruction on
reasonable alternative design, the plaintiffs were required to present
expert testimony regarding the alleged design defect of the Obtryx,
whether an alternative design was technically and economically feasible,
and whether the alternative would have reduced or avoided the risk of
harm to F, as those issues involved complicated medical principles that
were beyond the ken of the average juror; in the present case, the trial
court determined, and the plaintiffs agreed, that R was the plaintiffs’
product design expert, and, because the trial court correctly concluded
that R was the only witness qualified to testify concerning reasonable
alternative design, it properly focused on R’s testimony in considering
whether the plaintiffs had produced sufficient evidence to warrant such
an instruction.
c. The plaintiffs failed to produce sufficient evidence that the class of
retropubic slings consisting of TVTs constituted a reasonable alternative
design to the Obtryx and that B Co.’s failure to use that alternative design
rendered the Obtryx unreasonably dangerous: the plaintiffs’ references
to TVTs did not constitute identification of a reasonable alternative
design, as the evidence demonstrated that the safety data related to TVT
products, which can be made of many different types of mesh material
with different pore sizes and weights that alter the performance of those
products, varied considerably, and, to the extent that there was evidence
regarding the safety data of TVTs, the studies the plaintiffs relied on
indicated merely that there were risks and complications with the use
of TVT products, not that there was another product on the market that
would have reduced the risk of harm to F in comparison to the Obtryx;
moreover, some TVT products suffer from the same alleged defects as
the Obtryx, namely, its heat seal and detanged edges, R testified that all
transvaginal slings, including a specific TVT, made of polypropylene
mesh are defective and unreasonably dangerous, regardless of whether
they are heat-sealed or detanged, and the primary medical study on
which the plaintiffs relied compared the Obtryx to a TVT manufactured
by B Co., which was made of the same material and had the same heat
seal as the Obtryx, and, therefore, did not support the plaintiffs’ claim
that there was a reasonable alternative design that would have reduced
or avoided the risk of harm to F; furthermore, the plaintiffs did not point
to a specific existing product and demonstrate that its use would have
reduced or avoided the risk of harm to F but, rather, took a scattershot
approach, pointing to different alternatives to the Obtryx, including surgi-
cal options, such as the Burch procedure, and the class of products
known as TVTs, and that evidence did not demonstrate that any particular
product was safer or would have reduced or avoided the risk of harm
to F when compared to the Obtryx.
(One justice concurring in part and dissenting in part)
Argued April 27, 2020—officially released December 16, 2021*
Procedural History
Action to recover damages for, inter alia, personal
injuries resulting from an allegedly defective product,
and for other relief, brought to the Superior Court in the
judicial district of Stamford-Norwalk and transferred
to the Complex Litigation Docket, where the complaint
was withdrawn as to the defendant Bridgeport Hospital;
thereafter, the court, Zemetis, J., granted the motions
for summary judgment filed by the defendant Lee
Jacobs et al. and rendered judgment thereon; subse-
quently, the case was tried to a jury before Zemetis, J.;
verdict for the named defendant; thereafter, the court
denied the plaintiffs’ motion to set aside the verdict
and rendered judgment in accordance with the verdict,
from which the plaintiffs appealed. Affirmed.
Brenden P. Leydon and Jacqueline E. Fusco, for the
appellants (plaintiffs).
Daniel B. Rogers, pro hac vice, with whom were
Proloy K. Das, Jennifer M. DelMonico and Eric Anie-
lak, pro hac vice, for the appellee (named defendant).
James F. Biondo, with whom, on the brief, was Diana
M. Carlino, for the appellees (defendants Lee Jacobs
et al.).
Opinion
MULLINS, J. This appeal arises from an action in
which the named plaintiff, Lesly Fajardo (Fajardo),1
suffered injuries related to the implantation of a transva-
ginal mesh sling,2 a medical device that is implanted in
women to treat stress urinary incontinence.3 In this
action, the plaintiffs alleged that the named defendant,
Boston Scientific Corporation (Boston Scientific),
defectively designed its Obtryx Transobturator Mid-
Urethral Sling System (Obtryx),4 a polypropylene trans-
vaginal mesh sling, and that the product injured her in
various ways after Edward Paraiso, a nonparty urolo-
gist, implanted it in her. The plaintiffs claimed, as rele-
vant to this appeal, that Boston Scientific’s sale of the
Obtryx violated the Connecticut Product Liability Act,
General Statutes § 52-572m et seq.
The plaintiffs also brought, inter alia, claims of negli-
gence sounding in informed consent and misrepresenta-
tion against Fajardo’s gynecologist, the defendant Lee
D. Jacobs, and Jacobs’ medical practice, the defendant
OB-GYN of Fairfield County, P.C. (medical defen-
dants).5 Their claims against the medical defendants
rest on the theory that Jacobs, who referred Fajardo
to Paraiso for a mesh sling implant, voluntarily assumed
a duty to fully and accurately educate Fajardo as to the
risks and benefits of, and the alternatives to, a mesh
sling implant procedure. As to the misrepresentation
claims, the plaintiffs alleged that Jacobs innocently,
negligently and intentionally misled and misinformed
Fajardo regarding the quality, usefulness, risks and/or
benefits of the Obtryx.
Prior to trial, the trial court granted the medical
defendants’ motion for summary judgment, concluding,
as a matter of law, that Jacobs, as a referring physician,
had no duty to obtain Fajardo’s informed consent for
a procedure that Paraiso was to perform. The court also
rendered summary judgment in favor of the medical
defendants on the plaintiffs’ misrepresentation claims.
Thus, the case proceeded to trial only against Boston
Scientific, and the jury returned a verdict in its favor.
The plaintiffs moved to set aside the verdict, but the
trial court denied that motion and rendered judgment
in accordance with the jury’s verdict. This appeal fol-
lowed.6
On appeal, the plaintiffs claim that the trial court (1)
incorrectly concluded that Jacobs did not owe a duty
to procure Fajardo’s informed consent to the sling pro-
cedure, (2) improperly rendered summary judgment in
favor of the medical defendants on the plaintiffs’ mis-
representation claims, and (3) improperly failed to
instruct the jury that it could find Boston Scientific
liable under the Connecticut Product Liability Act if
Fajardo’s injuries resulted from Boston Scientific’s fail-
ure to adopt a reasonable alternative design that ren-
dered the Obtryx unreasonably dangerous. We con-
clude that the trial court properly rendered summary
judgment in favor of the medical defendants on the
informed consent and misrepresentation claims and
that it properly declined to instruct the jury on the
reasonable alternative design prong of the risk-utility
test. Accordingly, we affirm the judgment of the trial
court.
I
CLAIMS AGAINST MEDICAL DEFENDANTS
A
Informed Consent Claim
The plaintiffs assert that the trial court improperly
rendered summary judgment in favor of the medical
defendants because it incorrectly concluded that
Jacobs had not assumed a duty to obtain Fajardo’s
informed consent for implantation of the mesh sling
and the sling procedure. Specifically, the plaintiffs argue
that Jacobs assumed the duty by discussing and recom-
mending the sling procedure to treat Fajardo’s stress
urinary incontinence. The plaintiffs also claim that
Jacobs had a duty to obtain Fajardo’s informed consent
because Jacobs was involved in or maintained control
over the surgical procedure performed by Paraiso. Nei-
ther claim has merit.
The following facts and procedural history are rele-
vant to this claim. On March 26, 2010, Fajardo visited
Jacobs, her gynecologist, for her annual preventative
health examination. During that visit, Fajardo consulted
with Jacobs about her gynecological and urological con-
cerns. In his medical notes for this appointment, Jacobs
noted that ‘‘ ‘[the] patient complains of stress inconti-
nence daily, very disruptive, she wants surgical repair.’ ’’
After a physical examination, Jacobs diagnosed
Fajardo with pelvic organ prolapse—a weakness in the
vaginal wall that causes the bladder, colon, or rectum
to herniate into the vagina. Specifically, Jacobs deter-
mined that Fajardo suffered from a grade 2 cystocele
(prolapse of the bladder) and a grade 2 rectocele (pro-
lapse of the posterior vaginal wall). Jacobs explained
that a surgery to address the cystocele and rectocele
probably would not rectify the incontinence issues.
Consequently, given her interest in a more permanent
fix to the incontinence issues, Jacobs discussed with
Fajardo the option of ‘‘her see[ing] a urologist for an
evaluation to see what could be offered to her [to
address the incontinence].’’
Also, during or as a result of this appointment, Jacobs
wrote an office note, in which he stated that the ‘‘ ‘risks,
benefits, and alternatives of sling/AP (anterior and pos-
terior colporrhaphy)7 discussed, all questions
answered.’ ’’ (Footnote added; footnote omitted.) Then,
as he had with numerous other similarly situated
patients, he referred Fajardo to Paraiso, a urologist, for
consultation and evaluation regarding her stress urinary
incontinence.
On April 10, 2010, Fajardo consulted with Paraiso.
He diagnosed her with stress urinary incontinence and
recommended that she consent to having Paraiso surgi-
cally implant a midurethral mesh sling to treat it. Paraiso
described the risks and benefits of, and alternatives
to, the procedure. He then obtained Fajardo’s ‘‘oral
‘informed consent’ ’’ to proceed with surgical repairs
to both her vaginal walls (a colporrhaphy performed
by Jacobs) and urethra (a mesh sling implant performed
by Paraiso).
Paraiso also discussed with Fajardo that both proce-
dures would occur on the same day in a hospital surgical
setting. Fajardo thereafter signed two separate consent
forms, one for the A/P repair to be performed by Jacobs,
and one for the sling procedure to be performed by
Paraiso. Paraiso then communicated this plan to
Jacobs.
On December 15, 2010, Fajardo signed Bridgeport
Hospital’s informed consent form, after having read and
discussed it with Jacobs. Thereafter, Jacobs surgically
repaired Fajardo’s vaginal walls. Paraiso was not pres-
ent during Jacobs’ portion of the surgery. On the same
day, immediately following Jacobs’ procedure, Paraiso
surgically implanted the Obtryx in Fajardo to address
the stress urinary incontinence. Jacobs was not present
during Paraiso’s procedure. Jacobs also was not aware
of the type of mesh sling Paraiso implanted into Fajardo.
Furthermore, Paraiso is not associated with the medical
defendants and is not a party to this action. The plain-
tiffs also do not allege that Jacobs had any vicarious
liability for Paraiso’s actions.
After these surgeries, Fajardo still experienced pain.
Eventually, the sling had to be removed. As a result of
her continued issues, and her belief that Jacobs had
assumed a duty but failed to adequately inform her
of the risks associated with the sling procedure, the
plaintiffs brought claims against the medical defen-
dants, alleging, inter alia, lack of informed consent, as
well as intentional, negligent and innocent misrepresen-
tation.
Before trial, the plaintiffs moved for summary judg-
ment. They claimed that they were entitled to summary
judgment in connection with their informed consent
claim against Jacobs because Jacobs ‘‘voluntarily
assumed the duty to obtain informed consent from . . .
Fajardo for implantation of the mesh sling and the mesh
sling procedure when he recommended the sling proce-
dure, informed her that it was mesh that would be
permanently implanted into her to treat her stress uri-
nary incontinence . . . [and that] it would fix her
[stress urinary incontinence], and convinced her that
it was safe.’’ The plaintiffs argued that the undisputed
facts supported their claim.
The medical defendants also filed a motion for sum-
mary judgment on the informed consent issue. In sup-
port of their motion, the medical defendants asserted
that Jacobs was not obligated to obtain Fajardo’s
informed consent for implantation of the mesh sling
and the sling procedure because he was not the physi-
cian who performed that procedure. The medical defen-
dants relied on testimony from both their own and the
plaintiffs’ experts, who all agreed that it was Paraiso’s
duty—as the physician performing the surgery—to
obtain Fajardo’s informed consent for implantation of
the mesh sling and the sling procedure.
Although the plaintiffs and the medical defendants
gave slightly different accounts of the conversations
that occurred during the March 26, 2010 appointment,
both the plaintiffs and the medical defendants agreed
that there were no disputed issues of material fact rele-
vant to the informed consent claim. They agree that the
issue for the trial court was whether, on the undisputed
facts that Jacobs had discussed and recommended the
sling procedure to Fajardo, as a matter of law, Jacobs
was obligated to obtain Fajardo’s informed consent.
