Fajardo v. Boston Scientific Corp. ( 2022 )

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FAJARDO v. BOSTON SCIENTIFIC CORP.—CONCURRENCE AND
DISSENT
ECKER, J., concurring in part and dissenting in part.
I agree with, and join, part I and much of parts II A
and B1 of the majority opinion. I disagree, however,
with parts II C through E, in which the majority con-
cludes that the trial court properly declined to charge
the jury on the reasonable alternative design prong of
the risk-utility component of the Connecticut Product
Liability Act, General Statutes § 52-572m et seq., as
interpreted by this court in Bifolck v. Philip Morris,
Inc., 324 Conn. 402, 434–35, 152 A.3d 1183 (2016). Spe-
cifically, I do not agree with the majority’s conclusion
that the plaintiffs, Lesly Fajardo (Fajardo) and Jairo
Fajardo, ‘‘did not produce sufficient evidence . . . to
warrant an instruction on reasonable alternative design.’’
Part II E of the majority opinion.
The trial court concluded that there was insufficient
evidence in the trial record to support a jury instruction
on the plaintiffs’ claim that the Obtryx Transobturator
Mid-Urethral Sling System designed by the named
defendant, Boston Scientific Corporation, was defective
under the risk-utility test because there was a viable
and safer reasonable alternative design to the Obtryx.
For the reasons set forth at length in part II of this
opinion, I am convinced that this ruling was erroneous.
There was abundant evidence presented at trial from
which the jury could have concluded that one particular
competitor product, a retropubic tension free vaginal
sling trademarked ‘‘TVT’’ that is produced by Gynecare,
part of the Ethicon division of Johnson & Johnson,2
qualified as a reasonable alternative to the Obtryx. It
was undisputed that not only is this TVT commercially
viable, it is the most widely used treatment for stress
urinary incontinence, the condition suffered by Fajardo,
and meets the recognized standard of care for treatment
of that condition. The plaintiffs proffered expert testi-
mony, including the testimony of retained experts,
Fajardo’s treating physicians, and articles in respected
medical research journals, that, if credited by the jury,
together established that (1) the Obtryx differs from
Ethicon’s TVT in three primary respects, namely, its
transobturator approach, its heat-sealed middle section,
and its detanged edges, (2) each of those departures
from the design of the TVT constitutes a defect, because
they each increase the risks to the patient with no
offsetting benefit, (3) the injuries that Fajardo suffered
were caused by those design defects, and (4) the TVT
would have avoided or reduced the risk of those types
of harm and been a more suitable choice for Fajardo.
Nothing more is required to warrant a jury instruction
on a theory of reasonable alternative design under
Bifolck. For these reasons, I respectfully concur in part
and dissent in part.
I
Before I discuss the evidence in the record that war-
ranted a reasonable alternative design jury charge, I
emphasize three important preliminary points that
should be uncontroversial. First, I agree with the major-
ity regarding the standard of review. ‘‘[A] trial court
should instruct the jury in accordance with a party’s
request to charge if the proposed instructions are rea-
sonably supported by the evidence. . . . We therefore
review the evidence presented at trial in the light most
favorable to supporting the [plaintiffs’] proposed charge.’’
(Citation omitted; emphasis added; internal quotation
marks omitted.) Godwin v. Danbury Eye Physicians &
Surgeons, P.C., 254 Conn. 131, 139, 757 A.2d 516 (2000).
The emphasized language carries constitutional signifi-
cance. ‘‘It must always be borne in mind that litigants
have a constitutional right to have issues of fact decided
by the jury and not by the court.’’ (Internal quotation
marks omitted.) Larsen Chelsey Realty Co. v. Larsen,
232 Conn. 480, 499, 656 A.2d 1009 (1995). For this rea-
son, ‘‘[a] trial court should instruct a jury on [every]
issue for which there is any foundation in the evidence,
even if weak . . . .’’ (Internal quotation marks omit-
ted.) Henriques v. Magnavice, 59 Conn. App. 333, 336,
757 A.2d 627 (2000); see also Curran v. Kroll, 303 Conn.
845, 857, 37 A.3d 700 (2012) (‘‘it is well established that
a plaintiff has the same right to submit a weak case as
he has to submit a strong one’’ (internal quotation marks
omitted)).
Second, the essential elements of a product liability
claim predicated on a design defect are well established.
The plaintiff must establish each of the following ele-
ments by a preponderance of the evidence: (1) the
defendant was engaged in the business of selling the
product; (2) the product was, by reason of its design,
in a defective condition unreasonably dangerous to the
consumer; and (3) the defect caused the injury for
which compensation is sought. See, e.g., Bifolck v.
Philip Morris, Inc., supra, 324 Conn. 434; Connecticut
Civil Jury Instructions § 3.10-1, available at https://
www.jud.ct.gov/JI/Civil/Civil.pdf (last visited December
10, 2021). When the plaintiff seeks to establish the sec-
ond element—defective design—on a reasonable alter-
native design theory, he or she also must establish that
(A) a reasonable alternative design was available (B)
that would have avoided or reduced the risk of harm,
and (C) the failure to use that alternative design ren-
dered the product unreasonably dangerous. See, e.g.,
Bifolck v. Philip Morris, Inc., supra, 434–35; see also
footnote 16 of this opinion. A reasonable alternative
design instruction is required if there is sufficient evi-
dence in the record to permit the jury to find for the
plaintiff on each of these elements.
Third, although the majority correctly observes that
the existence of a reasonable alternative design typi-
cally must be established, at least in part, via expert
testimony;3 see part II C of the majority opinion; this
court never has imposed a unitary source requirement
such that a single expert must provide all component
parts of that expert opinion. As I discuss more fully in
part III C of this opinion, no rule or principle precludes
the jury from piecing together the requisite quantum of
proof from multiple sources, including the testimony of
one or more expert witnesses, articles or other writings
containing expert opinions admitted in evidence with-
out restriction, and other qualifying evidence, including
circumstantial evidence. See, e.g., Thompson v. Eth-
icon, Inc., Docket No. SAG-19-03159, 2020 WL 3893253,
*5 (D. Md. July 10, 2020) (court was aware of ‘‘no author-
ity [requiring] that a single expert witness establish each
element of a claim’’); Slepski v. Williams Ford, Inc.,
170 Conn. 18, 22, 364 A.2d 175 (1975) (jury in product
defect case may rely on combination of expert testimony,
lay witnesses, and circumstantial evidence); Morgan v.
Hill, 139 Conn. 159, 161–62, 90 A.2d 641 (1952) (trier
was privileged to accept portions of different experts’
conflicting testimony in arriving at estimate of damage);
Louisiana Dept. of Transportation & Development v.
Scramuzza, 673 So. 2d 1249, 1261 n.10 (La. App. 1996)
(‘‘[j]uries may even mix and match parts of several
expert opinions’’), rev’d in part on other grounds, 692
So. 2d 1024 (La. 1997); Bieniek v. Keir, Docket No. A-
3096-06T5, 2008 WL 1848293, *5 (N.J. Super. App. Div.
April 23, 2008) (jury properly could have accepted dif-
ferent portions of dueling experts’ conclusions).
Moreover, is well established that a jury may draw
reasonable inferences from an expert’s testimony no
less than the testimony of any other witness and come,
thereby, to a conclusion that it could not permissibly
reach solely on the basis of lay knowledge. See, e.g.,
Procaccini v. Lawrence + Memorial Hospital, Inc., 175
Conn. App. 692, 725–27, 168 A.3d 538 (although no single
expert testified that decedent died of delayed respira-
tory depression, jury reasonably could have inferred
such from all expert testimony considered together),
cert. denied, 327 Conn. 960, 172 A.3d 801 (2017); Carter
v. State, 620 S.W.3d 147, 153 (Tex. Crim. App. 2021)
(‘‘At first glance, it seems irrational to expect an ordi-
nary [fact finder] to make an inference regarding posi-
tioning of certain components in a synthetic compound.
But, the mere fact that an ordinary [fact finder], prior
to any evidence being presented, could not make the
required inferential step, does not mean that an
informed [fact finder] could not reasonably make such
an inference. That is all to say that an ordinary jury
could still draw a reasonable inference from an expert’s
testimony about technical elements as long as each
inference is supported by the evidence presented at
trial.’’), petition for cert. filed (U.S. August 24, 2021)
(No. 21-269); Anderson v. Combustion Engineering,
Inc., 256 Wis. 2d 389, 394, 647 N.W.2d 460 (2002) (‘‘a jury
is entitled to draw reasonable inferences from expert
testimony even if, at first blush, it may appear that the
jury’s conclusions based on those inferences require
proof by specialized expert testimony’’).
Likewise—and this becomes particularly important
with respect to the testimony of the plaintiffs’ primary
design expert, Bruce A. Rosenzweig, a professor of uro-
gynecology—the jury is free to credit one portion of an
expert’s testimony while rejecting a different part of
that same testimony. See, e.g., State v. Leroya M.,
Conn. , , A.3d (2021) (‘‘[t]he [fact finder]
is free to accept or reject each expert’s opinion in whole
or in part’’ (internal quotation marks omitted)); Gron-
din v. Curi, 262 Conn. 637, 657 n.20, 817 A.2d 61 (2003)
(‘‘[I]t is the province of the jury to weigh the evidence
and determine the credibility and the effect of testimony
. . . . [T]he jury is free to accept or reject each expert’s
opinion in whole or in part.’’ (Internal quotation marks
omitted.)); In re David W., 254 Conn. 676, 693, 759 A.2d
89 (2000) (‘‘the trier is entitled to accept in part . . .
[and] disregard in part . . . the uncontradicted testimony
of [an expert] witness’’); Champagne v. Raybestos-
Manhattan, Inc., 212 Conn. 509, 545, 562 A.2d 1100(1989) (‘‘the trier of fact may accept part of the testi-
mony of an expert without being bound by all of the
opinion of the expert’’ (internal quotation marks omit-
ted)); Yontef v. Yontef, 185 Conn. 275, 281, 440 A.2d
899 (1981) (‘‘[the trier of fact] is free to rely on whatever
parts of an expert’s opinion the [trier] finds probative
and helpful’’). I do not understand the majority to have
intended to dispense with this indisputable rule; nor
does the majority suggest any reason why it should not
apply in the present case. Indeed, it applies with full
force because Boston Scientific has relied—both at trial
and on appeal—almost exclusively on the specious
argument that the jury could not have credited Rosenz-
weig’s testimony that the Obtryx is defective vis-à-vis
the TVT because Rosenzweig also believed that all poly-
propylene slings are defective. I explain the many fail-
ings in this argument in part III B of this opinion, an
analysis to which the majority has offered no response.
II
With these principles in mind, I turn now to the evi-
dence that was presented at trial in support of the
plaintiffs’ theory that the TVT represented a reasonable
alternative design at the time Boston Scientific mar-
keted and sold Fajardo’s Obtryx. It is undisputed that
Boston Scientific was engaged in the business of selling
the Obtryx and, therefore, that the first element of the
plaintiffs’ product liability claim was established. My
disagreement with the majority centers on the second
(defective condition unreasonably dangerous to the
consumer, which includes proof of feasibility) and third
(causation) elements of the claim.
A
1
Beginning with feasibility, I note that there was over-
whelming evidence at trial that the TVT is a feasible
design. Indeed, 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,’’ ‘‘the standard
of care,’’ and/or the most widely used treatment for
precisely the condition from which Fajardo suffered.
A ‘‘gold standard,’’ commercially available product is
the paradigmatic feasible alternative.
