When Lack of Informed Consent Is Not the Issue

When an injury occurs, the first reaction of those in the medical office might be to ask, “Did the patient sign an informed consent form?” When the answer is “Yes,” and the harm that occurred is listed as a possibility on that signed form, everyone can breathe a sigh of relief. Right?

Wrong. Failure to obtain informed consent has nothing to do with, for instance, failure to diagnose. In some states (but not in others), failure to inform the patient sufficiently amounts to a battery, but not medical negligence. See, e.g., Montgomery v. Bazaz-Sehgal, 568 Pa. 574 (2002). And even if the patient gave his informed consent, that does not excuse negligent treatment. Yet the fact that informed consent was properly obtained has sometimes been trotted out as a defense to a medical malpractice claim when the lack thereof was not even pleaded. Thus, courts in a number of states have had to grapple with the issue of whether evidence of informed consent is admissible in a pure negligence case, and whether, once it has been admitted, the presence of such evidence at trial may be a basis for reversal.

The State of Virginia Says the Evidence Is Barred

Wright v. Kaye, 2004 Va. LEXIS 48 (Va. 2004), concerned the care of plaintiff Jennifer Wright, who was operated on by Dr. Kaye in 1997 after he discovered a cyst on her urachus. After the cyst was removed laparascopically, Dr. Kaye used a suturing device known as an endo-GIA stapler to close the affected area. In his operative report, Dr. Kaye noted that “it appeared that this was done away from the bladder.” Dr. Kaye filled Wright's bladder with methylene blue and none of it appeared to enter Wright's pelvis, but the doctor did not perform a cystoscopy to see if any staples had been inserted into the patient's bladder during the procedure.

Wright began to suffer bladder problems soon after the surgery, including bladder spasms and urinary frequency issues. She consulted with another physician about a year later, who found that six surgical staples had been left in Wright's bladder. The staples were then removed, but by this time had already caused Wright to suffer permanent bladder dysfunction. She therefore brought suit for negligence against Dr. Kaye.

The case was thrown out on the defense's motion for summary judgment after all of Wright's experts were disqualified. Before that happened, the court had also denied the plaintiff's motion in limine to prevent the defense from bringing up the fact that she had been informed of the possibility of her type of injury prior to the surgery, and yet had consented to undergo the procedure. As Wright had not pleaded a cause of action for failure to inform, she argued that any mention of her counseling and consent was irrelevant and would simply confuse the jury. The trial judge considered Wright's objection, then stated on the record: “I think indeed the jury knows that a prudent doctor must advise patients concerning any risk prior to surgery. If you don't show that, immediately you've implied that maybe this doctor is negligent to begin with. So I would find that it certainly would be fair to show that he did what a prudent doctor would do and advise of that particular risk.”

Virginia's Supreme Court reinstated the case, finding, among other things, that on remand, what Wright needed to prove in order to prevail on her claims concerned negligence and causation, not failure to inform. The court explained:

Wright's awareness of the general risks of surgery is not a defense available to Dr. Kaye against the claim of a deviation from the standard of care. While Wright or any other patient may consent to risks, she does not consent to negligence. Knowledge by the trier of fact of informed consent to risk, where lack of informed consent is not an issue, does not help the plaintiff prove negligence. Nor does it help the defendant show he was not negligent. In such a case, the admission of evidence concerning a plaintiff's consent could only serve to confuse the jury because the jury could conclude, contrary to the law and the evidence, that consent to the surgery was tantamount to consent to the injury which resulted from that surgery. In effect, the jury could conclude that consent amounted to a waiver, which is plainly wrong.

Thus, on remand, the Supreme Court of Virginia barred the admission of evidence of counseling concerning the possible risks of the proposed procedure, and Wright' s consent to go through with the surgery in spite of those risks.

Pennsylvania Offers Possible Exceptions

Judge G. Michael Green of Pennsylvania's Delaware County Court of Common Pleas oversaw the jury trial of Brady v. Urbas, 631 Pa. 329 (Pa. 2015), a suit brought by plaintiff Maria Brady. She had sought treatment from podiatrist William Urbas because she had been experiencing trouble with both her feet. Dr. Urbas successfully operated on one of her feet. Once Brady had healed, Dr. Urbas moved to her second foot, which proved more problematic. An initial surgery to remove a piece of bone from Brady's toe seemed to work, but the toe returned over time to its unsatisfactory and painful condition. Three subsequent surgeries also failed to relieve the condition, and left Brady with a short toe. She then consulted with another doctor, who operated on her foot and largely fixed the problem.