The trial court denied the motion for summary judg-
ment filed by the plaintiffs and granted the motion for
summary judgment filed by the medical defendants. In
doing so, the trial court explained: ‘‘[The plaintiffs urge]
the court to impose a duty on Jacobs to obtain
[Fajardo’s] informed consent for Paraiso’s implant of
the [Boston Scientific] mesh because Jacobs ‘assumed
a duty’ when, according to Jacobs’ . . . office note
[dated March 26, 2010], [he made the notation that]
the ‘risks, benefits, and alternatives of sling/AP surgery
discussed, all questions answered.’ The court rejects
this request.’’ (Footnote omitted.) In rejecting that
request, the trial court relied on Logan v. Greenwich
Hospital Assn., 191 Conn. 282, 465 A.2d 294 (1983), in
which this court concluded that ‘‘[t]he principle that
one who gratuitously undertakes a service [that] he has
no duty to perform must act with reasonable care in
completing the task assumed is not applicable to’’ a
physician who discussed a procedure with a patient
but then referred the patient to another physician to
perform the surgery. Id., 305.
The trial court concluded that, in the present case,
‘‘Jacobs was a referring physician regarding the urologi-
cal surgery performed by Paraiso. Jacobs is not alleged
to have any vicarious liability for the conduct of Para-
iso.’’ The trial court further concluded that the duty
to obtain informed consent ‘‘rests [with] the physician
performing the procedure. The procedure is the mesh
implant. Paraiso performed the implant. Paraiso, not
Jacobs, had to obtain [Fajardo’s] informed consent for
the surgical implantation of the [Boston Scientific]
mesh product.’’
On appeal, the plaintiffs assert that the trial court
misapplied Logan v. Greenwich Hospital Assn., supra,
191 Conn. 305, in concluding that a physician can never
assume a duty of obtaining informed consent. We read
neither Logan nor the trial court’s interpretation of
that decision as concluding that a physician can never
assume a such duty. Rather, as we explain herein, we
agree with the medical defendants that, under the cir-
cumstances of the present case and without expert
testimony to the contrary, the physician conducting the
vaginal mesh implantation surgery was responsible for
obtaining Fajardo’s informed consent.
We first set forth the applicable standard of review.
‘‘Practice Book [§ 17-49] provides that summary judg-
ment shall be rendered forthwith if the pleadings, affida-
vits 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 nonmoving party. . . . The party seek-
ing summary judgment has the burden of showing the
absence of any genuine issue [of] material facts which,
under applicable principles of substantive law, entitle
him to a judgment as a matter of law . . . and the party
opposing such a motion must provide an evidentiary
foundation to demonstrate the existence of a genuine
issue of material fact. . . . Finally, the scope of our
review of the trial court’s decision to grant the plaintiff’s
motion for summary judgment is plenary.’’ (Internal
quotation marks omitted.) Dougan v. Sikorsky Aircraft
Corp., 337 Conn. 27, 35, 251 A.3d 583 (2020).
We begin our analysis with a brief review of the law
of informed consent. ‘‘The informed consent doctrine
derives from the principle that [e]very human being of
adult years and sound mind has a right to determine
what shall be done with his own body; and a surgeon
who performs an operation without his patient’s con-
sent . . . commits an assault, for which he is liable in
damages.’’ (Internal quotation marks omitted.) Sher-
wood v. Danbury Hospital, 278 Conn. 163, 180, 896
A.2d 777 (2006). ‘‘The essential elements of a cause of
action based [on] a lack of informed consent are [1] a
breach of [2] duty by the defendant and [3] a causal
connection between that breach and [4] the harm to
the plaintiff.’’ Lambert v. Stovell, 205 Conn. 1, 6, 529
A.2d 710 (1987). Only the second element, duty, is at
issue in the present appeal.
In the realm of informed consent, as throughout the
law of tort, ‘‘[t]he existence of a duty is a question of
law and [o]nly if such a duty is found to exist does
the trier of fact then determine whether the defendant
violated that duty in the particular situation at hand.
. . . If the court determines, as a matter of law, that a
defendant owes no duty to a plaintiff, a verdict should
be directed [or summary judgment rendered] because
[i]t is merely reaching more speedily and directly a
result [that] would inevitably be reached in the end.’’
(Citation omitted; internal quotation marks omitted.)
Petriello v. Kalman, 215 Conn. 377, 382–83, 576 A.2d
474 (1990).
Several of our informed consent cases have pre-
sented, in one form or another, the issue of whether a
physician or institution may owe a duty to obtain a
patient’s informed consent to a procedure that is to be
performed by a third-party physician. In each case, this
court has concluded, as a matter of law, that the physi-
cian who performed the procedure was solely responsi-
ble for obtaining the patient’s informed consent. See,
e.g., Sherwood v. Danbury Hospital, supra, 278 Conn.
171 n.8 (treating physician, rather than hospital, is
responsible for procuring patient’s informed consent);
Petriello v. Kalman, supra, 215 Conn. 385 (‘‘informed
consent . . . is the sole responsibility of the attending
physician to obtain’’); Logan v. Greenwich Hospital
Assn., supra, 191 Conn. 304–306 (internist who dis-
cussed kidney biopsy with patient and referred her to
urologist to obtain biopsy did not assume duty to pro-
cure patient’s informed consent). The Appellate Court
has reached the same conclusion. See, e.g., Torres v.
Carrese, 149 Conn. App. 596, 622–23, 90 A.3d 256, cert.
denied, 312 Conn. 912, 93 A.3d 595 (2014); Mason v.
Walsh, 26 Conn. App. 225, 230–31, 600 A.2d 326 (1991),
cert. denied, 221 Conn. 909, 602 A.2d 9 (1992).
Those results are consistent with the rule, recognized
by other jurisdictions and legal and medical authorities,
that, when a physician refers a patient to a specialist
for a consultation, it is the specialist—assuming that
he ultimately performs the procedure at issue—who is
solely responsible for educating the patient and
obtaining her informed consent. See, e.g., Brotherton
v. United States, Docket No. 2:17-CV-00098-JLQ, 2018
WL 3747802, *4 (E.D. Wn. August 7, 2018) (‘‘the majority
of jurisdictions that have addressed whether referring
physicians have a duty to obtain a patient’s informed
consent have concluded that they do not’’ (internal quo-
tation marks omitted)); 61 Am. Jur. 2d 314, Physicians,
Surgeons, and Other Healers § 168 (2012) (‘‘only the
physician or health care provider who actually gives
the treatment or performs the operation has a duty to
inform the patient of the risks involved and [to] obtain
the patient’s informed consent’’).
As one federal court has explained, ‘‘[t]his makes
common sense. The physician performing a procedure
should advise on the risks of the procedure. When a
primary care physician refers a matter to a specialist,
it is not logical to impose a legal duty on the primary
care physician to explain the risk of a procedure [that]
the specialist may perform. Generally the reason for
the referral to a specialist is because the specialist has
more training, knowledge, or experience in the particu-
lar area of medicine.’’ Brotherton v. United States,
supra, 2018 WL 3747802, *5.
In Connecticut, Logan v. Greenwich Hospital Assn.,
supra, 191 Conn. 282, is the seminal case regarding
the duty of a referring physician to obtain informed
consent. In Logan, this court examined whether the
plaintiff’s internal medicine specialist (internist) had a
duty to obtain the plaintiff’s informed consent for a
needle biopsy of her kidney that was performed by a
different physician. See id., 304–306. The internist had
informed the patient that she had lupus and recom-
mended that she get a biopsy of her kidneys to deter-
mine to what extent the lupus had affected her kidneys.
Id., 284–85. The internist explained that the procedure
would involve the insertion of a needle into her back to
obtain a specimen of kidney tissue. Id., 285. He further
explained that it was a simple procedure in which local
anesthesia would be used, that she may experience
some bleeding and discomfort, and that she could leave
the hospital in a day or two if there were no complica-
tions. Id.
The internist referred the plaintiff to Peter Bogdan,
a urologist who would perform the operation, and told
the patient that Bogdan would describe the details more
fully. Id. Bogdan performed the needle biopsy and
injured the plaintiff during the procedure. Id., 286–87.
The plaintiff brought a claim of negligence against the
internist for failure to obtain her informed consent. Id.,
287. The trial court denied the internist’s motion for a
directed verdict, but the jury nonetheless returned a
verdict in favor of the internist. The plaintiff appealed.
Id., 284.
On appeal, this court concluded that the trial court
should have granted the internist’s motion for a directed
verdict. In doing so, this court explained: ‘‘Although it
is undisputed that [the internist] did discuss the kidney
biopsy with the plaintiff and describe the procedure
generally, there was no evidence that it was his duty
to do so. In fact, the testimony indicated the contrary.
The plaintiff’s expert witness . . . testified that an
internist . . . had no obligation to discuss the surgical
procedure with the plaintiff or to obtain her informed
consent. He stated unequivocally that those duties
rested [with] the physician who was to perform the
operation.’’ Id., 305.
In reaching this conclusion, this court expressly
rejected the voluntary assumption of duty principle on
which the plaintiffs rely in the present case. In Logan,
the plaintiff claimed that the internist, by discussing
the biopsy procedure with her, assumed and therefore
owed a duty to the plaintiff to obtain her informed
consent. Responding to this claim, this court clarified
that ‘‘[t]he principle that one who gratuitously under-
takes a service [that] he has no duty to perform must act
with reasonable care in completing the task assumed
is not applicable to this situation. . . . Although [the
internist] did describe the general nature of the opera-
tion to the plaintiff and some of the possible complica-
tions, he also told her that a more detailed explanation
would be provided by Bogdan, the urologist. There is
no evidence that his reliance [on] the operating surgeon
to provide the information necessary for informed con-
sent was contrary to normal medical practice or was
unreasonable under these particular circumstances.’’
(Citations omitted.) Id.
Logan is in line with the rule followed in most juris-
dictions, which is that the physician conducting the
surgery is the one who owes the duty of obtaining the
patient’s informed consent. This rule applies even under
circumstances in which the referring physician dis-
cusses the surgical procedure with the patient and rec-
ommends that the patient undergo the procedure.
Logan teaches that it is the physician who performs
the actual procedure who is responsible for obtaining
the informed consent to that procedure.
In the present case, Jacobs, Paraiso and the plaintiffs
all agree that the implantation of the sling, performed
by Paraiso, was a separate procedure from the repair
to the vaginal wall performed by Jacobs. And Paraiso
was solely responsible for performing the sling proce-
dure. Thus, like the internist in Logan, notwithstanding
the fact that Jacobs may have mentioned the sling pro-
cedure or even suggested that Fajardo may be a good
candidate for the sling procedure, the fact remains that
Jacobs referred her to Paraiso, the specialist, for further
consultation. The plaintiffs presented no evidence to
undermine the fact that Paraiso, as the physician who
performed the sling procedure, was the physician
responsible for obtaining Fajardo’s informed consent.
In fact, here, as in Logan, even the plaintiffs’ experts
explained that the physician who performs the surgery
is required to obtain a patient’s informed consent, not
the referring physician. Indeed, the plaintiffs’ expert,
Richard Bercik, a urologist, testified: ‘‘[T]he surgeon
who is doing the procedure is responsible for the evalua-
tion of the patient for that condition, the selection of
how they’re going to do the surgery, what they’re going
to do, and informing the patient. That’s all [in] the hands
of the person doing the procedure.’’ The medical defen-
dants’ expert also agreed that it was the duty of the
surgeon who performed the implantation procedure to
obtain the patient’s informed consent for that procedure
and not the referring physician.
In rendering summary judgment, the trial court relied
on the fact that ‘‘all disclosed medical experts agree
[that] Paraiso, not Jacobs, had to obtain [Fajardo’s]
informed consent for the implant[ation] of the mesh
product.’’ We conclude that the trial court properly
relied on the unanimous expert testimony to support
its conclusion that Jacobs did not owe a duty to Fajardo
to obtain her informed consent.
