Stethoscope book
Stethoscope book (Erwin Wodicka)

The New Jersey Supreme Court has long been committed to the principle that a patient should be fully informed about the benefits and risks associated with medical treatment. Generally, a patient has a cause of action for the breach of the duty to obtain informed consent when:

  1. the treatment rendered was associated with a known risk, and
  2. plaintiff was not advised of the risk, and
  3. the risk occurred, and
  4. a reasonable person in the plaintiff’s position would have rejected the treatment.

See Model Jury Charge (Civil) 5.50C.

Significantly, the standard for disclosure is imposed by law and not medical consensus. Largey v. Rothman, 110 N.J. 204 (1988). The Largey court held that the “breadth of disclosure” is measured by what it deemed to be an “objective standard” established not by either the subjective standards or expectations of either the physician or patient. Instead, Largey instructed that “the law must set the standard for adequate disclosure,” and therefore, the standard for disclosure is to be determined by the trial court as a matter of law.

Largey has been followed by a line of cases which have defined and expanded the scope of the duty to obtain informed consent. However, despite all of the discussion devoted to this topic, the number of meritorious informed consent cases are few. Informed consent generally only applies to elective procedures (see Petrolia v. Estate of Nova, 284 N.J. Super. 585 (App. Div. 1995) and Posta v. Chueng-Loy, 306 N.J. Super. 182 (App. Div. 1997)) and the failure to inform of the need for treatment, often called “informed refusal.” See Matthies v. Mastromonaco, 160 N.J. 26 (1999) and Battenfeld v. Gregory, 247 N.J. Super. 538 (App. Div. 1991).

The doctrine of informed consent does not apply to the failure to diagnose a medical condition, the failure to offer the choice of diagnostic testing or imaging, or to cases involving negligent treatment. See Eagel v. Newman, 325 N.J. Super. 467 (App. Div. 1999), Farina v. Kraus, 333 N.J. Super. 165 (App. Div. 2000), and Linquito v. Siegel, 370 N.J. Super. 21 (App. Div. 2004). Thus, meritorious informed consent cases tend to involve wrongful birth cases, “since each is premised upon the plaintiff’s right of self-determination,” Geler v. Akawie, 358 N.J. Super. 437, 460 (App. Div. 2003), see also Canesi v. Wilson, 158 N.J. 490 (1999), the failure to offer non-surgical treatment options, Caputa v. Antiles, 296 N.J. Super. 123 (App. Div. 1996), or cases involving elective surgery such as lasik or gastric bypass.

However, two recent Appellate Division cases have demonstrated that the doctrine of informed consent can be abused to confuse the issues, resulting in reversible error. In Ehrlich v. Sorokin, N.J. Super. (App. Div. 2017), the plaintiff suffered a perforation of her colon and peritonitis after an elective polypectomy. The plaintiff had a temporary ileostomy and had to undergo additional surgeries. The plaintiff filed suit, asserting only a negligence claim and not an informed consent claim. At trial, plaintiff moved to exclude use of the informed consent forms for the procedures, but the trial judge denied these motions. The defense counsel cross-examined the plaintiff about risks disclosed in the consent forms. The informed consent form was provided to the jury as part of its deliberation, and the jury found for the defendant.

On appeal, the Appellate Division reversed, explaining that “the sole issue was whether defendant was negligent.” The court agreed that “defendant misled the jury to believe consent was connected to the standard of care,” relying upon Eagel v. Newman and Brady v. Urbas, 111 A.3d 1155 (Pa. 2015).

[W]e are convinced the admission of the informed consent evidence in this matter, where plaintiff asserted only a claim of negligent treatment, constituted reversible error. The only issue at trial was whether defendant’s use of the APC without a saline lift deviated from the standard of care. Plaintiff’s acknowledgment of the risk for perforation had no bearing on this determination. Indeed, although negligent treatment and informed consent fall under the umbrella of medical negligence, our law clearly distinguishes the two claims, and they require different elements of proof. See Newmark-Shortino, supra, 427 N.J. Super. at 304. We therefore conclude the informed consent evidence was irrelevant to the issue presented at trial, N.J.R.E. 401, and should have been excluded on plaintiff’s motion in limine.