Four different research studies entered in evidence
as full exhibits, each published in respected medical
journals and relied on by the plaintiffs’ experts, identi-
fied the TVT—either the Ethicon TVT or another TVT-
type sling—as the primary accepted treatment for the
condition from which Fajardo suffered, namely, female
stress urinary incontinence. Three of the studies expressly
identified the TVT as the ‘‘gold standard’’ for treating
Fajardo’s condition. See 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) (‘‘[TVT is the]
widely accepted . . . gold standard for the treatment
of [stress urinary incontinence]’’); 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) (‘‘TVT . . . is commonly
acknowledged as the gold standard of [synthetic midur-
ethral slings] by virtue of its extensive safety and effi-
cacy data in the literature’’); P. Moalli et al., ‘‘Tensile
Properties of Five Commonly Used Mid-Urethral Slings
Relative to the TVT,’’ 19 International Urogynecology
J. 655, 656 (2008) (Moalli study) (TVT is ‘‘the gold stan-
dard’’).4 A fourth study in evidence referred to the TVT
as ‘‘the surgery of choice for treating stress urinary
incontinence’’ and ‘‘the standard of care.’’ S. Ross et
al., ‘‘Transobturator Tape Compared with Tension-Free
Vaginal Tape for Stress Incontinence: A Randomized
Controlled Trial,’’ 114 Obstetrics & Gynecology 1287,
1287–88 (2009) (Ross study).
In light of the fact that four of the studies relied on
by the plaintiffs’ experts expressly state that the TVT
is the ‘‘gold standard’’ or ‘‘standard of care’’ for the
treatment of female stress urinary incontinence, it is
difficult to understand the majority’s insistence that
‘‘the evidence in the record did not establish that the
Ethicon branded TVT is the ‘gold standard’ to treat
stress urinary incontinence.’’ Footnote 20 of the major-
ity opinion. The question is not whether the majority
would have been persuaded by that evidence had they
sat as jurors, or whether I am persuaded by it, but,
rather, whether there was any evidence on the basis
of which the jury could have reached that conclusion.
Clearly there was, and the majority offers no explana-
tion why the jury could not reasonably have relied on
the statements and opinions contained in medical stud-
ies admitted as substantive evidence at trial.5
In addition, the jury reasonably could have found that
two of Fajardo’s treating physicians, Richard Bercik, a
urogynelogical reconstructive surgeon and professor of
female pelvic medicine at Yale School of Medicine, and
Brian Hines, a urogynecologist, specifically recommended
that Fajardo consider use of the TVT to treat her condi-
tion. Bercik further testified that he and his colleagues
have had negative experiences with transobturator
slings such as the Obtryx and generally have stopped
implanting them in favor of the TVT.6 This evidence
would have permitted the jury to conclude not only
that the TVT is, in general, a viable alternative to the
Obtryx that is readily available in Connecticut, but also
that it was well suited to Fajardo’s individual needs.
Finally, it was clear from the evidence presented at
trial that the defendant’s own expert witness, Peter L.
Rosenblatt, also a urogynecologist, concurred that the
TVT is a feasible alternative design. In a 2004 article
that was admitted into evidence, Rosenblatt wrote that,
with the invention of the Gynecare TVT, ‘‘[f]or the first
time, surgeons had a reproducible, highly-effective,
minimally-invasive sling procedure.’’ P. Rosenblatt &
S. Pulliam, ‘‘Update on Suburethral 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); see id. (‘‘study after
study has consistently demonstrated the procedure’s
safety and effectiveness’’). Rosenblatt testified at trial
that, of the roughly 2000 studies showing that polypro-
pylene slings are safe and effective for the treatment
of female stress urinary incontinence, most have stud-
ied the TVT. Bercik agreed with Rosenblatt that the
TVT is safe and effective. The fact that a product has
been shown to be safe and effective in treating a particu-
lar condition necessarily implies that it is a feasible
alternative for that purpose. See, e.g., Kosmynka v.
Polaris Industries, Inc., 462 F.3d 74, 80 (2d Cir. 2006)
(‘‘[p]ractical engineering feasibility can be demon-
strated by expert testimony concerning either a proto-
type that the expert has prepared or similar equipment
using an alternative design that has been put into use
by other makers’’); Messina v. Ethicon, Inc., Docket
No. 6:20-cv-1170-Orl-40LRH, 2020 WL 7419586, *4 (M.D.
Fla. December 17, 2020) (‘‘safe and effective’’ implies
feasible); Wald v. Costco Wholesale Corp., Docket No.
03 Civ. 6308JSR, 2005 WL 425864, *7 (S.D.N.Y. February
22, 2005) (‘‘To satisfy the first and most important ele-
ment, lack of reasonable safety, plaintiffs must show
that it was feasible to design the product in a safer
manner. . . . [The] [p]laintiff has done so in one of the
most basic ways: he has identified makers of similar
equipment who have already put into use the alternative
design that has been proposed.’’ (Citation omitted; inter-
nal quotation marks omitted.)); Restatement (Third),
Torts, Products Liability § 2, comment (f), pp. 23–24
(1998) (‘‘Cases arise in which the feasibility of a reason-
able alternative design is obvious and understandable
to laypersons and therefore expert testimony is unnec-
essary to support a finding that the product should have
been designed differently and more safely. . . . [O]ther
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 reason-
able alternatives to the product in question.’’).
Once experts for both sides had established that the
TVT represents an alternative to the Obtryx that is
widely used to treat Fajardo’s condition and is deemed
safe and effective by the medical community, and had
provided the necessary context for the jury to under-
stand the supporting clinical studies in evidence, the
jury was free to conclude that the plaintiffs had shoul-
dered their burden of establishing feasibility under
Bifolck. Although the majority takes issue with some
of my analysis in this regard, I understand the majority
to agree with the ultimate conclusion in this part of
my opinion that the TVT, as a successful and widely
commercialized product, represents a technologically
and economically viable alternative to the Obtryx that
would have been a feasible option for Fajardo. I believe
that our disagreement, instead, is limited to whether
the jury reasonably could have found that use of the
TVT would have avoided or reduced the risk of harm
presented by the Obtryx. I address those issues in parts
II A 2 and B of this opinion.
2
The plaintiffs next needed to establish that the design
of the Obtryx renders it unreasonably dangerous rela-
tive to the TVT and, hence, defective. They did this by
demonstrating that, although the two slings are similar,
the Obtryx has three distinguishing features, each of
which renders it more dangerous than the TVT without
any corresponding benefit: it has a heat-sealed middle
section that makes it less flexible and more subject to
contraction than other slings, it features detanged edges
that hinder the integration of the sling with native tissue,
and it is designed for a transobturator approach, which
results in more palpable tape (a characteristic linked
to tape extrusion and vaginal erosion) and paraurethral
banding (linked to leading to internal dyspareunia), as
well as vaginal tenderness and groin pain.
There was abundant evidence from which the jury
could have found that these three design features,
which undisputedly constitute the primary design dif-
ferences between the TVT and the Obtryx, render the
Obtryx unreasonably dangerous. With respect to heat
sealing, Rosenzweig explained to the jury how the Lim
and Moalli studies found that the unique heat sealing
process used by Boston Scientific renders its sling prod-
ucts significantly stiffer than the TVT and, therefore,
potentially more likely to cause erosion, vaginal obstruc-
tion, and voiding dysfunction. See Y. Lim et al., supra,
21 International Urogynecology J. 1161; P. Moalli et al.,
supra, 19 International. Urogynecology J. 662.7 Rosenz-
weig also testified that the heat sealing process aggra-
vates the foreign body reaction associated with the use
of polypropylene mesh. He explained that the heat-
sealed center portion makes the Obtryx stiffer than
other midurethral slings and that ‘‘stiffness of mesh is
a bad property’’ that is associated with a higher rate of
complications, such as inflammation, groin pain, scarring,
urgency, overactive bladder, vaginal erosion, and dyspa-
reunia, or pain during intercourse. Whereas Rosenzweig
testified that midurethral slings such as the Obtryx can
contract, causing chronic pain, Bercik testified that, in
his clinical experience, significant contracture does not
tend to occur with the TVT.
Similarly, with respect to detanging, the Moalli study,
on which Rosenzweig relied, stated that the tanged
edges of the TVT were ‘‘designed to ‘grip’ tissue after
sling placement.’’ P. Moalli et al., supra, 19 International.
Urogynecology J. 655. Doreen Rao, a principal engineer
for Boston Scientific, acknowledged that some of her
colleagues thought that maintaining the tangs—rough
edges where the polypropylene mesh had been cut—
was useful in holding the sling in place and promoting
ingrowth of native tissue. Rao referred to this as the
‘‘leading theory.’’ Rao was unable to document any off-
setting benefits from Boston Scientific’s decision to
remove the tangs, other than that detanging ‘‘presents
a smoother surface.’’ Rosenzweig testified more defini-
tively that detanging adds no benefit to outweigh the
heightened risks associated with a lack of integration
of the sling with the patient’s native tissue. The jury
should have been given the option to agree with Rosenz-
weig insofar as his testimony spoke to the shortcomings
of the Obtryx relative to the TVT.
With respect to the risks associated with the transob-
turator design of the Obtryx, the plaintiffs highlighted
the Ross study, a randomized, double blind, clinical
study of nearly 200 women, which compared the Obtryx
to Boston Scientific’s own Advantage retropubic midur-
ethral sling. See S. Ross et al., supra, 114 Obstetrics &
Gynecology 1288–89. Because the two slings are made
from the same material and share other common design
features, the study was able to isolate the safety and
effectiveness of using a transobturator approach vis-à-
vis the traditional retropubic approach. The study found
no statistically significant difference in the products’
cure rates. See id., 1291. The study did find, however,
that the vaginal mesh was much more likely to remain
palpable to the touch one year after surgery among
women who received transobturator slings, an outcome
that the authors deemed ‘‘concerning’’ due to the height-
ened risk of tape extrusion and vaginal erosion. Id.,
1293; see id., 1287–88, 1290. More women in the trans-
obturator group also experienced tenderness and groin
pain. See id., 1290, 1292–93. The authors’ final conclu-
sion: ‘‘Compared with the [Advantage] TVT group, more
women in the transobturator tape group had tape that
was palpable and groin pain on vaginal examination.
The presence of palpable tape is concerning; longer
follow-up is needed to determine whether this outcome
leads to extrusion or resolves over time. Until long-
term follow-up is available from this and other trials,
TVT should remain the midurethral sling procedure of
choice.’’ Id., 1293–94. The Cholhan study likewise sug-
gested that tapes such as the TVT, which feature a
retropubic design, have a more favorable risk-benefit
profile than do transobturator tapes, such as the Obtryx,
for the treatment of female stress urinary incontinence.
See H. Cholhan et al., supra, 202 Am. J. Obstetrics &
Gynecology 481.e1. That study identified a ‘‘concerning’’
new complication—paraurethral banding, leading to
internal dyspareunia—that occurred in transobturator
but not retropubic sling patients.8 Id., 481.e3.
Rosenzweig testified that he relied on each of these
studies in forming his opinions regarding the product
defects and injuries at issue in this case and that they
are authoritative in the field. He also made crystal clear
the conclusion that the jury itself easily could have
drawn from the Cholhan, Lin, Moalli, Ross and other
studies in evidence, namely, that these three design
features render the Obtryx ‘‘defective . . . .’’ Rosenz-
weig opined that the unique detanged and heat-sealed
features of the Obtryx have no benefits that outweigh
the added risks. He characterized the research as dem-
onstrating that, because the transobturator design of
the Obtryx was associated with significantly higher inci-
dences of groin pain and other complications, ‘‘the ret-
ropubic sling is better than the [Obtryx] transobturator
sling.’’ Rosenzweig specifically linked negative research
findings regarding transobturator slings to Fajardo’s
Obtryx.9 He concluded, to a reasonable degree of medical
certainty, that ‘‘[the Obtryx sling] is defective in design.’’10
In an e-mail to Boston Scientific that also was admit-
ted as a full exhibit, Paul Tulikangas, a urogynecologist
and female pelvic medicine and reconstructive surgery
specialist, likewise interpreted the medical research to
mean that the Obtryx is ‘‘inferior’’ to other midurethral
slings, with higher rates of erosion, groin pain, and
voiding issues compared to the TVT.11 Bercik appeared
to concur, indicating that he had abandoned the use of
transobturator slings, including the Obtryx, because he
and other physicians experienced a high rate of compli-
cations and that he now exclusively uses the TVT.