The plaintiffs also raise a similar but slightly different
argument to support their claim that Jacobs had a duty
to obtain Fajardo’s informed consent to the sling proce-
dure. In particular, they argue that, because Jacobs was
Fajardo’s gynecologist and she had established a high
level of trust with him, she expected and trusted him
to give her the information necessary for her to give
informed consent. For support, they rely on the lay
standard of informed consent adopted in Logan. They
claim that the lay standard requires this court to deter-
mine whether a particular physician has a duty to obtain
informed consent based on the patient’s perspective of
the interaction, instead of by relying on expert testi-
mony regarding common practices in the medical com-
munity. We disagree.
In Logan v. Greenwich Hospital Assn., supra, 191
Conn. 282, this court concluded that, in order to obtain
informed consent from a patient, a physician must ‘‘pro-
vide the patient with that information [that] a reason-
able patient would have found material for making a
decision whether to embark [on] a contemplated course
of therapy.’’ Id., 292–93. This standard is referred to as
the ‘‘lay standard of disclosure’’ because it focuses on
what information a reasonable patient would want to
know about a particular procedure in order to give his
or her informed consent. Id.We have made clear that ‘‘[o]ur standard of disclosure
for informed consent in this state is an objective stan-
dard that does not vary from patient to patient based
on what the patient asks or what the patient would do
with the information if it were disclosed. . . . [T]he
lay standard of informed consent requires a physician
to provide the patient with that information [that] a
reasonable patient would have found material for mak-
ing a decision whether to embark [on] a contemplated
course of therapy. . . . In adopting the objective lay
standard, this court recognized that rather than impose
on the physician an obligation to disclose at his peril
whatever the particular patient might deem material to
his choice, most courts have attempted to frame a less
subjective measure of the physician’s duty.’’ (Citation
omitted; emphasis omitted; internal quotation marks
omitted.) Duffy v. Flagg, 279 Conn. 682, 692, 905 A.2d
15 (2006).
Contrary to the plaintiffs’ assertion, the lay standard
adopted in Logan does not speak to whether a physician
has a duty to inform, but, rather, the standard governs
how a physician who has a duty to obtain informed
consent fulfills that duty. In other words, the lay stan-
dard applies only to the content of the disclosure that
must be made. It is only once the duty to inform is
established that the lay standard dictates how that duty
must be satisfied. See Mason v. Walsh, supra, 26 Conn.
App. 230 (‘‘[o]nce the existence of the duty to inform
has been established, the degree or extent of disclosure
necessary to satisfy the duty must be proven in accor-
dance with the lay standard’’). If the physician does not
have a duty in the first instance, the lay standard simply
does not apply. Here, Jacobs never had the duty to
obtain Fajardo’s informed consent for the mesh implan-
tation procedure. Thus, for purposes of determining
whether Jacobs had a duty to inform at all, the lay
standard does not inform that question.
Lastly, the plaintiffs claim that, because the two sur-
geries here took place on the same day and Jacobs
maintained control over the procedures, he thus owed
a duty to obtain Fajardo’s informed consent. This claim
is factually and legally meritless.
First, it is undisputed that the two surgeries were
separate procedures, performed by different physicians
with different training and specialties. Jacobs was not
present when Paraiso performed the implantation pro-
cedure. Most important, it is undisputed that it was
Paraiso, not Jacobs, who decided which vaginal mesh
to implant in Fajardo, consistent with normal medical
practice. The plaintiffs have failed to point to any evi-
dence to support their claim that Jacobs retained con-
trol over the implantation of the surgical mesh, which
occurred during a different surgery. Thus, the fact that
these distinct surgeries took place on the same day
does not establish that Jacobs maintained control over
the separate procedure performed by Paraiso. As a fac-
tual matter, then, this is not a scenario in which multiple
physicians were performing or involved in a single surgi-
cal procedure.8
Second, even if we were to consider both surgeries
as one surgical procedure, despite all of the evidence
to the contrary, the plaintiffs’ claim still fails because
they provided no expert testimony to demonstrate that
Jacobs had any duty to obtain Fajardo’s informed con-
sent. To be sure, this court has clarified that, when
more than one physician provides care to the plaintiff,
in relation to a particular medical condition, the plaintiff
must prove by expert testimony which physician, if any,
owes the plaintiff a duty to obtain informed consent.
See Godwin v. Danbury Eye Physicians & Surgeons,
P.C., 254 Conn. 131, 144, 757 A.2d 516 (2000), citing
Mason v. Walsh, supra, 26 Conn. App. 230; see also
Mason v. Walsh, supra, 230 (‘‘[When] . . . a surgeon
engages one or more specialists to perform a portion
of a procedure, the issue as to who has the duty to obtain
the patient’s consent to that portion of the procedure
to be performed by the specialist arises. It was incum-
bent [on] the plaintiff to establish by expert testimony
which of the physicians, if any, owed him the duty of
disclosing sufficient facts to permit him to exercise an
informed consent to the use of general anesthesia.’’
(Emphasis added.)).
In the present case, even Bercik, the plaintiffs’ expert,
a urogynecologist and reconstructive surgeon, and pro-
fessor of female pelvic medicine, agreed with Jacobs
and Paraiso that, as a general matter, it is the consulting
surgeon who is going to perform the procedure who
is responsible for evaluating the patient, selecting the
appropriate treatment, and educating the patient
regarding that procedure. Frederick Rau, the medical
defendants’ expert, a board certified obstetrician and
gynecologist, agreed that, under circumstances such as
these, ‘‘[t]he referring physician has no medical duty
or responsibility to obtain a patient’s informed consent
for a surgical procedure he/she is not going to perform.
. . . [I]n this case . . . Jacobs acted entirely reason-
ably in discussing a potential sling procedure with
[Fajardo], but he had no duty to obtain [her] informed
consent for the ultimate sling procedure that was per-
formed.’’ Thus, not a single expert testified that Jacobs
had a duty to obtain Fajardo’s informed consent to the
mesh implant.
Based on the foregoing, we conclude that the trial
court properly rendered summary judgment in favor of
the medical defendants in connection with the informed
consent claim.
B
Misrepresentation Claims
The plaintiffs also claim on appeal that the trial court
improperly rendered summary judgment in favor of the
medical defendants on the claims of innocent, negligent,
and intentional misrepresentation. We disagree.
First, this court recently concluded that a claim of
innocent misrepresentation against a urogynecologic
surgeon did not lie as a matter of law. See Farrell v.
Johnson & Johnson, 335 Conn. 398, 421, 238 A.3d 698(2020). In so concluding, this court explained that the
surgeon’s ‘‘provision of medical services did not qualify
as a ‘sale, rental or exchange transaction’ under § 552C
of the Restatement (Second) [of Torts], and, therefore,
a claim for innocent misrepresentation does not lie
under our existing innocent misrepresentation prece-
dent.’’ Id. Similarly, in the present case, Jacobs’ provi-
sion of medical services, which involved only his recom-
mendation that Fajardo see a specialist and discuss the
sling procedure, does not qualify as a ‘‘sale, rental or
exchange transaction . . . .’’ 3 Restatement (Second),
Torts § 552C, p. 141 (1977). Therefore, the plaintiffs’
claim of innocent misrepresentation fails as a matter
of law.
Second, we agree with the trial court that the plain-
tiffs’ claims of negligent and/or intentional misrepresen-
tation also fail. The trial court found that ‘‘Jacobs was
unaware of what kind of a sling Paraiso planned to
implant in [Fajardo].’’ Indeed, the trial court also found
that ‘‘the parties agree [that] Jacobs never discussed
[Boston Scientific] products with [Fajardo].’’ Thus,
because Jacobs did not know what product Paraiso
would implant in Fajardo and never discussed Boston
Scientific products with Fajardo, he could not have
negligently or intentionally misled, misinformed or mis-
represented the quality, usefulness, risks and benefits
of the Obtryx.
Accordingly, we conclude that the trial court properly
rendered summary judgment in favor of the medical
defendants on the plaintiffs’ misrepresentation claims.
II
INSTRUCTIONAL ERROR CLAIM AGAINST
BOSTON SCIENTIFIC
We next turn to the plaintiffs’ claim that the trial
court improperly declined to charge the jury on the
reasonable alternative design prong of the risk-utility
test. Specifically, the plaintiffs claim that they intro-
duced sufficient evidence that the tension free vaginal
tape (TVT)9 was a safer reasonable alternative design
to Boston Scientific’s device, the Obtryx, which caused
Fajardo’s injuries. Boston Scientific contends that the
plaintiffs’ instructional error claim is unreviewable
because it was not timely or properly preserved. Boston
Scientific argues, in the alternative, that, if we conclude
that the claim is reviewable, no such instruction was
warranted in light of the evidence that was presented
at trial and the governing law.
Even if we assume, for purposes of this appeal, that
the request for a reasonable alternative design instruc-
tion was timely and properly made, we agree with the
trial court that the evidence did not support such an
instruction. Accordingly, we affirm the judgment of the
trial court.
A
Legal Background
Before we turn to the parties’ specific contentions,
it is helpful briefly to situate the dispute within its
broader legal context. In 2016, we decided a pair of
cases that required us to reexamine and clarify the
legal standards that govern claims brought under the
Connecticut Product Liability Act. See Bifolck v. Philip
Morris, Inc., 324 Conn. 402, 152 A.3d 1183 (2016); Izzar-
elli v. R.J. Reynolds Tobacco Co., 321 Conn. 172, 136
A.3d 1232 (2016).
In Izzarelli, we sharply limited the scope of the tradi-
tional legal standard governing defective product design
claims, the so-called ‘‘ordinary consumer expectation
test,’’ under which, ‘‘[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 charac-
teristics.’’ (Internal quotation marks omitted.) Izzarelli
v. R.J. Reynolds Tobacco Co., supra, 321 Conn. 185. We
clarified that that test ‘‘would be appropriate [only]
when the incident causing injury is so bizarre or unusual
that the jury would not need expert testimony to con-
clude that the product failed to meet the consumer’s
expectations.’’ Id., 191. In other words, ‘‘[t]he ordinary
consumer expectation test is reserved for cases in
which the product failed to meet the ordinary consum-
er’s minimum safety expectations, such as res ipsa
[loquitur] type cases.’’ (Emphasis omitted.) Id., 194.
In most product liability cases, by contrast, the plain-
tiff is required to establish a defective design under the
modified consumer expectation test, pursuant to which
‘‘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 unreasonably dangerous.’’ (Internal quotation
marks omitted.) Id., 190; see id., 194. In applying that
test, we indicated that the jury is to be instructed to
consider a nonexclusive list of factors, one of which
may be the availability of a feasible alternative design.
See id., 190–91, 208–10.
In Bifolck, we further clarified Izzarelli’s ordinary
and modified consumer expectation tests. First, we
renamed them the ‘‘consumer expectation test’’ and the
‘‘risk-utility test,’’ respectively. Bifolck v. Philip Morris,
Inc., supra, 324 Conn. 432. Second, we set forth two
distinct prongs or methods by which the latter test
may be satisfied. ‘‘Under the risk-utility test, which will
govern most cases, a product is in a defective condition
unreasonably dangerous to the consumer or user if:
‘‘(1) A reasonable alternative design was available
that would have avoided or reduced the risk of harm
and the absence of that alternative design renders the
product unreasonably dangerous. In considering
whether there is a reasonable alternative design, the
jury must consider the feasibility of the alternative.
Other relevant factors that a jury may consider include,
but are not limited to, the ability of the alternative
design to reduce the product’s danger without unrea-
sonably impairing its usefulness, longevity, mainte-
nance, and esthetics, without unreasonably increasing
cost, and without creating other equal or greater risks
of danger [Bifolck 1]; or
‘‘(2) The product is a manifestly unreasonable design
in that the risk of harm so clearly exceeds the product’s
utility that a reasonable consumer, informed of those
risks and utility, would not purchase the product
[Bifolck 2].’’ Id., 434–35.
Here, the trial court declined to give an instruction
under Bifolck 1 and gave only a Bifolck 2 instruction.
The question in the present case is whether the trial
court correctly concluded that the evidence did not
support an instruction under the reasonable alternative
design prong of the risk-utility test (i.e., Bifolck 1). We
conclude that it did.
