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Editorial: Can Surgeons Delegate Informed Consent? As Goes Pennsylvania, So Goes the Nation (or Not)

Leopold, Seth S., MD; Calabro, Anthony M., MA

Clinical Orthopaedics and Related Research®: August 2018 - Volume 476 - Issue 8 - p 1551–1552
doi: 10.1097/CORR.0000000000000366
REGULAR FEATURES

S. S. Leopold, Editor-In-Chief, Clinical Orthopaedics and Related Research®, Philadelphia, PA, USA

A. M. Calabro, Associate Editor, Clinical Orthopaedics and Related Research®, Philadelphia, PA, USA

S.S. Leopold MD, Clinical Orthopaedics and Related Research®, 1600 Spruce Street, Philadelphia, PA, 19013 USA, Email: sleopold@clinorthop.org

The authors certify that neither they, nor any members of their immediate families, have any commercial associations (such as consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

The opinions expressed are those of the writers, and do not reflect the opinion or policy of CORR® or The Association of Bone and Joint Surgeons®.

Received May 08, 2018

Accepted May 09, 2018

A high court in Pennsylvania has changed the way surgeons there must obtain informed consent, and that court’s legal findings may influence the surgical consent process across the country. The changes imposed by this 2017 ruling are so important that if they are not accommodated in practice, some informed consent documents may not be worth the paper they are written on.

If you practice in Pennsylvania, the game has already changed. As we see in this month’s “Medicolegal Sidebar” column [6], the Pennsylvania Supreme Court in Shinal v Toms [5] held that informed consent may not be delegated to a physician assistant or a resident. That now is the law in Pennsylvania, and for many practices that employ physician assistants or teach residents there, this is a sea change. A summary from the American Medical Association put the impact of this decision succinctly: “[Physicians in Pennsylvania can] seemingly no longer rely on the aid of their qualified staff in the informed consent process” [3]; others support this interpretation [1] including CORR’s columnists in this month’s issue [6].

Feel safe (or grateful) because you practice outside Pennsylvania? Not so fast. Nadia N. Sawicki JD, Academic Director of the Beazley Institute for Health Law & Policy at Loyola University Chicago noted in Harvard Law’s Bill of Health blog that Pennsylvania is not the first state to restrict who can obtain informed consent. “[C]ourts in other jurisdictions (Connecticut, Louisiana, South Dakota, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone” [4].

In Texas, for example, it seems clear that the responsibility to obtain informed consent rests with the treating physician (as opposed to a nurse or a physician assistant), and that this cannot be delegated [7]. One healthcare attorney opined that, “Although this case [the Pennsylvania Supreme Court decision] binds only those in Pennsylvania, it alerts surgeons in other states to conduct an assessment of their consent process” [1].

Not all medicolegal experts believe the Pennsylvania Supreme Court got it right; in this month’s CORR, Bal and colleagues describe the reasoning used in the case as “flawed” and “contrary to a holistic, team-based approach to medical care” [6]. Others agree. “I think the Pennsylvania Supreme Court made the wrong call,” William M. Sage MD, JD, James R. Dougherty Chair at the University of Texas at Austin School of Law and Professor of Surgery and Perioperative Care at Dell Medical School told CORR in an interview.

Still others believe that perhaps too much has been made of this decision, particularly outside Pennsylvania. A senior malpractice-defense attorney for a major university program (who declined to be quoted by name) told CORR: “In my 25 years of dealing with [medical malpractice] claims, I have never seen an informed consent claim that focused on who delivered the informed consent discussion.”

Instead, according to this attorney, the focus is generally on the quality of the discussion, which is commonly determined by: (1) Whether the consent was consistent with institutional protocols, (2) whether there was adequate documentation to support the claims of the defense, (3) whether there was adequate time for discussion, and (4) whether it was clear that the patient understood the risks associated with the surgical procedure.

While these cases often succeed or fail on basis of the documentation, if any of those four elements is missing, the plaintiff is likely to prevail in Pennsylvania or outside it. But in Pennsylvania, this attorney acknowledges, “[The Shinal decision] is the law now. If this [who obtained the consent] is the only issue in the case, a summary judgment motion will be filed. If the physician didn’t obtain the consent him or herself in Pennsylvania, the summary judgment motion likely will be granted” in favor of the plaintiff.

