Recognized Complications of Treatment and Informed Consent Evidence

It is axiomatic that negligence ordinarily will not be presumed from the occurrence of injury, but must be proven and with the burden in this regard being on the plaintiff. The standard jury charge for medical malpractice cases in New Jersey continues to reflect long-standing case law: “The law recognizes that the practice of medicine is not an exact science. Therefore, the practice of medicine according to accepted medical standards may not prevent a poor or unanticipated result.” Model Civil Jury Charges 5.50A. See, e.g., Schueler v. Strelinger, 43 N.J. 330, 346 (1964).  The poor outcome may be the result of a deviation from accepted standards of care – negligence in its most basic sense.  But when the physician has not disclosed the potential for an adverse event or complication, the doctrine of informed consent can be invoked.  Informed consent is considered a form of medical negligence. Teilhaber v. Greene, 320 N.J. Super. 453, 463 (App. Div. 1999).  New Jersey permits pleadings with alternative and inconsistent theories. R.4:5-6. In many instances, both theories are pursued.  But in some cases involving a treatment complication, no claim for lack of informed consent is advanced.

This has led to a substantial body of case law that holds, in broad terms, that in the absence of a claim for lack of informed consent, evidence of disclosure of risks to the plaintiff patient is irrelevant and should be excluded.  With the decision in Ehrlich v. Sorokin, 451 N.J. Super. 119 (App. Div. 2017), New Jersey joined what has become the majority view.  This was reiterated in a more recent New Jersey decision that was not approved for publication and as to which the Supreme Court denied certification on January 23, 2018. Granovsky v. Chagares, 2017 WL 3480771, 2017 N.J. Super. Unpub. LEXIS 2074 (App. Div. Aug. 15, 2017), certif. denied, 232 N.J. 85 (2018).

The patient in Ehrlich, experiencing back pain and rectal bleeding, had undergone a diagnostic colonoscopy procedure by Dr. Sorokin in 2003 that identified the presence of a polyp in her colon. The patient declined a recommendation for surgery and elected to undergo removal with a colonoscope.  This was done by a different gastroenterologist who referred the patient back to Dr. Sorokin for follow-up monitoring and surveillance of her GI status.  Several procedures were done by Dr. Sorokin for recurrent polyps using different techniques.  Following one of these procedures in which an electric charge was used to vaporize the polyp, the patient was found to have a perforation of her colon and peritonitis.  She underwent surgery to remove a portion of her colon.

Plaintiff intended to proceed at trial only on the assertion of a deviation from accepted standards of care in the manner in which the defendant gastroenterologist had performed this particular procedure.  Plaintiff’s counsel moved in limine to exclude informed consent evidence.  The motion was denied.  The patient was cross-examined with the signed consent form that stated that the procedure could result in injury with perforation and hospitalization for further care.  The jury returned a verdict that the defendant did not breach the standard of care.

In reversing, the Appellate Division found that in the absence of an allegation of lack of informed consent, the information concerning risk disclosure was irrelevant and prejudicial.  Drawing on the analysis developed in various out-of-state cases, the court indicated that a jury’s knowledge of a treatment’s risks, 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 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 of liability for negligence, which is plainly wrong. A patient does not consent to being treated negligently.  Similarly, in Granovsky, the surgeon did an operation to remove the patient’s gallbladder through a laparoscopic cholecystectomy procedure.  In the course of the operation, the common bile duct was cut.  The defense experts stated that common bile duct injuries were known complications of this type of surgery that occur in the absence of negligence.  The defendant also introduced and relied on the signed surgical consent which made reference to possible injury to the common bile duct requiring surgical repair.  The Appellate Division reversed.  It followed the reasoning of Ehrlich that the patient’s knowledge of the risk of bile duct injury was irrelevant to whether the defendant had performed the operation in accordance with accepted standards of care with the risk of confusing the jury.

Neither Ehrlich nor Granovsky established an absolute prohibition on presenting evidence of known risks of a surgical procedure in general as opposed to the discussions with the particular patient.  Indeed, the Granovsky panel noted that in support of an argument that common bile duct injuries can occur in the absence of negligence, a defendant could present evidence of the known risks of a surgical procedure.  The documented presence of the complication on the patient’s surgical consent limits the perception that the claim of “recognized complication” was an after-the-fact excuse.  It also provides a very tangible piece of physical evidence to be used in cross-examining an opposing expert who denies the status of the outcome as a recognized complication of the procedure.

But the Appellate Division indicated that such evidence should be presented “through the testimony of a defense expert regarding the risks of procedure, without reference to what advice the expert provides or what plaintiff was told of the risks of the surgery.” 2017 WL 3480771 at *9, 2017 N.J. Super. Unpub. LEXIS 2074 at *27-28. See also Hayes v. Camel, 927 A.2d 880, 890 (Conn. 2007); Waller v. Aggarwal, 688 N.E.2d 274, 276 (Ohio Ct. App. 1996).  In Brady v. Urbas, 111 A.2d 1155, 1162 (Pa. 2015), the Pennsylvania Supreme Court had seemed to agree with the admissibility of evidence of general risks and complications in a medical negligence claim.

But the Pennsylvania intermediate appellate court in Mitchell v. Shikora, 161 A.2d 90 (Pa. Super. 2017), rejected the admissibility of such evidence even when presented through experts:

The fact that one of the risks and complications of the laparoscopic hysterectomy, i.e., the perforation of the bowel, was the injury suffered by Mitchell does not make it more or less probable that Dr. Shikora conformed to the proper standard of care for a laparoscopic hysterectomy and was negligent. … Moreover, the evidence would tend to mislead and/or confuse the jury by leading it to believe that Mitchell’s injuries were simply the result of the risks and complications of the surgery. … Thus, the risks and complications evidence was immaterial to the issue of whether Defendants’ treatment of Mitchell met the standard of care. Accordingly, we hold that the evidence was inadmissible.   [Id. at 975.]

The Pennsylvania Supreme Court agreed to review this decision and whether it conflicted with the earlier Brady v. Urbas ruling. 174 A.2d 573 (2017). Oral argument took place on October 23, 2018. The forthcoming opinion is something to watch for. Some commentators have remarked that without being able to introduce evidence that a complication occurs in the absence of negligence, the potential is created that the medical negligence claim will be turned into one of strict liability. The occurrence of the complication without the context of how it occurs without breach of the standard of care would effectively create a presumption of liability. Such an outcome in the Mitchell case would represent a tectonic shift in principles of medical liability law.