It is well established that, ‘‘[i]n determining whether
the trial court improperly refused a request to charge,
[w]e . . . review the evidence presented at trial in the
light most favorable to supporting the . . . proposed
charge. . . . A request to charge [that] is relevant to
the issues of [a] case and [that] is an accurate statement
of the law must be given. . . . If, however, the evidence
would not reasonably support a finding of the particular
issue, the trial court has a duty not to submit it to the
jury. . . . Thus, a trial court should instruct the jury
in accordance with a party’s request to charge [only]
if the proposed instructions are reasonably supported
by the evidence. . . . If . . . the evidence reasonably
does not support a finding on the particular issue, the
trial court is duty bound to refrain from submitting it
to the jury.’’ (Citation omitted; internal quotation marks
omitted.) Brown v. Robishaw, 282 Conn. 628, 633, 922
A.2d 1086 (2007).
Whether the evidence presented by a party reason-
ably supports a particular request to charge ‘‘is a ques-
tion of law over which our review is plenary.’’ Id. Simi-
larly, whether there is a legal basis for the requested
charge is a question of law also entitled to plenary
review. See id., 633–34.
B
Reviewability of Plaintiffs’ Instructional Claim
First, we must address Boston Scientific’s assertion
that the plaintiffs’ claim is unreviewable because the
plaintiffs failed to properly preserve their challenge
regarding the instruction. Boston Scientific contends
that the plaintiffs’ Bifolck 1 instruction claim is unpre-
served because they did not submit a written request
to charge on the instruction and also failed to cite evi-
dence in the record to support such an instruction pur-
suant to Practice Book §§ 16-21 and 16-23. The following
facts are necessary to address this contention.
Before the trial court charged the jury, the parties
and the court had off-the-record discussions regarding
Bifolck 1, the reasonable alternative design charge. Fol-
lowing those discussions, the plaintiffs requested the
charge through an e-mail to the court and did not cite
to any evidence in the record to support the request.10
However, the plaintiffs did not formally submit a written
request for the court to charge the jury as to Bifolck 1
pursuant to Practice Book §§ 16-21 and 16-23; nor did
they take exception to the court’s charge on the record
before the jury was instructed.11
It was not until the jury had been charged and dis-
missed for the day that the plaintiffs formally took
exception to the court’s design defect instruction,
claiming entitlement to an instruction on Bifolck 1.
Although the plaintiffs’ request did not technically com-
ply with the requirements of Practice Book §§ 16-21
and 16-23, the trial court determined that the plaintiffs
‘‘did timely submit a request to charge on the ‘reason-
able alternative design’ test . . . .’’ Ultimately, in
response to the plaintiffs’ motion to set aside the ver-
dict, the trial court addressed the merits of the plaintiffs’
claim and rejected it.
It is important to note that, in their e-mail request to
the court, the plaintiffs did not cite to any evidence to
support their request for a Bifolck 1 charge. In failing
to cite to any evidence in the request to charge, the
plaintiffs failed to comply with Practice Book §§ 16-21
and 16-23. Accordingly, the trial court would have been
warranted in denying the plaintiffs’ request on the basis
that the plaintiffs did not cite to evidence to support
it. See, e.g., State v. Bettini, 11 Conn. App. 684, 690,
528 A.2d 1180 (‘‘[i]n the absence of compliance with
the rules of practice, the trial court is entitled to deny
a request to charge’’), cert. denied, 205 Conn. 804, 531
A.2d 937 (1987); see also State v. Kendall, 123 Conn.
App. 625, 672, 2 A.3d 990, cert. denied, 299 Conn. 902,
10 A.3d 521 (2010).
We point this out because it is this lack of specificity
in the plaintiffs’ request to charge that the concurrence
and dissent capitalizes on and uses as an opportunity
to recast and create its own arguments that, in its opin-
ion, the plaintiffs should have made at trial to support
their request for a reasonable alternative design instruc-
tion.
Nevertheless, despite the plaintiffs’ failure to comply
with Practice Book §§ 16-21 and 16-23, the trial court
determined that the plaintiffs timely requested a Bifolck
1 charge and addressed the request on the merits.
Therefore, for the purposes of this appeal, we assume,
without deciding, that the plaintiffs have preserved their
challenge to the jury instruction.
C
Plaintiffs’ Instructional Claim
The plaintiffs assert that the evidence presented at
trial was sufficient to support the instruction, and, as
a result, the trial court improperly declined to charge
the jury on the reasonable alternative design prong of
the risk-utility test. In support of their claim, the plain-
tiffs cite to a study introduced into evidence; see S.
Ross et al., ‘‘Transobturator Tape Compared with Ten-
sion-Free Vaginal Tape for Stress Incontinence: A Ran-
domized Controlled Trial,’’ 114 Obstetrics & Gynecol-
ogy 1287 (2009) (Ross study); the testimony of their
product design expert, Bruce Rosenzweig, and other
studies admitted into evidence.
Our decisions in Bifolck and Izzarelli establish the
sonable alternative design instruction under the risk-
utility test. In Bifolck, this court explained: ‘‘In order
to state a prima facie case that will permit the case to
be submitted to the jury, the plaintiff must simply prove
that the alternative design was feasible (technically and
economically) and that the alternative would have
reduced or avoided the harm.’’ Bifolck v. Philip Morris,
Inc., supra, 324 Conn. 433. In Izzarelli, in which we
addressed cigarette design, this court explained that,
‘‘[t]o establish the defect, the plaintiff’s case required
expert testimony on [product] design and manufacture,
as well as the feasibility of an alternative design.’’ Izzar-
elli v. R.J. Reynolds Tobacco Co., supra, 321 Conn. 203–
204.
At the outset, we must determine what type of evi-
dence is sufficient to prove that an ‘‘alternative design
was feasible (technically and economically) and that the
alternative would have reduced or avoided the harm.’’
Bifolck v. Philip Morris, Inc., supra, 324 Conn. 433.
Although we concluded in Izzarelli that expert testi-
mony was required in that case, a question has arisen
as to whether expert testimony is always required as
a necessary component under the risk-utility test. This
court has not addressed that specific question.
The issue has, however, received some attention in
the federal courts. Indeed, as the United States District
Court for the District of Connecticut has recognized,
‘‘[n]either Izzarelli nor Bifolck state[s] explicitly that
expert testimony is required under the risk-utility test.
However, both cases suggest it by juxtaposing the con-
sumer expectation test, which does not require expert
testimony, and the risk-utility test.’’ Frederick v. Deco
Salon Furniture, Inc., Docket No. 3:16-cv-00060 (VLB),
2018 WL 2750319, *7 (D. Conn. March 27, 2018). Consis-
tent therewith, the United States District Court for the
District of Connecticut and the Second Circuit have
applied the expert requirement to such claims.
For example, in deciding a motion for summary judg-
ment for a defective design claim involving a water
treatment pump, the United States District Court for
the District of Connecticut concluded that ‘‘this is the
type of complex case [that] requires an expert opinion
as to defect and as to feasible alternative design.’’ Water
Pollution Control Authority v. Flowserve US, Inc.,
Docket No. 3:14-cv-00549 (VLB), 2018 WL 1525709, *24
(D. Conn. March 28, 2018), aff’d, 782 Fed. Appx. 9 (2d
Cir. 2019).
The court explained that, because the case involved
the requirements of a pump for a wastewater treatment
facility, the jury would not be ‘‘as capable of compre-
hending the primary facts and of drawing correct con-
clusions from them as are witnesses possessed of spe-
cial or peculiar training.’’ (Internal quotation marks
omitted.) Id. The Second Circuit agreed with this analy-
sis, explaining that, under Connecticut law, ‘‘[e]xpert
evidence is necessary to satisfy the risk-utility test
[when] the nexus between the injury and the alleged
cause would not be obvious to the lay juror, because
expert knowledge is often required in such circum-
stances to establish the causal connection between the
accident and some item of physical or mental injury.’’
(Internal quotation marks omitted.) Water Pollution
Control Authority v. Flowserve US, Inc., 782 Fed. Appx.
9, 14–15 (2d Cir. 2019).
This position is consistent with the majority of other
jurisdictions. ‘‘[W]hen technical issues are involved
(issues beyond common knowledge and experience) in
a [product] liability or a [product related] case, expert
testimony is required to generate a jury issue. . . .
Technical issues requiring expert testimony include
engineering, metallurgical and medical principles. . . .
When such principles are at issue in a design defect
case, expert testimony is necessary to establish a rea-
sonable alternative design and the ability of such design
to reduce the foreseeable harm of the challenged prod-
uct—that is to say, expert testimony may be needed
to establish the elements of breach and causation.’’
(Citations omitted; internal quotation marks omitted.)
Farm Bureau Property & Casualty Ins. Co. v. CNH
Industrial America, LLC, Docket No. C16-3122-LTS,
2018 WL 2077727, *17 (N.D. Iowa February 5, 2018).
Other jurisdictions have explained that, ‘‘[w]hen
understanding the nature of the alleged defect requires
knowledge . . . beyond that possessed by the average
lay person . . . [the] law requires expert testimony to
establish both the defect and the practical and techni-
cally feasible alternative design.’’ (Internal quotation
marks omitted.) Buck v. Ford Motor Co., Docket No.
3:08CV998, 2012 WL 12887708, *3 (N.D. Ohio June 25,
2012), aff’d, 526 Fed. Appx. 603 (6th Cir. 2013); see,
e.g., Hilaire v. DeWalt Industrial Tool Co., 54 F. Supp.
3d 223, 252 (E.D.N.Y. 2014) (‘‘New York law requires
plaintiffs to use expert testimony as to the feasibility
and efficacy of alternative designs in order to prove a
design defect’’). Indeed, in another product liability case
involving vaginal mesh products, the United States Dis-
trict Court for the Southern District of Iowa explained
that expert testimony was required on the issue of
‘‘whether an alternative safer design existed for a medi-
cal device, which plainly involves medical principles.’’
Willet v. Johnson & Johnson, 465 F. Supp. 3d 895, 905
(S.D. Iowa 2020).
Thus, as we have in other contexts, we conclude that
expert testimony is required in a reasonable alternative
design case when the evidence regarding the defect and
whether the alternative was feasible (technically and
economically) and whether the alternative would have
reduced or avoided the risk of harm is beyond the ken
of the average juror. See, e.g., LePage v. Horne, 262
Conn. 116, 125, 809 A.2d 505 (2002) (‘‘[e]xpert testimony
is required when the question involved goes beyond
the field of the ordinary knowledge and experience of
judges or jurors’’ (emphasis omitted; internal quotation
marks omitted)). In the present case, the evidence
regarding whether there was an alternative design to
the Obtryx that would have reduced or avoided the
risk of harm to Fajardo involved complicated medical
principles. These medical principles included the mate-
rial from which the products were made, how the differ-
ent products were placed in the body, how each worked
to treat the condition of stress urinary incontinence,
how the products interacted with the human body when
implanted, and the risks and potential side effects.
Accordingly, in order to prove that Boston Scientific’s
product was unreasonably dangerous under Bifolck 1,
the plaintiffs were required to produce expert testimony
on a reasonable alternative design.
Here, the trial court determined that Rosenzweig
‘‘was [the plaintiffs’] product design expert.’’ The plain-
tiffs agree that he was their design expert. In fact, in
their brief to this court, the plaintiffs focus on Rosenz-
weig and his testimony in other cases.12 Therefore, in
evaluating the plaintiffs’ motion to set aside the verdict
based on the failure of the trial court to give the Bifolck
1 instruction, the trial court reviewed Rosenzweig’s tes-
timony and the documentary evidence that came in
through him.
The trial court determined: ‘‘While [Rosenzweig] was
critical of several design characteristics of the Obtryx
product, he offered no reasonable alternative design of
a mesh product that was available to [Boston Scientific]
when the Obtryx [implanted] in [Fajardo] was pro-
duced. The court rejects [the plaintiffs’] current sugges-
tions [that] the jury might infer [that Rosenzweig]
endorsed any polypropylene transvaginal mesh prod-
uct, however designed or configured, as [Rosenzweig]
. . . in this case . . . testified [that] transvaginal poly-
propylene implants are defective and unreasonably dan-
gerous because transvaginal polypropylene mesh prod-
ucts provoke a foreign body rejection or reaction in
women.’’ Indeed, Rosenzweig testified that, in his opin-
ion, all vaginal slings made of polypropylene mesh are
defective. He specifically testified that a TVT produced
by Gynecare, which is part of the Ethicon division of
Johnson & Johnson (Ethicon branded TVT), is defec-
tive.
