Avoiding orthopedic medical negligence claims: A plaintiff’s attorney’s perspective

Lawrence H. Brenner

B. Sonny Bal

Given the charged relations between physicians and attorneys arising out of professional liability litigation it is inevitable that most discussions on this matter are contentious. Even so, plaintiffs’ attorneys often have an opportunity to contribute to the reduction of professional liability claims by recognizing patterns of risk that give rise to professional liability lawsuits.

The purpose of this article is to provide constructive insight into some factors within the orthopedic surgeon’s control that can reduce claims and lawsuits. This is particularly important because the experience of most plaintiffs’ attorneys is that of the many claims that they review, only a few are deemed meritorious by the attorney and their consulting experts.

In an attempt to assist orthopedic surgeons in recognizing these patterns and in developing strategies for reducing professional liability losses, what follows are a series of suggestions based on our firm’s review of numerous cases involving orthopedic patients who came to our office dissatisfied with the care that they received. Before you make that incision, consider the following concerns. Most of these may already be part of your clinical practice, but are nonetheless worthy of review.

Informed consent issues

It is understandable that the process of providing legally acceptable informed consent can be a difficult task for orthopedic surgeons, particularly in the modern era of emerging technologies, enhanced perception of conflicts of interest, and surgeon-industry relations. From a legal standpoint, recognize that the law requires patients be advised of material and inherent risks of any procedure as well as alternatives to the procedure as demonstrated in the 1972 case Canterbury v. Spence. Material risks are those risks deemed pertinent to the decision-making process, usually as viewed from the perspective of a lay person, or as the law often states, from the perspective of a “reasonable person.” In other words, material risks are those that would matter to the patient, even though they might seem trivial to the surgeon. Inherent risks are defined as those risks that are unavoidable even when a procedure is flawlessly performed; these are generally known to the surgeon but may not be clear to the patient.

The fear of litigation has led to informed consent becoming less of a process of communication, and more of an effort by a physician or surgeon to create a litigation shield. In a review on this subject titled “Consent Forms as Part of the Informed Consent Process: Moving Away from Medical Miranda,” Ali and colleagues astutely observed “... this approach elevates the formalistic provisions of information above all other considerations in the informed consent process.” The article also notes that a formalistic approach to informed consent “perpetuates a view of informed consent as something detached from the unique rhythm of the clinical setting — something imposed on medicine by an uncomprehending legal system.” However safe the idea of forms, fine print, and other mechanistic means of capturing every possible risk might seem, a formalistic model of informed consent detracts from the values of communication and trust, which are at the heart of obtaining proper consent from a patient.

Todd Hendrickson

Recommendations

Thomas G. Gutheil, MD, in an article in the New England Journal of Medicine, described informed consent as a process of mutual discovery that leads to a therapeutic alliance between the physician and patient. This article should be essential reading for every orthopedic surgeon. From our experience in reviewing claims submitted by unhappy patients we recommend that orthopedic surgeons consider the following:

• It is essential that uncertainty be acknowledged and dealt with frankly. This is particularly true today when patients are seeking new technologies such as minimally invasive surgery, and when the competing benefits and risks of new technologies vs. conventional approaches remain uncertain.
• When complications occur, avoid the temptation to delay advising the patient by adopting a form of “wishful thinking” that can have disastrous results.
• Make it a rule to end the informed consent process by asking patients if they have any questions that haven’t been answered, and reminding them that you will be there for them no matter what happens.

Document testing and results

Before engaging in any surgical procedure the surgeon should clearly document the need for the procedure. Test results should be included in the patient’s chart and should be referenced in the patient’s workup or clinic notes. If there are any inconsistencies in results, the surgeon should document that these inconsistencies were explained to the patient and why the surgeon and patient have elected to proceed with surgical intervention. Missing, incomplete or inconsistent test results in the preoperative records can be critical evidence against the surgeon in the event of litigation.

