Orthopedic Medical Legal Advisor

Trends in negligence law: Excluding informed consent

In medical malpractice litigation, documentation of the informed consent process can play a major role. Medical providers usually believe that an accurate informed consent must capture all the known risks of an intervention and that the signed consent can be an effective defense to a medical malpractice lawsuit. Finely printed informed consent forms can run into several pages, often prepared by hospital attorneys and committees to capture any and all foreseeable outcomes of surgery.

The view of the informed consent as a legal defense is misplaced. Increasingly, courts are beginning to clarify the proper role of informed consent, particularly in terms of its admissibility vs. exclusion from medical malpractice trials.

Informed consent as evidence

B. Sonny Bal

B. Sonny Bal

As a threshold matter, not all evidence is allowed into a civil trial, such as one alleging medical malpractice. As a general rule, only that evidence is admissible which is relevant to the issues being litigated, and that has probative value. Probative value refers to the ability of a piece of evidence to make a disputed point in litigation either more likely or less likely. In other words, evidence is properly admitted by a court when it is relevant and has practical value in helping the jury make its decision. Evidence that lacks relevance or probative value, or that could prejudice and confuse the jury, is excluded by courts to ensure judicial economy, and to ensure there is expediency and fairness in litigation.

If a piece of evidence presented by either party runs the risk of misleading the jury, then the court must weigh the probative value of that evidence against the risk of juror confusion. In selected instances, a court may therefore exclude evidence that may otherwise have been admissible.

Informed consent as defense

In trial practice, attorneys defending hospitals and physicians almost invariably introduce the informed consent documents into evidence, even if the consent process is itself not in dispute. The goal of introducing consent documents into the trial is to assure jurors that the injured patient knew about the risks of the procedure. This practice raises the concern that a signed document might confuse or prejudice jurors into thinking the patient waived the listed risks of the operation. This juror confusion would work against the plaintiff, whose signed consent only reflected the understanding that the listed risks can manifest even if the procedure is performed consistent with the standard of care. In other words, the consent form, no matter how detailed, does not acknowledge the acceptance of the risk of negligent treatment and the damages flowing from such. Some recent judicial decisions are instructive in this regard and should encourage clinicians to reevaluate the role of the informed consent.

Illustrative case law

In 2015, the Pennsylvania Supreme Court confronted the issue of whether to allow informed consent into a medical malpractice trial. In the legal ruling Brady v. Urbas, the patient had hammertoes and underwent corrective surgery. As it turned out, more than one operation was required, including resection arthroplasty that resulted in shortened toes. The patient was left with a cosmetic deformity and continuing pain, and sought a second opinion. The second surgeon performed corrective surgery, restoring toe length with bone graft implantation. The patient had a successful result with pain relief and restoration of normal activity.

The patient sued the first surgeon, alleging negligent performance of surgery. During pretrial proceedings, the patient sought to exclude the surgical consent forms that she had signed before each procedure by the first surgeon. The plaintiff argued that whether she had affirmative knowledge of the risks of surgery was irrelevant to the question of whether her surgeon had complied with the standard of care. The defendant surgeon argued that a discussion of the risks and complications of surgery were relevant to the credibility of the patient, and to her state of mind when she decided to have surgery. The trial court agreed with the surgeon, such that the jury was presented with the detailed informed consent documents that showed the patient knew about the potential unsatisfactory outcomes from surgery. The jury found in favor of the defendant doctor, and the patient appealed.

Lawrence H. Brenner

Lawrence H. Brenner

The appeal ultimately came before the Pennsylvania Supreme Court, which reversed the trial court’s ruling. The court clarified that signing a consent for surgery is unrelated to the issue of whether the surgeon was negligent. The risks of surgery, when they occur from the negligent execution of the operation, are not automatically assumed by the patient who signed an informed consent. The court cited a 2004 ruling from Virginia titled Wright v. Kaye in its opinion. In Wright, the patient underwent laparoscopic surgery to treat pelvic pain. Bladder dysfunction ensued that was later determined to be the result of retained staples erroneously placed into bladder tissue. In excluding the informed consent from litigation, the Supreme Court of Virginia clarified that evidence of a patient consenting to surgery could confuse jurors that the patient also consented to injury from negligent surgery. Such waiver of risk is not the purpose of informed consent, according the court.