We agree with the trial court that Rosenzweig was
the only witness qualified to opine on reasonable alter-
native design, and, therefore, the trial court properly
focused on the testimony of Rosenzweig to determine
whether the plaintiffs had produced sufficient evidence
to warrant an instruction under the reasonable alterna-
tive design prong. We do the same and, as explained
more fully in this opinion, conclude that the evidence
was not sufficient to warrant an instruction on reason-
able alternative design.13
D
Framing of the Issue Presented
In order to better understand the issue that is truly
in dispute in this appeal, it is important to keep in mind
that a plaintiff in Connecticut has two ways to establish
that ‘‘a product is in a defective condition unreasonably
dangerous to the consumer or user . . . .’’ Bifolck v.
Philip Morris, Inc., supra, 324 Conn. 434. Those two
ways are: ‘‘(1) A reasonable alternative design was avail-
able that would have avoided or reduced the risk of
harm and the absence of that alternative design renders
the product unreasonably dangerous. . . . [O]r (2)
[t]he product is a manifestly unreasonable design in
that the risk of harm so clearly exceeds the product’s
utility that a reasonable consumer, informed of those
risks and utility, would not purchase the product.’’
(Emphasis added.) Id., 434–35. Therefore, in Connecti-
cut, unlike in some states and in accordance with the
position of the Restatement (Third) of Torts, Products
Liability, proof of a reasonable alternative design is not
necessary to prove that a product has a defective design.
It is only one way of proving defective design.
In the present case, the jury was instructed under
the second theory of liability, namely, that the risk of
harm from the Obtryx so clearly exceeded its utility
that a reasonable consumer would not purchase it.
Accordingly, although the concurring and dissenting
opinion spends considerable energy laying out how the
plaintiffs demonstrated that the Obtryx was defective,
it is important to remember that the jury considered
whether the product was defective insofar that it was
a ‘‘manifestly unreasonable design in that the risk of
harm so clearly exceeds the product’s utility . . . .’’
Id., 435. Indeed, the jury was able to consider all of
the evidence presented and ultimately found that the
Obtryx was not defective under Bifolck 2.
The issue on appeal is not whether the jury should
have been able to consider the plaintiffs’ claims at all.
Instead, the question is whether the plaintiffs intro-
duced sufficient evidence that the Obtryx is defective
because a reasonable alternative design was available
that would have reduced or avoided the risk of harm
to Fajardo and Boston Scientific’s failure to adopt that
reasonable alternative design rendered the Obtryx
unreasonably dangerous. In considering the plaintiffs’
claim and the position of the concurrence and dissent,
it is important to remember that ‘‘a manufacturer is not
required to design the safest possible product or a safer
product than the one it designed, so long as the design
adopted was reasonably safe. The duty assumed by the
manufacturer is to design the product for its intended
use, namely, that use which could reasonably be fore-
seen. Stated differently, a manufacturer has a duty to
avoid placing on the market a product [that], because
of its defective design, presents an unreasonable risk
of harm to others.’’ (Footnotes omitted.) 6 S. Speiser
et al., American Law of Torts (2010) § 18:73, pp. 180–81.
Accordingly, in considering the plaintiffs’ claim, the
issue is not whether the plaintiffs have produced suffi-
cient evidence that the Obtryx had defects and that
some of those defects may have caused Fajardo’s injur-
ies, which is the claim under Bifolck 2 that the jury
considered and rejected. Rather, the issue presented
by this appeal is whether the plaintiffs introduced suffi-
cient evidence that there was a reasonable alternative
design available to Boston Scientific’s Obtryx and that
Boston Scientific’s failure to use that alternative design
rendered the Obtryx unreasonably dangerous.
E
Whether an Instruction on a Reasonable
Alternative Design Was Warranted
On appeal, the plaintiffs assert that Rosenzweig’s tes-
timony, the Ross study, and other studies introduced
into evidence established a reasonable alternative
design to the Obtryx, namely, the TVT. To the extent
that the plaintiffs assert that they presented sufficient
evidence that the TVT is a reasonable alternative design
to the Obtryx, it appears—from the evidence on which
they rely—that they must be referring to the class of
tension free vaginal tape that is implanted in a retropu-
bic fashion.14 First, Rosenzweig does not compare the
Obtryx to the Ethicon branded TVT. Second, the Ross
study did not compare the Obtryx to the Ethicon
branded TVT but compared the Obtryx to another retro-
pubic sling manufactured by Boston Scientific. Third,
the other studies entered into evidence did not compare
the Obtryx device to the Ethicon branded TVT.15 Finally,
despite the efforts of the concurrence and dissent; see
part III A 1 and footnote 22 of the concurring and dis-
senting opinion; Bercik did not compare the Ethicon
branded TVT to the Obtryx; he notes only that he and
a few other physicians with whom he works prefer the
Ethicon branded TVT to other slings but that one of
his superiors in his working group at Yale School of
Medicine still uses the Obtryx.16
The class of TVTs cannot, however, be a reasonable
alternative design that would have reduced or avoided
the risk of harm to Fajardo. Specifically, the evidence
in the record demonstrates that products that belong
to the class of TVTs can be made of many different
types of mesh material of various pore sizes and dif-
fering weights and that those design differences can
alter performance and safety. Therefore, the plaintiffs’
repeated reference to TVT does not constitute identifi-
cation of a reasonable alternative design when the
safety data related to that class of products vary consid-
erably. By referring to the class of TVTs when some
products within that class suffer from the same alleged
defects as the Obtryx—a point we will elaborate on
shortly—the plaintiffs failed to produce sufficient evi-
dence of a reasonable alternative design that would
have reduced or avoided the risk of harm to Fajardo.
A review of Rosenzweig’s testimony reveals that he
testified regarding defects in the Obtryx. First, he
explained that, in his opinion, all slings made with poly-
propylene mesh are defective. Rosenzweig explained
that the use of that type of mesh caused a foreign body
reaction in Fajardo and contributed to the cause of her
injuries. The Obtryx is made of polypropolyene mesh,
but so, too, is the Ethicon TVT.
Second, Rosenzweig testified that the mesh used in
the Obtryx had a detanged or heat-sealed edge and that
it made the mesh stiffer in the area that had been sealed.
Rosenzweig explained: ‘‘When you seal the edge of the
mesh, you increase the stiffness of the mesh. . . . But,
what scientists have shown is that stiffness of mesh is
a bad property. It increases the foreign body reaction
. . . the inflammatory reaction, the amount of scarring,
and all the sequelae that we’re going to continue to talk
about . . . .’’ Rosenzweig was later asked: ‘‘Earlier, you
described some problems with the detanging or the
heat sealing of the center portion of the . . . Obtryx
sling. Does that detanging add any benefit that would
outweigh the added risks . . . from the stiffness?’’
Rosenzweig responded, ‘‘[n]o.’’17
To the extent that the plaintiffs are claiming that the
class of TVTs is a reasonable alternative design that
would have reduced or avoided the risk of harm to
Fajardo, this testimony does not support the plaintiffs’
claims. First, there was evidence that other products
within the class of TVTs are made of the exact same
mesh as the Obtryx, and those products have the same
heat seal and detanging. Rosenzweig testified that the
Advantage sling has the ‘‘same heat-sealed center.’’ The
plaintiffs did not demonstrate how a TVT product with
the same allegedly defective material and heat sealing
as the Obtryx would have reduced or avoided the risk
of harm to Fajardo. Second, even if the plaintiffs estab-
lished that other TVTs do not have the heat seal and
detanging, that does not prove that the use of that other
product would have reduced or avoided the risk of
harm to Fajardo. In fact, the plaintiffs’ product design
expert testified that all vaginal slings made of polypro-
pylene mesh are defective and unreasonably dangerous.
Even more to the point, Rosenzweig admitted that he
considered the Ethicon branded TVT defective for
that reason.
Nevertheless, the plaintiffs also rely heavily on the
Ross study in support of their claim that the class of
products known as TVTs is a reasonable alternative
design to the Obtryx. It cannot be emphasized enough
that the Ross study does not address the Ethicon
branded TVT at all. Instead, it compared two products
made by Boston Scientific—the Obtryx and the Advan-
tage branded TVT. See S. Ross et al., supra, 114 Obstet-
rics & Gynecology 1288. Therefore, the plaintiffs’ reli-
ance on that study undermines the claim of the
concurrence and dissent that the plaintiffs pointed to
the Ethicon branded TVT as a reasonable alternative
design.
Furthermore, the Ross study does not even support
the plaintiffs’ claim that the class of TVTs was a reason-
able alternative design to the Obtryx that would have
reduced or avoided the risk of harm to Fajardo. Specifi-
cally, there was evidence at trial that the Obtryx and
the Advantage branded TVT are made of the exact same
mesh material. In explaining the Ross study, Rosenz-
weig stated: ‘‘This is a study that was done and pub-
lished in 2009. It’s a randomized control trial comparing
the Obtryx sling made of Advantage mesh with the
Advantage sling that goes behind the pubic bone, also
made of Advantage mesh.’’ Rosenzweig also testified
that the Advantage sling is made of the exact same
material as the Obtryx, including the heat seal. Because
Rosenzweig identified the heat seal in the mesh that is
used in the Obtryx as one of the primary defects that
caused Fajardo’s injury, a study that compared two
products made of the same mesh with the same heat
seal does not support the plaintiffs’ claim that there
was a reasonable alternative design that would have
reduced or avoided the risk of harm to Fajardo.
The only difference between the two devices com-
pared in the Ross study was their placement in the
body. The Advantage sling was designed to be placed
in a retropubic fashion, meaning behind the pubic bone.
The Obtryx, on the other hand, was designed to be
placed using a transobturator approach. See S. Ross et
al., supra, 114 Obstetrics & Gynecology 1287. Rosenz-
weig did not testify that the risk of harm to Fajardo
would have been reduced or avoided if a retropubic
sling was used. Instead, Rosenzweig identified only the
polypropylene mesh and the heat seal as the defects
that caused Fajardo’s injuries. Accordingly, contrary to
the plaintiffs’ position, the Ross study did not support
their request for a reasonable alternative design instruc-
tion.
Furthermore, even if the plaintiffs were able to make
a claim of reasonable alternative design by pointing to
a class of products, it is important to note that Rosenz-
weig testified that, in his opinion, all mesh products
fabricated from polypropylene, including the Ethicon
branded TVT, as well as other products within the class
of TVTs, are unsafe and unsuitable for implantation in
the human body. Rosenzweig’s testimony was that any
vaginal sling made of polypropylene mesh is defective
and not reasonably safe, and that the Burch procedure,
a surgical option, was the best approach to treat stress
urinary incontinence.18
As the Fifth Circuit has explained, ‘‘[a] design is not
a safer alternative if, under other circumstances, [it
would] impose an equal or greater risk of harm than
the design at issue. . . . Similarly, the plaintiff must
show the safety benefits from [the] proposed design
are foreseeably greater than the resulting costs, includ-
ing any diminished usefulness or diminished safety.’’
(Citation omitted; emphasis omitted.) Casey v. Toyota
Motor Engineering & Mfg. North America, Inc., 770
F.3d 322, 331 (5th Cir. 2014). Accordingly, we cannot
conclude that the plaintiffs produced sufficient evi-
dence to warrant an instruction that the class of TVTs
constitutes a reasonable alternative design.
We agree with the concurrence and dissent that point-
ing to an existing product that has been successfully
commercialized can serve as evidence of the feasibility
of an alternative design; see part II A 1 of the concurring
and dissenting opinion; but we simply find that proposi-
tion inapplicable to the present case.