The Appellate Division explained that the informed consent form “had the capacity to mislead the jury, N.J.R.E. 403, thereby making it capable of producing an unjust result. R. 2:10-2.” The court would not even permit the informed consent form to be used during cross-examination to “counter plaintiff’s testimony on direct examination that [defendant] gave plaintiff absolutely no information about her condition and treatment.”

The same conclusion was reached by a different panel of the Appellate Division in Granovsky v. Chagares, A-0090-15 (App. Div. 2017). In this case, the defendant performed a laparoscopic cholecystectomy and while doing so unknowingly severed the common bile duct. The plaintiff had to undergo a Roux-en-Y hepaticojejunostomy to repair the injury. Once again, the plaintiff only asserted that the defendant was negligent in performing the procedure. The plaintiff did not assert a claim for breach of the duty to provide informed consent. Plaintiff’s counsel also moved to exclude evidence of informed consent at trial. A motion judge granted this motion in advance of trial, but at trial the trial judge permitted evidence of the informed consent information to be provided to the jury. The jury found for the defendant. In reversing, the Granovsky panel concurred with the panel in Ehrlich, concluding that admitting evidence of the informed consent forms was reversible error.

The Granovsky panel observed that the trial judge permitted: (1) the defendant to testify about his informed consent discussion; (2) one defense expert to testify regarding his informed consent form and what he tells patients; (3) a second defense expert to testify that a “bile duct injury is part of every gallbladder surgeon’s consent form”; (4) a subsequent treating surgeon to testify about his consent form and discussion with his patients; and (5) the cross examination of plaintiff’s expert regarding what he informs patients about the risk of an injury to the bile duct during a laparoscopic cholecystectomy. The Granovsky panel explained that an informed consent claim is “is separate and distinct from a cause of action predicated on a physician’s breach of a standard of care,” citing Matthies. Informed consent is not based upon a claim the defendant was negligent, citing Eagel. The duty of providing informed consent is based upon “the failure to have provided the patient with adequate information regarding the risks of a given treatment or with adequate information regarding the availability of alternative treatments and the comparative risks and benefits of each.” The Granovsky court concluded:

We agree with the reasoning of Ehrlich and follow it here. Plaintiff’s knowledge of the risk of bile duct injury in the course of a laparoscopic cholecystectomy is entirely irrelevant to whether defendant performed the procedure in accordance with the applicable standard of care …. We reject defendant’s argument that the informed consent evidence could assist in either establishing the standard of care for the procedure or bolstering his claim that plaintiff’s transected bile duct resulted from a recognized complication of the procedure and not negligence

The Granovsky court emphasized that the defense counsel, who is almost certainly the most experienced member of the medical malpractice defense bar, “highlighted the testimony and defendant’s advice to plaintiff regarding the risks repeatedly in his closing argument, asking the jury: “Do you think he’s telling her, hey I may commit malpractice on you? Or is he telling her the possible risks, known risks and complication[s] which he has a duty to do which he did do.”

The court admonished:

Although defendant undoubtedly has the right to defend himself against the complaint made against him, he does not have the right to set up a straw manargument against the complaint he would rather defend, diverting the jury’s attention from the negligent treatment claim plaintiff brought, and improperly suggesting to the jury that having been advised of the possibility of bile duct injury and having consented to the surgery, plaintiff assumed the risk. [Emphasis added.]

The law is now settled. Although a patient may consent to undergo a procedure which is associated with known, unavoidable risks in some cases, the patient does not consent to the negligent performance of that procedure. The fact that a patient signed a form acknowledging a risk does not exonerate a physician who negligently causes that risk to occur. It is now clear that defendants may not use an informed consent form to confuse a jury into believing that the fact that a risk is listed means that the doctor is not at fault.•

Next Week…

Personal Injury

The New Jersey Supreme Court has long been committed to the principle that a patient should be fully informed about the benefits and risks associated with medical treatment. Generally, a patient has a cause of action for the breach of the duty to obtain informed consent when:

  1. the treatment rendered was associated with a known risk, and
  2. plaintiff was not advised of the risk, and
  3. the risk occurred, and
  4. a reasonable person in the plaintiff’s position would have rejected the treatment.

