Fajardo v. Boston Scientific Corp.Fajardo v. Boston Scientific Corp.
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Syllabus
Pursuant to this court‘s decision in Bifolck v. Philip Morris, Inc. (324 Conn. 402), under the risk-utility test, a product is in a defective condition that is unreasonably dangerous to the consumer if (1) a reasonable alternative design that would have avoided or reduced the risk of harm was available and the absence of that alternative design renders the product unreasonably dangerous, or (2) the product is a manifestly unreasonable design in that the risk of harm so clearly exceeds the product‘s utility that a reasonable consumer, informed of those risks and utility, would not purchase the product.
The plaintiffs, F and F‘s husband, sought to recover damages from, among others, the defendant L, who was F‘s gynecologist, L‘s medical practice, and the defendant B Co. for personal injuries that F sustained in connection with an unsuccessful surgery in which a transvaginal mesh sling designed by B Co., known as the Obtryx, was implanted in F‘s body for the purpose of treating F‘s stress urinary incontinence. During F‘s annual health examination, L diagnosed F with pelvic organ prolapse and recommended that he perform a surgical repair known as a colporrhaphy. L also recommended that F undergo a sling procedure to rectify her stress urinary incontinence. Because L did not perform the sling procedure, he referred F to P, a urologist. P described to F the risks and benefits of, and alternatives to, the sling procedure, and F gave P her informed consent to proceed with both the colporrhaphy and the sling procedure. The procedures were scheduled for the same day but performed consecutively. Immediately after L performed the colporrhaphy, P implanted the Obtryx in F. Thereafter, F continued to experience pain and had the Obtryx removed. The plaintiffs’ complaint included claims against L and L‘s medical practice, alleging that L had failed to obtain F‘s informed consent to the sling procedure and that L made innocent, negligent or intentional misrepresentations regarding the risks and benefits of the sling procedure. The complaint also alleged a product liability claim against B Co. under the Connecticut Product Liability Act (
- The trial court properly rendered summary judgment for L and L‘s medical practice in connection with the plaintiffs’ informed consent claim: this court previously had concluded, as a matter of law, that the duty to obtain a patient‘s informed consent rests solely with the physician who is to perform the procedure, and that jurisprudence was consistent with the rule recognized by most jurisdictions and legal and medical authorities that, when a physician refers a patient to a specialist for a consultation and that specialist performs the procedure, the specialist is solely responsible for educating the patient and obtaining her informed consent, even when the referring physician discussed the procedure with, or recommended it to, the patient; in the present case, the implantation of the Obtryx by P was an entirely separate procedure from the colporrhaphy performed by L, P was solely responsible for the sling procedure, even though L suggested it to F and referred her to P, and the trial court properly relied on the unanimous expert testimony presented at trial that the physician who performs a procedure, and not the referring physician, has the duty to obtain the patient‘s informed consent to the procedure; moreover, the plaintiffs’ reliance on the lay standard of informed consent, which relates to the extent or degree of disclosure a physician must make to fulfill his duty rather than whether a physician has a duty to inform, was misplaced because L did not have a duty to obtain F‘s informed consent in the first instance; furthermore, even if this court were to consider the colporrhaphy and the sling procedure to be a single procedure, the plaintiffs’ claim would nonetheless fail because, when more than one physician provides care to a patient in relation to a particular medical condition, the patient must prove by expert testimony which physician, if any, owes the patient a duty to obtain informed consent, and all the experts testified at trial that it was the duty of P, not L, to obtain F‘s informed consent to the sling procedure.
- The trial court properly rendered summary judgment for L and L‘s medical practice in connection with the plaintiffs’ misrepresentation claims: this court recently held that an innocent misrepresentation claim is not viable in the context of a urogynecologist‘s provision of medical services because such claims generally are governed by
§ 552C of the Restatement (Second) of Torts , which requires that the misrepresentation occur in a “sale, rental or exchange transaction with another,” and the plaintiffs’ innocent misrepresentation claim failed as a matter of law because the only medical services L provided to F, namely, recommending that F see a specialist and discussing the sling procedure, did not qualify as a sale, rental or exchange transaction; moreover, the plaintiffs’ negligent and intentional misrepresentation claims also failed because L could not have negligently or intentionally misled, misinformed or misrepresented the quality, usefulness, risks or benefits of the Obtryx in light of the trial court‘s findings that L was unaware of what brand of sling P planned to implant in F and that L never discussed with F the Obtryx or any other products manufactured by B Co. - The plaintiffs could not prevail on their claim that the trial court improperly declined to instruct the jury on the reasonable alternative design prong of the risk-utility test:
- This court assumed, without deciding, that the plaintiffs preserved their challenge to the trial court‘s jury instruction for purposes of this appeal because, even though the plaintiffs did not take exception to the instruction until after the jury was instructed and even though their e-mail request to charge the jury did not comply with the relevant rules of practice (
§§ 16-21 and16-23 ) insofar as it neither constituted a written request nor cited to any supporting evidence in the record, the trial court nonetheless determined that the plaintiffs timely requested a reasonable alternative design charge and addressed the claim on the merits. - In order to establish that they were entitled to an instruction on reasonable alternative design, the plaintiffs were required to present expert testimony regarding the alleged design defect of the Obtryx, whether an alternative design was technically and economically feasible, and whether the alternative would have reduced or avoided the risk of harm to F, as those issues involved complicated medical principles that were beyond the ken of the average juror; in the present case, the trial court determined, and the plaintiffs agreed, that R was the plaintiffs’ product design expert, and, because the trial court correctly concluded that R was the only witness qualified to testify concerning reasonable alternative design, it properly focused on R‘s testimony in considering whether the plaintiffs had produced sufficient evidence to warrant such an instruction.
- The plaintiffs failed to produce sufficient evidence that the class of retropubic slings consisting of TVTs constituted a reasonable alternative design to the Obtryx and that B Co.‘s failure to use that alternative design rendered the Obtryx unreasonably dangerous: the plaintiffs’ references to TVTs did not constitute identification of a reasonable alternative design, as the evidence demonstrated that the safety data related to TVT products, which can be made of many different types of mesh material with different pore sizes and weights that alter the performance of those products, varied considerably, and, to the extent that there was evidence regarding the safety data of TVTs, the studies the plaintiffs relied on indicated merely that there were risks and complications with the use of TVT products, not that there was another product on the market that would have reduced the risk of harm to F in comparison to the Obtryx; moreover, some TVT products suffer from the same alleged defects as the Obtryx, namely, its heat seal and detanged edges, R testified that all transvaginal slings, including a specific TVT, made of polypropylene mesh are defective and unreasonably dangerous, regardless of whether they are heat-sealed or detanged, and the primary medical study on which the plaintiffs relied compared the Obtryx to a TVT manufactured by B Co., which was made of the same material and had the same heat seal as the Obtryx, and, therefore, did not support the plaintiffs’ claim that there was a reasonable alternative design that would have reduced or avoided the risk of harm to F; furthermore, the plaintiffs did not point to a specific existing product and demonstrate that its use would have reduced or avoided the risk of harm to F but, rather, took a scattershot approach, pointing to different alternatives to the Obtryx, including surgical options, such as the Burch procedure, and the class of products known as TVTs, and that evidence did not demonstrate that any particular product was safer or would have reduced or avoided the risk of harm to F when compared to the Obtryx.
