Although the claim for lack of informed consent is usually seen in the context of a medical malpractice action, their origins are not the same. Informed consent claims in New York derive from Public Health Law §2805-d, whereas the medical malpractice claim evolved from the common law.

The law of informed consent is further qualified by Civil Practice Law and Rules §4401-a, which requires the trial court to dismiss the cause of action for lack of informed consent where there is inadequate expert testimony to support the alleged qualitative insufficiency of the consent. In order to survive dismissal, there must be expert testimony supporting the three separate elements of the cause of action, those being the failure to disclose, the refusal by the reasonably prudent patient, and proximate cause. Balzola v. Giese, 107 A.D.3d 587 (1st Dept. 2013). The purpose of this column is to discuss the approach to the defense of the informed consent claim at trial.

Pleadings

The defense of the informed consent cause of action begins with an assessment of the complaint, where the statutory claim must be separately stated, related to invasion of the patient's bodily integrity, and connected to the alleged damages (see Etkin v. Marcus, 74 A.D.2d 633 (2d Dept. 1980)). In the presence of claims of damages against several defendants for malpractice and other specifications of liability, this is a statutory cause of action which may require proof of damages apart from those which are attributed to other claims. Whether the defense should move against the complaint, answer with affirmative defenses, await the bill of particulars, or address shortcoming by demanding and moving for further amplification depends upon the particular situation presented. The adequacy of the Defendant's bill of particulars of affirmative defenses may also be a matter of concern.

Discovery

The plaintiff has claimed that if the discussion of risks, benefits and alternatives had been more complete, a reasonable patient in the same position would not have consented. What the patient thinks she would have done has to be seen as subjective and not conclusive one way or the other (see Fogal v. Genesee Hospital, 41 A.D.2d 468 (4th Dept. 1973)) but some trial courts will admit that testimony. The defense needs to identify the other procedures the patient consented to before or after the procedure in issue, and determine what risks and alternative treatments were discussed in that connection. Access to the records of other instances where invasive procedures were performed should not be limited by the court or opposing counsel.

At deposition, the patient's recollection of all relevant consent discussions is subject to discovery. If the patient had undergone colonoscopy before or after the colonoscopy in issue, the records of the other procedures may be used to test or refresh the recollection of the patient and determine whether the patient was in a similar position when consent was given for the same procedure.

Consent to a surgical procedure is a process which extends well beyond the signing of the consent form on the date of surgery. The deposition of the plaintiff gives access to the understanding of the patient as to why he was referred to the surgeon in the first place, the medical alternatives which had been discussed or attempted without success, the explanations of other professionals, and the result of any independent reading done by the patient. These and other factors all bear upon whether his consent was informed. The patient may not recall the result of research on the topic, but the concept of informed consent deals with the patient's right to knowledge. If the jury feels that the patient did not fulfill the obligations of the hypothetical reasonable patient to inform himself, that evidence could affect the determination of culpable conduct, causation, credibility and/or mitigation of damages (see Tenney v. Bedell, 624 F. Supp 305 (S.D.N.Y., 1985)).

The plaintiff's deposition is also useful to establish the understanding of the patient following the first mention of the procedure. Why was it necessary to perform surgery in a sterile hospital operating room? What risk was actually expected? Why should the patient to be accompanied by a family member at the time of the procedure? Why would it be days to weeks before the patient would return to full activity? Why did loved ones spend hours in the hospital waiting room for reassurance that the patient has come through the surgery? What information made the family set aside their other responsibilities and travel to the hospital to await the outcome? Experience shows that patients are proficient at forgetting the discussion of risk prior to a procedure, but when they do have recollection, they often overestimate the percentage risk of complications, or supply other helpful information.

The depositions of the co-defendants may also support the defense on the informed consent claim. Most surgical facilities have independent procedures for verifying the patient's consent to the procedure. Medical centers where elective procedures such as Lasik surgery, colonoscopy, interventional radiology, and plastic surgery are routinely performed will often provide literature which addresses the risk well in advance of the scheduled procedure. While that literature may not be exhaustive, the information places the patient on notice that her questions regarding the procedure and its alternatives should be answered before the day of surgery.

The defendant who performed the procedure will usually provide evidence that the procedure was indicated even though it entailed risks and complications, the consent was discussed well before the patient was scheduled for the procedure, and the patient was not scheduled until she had accepted the risks of the surgery. The operating room supervisor will usually confirm that the consent form was executed just before surgery to formalize and document the patient's prior agreement to surgery and that her consent was confirmed before any medications affected her cognition.

Trial Preparation

Given the fact that the separate elements of the informed consent cause of action require support by expert testimony, attention should be directed toward the expert witness responses required by CPLR §3101-d. Expert witness responses must disclose in reasonable detail the subject matter upon which the expert is expected to testify, and the opinions on the consent claims must be disclosed in reasonable detail.

It is further required that a summary of the grounds for the expert opinions are to be disclosed, which would include the opinions of the patient's expert on the separate elements of the cause of action as opposed to generic language repeated from the bill of particulars. When a letter rejecting the deficient expert disclosure is not availing, a motion for a proper response or a motion to preclude the expert testimony on informed consent may be required.

The expert disclosure of the defense may require attention if there are independent defenses including these countenanced by PHL §2805-d(4). Depending upon the extent of the expert disclosure of counsel for the patient, elaboration may be required from defense counsel on the distinct elements of informed consent.

Trial

Whether the patient himself would have refused consent to the procedure with full disclosure is a hypothetical question which cannot be based upon the evidence in the case, and cannot be determined with any degree of certainty (see Zeleznik v. Jewish Hospital, 47 A.D.2d 199 (2d Dept. 1975)). On the other hand, if the patient assured the practitioner that she would undergo the procedure regardless of its risks, that is an admission which is not hypothetical, does not depend on hindsight analysis, and is specifically allowed by PHL §2805-d.

In Lipsius v. White, 91 A.D.2d 271, 275 (2d Dept. 1983) the trial court actually permitted the following question:

Q: If you had known, prior to the surgery, that you were going to have the problems with your hand post-operatively, would you have consented to the surgery?

A: No, sir.

Certainly, that question should not have been answered, but consider asking the surgeon whether she would have performed the procedure if she had known that this was the patient who was “going to have” the complication. Had they known that the airplane would crash, neither the pilot or the passengers would have taken the trip.

It is useful to have those who have had experience with the relevant consent process inform the jury of the incidence of complications and how rare it is for a well informed patient to refuse consent for the procedure. The response of thousands of patients to full and proper disclosure is a valid determinant of what the hypothetical prudent patient would have done. The retrospective testimony by the patient who has had the complication, even if admissible, should not carry the same weight.

Conclusion

On a daily basis, all people engage in activity which requires them to accept a small risk of a disastrous outcome. In the proper context, the defense should be able to demonstrate that although the outcome was undesirable, the decision to accept the risk prior to the procedure was a rational one and a reasonably prudent person would not have refused consent.

John L. A. Lyddane is a partner at Dorf & Nelson.