The foregoing evidence leads me to conclude with
confidence that the plaintiffs set out a prima facie case
that the three design features by which the Obtryx
departs from the TVT render the Obtryx defective. The
majority disagrees and, deploying an argument never
articulated by Boston Scientific, appears to take the
position that the Obtryx could not have been defective
relative to the TVT because both products present
potential dangers and risks. The majority emphasizes,
for example, that ‘‘there were risks and complications
with the use of the [Ethicon branded] TVT’’; part II E
of the majority opinion; and that ‘‘the Ethicon branded
TVT and each of the other products within the class
of TVTs had risks and complications associated with
them.’’ Footnote 25 of the majority opinion. These
observations miss the fundamental point. A design is
defective if it creates a greater risk of harm than the
alternative design without sufficient offsetting benefit,
which means that the question is not whether the alter-
native is risk free, but whether it confers the same
benefits with a lesser risk of harm. See, e.g., Bifolck v.
Philip Morris, Inc., supra, 324 Conn. 434–35. This point
is clear even in the very cases that the majority cites
in support of its argument. Thus, the majority cites
Casey v. Toyota Motor Engineering Mfg. North
America, Inc., 770 F.3d 322, 331 (5th Cir. 2014), for the
proposition that ‘‘ ‘[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.’ ’’
(Emphasis altered.) Part II E of the majority opinion;
see Water Pollution Control Authority v. Flowserve US,
Inc., Docket No. 3:14-cv-00549 (VLB), 2018 WL 1525709,
*25 (D. Conn. March 28, 2018) (plaintiff was required
to establish that reasonable alternative design ‘‘would
have avoided or reduced the risk of harm without
unreasonably increasing cost’’ (emphasis added; inter-
nal quotation marks omitted)), aff’d, 782 Fed. Appx. 9(2d Cir. 2019).
It is, of course, true that, if an alternative design
reduces certain risks but increases other risks, or raises
costs, or reduces functionality, it may not be a reason-
able alternative design. But the majority is incorrect
that, if two competing medical product designs both
have benefits, and both have risks, then neither can be
defective, and neither can be a reasonable alternative
design. Every medical product and procedure involve
some degree of risk. The plaintiffs’ task was not to
demonstrate that the TVT is risk free. Rather, they had
only to present evidence from which the jury reasonably
could conclude that the Obtryx was unnecessarily dan-
gerous and that the TVT reduces those dangers without
sacrificing functionality and without adding other, off-
setting risks or costs.
The evidence cited in the preceding paragraphs estab-
lishes precisely that. Indeed, viewing the evidence in the
light most favorable to the plaintiffs, this case presents
a textbook example of a reasonable alternative design,
insofar as Boston Scientific, in designing the Obtryx,
essentially took the TVT and altered it in three ways.12
The jury could have found that, in addition to those
risks shared equally by the two products (e.g., surgical
risks or risks involved in the body’s reaction to foreign
materials such as polypropylene), the Obtryx, by virtue
of those three alterations, carries three additional sets
of risks—stemming from its heat-sealed middle, detanged
edges, and transobturator design—that (1) are not
shared by the TVT, and (2) do not offer any significant
offsetting benefits or cost savings.13 Indeed, Boston Sci-
entific itself acknowledges that, although Rosenzweig
was of the view that all polypropylene mesh devices
are defective, ‘‘Rosenzweig may believe the . . . char-
acteristics [of the Obtryx] allegedly make it more defec-
tive/unreasonably dangerous . . . .’’ Under the appli-
cable law, including the cases on which the majority
relies, that showing is enough for the jury to find the
Obtryx unreasonably dangerous, and hence defective,
on a theory of reasonable alternative design.
B
With respect to the third element of the plaintiffs’
defective design claim, which requires evidence that
the defective features of the design of the Obtryx caused
or contributed to Fajardo’s injuries, there was sufficient
evidence from which the jury reasonably could have
reached that conclusion. First, as I discussed, there was
extensive evidence that three specific design elements
of the Obtryx increase the risk of harm to patients,
including Fajardo. The heat-sealed middle section
makes the sling less flexible and more subject to con-
traction than other slings, which, in turn, aggravates
the foreign body reaction associated with the use of
polypropylene mesh and results in a higher rate of com-
plications, such as inflammation, groin pain, scarring,
urgency, overactive bladder, vaginal erosion, and dyspa-
reunia. The detanged edges hinder the integration of
the sling with native tissue. The transobturator design
results in vaginal tenderness and groin pain, and may be
linked to tape extrusion, vaginal erosion, and internal
dyspareunia. Dyspareunia, pelvic pain and swelling, and
worsening incontinence are the very symptoms that
Fajardo alleged.
Second, the plaintiffs’ expert witnesses were of the
opinion that these defective characteristics of the
Obtryx were in fact responsible for Fajardo’s injuries.
Rosenzweig testified that the decision by Boston Scien-
tific to heat seal the middle portion of the Obtryx stiff-
ened the sling, which, in turn, aggravated Fajardo’s
incontinence and exacerbated the foreign body reac-
tion, inflammation, scarring, and the other sequelae of
her condition. He opined that ‘‘Fajardo has . . .
chronic groin pain from the Obtryx sling . . . .’’ He
further noted that Fajardo’s sling was palpable when
removed, consistent with the cautions contained in the
Ross study regarding the transobturator design, and
that her injuries were to her obturator foramen, which
was precisely where the Obtryx was inserted. Ulti-
mately, Rosenzweig unequivocally opined, to a reason-
able degree of medical certainty, that ‘‘[t]he defects of
the Obtryx sling caused the injuries to . . . Fajardo.’’14
The majority’s statement to the contrary fails to acknow-
ledge the clear significance of this evidence.15
Finally, the jury reasonably could have concluded,
on this record, that using a TVT in lieu of the Obtryx
would have reduced, if not avoided altogether, the risks
of harm that the Obtryx presented.16 Indeed, insofar as
the primary design differences between the Obtryx and
the TVT were also the precise defects alleged to have
injured her, by far the most logical conclusion is that
selecting a TVT would have reduced her risk of dyspa-
reunia, groin pain, and incontinence, consistent with
the medical studies in evidence.
As I previously discussed, it is well within the prov-
ince of the jury to draw reasonable inferences from an
expert’s testimony and, thus, to come to a conclusion
that it could not permissibly reach solely on the basis
of lay knowledge. In the present case, the jury was
at liberty to combine various elements of the expert
evidence—Rosenzweig’s testimony, the Tulikangas
opinion letter, and the medical studies admitted as full
exhibits17—to reach the reasonable conclusion that the
elimination of three specific dangerous features of the
Obtryx would reduce the risk of danger presented by
that product. See, e.g., State v. Nunes, 260 Conn. 649,
675, 800 A.2d 1160 (2002) (substance of experts’ testi-
mony was held sufficient to establish causation to rea-
sonable degree of medical certainty, despite fact that
experts merely stated that ‘‘the symptoms experienced
by the victim were consistent with those of chloral
hydrate’’ (emphasis omitted)); Procaccini v. Lawrence
+ Memorial Hospital, Inc., supra, 175 Conn. App.
725–26 (recognizing that expert opinion is required to
prove causation in medical malpractice action but hold-
ing that jury could find causation from cumulative effect
of expert testimony and other evidence, including cir-
cumstantial evidence); see also Thompson v. Ethicon,
Inc., supra, 2020 WL 3893253, *5 (applying same rule
in context of mesh litigation). Because the plaintiffs
had only to persuade the jury that use of the TVT would
have reduced the risks posed by the Obtryx, establish-
ing that the TVT posed a lower danger to Fajardo with
respect to any one of the three suspect design features
would have been sufficient to warrant a reasonable
alternative design instruction. Construing the evidence
in the light most favorable to the plaintiffs, as we must,
there was sufficient evidence of all three defects to
warrant such an instruction.18
C
I have established that the plaintiffs were entitled to
the requested instruction if there was evidence tending
to show that a reasonable alternative design was avail-
able that would have avoided or reduced the risk of
harm and the failure to use that alternative design ren-
dered the product unreasonably dangerous. The plain-
tiffs claimed in particular that the unique characteristics
of the Obtryx—a heat-sealed middle section, detanged
edges, and a transobturator design—rendered it less
safe than the TVT and that those differences caused or
contributed to Fajardo’s injuries. They contended that
the TVT was a generally safe, effective, and widely used
mesh sling product for the treatment of female stress
urinary incontinence and that the Obtryx did not offer
any significant advantages in safety or effectiveness vis-
à-vis the ‘‘gold standard’’ TVT that would justify the
increased rate of complications. They offered expert
testimony, bolstered by respected clinical studies, in
support of those contentions, and in support of the
conclusion that the Obtryx should not be used due to
its unnecessarily high rate of serious complications.
The claim as presented was not oblique or difficult
to understand. The plaintiffs’ counsel throughout trial
directly and repeatedly referenced the foregoing body
of research suggesting that TVT slings are superior in
design and feature a more favorable risk-benefit profile
vis-à-vis transobturator slings in general, and the Obtryx
in particular. In his closing argument, the plaintiffs’
counsel began by discussing this body of research at
some length and by emphasizing that the TVT had been
proven to be a safer product than the Obtryx, with fewer
complications, and, therefore, that it should remain the
midurethral procedure of choice. He specifically linked
the higher incidence of complications relative to TVT
with the unique design features of the Obtryx, such as
the detanged edges and heat-sealed mid-portion, and
the resulting increase in material stiffness, as well as
the Obtryx’ transobturator approach. Later, counsel
analogized the Obtryx to the Ford Pinto and its procliv-
ity to burst into flames during rear-end collisions,
explaining that evidence that mesh slings are generally
safe was simply irrelevant to the plaintiffs’ claim that
the Obtryx is specifically dangerous.
Finally, in his rebuttal, the plaintiffs’ counsel argued:
‘‘[A]lmost their whole defense was saying mesh slings
are good. Very, very little of what they said had to do
with the Obtryx. And they said that [the] plaintiffs are
here telling you all mesh slings are bad. Those words
never left my mouth once. I put a lot of evidence in
front of you, but there’s a feasible alternative called the
TVT, which is superior. And that’s just not my words,
that’s . . . Tulikangas who told them that, that their
product is inferior.’’ A few minutes later, he returned
to this theme: ‘‘So, then [the defendants’ counsel] tell[s]
you how great TVT is, is a complete distraction and
actually supports our claim that there is a better product
that doesn’t have near[ly] as many problems. And they
were told that.’’ He then closed with a final reference
to the Ross study: ‘‘Here’s the 2009 Ross study, and
let’s look at the last sentence. Use TVT, don’t use the
Obtryx. That’s th[e] conclusion.’’ The evidence of rea-
sonable alternative design was presented at trial as a
distinct theory of product defect, the claim was argued
forcefully on the basis of that evidence, and the evi-
dence was sufficient in all respects to allow the jury to
exercise its constitutional function.19
III
Despite the evidence discussed in part II of this opin-
ion, and the requirement that we construe that evidence
in the light most favorable to the plaintiffs, the majority
remains unpersuaded that a reasonable alternative design
instruction was appropriate, for four primary reasons.
First, the majority contends that the TVT cannot qualify
as a reasonable alternative design because the term
‘‘TVT,’’ as used at trial, is ambiguous, and did not ade-
quately identify one specific product brand. Second,
the majority contends that the plaintiffs could not rely
on the expert opinion of Rosenzweig to establish that
the TVT represents a reasonable alternative design when
Rosenzweig also opined that all polypropylene mesh
products are unsafe. Third, the majority contends that
the jury was precluded from considering published
medical research studies, the testimony of treating phy-
sicians, and certain other testimony when evaluating
whether the Obtryx was defectively designed. Fourth,
the majority, having weighed the evidence presented at
trial, finds that the evidence in support of the plaintiffs’
reasonable alternative design theory was unpersuasive,
lacked credibility, or was contradicted by other evi-
dence of record. I consider each argument in turn.
A
The majority first argues that the TVT cannot qualify
as a reasonable alternative design because the term
‘‘TVT’’ is ambiguous. The majority contends that ‘‘[t]he
record demonstrates that the term ‘TVT’ is used both
with respect to the Ethicon branded tension free vaginal
tape (the specific TVT type product [Fajardo] 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 oth-
erwise noted, [the majority] use[s] the term in that
broader, generic context. Although the plaintiffs juxta-
posed the Obtryx to the class of TVT products generally,
they did not focus on a particular TVT product with
which to compare the Obtryx . . . .’’ Footnote 9 of the
majority opinion. On the basis of this premise—which,
as I will explain, is incorrect—the majority proceeds
on the assumption that a plaintiff may not satisfy its
burden of producing sufficient evidence of a reasonable
alternative design by pointing to a class of products
that themselves differ in material, design, safety and
efficacy with some containing the very same defects of
which the plaintiff complains. The majority proceeds
to evaluate the expert testimony and other evidence
presented by the plaintiffs through the lens of its errone-
ous assumption that ‘‘the plaintiffs are claiming that
the class of TVTs is a reasonable alternative design
. . . .’’20 Part II E of the majority opinion.