Prior to all four of the procedures Dr. Urbas performed Brady had been advised of the risks of surgery, but gave her consent anyway.

In December 2010, Brady sued Dr. Urbas for negligence in performing the three follow-up surgeries — though not for the successful surgery on the first foot or for the first surgery on the other foot. In her complaint, Brady stated that the doctor did not diagnose her problem after the first surgery on the second foot, that he performed the final three surgeries on it even though her condition contra-indicated them, and that she could not reasonably have discovered the harm she suffered until after the fourth surgery because “Dr. Urbas' advice, assurances and recommendations … lulled [her] into a false sense of security and concealed the true nature of [her] condition[.]” Brady did not allege, however, that her informed consent was not obtained prior to any of the surgeries.

Prior to trial before a jury, Brady moved to exclude any evidence of consent, arguing that such would be irrelevant to whether Dr. Urbas' treatment of her foot was within the standard of care — and that the jury might become confused as to the real issues if asked to consider consent evidence. Dr. Urbas argued for inclusion of evidence of consent, saying that he would not use such evidence in an attempt to prove informed consent, but only to show Brady's state of mind at the time of the surgeries. The trial court allowed the evidence in.

At trial, both sides' experts discussed the fact that Brady gave her informed consent and that the injuries she suffered were known complications of those surgical procedures. They differed, however, on whether Dr. Urbas' recommendations, care and treatment fell below the standard of care.

During deliberations, the jury asked specifically to see the consent forms, explaining that they wanted to know just what Brady had “ agreed to.” Shortly after being provided with these forms, the jury returned a defense verdict in which they explained that Dr. Urbas had not given Brady negligent care. The jury did not reach the issues of causation or damages.

Brady appealed, and the trial court provided the appeals court with an explanatory opinion, which stated that “[t]he risks and complications associated with the alleged negligent procedures and the course of treatment to alleviate those complications were relevant to determine if Dr. Urbas was negligent,” and that the jury had been “aptly and repeatedly” informed that Brady had never signed a consent form indicating that “negligent surgery” was a known risk of the procedures she underwent, or that she was authorizing any such negligent surgery.

The intermediate appeals court reversed. It relied on Virginia's Wright decision to announce a per-se rule of exclusion, which amounted to the following: Evidence that a patient gave his or her informed consent is inadmissible in medical malpractice cases, and is only appropriately admitted if lack of informed consent is pleaded. See Brady v. Urbas, 2013 PA Super 296, 80 A.3d 480 (Pa. Super. 2013).

The case was further appealed to the Commonwealth of Pennsylvania's highest court. There, the Superior Court's exclusionary rule was toned down, but only minimally, because the court allowed that there might be situations in which a patient's informed consent could be relevant to a medical malpractice suit. For example, if an experimental procedure is not typically done in a certain locality (so it is not within the standard of care for that region) yet the patient consents to undergo the procedure nonetheless after being informed of the possible negative outcomes, evidence of such consent could be relevant to whether the procedure the doctor chose to perform was within the standard of care. As another example, the court pointed out that although Pennsylvania treats failure to obtain informed consent as a battery, other jurisdictions hold that offering information to a patient and obtaining her consent are part of the standard of care; therefore, failure to do these things violates the standard of care and can be the basis for liability under a medical negligence theory.

Under the facts of Brady, however, the court could find no reason for the admission of evidence of consent. This was so even though Brady alleged that “Dr. Urbas' advice, assurances and recommendations … lulled [her] into a false sense of security and concealed the true nature of [her] condition[.]” This allegation, the court observed, was merely aimed at explaining any delays in filing the suit, not at explaining whether Dr. Urbas' treatment was negligent. Furthermore, considering that the jury had asked to see the consent evidence in order to understand what Brady had “ agreed to,” and had rendered the defense verdict shortly thereafter, the court concluded that there was “a substantial possibility, then, that the jury's verdict rested on an improper consideration.” Thus, Pennsylvania's Supreme Court affirmed the Superior Court's order vacating the judgment and remanding for a new trial.

Two New Jersey Cases

Two defense verdicts were recently reversed by New Jersey appellate courts because the trial courts had admitted evidence of informed consent in cases where the lack thereof was not alleged.