To put it simply, that is just not the way that the
plaintiffs tried this case. The plaintiffs did not produce
sufficient facts to support a reasonable alternative
design claim. Namely, the plaintiffs did not point to a
specific existing product on the market and demon-
strate that its use would have reduced or avoided the
risk of harm to Fajardo. At best, the plaintiffs took a
scattershot approach, pointing to different alternatives
to the Obtryx that included surgical options and a class
of products known as TVTs. Specifically, the plaintiffs’
product design expert recommended a surgical alterna-
tive known as the Burch procedure, the Ross study
compared the Obtryx to an entirely different product,
the Advantage tape, another study compared transobt-
urator slings like the Obtryx to retropubic slings (the
class of products known as the TVT), and another study
compared mesh used in products within the class of
TVTs to the mesh used in the Ethicon branded TVT.
The evidence did not, however, demonstrate that any
particular product was safer or, most important, would
have reduced or avoided the risk of harm to Fajardo
when compared to the Obtryx.
We recognize that the commentary to the
Restatement (Third) provides that ‘‘other products
already available on the market may serve the same or
very similar function at lower risk and at comparable
cost. Such products may serve as reasonable alterna-
tives to the product in question.’’ Restatement (Third),
Torts, Products Liability § 2, comment (f), p. 24 (1998);
see part II A 1 of the concurring and dissenting opinion.
This court, however, has not adopted the Restatement
(Third). See Bifolck v. Philip Morris, Inc., supra, 324
Conn. 431 (‘‘the defendant’s arguments have not per-
suaded us that we should adopt the Restatement (Third)
at this time’’).
Although we have not expressly adopted the
Restatement (Third), it does inform our analysis in the
present case. Even if this court had adopted the
Restatement (Third), and if we agreed with the concur-
rence and dissent that the plaintiffs pointed to a single
product on the market as a reasonable alternative—
namely, the Ethicon branded TVT—pointing to a prod-
uct on the market alone would not have satisfied the
plaintiffs’ burden in this case. Although pointing to a
product on the market with an alternative design may
demonstrate that the alternative design is feasible, it
does not by itself establish that the alternative design
would have reduced or avoided the harm to Fajardo.
See, e.g., Bic Pen Corp. v. Carter, 171 S.W.3d 657, 671–72
(Tex. App. 2005) (not requiring expert testimony based
on counsel’s concession but reviewing safety data intro-
duced into evidence to determine whether products on
market were reasonable alternative design that would
have avoided injury), rev’d on other grounds, 251 S.W.3d
500 (Tex. 2008). The plaintiffs still needed to produce
sufficient evidence to demonstrate that, if Boston Scien-
tific had adopted the design of the Ethicon branded
TVT, it would have reduced or avoided the risk of harm
to Fajardo.
To the extent that there was information regarding
the safety data of the TVT, that evidence was that there
were risks and complications with the use of the TVT.
For example, one study explained that ‘‘one of the pri-
mary problems in using the TVT is that as a result of its
low stiffness, the mesh easily deforms when tensioning
under the urethra. Specifically, pulling the sling gently
results in thinning of the mesh (permanent deforma-
tion) and fraying at the tanged edges. Consequently,
various companies have modified polypropylene sling
meshes for easier placement by heat sealing the mid-
portion of the sling that lays under the urethra . . . .’’
P. Moalli et al., ‘‘Tensile Properties of Five Commonly
Used Mid-Urethral Slings Relative to the TVT,’’ 19 Inter-
national Urogynecology J. 655, 656 (2008) (Moalli
study). Another study explained the complications from
the TVT to ‘‘include bladder perforation, excessive
blood loss, urinary retention, pelvic hematoma, and
suprapubic wound infection. Later complications
include exacerbation of existing or development of de
novo overactive bladder, persistent suprapubic discom-
fort, and vaginal mesh erosion. Rare complications,
such as bowel injuries and female sexual dysfunction,
have been reported.’’ H. Cholhan et al., ‘‘Dyspareunia
Associated with Paraurethral Banding in the Transobt-
urator Sling,’’ 202 Am. J. Obstetrics & Gynecology
481.e1, 481.e1 (2010) (Cholhan study). The authors of
the Ross study also explained that ‘‘the most common
perioperative complications associated with TVT were
bladder perforation and bleeding’’; S. Ross et al., supra,
114 Obstetrics & Gynecology 1291; and that ‘‘[c]oncern
about complications associated with TVT led in 2001
to the development of another minimally invasive pro-
cedure using the transobturator tape.’’ (Footnotes omit-
ted.) Id., 1287–88.19 Contrary to the assertions of the
concurrence and dissent; see part II A 2 of the concur-
ring and dissenting opinion; we do not conclude that
the plaintiffs had to point to a risk free product on
the market to allow the jury to find that there was a
reasonable alternative design for the Obtryx. Neverthe-
less, the plaintiffs did have to produce evidence that
the other product on the market would have reduced
the risk of harm to Fajardo.
Furthermore, because this case involves complex
medical devices with complicated medical risks and
injuries, evidence comparing their relative safety data
would have had to come from an expert qualified to
testify regarding the designs of the Ethicon branded
TVT and the Obtryx, and qualified to explain how use
of the Ethicon branded TVT would have reduced or
avoided the risk of harm to Fajardo.20 In discussing
whether expert testimony was required for a reasonable
alternative design in another case involving a pelvic
mesh product, the United States District Court for the
Southern District of Iowa explained: ‘‘Whether expert
testimony is required ultimately depends on whether it
is a fact issue [on] which the jury needs assistance to
reach an intelligent or correct decision. . . . Although
Iowa law does not appear to require expert testimony
for recovery in a [product] liability action, the plaintiff
must supply sufficient evidence to satisfy the trial court
that the jury, with its common knowledge, could reason-
ably find an alternative design to be practicable and
feasible. . . . Technical issues requiring expert testi-
mony include engineering, metallurgical and medical
principles. . . . When such principles are at issue in a
design defect case, expert testimony is necessary to
establish a reasonable alternative design and the ability
of such design to reduce the foreseeable harm of the
challenged product—that is to say, expert testimony
may be needed to establish the elements of breach
and causation. . . . Also, [e]xpert testimony regarding
reasonable alternative designs is subject to the same
standard as any other expert testimony. . . . Here, the
issue is whether an alternative safer design existed
for a medical device, which plainly involves medical
principles. . . . Indeed, this is a case well outside the
common experience of jurors, such as a stuffed toy
with hard plastic buttons, because it involves more
technical and scientific issues.’’ (Citations omitted;
emphasis added; internal quotation marks omitted.)
Willet v. Johnson & Johnson, supra, 465 F. Supp. 3d
905. We conclude that, under Connecticut law, the issue
of whether one particular vaginal mesh sling on the
market would reduce or avoid the risk of harm is an
issue on which the jury needed assistance to reach an
intelligent decision.21 Therefore, we agree with the trial
court that the plaintiffs’ failure to produce such expert
testimony on that issue was fatal to the plaintiffs’ claim
under the reasonable alternative design theory of
Bifolck 1.
To be sure, the Restatement (Third) also makes clear
that ‘‘[i]t is not sufficient that the alternative design
would have reduced or prevented the harm suffered by
the plaintiff if it would also have introduced into the
product other dangers of equal or greater magnitude.’’
Restatement (Third), supra, § 2, comment (f), p. 23.
Rosenzweig testified that a substantial contributing fac-
tor of Fajardo’s injuries was the fact that she experi-
enced a foreign body reaction to the Obtryx. Rosenz-
weig explained that polypropylene mesh slings can
cause this type of reaction. Accordingly, Rosenzweig
opined that all polypropylene mesh slings are defective
and unreasonably dangerous. He specifically opined
that the Ethicon branded TVT, which is made of poly-
propylene mesh, was defective. Given this testimony
from the plaintiffs’ product design expert, we cannot
see how the plaintiffs could have successfully claimed
that the Ethicon branded TVT or the class of TVTs was
a reasonable alternative design that would have reduced
or avoided the harm suffered by Fajardo. Therefore,
the trial court was correct not to instruct the jury on
the reasonable alternative design prong.
Even if we were to consider Bercik’s testimony as
expert testimony on reasonable alternative design, as
the concurrence and dissent suggests; see, e.g., footnote
6 of the concurring and dissenting opinion; we cannot
conclude that it supports the plaintiffs’ request for a
reasonable alternative design instruction. First, Bercik’s
testimony was not based on sufficient data to comment
on reasonable alternative design. Bercik never estab-
lished his qualifications regarding product design and
testified that he was unaware of a key design element
of the Ethicon branded TVT, namely, the type of mesh
used in the product.22 Furthermore, the fact that Bercik
testified that he prefers the Ethicon branded TVT does
not support a reasonable finding that it would have
reduced or avoided the risk of harm to Fajardo. Beside
knowing next to nothing about the design features of
the Obtryx, and not remembering why he stopped using
it, he also admitted that, although his preference is
for the Ethicon branded TVT, his supervisor uses the
Obtryx. Thus, in his testimony, he acknowledged his
preference for the Ethicon branded TVT, but that testi-
mony does not establish that it is a reasonable alterna-
tive design to the Obtryx that would have reduced or
avoided the risk of harm to Fajardo.23
We do not agree with the concurrence and dissent
that other studies and documents that were entered
into evidence were sufficient to support a reasonable
alternative design claim.24 See parts II A 1 and 2 of
the concurring and dissenting opinion. At most, these
studies demonstrate that the Ethicon branded TVT was
the first tension free vaginal tape manufactured, and
for that reason, there is more data evaluating its safety
and effectiveness. Nevertheless, the evidence in the
studies demonstrate that, ‘‘[a]lthough the [Ethicon
branded] TVT was the first [midurethral] sling to gain
widespread acceptance, numerous other [midurethral]
sling systems have subsequently been introduced. While
all of the meshes consist of a knitted polypropylene
material, they have been altered as a marketing strategy
to overcome [clinician perceived] deficiencies in the
[Ethicon branded] TVT.’’ P. Moalli et al., supra, 19 Inter-
national Urogynecology J. 655.
Furthermore, also contrary to the representations of
the concurrence and dissent, the evidence did not dem-
onstrate that the class of TVTs or the Ethicon branded
TVT is the ‘‘gold standard’’ to treat stress urinary incon-
tinence. Part II A 1 of the concurring and dissenting
opinion. The concurrence and dissent asserts that,
‘‘although the majority steadfastly resists this fact,
expert witnesses and evidence from scholarly journals
on which those witnesses relied repeatedly identified
the TVT as the ‘gold standard,’ [and/or] ‘the standard
of care’ . . . .’’ Id. However, no expert in the present
case pointed to the TVT (either the Ethicon branded
TVT or the class of products known as the TVT) as the
‘‘gold standard.’’ Thus, no one explained what is meant
by the term. Instead, the design expert in the present
case testified that all slings made of polypropylene mesh
are unreasonably dangerous and that a surgical proce-
dure is the best method for treating stress urinary incon-
tinence.25
In the present case, the plaintiffs simply did not intro-
duce sufficient evidence to warrant an instruction on
a reasonable alternative design. We find a recent case
from the United States District Court for the District
of Connecticut instructive in this regard. In granting
a manufacturer’s motion for summary judgment on a
reasonable alternative design claim, the court explained
that the plaintiff ‘‘has not established that a reasonable
alternative [water treatment] pump design was avail-
able. [The expert’s] report, even if admitted, does not
identify a reasonable alternative. Rather, [the expert’s]
report opines that [the plaintiff] should have used [the
competitor’s] pumps, which have larger motors. How-
ever, the [competitor’s] motors would have required an
expensive reworking of the system as a whole, and
were considered and rejected by [the plaintiff] during
the bidding process. . . . [The plaintiff] has offered no
evidence that a ‘reasonable alternative design was avail-
able’ for pumps that would meet the [plaintiff’s] system
specifications ‘that would have avoided or reduced the
risk of harm’ without ‘unreasonably increasing cost.’ ’’
(Citation omitted.) Water Pollution Control Authority
v. Flowserve US, Inc., supra, 2018 WL 1525709, *25.
Similarly, the plaintiffs in the present case did not
produce sufficient evidence that an alternative design
was available that would have met Fajardo’s needs and
have avoided or reduced the risk of harm without unrea-
sonably increasing cost. To the contrary, evidence pre-
sented at trial showed that the class of TVTs had varying
degrees of safety, depending on the type of material
that was used to make them, and some even had the
exact same defect alleged to have caused Fajardo’s
injuries in this case. Furthermore, the plaintiffs’ expert
testified that all polypropylene mesh slings are defec-
tive, including the Ethicon branded TVT. Accordingly,
we cannot conclude that the trial court incorrectly
determined that the plaintiffs did not produce sufficient
evidence of a reasonable alternative design that would
have avoided injuries to Fajardo to warrant an instruc-
tion on reasonable alternative design.