- This court assumed, without deciding, that the plaintiffs preserved their challenge to the trial court‘s jury instruction for purposes of this appeal because, even though the plaintiffs did not take exception to the instruction until after the jury was instructed and even though their e-mail request to charge the jury did not comply with the relevant rules of practice (
(One justice concurring in part and dissenting in part)
Argued April 27, 2020—officially released December 16, 2021*
Procedural History
Action to recover damages for, inter alia, personal injuries resulting from an allegedly defective product, and for other relief, brought to the Superior Court in the judicial district of Stamford-Norwalk and transferred to the Complex Litigation Docket, where the complaint was withdrawn as to the defendant Bridgeport Hospital; thereafter, the court, Zemetis, J., granted the motions for summary judgment filed by the defendant Lee Jacobs et al. and rendered judgment thereon; subsequently, the case was tried to a jury before Zemetis, J.; verdict for the named defendant; thereafter, the court denied the plaintiffs’ motion to set aside the verdict and rendered judgment in accordance with the verdict, from which the plaintiffs appealed. Affirmed.
Brenden P. Leydon and Jacqueline E. Fusco, for the appellants (plaintiffs).
Daniel B. Rogers, pro hac vice, with whom were Proloy K. Das, Jennifer M. DelMonico and Eric Anielak, pro hac vice, for the appellee (named defendant).
James F. Biondo, with whom, on the brief, was Diana M. Carlino, for the appellees (defendant Lee Jacobs et al.).
Opinion
The plaintiffs also brought, inter alia, claims of negligence sounding in informed consent and misrepresentation against Fajardo‘s gynecologist, the defendant Lee D. Jacobs, and Jacobs’ medical practice, the defendant OB-GYN of Fairfield County, P.C. (medical defendants).5 Their claims against the medical defendants rest on the theory that Jacobs, who referred Fajardo to Paraiso for a mesh sling implant, voluntarily assumed a duty to fully and accurately educate Fajardo as to the risks and benefits of, and the alternatives to, a mesh
Prior to trial, the trial court granted the medical defendants’ motion for summary judgment, concluding, as a matter of law, that Jacobs, as a referring physician, had no duty to obtain Fajardo‘s informed consent for a procedure that Paraiso was to perform. The court also rendered summary judgment in favor of the medical defendants on the plaintiffs’ misrepresentation claims. Thus, the case proceeded to trial only against Boston Scientific, and the jury returned a verdict in its favor. The plaintiffs moved to set aside the verdict, but the trial court denied that motion and rendered judgment in accordance with the jury‘s verdict. This appeal followed.6
On appeal, the plaintiffs claim that the trial court (1) incorrectly concluded that Jacobs did not owe a duty to procure Fajardo‘s informed consent to the sling procedure, (2) improperly rendered summary judgment in favor of the medical defendants on the plaintiffs’ misrepresentation claims, and (3) improperly failed to instruct the jury that it could find Boston Scientific liable under the Connecticut Product Liability Act if Fajardo‘s injuries resulted from Boston Scientific‘s failure to adopt a reasonable alternative design that ren-dered the Obtryx unreasonably dangerous. We conclude that the trial court properly rendered summary judgment in favor of the medical defendants on the informed consent and misrepresentation claims and that it properly declined to instruct the jury on the reasonable alternative design prong of the risk-utility test. Accordingly, we affirm the judgment of the trial court.
I
CLAIMS AGAINST MEDICAL DEFENDANTS
A
Informed Consent Claim
The plaintiffs assert that the trial court improperly rendered summary judgment in favor of the medical defendants because it incorrectly concluded that Jacobs had not assumed a duty to obtain Fajardo‘s informed consent for implantation of the mesh sling and the sling procedure. Specifically, the plaintiffs argue that Jacobs assumed the duty by discussing and recommending the sling procedure to treat Fajardo‘s stress urinary incontinence. The plaintiffs also claim that Jacobs had a duty to obtain Fajardo‘s informed consent because Jacobs was involved in or maintained control over the surgical procedure performed by Paraiso. Neither claim has merit.
The following facts and procedural history are relevant to this claim. On March 26, 2010, Fajardo visited Jacobs, her gynecologist, for her annual preventative health examination. During that visit, Fajardo consulted with Jacobs about her gynecological and urological concerns. In his medical notes for this appointment, Jacobs noted that ” [the] patient complains of stress incontinence daily, very disruptive, she wants surgical repair. ”
After a physical examination, Jacobs diagnosed Fajardo with pelvic organ prolapse—a weakness in the vaginal wall that causes the bladder, colon, or rectum to herniate into the vagina. Specifically, Jacobs determined that Fajardo suffered from a grade 2 cystocele (prolapse of the
Also, during or as a result of this appointment, Jacobs wrote an office note, in which he stated that the ” ‘risks, benefits, and alternatives of sling/AP (anterior and posterior colporrhaphy) discussed, all questions answered. ” (Footnote added; footnote omitted.) Then, as he had with numerous other similarly situated patients, he referred Fajardo to Paraiso, a urologist, for consultation and evaluation regarding her stress urinary incontinence.
On April 10, 2010, Fajardo consulted with Paraiso. He diagnosed her with stress urinary incontinence and recommended that she consent to having Paraiso surgically implant a midurethral mesh sling to treat it. Paraiso described the risks and benefits of, and alternatives to, the procedure. He then obtained Fajardo‘s “oral ‘informed consent’ ” to proceed with surgical repairs to both her vaginal walls (a colporrhaphy performed by Jacobs) and urethra (a mesh sling implant performed by Paraiso).
Paraiso also discussed with Fajardo that both procedures would occur on the same day in a hospital surgical setting. Fajardo thereafter signed two separate consent forms, one for the A/P repair to be performed by Jacobs, and one for the sling procedure to be performed by Paraiso. Paraiso then communicated this plan to Jacobs.
On December 15, 2010, Fajardo signed Bridgeport Hospital‘s informed consent form, after having read and discussed it with Jacobs. Thereafter, Jacobs surgically repaired Fajardo‘s vaginal walls. Paraiso was not present during Jacobs’ portion of the surgery. On the same day, immediately following Jacobs’ procedure, Paraiso surgically implanted the Obtryx in Fajardo to address the stress urinary incontinence. Jacobs was not present during Paraiso‘s procedure. Jacobs also was not aware of the type of mesh sling Paraiso implanted into Fajardo. Furthermore, Paraiso is not associated with the medical defendants and is not a party to this action. The plaintiffs also do not allege that Jacobs had any vicarious liability for Paraiso‘s actions.
After these surgeries, Fajardo still experienced pain. Eventually, the sling had to be removed. As a result of her continued issues, and her belief that Jacobs had assumed a duty but failed to adequately inform her of the risks associated with the sling procedure, the plaintiffs brought claims against the medical defendants, alleging, inter alia, lack of informed consent, as well as intentional, negligent and innocent misrepresentation.
Before trial, the plaintiffs moved for summary judgment. They claimed that they were entitled to summary judgment in connection with their informed consent claim against Jacobs because Jacobs “voluntarily assumed the duty to obtain informed consent from . . . Fajardo for implantation of the mesh sling and the mesh sling procedure when he recommended the sling procedure, informed her that it was mesh that would be permanently implanted into her to treat
The medical defendants also filed a motion for summary judgment on the informed consent issue. In support of their motion, the medical defendants asserted that Jacobs was not obligated to obtain Fajardo‘s informed consent for implantation of the mesh sling and the sling procedure because he was not the physician who performed that procedure. The medical defendants relied on testimony from both their own and the plaintiffs’ experts, who all agreed that it was Paraiso‘s duty—as the physician performing the surgery—to obtain Fajardo‘s informed consent for implantation of the mesh sling and the sling procedure.
Although the plaintiffs and the medical defendants gave slightly different accounts of the conversations that occurred during the March 26, 2010 appointment, both the plaintiffs and the medical defendants agreed that there were no disputed issues of material fact relevant to the informed consent claim. They agree that the issue for the trial court was whether, on the undisputed facts that Jacobs had discussed and recommended the sling procedure to Fajardo, as a matter of law, Jacobs was obligated to obtain Fajardo‘s informed consent.