See Model Jury Charge (Civil) 5.50C.

Significantly, the standard for disclosure is imposed by law and not medical consensus. Largey v. Rothman , 110 N.J. 204 ( 1988 ) . The Largey court held that the “breadth of disclosure” is measured by what it deemed to be an “objective standard” established not by either the subjective standards or expectations of either the physician or patient. Instead, Largey instructed that “the law must set the standard for adequate disclosure,” and therefore, the standard for disclosure is to be determined by the trial court as a matter of law.

Largey has been followed by a line of cases which have defined and expanded the scope of the duty to obtain informed consent. However, despite all of the discussion devoted to this topic, the number of meritorious informed consent cases are few. Informed consent generally only applies to elective procedures (see Petrolia v. Estate of Nova , 284 N.J. Super. 585 ( App. Div. 1995 ) and Posta v. Chueng-Loy , 306 N.J. Super. 182 ( App. Div. 1997 ) ) and the failure to inform of the need for treatment, often called “informed refusal.” See Matthies v. Mastromonaco , 160 N.J. 26 ( 1999 ) and Battenfeld v. Gregory , 247 N.J. Super. 538 ( App. Div. 1991 ) .

The doctrine of informed consent does not apply to the failure to diagnose a medical condition, the failure to offer the choice of diagnostic testing or imaging, or to cases involving negligent treatment. See Eagel v. Newman , 325 N.J. Super. 467 ( App. Div. 1999 ) , Farina v. Kraus , 333 N.J. Super. 165 ( App. Div. 2000 ) , and Linquito v. Siegel , 370 N.J. Super. 21 ( App. Div. 2004 ) . Thus, meritorious informed consent cases tend to involve wrongful birth cases, “since each is premised upon the plaintiff’s right of self-determination,” Geler v. Akawie , 358 N.J. Super. 437, 460 ( App. Div. 2003 ) , see also Canesi v. Wilson , 158 N.J. 490 ( 1999 ) , the failure to offer non-surgical treatment options, Caputa v. Antiles , 296 N.J. Super. 123 ( App. Div. 1996 ) , or cases involving elective surgery such as lasik or gastric bypass.

However, two recent Appellate Division cases have demonstrated that the doctrine of informed consent can be abused to confuse the issues, resulting in reversible error. In Ehrlich v. Sorokin, N.J. Super. (App. Div. 2017), the plaintiff suffered a perforation of her colon and peritonitis after an elective polypectomy. The plaintiff had a temporary ileostomy and had to undergo additional surgeries. The plaintiff filed suit, asserting only a negligence claim and not an informed consent claim. At trial, plaintiff moved to exclude use of the informed consent forms for the procedures, but the trial judge denied these motions. The defense counsel cross-examined the plaintiff about risks disclosed in the consent forms. The informed consent form was provided to the jury as part of its deliberation, and the jury found for the defendant.

On appeal, the Appellate Division reversed, explaining that “the sole issue was whether defendant was negligent.” The court agreed that “defendant misled the jury to believe consent was connected to the standard of care,” relying upon Eagel v. Newman and Brady v. Urbas , 111 A.3d 1155 ( Pa. 2015 ) .

[W]e are convinced the admission of the informed consent evidence in this matter, where plaintiff asserted only a claim of negligent treatment, constituted reversible error. The only issue at trial was whether defendant’s use of the APC without a saline lift deviated from the standard of care. Plaintiff’s acknowledgment of the risk for perforation had no bearing on this determination. Indeed, although negligent treatment and informed consent fall under the umbrella of medical negligence, our law clearly distinguishes the two claims, and they require different elements of proof. See Newmark-Shortino, supra, 427 N.J. Super. at 304. We therefore conclude the informed consent evidence was irrelevant to the issue presented at trial, N.J.R.E. 401, and should have been excluded on plaintiff’s motion in limine.