More recently, the Pennsylvania Supreme Court has agreed to hear arguments in the 2017 case of Mitchell v. Shikora, arising from a bowel injury during a hysterectomy. An earlier jury verdict in favor of the defendant hospital was challenged by the patient who said evidence of the general risks and complications of hysterectomies may have improperly influenced the jury verdict. Defendants countered that legal precedent permits evidence of risks and complications of surgery during a medical malpractice claim.

Before the issue was brought before the Pennsylvania Supreme Court, a lower appeals court sided with the patient. “While evidence of risks and complications of a surgical procedure may be admissible to establish the relevant standard of care, in this case, such evidence was irrelevant in determining whether defendants ... acted within the applicable standard of care,” said the appellate decision. The court added that, “In deciding to undergo this surgery, Mitchell expects that the treatment will be rendered in accordance with the applicable standard of care, regardless of the risks.” The defendants cited the earlier Pennsylvania Supreme Court ruling in Brady v. Urbas, which, while excluding evidence of informed consent from medical malpractice cases, had left the door open by saying “some of this information may be relevant to the question of negligence if, for example, the standard of care requires that the doctor discuss certain risks with the patient.” The Brady court also acknowledged that “Evidence about the risks of surgical procedures in the form of either testimony or a list of such risks as they appear on an informed consent sheet may also be relevant in establishing the standard of care.”

Analysis of legal rulings

While the outcome of Mitchell v. Shikora is yet unknown, many surgeons will agree with the defense position that a surgeon should be allowed to routinely introduce evidence that a complication can occur in the absence of negligence. Otherwise, medical negligence could inadvertently turn into strict tort liability. Countering this proposition is the concern addressed by the Brady and Wright courts, ie, jurors may mistakenly believe that awareness of risk is the same was waiver of risk, regardless of how the operation was performed. The concern is especially heightened during trials when defense counsel shrug off complications as an inherent part of performing any surgical procedure, asking plaintiffs’ experts to agree with the general proposition that no operative procedure comes without risk.

Brady and Wright reflect modern trends in medical negligence law in the United States, and additional state jurisdictions are adopting the reasoning behind these cases. These cases stand for the proposition that a surgeon cannot compel a patient to accept as a risk that the patient will be injured by a negligent act. As such, the probative value of informed consent forms may be uncertain in legal cases where the plaintiff raises only the issue of negligent performance of surgery, but does not assert that he or she was inadequately informed.

At first glance, the exclusion of informed consent from a medical negligence trial may be discouraging to clinicians who have invested time and effort in crafting a detailed listing of the risks and complications of surgery. In our opinion however, Brady and Wright are correct interpretations of evidentiary law. As an example, consider a permanent sciatic palsy that manifests after a routine total hip replacement done with the posterior approach. Work-up, including an expedient return to the OR to examine the sciatic nerve is entirely unrevealing, ie, with no compressive hematoma, leg lengthening, spinal disease or physical signs of nerve injury. Now consider an identical case, in which the exploratory operation revealed a complete laceration of the sciatic nerve. Would routine introduction of sciatic palsy as a known risk of surgery prejudice a jury in the second instance, where the patient claimed only that cutting the sciatic nerve during THR constitutes negligent conduct?

The clarifications offered by the Brady and Wright courts may be helpful to careful surgeons in addressing the common misconception that informed consent is a legal compliance matter, to be prepared by hospital committees and lawyers. In reality, an informed consent form is a checklist, helping the clinician address the risks that need to be discussed with the patient. The document is the beginning point of a thoughtful, nuanced discussion that builds patient trust and understanding. The informed consent is but one tool in the difficult task of conveying medical uncertainty to the patient. Its purpose is achieved when the patient accepts uncertainty, with the assurance and belief that no matter what the outcome, the surgeon will be there for the patient.

Disclosures: Bal and Brenner report no relevant financial disclosures.