The flaws in the majority’s position become manifest
upon careful review of its reasoning. The majority elab-
orates: ‘‘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 retropubic fashion. 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 retropubic sling manufactured by
Boston Scientific. Third, the other studies entered into
evidence did not compare the Obtryx device to the
Ethicon branded TVT. Finally . . . Bercik did not com-
pare 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.’’ (Citation
omitted; footnotes omitted.) Part II E of the majority
opinion. The majority also contends that, insofar as
certain TVTs, such as Boston Scientific’s own Advan-
tage, have the same alleged design defects as the
Obtryx—a heat-sealed, detanged center section—there
is no evidence that use of the TVT would have prevented
Fajardo’s injuries.
The argument of the majority, in summary, relies on
five propositions: (1) the term ‘‘TVT’’ can refer both to
the Ethicon branded TVT and to the broader class of
retropubic slings; (2) the plaintiffs use the term in the
latter, broader sense, not with reference to any particu-
lar sling product; (3) a class of products cannot qualify
as a reasonable alternative design; (4) some members
of the class of TVTs, most notably Boston Scientific’s
Advantage retropubic sling, have the same design fea-
tures as, and are no safer than, the Obtryx; and (5) the
plaintiffs, therefore, did not proffer sufficient evidence
to warrant a reasonable alternative design instruction.21
I agree with the first proposition, that the term ‘‘TVT’’
can be ambiguous. The majority is simply mistaken,
however, with respect to the latter three propositions.
First, the vast majority of the evidence in the record, and
the focal point of the plaintiffs’ reasonable alternative
design argument, addressed the original, Ethicon
branded TVT, rather than a generic class of retropubic
slings. Second, nothing in law or logic bars the plaintiffs
from arguing that all TVT-type retropubic slings are
superior to the Obtryx and that the original, Ethicon
branded TVT is especially superior. And third, the plain-
tiffs presented compelling evidence that the Obtryx was
less safe than both the Ethicon TVT and other TVT-
type retropubic slings. Accordingly, the fact that the
term ‘‘TVT’’ is occasionally used loosely, in the course
of a ten day trial, to refer to retropubic slings generally
is of no consequence; the trial court did not rely on
that argument, and nothing about it justifies the court’s
instructional ruling.
1
The majority incorrectly suggests that the plaintiffs
never compared the Obtryx to any particular TVT prod-
uct and that their references were only to the class of
tension free tape that is implanted in a retropubic fash-
ion. The truth is that, with just a handful of exceptions,
all of the references to ‘‘TVT’’ in the record were
expressly to the product that bears that name, the TVT-
brand sling manufactured by the Gynecare unit of John-
son & Johnson’s Ethicon division. This is no surprise.
As the majority acknowledges, the plaintiffs identified
one particular TVT product in their complaint, and only
one—the Ethicon TVT. Indeed, unless my review of the
record missed contrary evidence, Ethicon’s is the only
vaginal mesh that uses the trade name ‘‘TVT.’’ In light
of these facts, I do not understand why the majority
resists the reasonable assumption that the Ethicon TVT
is the TVT to which the plaintiffs were referring.
The cross-examination of one of the plaintiffs’
experts at trial illustrates that everyone in the court-
room—including Boston Scientific’s own lawyers—
clearly understood that the TVT under discussion was
the Ethicon TVT. Bercik testified, among other things,
that Fajardo would have been a suitable candidate for
the TVT. He repeatedly made clear that the TVT to
which he was referring was the Ethicon TVT in particu-
lar, and not retropubic slings more generally. The fol-
lowing colloquies, for example, took place during his
cross-examination.
‘‘Q. And then you say [that Fajardo] may potentially
benefit from repeat sling procedure, and what you left
out when you read to the jury was the word TVT. You
wrote TVT at the end of the sentence, right?
‘‘A. I did.
‘‘Q. Okay. And so what you were reporting in your
note is that . . . Fajardo might benefit from a repeat
sling procedure, TVT, right? That’s what you wrote?
***
‘‘Q. But a TVT is a polypropylene sling, right? It’s
made from polypropylene?
‘‘A. So, it’s a specific brand of a polypropylene sling.
‘‘Q. Sir, my . . . question is [whether] the TVT is a
polypropylene sling, right?
‘‘A. Yes, sir.
‘‘Q. Okay. And it’s also . . . made by Johnson &
Johnson and not Boston Scientific, right?
‘‘A. That’s correct.
‘‘Q. Ethicon. And you have implanted that polypro-
pylene sling for many years. You talked . . . with
. . . Fajardo’s lawyers about that, right?
‘‘A. Yes, sir.
’’Q. Okay. And you currently use and recommend
that polypropylene sling to women with stress urinary
incontinence, right?
‘‘A. Yes, sir, I do.
‘‘Q. And you place about 100 of those polypropylene
midurethral slings a year, right?
‘‘A. Give or take, yeah.
***
‘‘Q. Sure. . . . For the slings that . . . you have
implanted . . . the TVT sling manufactured by John-
son & Johnson, those women [who] have that sling,
there’s a risk that their sling[s] may need to be removed?
‘‘A. Oh, I see what you’re saying. Yes.
‘‘Q. Yeah. And any time that you implant a TVT sling
in the hundreds of women that you have recently, you
discuss with them the potential that the sling may need
to be removed as a potential risk, right?
‘‘A. I do. I generally quote about a 1 percent risk.
‘‘Q. All right. And you continue to recommend slings
as an option for women to use despite the fact that
there’s a risk that they may need to be . . . removed,
correct?
‘‘A. No, I don’t—I don’t recommend slings, plural. I
recommend a sling, a specific sling.
‘‘Q. You recommend a specific sling, the one that you
choose to use, even with a risk of potential removal,
correct?
‘‘A. Right. Based [on] my experience and my knowl-
edge of—of the risk and complication rates, yes.
‘‘Q. And you also agree that, [with] the sling that you
recommend, there is a risk of contracture with that
sling, as well, agreed?
‘‘A. . . . With my experience, I have not seen signifi-
cant contracture with that sling.’’ (Emphasis added.)
The following additional colloquies took place on
redirect examination.
‘‘Q. [I]s TVT made by the same manufacturer as the
Obtryx sling?
‘‘A. No, ma’am.
‘‘Q. Okay.
‘‘A. Different company.
***
‘‘Q. Okay. So the TVT that you use has a different
approach than the Obtryx sling. Correct?
‘‘A. Yes, ma’am.’’ (Emphasis added.)
It could not be any clearer that Fajardo’s treating
physician was comparing the Ethicon TVT to the
Obtryx.22 He opined that the Ethicon sling was a suitable
alternative for Fajardo specifically. He opined that the
Ethicon sling was safer than the Obtryx in various
respects, with fewer complications, less contraction,
and less risk of removal. He went out of his way to
emphasize that he was recommending only one particu-
lar sling, sold by one particular company. And both
the plaintiffs’ and the defendants’ counsel repeatedly
indicated that they understood that the sling at issue
was the Ethicon TVT, not a general class of retropubic
slings or Boston Scientific’s own retropubic Advantage
sling. It is impossible to read the record any other way.
Other key testimony at trial would have reinforced
the fact that the term ‘‘TVT’’ is primarily used in refer-
ence to the Ethicon branded TVT, and not to a class
of TVT-like products. Rosenblatt, the primary defense
expert, testified that the first mesh sling was the TVT,
which was developed in 1998. He referred to it as the
‘‘Ethicon TVT,’’ and he explained that, unlike Boston
Scientific’s vaginal slings, the TVT was manufactured
from Prolex branded polypropylene, rather than Mar-
lex. Indeed, Rosenblatt repeatedly distinguished ‘‘the
TVT’’ from ‘‘TVT-like retropubic slings,’’ such as Boston
Scientific’s Advantage, making perfectly clear that he
was not using the term ‘‘TVT’’ broadly to encompass
all retropubic slings. Notably, he emphasized that the
TVT—unlike the Advantage and the Obtryx—does not
have the controversial detanged edges, which, he
explained, is a novel development and is unique to the
Boston Scientific products.23
In addition, Rao, the Boston Scientific engineer, dis-
tinguished the Advantage from the Ethicon branded
TVT, making clear that the TVT, unlike Boston Scientif-
ic’s products, did not have the heat-sealed center,
detanged edges, and other design flaws alleged to have
caused Fajardo’s injuries.24 I am not aware of any trial
testimony, by contrast, that suggested that the TVT that
was held up as an alternative to the Obtryx represented
a class of products.
Most of the exhibits introduced at trial likewise used
the term ‘‘TVT’’ in reference to the Ethicon branded
product of that name, rather than as a synonym for
retropubic slings generally; many expressly distin-
guished Boston Scientific’s Advantage retropubic sling
from the TVT. The Lim study, for example, distinguished
the Advantage from the ‘‘Gynecare’’ TVT and postulated
that the defects in the former result from the heat seal-
ing process, which renders the Advantage stiffer and
less elastic than the TVT. See Y. Lim et al., supra, 21
International Urogynecology J. 1157, 1161. Moalli com-
pared the ‘‘Gynecare TVT’’ from Ethicon with the
Advantage and four other midurethral slings. See P.
Moalli et al., supra, 19 International. Urogynecology J.
655. The authors stated that the Gynecare TVT, which
has unique tensile properties, is ‘‘the gold standard’’;
id., 656; and explained how newer slings, such as the
Advantage, depart from the TVT by adding a heat-sealed
middle, a tensioning suture, or a different weave pat-
tern. See id., 662. Another study in evidence likewise
distinguished the TVT from subsequent retropubic
slings such as Advantage. See generally 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).
In other trial exhibits, physician consultants to Bos-
ton Scientific also used the term ‘‘TVT’’ to specifically
reference the Ethicon product. In an e-mail, one consul-
tant, Joseph Macaluso, referred to the ‘‘TVT,’’ distin-
guishing the actual trademarked TVT from what he
refers to as ‘‘TVT-type’’ mesh. Similarly, in his corre-
spondence with Boston Scientific, Tulikangas responded
to an e-mail from Boston Scientific, stating: ‘‘Advantage
vs TVT—Longer term follow-up—Retrospective—Mul-
tiple Institutions—Shows that [Advantage] is just as
effective as TVT . . . .’’25 Indeed, of the scores of exhib-
its in evidence, only one, the Ross study, consistently
used the terms ‘‘TVT’’ and ‘‘retropubic’’ interchange-
ably. See generally S. Ross et al., supra, 114 Obstetrics &
Gynecology 1287.
In most instances, it also was apparent that counsel
for both sides, when referencing the ‘‘TVT,’’ were refer-
ring to the Ethicon product in particular. As the majority
concedes, all of the plaintiffs’ references to ‘‘TVT’’ in
the operative complaint expressly referenced Ethicon’s
original, branded TVT. See footnote 9 of the majority
opinion. In his closing argument, the plaintiffs’ counsel
identified the TVT as ‘‘a competitor’s product,’’ which
eliminates any possibility that he was referencing the
class of TVTs that includes Boston Scientific’s Advan-
tage sling. In support of his claim that the TVT is a
superior product for which Fajardo would have been
well suited, he discussed the Moalli study and the testi-
mony of Bercik, both of which addressed the Ethicon
TVT, in particular. Counsel explained how ‘‘the TVT
people,’’ unlike Boston Scientific, designed the TVT
with tanged edges ‘‘for a functional purpose to grip
tissue.’’ Although counsel’s other references to TVT,
such as in the context of discussing the Ross study,
were arguably ambiguous, at no point did he suggest
that the TVT that he was holding up as a comparator
was the class of retropubic slings, much less Boston
Scientific’s own Advantage product.