The trial court denied the motion for summary judgment filed by the plaintiffs and granted the motion for summary judgment filed by the medical defendants. In doing so, the trial court explained: “[The plaintiffs urge] the court to impose a duty on Jacobs to obtain [Fajardo‘s] informed consent for Paraiso‘s implant of the [Boston Scientific] mesh because Jacobs ‘assumed a duty’ when, according to Jacobs’ . . . office note [dated March 26, 2010], [he made the notation that] the ‘risks, benefits, and alternatives of sling/AP surgery discussed, all questions answered.’ The court rejects this request.” (Footnote omitted.) In rejecting that request, the trial court relied on Logan v. Greenwich Hospital Assn., 191 Conn. 282, 465 A.2d 294 (1983), in which this court concluded that “[t]he principle that one who gratuitously undertakes a service [that] he has no duty to perform must act with reasonable care in completing the task assumed is not applicable to” a physician who discussed a procedure with a patient but then referred the patient to another physician to perform the surgery. Id., 305.
The trial court concluded that, in the present case, “Jacobs was a referring physician regarding the urological surgery performed by Paraiso. Jacobs is not alleged to have any vicarious liability for the conduct of Paraiso.” The trial court further concluded that the duty to obtain informed consent “rests [with] the physician performing the procedure. The procedure is the mesh implant. Paraiso performed the implant. Paraiso, not Jacobs, had to obtain [Fajardo‘s] informed consent for the surgical implantation of the [Boston Scientific] mesh product.”
On appeal, the plaintiffs assert that the trial court misapplied Logan v. Greenwich Hospital Assn., supra, 191 Conn. 305, in concluding that a physician can never assume a duty of obtaining informed consent. We read neither Logan nor the trial court‘s interpretation of that decision as concluding that a physician can never assume a such duty. Rather, as we explain herein, we agree with the medical defendants that, under the circumstances of the present case and without expert testimony to the contrary, the physician conducting the vaginal mesh implantation surgery was responsible for obtaining Fajardo‘s informed consent.
We begin our analysis with a brief review of the law of informed consent. “The informed consent doctrine derives from the principle that [e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient‘s consent commits an assault, for which he is liable in damages.” (Internal quotation marks omitted.) Sherwood v. Danbury Hospital, 278 Conn. 163, 180, 896 A.2d 777 (2006). “The essential elements of a cause of action based [on] a lack of informed consent are [1] a breach of [2] duty by the defendant and [3] a causal connection between that breach and [4] the harm to the plaintiff.” Lambert v. Stovell, 205 Conn. 1, 6, 529 A.2d 710 (1987). Only the second element, duty, is at issue in the present appeal.
In the realm of informed consent, as throughout the law of tort, “[t]he existence of a duty is a question of law and [o]nly if such a duty is found to exist does the trier of fact then determine whether the defendant violated that duty in the particular situation at hand. . . . If the court determines, as a matter of law, that a defendant owes no duty to a plaintiff, a verdict should be directed [or summary judgment rendered] because [i]t is merely reaching more speedily and directly a result [that] would inevitably be reached in the end.” (Citation omitted; internal quotation marks omitted.) Petriello v. Kalman, 215 Conn. 377, 382–83, 576 A.2d 474 (1990).
Several of our informed consent cases have presented, in one form or another, the issue of whether a physician or institution may owe a duty to obtain a patient‘s informed consent to a procedure that is to be performed by a third-party physician. In each case, this court has concluded, as a matter of law, that the physician who performed the procedure was solely responsible for obtaining the patient‘s informed consent. See, e.g., Sherwood v. Danbury Hospital, supra, 278 Conn. 171 n.8 (treating physician, rather than hospital, is responsible for procuring patient‘s informed consent); Petriello v. Kalman, supra, 215 Conn. 385 (“informed consent . . . is the sole responsibility of the attending physician to obtain“); Logan v. Greenwich Hospital Assn., supra, 191 Conn. 304–306 (internist who discussed kidney biopsy with patient and referred her to urologist to obtain biopsy did not assume duty to procure patient‘s informed consent). The Appellate Court has reached the same conclusion. See, e.g., Torres v. Carrese, 149 Conn. App. 596, 622–23, 90 A.3d 256, cert. denied, 312 Conn. 912, 93 A.3d 595 (2014); Mason v. Walsh, 26 Conn. App. 225, 230–31, 600 A.2d 326 (1991), cert. denied, 221 Conn. 909, 602 A.2d 9 (1992).
Those results are consistent with the rule, recognized by other jurisdictions and legal and medical authorities, that, when a physician refers a patient to a specialist for a consultation, it is the specialist—assuming that he ultimately performs the procedure at issue—who is solely responsible for educating the patient and obtaining her informed consent. See, e.g., Brotherton v. United States, Docket No. 2:17-CV-00098-JLQ, 2018 WL 3747802, *4 (E.D. Wn. August 7, 2018) (“the majority of jurisdictions that have addressed whether referring physicians have a duty to obtain a patient‘s informed consent have concluded that they do not” (internal quotation marks omitted)); 61 Am. Jur. 2d 314, Physicians, Surgeons, and Other Healers § 168 (2012) (“only the physician or health care provider who actually gives the treatment or performs the operation has a duty to inform the patient of the risks involved and [to] obtain the patient‘s informed consent“).
As one federal court has explained, “[t]his makes common sense. The physician performing a procedure should advise on the risks of the procedure. When a primary care physician refers a matter to a specialist, it is not logical to impose a legal duty on the primary care physician to explain the risk of a procedure [that] the specialist may perform. Generally the reason for the referral to a specialist is because the specialist has more training, knowledge, or experience in the particular area of medicine.” Brotherton v. United States, supra, 2018 WL 3747802, *5.
In Connecticut, Logan v. Greenwich Hospital Assn., supra, 191 Conn. 282, is the seminal case regarding the duty of a referring physician to obtain informed consent. In Logan, this court examined whether the plaintiff‘s internal medicine specialist (internist) had a duty to obtain the plaintiff‘s informed consent for a needle biopsy of her kidney that was performed by a different physician. See id., 304–306. The internist had informed the patient that she had lupus and recommended that she get a biopsy of her kidneys to determine to what extent the lupus had affected her kidneys. Id., 284–85. The internist explained that the procedure would involve the insertion of a needle into her back to obtain a specimen of kidney tissue. Id., 285. He further explained that it was a simple procedure in which local anesthesia would be used, that she may experience some bleeding and discomfort, and that she could leave the hospital in a day or two if there were no complications. Id.
The internist referred the plaintiff to Peter Bogdan, a urologist who would perform the operation, and told the patient that Bogdan would describe the details more fully. Id. Bogdan performed the needle biopsy and injured the plaintiff during the procedure. Id., 286–87. The plaintiff brought a claim of negligence against the internist for failure to obtain her informed consent. Id., 287. The trial court denied the internist‘s motion for a directed verdict, but the jury nonetheless returned a verdict in favor of the internist. The plaintiff appealed. Id., 284.
On appeal, this court concluded that the trial court should have granted the internist‘s motion for a directed verdict. In doing so, this court explained: “Although it is undisputed that [the internist] did discuss the kidney biopsy with the plaintiff and describe the procedure generally, there was no evidence that it was his duty to do so. In fact, the testimony indicated the contrary. The plaintiff‘s expert witness
In reaching this conclusion, this court expressly rejected the voluntary assumption of duty principle on which the plaintiffs rely in the present case. In Logan, the plaintiff claimed that the internist, by discussing the biopsy procedure with her, assumed and therefore owed a duty to the plaintiff to obtain her informed consent. Responding to this claim, this court clarified that “[t]he principle that one who gratuitously under-takes a service [that] he has no duty to perform must act with reasonable care in completing the task assumed is not applicable to this situation. . . . Although [the internist] did describe the general nature of the operation to the plaintiff and some of the possible complications, he also told her that a more detailed explanation would be provided by Bogdan, the urologist. There is no evidence that his reliance [on] the operating surgeon to provide the information necessary for informed consent was contrary to normal medical practice or was unreasonable under these particular circumstances.” (Citations omitted.) Id.