In medical malpractice litigation, documentation of the informed consent process can play a major role. Medical providers usually believe that an accurate informed consent must capture all the known risks of an intervention and that the signed consent can be an effective defense to a medical malpractice lawsuit. Finely printed informed consent forms can run into several pages, often prepared by hospital attorneys and committees to capture any and all foreseeable outcomes of surgery.

The view of the informed consent as a legal defense is misplaced. Increasingly, courts are beginning to clarify the proper role of informed consent, particularly in terms of its admissibility vs. exclusion from medical malpractice trials.

Informed consent as evidence

B. Sonny Bal

B. Sonny Bal

As a threshold matter, not all evidence is allowed into a civil trial, such as one alleging medical malpractice. As a general rule, only that evidence is admissible which is relevant to the issues being litigated, and that has probative value. Probative value refers to the ability of a piece of evidence to make a disputed point in litigation either more likely or less likely. In other words, evidence is properly admitted by a court when it is relevant and has practical value in helping the jury make its decision. Evidence that lacks relevance or probative value, or that could prejudice and confuse the jury, is excluded by courts to ensure judicial economy, and to ensure there is expediency and fairness in litigation.

If a piece of evidence presented by either party runs the risk of misleading the jury, then the court must weigh the probative value of that evidence against the risk of juror confusion. In selected instances, a court may therefore exclude evidence that may otherwise have been admissible.

Informed consent as defense

In trial practice, attorneys defending hospitals and physicians almost invariably introduce the informed consent documents into evidence, even if the consent process is itself not in dispute. The goal of introducing consent documents into the trial is to assure jurors that the injured patient knew about the risks of the procedure. This practice raises the concern that a signed document might confuse or prejudice jurors into thinking the patient waived the listed risks of the operation. This juror confusion would work against the plaintiff, whose signed consent only reflected the understanding that the listed risks can manifest even if the procedure is performed consistent with the standard of care. In other words, the consent form, no matter how detailed, does not acknowledge the acceptance of the risk of negligent treatment and the damages flowing from such. Some recent judicial decisions are instructive in this regard and should encourage clinicians to reevaluate the role of the informed consent.

PAGE BREAK

Illustrative case law

In 2015, the Pennsylvania Supreme Court confronted the issue of whether to allow informed consent into a medical malpractice trial. In the legal ruling Brady v. Urbas, the patient had hammertoes and underwent corrective surgery. As it turned out, more than one operation was required, including resection arthroplasty that resulted in shortened toes. The patient was left with a cosmetic deformity and continuing pain, and sought a second opinion. The second surgeon performed corrective surgery, restoring toe length with bone graft implantation. The patient had a successful result with pain relief and restoration of normal activity.

The patient sued the first surgeon, alleging negligent performance of surgery. During pretrial proceedings, the patient sought to exclude the surgical consent forms that she had signed before each procedure by the first surgeon. The plaintiff argued that whether she had affirmative knowledge of the risks of surgery was irrelevant to the question of whether her surgeon had complied with the standard of care. The defendant surgeon argued that a discussion of the risks and complications of surgery were relevant to the credibility of the patient, and to her state of mind when she decided to have surgery. The trial court agreed with the surgeon, such that the jury was presented with the detailed informed consent documents that showed the patient knew about the potential unsatisfactory outcomes from surgery. The jury found in favor of the defendant doctor, and the patient appealed.

Lawrence H. Brenner

Lawrence H. Brenner

The appeal ultimately came before the Pennsylvania Supreme Court, which reversed the trial court’s ruling. The court clarified that signing a consent for surgery is unrelated to the issue of whether the surgeon was negligent. The risks of surgery, when they occur from the negligent execution of the operation, are not automatically assumed by the patient who signed an informed consent. The court cited a 2004 ruling from Virginia titled Wright v. Kaye in its opinion. In Wright, the patient underwent laparoscopic surgery to treat pelvic pain. Bladder dysfunction ensued that was later determined to be the result of retained staples erroneously placed into bladder tissue. In excluding the informed consent from litigation, the Supreme Court of Virginia clarified that evidence of a patient consenting to surgery could confuse jurors that the patient also consented to injury from negligent surgery. Such waiver of risk is not the purpose of informed consent, according the court.