We can be certain that Boston Scientific was not
confused by the supposed ambiguity. In its closing,
Boston Scientific continued to hew to the position that
it took throughout the trial, namely, that the TVT is a
particular product rather than a class. Counsel walked
the jury through the historical use of polypropylene in
medical devices: ‘‘You then have the first product that
comes onto the market in 1998, and that’s called, you’ve
heard, the TVT. It’s a polypropylene mesh sling. Five
years later, Boston Scientific puts out its first polypro-
pylene mesh sling called the Advantage . . . .’’
The majority cites no examples of any instance at
trial when Boston Scientific uses the term ‘‘TVT’’ to
refer to a class of products. Indeed, even on appeal,
the defendants themselves have not taken the position
espoused by the majority that the term ‘‘TVT’’ was used
at trial in reference to the class of retropubic slings. In
its brief, Boston Scientific repeatedly distinguishes ‘‘the
TVT,’’ which was ‘‘first . . . marketed in 1998’’ and
‘‘lacks detanged edges,’’ from retropubic slings such as
the Advantage. Although Boston Scientific does fault
the plaintiffs for not identifying a competitor product
that, in its view, ‘‘would have reduced or avoided the
risk of harm to . . . Fajardo,’’ it is perfectly clear from
its brief that Boston Scientific understands that the
Ethicon TVT is among the reasonable alternative
designs at issue. (Emphasis omitted.)
It is clear, then, that there was abundant evidence
from which the jury reasonably could have found that
the original TVT, the branded product manufactured
and sold by the Gynecare unit of Johnson & Johnson’s
Ethicon division, represented a reasonable alternative
to the Obtryx. Expert testimony and supporting scien-
tific studies established that that particular sling (1) is
widely used, (2) is safe and effective, (3) was a feasible
option for Fajardo, (4) is superior to the Obtryx, and
(5) does not have the design features that allegedly
caused Fajardo’s injuries, namely, a heat-sealed middle
section, detanged edges, and a transobturator approach.
If there are concerns that the jury might have been
confused by Ross’ looser use of the term ‘‘TVT,’’ or
ambiguities in the arguments of counsel, then the trial
court could have solved the problem by instructing the
jury to consider only the evidence tending to show that
the Ethicon TVT in particular represented a reasonable
alternative design. There was no justification for throw-
ing out the entire claim.
2
Even were we to assume, purely for the sake of
argument, that the plaintiffs intended the ‘‘TVT’’ to refer
to a class of products rather than a particular product,
the majority has provided neither authority nor argu-
ment in support of its contention that a class of products
cannot serve as a reasonable alternative design. A con-
sumer injured by a cigarette lighter using a novel igni-
tion device would be entirely justified in holding up the
class of disposable butane lighters using a flint wheel
as a reasonable alternative design, rather than, say,
arbitrarily pointing to some particular BIC or Scripto
model. As one federal court in Connecticut has
explained, ‘‘proof of a feasible alternative design [is] a
euphemism for avoidability . . . .’’ (Internal quotation
marks omitted.) Mals v. Smith & Nephew, Inc., Docket
No. 3:19-cv-01770 (VLB), 2020 WL 3270835, *5 (D. Conn.
June 17, 2020). If the defendant’s product differs in
some important way from all competitor products, and
in a way that is demonstrably responsible for the plain-
tiff’s injuries, then why should it matter that those vari-
ous, safer alternatives are not in every respect identical?
In the present case, every sling in the class of TVT-
type products lacks at least one of the three defects of
the Obtryx, namely, the use of a transobturator rather
than a retropubic design. Evidence in the record that
was introduced and relied on by the plaintiffs’ design
experts and emphasized by the plaintiffs’ counsel during
both opening and closing arguments, such as the Ross
and Cholhan studies, as well as other evidence, such
as the Petri study; see footnote 8 of this opinion; indi-
cated that the use of a transobturator approach was a
defect of the Obtryx that is associated with injuries
of the type suffered by Fajardo. Rosenzweig clearly
summarized this body of research for the jury, stating
that, because the transobturator design of the Obtryx
was associated with significantly higher incidences of
groin pain and other complications, ‘‘the retropubic
sling is better than the [Obtryx] transobturator sling.’’
He summed up his discussion of these and other compli-
cations associated with the Obtryx by opining that the
Obtryx is defective and that its defects caused Fajardo’s
injuries. Accordingly, even if the majority were correct
that the plaintiffs tried the case by comparing the
Obtryx only to the class of retropubic slings, rather than
to the Ethicon TVT in particular, there was abundant
evidence from which the jury could have found that
the use of any retropubic sling would have reduced the
risk of the types of injuries that Fajardo suffered.
To summarize, the plaintiffs demonstrated at trial
that both of the Boston Scientific products, the Advan-
tage and the Obtryx, are inferior to the Ethicon TVT
insofar as they have two unique design elements:
detanged edges and a heat-sealed middle section. The
plaintiffs also demonstrated that the Obtryx is worse
even than the Advantage, insofar as the former sling
has a third design defect: transobturator slings are more
dangerous than retropubic slings, without offsetting
benefits. So, the Obtryx is the worst of both worlds.
Fajardo would have reduced her risks had she used
any TVT-style retropubic sling, and she would have
minimized her risks to the greatest extent by using
the Ethicon TVT, rather than a heat-sealed, detanged
Boston Scientific TVT product. However defined, TVT
was a safer product, a less defective, reasonable alterna-
tive design. At least, the jury could have so found. It
should have been allowed to do so.
B
The second reason that the majority believes that a
reasonable alternative design instruction was not war-
ranted, despite the abundant evidence that the TVT was
a viable, superior alternative that could have prevented
Fajardo’s injuries, is that the plaintiffs also presented
some evidence that all polypropylene slings are unrea-
sonably dangerous because polypropylene is not suit-
able for use in the human body. Specifically, the major-
ity embraces Boston Scientific’s principal argument—
the same argument that apparently persuaded the trial
court—that the plaintiffs could not, as a matter of law,
have established that the TVT is a reasonable alternative
design because their own product design expert, Rosen-
zweig, testified that, in his opinion, all mesh products
fabricated from polypropylene, including the TVT, are
unsafe and unsuitable for implantation in the human
body. The plaintiffs counter, and I agree, that the fact
that Rosenzweig was of the view that all polypropylene
mesh products are unsafe does not mean that the jury
was precluded from finding that the TVT represents a
reasonable alternative design to the Obtryx sling. I
reach this conclusion for several reasons.
1
As I explained in part I of this opinion, the jury was
not confined to the binary choice of either crediting all
of Rosenzweig’s opinions or rejecting them whole hog.
Our law governing expert witnesses is very clear on
this point. The jurors were free to credit Rosenzweig’s
opinion that the unique features of the Obtryx—a heat-
sealed center, detanged edges, and a transobturator
approach—constituted design flaws that caused or con-
tributed to Fajardo’s injuries, while at the same time
rejecting his more idiosyncratic view that all polypro-
pylene mesh products are defective and, instead, credit-
ing the trial testimony of other experts that polypropyl-
ene is a suitable material for use in medical implants
and that the TVT is a safe and effective treatment for
female stress urinary incontinence. Indeed, the trial
court instructed the jury to that effect immediately
before Rosenzweig testified.
Rosenzweig himself provided ample basis for the jury
to disregard his more extreme views regarding the dan-
gers of polypropylene. Although Rosenzweig’s own
opinion was that polypropylene is not a suitable mate-
rial for medical implants and that the alternative Burch
procedure is a preferable means of treating stress uri-
nary incontinence, he also repeatedly acknowledged at
trial that those views do not represent the prevailing
opinion among urogynecologists and, indeed, are well
outside the medical mainstream. For example, Rosenz-
weig testified that, according to the medical literature,
polypropylene mesh is the ‘‘gold standard’’ for treating
stress incontinence and that its use has been endorsed
as safe and effective by every major urological associa-
tion. He agreed with the defendants’ counsel that poly-
propylene has been used in the human body for more
than fifty years in millions of patients, that polypropyl-
ene slings such as the TVT are effective and widely used,
and that physicians who use them do so reasonably
and consistent with the prevailing standard of care.
Rosenzweig acknowledged that his own colleagues at
Rush University Medical Center regularly use such
slings and continue to train residents in the use thereof.
In short, he agreed that polypropylene slings represent
the most commonly used modality for treating stress
urinary incontinence and that their use is supported
by extensive medical data, including more than 2000
studies.
Accordingly, the jury reasonably could have credited
Rosenzweig’s testimony that the unique design charac-
teristics of the Obtryx render it especially dangerous
and contributed to Fajardo’s injuries while simultane-
ously concluding that Rosenzweig is an outlier with
respect to his strident opposition to any medical use
of polypropylene. The jury could have credited the testi-
mony of various other witnesses—such as Bercik,
Rosenblatt, and Boston Scientific’s biomaterials expert,
Stephen Badylak—that polypropylene, such as that
used in the TVT, is a generally safe material that is
widely used for the fabrication of medical implants and
accepted by all major medical associations.
2
Another reason that Rosenzweig’s beliefs regarding
the dangers associated with polypropylene did not
fatally taint his entire testimony is that I do not accept
Boston Scientific’s view, apparently shared by the
majority, that an alternative product design that is
unsafe, but significantly less so than the defendant’s
product design, cannot, ipso facto, be a reasonable
design. It is noteworthy that neither Boston Scientific
nor the majority has identified a single authority for
the theory that a federally regulated product that is
legally on the market and in widespread use cannot
qualify as a reasonable alternative design if it is safer
than the product at issue but, nevertheless, poses safety
risks that arguably outweigh its advantages. Rather, the
few courts and commentators to have considered the
issue uniformly have concluded that a less unsafe prod-
uct can qualify as a reasonable alternative design if that
product lacks the features that caused or contributed
to the plaintiff’s injuries. Indeed, several federal courts
have reached that very conclusion in the multidistrict
vaginal mesh litigation, rejecting similar arguments.
See, e.g., Herrera-Nevarez by Springer v. Ethicon, Inc.,
Docket No. 17 C 3930, 2017 WL 3381718, *7 (N.D. Ill.
August 6, 2017) (‘‘the fact that [an expert] evidently
does not believe that any such devices are safe does
not preclude him from ranking them on a comparative
basis’’); Kaiser v. Johnson & Johnson, Docket No. 2:17-
CV-114-PPS, 2018 WL 739871, *7 (N.D. Ind. February 7,
2018) (similar); Wiltgen v. Ethicon, Inc., Docket No.
12-cv-2400, 2017 WL 4467455, *5 (N.D. Ill. October 6,
2017) (similar); see also Campbell v. Boston Scientific
Corp., 882 F.3d 70, 79 (4th Cir. 2018) (rejecting argument
that Rosenzweig’s testimony did not support finding of
reasonable alternative design).
Although those courts did not elaborate on the rea-
soning underlying their rulings, legal scholars have
made a persuasive case. For example, Professor Doug-
las A. Kysar has explained that ‘‘even an unavoidably
unsafe product sometimes can be made marginally less
unsafe. By allowing courts to balance the risks and
rewards posed by alternative product designs, the risk-
utility test provides manufacturers with incentives to
constantly evaluate and [to] adopt such reasonable
alternative designs.’’ D. Kysar, ‘‘The Expectations of
Consumers,’’ 103 Colum. L. Rev. 1700, 1717 (2003). The
Restatement (Third) is of the same view: ‘‘The require-
ment . . . that the plaintiff show a reasonable alterna-
tive design applies in most instances even though the
plaintiff alleges that the category of product sold by
the defendant is so dangerous that it should not have
been marketed at all. . . . [This applies to] [c]ommon
and widely distributed products such as alcoholic bev-
erages, firearms, and [aboveground] swimming pools
. . . .’’ (Citation omitted.) Restatement (Third), supra,
§ 2, comment (d), p. 20.
Consider the hypothetical of a tobacco company that
develops a cigarette featuring a novel design that, while
more stylish in appearance than those currently on the
market, has a less effective filter that removes fewer
carcinogens. A cigarette design expert might well testify
that the new product is unnecessarily dangerous rela-
tive to traditional designs, which are less likely to cause
cancer, while also acknowledging that she would never
smoke or allow her children to smoke and that she is
of the view that no cigarettes should be legal due to
the well-known medical risks associated with smoking.