Logan is in line with the rule followed in most jurisdictions, which is that the physician conducting the surgery is the one who owes the duty of obtaining the patient‘s informed consent. This rule applies even under circumstances in which the referring physician discusses the surgical procedure with the patient and recommends that the patient undergo the procedure. Logan teaches that it is the physician who performs the actual procedure who is responsible for obtaining the informed consent to that procedure.
In the present case, Jacobs, Paraiso and the plaintiffs all agree that the implantation of the sling, performed by Paraiso, was a separate procedure from the repair to the vaginal wall performed by Jacobs. And Paraiso was solely responsible for performing the sling procedure. Thus, like the internist in Logan, notwithstanding the fact that Jacobs may have mentioned the sling procedure or even suggested that Fajardo may be a good candidate for the sling procedure, the fact remains that Jacobs referred her to Paraiso, the specialist, for further consultation. The plaintiffs presented no evidence to undermine the fact that Paraiso, as the physician who performed the sling procedure, was the physician responsible for obtaining Fajardo‘s informed consent.
In fact, here, as in Logan, even the plaintiffs’ experts explained that the physician who performs the surgery is required to obtain a patient‘s informed consent, not the referring physician. Indeed, the plaintiffs’ expert, Richard Bercik, a urologist, testified: “[T]he surgeon who is doing the procedure is responsible for the evaluation of the patient for that condition, the selection of how they‘re going to do the surgery, what they‘re going to do, and informing the patient. That‘s all [in] the hands of the person doing the procedure.” The medical defendants’ expert also agreed that it was the duty of the surgeon who performed the implantation procedure to obtain the patient‘s informed consent for that procedure and not the referring physician.
In rendering summary judgment, the trial court relied on the fact that “all disclosed medical experts agree [that] Paraiso, not Jacobs, had to obtain [Fajardo‘s] informed consent for the implant[ation] of the mesh product.” We conclude that the trial court properly relied on the unanimous expert testimony to support its conclusion
The plaintiffs also raise a similar but slightly different argument to support their claim that Jacobs had a duty to obtain Fajardo‘s informed consent to the sling procedure. In particular, they argue that, because Jacobs was Fajardo‘s gynecologist and she had established a high level of trust with him, she expected and trusted him to give her the information necessary for her to give informed consent. For support, they rely on the lay standard of informed consent adopted in Logan. They claim that the lay standard requires this court to determine whether a particular physician has a duty to obtain informed consent based on the patient‘s perspective of the interaction, instead of by relying on expert testimony regarding common practices in the medical community. We disagree.
In Logan v. Greenwich Hospital Assn., supra, 191 Conn. 282, this court concluded that, in order to obtain informed consent from a patient, a physician must “provide the patient with that information [that] a reasonable patient would have found material for making a decision whether to embark [on] a contemplated course of therapy.” Id., 292–93. This standard is referred to as the “lay standard of disclosure” because it focuses on what information a reasonable patient would want to know about a particular procedure in order to give his or her informed consent. Id.
We have made clear that “[o]ur standard of disclosure for informed consent in this state is an objective standard that does not vary from patient to patient based on what the patient asks or what the patient would do with the information if it were disclosed. . . . [T]he lay standard of informed consent requires a physician to provide the patient with that information [that] a reasonable patient would have found material for making a decision whether to embark [on] a contemplated course of therapy. . . . In adopting the objective lay standard, this court recognized that rather than impose on the physician an obligation to disclose at his peril whatever the particular patient might deem material to his choice, most courts have attempted to frame a less subjective measure of the physician‘s duty.” (Citation omitted; emphasis omitted; internal quotation marks omitted.) Duffy v. Flagg, 279 Conn. 682, 692, 905 A.2d 15 (2006).
Contrary to the plaintiffs’ assertion, the lay standard adopted in Logan does not speak to whether a physician has a duty to inform, but, rather, the standard governs how a physician who has a duty to obtain informed consent fulfills that duty. In other words, the lay standard applies only to the content of the disclosure that must be made. It is only once the duty to inform is established that the lay standard dictates how that duty must be satisfied. See Mason v. Walsh, supra, 26 Conn. App. 230 (“[o]nce the existence of the duty to inform has been established, the degree or extent of disclosure necessary to satisfy the duty must be proven in accordance with the lay standard“). If the physician does not have a duty in the first instance, the lay standard simply does not apply. Here, Jacobs never had the duty to obtain Fajardo‘s informed consent for the mesh implantation procedure. Thus, for purposes of determining whether Jacobs had a duty to inform at all, the lay standard does not inform that question.
Lastly, the plaintiffs claim that, because the two surgeries here took place on the same day and Jacobs maintained control over the procedures, he thus owed a duty to obtain Fajardo‘s informed consent.
First, it is undisputed that the two surgeries were separate procedures, performed by different physicians with different training and specialties. Jacobs was not present when Paraiso performed the implantation procedure. Most important, it is undisputed that it was Paraiso, not Jacobs, who decided which vaginal mesh to implant in Fajardo, consistent with normal medical practice. The plaintiffs have failed to point to any evidence to support their claim that Jacobs retained control over the implantation of the surgical mesh, which occurred during a different surgery. Thus, the fact that these distinct surgeries took place on the same day does not establish that Jacobs maintained control over the separate procedure performed by Paraiso. As a factual matter, then, this is not a scenario in which multiple physicians were performing or involved in a single surgical procedure.8
Second, even if we were to consider both surgeries as one surgical procedure, despite all of the evidence to the contrary, the plaintiffs’ claim still fails because they provided no expert testimony to demonstrate that Jacobs had any duty to obtain Fajardo‘s informed consent. To be sure, this court has clarified that, when more than one physician provides care to the plaintiff, in relation to a particular medical condition, the plaintiff must prove by expert testimony which physician, if any, owes the plaintiff a duty to obtain informed consent. See Godwin v. Danbury Eye Physicians & Surgeons, P.C., 254 Conn. 131, 144, 757 A.2d 516 (2000), citing Mason v. Walsh, supra, 26 Conn. App. 230; see also Mason v. Walsh, supra, 230 (“[When] . . . a surgeon engages one or more specialists to perform a portion of a procedure, the issue as to who has the duty to obtain the patient‘s consent to that portion of the procedure to be performed by the specialist arises. It was incumbent [on] the plaintiff to establish by expert testimony which of the physicians, if any, owed him the duty of disclosing sufficient facts to permit him to exercise an informed consent to the use of general anesthesia.” (Emphasis added.)).
In the present case, even Bercik, the plaintiffs’ expert, a urogynecologist and reconstructive surgeon, and professor of female pelvic medicine, agreed with Jacobs and Paraiso that, as a general matter, it is the consulting surgeon who is going to perform the procedure who is responsible for evaluating the patient, selecting the appropriate treatment, and educating the patient regarding that procedure. Frederick Rau, the medical defendants’ expert, a board certified obstetrician and gynecologist, agreed that, under circumstances such as these, “[t]he referring physician has no medical duty or responsibility to obtain a patient‘s informed consent for a surgical procedure he/she is not going to perform. . . . [I]n this case . . . Jacobs acted entirely reasonably in discussing a potential sling procedure with [Fajardo], but he had no duty to obtain [her] informed consent for the ultimate sling procedure that was performed.” Thus, not a single expert testified that Jacobs had a duty to
Based on the foregoing, we conclude that the trial court properly rendered summary judgment in favor of the medical defendants in connection with the informed consent claim.
