Fajardo v. Boston Scientific Corporation

CourtSupreme Court of Connecticut
Citation341 Conn. 535,267 A.3d 691
Docket NumberSC 20455
Decision Date16 December 2021

Brenden P. Leydon and Jacqueline E. Fusco, Stamford, for the appellants (plaintiffs).

Daniel B. Rogers, pro hac vice, with whom were Proloy K. Das, Hartford, Jennifer M. DelMonico, New Haven, 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.).

Robinson, C. J., and Palmer, D'Auria, Mullins, Kahn and Ecker, Js.*


This appeal arises from an action in which the named plaintiff, Lesly Fajardo (Fajardo),1 suffered injuries related to the implantation of a transvaginal mesh sling,2 a medical device that is implanted in women to treat stress urinary incontinence

.3 In this action, the plaintiffs alleged that the named defendant, Boston Scientific Corporation (Boston Scientific), defectively designed its Obtryx Transobturator Mid-Urethral Sling System (Obtryx),4 a polypropylene transvaginal mesh sling, and that the product injured her in various ways after Edward Paraiso, a nonparty urologist, implanted it in her. The plaintiffs claimed, as relevant to this appeal, that Boston Scientific's sale of the Obtryx violated the Connecticut Product Liability Act, General Statutes § 52-572m et seq.

The plaintiffs also brought, inter alia, claims of 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 sling implant procedure. As to the misrepresentation claims, the plaintiffs alleged that Jacobs innocently, negligently and intentionally misled and misinformed Fajardo regarding the quality, usefulness, risks and/or benefits of the Obtryx.

Prior to trial, the trial court granted the medical defendants' motion for summary judgment, concluding, as a matter of law, that Jacobs, as a referring physician, had no duty to obtain Fajardo's informed consent for a procedure that Paraiso was to perform. The court also rendered summary judgment in favor of the medical defendants on the plaintiffs' misrepresentation claims. Thus, the case proceeded to trial only against Boston Scientific, and the jury returned a verdict in its favor. The plaintiffs moved to set aside the verdict, but the trial court denied that motion and rendered judgment in accordance with the jury's verdict. This appeal 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 rendered 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.



AInformed 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 bladder) and a grade 2 rectocele

(prolapse of the posterior vaginal wall ). Jacobs explained that a surgery to address the cystocele and rectocele probably would not rectify the incontinence issues. Consequently, given her interest in a more permanent fix to the incontinence issues, Jacobs discussed with Fajardo the option of "her see[ing] a urologist for an evaluation to see what could be offered to her [to address the incontinence]."

Also, during or as a result of this appointment, Jacobs wrote an office note, in which he stated that the " ‘risks, benefits, and alternatives of sling/AP (anterior and posterior colporrhaphy

)7 discussed, all questions answered.’ " (Footnote added; footnote omitted.) Then, as he had with numerous other similarly situated patients, he referred Fajardo to Paraiso, a urologist, for consultation and evaluation regarding her stress urinary incontinence.

On April 10, 2010, Fajardo consulted with Paraiso. He diagnosed her with stress urinary incontinence

and recommended that she consent to having Paraiso 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 her stress urinary incontinence

... [and that] it would fix her [stress urinary incontinence ], and convinced her that it was safe." The plaintiffs argued that the undisputed facts supported their claim.

The medical defendants also filed a motion for 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...

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