Of course, cigarettes are legal. They are heavily regu-
lated, but society has accepted that the health and finan-
cial costs associated with smoking related illnesses are
justified by the economic benefits and the rights of
adults to make their own determination that the plea-
sure that they derive from smoking outweighs the risks.
Moreover, this in for a penny, in for a pound theory
of product liability is especially poorly suited to the
medical device field. The parties, and all of the experts
who testified at trial, agreed that every surgical inter-
vention and every internally implanted medical device
carry some potentially serious risks. Much of the prac-
tice of Western medicine involves the process of
attempting to identify and quantify such relative risks
so that clinicians and patients can make informed deci-
sions as to whether the dangers associated with a partic-
ular intervention are justified by the potential benefits.
As is clear from the present case, medical experts no
less than their patients reasonably may reach different
conclusions about whether, for example, it is prudent
to implant a particular medical device that has a reason-
able likelihood of curing an irksome but nonlethal con-
dition, such as chronic stress urinary incontinence, but
that also has the potential to cause serious pain and
other side effects. So long as that device falls within
the standard of care and is deemed to have some medi-
cal utility, I see no reason why the law should not
incentivize manufacturers to minimize those risks,
rather than pile risk upon risk, to the extent reasonably
possible. The majority’s holding in the present case
removes that incentive and potentially disincentivizes
manufacturers of certain categories of products from
developing design innovations that reduce the risk of
harm.
3
Finally, the majority ignores the fact that this court
already has, in essence, decided this very question in
the plaintiffs’ favor. In Bifolck, we made clear that a
plaintiff is not precluded from arguing that a class of
products is inherently, manifestly unsafe while, in the
alternative, also contending that the particular product
at issue could have been designed to be less unsafe.
See Bifolck v. Philip Morris, Inc., supra, 324 Conn. 435(‘‘Although the fact finder considers under either theory
whether the risk of danger inherent in the challenged
design outweighs the benefits of that design, these theo-
ries are not mutually exclusive. A plaintiff may consis-
tently allege that a product had excessive preventable
danger (reasonable alternative design) and that the
product was too dangerous to market to the consumer
irrespective of whether it could have been designed
to be safer (manifestly unreasonable design).’’). The
majority does not appear to recognize that its holding
in the present case deviates from the court’s guidance
in Bifolck and offers no rationale for this departure.
C
Third, as I have alluded to throughout this opinion,
I am troubled by the majority’s view that the only evi-
dence that the jury was permitted to consider in
assessing a potential reasonable alternative design
claim was the testimony of the plaintiffs’ primary prod-
uct design expert, Rosenzweig, and that the plaintiffs’
case was not established unless Rosenzweig himself
recited the talismanic words that the Ethicon TVT was
a reasonable alternative design, use of which would
have averted or reduced the risk of harm to Fajardo.
This idea, that a jury in a product liability lawsuit is
permitted to consider only a limited category of expert
testimony regarding the design of medical devices and
cannot take into account and draw reasonable infer-
ences from other relevant expert evidence, such as sci-
entific and medical studies and the testimony of treating
physicians, even when that evidence was admitted with-
out objection or limitation, is flatly inconsistent with
established law. This aspect of the majority opinion
encroaches on the autonomy of the jury and overlooks
the realities of how expert witnesses are actually used,
especially in complex civil cases.26
First, no one is arguing that expert testimony was
not required in this case. The plaintiffs presented the
testimony of a product design expert, Rosenzweig,
whom they disclosed as an expert on safer alternatives
to the Obtryx, and whom the trial court permitted to
testify, over the objection of Boston Scientific. The
plaintiffs also disclosed and presented the expert testi-
mony of Richard W. Trepeta, a pathologist, who testified
as to the material condition of the Obtryx that was
implanted in Fajardo. As I previously discussed, Rosenz-
weig testified as to the design flaws in the Obtryx—
heat sealing, detanging, a transobturator insertion—
relative to the TVT, and he linked those differences to
Fajardo’s poor outcome. Although the majority worries
that the jury was incapable of understanding the medi-
cal studies in evidence, contending that ‘‘the jury [did]
not have the assistance necessary to reach an intelligent
or correct decision’’; footnote 20 of the majority opin-
ion; the reality is that Rosenzweig made it about as
basic as one can: ‘‘[T]he retropubic sling is better than
the [Obtryx] transobturator sling.’’
For its part, Boston Scientific disclosed and pre-
sented experts of its own, some of whom verified that
the TVT is the most well established vaginal sling and
that the primary differences between the TVT and the
Obtryx are the latter’s heat-sealed middle, detanged
edges, and transobturator approach.
As discussed, the plaintiffs also introduced the expert
opinions of Fajardo’s treating physicians via the testi-
mony of Bercik, whom the plaintiffs also disclosed as
an expert on product design and reasonable alternatives
to the Obtryx, and the office notes of Hines. The expert
opinion of a third physician, Tulikangas, was before the
jury, as well. It is well established that a plaintiff’s
treating physicians may provide expert testimony
within their realm of practice, without the need for
formal expert certification or detailed disclosures. See
Practice Book § 13-4 (b) (2) (defining expert disclosure
requirements for treating physicians). Moreover, even
physicians who are not formal product design experts
may provide relevant testimony as to elements of prod-
uct design to the extent that there is overlap with their
professional experience. See, e.g., Procaccini v. Law-
rence + Memorial Hospital, Inc., supra, 175 Conn. App.
723 (causation testimony of physician disclosed as stan-
dard of care expert constituted ‘‘ ‘expert’ ’’ testimony,
insofar as it reflected his medical expertise and experi-
ence, and, once admitted without objection or limita-
tion, was before jury to use for any purpose); see also
Allen v. C. R. Bard, Inc., Docket No. 11-cv-2031-LRR,
2017 WL 4127765, *2 (N.D. Iowa September 15, 2017)
(treating physician may opine that product feature
caused patient’s injuries without offering improper
opinion as to design defect). Indeed, courts in other
vaginal mesh cases have concluded that surgeons who
perform mesh removal procedures may thereby be qual-
ified to opine as to the design of such devices. See, e.g.,
Heatherly v. Boston Scientific Corp., Docket No. 2:13-
cv-00702, 2018 WL 3797507, *4, *9 (S.D. W. Va. August
9, 2018).
So, the question is not whether expert testimony is
normally required in a product liability action involving
a medical device. Nor is there any question that the
plaintiffs had to supply expert evidence to demonstrate
that Fajardo’s injuries were likely caused by certain
defective design features of Boston Scientific’s product
and that there is some reasonable alternative design
that is economically and technically feasible, use of
which would have reduced the risk of harm to end-users,
including Fajardo. The question, rather, is whether that
evidence was required to take a very particular form.
As I discussed in part I of this opinion, the majority
has not pointed to any authority in support of its posi-
tion that the plaintiffs’ proof cannot be forged from the
combined testimony of different design and materials
experts, treating physicians, scientific studies, and
other evidence of record, both direct and circumstan-
tial. Nor is there some magic words requirement that
an expert express his or her opinion using the precise
legal jargon that an appellate court might employ. See,
e.g., State v. Nunes, supra, 260 Conn. 672–73;
Struckman v. Burns, 205 Conn. 542, 555, 534 A.2d 888(1987). Truly complex design questions plainly require
the testimony of design experts. The cases cited by the
majority say no more, no less.27 But expert testimony
is required when, and only when, the specific point to be
established cannot be ascertained by a lay jury. Expert
testimony must not be fetishized to the point where it
replaces our trust in the jurors’ native intelligence and
good sense.
Moreover, once the opinion testimony of a purported
expert has been admitted without objection or limita-
tion, it becomes part of the trial record, and it is inappro-
priate for either the trial court or this court to determine
that it is off-limits for purposes of assessing the suffi-
ciency of the evidence or an instructional request simply
because that court, in hindsight, questions whether the
witness was a proper expert, or the right species of
expert. See, e.g., State v. Carey, 228 Conn. 487, 496, 636
A.2d 840 (1994) (‘‘If [inadmissible] evidence is received
without objection, it becomes part of the evidence in
the case, and is usable as proof to the extent of the
rational persuasive power it may have. The fact that it
was inadmissible does not prevent its use as proof so far
as it has probative value. . . . This principle is almost
universally accepted. . . . The principle applies to any
ground of incompetency under the exclusionary rules
. . . [including] the expertness qualification.’’ (Internal
quotation marks omitted.)); Maurice v. Chester Hous-
ing Associates Ltd. Partnership, 189 Conn. App. 754,
759 n.2, 208 A.3d 691 (2019) (‘‘We note that it is not
necessary for a party to ask that the court recognize
the witness as an expert before asking the witness to
provide an opinion. . . . The proponent of the expert
simply must lay the necessary foundation before asking
the witness a question that calls for an expert opinion.
If there is no objection to the question, the witness may
give the opinion. If there is an objection to the witness’
qualifications or to whether the witness’ testimony will
assist the trier of fact, the court can then rule on the
objection in the context of the specific questions asked.’’
(Citation omitted.)).
The same principles apply with respect to research
studies published in scientific and medical journals.
The majority has failed to identify any authority indicat-
ing that, once a study has been admitted into evidence
without objection or limitation, supported by the foun-
dational testimony of an expert that the study is authori-
tative and that he or she relied on it in forming his or
her opinions, the jury is barred from reading the study
and drawing all reasonable conclusions therefrom. The
studies at issue were admitted into evidence as full
exhibits, without limitation. They contain statements
of fact and opinion that the jury was entitled to consider
as if the entire article had been read into the record
verbatim. See Conn. Code Evid. § 8-3 (8);28 see also,
e.g., Curran v. Kroll, supra, 303 Conn. 864 (‘‘Th[e] evi-
dence was admitted in full, without limitation. In the
absence of any limiting instruction, the jury was entitled
to draw any inferences from the evidence that it reason-
ably would support.’’); Procaccini v. Lawrence + Memo-
rial Hospital, Inc., supra, 175 Conn. App. 724 (‘‘[i]n the
absence of any [limiting] instruction from the court,
the evidence . . . was before the jury for it to use for
any purpose’’).29
If the defendants wanted to limit the jury’s consider-
ation to certain portions of the articles, or wished to
limit the jury’s use of the contents of the articles, they
should have asked to have the articles redacted or
requested a limiting instruction.30 See, e.g., Filippelli v.
Saint Mary’s Hospital, 319 Conn. 113, 135–36, 124 A.3d
501 (2015). They did not do so, and it is inconceivable
to me that an appellate tribunal can now retroactively
deem portions of those articles to be off-limits, or other-
wise preclude the jury from using the contents of the
articles to reach any conclusions supported by them,
regardless of whether supplemented by expert testi-
mony. If the defendants believed that the opinions con-
tained in the articles required explanation, they had
their opportunity to pursue that line of examination
through witnesses at trial.31
Insofar as the trial court overlooked or opted not to
consider any of this evidence, and restricted its consid-
eration of the plaintiffs’ requested charge to the uni-
verse of Rosenzweig’s testimony,32 that represents a
legal error, rather than a factual finding to which we
must defer, as the majority appears to believe. See foot-
note 13 of the majority opinion; see also, e.g., Brown
v. Robishaw, 282 Conn. 628, 633, 922 A.2d 1086 (2007)
(whether evidence presented reasonably supports par-
ticular request to charge is question of law subject to
plenary review). Had the trial court excluded any of
the evidence that I have cited, then that decision would
be subject to deference and reviewable only for abuse of
discretion. But once the evidence was admitted without
limitation, the jury was free to consider it for any pur-
pose, and it is inappropriate for the majority to direct
otherwise.
D
Fourth, returning to where we began, I am concerned
that the majority not only fails to construe the evidence
in the light most favorable to the plaintiffs, as required
by law, but also steps into the jury’s role by making
its own assessments of the strength of the plaintiffs’
evidence and the credibility of their witnesses, ulti-
mately downplaying any evidence that supports the
requested instruction while highlighting conflicting evi-
dence. Two examples illustrate this slippage.
