Court rules that surgeons must personally deliver informed consent
On June 20, 2017, the Commonwealth of Pennsylvania Supreme Court handed down a 4–3 decision that has the potential to rock the world of medical liability. The justices ruled that surgeons, in order to obtain informed consent, have the duty to provide their patients with information about the risks, benefits, and alternatives of a particular procedure. Furthermore, surgeons must deliver that information personally.

Who is responsible?
In the underlying case, the patient filed a lawsuit alleging that all risks of a procedure were not fully discussed, which lead to discovery of the consent process. The Pennsylvania MCARE (Medical Care Availability and Reduction of Error) Act requires that physicians obtain informed consent and that certain information must be conveyed to patients to inform their consent. Utilizing Pennsylvania common law, a majority of the justices declared that the duty to obtain informed consent rests with the physician performing a procedure and not the hospital where it will be performed.

It was a split decision. In a dissenting opinion, Judge Max Baer wrote, “The Act conspicuously does not mandate that only physicians themselves can provide information to patients to inform their consent. The legislature could have, but did not, expressly require that only physicians can provide patients with information regarding informed consent.” However, we are left with the majority opinion.

He continued, “In addition to my conclusion that the majority’s holding is legally inaccurate, I fear that today’s decision will have a far-reaching, negative impact on the manner in which physicians serve their patients. For fear of legal liability, physicians now must be involved with every aspect of informing their patients’ consent, thus delaying seriously ill patients’ access to physicians and the critical services that they provide. Courts should not impose such unnecessary burdens upon an already strained and overwhelmed occupation when the law does not clearly warrant this judicial interference.”

The informed consent process
This decision should prompt each of us as orthopaedic surgeons to review the process of informed consent. Informed consent has the following six components:

• discussion of clinical issues
• discussion of options
• pros and cons of surgery
• uncertainty with outcomes
• assessing the patient’s (family’s) understanding of the procedure
• discerning and documenting the patient’s preference

A study looking at informed consent found that surgeons discuss clinical issues 83 percent of the time, but assess a patient’s understanding of treatment only 2 percent of the time. Patient preferences are discussed 19 percent of the time—and that ranks as the second highest component. Clearly, as surgeons, we don’t cover all the elements very well.

Mike Sacopulos, JD, founder and president of the Medical Risk Institute, has the following five tips for informed consent:

• Start early and point patients to trusted sources of information where they can learn of risks and benefits.
• Give options and expose patients to treatment options. Even if one option is clearly preferable, present alternatives.
• Don’t outsource this conversation to anyone, including your nurse or physician’s assistant. Physicians need to handle the informed consent conversation. It will convey importance and build a better relationship with the patient.
• Ask open-ended questions during the conversation; this will enable the physician to learn more about the patient and send the message that the physician cares just as much about the patient’s thoughts and concerns as he or she does about their treatment.
• Informed consent isn’t just about surgical procedures. Recent medical liability cases have involved physicians who inappropriately prescribe opioids and create addicts. Physicians should go through the informed consent process for prescriptions.

In one academic institution in Georgia, resident staff and physician extenders can obtain consents. A registered nurse reviews the consent with the patient in the operating room’s holding area. If the patient raises any questions pertaining to risks, benefits, or alternatives, the attending surgeon is notified. If the nurse deems that all is in order, the attending surgeon only has to sign the consent form, and the surgical procedure proceeds. With such a system, the potential implications of the Pennsylvania ruling may be significant and will likely vary from state to state.

As surgeons consider this case, they must understand that lack of informed consent can lead to a medical malpractice suit. However, the risk can be avoided if the surgeon communicates appropriately with patients and remembers that healthcare has moved toward patient-centric care and shared decision making.

Can lack of informed consent be considered battery?
In the early development of medical malpractice law, the failure to obtain consent meant the physician was touching the patient without permission, which would be a battery/assault. However, the law has evolved and now failure to obtain a patient’s informed consent is a tort and can be alleged separately or in conjunction with a claim of medical negligence, for example, failure to diagnose and or a surgical injury. As a tort, it is covered by medical malpractice insurance. The plaintiff doesn’t have to provide expert testimony to prove “lack of informed consent.” It has to prove that the patient was not informed of the known material risks, alternatives, and the benefits of the proposed course of treatment. The jury must answer the question, whether a “reasonable” person, not the patient, would have decided not to undergo the course of care if they had been fully advised. If a reasonable person would have made the decision to proceed if they had been fully informed, then there is no causal link between the failure to fully inform and the outcome.

However, a physician can be charged with battery, which is a felony in the circumstance where an exam or procedure was performed that was medically inappropriate. This action is considered a criminal act, which can be punishable by both jail time and financial penalty and is not covered by malpractice insurance. The authors suggest that readers reach out to their hospital legal counsel, state orthopaedic society, and medical liability insurance provider to obtain their opinions on current local rules and regulations and on the potential impact the Pennsylvania ruling may have on current practices.

Readers who discover that their state has rules or regulations akin to the Pennsylvania Supreme Court ruling are asked to contact Stephanie Hazlett (shazlett@aaos.org) in the AAOS office of government relations.

Daniel R. Schlatterer, DO, MS, is vice chairman of the orthopaedic residency program and co-chief of orthopaedic trauma at Atlanta Medical Center. He is also a member of the AAOS Medical Liability Committee.

Michael R. Marks, MD, MBA, is a member of the AAOS Medical Liability and Patient Safety Committees and a mentor for the AAOS Communications Skills Mentoring Program.

Editor’s note: Articles labeled Orthopaedic Risk Manager (ORM) are presented by the Medical Liability Committee under the direction of John P. Lyden, MD, and Michael R. Marks, MD, MBA, ORM co-editors. Articles are provided for general information and are not legal advice. For legal advice, consult a qualified professional. Email your comments to feedback-orm@aaos.org or contact this issue’s contributors directly.

References:

1. Robeznieks A. Informed-consent ruling may have “far-reaching, negative impact.” AMA Wire, Aug. 8, 2017. Available at: https://wire.ama-assn.org/practice-management/informed-consent-ruling-may-have-far-reaching-negative-impact.
2. Braddock CH III, Fihn SD, Levinson W, Jonsen AR, Pearlman RA. How Doctors and Patients Discuss Routine Clinical Decisions. J Gen Intern Med. 1997 Jun; 12(6): 339–345. doi: 10.1046/j.1525-1497.1997.00057.x
3. Michael Sacopulos, JD, Terre Haute, IN, personal communication, (September 2017).
4. Thomas Boyce, JD, New London, CT, personal communication (December 2017).