Malpractice Minute

Detailed Informed Consent Form Aids Malpractice Claim Defense

Marc Leffler, DDS, Esq.

Reading time: 8 minutes

OMS patient signing informed consent form.

Informed consent can help oral surgeons mitigate risk. In this case study, an OMS is accused of negligence after a patient loses nerve function in their eyelid post-op. However, loss of nerve function had been discussed during the informed consent process.

Key Concepts

  • Obtaining comprehensive informed consent
  • Claim withdrawn due to detailed informed consent form
  • Informed consent and mitigating malpractice risk

Background Facts

V was a healthy 32-year-old man who presented to a local oral and maxillofacial surgeon, Dr. B, having had no improvement of a chronic problem, despite various treatments by his general dentist and several “TMJ specialists.” For several years, he had been experiencing repeated episodes of TMJ dislocation, associated with yawning and other wide mouth opening, which caused him significant amounts of pain. As a result, he had made numerous trips to hospital emergency departments, where he was manually reduced on-site after being given sedative medications. V had accepted this problem as a part of his life until the most recent episode, which required a hospital admission and general anesthesia to have his dislocation reduced. From that point, he sought and received treatment from his general dentist (an occlusal splint), a restorative dentist whose practice focused on TMJ issues (occlusal build-up to open vertical dimension), and a “holistic TMJ” dentist (massage therapy with an exercise regimen).

With further similar episodes occurring despite these therapies, he contacted Dr. B on the recommendation of his general dentist. After an initial consultation, Dr. B ordered imaging studies to try to determine the cause of the recurrent problem. Although Dr. B did not regularly treat TMJ problems or complaints as part of his usual practice, he felt confident in explaining to V that he viewed the issue as having 2 components: (1) that V had a joint soft tissue “laxity” which allowed the condyle to translate excessively far forward during opening, but more importantly (2) that the articular eminences, bilaterally, were particularly pronounced so as to prevent the condyles from returning back to the glenoid fossae after translating anteriorly, thereby holding them in dislocated, open-lock position.

Dr. B concluded, and explained to V, that the most appropriate treatment would be to surgically enter both joints and mechanically reduce the articular eminences, so that even when the lax soft tissues would allow the condyles to move excessively forward, there would be nothing to mechanically prevent their posterior drift posteriorly, back into normal position. Dr. B clearly discussed with V that there would be no absolute certainty that such a surgical procedure would fully prevent an open-lock situation from occurring again, and he also advised his patient that some practitioners might suggest tightening the soft tissues, either alone or in conjunction with eminectomy.

In further discussing what the surgery as proposed might entail, Dr. B talked about the more general risks – such as infection, bleeding, and prolonged healing periods – and the more specific risks – such as scarring and the possibility of temporary or rarely permanent motor and/or sensory nerve injury. After considering what to do, and speaking with close family members and friends, V agreed to Dr. B’s proposed treatment, to be performed under general anesthesia in an ambulatory surgery center. On the day prior to surgery, V came to Dr. B’s office to get final instructions and to sign a consent form which included the detail previously discussed. Dr. B made complete notes regarding all his discussions with V, including the informed consent process.

Surgery the following day was, by Dr. B’s description, uneventful. He did a layered incision and was able to reduce the eminence heights to flatter profiles so that they would no longer interfere with the return of the condyles into the glenoid fossae. When V first returned to see Dr. B for suture removal, the surgical site appeared to be healing well, with V’s only complaint being that he was unable to close his left eyelid fully, which he found upsetting. Dr. B reminded V that this was one of the risks discussed pre-operatively – because a branch of the facial nerve travels close to, or sometimes within, the surgical field – but he also said it was likely that some or all that nerve function would return over the course of a year or so. V continued to return for post-op appointments for 18 months, as directed by Dr. B, and he never again experienced an open lock, even with yawning and taking large bites into apples. However, the nerve function did not normalize, and Dr. B acknowledged to V that it probably never would.