More recently, the Pennsylvania Supreme Court has agreed to hear arguments in the 2017 case of Mitchell v. Shikora, arising from a bowel injury during a hysterectomy. An earlier jury verdict in favor of the defendant hospital was challenged by the patient who said evidence of the general risks and complications of hysterectomies may have improperly influenced the jury verdict. Defendants countered that legal precedent permits evidence of risks and complications of surgery during a medical malpractice claim.

PAGE BREAK

Before the issue was brought before the Pennsylvania Supreme Court, a lower appeals court sided with the patient. “While evidence of risks and complications of a surgical procedure may be admissible to establish the relevant standard of care, in this case, such evidence was irrelevant in determining whether defendants ... acted within the applicable standard of care,” said the appellate decision. The court added that, “In deciding to undergo this surgery, Mitchell expects that the treatment will be rendered in accordance with the applicable standard of care, regardless of the risks.” The defendants cited the earlier Pennsylvania Supreme Court ruling in Brady v. Urbas, which, while excluding evidence of informed consent from medical malpractice cases, had left the door open by saying “some of this information may be relevant to the question of negligence if, for example, the standard of care requires that the doctor discuss certain risks with the patient.” The Brady court also acknowledged that “Evidence about the risks of surgical procedures in the form of either testimony or a list of such risks as they appear on an informed consent sheet may also be relevant in establishing the standard of care.”

Analysis of legal rulings

While the outcome of Mitchell v. Shikora is yet unknown, many surgeons will agree with the defense position that a surgeon should be allowed to routinely introduce evidence that a complication can occur in the absence of negligence. Otherwise, medical negligence could inadvertently turn into strict tort liability. Countering this proposition is the concern addressed by the Brady and Wright courts, ie, jurors may mistakenly believe that awareness of risk is the same was waiver of risk, regardless of how the operation was performed. The concern is especially heightened during trials when defense counsel shrug off complications as an inherent part of performing any surgical procedure, asking plaintiffs’ experts to agree with the general proposition that no operative procedure comes without risk.

Brady and Wright reflect modern trends in medical negligence law in the United States, and additional state jurisdictions are adopting the reasoning behind these cases. These cases stand for the proposition that a surgeon cannot compel a patient to accept as a risk that the patient will be injured by a negligent act. As such, the probative value of informed consent forms may be uncertain in legal cases where the plaintiff raises only the issue of negligent performance of surgery, but does not assert that he or she was inadequately informed.

PAGE BREAK

At first glance, the exclusion of informed consent from a medical negligence trial may be discouraging to clinicians who have invested time and effort in crafting a detailed listing of the risks and complications of surgery. In our opinion however, Brady and Wright are correct interpretations of evidentiary law. As an example, consider a permanent sciatic palsy that manifests after a routine total hip replacement done with the posterior approach. Work-up, including an expedient return to the OR to examine the sciatic nerve is entirely unrevealing, ie, with no compressive hematoma, leg lengthening, spinal disease or physical signs of nerve injury. Now consider an identical case, in which the exploratory operation revealed a complete laceration of the sciatic nerve. Would routine introduction of sciatic palsy as a known risk of surgery prejudice a jury in the second instance, where the patient claimed only that cutting the sciatic nerve during THR constitutes negligent conduct?

The clarifications offered by the Brady and Wright courts may be helpful to careful surgeons in addressing the common misconception that informed consent is a legal compliance matter, to be prepared by hospital committees and lawyers. In reality, an informed consent form is a checklist, helping the clinician address the risks that need to be discussed with the patient. The document is the beginning point of a thoughtful, nuanced discussion that builds patient trust and understanding. The informed consent is but one tool in the difficult task of conveying medical uncertainty to the patient. Its purpose is achieved when the patient accepts uncertainty, with the assurance and belief that no matter what the outcome, the surgeon will be there for the patient.

Disclosures: Bal and Brenner report no relevant financial disclosures.