DON'T RUSH Don't ask the patient to sign a consent form just before the anesthesia is about to be administered.

The issue of informed consent raises its head in many medical malpractice cases. Usually it happens with cases in which the patient claims the surgeon didn't properly inform him of the risks associated with a given surgical procedure. But what about those malpractice cases that don't raise a challenge to consent? Is the fact that a surgeon made a patient aware of the risks relevant to the standard of care? Not according to a recent ruling in the case of Mitchell v. Shikora. Here's why.

The value of consent
When we use the term "informed consent," we're referring to the form a patient signs authorizing the surgeon to perform a specific procedure, with full knowledge of the inherent risks and potential complications. The issue played a central role in Mitchell v. Shikora (osmag.net/EDQa8a), which involved a patient who had her bowel severed during a hysterectomy performed by an obstetric and gynecologic surgeon at a Pittsburgh, Pa., hospital in May 2012.

Six months ago, the Superior Court of Pennsylvania determined that even though the patient was informed of the risks and consented to the surgery, the patient's consent had no bearing on whether the surgeon was negligent. The Superior Court's decision, which effectively reversed a February 2016 trial court verdict, said the trial court erred by allowing the defendants to present evidence at trial — whether a bowel injury was a known risk or complication of the surgery — that should have been inadmissible.

Furthermore, the court said the defendants "misled" jurors into believing that informing the patient about the risks and complications established the standard of care, and this ultimately affected the outcome of the trial. In other words, just because the patient knows of the risk of potential complications associated with a particular procedure, it doesn't absolve the surgeon of responsibility if the patient sustains an injury stemming from a breach in the standard of care — in this case, the suit alleges, by failing to identify the bowel before cutting it.

The Mitchell v. Shikora case shows that trial courts will continue to consider the admissibility of informed consent in malpractice cases, but whether it will be deemed relevant in a particular case is somewhat murky. Given the Superior Court's recent ruling, another jury will soon determine the negligence allegation outlined in the injured patient's claim, this time without the admission of the risks-and-complications evidence.

Although evidence of known risks and complications may not be admissible in every malpractice case, obtaining consent before surgery is imperative for every surgical facility and for every patient. While consent laws may differ from state to state, a patient's medical record should contain a signed consent form that includes, among other things, the names of the patient and the physician performing the procedure, the details of the procedure itself and the known risks and potential complications associated with the procedure. You also have to consider how you go about obtaining the consent. Keep these 4 points in mind.

Always have surgeons take the lead. Only surgeons can obtain consent, and they must do so in their offices, before the surgery. Ideally, patients should have a "thinking period," so the consent process should never be rushed; asking the patient for consent just before the anesthesia is about to be administered is not appropriate. If a patient has questions before the surgeon arrives, the nursing staff needs to find the surgeon so he can provide the answers.

Provide specifics. Some surgical facilities keep their consent forms intentionally vague, but specificity may be your friend. Consent should include a description of who is performing the surgery, if possible, so there would be no question if the patient were to say later on, "I consented to Dr. X, because he has this credential and that credential, but instead the surgery was performed by Dr. Y, who has no credentials." Does the patient face any special risks because he's going home after the procedure rather than to a hospital bed? If so, outline those risks in the consent form. Also, if the surgery changes mid-procedure from what the patient agreed to on the consent form, a modified consent may be needed from the patient's family or representative.

Never misrepresent. Obtaining informed consent based upon misrepresentations — say, knowingly exaggerating or misrepresenting a surgeon's credentials, training or experience — is just as egregious as not getting the patient's consent, because the consent is based on false pretenses. In either case, the physician may be held liable for failure to seek consent. In many jurisdictions, the claim may be considered one of battery, and substantiating a battery claim requires neither proof of negligence nor expert testimony; the unwanted contact and any damages that occur as a result will suffice.

Have a discussion and document the exchange. Although some patients may look at informed consent as "just another form to sign," its purpose is to give patients an opportunity to have a conversation about the procedure, so they can make an informed decision. Give each patient an opportunity to ask questions, and have the surgeon take precise notes of the exchange, including any concerns the patient has, along with the surgeon's response to those concerns.

Alleviating tensions
If an adverse event does occur, a signed consent form may offer some protections, legally speaking, if the patient raises a challenge to consent. But some of your best protections in that kind of situation may be the efforts you make to keep the lines of communication open. Offer a willing ear and enable patients and their families to ask questions about what happened; your job then is to provide honest answers in return: "This is what happened, here's what we did about it to resolve the situation, and here's what we intend to do to make sure something similar doesn't happen to someone else."

If there's a good relationship established between patient and provider at the outset, it may help to alleviate tensions, and it may even diminish the likelihood of the patient taking legal action down the road. In many malpractice lawsuits, you tend to hear plaintiffs offer the same kind of complaint when they are deposed: "They wouldn't talk to me after X happened." It's this kind of anger and offense that ultimately leads an injured party to the doorstep of a malpractice lawyer. OSM