341 Conn. 535
Conn.2021Background
- Lesly Fajardo underwent two same-day pelvic surgeries: a colporrhaphy performed by Dr. Lee Jacobs and a transvaginal mesh sling (Boston Scientific Obtryx) implanted by nonparty Dr. Paraiso; Fajardo later suffered pain and had the sling removed.
- Plaintiffs sued Boston Scientific under the Connecticut Product Liability Act for defective design, and sued Jacobs and his practice for lack of informed consent and misrepresentation (innocent, negligent, intentional).
- Trial court granted summary judgment for Jacobs and his practice on informed consent and misrepresentation claims; trial proceeded only against Boston Scientific and the jury returned a verdict for the manufacturer.
- Plaintiffs sought a jury instruction under Bifolck’s risk-utility test prong (reasonable alternative design, i.e., that a retropubic TVT was safer); trial court refused that charge and instructed only on the manifestly unreasonable design prong; plaintiffs moved to set aside the verdict and appealed.
- Supreme Court affirmed: (1) referring physician (Jacobs) owed no duty to obtain consent for a procedure performed by another physician (Paraiso); (2) innocent misrepresentation not available for pure medical services and misrepresentation claims failed because Jacobs lacked knowledge of the Obtryx; and (3) the evidence did not support a reasonable alternative design instruction because expert proof that a specific alternative was feasible and would have reduced Fajardo’s harm was lacking.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Duty to obtain informed consent (referring physician) | Jacobs discussed/recommended sling and thus assumed duty to obtain informed consent | Duty rests with the physician who performs the procedure (Paraiso); referring physician does not assume that duty | Summary judgment for Jacobs — duty to obtain consent belongs to the surgeon who performs the procedure; unanimous expert testimony supported this rule |
| Misrepresentation claims against Jacobs (innocent, negligent, intentional) | Jacobs misrepresented/suppressed risks and benefits of sling when recommending referral | Innocent misrep inapplicable to medical services; Jacobs did not know the brand and never discussed Obtryx specifically, so cannot have negligently/ intentionally misrepresented it | Summary judgment for Jacobs — innocent misrep inapplicable under Restatement §552C; negligent/intentional claims fail for lack of knowledge/evidence |
| Jury instruction on reasonable alternative design (Bifolck prong 1) | Evidence (expert Rosenzweig, Ross study, other literature) showed retropubic TVTs (or TVT class) were feasible safer alternatives to Obtryx | Request not properly preserved and, on the merits, plaintiffs lacked expert proof that a specific alternative was technically/economically feasible and would have reduced Fajardo’s harm | Instruction properly denied — expert testimony required here; plaintiffs’ expert testified all polypropylene slings are defective, and plaintiffs failed to identify a specific alternative shown to reduce the risk |
| Preservation of the Bifolck 1 instruction request | Plaintiffs contend they timely requested the charge via off‑record talks and email | Boston Scientific: no written request, no record citations as required by Practice Book; claim unpreserved | Court assumed preservation for appeal but noted procedural defects; addressed merits and denied instruction on substantive grounds |
Key Cases Cited
- Bifolck v. Philip Morris, Inc., 324 Conn. 402 (2016) (articulates Connecticut risk-utility test with two prongs: reasonable alternative design or manifestly unreasonable design)
- Izzarelli v. R.J. Reynolds Tobacco Co., 321 Conn. 172 (2016) (limits ordinary consumer-expectation test; explains when expert proof is required)
- Logan v. Greenwich Hosp. Assn., 191 Conn. 282 (1983) (referring physician who discusses a procedure but refers to specialist does not as a matter of law assume duty to obtain consent)
- Sherwood v. Danbury Hosp., 278 Conn. 163 (2006) (treating physician, not hospital, bears responsibility to procure informed consent)
- Petriello v. Kalman, 215 Conn. 377 (1990) (existence of duty is a question of law; if no duty, directed verdict/summary judgment appropriate)
- Lambert v. Stovell, 205 Conn. 1 (1987) (elements of lack-of-informed-consent cause of action)
- Farrell v. Johnson & Johnson, 335 Conn. 398 (2020) (innocent misrepresentation claim does not lie for provision of pure medical services)