The plaintiffs cite to Campbell v. Boston Scientific
Corp., 882 F.3d 70 (4th Cir. 2018), in support of their
claim that there was sufficient evidence in the present
case to warrant an instruction on the reasonable alter-
native design prong. We disagree. In that case, the
defendant claimed that there was insufficient evidence
to support the jury verdict and, specifically, to show
that there was a safer alternative design. See id., 79.
Based on the trial record and the expert’s testimony in
that case, the Fourth Circuit concluded that there was
sufficient evidence to support the safer alternative
design claim. As one example of evidence that sup-
ported the plaintiffs’ claim in that case, the court
pointed to the expert’s testimony regarding the Ross
study. See id. The Fourth Circuit’s conclusion that,
based on the particular safer alternative design claim
made by the plaintiffs in that case and supported by
evidence, the Ross study supported the safer alternative
design claim.
The Fourth Circuit’s conclusion, however, does not
mean that the Ross study will always support a reason-
able alternative design claim. In the present case, the
Ross study does not support the plaintiffs’ claim that
there is a reasonable alternative design, particularly
because the plaintiffs claimed and their expert testified
that the heat-sealed mesh used in the Obtryx caused
Fajardo’s injuries. Because the Ross study compared
two slings made of the exact same heat-sealed mesh,
that study is not evidence of a reasonable alternative
design, in light of the claim that was presented by the
plaintiffs in this case.
Based on the foregoing, we conclude that the plain-
tiffs did not produce sufficient evidence to warrant an
instruction on a reasonable alternative design. Accord-
ingly, we conclude that the trial court properly declined
their request for such an instruction.
The judgment is affirmed.
In this opinion ROBINSON, C. J., and PALMER,
D’AURIA and KAHN, Js., concurred.
* The listing of justices reflects their seniority status on this court as of
the date of oral argument.
* December 16, 2021, the date that this decision was released as a slip
opinion, is the operative date for all substantive and procedural purposes.
1
Fajardo’s husband, Jairo Fajardo, is also a plaintiff. We need not sepa-
rately address his derivative claims for loss of consortium, insofar as they
rise or fall with Fajardo’s claims.
2
The terms ‘‘mesh sling,’’ ‘‘tape,’’ and ‘‘sling’’ are used interchangeably in
this opinion.
3
Stress urinary incontinence is defined as the ‘‘leakage of urine as a
result of coughing, straining, or some sudden voluntary movement, due to
incompetence of the sphincteric mechanisms.’’ Stedman’s Medical Diction-
ary (28th Ed. 2006) p. 962.
4
The midurethral sling is a narrow strap made of synthetic mesh or native
tissue that is placed under the urethra. It acts as a hammock to lift or to
support the urethra and the neck of the bladder.
5
The plaintiffs withdrew their complaint against another defendant,
Bridgeport Hospital.
6
The plaintiffs appealed to the Appellate Court, and we transferred the
appeal to this court pursuant to General Statutes § 51-199 (c) and Practice
Book § 65-1.
7
Colporrhaphy is surgical repair of the vaginal wall. An anterior colporrha-
phy treats a cystocele or urethrocele (prolapse of the urethra into the vagina),
whereas a posterior colporrhaphy treats a rectocele.
8
The plaintiffs cite to cases from other jurisdictions that have concluded
that a referring physician owes a duty to obtain a patient’s informed consent
when the referring physician maintains control over the procedure per-
formed. See, e.g., O’Neal v. Hammer, 87 Haw. 183, 187, 953 P.2d 561 (1998).
Because we conclude that the plaintiffs did not produce sufficient evidence
for the jury to conclude that Jacobs maintained control over Fajardo’s vaginal
mesh procedure, we need not address these cases from other jurisdictions.
9
The record demonstrates that the term ‘‘TVT’’ is used both with respect
to the Ethicon branded tension free vaginal tape (the specific TVT type
product the plaintiff identified in her complaint) and as a generic term for
similar tension free vaginal tapes in the class of TVT products, such as
Boston Scientific’s Advantage tape. Unless otherwise noted, we use the term
in that broader, generic context. Although the plaintiffs juxtaposed the
Obtryx to the class of TVT products generally, they did not focus on a
particular TVT product with which to compare the Obtryx and, most
important, did not demonstrate how another specific product without the
alleged defects of the Obtryx would have avoided her injuries, a point we
discuss in more detail subsequently in this opinion. See parts II C through
E of this opinion.
10
Counsel for the plaintiffs submitted the following request by e-mail:
‘‘In further response to [the defendants’] prior comments [the] [p]laintiffs
contend that both consumer expectation and risk utility . . . of Bifolck are
all applicable.’’
11
The court charged the jury in relevant part: ‘‘The plaintiff[s] [claim] the
Obtryx was defectively designed. In order to prove that a product was
defective, the plaintiff[s] must prove the condition [they] claimed to be a
defect made the product unreasonably dangerous. A product is in a defective
condition unreasonably dangerous to the consumer or user if the design of
the product [was] so manifestly unreasonable in that the risk of harm so
clearly exceeds the product’s utility that a reasonable consumer, informed
of those risks and utility, would not purchase the product.’’
12
The plaintiffs do not rely on Bercik, whom the concurrence and dissent
is forced to rely on to support its position. It is not surprising that the
plaintiffs do not rely on Bercik because, as we explain subsequently in this
opinion; see footnote 23 of this opinion and accompanying text; Bercik did
not testify about the design of the Obtryx or its defects; he merely explained
that he had implanted the Obtryx once or twice but usually implants the
Ethicon branded TVT. He gave no opinion on whether use of the Ethicon
branded TVT would have reduced or avoided the risk of harm to Fajardo.
13
Although the ultimate determination of whether the facts supported the
instruction is a legal question subject to plenary review, the facts underpin-
ning that determination will not be overturned in the absence of a finding
that they were clearly erroneous. In the present case, the trial court deter-
mined that Rosenzweig was the plaintiffs’ product design expert, and the
plaintiffs do not challenge that finding, let alone assert that it is clearly
erroneous. The trial court further found that Rosenzweig’s testimony was
that all polypropylene mesh slings are defective and unreasonably dangerous
and that the Burch procedure, which is a surgical repair, was his preferred
method. The plaintiffs do not challenge these findings by the trial court as
clearly erroneous, and the concurrence and dissent does not find them to
be unsupported by the evidence. In fact, instead of addressing why the trial
court’s findings are clearly erroneous, the concurrence and dissent ignores
them and engages in its own fact-finding. At no point did Rosenzweig opine
that use of the Ethicon branded TVT or any other TVT product would have
reduced or avoided Fajardo’s injuries.
14
The concurrence and dissent asserts that it is an ‘‘erroneous assumption’’
that, to the extent that the plaintiffs referred to the TVT, it was the class
of retropubic slings rather than the Ethicon branded TVT. Part III A of the
concurring and dissenting opinion. That claim is belied by the record. Indeed,
a review of the plaintiffs’ memorandum in support of their motion for a
new trial reveals that the plaintiffs never once identified the Ethicon branded
TVT as the reasonable alternative design for which they had presented
sufficient evidence to support a charge. Instead, in their memorandum in
support of the motion, the plaintiffs cited to ‘‘safer alternatives’’ to the
Obtryx, including the Burch procedure. Even in their brief to this court, the
plaintiffs again referred to ‘‘safer alternatives’’ and the Burch procedure,
and, for the first time, mentioned ‘‘TVT’’ as one of the safer alternatives
without indicating whether it was the Ethicon branded TVT.
Furthermore, Boston Scientific’s brief to this court demonstrates that it
also understood the plaintiffs to be claiming that the class of TVTs was a
reasonable alternative design. Boston Scientific argues specifically in its
brief: ‘‘Without naming a specific product, the plaintiffs argue that other
polypropylene slings, presumably without detanged portions, are reasonable
alternative designs to the Obtryx.’’ Boston Scientific further asserted that
‘‘the plaintiffs never identified at trial any specific alternative design [that]
they claim [Boston Scientific] should have used with the Obtryx.’’ (Emphasis
omitted.) Boston Scientific also explained that ‘‘[t]he plaintiffs’ posttrial
reliance on a single clinical study for the proposition that other polypropyl-
ene slings constitute reasonable alternative designs is inconsistent with the
evidence presented by the plaintiffs at trial.’’
15
Although the Moalli study compared the tensile property of the mesh
used in five other devices (including the mesh used in the Obtryx) to the
mesh used in the Ethicon branded TVT, it did not compare how the Obtryx
performed in the human body to how the Ethicon branded TVT performed
in the human body; nor did it compare the risks of harm from the two
devices. See P. Moalli et al., ‘‘Tensile Properties of Five Commonly Used
Mid-Urethral Slings Relative to the TVT,’’ 19 International Urogynecology
J. 655, 663 (2008) (‘‘Although it is important to understand the behavior of
a sling before implantation, the behavior of these slings in vivo and after
incorporation into host tissue may be inferred, but is not directly apparent
from these studies. Indeed, the next logical step to the current study is the
implementation of rigorous in vivo studies to determine how the textile and
tensile properties of polypropylene slings relate to tissue behavior, efficacy,
patient morbidity, and patient satisfaction.’’).
16
The concurrence and dissent asserts that Bercik ‘‘testified that Fajardo
could have been a candidate for the TVT, that the Obtryx was the cause of
her injuries, and that he had begun using the TVT in favor of transobturator
slings, including the Obtryx, because of his negative experience with the
latter.’’ Footnote 17 of the concurring and dissenting opinion. Bercik actually
testified that, at the time Farjado came to see him in 2014 when she was
experiencing pain from the Obtryx, he recommended that she could poten-
tially benefit from the TVT. Bercik explained that he recommended the TVT
at that time because the transobturator sling procedure had not worked,
so he would not try that again. This clearly is not testimony suggesting that
the TVT was safer or a more reasonable alternative and should have been
used in 2010 when Fajardo had the Obtryx implanted, as the concurrence
and dissent suggests.
Similarly, Brian Hines, a urogynecologist who did not testify at the trial
in the present case, also saw Fajardo after she was having pain from the
Obtryx. A review of his notes from that appointment, which were an exhibit
at the trial, reveals that Hines suggested the TVT as an option for Fajardo
after she had already tried the Obtryx, but he also notified her that it had
many of the same risks of injury that she experienced with the Obtryx and
that further testing was required to determine if she would be a good
candidate for this procedure. Again, Hines did not opine on whether the
TVT should have been used at the time of Fajardo’s original surgery, only
that, after she already had issues with the Obtryx, the TVT could possibly
be an alternative. Accordingly, we disagree with the concurrence and dissent
that ‘‘[t]his evidence would have permitted the jury to conclude not only
that the TVT is, in general, a viable alternative to the Obtryx . . . but also
that it was well suited to Fajardo’s individual needs.’’ Part II A 1 of the
concurring and dissenting opinion.
17
Rosenzweig never testified that a particular TVT would have been a
reasonable alternative design. At most, Rosenzweig testified that ‘‘the data
[are] limited but [show] that . . . for [the] Obtryx and the Advantage mesh
. . . it’s inferior to the other slings that are on the market.’’
18
To the extent that the plaintiffs’ claim may be understood to be that
the surgical procedure testified to by Rosenzweig constitutes a reasonable
alternative design, we agree with the courts that have considered this issue
and concluded that a surgery is not a reasonable alternative design to a
particular product. See, e.g., Mullins v. Johnson & Johnson, 236 F. Supp.
3d 940, 943 (S.D. W. Va. 2017) (‘‘[e]vidence that a surgical procedure should
have been used in place of a device is not an alternative, feasible design in
relation to the TVT’’).