Approximately 6 weeks after V’s final office visit, Dr. B received a letter from an attorney representing V, requesting copies of all records. Dr. B immediately provided copies and contacted his professional liability carrier. A lawsuit followed shortly thereafter. The claims in the action were that Dr. B had failed to adequately obtain informed consent from V, and that he performed the surgery in a negligent fashion to injure the facial nerve.

Dr. B’s carrier assigned the case to defense counsel, who reviewed the records with Dr. B and listened to his explanations. To counsel, it seemed evident that the informed consent process was precisely as it ideally should have been. Regarding the surgery and its nerve complication, counsel enlisted a board-certified oral and maxillofacial surgeon who regularly taught residents about TMJ surgery, to serve as an expert on Dr. B’s behalf; the expert determined from Dr. B’s surgical description in the operative report, and from his own experience and knowledge about the local anatomy, that the nerve complication arose despite all having been performed well within the standard of surgical care.

Following Court-ordered depositions, during which Dr. B correctly explained the course of the branches of the facial nerve, and during which he confirmed the accuracy of his dictated operative report, Dr. B’s counsel decided to seek dismissal of the case by way of a motion seeking summary judgment, which had attached to it the affidavit of the expert.

The Court quickly ruled that the claim for lack of informed consent had no merit, based upon Dr. B’s testimony, the detailed, signed consent form (which specified the risk of potentially permanent motor nerve injury), the testimonial acknowledgement of V that he had been informed of that risk, and the statement of the defense expert which was that this process was properly carried out in all regards. That claim regarding informed consent was dismissed. However, the claim of surgical negligence was permitted to stand, the merits of which would be determined by a trial jury.

Apparently concerned that the consent form – joined with the expert’s presumed trial testimony that this risk can come to pass absent negligence – might prejudice the jury against V regarding the negligence claim, V’s attorney sought to have any mention about the known risk of nerve injury excluded from the trial, in a pretrial application known as a motion in limine, under the theory that the jury would not be making any judgment regarding informed consent, rendering all issues about risks moot. The Court would not agree to such an exclusion, holding that this was an important aspect of surgical preparation and a critical portion of the chart, which would come into evidence in its entirety. Realizing the realities of what the jury would hear, V and his counsel opted against spending the time and money to proceed with trial, and withdrew the case, ending the litigation.

Takeaways

The concept of informed consent is often overlooked in importance by many practitioners, but this case demonstrates its significance and the value of documenting it thoroughly. Here, the fact that Dr. B had both a detailed, signed consent form and contemporaneous chart entries served well to prove that the process was not discounted but instead seen as a meaningful part of preparation for surgery. In documenting as diligently as he did, Dr. B paved the way to allow his defense attorneys to make a viable, successful request for dismissal of that claim. And once that claim fell, the door was opened toward withdrawal of the remaining claim of negligence. Oral surgeons who fully abide by the requirements to obtain informed consent, and document well, regardless of the surgical procedure performed, not only educate their patients but assist their own defense if a lawsuit later arises.

Far too often, oral surgeons and other healthcare practitioners assume that, once they are sued, they must settle their case or subject themselves to a jury trial. While settlement or trial is a common legal ending, this case shows that many factors can play into other outcomes, 2 of which – dismissal of one or more claims, and withdrawal – were aspects of the resolution of this case.

Finally, this case study exemplifies how defense attorneys, well-versed in the subject matters of oral surgery practice, amply knowledgeable to prepare their clients for deposition, and aligned with experts who truly are expert in their field, can lead to positive results for their oral surgeon clients. A very important function of a malpractice carrier is to retain defense attorneys who can properly and fully defend their clients, in whatever directions that defense might go.


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This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

MedPro Group is the marketing name used to refer to the insurance operations of The Medical Protective Company, Princeton Insurance Company, PLICO, Inc. and MedPro RRG Risk Retention Group. All insurance products are underwritten and administered by these and other Berkshire Hathaway affiliates, including National Fire & Marine Insurance Company. Product availability is based upon business and/or regulatory approval and/or may differ among companies.

© MedPro Group Inc. All rights reserved.