The same may be true in the other jurisdictions mentioned earlier [4].

What can those of us who practice elsewhere in the United States learn from all this?

First, the pendulum may be swinging further away from the physician’s ability to delegate elements of care that laypeople—including courts of law—deem essential to the physician-patient relationship. We believe, as do others [1, 2], that this spirit will gain some momentum outside of Pennsylvania [1] and those few other jurisdictions that have standards similar to those in Pennsylvania [4].

Additionally, Christopher D. Stombaugh JD, an attorney and Past President of The Wisconsin Association of Justice, identified an even broader issue. Responding to those who believe the Pennsylvania court erred in its decision, Mr. Stombaugh told CORR: “It depends entirely upon whether you view the purpose of informed consent as primarily transactional or primarily relational. In the transactional analysis, the emphasis is on whether the appropriate information was ‘downloaded’ to the patient. For that purpose, it could be argued that it doesn’t particularly matter what ‘server’ or person the patient received it from.”

He suggested that the transactional model may have evolved as part of the time-pressured reality of modern medicine, in which informed consent is perceived by some as merely a checklist task.

By contrast, according to Mr. Stombaugh, the relational model is “process-oriented. It is about trust and the comfort of the patient in a discussion that is a two-way interaction with her physician revealing not only data but, essentially, demeanor as well.”

He considers the spirit behind the Pennsylvania decision to be more relational and traditional in origin. But Mr. Stombaugh also believes that the decision is well rooted in common sense, and in the enhancement of a therapeutic relationship between physicians and their patients, and because of that, he does not have difficulty imagining the Pennsylvania precedent carrying beyond that state.

“Far from being ‘wrong,’” Mr. Stombaugh said, “the ruling is a call to medicine to resist further outsourcing of essential features of the physician-patient relationship. The therapeutic relationship is absolutely essential to the formation of trust. This decision anchors informed consent in the center of meaningful physician-patient dialogue.”

We favor a relational over a transactional approach in the clinic, and so we did not have the same negative impression of the Pennsylvania ruling that some others have had, including Dr. Sage from the University of Texas in his interview with CORR, and Dr. Bal and his colleagues [6] in this month’s issue. But we recognize that this is complicated, and that surgeons and practices are under tremendous pressures to find efficiencies wherever possible. Regardless, news of this ruling [4]—and Dr. Bal’s coverage of it in this month’s Medicolegal Sidebar in CORR [6]—are essential reading for all orthopaedic surgeons in the United States. And each needs to decide how (s)he will handle this important issue in the context of his or her own practice.

Did the Pennsylvania high court get it right? How might how the Pennsylvania ruling change practice in the United States and elsewhere? Please share your thoughts in a letter to the editor (EIC@CORR.org).

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Acknowledgment

We thank B. Sonny Bal MD, JD, MBA, PhD for bringing the topic to our attention and for his review of this editorial.

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References

1. Buppert C. A major court decision: Only physicians can obtain consent. Available at: https://www.medscape.com/viewarticle/885579. Accessed May 7, 2018.
2. Koch VG. Delegating informed consent. Hastings Cent Rep. 2017;47:5–6.
3. Robeznieks A. Informed-consent ruling may have “far-reaching, negative impact”. Available at: https://wire.ama-assn.org/practice-management/informed-consent-ruling-may-have-far-reaching-negative-impact. Accessed May 7, 2018.
4. Sawicki NN. IRBs advise physician involvement in informed consent. Available at: http://blogs.harvard.edu/billofhealth/category/contributors/nadia-sawicki/. Accessed May 7, 2018.
5. Shinal v Toms, 162 A.3d 429 (2017).
6. Teo WZW, Brenner LH, Bal BS. Medicolegal sidebar: Who should obtain informed consent? Clin Orthop Relat Res. [Published online ahead of print]. DOI: 10.1097/CORR.0000000000000351.
7. Thornton RG. Informed consent. Proc (Bayl Univ Med Cent). 2000;13:187–190.
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