19
The authors of the Ross study also explained that ‘‘[t]wo systematic
reviews have examined the evidence on effectiveness of transobturator tape
compared with TVT, without finding clear differences in outcome. Objective
cure [rates] after transobturator tape ranged from 84 [percent] to 98 [per-
cent]; for TVT it ranged from 86 [percent] to 99 [percent]. The objective
cure rates in [the Ross] study (81 [percent] for transobturator tape, 77
[percent] for TVT) appear lower than those previously reported, but the
difference is likely because [the Ross study’s] follow-up and definition of
objective cure was very rigorous.’’ S. Ross et al., supra, 114 Obstetrics &
Gynecology 1291.
20
In the present case, the concurrence and dissent asserts that the plain-
tiffs produced sufficient evidence for the jury to consider their claim that
the Ethicon branded TVT was a reasonable alternative design to the Obtryx.
The basic premise underlying that position is that the evidence at trial
established that the Ethicon branded TVT is the ‘‘gold standard’’ to treat
stress urinary incontinence, that the Obtryx differed from the Ethicon
branded TVT in three ways, and that those three design differences rendered
the Obtryx unreasonably dangerous. We disagree with the position of the
concurrence and dissent in three fundamental ways.
First, despite the repeated protestations of the concurrence and dissent,
the evidence in the record did not establish that the Ethicon branded TVT
is the ‘‘gold standard’’ to treat stress urinary incontinence. See, e.g., part II
A 1 of the concurring and dissenting opinion. To the contrary, the one
product design expert who testified at trial testified that a surgical procedure,
not the Ethicon branded TVT, was the best method to treat stress urinary
incontinence. The product design expert also testified that all products made
of polypropylene mesh are defective, including the Ethicon branded TVT.
Furthermore, as we discuss subsequently in this opinion, there was evidence
in the studies introduced at trial that, although the Ethicon branded TVT
may have been the first such product on the market, it had several deficienc-
ies that caused manufacturers to create alternatives. What the plaintiffs’
expert never did was testify that the design of the Ethicon branded TVT
would have entailed less risk of harm to Fajardo and, thus, would not have
caused greater or equal injury. At best, the plaintiffs’ expert testified that
the Obtryx had three alleged defects, but we do not learn from Rosenzweig
or any other expert how or whether the Ethicon branded TVT would have
reduced or avoided the risk of harm to Fajardo.
Second, the concurrence and dissent acknowledges that the one product
design expert who testified did not identify the Ethicon branded TVT as a
reasonable alternative design to the Obtryx. Nevertheless, while acknowledg-
ing that expert testimony on reasonable alternative design is required in
this case, the concurrence and dissent asserts that any evidence that the
product design expert did not provide is supplemented by other evidence
in the case, including circumstantial evidence. We disagree.
The question of whether there was a reasonable alternative design avail-
able for the Obtryx involved complex medical principles, and the jury needed
qualified expert testimony about each element of the prima facie case of
reasonable alternative design. Courts have repeatedly explained that ‘‘[a]ny
decision [that] pertains to the design of the device involves engineering,
metallurgical and medical principles beyond common knowledge and experi-
ence. Whether the device had a design defect, whether the foreseeable risks
of harm the device posed could have been reduced or avoided by the
adoption of a reasonable alternative design and whether the omission of
such design rendered the device not reasonably safe are technical, scientific
issues that cannot be fully understood by the average juror without some
expert assistance.’’ Benedict v. Zimmer, Inc., 405 F. Supp. 2d 1026, 1033
(N.D. Iowa 2005); see also Neilson v. Whirlpool Corp., Docket No. 3:10-cv-
00140-JAJ-RAW, 2012 WL 13018693, *11 (S.D. Iowa January 3, 2012) (‘‘An
average juror has no understanding as to the actual design of the Whirlpool
washer or any alternative designs [that] might reduce the risk of foreseeable
harm. This is the exact type of case in which a ‘jury needs assistance to
reach an intelligent or correct decision. . . . Design defect cases sometimes
involve technical, scientific issues [that] cannot be fully understood by the
average juror without some expert assistance.’ ’’). If we adopt the position
of the concurrence and dissent and allow other nonexpert testimony to fill
in gaps left by the qualified expert in this type of case, the jury does not
have the assistance necessary to reach an intelligent or correct decision.
Third, although the Obtryx may have differed from the Ethicon branded
TVT in three ways, evidence of these different design elements is not enough.
The plaintiffs needed to prove, through expert testimony, that use of the
Ethicon branded TVT would have reduced or avoided the risk of harm to
Fajardo. There simply was not sufficient evidence on this point. To the
contrary, Rosenzweig testified that Fajardo suffered from a chronic foreign
body reaction, that use of polypropylene mesh can cause a foreign body
reaction, and that both the Ethicon branded TVT and the Obtryx were made
of polypropylene mesh. Accordingly, the plaintiffs did not produce sufficient
evidence to support an instruction under Bifolck 1.
21
There was evidence introduced in the present case that the transobtura-
tor approach was as effective and reduced or avoided some risk of injuries
to patients. For example, the authors of the Petri study explained that
‘‘numerous different types of transobturator slings like inside-out tapes
and thermally annealed non-knitted, non-interwoven polypropylene tape
(Obtape) were developed and tested in clinical trials. In terms of efficacy,
both retropubic and transobturator tapes are found to have similar subjective
and objective cure rates . . . . Only one meta-analysis showed that the
occurrence of bladder perforations, pelvic hematoma, and storage lower
urinary tract symptoms was significantly less common in patients treated
by transobturator tapes . . . .’’ (Citations omitted.) E. Petri & K. Ashok,
‘‘Comparison of Late Complications of Retropubic and Transobturator Slings
in Stress Urinary Incontinence,’’ 23 International Urogynecology J. 321, 321
(2012); see id., 324 (concluding that obstructive complications seen more
commonly in retropubic tapes as compared to transobturator tapes were
more frequently associated with persistent pain, dyspareunia, and tape
related infections). Other studies introduced at trial explained that ‘‘[p]oten-
tial advantages of the transobturator approach include fewer bladder and
bowel injuries and less voiding dysfunction and urinary retention than with
traditional sling procedures.’’ P. Rosenblatt & S. Pulliam, ‘‘Update on Subur-
ethral Slings for Stress Urinary Incontinence,’’ Contemporary OB/GYN, April
15, 2004, available at https://www.contemporaryobgyn.net/view/update-
suburethral-slings-stress-urinary-incontinence (last visited December 10,
2021). Another study concluded that, ‘‘[i]n short-term follow-up there was
no obvious difference between [retropubic] and [transobturator] routes in
terms of safety and efficacy.’’ T. Tarcan et al., ‘‘Safety and Efficacy of
Retropubic or Transobturator Midurethral Slings in a Randomized Cohort
of Turkish Women,’’ 93 Urologia Internationalis 449 (2014).
The studies showed that each approach had benefits and risks. The ques-
tion under Bifolck 1 is not simply whether there are other feasible designs,
but whether there is a feasible design that would have reduced or avoided
the risk of harm to Fajardo. This complicated medical evidence demonstrates
that the jury needed the assistance of an expert qualified to testify regarding
product design to enable the jury to make an intelligent decision regarding
whether there was a reasonable alternative design that would have reduced
or avoided the risk of harm to Fajardo. The plaintiffs failed to produce that
expert evidence, and therefore, its request for an instruction under Bifolck
1 was properly denied.
22
At trial, Bercik testified as follows:
‘‘Q. What kind of polypropylene is the TVT sling made of that you use?
‘‘A. I’m not sure—I’m not sure what you’re asking.
‘‘Q. Is a TVT sling made of the same polypropylene as the Obtryx sling?
***
‘‘Q. Doctor, do you know what kind of polypropylene the Obtryx sling is
made of?
‘‘A. I do know it’s made of something called—I think Marlex.
‘‘Q. Okay.
‘‘A. It’s what they use.
‘‘Q. Okay. Do you know . . . if the TVT sling is made of the same Marlex?
‘‘A. I don’t know if it’s made of the same—like, from the same manufacturer
or anything like that.
‘‘Q. Okay. Is—
‘‘A. I don’t know.
‘‘Q. —is TVT made by the same manufacturer as the Obtryx sling?
‘‘A. No, ma’am.
‘‘Q. Okay.
‘‘A. Different company.’’
Although the concurrence and dissent asserts that Bercik’s testimony is
not necessary or important to its position; see footnote 6 of the concurring
and dissenting opinion; it cites to his testimony no less than thirty-seven
times, refers to the fact that Bercik was disclosed as a product design expert,
and relies on him as such. However, by characterizing Bercik as a product
design expert, the concurrence and dissent disregards the fact that there
was a motion in limine to exclude him from testifying as a product design
expert. Although there is not a clear ruling on that motion in the record,
there is discussion on the record about his testimony being limited, and
Bercik testified that he was not aware of a key aspect of the design of the
Ethicon branded TVT, namely, the type of mesh from which it is made.
Moreover, in its memorandum of decision, the trial court explained that
‘‘Rosenzweig . . . was [the plaintiffs’] product design expert,’’ and the plain-
tiffs neither challenge that conclusion on appeal nor cite to Bercik in support
of their claim. Accordingly, we disagree with the efforts of the concurrence
and dissent to cast Bercik as qualified to give expert testimony regarding
whether the TVT was a reasonable alternative design for the Obtryx.
23
The concurrence and dissent asserts that Bercik ‘‘indicated that he had
tried using the Obtryx, which employs a transobturator approach, had a
negative experience with it, and so began using the Ethicon TVT, which
uses a different approach.’’ Footnote 22 of the concurring and dissenting
opinion. That does not accurately characterize Bercik’s actual testimony.
He testified that he had implanted slings using the transobturator approach
in the past but that he had stopped doing that because of complications.
He then clarified that he had ‘‘trialed the [Obtryx] maybe once in the
operating room’’ and had ‘‘never used it on a regular basis . . . .’’ He further
explained: ‘‘I think I mentioned I [tried] the Obtryx once, and I don’t remem-
ber why I don’t—it was something about it that I didn’t like. I don’t know,
I don’t recall, it was ten years ago. But I gave up using other obturator
approach slings because of my experience.’’ Contrary to the representations
of the concurring and dissenting opinion; see footnote 22 of the concurring
and dissenting opinion and accompanying text; Bercik clearly testified that
his ‘‘negative experience’’ was with other slings implanted using the transobt-
urator approach, not the Obtryx.
24
The plaintiffs assert that ‘‘[t]here were also a number of other studies
admitted as full exhibits [that] supported the claim that the risks of the
Obtryx outweigh its benefits in comparison with safer alternatives on the
market at the time.’’ The plaintiffs did not, however, identify the studies to
which they refer.
25
One of the studies introduced into evidence explains: ‘‘The retropubic
tension-free vaginal tape (TVT, Gynecare, Somerville, NJ, USA) which was
introduced in [the] 1990s is commonly acknowledged as the gold standard
of [midurethral slings] by virtue of its extensive safety and efficacy data in
the literature.’’ Y. Lim et al., ‘‘Do the Advantage Slings Work As Well As the
Tension-Free Vaginal Tapes?,’’ 21 International Urogynecology J. 1157, 1157
(2010) (Lim study). Although the Lim study does state that the TVT has the
most extensive data and was the original vaginal sling on the market, its
authors concluded: ‘‘In this study, we found that the Advantage sling appears
to be as effective as the TVT. There was a trend [toward] more overactive
bladder and voiding difficulty issues, which may be related to the slightly
stiffer nature of the Advantage sling, thus requiring the Advantage slings to
be left slightly looser than [the] TVT. Further randomized controlled trials
are necessary to confirm this supposition.’’ Id., 1161.
Thus, although the Lim study may establish that the Ethicon branded TVT
was a feasible alternative to the Obtryx, it does not establish that it would
have reduced or avoided the risk of harm to Fajardo. The concurrence and
dissent repeatedly uses the term ‘‘gold standard’’ to imply that the Ethicon
branded TVT was the safest product on the market. But, as we have explained
previously in this opinion, there was evidence presented at trial that the
Ethicon branded TVT and each of the other products within the class of
TVTs had risks and complications associated with them. In light of the
fact that they were complicated medical devices with complicated safety
information, the plaintiffs had to do more to demonstrate that use of the
Ethicon branded TVT would have reduced or avoided the risk of harm
to Fajardo.