Malpractice: When Informed Consent Is Not Good Enough

You let your patient know about the risks of a procedure before it began, but something went wrong and now he’s suing you. Luckily, you have a signed informed consent form. You’re protected from a medical malpractice suit, aren’t you?

Not necessarily.

It’s important for you to know the limitations of informed consent and the increasing possibility that courts will exclude evidence of informed consent from medical malpractice trials.

Informed Consent as Evidence

In a medical malpractice suit, attorneys who defend hospitals and physicians often introduce informed consent documents into evidence. Attorneys present these documents to establish that a patient knew about the procedure’s risks. This tactic is used almost routinely as a defense during medical malpractice claims, even when consent is not an issue in the case.

But, because this tactic may confuse jurors, some courts have begun to exclude informed consent documents from jury consideration.

Why would a court exclude informed consent documents from evidence?

To understand this, it’s important to understand that courts do not automatically allow all evidence to be presented at trial. Courts only allow evidence that is both relevant to the issues on trial and has probative value.

Probative value means information that could potentially prove something important at trial. If a piece of evidence has probative value, the court then evaluates whether the value of the evidence outweighs the dangers of unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.

For example, if a piece of evidence is confusing or misleading to a jury, the court will weigh the probative value of the evidence against those risks. If the court finds that the risk of confusion outweighs the probative value of evidence, a court will exclude that evidence.

When Informed Consent Is Not a Defense

In Brady v. Urbas, Maria Brady sued a podiatrist who had performed surgery on her feet.

She argued that her doctor negligently performed the surgery, resulting in constant pain and a shortened toe.

Before trial began, Brady tried to exclude the consent forms from evidence, arguing that the forms had no relevance to whether her doctor had complied with the standard of care.

The doctor argued that the documents were relevant to the patient’s credibility and state of mind when she decided to have surgery. The court agreed with the doctor and allowed the consent forms into evidence.

At trial, defense counsel questioned Brady about the informed consent forms that she had signed prior to the surgery. When the jury went to deliberate, they asked to see the consent forms, to see what the patient “had agreed to.”

The jury returned a verdict for the doctor.

Brady appealed.

The Pennsylvania Supreme Court reversed the verdict in favor of the patient.

The top court explained that the patient’s consent to the risks of the procedure was irrelevant to the question of whether the physician acted negligently.

The court wrote, “the fact that a patient may have agreed to a procedure in light of the known risks does not make it more or less probable that the physician was negligent in either considering the patient an appropriate candidate for the operation or in performing it in the post-consent timeframe. Put differently, there is no assumption-of-the-risk defense available to a defendant physician which would vitiate his duty to provide treatment according to the ordinary standard of care. The patient’s actual, affirmative consent, therefore, is irrelevant to the question of negligence.”

And It Failed Again

Here’s a case where a neurosurgeon performed a microdiscectomy on a patient and the patient experienced post-operative numbness and excruciating pain.

The case, Hayes v. Camel, also wound up at a state supreme court—this time in Connecticut. That court ruled that it was improper to admit evidence pertaining to informed consent in a medical malpractice suit when a lack of informed consent was not an issue.

The patient, in this case, sued the neurosurgeon, alleging medical malpractice. The patient’s attorneys sought to prevent the informed consent documents from being admitted to trial. The judge denied those motions.

And the jury returned a verdict for the defendant surgeon. The patient, Hayes, appealed.

On appeal, the Supreme Court of Connecticut concluded that it was an abuse of discretion for the trial court to admit evidence of the disclosure of risks to the plaintiff. The court noted that the evidence of informed consent implicated concerns about jury confusion.

The court stated that “although evidence of the risks of a surgical procedure is relevant in the determination of whether the standard of care was breached, it was unduly prejudicial to admit such evidence in the context of whether and how they were communicated to the plaintiff.” The court further noted that a more appropriate way to introduce evidence of surgical risk without the danger of confusion and inappropriate prejudice would be to have defendants or nonparty experts testify about the risks of relevant surgical procedures in general.

Virginia Also Tackled Informed Consent

The Supreme Court of Virginia has also ruled on this matter.

In Wright v. Kaye, Dr. Richard Kaye performed a diagnostic laparoscopic surgery on patient Jennifer Wright. During the procedure, Dr. Kaye found and removed a cyst on Wright’s urachus and stapled the area closed. Following the surgery, Wright experienced urinary frequency and urgency with bladder spasms. One year after the surgery, another surgeon discovered and removed six surgical staples from Wright’s bladder that had been apparently left from the laparoscopy. Wright continues to suffer permanent bladder dysfunction. Wright sued for medical malpractice and sought to exclude evidence of discussions between herself and Dr. Kaye about the risk of injury to the bladder. Wright argued that any mention of her consent was irrelevant and would only confuse the jury. The trial court denied her motion, reasoning that the jury would know that a prudent doctor must advise patients of risk and failure to show that he had done so would imply negligence.

On appeal, the Supreme Court of Virginia found that the trial court erred in allowing evidence of informed consent to be presented at trial. The court noted that Wright did not claim or place into issue any failure to obtain informed consent; the only issue was whether Dr. Kaye had been negligent. Therefore, the court reasoned that any pre-operative discussion of risk was not probative of the issue of negligence and its admission “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.”

Reasoning Behind Decisions

Brady, Hayes, and Wright represent the growing trend of courts excluding evidence of informed consent from medical malpractice trials when consent is not an issue being litigated. These courts are recognizing that, even if a patient consented to the risks of a procedure if done properly, the patient did not consent to negligent treatment.

Orthopedics This Week spoke about this trend with B. Sonny Bal, M.D., J.D., Ph.D., who serves as the President and CEO of Amedica Corporation. Dr. Bal and his co-author, Lawrence H. Brenner, J.D., have written extensively on subjects of medicolegal interest in the peer literature, and are editing a forthcoming book about judicial reasoning and its impact on clinical decision-making.

Informed Consent Is a Dialogue Between Doctor and Patient

In Dr. Bal’s opinion, the use of informed consent as a weapon against a patient and protecting an institution is misplaced and courts are entirely correct in excluding this evidence unless the trial involves the issue of consent itself.

Dr. Bal shared that “very few physicians understand the law or how judges and lawyers think when they are confronted with the issues that physicians face” and suggested that physicians would help themselves if they understand the judicial reasoning behind these decisions. Dr. Bal noted that surgeons have two common misconceptions about informed consent: First, that an informed consent form must contain every single risk. Second, that if a risk is put on the informed consent form, it absolves the surgeon of liability.

Dr. Bal advised that surgeons should understand that “informed consent is a dialogue between the patient and the physician—and that it does not need to cover not all the risks, but those risks that are material, i.e., those that a reasonable person should know before embarking upon a procedure.”

Indeed, Dr. Bal believes that “informed consent captures a very special discussion between a physician and a patient—a very private discussion—in which a patient tells you about their anxieties, fears going into surgery, their uncertainties.

The physician practices the very art of medicine in dealing with that uncertainty. No surgery is perfect; there are always risks. Even if everything is done properly, there is always a risk of something unexpected happening or an adverse outcome. That uncertainty is what creates anxiety on the part of any of us before we have any kind of surgery. How that uncertainty is conveyed to the patient and how the therapeutic alliance is built up is the very art of medicine.

If the physician practices that art then there is no medical violation in terms of the informed consent process, and the fear of lawsuits related to such is misplaced. And even if there is a lawsuit it’s not going to go anywhere.”