First, the majority determines that Bercik cannot
credibly opine as to the question of a reasonable alterna-
tive design merely because, although Bercik knew that
the Obtryx was fabricated from the Marlex brand of
type 1 microporous polypropylene, he was uncertain
whether the TVT was made from the same brand of
that material. See footnote 22 of the majority opinion.
On the basis of this one statement, which a reasonable
juror may deem wholly insignificant, the majority finds
that Bercik ‘‘[knew] next to nothing about the design
features of the Obtryx . . . .’’ Part II E of the majority
opinion. The majority never explains why Bercik’s lack
of knowledge as to the brand of polypropylene used in
the TVT says anything about his knowledge of the
design features of the Obtryx; nor does it tell us why
the brand of plastic used would be relevant to any of
the defects under discussion. Bercik is a surgeon, who
implants slings into women and removes them when
they have proven to be ineffective or defective. On
the basis of that experience, he testified about his and
several of his colleagues’ strong preference for slings,
such as the TVT, that use a retropubic approach. In
combination with the other evidence of record, the jury
reasonably might have found this testimony compelling
and relevant, or not. But it is not this court’s role to
deem the testimony unimportant or unpersuasive, and
certainly not on such arbitrary grounds.
Second, rather than taking at face value the medical
research in evidence that indicated that the Ethicon
TVT is the gold standard treatment for female inconti-
nence, that the TVT has a lower rate of complications,
and that the ‘‘TVT should remain the midurethral sling
procedure of choice,’’ the majority dwells at length on
other evidence that arguably called into question
whether the TVT is, in fact, a superior product. I under-
stand that the plaintiffs did not demonstrate the superi-
ority of the TVT or the defectiveness of the Obtryx to the
satisfaction of the majority. The only question before
us, however, is whether there was some minimal quan-
tum of evidence from which the jury reasonably could
have been persuaded of those allegations. Clearly there
was.
It is not our role to make assessments of this nature
under these circumstances. Our only proper role, given
the procedural posture in which this case reaches us,
is to assess whether there was sufficient evidence from
which a reasonable, properly instructed jury could have
found that the Obtryx is defective because its design
renders it unreasonably dangerous and there is a feasi-
ble alternative design that would have reduced the risks
of the types of injuries that Fajardo suffered. Before
the majority upholds the trial court’s instructional error,
it was compelled to marshal the evidence of record in
the manner that best supported the requested instruc-
tion, and only then to explain why that evidence, so
construed, was legally insufficient. I do not believe it
has done so.
IV
There is evidence in the record from which the jury
reasonably could have found that (1) the Ethicon TVT is
a feasible, federally approved, and widely used product
that was a suitable candidate to treat Fajardo’s condi-
tion, (2) the Obtryx differs from the Ethicon TVT pri-
marily with respect to the former’s heat-sealed middle
section, detanged edges, and transobturator approach,
(3) those particular features of the Obtryx tend to
increase its stiffness and have been linked to higher
incidences of the injuries that Fajardo suffered relative
to the TVT, and (4) according to Rosenzweig, the plain-
tiffs’ primary design expert, those features are defects—
their increased risks outweigh any benefits—that were
responsible for Fajardo’s injuries. If the jury had been
instructed in accordance with Bifolck and had found
for the plaintiffs on that theory, it is inconceivable to
me that, on this record, we would have concluded that
there was insufficient evidence and overturned the ver-
dict. In my view, no more was necessary to warrant a
reasonable alternative design instruction and put the
issue before the jury. Accordingly, I respectfully concur
in part and dissent in part.
1
I agree with all of part II A except the majority’s ultimate conclusion
that ‘‘the trial court correctly concluded that the evidence did not support
an instruction under the reasonable alternative design prong of the risk-
utility test . . . .’’ Part II A of the majority opinion. In part II B, the majority
assumes, without deciding, that the plaintiffs’ instructional challenge was
properly preserved at trial. For the reasons identified by the majority, I
have no difficulty concluding that the issue is in fact properly preserved.
Specifically, I agree with the majority that it would elevate form over sub-
stance to refuse to consider the issue on appeal when the trial court resolved
it on the merits after concluding that the legal claim was timely presented.
See part II B of the majority opinion.
2
In part III A of this opinion, I explain why the majority is incorrect when
it contends that all of the references to ‘‘TVT’’ at trial were to the category
of TVT-type retropubic slings modeled on Ethicon’s branded TVT, rather
than to that market-leading product itself. See footnote 14 of the majority
opinion and accompanying text. Unless otherwise noted, all references in
this opinion to the TVT are to the Ethicon product.
3
See, e.g., Izzarelli v. R.J. Reynolds Tobacco Co., 321 Conn. 172, 203–204,
136 A.3d 1232 (2016).
4
Two of these studies, Lim and Moalli, specifically discuss the Ethicon
TVT, rather than the class of TVT-like slings, as the gold standard. See Y.
Lim et al., supra, 21 International Urogynecology J. 1157; P. Moalli et al.,
supra, 19 International Urogynecology J. 656. To the extent that the majority
faults the plaintiffs for not having identified by name the particular studies
that support their reasonable alternative design claim; see footnote 24 of
the majority opinion; the studies that they reference and that I discuss in
this opinion were provided to us in the appendix to the plaintiffs’ brief, and
are the same studies that their experts discussed at length at trial and that
they cited in their arguments to the judge and jury.
5
None of these studies, for example, suggested that the TVT is suitable
only for certain women or only under certain conditions, or only as a
replacement after another sling has been removed, or that it is more expen-
sive than other slings, or otherwise not feasible for patients such as Fajardo.
6
The majority seems to take the position that we should not take Bercik’s
testimony into account for any purpose when considering whether there
was sufficient evidence before the jury to warrant a reasonable alternative
design instruction. The majority argues that (1) although Bercik was dis-
closed as an expert on sling design and design alternatives, and apparently
recognized by the defendants’ counsel as such, he purported to testify only
as a ‘‘treating physician,’’ (2) the plaintiffs do not cite to Bercik’s testimony
in their appellate briefs, (3) the trial court did not consider Bercik’s testimony
when it denied the plaintiffs’ instructional request, and (4) Bercik’s testimony
lacked credibility. See footnotes 12, 13 and 22 of the majority opinion and
accompanying text. First, Bercik’s testimony is cited herein for very limited
purposes, is relied on only as secondary evidence, and is not necessary or
even important to my position—the testimony of Rosenzweig (who testified
that he relied on Bercik’s assessment and testimony in forming his own
opinions) and the various studies and other documents on which he relied
were sufficient to warrant a reasonable alternative design instruction. Sec-
ond, and more generally, I disagree with the majority’s all-or-nothing analysis
with respect to the use of Bercik’s testimony. As I explain in part III C of
this opinion, once Bercik’s testimony was admitted without objection or
limitation, it was available for the jury to use for any purpose; it must be
construed in the light most favorable to the plaintiffs’ request, regardless
of whether the trial court overlooked it or whether the majority deems
it to be credible or deems Bercik to be a fitting expert. Bercik’s notes
recommending that Fajardo consider a TVT were before the trial court when
it considered the plaintiffs’ motion, and, indeed, the defendants’ counsel
himself solicited much of the testimony to which the majority objects. To
the extent that the trial court failed or declined to consider that evidence
of record, that omission was either proper or improper as a matter of law
and was not, as the majority incorrectly posits, a factual ‘‘finding’’ to which
we must defer. Footnote 13 of the majority opinion. I do agree with the
majority that the plaintiffs’ counsel has not relied on Bercik’s testimony on
appeal, and I discount its importance primarily for that reason. That said,
I do not ignore this evidence altogether when it was relied on by Rosenzweig
and reinforces a proposition established by other evidence.
7
I disagree with the majority’s statement that, ‘‘[a]t 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.’’ Part II E of the majority opinion. The significance
of the studies is not so limited. The Moalli study, for example, compared
the Ethicon TVT to five more recently developed slings, including the Obtryx,
and concluded that the TVT ‘‘has a unique tensile behavior’’ that ‘‘in theory
. . . lowers the rate of erosions of a sling into the urethra or bladder.’’ P.
Moalli et al., supra, 19 International Urogynecology J. 662.
8
Although the plaintiffs’ counsel highlighted the Ross and Cholhan studies
to make this point, that was not the only evidence before the jury indicating
that the use of a transobturator design was a defect relative to the TVT.
One study on which Rosenzweig relied, for example, found that ‘‘[t]he compli-
cations of persistent pain and dyspareunia were strikingly more frequent
among [the transobturator] compared to [the retropubic] group.’’ E. Petri &
K. Ashok, ‘‘Comparison of Late Complications of Retropubic and Transobtur-
ator Slings in Stress Urinary Incontinence,’’ 23 International Urogynecology
J. 321, 324 (2012) (Petri study).
9
The majority incorrectly states that ‘‘Rosenzweig identified only the
polypropylene mesh and the heat seal as the defects that caused Fajardo’s
injuries’’ and did not consider the transobturator design of the Obtryx to
be a defect. Part II E of the majority opinion. Boston Scientific itself concedes
that ‘‘Rosenzweig testified that retropubic and nondetanged slings may be
better’’ than the Obtryx. I further address this point in part III A of this opin-
ion.
10
For reasons elaborated in part III B of this opinion, it is of no legal
consequence that Rosenzweig also held the view that all polypropylene
mesh devices (including the TVT) are defective. The jury was entitled to
accept Rosenzweig’s opinion with respect to the Obtryx in particular and
reject his broader opinion regarding the entire class of products.
11
The majority makes no mention of the Tulikangas opinion letter, but the
plaintiffs’ counsel referenced the letter three times during closing argument,
highlighted the fact that Tulikangas believed that the Obtryx is an inferior
product, and referenced the letter in briefing to the trial court.
12
In its brief, Boston Scientific acknowledges that it ‘‘developed the Advan-
tage mesh from which it makes the Obtryx (and all its midurethral slings)
to be substantially similar to other mesh on the market, like the TVT mesh.’’
13
The majority repeatedly contends, erroneously, that some products in
the class of TVT-type slings ‘‘had the exact same defect alleged to have
caused Fajardo’s injuries in this case.’’ Part II E of the majority opinion.
Not so. In fact, the record demonstrates that no TVT-type sling has all of
the defects alleged to make the Obtryx unreasonably dangerous. The jury
reasonably could have found, on the basis of the evidence in the record,
that any TVT-type sling would have reduced at least some of the risks to
Fajardo, such as the risks associated with the use of a transobturator design,
without any offsetting costs or risks. The plaintiffs’ claim, in any event, was
targeted at the Ethicon TVT in particular. See part III A of this opinion.
14
Fajardo’s treating physicians concurred with Rosenzweig that the Obtryx
was the cause of her injuries. Bercik testified that, to a reasonable degree
of medical certainty, the Obtryx had caused Fajardo’s worsening inconti-
nence and dyspareunia. This was consistent with Hines’ recommendation
to Fajardo that she have the mesh removed because it was ‘‘clearly . . .
what’s causing her pain.’’
15
As I previously noted, the majority contends that Rosenzweig’s testi-
mony regarding the dangers created by these particular defects is of no force
because Rosenzweig also believed that the Obtryx was defective because
it contained polypropylene. The logic of this point escapes me. See part III
B of this opinion.
16
The required showing should not be misunderstood. The plaintiff is not
required to show that the alternative design would have avoided or reduced
the plaintiff’s injuries. The legal standard requires evidence only that the
alternative design could avoid or reduce the risk of harm created by the
defendant’s product. See footnote 3 of this opinion. This is not a causation
requirement but, rather, proof that a product is defective because an alterna-
tive would present a reduced risk of harm to a user or consumer. See, e.g.,
Gardner v. Ethicon, Inc., Docket No. 4:20-cv-00067-SAL, 2020 WL 5077957,
*4–5 (D.S.C. August 27, 2020) (rejecting defendant’s argument that plaintiff
was required ‘‘to connect the reasonable alternative design to her specific
injuries’’ by presenting expert testimony that safer alternative design existed
for defective products that would have prevented or reduced plaintiff’s
injuries, and holding that ‘‘the risk-utility test relates to the defectiveness
of the design—not causation’’); Thompson v. Ethicon, Inc., supra, 2020
WL 3893253, *6 (rejecting ‘‘hypertechnical criticism’’ of plaintiff’s expert
testimony and holding that it was enough that expert established that device
was defective and tied that defect to plaintiff’s injuries); Rheinfrank v.