B
Misrepresentation Claims
The plaintiffs also claim on appeal that the trial court improperly rendered summary judgment in favor of the medical defendants on the claims of innocent, negligent, and intentional misrepresentation. We disagree.
First, this court recently concluded that a claim of innocent misrepresentation against a urogynecologic surgeon did not lie as a matter of law. See Farrell v. Johnson & Johnson, 335 Conn. 398, 421, 238 A.3d 698 (2020). In so concluding, this court explained that the surgeon‘s “provision of medical services did not qualify as a ‘sale, rental or exchange transaction’ under
Second, we agree with the trial court that the plaintiffs’ claims of negligent and/or intentional misrepresentation also fail. The trial court found that “Jacobs was unaware of what kind of a sling Paraiso planned to implant in [Fajardo].” Indeed, the trial court also found that “the parties agree [that] Jacobs never discussed [Boston Scientific] products with [Fajardo].” Thus, because Jacobs did not know what product Paraiso would implant in Fajardo and never discussed Boston Scientific products with Fajardo, he could not have negligently or intentionally misled, misinformed or misrepresented the quality, usefulness, risks and benefits of the Obtryx.
Accordingly, we conclude that the trial court properly rendered summary judgment in favor of the medical defendants on the plaintiffs’ misrepresentation claims.
II
INSTRUCTIONAL ERROR CLAIM AGAINST BOSTON SCIENTIFIC
We next turn to the plaintiffs’ claim that the trial court improperly declined to charge the jury on the reasonable alternative design prong of the risk-utility test. Specifically, the plaintiffs claim that they introduced sufficient evidence that the tension free vaginal tape (TVT)9 was a safer reasonable alternative design to Boston
Even if we assume, for purposes of this appeal, that the request for a reasonable alternative design instruction was timely and properly made, we agree with the trial court that the evidence did not support such an instruction. Accordingly, we affirm the judgment of the trial court.
A
Legal Background
Before we turn to the parties’ specific contentions, it is helpful briefly to situate the dispute within its broader legal context. In 2016, we decided a pair of cases that required us to reexamine and clarify the legal standards that govern claims brought under the Connecticut Product Liability Act. See Bifolck v. Philip Morris, Inc., 324 Conn. 402, 152 A.3d 1183 (2016); Izzarelli v. R.J. Reynolds Tobacco Co., 321 Conn. 172, 136 A.3d 1232 (2016).
In Izzarelli, we sharply limited the scope of the traditional legal standard governing defective product design claims, the so-called “ordinary consumer expectation test,” under which, “[t]o be considered unreasonably dangerous, the article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its charac-teristics.” (Internal quotation marks omitted.) Izzarelli v. R.J. Reynolds Tobacco Co., supra, 321 Conn. 185. We clarified that that test “would be appropriate [only] when the incident causing injury is so bizarre or unusual that the jury would not need expert testimony to conclude that the product failed to meet the consumer‘s expectations.” Id., 191. In other words, “[t]he ordinary consumer expectation test is reserved for cases in which the product failed to meet the ordinary consumer‘s minimum safety expectations, such as res ipsa [loquitur] type cases.” (Emphasis omitted.) Id., 194.
In most product liability cases, by contrast, the plaintiff is required to establish a defective design under the modified consumer expectation test, pursuant to which “the jury would weigh the product‘s risks and utility and then inquire, in light of those factors, whether a reasonable consumer would consider the product design unreasonably dangerous.” (Internal quotation marks omitted.) Id., 190; see id., 194. In applying that test, we indicated that the jury is to be instructed to consider a nonexclusive list of factors, one of which may be the availability of a feasible alternative design. See id., 190–91, 208–10.
In Bifolck, we further clarified Izzarelli‘s ordinary and modified consumer expectation tests. First, we renamed them the “consumer expectation test” and the “risk-utility test,” respectively. Bifolck v. Philip Morris, Inc., supra, 324 Conn. 432. Second, we set forth two distinct prongs or methods by which the latter test may be satisfied. “Under the risk-utility test, which will govern most cases, a product is in a defective condition unreasonably dangerous to the consumer or user if:
“(1) A reasonable alternative design was available that would have avoided or reduced the risk of harm and the absence of that alternative design renders the product unreasonably dangerous. In considering whether there is a reasonable alternative design, the jury must consider the feasibility of the alternative. Other relevant factors that a jury may consider include, but are not limited to, the ability of the alternative design to reduce the product‘s danger without unreasonably impairing its usefulness, longevity, maintenance, and esthetics, without unreasonably increasing cost, and without creating other equal or greater risks of danger [Bifolck 1]; or “(2) The product is a manifestly unreasonable design in that the risk of harm so clearly exceeds the product‘s utility that a reasonable consumer, informed of those risks and utility, would not purchase the product [Bifolck 2].” Id., 434–35.
Here, the trial court declined to give an instruction under Bifolck 1 and gave only a Bifolck 2 instruction. The question in the present case is whether the trial court correctly concluded that the evidence did not support an instruction under the reasonable alternative design prong of the risk-utility test (i.e., Bifolck 1). We conclude that it did.
It is well established that, “[i]n determining whether the trial court improperly refused a request to charge, [w]e . . . review the evidence presented at trial in the light most favorable to supporting the . . . proposed charge. . . . A request to charge [that] is relevant to the issues of [a] case and [that] is an accurate statement of the law must be given. . . . If, however, the evidence would not reasonably support a finding of the particular issue, the trial court has a duty not to submit it to the jury. . . . Thus, a trial court should instruct the jury in accordance with a party‘s request to charge [only] if the proposed instructions are reasonably supported by the evidence. . . . If . . . the evidence reasonably does not support a finding on the particular issue, the trial court is duty bound to refrain from submitting it to the jury.” (Citation omitted; internal quotation marks omitted.) Brown v. Robishaw, 282 Conn. 628, 633, 922 A.2d 1086 (2007).
Whether the evidence presented by a party reasonably supports a particular request to charge “is a question of law over which our review is plenary.” Id. Similarly, whether there is a legal basis for the requested charge is a question of law also entitled to plenary review. See id., 633–34.
B
Reviewability of Plaintiffs’ Instructional Claim
First, we must address Boston Scientific‘s assertion that the plaintiffs’ claim is unreviewable because the plaintiffs failed to properly preserve their challenge regarding the instruction. Boston Scientific contends that the plaintiffs’ Bifolck 1 instruction claim is unpreserved because they did not submit a written request to charge on the instruction and also failed to cite evidence in the record to support such an instruction pursuant to
Before the trial court charged the jury, the parties and the court had off-the-record discussions regarding Bifolck 1, the reasonable alternative design charge. Following those discussions, the plaintiffs requested the charge through an e-mail to the court and did not cite to any evidence in the record to support the request.10
It was not until the jury had been charged and dismissed for the day that the plaintiffs formally took exception to the court‘s design defect instruction, claiming entitlement to an instruction on Bifolck 1. Although the plaintiffs’ request did not technically comply with the requirements of
It is important to note that, in their e-mail request to the court, the plaintiffs did not cite to any evidence to support their request for a Bifolck 1 charge. In failing to cite to any evidence in the request to charge, the plaintiffs failed to comply with
We point this out because it is this lack of specificity in the plaintiffs’ request to charge that the concurrence and dissent capitalizes on and uses as an opportunity to recast and create its own arguments that, in its opinion, the plaintiffs should have made at trial to support their request for a reasonable alternative design instruction.