Wrong-site surgery

Lawsuits filed because of wrong-site surgery are difficult to defend because the negligence is apparent. As difficult as they are to defend, they are also simple for the surgeon to prevent. Follow prescribed time-out procedures rigorously and make certain that everyone on your team does the same. This is particularly true for busy surgeons who are running two or more operating rooms with residents and fellows; in such scenarios a break in the schedule, such as a delay in the next case, and the staff substituting a different patient to keep the schedule moving, can be particularly dangerous.

Remember that wrong-site surgery can happen to the best surgeons; constant diligence is the only antidote to preventing this obvious problem. Wrong-site surgery happens when several individual links in a chain break simultaneously; keep an eye open for each step you normally take to prevent wrong-site surgery from happening and do not accept a breach of any step.

What goes in sometimes shouldn’t

A unique concern that orthopedic surgeons confront is the use of mislabeled, mismatched, mis-sized or wrong-sided implants. Like the wrong-site surgery cases, a legal case involving a mismatched implant is simple for a jury to understand and very difficult for an orthopedic surgeon to defend.

To minimize the risk of professional liability claims related to implants, the surgeon should require the team to follow defined procedures in handling implants. All members of the operating team should be familiar with the hospital protocol concerning implants. This is relevant because a plaintiff’s attorney can establish a meritorious claim by demonstrating that the surgeon violated a written policy or procedure established by the hospital to assure patient safety. If there is no protocol in place at the hospital for the safe handling of implants the following procedure should be followed:

• The surgeon should request the implant size and relay related information to the circulating nurse, who should then request the implant from the manufacturer’s representative.
• The surgeon should clearly identify the type, size and configuration (left or right if appropriate to the implant) in his/her request for the implant. The surgeon should never rely upon the rest of the surgical team to remember that it is a right knee case and not a left knee case.
• The manufacturer’s representative should verbally and visually confirm the implant identity to the circulating nurse.
• The surgeon should request the implant from the circulating nurse and not directly to the manufacturer’s representative. The circulating nurse should be sufficiently familiar with the procedure to catch any inadvertent mistake made by the surgeon in identifying an implant.
• Before opening the implant, the circulating nurse should verbally and visually confirm the implant identity with the surgeon. The surgeon should visually inspect the package label to confirm that it is the correct implant.
• After verbal and visual confirmation, the circulator should open the box and check that the exterior and interior labeling matches, and then deliver the implant to the sterile field.
• Prior to implantation, the surgeon should visually confirm that any markings on the implant properly identifying the implant as the size and configuration requested. The implants may be physically etched with a size and other identifying information. These markings should be cross-checked with the box label.
• The manufacturer’s representative should never open the implant and should never present the implant to the surgical field. No matter how experienced, the representative is not a medical care provider and should not be involved in directly presenting implants. This procedure should be followed to each component, if there is more than one used in a procedure. Everyone involved should be cross-checking each component of a multi-component system to insure that each matches the other(s).
• Following surgery, the implant documentation placed in the patient’s chart should be cross-checked again by the surgeon to confirm that the correct implant was used. Even though the surgery is over, a mistake can be caught and dealt with before the patient leaves the room, rather than later discovery.

Conclusion

An orthopedic surgeon who takes the time to make himself or herself aware of the potential complications of surgery, takes reasonable actions to reduce the risk of those complications, communicates with his or her patients so that they form a therapeutic alliance in the face of the inherent uncertainty of surgery, and instills in the patient a sense that they are partners is likely to have the patient return to the surgeon for unanswered questions rather than to an attorney.

References:

• Ali V, et al. Consent Forms as Part of the Informed Consent Process: Moving Away from “Medical Miranda” Hastings Law J. 2003;54(5):1575-1591.
• Canterbury v. Spence 464 F.2d 772(1972)
• Gutheil TG, et al. Malpractice Prevention through the Sharing of Uncertainty: Informed Consent and Therapeutic Alliance. N Engl J Med. 1984:311:49-51.

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