Abbott Laboratories, Inc., 137 F. Supp. 3d 1035, 1040–41 (S.D. Ohio 2015)
(plaintiff need only establish that use of alternative design would reduce
general risk of similar harm for similarly situated patients).
17
I would also add to this list the testimony of Bercik, one of the physicians
who treated Fajardo for her sling related injuries and ultimately removed
the Obtryx. He 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. The majority offers a different
interpretation of Bercik’s opinion on this subject, on the basis of other
testimony of his. See footnote 16 of the majority opinion. Rather than
explaining why I read that testimony differently, it will suffice to say that
the jury should have been allowed to choose which of Bercik’s testimony
to emphasize and whether Bercik’s opinions ultimately supported the plain-
tiffs’ claims.
18
In rejecting this conclusion, the majority relies on generalities and tru-
isms regarding the need for expert testimony in product design defect cases.
See footnote 20 of the majority opinion. Those generic propositions are
unhelpful here because the plaintiffs in this case presented extensive expert
testimony and peer reviewed scientific research studies that permitted the
jury to decide the case. The majority consistently states that expert testimony
is necessary to allow the jury to conclude that there is an alternative design
that is feasible, which is sufficiently safer than the product at issue to render
the latter defective, and that the use of that alternative design would have
reduced the risk of the types of injuries suffered by the plaintiff. Once the
experts and the research studies had demonstrated that there are three
primary design features that distinguish the Obtryx from the TVT, that each
of those three differences makes the Obtryx unnecessarily dangerous, that
those features are defects that caused or contributed to Fajardo’s injuries,
and that the TVT was a viable alternative, it is unclear what more the majority
believes the jury needed to hear from the experts before it could reasonably
conclude that the TVT was a reasonable alternative design, the use of which
would have reduced the risk of the injuries caused by the defective design
of the Obtryx.
19
I reject the majority’s position that, although the plaintiffs (1) disclosed
two experts who would testify as to safer alternatives to the Obtryx, (2)
set forth abundant evidence of a reasonable alternative design, (3) referenced
their ‘‘feasible alternative’’ theory during closing argument, and (4) requested
a reasonable alternative design jury instruction, they nevertheless were not
entitled to such an instruction because they ‘‘took a scattershot approach’’
to arguing the case. Part II E of the majority opinion. It is true that the
plaintiffs and their various expert witnesses offered several different theories
of liability: they argued that the TVT was a reasonable alternative design,
that the Burch procedure is a better treatment option than vaginal mesh,
and that polypropylene is ill-suited for use in medical devices. It is beyond
dispute, however, that a plaintiff is free to present multiple alternative or
even contradictory theories of liability to the jury and is entitled to an
instruction on any of the theories for which there is minimally sufficient
evidence to support a verdict. See, e.g., Meribear Productions, Inc. v. Frank,
328 Conn. 709, 722, 183 A.3d 1164 (2018) (‘‘ ‘a party may plead, in good faith,
inconsistent facts and theories’ ’’); Dreier v. Upjohn Co., 196 Conn. 242, 245,
492 A.2d 164 (1985) (‘‘[u]nder our pleading practice, a plaintiff is permitted
to advance alternative and even inconsistent theories of liability’’). The
question is not whether a reasonable alternative design was the plaintiffs’
only or even principal theory of the case but, rather, whether there was
sufficient evidence before the jury to warrant an instruction. The answer,
quite clearly, in my view, is yes.
20
The majority points to nothing in the record suggesting that the trial
court declined to give the requested instruction for this reason or even
considered the issue.
21
I might quibble as well with other assumptions underlying the majority’s
argument. Its claim, for example, that different TVTs are made from many
different materials finds little, if any, support in the record. See part II E
of the majority opinion. Indeed, the defense expert, Rosenblatt, testified
that, although the brands of polypropylene used may vary, all synthetic
slings are produced from type 1 microporous polypropylene and are ‘‘about
the same’’ and ‘‘extremely similar.’’ Certainly, the jury could have so con-
cluded. But, for reasons of expediency, I will focus my attention on the
most prominent flaws in the majority’s argument.
22
Despite the majority’s statement to the contrary; see footnote 16 of the
majority opinion; Bercik did compare the Ethicon TVT to the Obtryx. He
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. This comparative testimony was not
dwelled on at any length, but it is part of the trial transcript, and it was for
the jury to determine its persuasiveness.
23
Rosenzweig was operating on the same premise, using ‘‘the TVT’’ as
synonymous with the Ethicon branded TVT. When asked whether he
‘‘recall[ed] what the first sling—transvaginal sling, or through the vagina
. . . was called,’’ he responded, ‘‘[t]he TVT.’’
24
Rao was examined as follows:
‘‘Q. So, can you tell me how the Advantage project—[how] you came to
work on that project?
‘‘A. Well, the project started before I was assigned to work on it. And I
was assigned to help to develop a mesh that was very similar to the TVT
mesh that was currently on the market.
‘‘Q. And what were your duties as assigned to the Advantage mesh project?
‘‘A. To characterize the TVT mesh so we understood its structure and
understood what it was made of and to find a manufacturer that could make
a comparable mesh product that we could then test and see if it was indeed
similar to the TVT mesh, and also to look for ways to improve [on] the
existing TVT mesh that was in the field.
***
‘‘A. I’m not 100 percent sure. I know that, by the time I joined, we knew
that the TVT mesh was made from polypropylene, and we also knew that
we, Boston Scientific, had a polypropylene mesh on the market made from
the same—that could be used to knit the structure that we wanted for the
Advantage mesh.
***
‘‘Q. Okay. Now, can you describe to me your responsibilities as technical
team leader for the mesh?
‘‘A. So, my responsibility was to figure out how to make a mesh that was
similar, if not better, than the TVT mesh. So, we needed to figure out what
the TVT mesh was made [of], what its properties were, what its structure
was, and then find a vendor that could knit and heat-set the mesh.
***
‘‘Q. Okay. What changes did you-all actually make to the Advantage mesh
to differentiate your product from [the] TVT?
‘‘A. So we detanged the section that would go under the urethra. If I can
explain that, when you cut a knit structure, there [are] little fibers that stick
out [of] the edges. We smooth those fibers through a heat process so that
they wouldn’t be as kind of prickly to the tissue. And we also made sure
that we cut our mesh very straight.
***
‘‘Q. Did Boston Scientific, during the development of the Advantage mesh,
do testing on the TVT product?
‘‘A. Yes, we did.
***
‘‘Q. Your role, as you indicated earlier, was to basically try to develop a
mesh that was substantially similar to the TVT mesh, right?
‘‘A. Yes.’’
25
In addition, plaintiffs’ exhibit 86, a review of mesh testing data by John
Lehmann, identifies the TVT tested as ‘‘Gynecare’’ and states that ‘‘[t]he
TVT device has a significant clinical record of success . . . .’’ Plaintiffs’
exhibit 87, another study conducted by another Boston Scientific consultant,
likewise identifies ‘‘the commercially available TVT device’’ with Gynecare.
26
In complex civil cases such as medical malpractice actions, it is not at
all uncommon for plaintiffs to prove their case through the combined testi-
mony of various experts and treating physicians. See, e.g., Mather v. Griffin
Hospital, 207 Conn. 125, 136, 540 A.2d 666 (1988) (holding that causation
was adequately established and that deficiencies in testimony of plaintiffs’
primary expert were filled by testimony of other experts and hospital staff).
To impose an artificial requirement that one single expert make one pro-
nouncement that explicitly establishes breach and causation is legally
groundless and could potentially wreak havoc on litigation of this sort.
27
Although the majority cites various cases—most of them from Iowa—
regarding the need for expert testimony, none of those cases supports the
position taken by the majority, which is that, in a case such as this, one single
designated product design expert must testify clearly and unequivocally as
to every element of the plaintiff’s claim and every step in the logical process.
Rather, the cited cases qualify the need for expert testimony in all sorts of
ways and largely stand only for the unremarkable proposition that some
expert testimony is necessary to establish some elements of most product
design defect cases. See, e.g., Water Pollution Control Authority v. Flow-
serve US, Inc., 782 Fed. Appx. 9, 15 (2d Cir. 2019) (‘‘expert knowledge is
often required in such circumstances’’ and holding that expert testimony
was required as to specific technical aspects of plaintiff’s particular claim
(emphasis added)); Willet v. Johnson & Johnson, 465 F. Supp. 3d 895, 905
(S.D. Iowa 2020) (‘‘Whether expert testimony is required ultimately depends
on whether it is a fact issue upon 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 products liability action, the
plaintiff must supply sufficient evidence to satisfy the trial court that the
jury, with its common knowledge, could reasonably find an alternative design
to be practicable and feasible.’’ (Citations omitted; internal quotation marks
omitted.)); 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 which 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 which cannot be fully understood by the average
juror without some expert assistance . . . .’’ (Emphasis added; internal
quotation marks omitted.)); Benedict v. Zimmer, Inc., 405 F. Supp. 2d 1026,
1032–33 (N.D. Iowa 2005) (‘‘Although the . . . Restatement (Third) does
not require expert testimony in every case, the plaintiff must rely on expert
testimony in many cases. . . . Expert testimony as to the existence of a
design defect is not required when the feasibility of a reasonable alternative
design is obvious and understandable to laypersons. . . . 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.’’
(Citations omitted; emphasis added.)). Critically, in each of these cases
relied on by the majority, the plaintiffs had provided no admissible expert
testimony whatsoever, and, so, unlike in the present case, the question
before the court was simply whether the jury could identify a product defect
and/or a reasonable alternative design without any expert assistance.
28
Section 8-3 (8) of the Connecticut Code of Evidence provides: ‘‘To the
extent called to the attention of an expert witness on cross-examination or
relied on by the expert witness in direct examination, a statement contained
in a published treatise, periodical or pamphlet on a subject of history,
medicine, or other science or art, recognized as a standard authority in the
field by the witness, other expert witness or judicial notice [is not excluded
by the hearsay rule].’’
29
The Appellate Court discussed this principle at some length in Procac-
cini, explaining how, even if expert evidence is offered strictly for one
specific purpose, once it has been admitted in full, the jury may use it for
any purpose. The onus is on the opposing party to seek a limiting instruction
or otherwise object. See Procaccini v. Lawrence + Memorial Hospital, Inc.,
supra, 175 Conn. App. 714–15, 723–24. The majority offers no reason why
the same principle should not apply in the present case.
30
Similarly, if a party objects and the trial court is concerned that the
jury would be confused or misled by examining the materials unaided by
expert testimony, the court may decline to admit the materials. See, e.g.,
Cross v. Huttenlocher, 185 Conn. 390, 397, 440 A.2d 952 (1981). Huttenlocher
is instructive because, in that case, the trial court properly declined to admit
a medical study that addressed a drug similar, but not identical, to the one
at issue and found side effects different from those alleged. See id., 398.
The clear implication of this court’s decision in Huttenlocher is that, had
the study been more directly on point, as are the studies at issue in the
present case, reading and drawing conclusions from the study would have
been well within the purview of the jury.
31
It bears emphasizing in this regard that Connecticut has a more liberal
rule governing the use of scientific journal articles and other learned treatises
than do many of our sister states. See, e.g., Filippelli v. Saint Mary’s
Hospital, supra, 319 Conn. 135–36. Specifically, once an expert witness has
qualified an article as admissible under § 8-3 (8) of the Connecticut Code
of Evidence, that article may be admitted as a full exhibit and, if not otherwise
limited by the trial court, used by the jury for any purpose during its delibera-
tions, despite ‘‘the danger of misunderstanding or misapplication by the jury
. . . .’’ (Internal quotation marks omitted.) Id., 140; see E. Prescott, Tait’s
Handbook of Connecticut Evidence (6th Ed. 2019) § 7.9.1, p. 469.
32
Although it is impossible to know for certain what was said in chambers,
the plaintiffs have represented that the trial court indicated that it was aware
of but declined to consider certain potentially relevant evidence, such as
the cited studies.