Nevertheless, despite the plaintiffs’ failure to comply with
C
Plaintiffs’ Instructional Claim
The plaintiffs assert that the evidence presented at trial was sufficient to support the instruction, and, as a result, the trial court improperly declined to charge the jury on the reasonable alternative design prong of the risk-utility test. In support of their claim, the plaintiffs cite to a study introduced into evidence; see S. Ross et al., “Transobturator Tape Compared with Tension-Free Vaginal Tape for Stress Incontinence:
Our decisions in Bifolck and Izzarelli establish the framework within which a plaintiff is entitled to a reasonable alternative design instruction under the risk-
utility test. In Bifolck, this court explained: “In order to state a prima facie case that will permit the case to be submitted to the jury, the plaintiff must simply prove that the alternative design was feasible (technically and economically) and that the alternative would have reduced or avoided the harm.” Bifolck v. Philip Morris, Inc., supra, 324 Conn. 433. In Izzarelli, in which we addressed cigarette design, this court explained that, “[t]o establish the defect, the plaintiff‘s case required expert testimony on [product] design and manufacture, as well as the feasibility of an alternative design.” Izzarelli v. R.J. Reynolds Tobacco Co., supra, 321 Conn. 203-204.
At the outset, we must determine what type of evidence is sufficient to prove that an “alternative design was feasible (technically and economically) and that the alternative would have reduced or avoided the harm.” Bifolck v. Philip Morris, Inc., supra, 324 Conn. 433. Although we concluded in Izzarelli that expert testimony was required in that case, a question has arisen as to whether expert testimony is always required as a necessary component under the risk-utility test. This court has not addressed that specific question.
The issue has, however, received some attention in the federal courts. Indeed, as the United States District Court for the District of Connecticut has recognized, “[n]either Izzarelli nor Bifolck state[s] explicitly that expert testimony is required under the risk-utility test. However, both cases suggest it by juxtaposing the consumer expectation test, which does not require expert testimony, and the risk-utility test.” Frederick v. Deco Salon Furniture, Inc., Docket No. 3:16-cv-00060 (VLB), 2018 WL 2750319, *7 (D. Conn. March 27, 2018). Consistent therewith, the United States District Court for the District of Connecticut and the Second Circuit have applied the expert requirement to such claims.
For example, in deciding a motion for summary judgment for a defective design claim involving a water treatment pump, the United States District Court for the District of Connecticut concluded that “this is the type of complex case [that] requires an expert opinion as to defect and as to feasible alternative design.” Water Pollution Control Authority v. Flowserve US, Inc., Docket No. 3:14-cv-00549 (VLB), 2018 WL 1525709, *24 (D. Conn. March 28, 2018), aff‘d, 782 Fed. Appx. 9 (2d Cir. 2019).
The court explained that, because the case involved the requirements of a pump for a wastewater treatment facility, the jury would not be “as capable of comprehending the primary facts and of drawing correct conclusions from them as are witnesses possessed of special or peculiar training.” (Internal quotation marks omitted.) Id. The Second Circuit agreed with this analysis, explaining that, under Connecticut law, “[e]xpert evidence is necessary to satisfy the risk-utility test [when] the nexus between the injury and the alleged cause would not be obvious to the lay juror, because expert knowledge is often required in such circumstances to establish the causal connection between the accident and some item of physical or mental injury.” (Internal quotation marks omitted.) Water Pollution Control Authority v. Flowserve US, Inc., 782 Fed. Appx. 9, 14-15 (2d Cir. 2019).
This position is consistent with the majority of other jurisdictions. “[W]hen technical issues are involved (issues beyond common knowledge and experience) in a [product] liability or a [product related] case, expert testimony is required to generate a jury issue. . . . Technical issues requiring expert testimony include engineering, metallurgical and medical principles. . . . When such principles are at issue in a design defect case, expert testimony is necessary to establish a reasonable alternative design and the ability of such design to reduce the foreseeable harm of the challenged product—that is to say, expert testimony may be needed to establish the elements of breach and causation.” (Citations omitted; internal quotation marks omitted.) Farm Bureau Property & Casualty Ins. Co. v. CNH Industrial America, LLC, Docket No. C16-3122-LTS, 2018 WL 2077727, *17 (N.D. Iowa February 5, 2018).
Other jurisdictions have explained that, “[w]hen understanding the nature of the alleged defect requires knowledge . . . beyond that possessed by the average lay person . . . [the] law requires expert testimony to establish both the defect and the practical and technically feasible alternative design.” (Internal quotation marks omitted.) Buck v. Ford Motor Co., Docket No. 3:08CV998, 2012 WL 12887708, *3 (N.D. Ohio June 25, 2012), aff‘d, 526 Fed. Appx. 603 (6th Cir. 2013); see, e.g., Hilaire v. DeWalt Industrial Tool Co., 54 F. Supp. 3d 223, 252 (E.D.N.Y. 2014) (“New York law requires plaintiffs to use expert testimony as to the feasibility and efficacy of alternative designs in order to prove a design defect“). Indeed, in another product liability case involving vaginal mesh products, the United States District Court for the Southern District of Iowa explained that expert testimony was required on the issue of “whether an alternative safer design existed for a medical device, which plainly involves medical principles.” Willet v. Johnson & Johnson, 465 F. Supp. 3d 895, 905 (S.D. Iowa 2020).
Thus, as we have in other contexts, we conclude that expert testimony is required in a reasonable alternative design case when the evidence regarding the defect and whether the alternative was feasible (technically and economically) and whether the alternative would have reduced or avoided the risk of harm is beyond the ken of the average juror. See, e.g., LePage v. Horne, 262 Conn. 116, 125, 809 A.2d 505 (2002) (“[e]xpert testimony is required when the question involved goes beyond the field of the ordinary knowledge and experience of judges or jurors” (emphasis omitted; internal quotation marks omitted)). In the present case, the evidence regarding whether there was an alternative design to the Obtryx that would have reduced or avoided the risk of harm to Fajardo involved complicated medical principles. These medical principles included the material from which the products were made, how the different products were placed in the body, how each worked to treat the condition of stress urinary incontinence, how the products interacted with the human body when implanted, and the risks and potential side effects. Accordingly, in order to prove that Boston Scientific‘s product was unreasonably dangerous under Bifolck 1, the plaintiffs were required to produce expert testimony on a reasonable alternative design.
Here, the trial court determined that Rosenzweig “was [the plaintiffs‘] product design expert.” The plaintiffs agree that he was their design expert. In fact, in their brief to this court, the plaintiffs focus on Rosenzweig and his testimony in other
The trial court determined: “While [Rosenzweig] was critical of several design characteristics of the Obtryx product, he offered no reasonable alternative design of a mesh product that was available to [Boston Scientific] when the Obtryx [implanted] in [Fajardo] was produced. The court rejects [the plaintiffs‘] current suggestions [that] the jury might infer [that Rosenzweig] endorsed any polypropylene transvaginal mesh product, however designed or configured, as [Rosenzweig] . . . in this case . . . testified [that] transvaginal polypropylene implants are defective and unreasonably dangerous because transvaginal polypropylene mesh products provoke a foreign body rejection or reaction in women.” Indeed, Rosenzweig testified that, in his opinion, all vaginal slings made of polypropylene mesh are defective. He specifically testified that a TVT produced by Gynecare, which is part of the Ethicon division of Johnson & Johnson (Ethicon branded TVT), is defective.