The Appellate Division explained that the informed consent form “had the capacity to mislead the jury, N.J.R.E. 403, thereby making it capable of producing an unjust result. R. 2:10-2.” The court would not even permit the informed consent form to be used during cross-examination to “counter plaintiff’s testimony on direct examination that [defendant] gave plaintiff absolutely no information about her condition and treatment.”

The same conclusion was reached by a different panel of the Appellate Division in Granovsky v. Chagares, A-0090-15 (App. Div. 2017). In this case, the defendant performed a laparoscopic cholecystectomy and while doing so unknowingly severed the common bile duct. The plaintiff had to undergo a Roux-en-Y hepaticojejunostomy to repair the injury. Once again, the plaintiff only asserted that the defendant was negligent in performing the procedure. The plaintiff did not assert a claim for breach of the duty to provide informed consent. Plaintiff’s counsel also moved to exclude evidence of informed consent at trial. A motion judge granted this motion in advance of trial, but at trial the trial judge permitted evidence of the informed consent information to be provided to the jury. The jury found for the defendant. In reversing, the Granovsky panel concurred with the panel in Ehrlich, concluding that admitting evidence of the informed consent forms was reversible error.

The Granovsky panel observed that the trial judge permitted: (1) the defendant to testify about his informed consent discussion; (2) one defense expert to testify regarding his informed consent form and what he tells patients; (3) a second defense expert to testify that a “bile duct injury is part of every gallbladder surgeon’s consent form”; (4) a subsequent treating surgeon to testify about his consent form and discussion with his patients; and (5) the cross examination of plaintiff’s expert regarding what he informs patients about the risk of an injury to the bile duct during a laparoscopic cholecystectomy. The Granovsky panel explained that an informed consent claim is “is separate and distinct from a cause of action predicated on a physician’s breach of a standard of care,” citing Matthies. Informed consent is not based upon a claim the defendant was negligent, citing Eagel. The duty of providing informed consent is based upon “the failure to have provided the patient with adequate information regarding the risks of a given treatment or with adequate information regarding the availability of alternative treatments and the comparative risks and benefits of each.” The Granovsky court concluded:

We agree with the reasoning of Ehrlich and follow it here. Plaintiff’s knowledge of the risk of bile duct injury in the course of a laparoscopic cholecystectomy is entirely irrelevant to whether defendant performed the procedure in accordance with the applicable standard of care …. We reject defendant’s argument that the informed consent evidence could assist in either establishing the standard of care for the procedure or bolstering his claim that plaintiff’s transected bile duct resulted from a recognized complication of the procedure and not negligence

The Granovsky court emphasized that the defense counsel, who is almost certainly the most experienced member of the medical malpractice defense bar, “highlighted the testimony and defendant’s advice to plaintiff regarding the risks repeatedly in his closing argument, asking the jury: “Do you think he’s telling her, hey I may commit malpractice on you? Or is he telling her the possible risks, known risks and complication[s] which he has a duty to do which he did do.”

The court admonished:

Although defendant undoubtedly has the right to defend himself against the complaint made against him, he does not have the right to set up a straw manargument against the complaint he would rather defend, diverting the jury’s attention from the negligent treatment claim plaintiff brought, and improperly suggesting to the jury that having been advised of the possibility of bile duct injury and having consented to the surgery, plaintiff assumed the risk. [Emphasis added.]

The law is now settled. Although a patient may consent to undergo a procedure which is associated with known, unavoidable risks in some cases, the patient does not consent to the negligent performance of that procedure. The fact that a patient signed a form acknowledging a risk does not exonerate a physician who negligently causes that risk to occur. It is now clear that defendants may not use an informed consent form to confuse a jury into believing that the fact that a risk is listed means that the doctor is not at fault.•

Next Week…

Personal Injury