In one, Ehrlich v. Sorokin, 451 N.J. Super. 119 (App. Div. 2017), plaintiff Norma Ehrlich's colon was perforated during an elective polypectomy, and she suffered peritonitis, had a temporary ileostomy and had to undergo further surgery to reverse the ileostomy. She sued for negligence, asserting that the doctor failed to inject the polyp and surrounding colon with Saline to create a cushion underneath the polyp when performing the surgery. The plaintiff moved to exclude evidence of consent to surgery, but the trial court allowed it in, stating that “the [consent] forms and any information provided to the patient was part of the standard of care, and therefore relevant.” Defense counsel cross-examined the plaintiff about the consent form, and the form itself was provided to the jury during deliberations. The jury returned a verdict for the defendant. Ehrlich appealed.

As the Appellate Division in Ehrlich pointed out, no case in New Jersey had yet dealt with the question of whether consent evidence should or should not be admitted when the plaintiff has not alleged failure to obtain such. This being so, plaintiff Ehrlich relied on precedent from other jurisdictions for her argument — in particular, Pennsylvania's Brady decision. But other state decisions in which consent evidence was deemed irrelevant and prejudicial were cited by the plaintiff as well, including Virginia's Wright v. Kaye, Delaware's Baird v. Owczarek, 93 A.3d 1222, 1232 (Del. 2014), and Ohio's Waller v. Aggarwal, 116 Ohio App. 3d 355 (Ohio Ct. App. 1996).

The court was swayed not only by these out-of-state decisions, but also by its own decision in Gonzalez v. Silver, 407 N.J. Super. 576 (App. Div. 2009), a case in which a doctor accused of medical malpractice was allowed at trial to present hearsay evidence regarding statements the plaintiff allegedly made about the cause of his injury. In that case, the appeals court determined the evidence should not have been admitted because it had no bearing on whether the medical care the plaintiff received was within the standard of care. Because this evidence had the potential to prejudice the jury against the plaintiff, the case was remanded for a new trial. The court found the irrelevant information about cause of injury in Gonzalez analogous to the information of informed consent that the trial court permitted to be presented to the jury in Ehrlich.

The appellate court observed that both negligent treatment and failure to obtain informed consent “fall under the umbrella of medical negligence” in New Jersey, but that the state's “law clearly distinguishes the two claims, and they require different elements of proof.” In Ehrlich's case, the court considered Gonzalez and the non-binding but persuasive out-of-state cases that had already dealt with the question to conclude that “the admission of the informed consent evidence in this matter, where plaintiff asserted only a claim of negligent treatment, constituted reversible error.” The court found that the only issue at trial was whether the technique used by the doctor to remove the plaintiff's polyp deviated from the standard of care, and Ehr- lich's “acknowledgment of the risk for perforation had no bearing on this determination.” Therefore, the evidence should have been excluded.

A different panel of New Jersey's Appellate Division came to the same conclusion soon afterward, in Granovsky v. Chagares, 2017 N.J. Super. Unpub. LEXIS 2074 (App. Div. 9/28/17). In this case, the plaintiff alleged that the defendant surgeon negligently performed a laparoscopic cholecystectomy, accidentally severing the patient's common bile duct. The plaintiff pleaded negligence, but not lack of informed consent, and moved to exclude evidence of her consent from the proceedings. The defense successfully argued that consent evidence should be admitted, as the plaintiff's consent after being informed of this risk constituted proof that the occurrence of injury to the common bile duct was not a deviation from the standard of care. The evidence was allowed in and the jury returned a defense verdict. The plaintiff appealed.

The Granovsky appellate panel noted that the trial judge had not only allowed the defendant to testify about his informed consent discussion with the plaintiff, but also allowed a defense experts to testify about whether a bile duct injury is a known risk of the type of surgery the plaintiff underwent and whether the patient had been informed of this (which she had been). Additionally, a subsequent treating surgeon was asked to testify about his consent form and what he discusses with his patients, and the plaintiff's own expert was cross-examined as to how he informs his patients when they are about to undergo surgeries similar to the plaintiff's.

The Granovsky appeals court found that the trial court had erred in allowing the consent evidence in, stating:

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 court stated further:

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 man argument 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.

Conclusion

Failure to tell a patient of the risks of a medical procedure and to obtain their informed consent to go through with it is only one way that a medical injury case might lead to liability, yet even those in the legal field can become confused, conflating the idea that a patient understands a risk with their giving permission for that bad outcome to occur. But being injured is not what a patient consents to; he or she consents only to undergo a procedure, knowing that bad outcomes may occur, but expecting the medical provider to conform to the standard of care.

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Janice G. Inman is Editor-in-Chief of this newsletter.