We agree with the trial court that Rosenzweig was the only witness qualified to opine on reasonable alternative design, and, therefore, the trial court properly focused on the testimony of Rosenzweig to determine whether the plaintiffs had produced sufficient evidence to warrant an instruction under the reasonable alternative design prong. We do the same and, as explained more fully in this opinion, conclude that the evidence was not sufficient to warrant an instruction on reasonable alternative design.13
D
Framing of the Issue Presented
In order to better understand the issue that is truly in dispute in this appeal, it is important to keep in mind that a plaintiff in Connecticut has two ways to establish that “a product is in a defective condition unreasonably dangerous to the consumer or user . . . .” Bifolck v. Philip Morris, Inc., supra, 324 Conn. 434. Those two ways are: “(1) A
In the present case, the jury was instructed under the second theory of liability, namely, that the risk of harm from the Obtryx so clearly exceeded its utility that a reasonable consumer would not purchase it. Accordingly, although the concurring and dissenting opinion spends considerable energy laying out how the plaintiffs demonstrated that the Obtryx was defective, it is important to remember that the jury considered whether the product was defective insofar that it was a “manifestly unreasonable design in that the risk of harm so clearly exceeds the product‘s utility . . . .” Id., 435. Indeed, the jury was able to consider all of the evidence presented and ultimately found that the Obtryx was not defective under Bifolck 2.
The issue on appeal is not whether the jury should have been able to consider the plaintiffs’ claims at all. Instead, the question is whether the plaintiffs introduced sufficient evidence that the Obtryx is defective because a reasonable alternative design was available that would have reduced or avoided the risk of harm to Fajardo and Boston Scientific‘s failure to adopt that reasonable alternative design rendered the Obtryx unreasonably dangerous. In considering the plaintiffs’ claim and the position of the concurrence and dissent, it is important to remember that “a manufacturer is not required to design the safest possible product or a safer product than the one it designed, so long as the design adopted was reasonably safe. The duty assumed by the manufacturer is to design the product for its intended use, namely, that use which could reasonably be foreseen. Stated differently, a manufacturer has a duty to avoid placing on the market a product [that], because of its defective design, presents an unreasonable risk of harm to others.” (Footnotes omitted.) 6 S. Speiser et al., American Law of Torts (2010) § 18:73, pp. 180-81.
Accordingly, in considering the plaintiffs’ claim, the issue is not whether the plaintiffs have produced sufficient evidence that the Obtryx had defects and that some of those defects may have caused Fajardo‘s injuries, which is the claim under Bifolck 2 that the jury considered and rejected. Rather, the issue presented by this appeal is whether the plaintiffs introduced sufficient evidence that there was a reasonable alternative design available to Boston Scientific‘s Obtryx and that Boston Scientific‘s failure to use that alternative design rendered the Obtryx unreasonably dangerous.
E
Whether an Instruction on a Reasonable Alternative Design Was Warranted
On appeal, the plaintiffs assert that Rosenzweig‘s testimony, the Ross study, and other studies introduced into evidence established a reasonable alternative
A review of Rosenzweig‘s testimony reveals that he testified regarding defects in the Obtryx. First, he explained that, in his opinion, all slings made with polypropylene mesh are defective. Rosenzweig explained that the use of that type of mesh caused a foreign body reaction in Fajardo and contributed to the cause of her injuries. The Obtryx is made of polypropylene mesh, but so, too, is the Ethicon TVT.
Second, Rosenzweig testified that the mesh used in the Obtryx had a detanged or heat-sealed edge and that it made the mesh stiffer in the area that had been sealed. Rosenzweig explained: “When you seal the edge of the mesh, you increase the stiffness of the mesh. . . . But, what scientists have shown is that stiffness of mesh is a bad property. It increases the foreign body reaction . . . the inflammatory reaction, the amount of scarring, and all the sequelae that we‘re going to continue to talk about. . . .” Rosenzweig was later asked: “Earlier, you described some problems with the detanging or the heat sealing of the center portion of the . . . Obtryx sling. Does that detanging add any benefit that would outweigh the added risks . . . from the stiffness?” Rosenzweig responded, “[n]o.”17
To the extent that the plaintiffs are claiming that the class of TVTs is a reasonable alternative design that would have reduced or avoided the risk of harm to Fajardo, this testimony does not support the plaintiffs’ claims. First, there was evidence that other products within the class of TVTs are made of the exact same mesh
Nevertheless, the plaintiffs also rely heavily on the Ross study in support of their claim that the class of products known as TVTs is a reasonable alternative design to the Obtryx. It cannot be emphasized enough that the Ross study does not address the Ethicon branded TVT at all. Instead, it compared two products made by Boston Scientific—the Obtryx and the Advantage branded TVT. See S. Ross et al., supra, 114 Obstet. & Gynecol. 1288. Therefore, the plaintiffs’ reliance on that study undermines the claim of the concurrence and dissent that the plaintiffs pointed to the Ethicon branded TVT as a reasonable alternative design.
Furthermore, the Ross study does not even support the plaintiffs’ claim that the class of TVTs was a reasonable alternative design to the Obtryx that would have reduced or avoided the risk of harm to Fajardo. Specifically, there was evidence at trial that the Obtryx and the Advantage branded TVT are made of the exact same mesh material. In explaining the Ross study, Rosenzweig stated: “This is a study that was done and published in 2009. It‘s a randomized control trial comparing the Obtryx sling made of Advantage mesh with the Advantage sling that goes behind the pubic bone, also made of Advantage mesh.” Rosenzweig also testified that the Advantage sling is made of the exact same material as the Obtryx, including the heat seal. Because Rosenzweig identified the heat seal in the mesh that is used in the Obtryx as one of the primary defects that caused Fajardo‘s injury, a study that compared two products made of the same mesh with the same heat seal does not support the plaintiffs’ claim that there was a reasonable alternative design that would have reduced or avoided the risk of harm to Fajardo.
The only difference between the two devices compared in the Ross study was their placement in the body. The Advantage sling was designed to be placed in a retropubic fashion, meaning behind the pubic bone. The Obtryx, on the other hand, was designed to be placed using a transobturator approach. See S. Ross et al., supra, 114 Obstet. & Gynecol. 1287. Rosenzweig did not testify that the risk of harm to Fajardo would have been reduced or avoided if a retropubic sling was used. Instead, Rosenzweig identified only the polypropylene mesh and the heat seal as the defects that caused Fajardo‘s injuries. Accordingly, contrary to the plaintiffs’ position, the Ross study did not support their request for a reasonable alternative design instruction.
Furthermore, even if the plaintiffs were able to make a claim of reasonable alternative design by pointing to a class of products, it is important to note that Rosenzweig testified that, in his opinion, all mesh products fabricated from polypropylene, including the Ethicon branded TVT, as well as other products within the class of TVTs, are unsafe and unsuitable for
As the Fifth Circuit has explained, “[a] design is not a safer alternative if, under other circumstances, [it would] impose an equal or greater risk of harm than the design at issue. . . . Similarly, the plaintiff must show the safety benefits from [the] proposed design are foreseeably greater than the resulting costs, including any diminished usefulness or diminished safety.” (Citation omitted; emphasis omitted.) Casey v. Toyota Motor Engineering & Mfg. North America, Inc., 770 F.3d 322, 331 (5th Cir. 2014). Accordingly, we cannot conclude that the plaintiffs produced sufficient evidence to warrant an instruction that the class of TVTs constitutes a reasonable alternative design.
We agree with the concurrence and dissent that pointing to an existing product that has been successfully commercialized can serve as evidence of the feasibility of an alternative design; see part II A 1 of the concurring and dissenting opinion; but we simply find that proposition inapplicable to the present case.
To put it simply, that is just not the way that the plaintiffs tried this case. The plaintiffs did not produce sufficient facts to support a reasonable alternative design claim. Namely, the plaintiffs did not point to a specific existing product on the market and demonstrate that its use would have reduced or avoided the risk of harm to Fajardo. At best, the plaintiffs took a scattershot approach, pointing to different alternatives to the Obtryx that included surgical options and a class of products known as TVTs. Specifically, the plaintiffs’ product design expert recommended a surgical alternative known as the Burch procedure, the Ross study compared the Obtryx to an entirely different product, the Advantage tape, another study compared transobturator slings like the Obtryx to retropubic slings (the class of products known as the TVT), and another study compared mesh used in products within the class of TVTs to the mesh used in the Ethicon branded TVT. The evidence did not, however, demonstrate that any particular product was safer or, most important, would have reduced or avoided the risk of harm to Fajardo when compared to the Obtryx.
We recognize that the commentary to the Restatement (Third) provides that “other products already available on the market may serve the same or very similar function at lower risk and at comparable cost. Such products may serve as reasonable alternatives to the product in question.” Restatement (Third), Torts, Products Liability § 2, comment (f), p. 24 (1998); see part II A 1 of the concurring and dissenting opinion. This court, however, has not adopted the Restatement (Third). See Bifolck v. Philip Morris, Inc., supra, 324 Conn. 431 (“the defendant‘s arguments have not persuaded us that we should adopt the Restatement (Third) at this time“).
To the extent that there was information regarding the safety data of the TVT, that evidence was that there were risks and complications with the use of the TVT. For example, one study explained that “one of the primary problems in using the TVT is that as a result of its low stiffness, the mesh easily deforms when tensioning under the urethra. Specifically, pulling the sling gently results in thinning of the mesh (permanent deformation) and fraying at the tanged edges. Consequently, various companies have modified polypropylene sling meshes for easier placement by heat sealing the mid-portion of the sling that lays under the urethra . . . .” P. Moalli et al., “Tensile Properties of Five Commonly Used Mid-Urethral Slings Relative to the TVT,” 19 International Urogynecology J. 655, 656 (2008) (Moalli study). Another study explained the complications from the TVT to “include bladder perforation, excessive blood loss, urinary retention, pelvic hematoma, and suprapubic wound infection. Later complications include exacerbation of existing or development of de novo overactive bladder, persistent suprapubic discomfort, and vaginal mesh erosion. Rare complications, such as bowel injuries and female sexual dysfunction, have been reported.” H. Cholhan et al., “Dyspareunia Associated with Paraurethral Banding in the Transobturator Sling,” 202 Am. J. Obstetrics & Gynecology 481.e1, 481.e1 (2010) (Cholhan study). The authors of the Ross study also explained that “the most common perioperative complications associated with TVT were bladder perforation and bleeding“; S. Ross et al., supra, 114 Obstet. & Gynecol. 1291; and that “[c]oncern about complications associated with TVT led in 2001 to the development of another minimally invasive pro-cedure using the transobturator tape.” (Footnotes omitted.) Id., 1287-88.19
Contrary to the assertions of the concurrence and dissent; see part II A 2 of the concurring and dissenting opinion; we do not conclude that the plaintiffs had to point
Furthermore, because this case involves complex medical devices with complicated medical risks and injuries, evidence comparing their relative safety data would have had to come from an expert qualified to testify regarding the designs of the Ethicon branded TVT and the Obtryx, and qualified to explain how use of the Ethicon branded TVT would have reduced or avoided the risk of harm to Fajardo.20 In discussing whether expert testimony
To be sure, the Restatement (Third) also makes clear that “[i]t is not sufficient that the alternative design would have reduced or prevented the harm suffered by the plaintiff if it would also have introduced into the product other dangers of equal or greater magnitude.” Restatement (Third), supra, § 2, comment (f), p. 23. Rosenzweig testified that a substantial contributing factor of Fajardo‘s injuries was the fact that she experienced a foreign body reaction to the Obtryx. Rosenzweig explained that polypropylene mesh slings can cause this type of reaction. Accordingly, Rosenzweig opined that all polypropylene mesh slings are defective and unreasonably dangerous. He specifically opined that the Ethicon branded TVT, which is made of polypropylene mesh, was defective. Given this testimony from the plaintiffs’ product design expert, we cannot see how the plaintiffs could have successfully claimed that the Ethicon branded TVT or the class of TVTs was a reasonable alternative design that would have reduced or avoided the risk of harm suffered by Fajardo. Therefore, the trial court was correct not to instruct the jury on the reasonable alternative design prong.
Even if we were to consider Bercik‘s testimony as expert testimony on reasonable alternative design, as the concurrence and dissent suggests; see, e.g., footnote 6 of the concurring and dissenting opinion; we cannot conclude that it supports the plaintiffs’ request for a reasonable alternative design instruction. First, Bercik‘s testimony was not based on sufficient data to comment on reasonable alternative design. Bercik never established his qualifications regarding product design and testified that he was unaware of a key design element of the Ethicon branded TVT, namely, the type of mesh used in the product.22 Furthermore,
We do not agree with the concurrence and dissent that other studies and documents that were entered into evidence were sufficient to support a reasonable alternative design claim.24 See parts II A 1 and 2 of the concurring and dissenting opinion. At most, these studies demonstrate that the Ethicon branded TVT was the first tension free vaginal tape manufactured, and for that reason, there is more data evaluating its safety and effectiveness. Nevertheless, the evidence in the studies demonstrate that, “[a]lthough the [Ethicon branded] TVT was the first [midurethral] sling to gain widespread acceptance, numerous other [midurethral] sling systems have subsequently been introduced. While all of the meshes consist of a
Furthermore, also contrary to the representations of the concurrence and dissent, the evidence did not demonstrate that the class of TVTs or the Ethicon branded TVT is the “gold standard” to treat stress urinary incontinence. Part II A 1 of the concurring and dissenting opinion. The concurrence and dissent asserts that, “although the majority steadfastly resists this fact, expert witnesses and evidence from scholarly journals on which those witnesses relied repeatedly identified the TVT as the ‘gold standard,’ [and/or] ‘the standard of care’ . . . .” Id. However, no expert in the present case pointed to the TVT (either the Ethicon branded TVT or the class of products known as the TVT) as the “gold standard.” Thus, no one explained what is meant by the term. Instead, the design expert in the present case testified that all slings made of polypropylene mesh are unreasonably dangerous and that a surgical procedure is the best method for treating stress urinary incontinence.25
In the present case, the plaintiffs simply did not introduce sufficient evidence to warrant an instruction on a reasonable alternative design. We find a recent case from the United States District Court for the District of Connecticut instructive in this regard. In granting a manufacturer‘s motion for summary judgment on a reasonable alternative design claim, the court explained that the plaintiff “has not established that a reasonable alternative [water treatment] pump design was available. [The expert‘s] report, even if admitted, does not identify a reasonable alternative. Rather, [the expert‘s] report opines that [the plaintiff] should have used [the competitor‘s] pumps, which have larger motors. However, the [competitor‘s] motors would have required an expensive reworking of the system as a whole, and were considered and rejected by [the plaintiff] during the bidding process. . . . [The plaintiff] has offered no evidence that a ‘reasonable alternative design was available’ for pumps that would meet the [plaintiff‘s] system specifications ‘that would have
Similarly, the plaintiffs in the present case did not produce sufficient evidence that an alternative design was available that would have met Fajardo‘s needs and have avoided or reduced the risk of harm without unreasonably increasing cost. To the contrary, evidence presented at trial showed that the class of TVTs had varying degrees of safety, depending on the type of material that was used to make them, and some even had the exact same defect alleged to have caused Fajardo‘s injuries in this case. Furthermore, the plaintiffs’
The plaintiffs cite to Campbell v. Boston Scientific Corp., 882 F.3d 70 (4th Cir. 2018), in support of their claim that there was sufficient evidence in the present case to warrant an instruction on the reasonable alternative design prong. We disagree. In that case, the defendant claimed that there was insufficient evidence to support the jury verdict and, specifically, to show that
The Fourth Circuit‘s conclusion,
Based on the foregoing, we conclude that the plaintiffs did not produce sufficient evidence to warrant an instruction on a reasonable alternative design. Accordingly, we conclude that the trial court properly declined their request for such an instruction.
The judgment is affirmed.
In this