Botox Consent Form

Review the Botox consent form at least annually.

Cosmetic botulinum toxin and/or filler injections are frequently administered in ophthalmology practices. Sometimes, ophthalmologists are asked to provide them at a spa or “botulinum toxin and/or filler party” at a private home. The recommendations in Botox and Fillers are designed to promote patient safety and reduce the physician’s liability exposure.

Poor Results from Bilateral Upper Lid Blepharoplasty

Digest, Winter, 1993

ALLEGATION  Insured ophthalmologist allegedly failed to advise claimant to discontinue use of an antiplatelet medication prior to surgery. Additionally, there were allegations of failure to obtain proper informed consent and failure to refer to a plastic surgeon.

DISPOSITION  Settled with indemnity payment for subsequent repair surgery.

Case Summary

The patient was a 55 year-old male. A short-term patient of the insured ophthalmologist, he presented with ptosis and dermatochalasis OU, and elected to have a bilateral upper lid blepharoplasty. Visual acuity was not a significant factor. The risks and complications were discussed, and informed consent obtained. Past medical history revealed the patient had been on antiplatelet therapy due to a history of circulatory impairment.

Two days postoperatively, the patient demonstrated excessive swelling and ecchymosis below OU. He had not applied ice postoperatively and had not stopped taking his antiplatelets pre or postoperatively. One month later, the patient still demonstrated swelling of the lower lids and discoloration. At his six-month postoperative exam, a second opinion was obtained from a plastic surgeon who was critical of the insured’s surgery.

By this time as well, the patient’s health insurance carrier had denied coverage of the surgery on the grounds that it was elective in nature and did not meet the guidelines of medical necessity. Dissatisfied with his outcome, the patient refused to pay the insured and efforts on the part of the office staff to collect prompted the patient to seek an attorney.

Outcome

In reviewing the records, it became evident that there were documentation deficiencies which impeded the defense. There was no indication that the ophthalmologist had advised the patient to discontinue the antiplatelet preoperatively. Continuing the antiplatelet delayed postop healing. The operative report indicated a manipulation of the lacrimal glands which, according to claimant’s counsel, had not been discussed in the informed consent process. These factors, coupled with the bill dispute, led the insured to consent to settle the claim, which included compensation for the claimant’s “second repair surgery” with improved results.

Risk Management Principles and Commentary

Patient dissatisfaction with the result does not necessarily obligate the surgeon to compensate the patient. Each case warrants evaluation of its own merits. Often, oculoplastic procedures do not meet the medical necessity criteria for third-party reimbursement. This, combined with the risk of imperfect results, can strain the physician-patient relationship.

The following risk control measures on the part of the ophthalmologist and staff may help prevent or reduce the severity of a claim:

• Although an ophthalmologist’s focus is specific, a complete review of systems and discussion of medical history should be part of the patient’s medical record.
• A thorough discussion of the procedure as well as photos taken prior to surgery (preferably as part of the informed consent process) may be prudent, particularly when the surgery may not meet “medical necessity guidelines.”
• A procedure- and patient-specific postop instruction sheet with a copy filed in the medical record undermines the credibility of a patient who claims “ignorance” following a bad result. If the hospital provides the instruction sheet, as is often the case, the ophthalmologist should add any specifics relevant to that patient’s medical history.
• Continued rapport between ophthalmologist and staff and the patient is important, particularly with dissatisfied patients. Avoiding “difficult” patients only fuels the situation. A “no-charge visit” to discuss options with the dissatisfied patient may preclude the costs associated with the filing of a claim. If there is difficulty establishing rapport with the patient from the outset, it may be a cue to the physician to recommend a second opinion.
• Finally, bill abatement or adjustment may be considered. This is not necessarily an admission of liability, but rather a courtesy gesture and should not be practiced as a general rule. However, if the facts of the case merit it, waiving the fee can go a long way toward averting or mitigating a claim.

Charges That Inadvertent Orbital Biopsy Caused Permanent Ptosis

Digest, Fall, 1993

Allegation

Minor plaintiff, through a guardian, alleged that the insured ophthalmologist negligently performed an exploratory orbital surgery and tissue biopsy of the right eyelid, which damaged the levator muscle and caused permanent ptosis, resulting in dense amblyopia.

Disposition

Plaintiff’s counsel demanded $750,000 prior to trial. No settlement offer was made. Jury verdict in favor of the OMIC policyholder.

Background

A common catalyst of medical malpractice suits is an unintentional critical comment by a colleague. Even though the colleague may not mean to indict the other physician’s treatment, the statement often takes on a life of its own when a claim is pursued by a dissatisfied patient.

Case Summary

The patient was a 10-month-old girl who was first seen by the insured, a pediatric ophthalmologist, in his office upon referral from the emergency room at a nearby hospital. The patient had a rapid onset of proptosis of the right eye. The ER physicians and the insured concurred in the initial differential diagnosis of intraorbital tumor, possibly a rhabdomyosarcoma or lymphangioma, based upon the patient’s clinical history and CT-scan.

The insured performed exploratory orbital surgery four days after the initial exam for the purpose of taking a biopsy of the orbital tissue to rule out rhabdomyosarcoma and ascertain the nature of the tumor. The orbital tissue biopsy (frozen section) was found to be benign and the insured reentered the orbit in a further effort to determine the cause of the proptosis. A 5-centimeter cyst was located behind the globe near the optic nerve. Semi-clotted blood was aspirated from the cyst, resulting in an immediate reduction of the marked proptosis.

The patient had an expected postoperative partial ptosis of the right eyelid, which improved, then worsened with subsequent recurrences of orbital swelling. Based upon this subsequent clinical history, it appeared the patient had a lymphangioma.

A subsequent treating ophthalmologist performed a sling operation. The operative report, which was dictated by the assisting resident, stated that “a large gap of levator muscle was missing centrally due to inadvertent biopsy.” Minor plaintiff’s parents contacted an attorney and initiated a claim soon thereafter.

Outcome

The plaintiff’s attorney’s strategy in this case was twofold:

• Dispute the suspicion of rhabdomyosarcoma as a proper differential diagnosis.
• Allege that the insured failed to identify and isolate anatomical structures, thereby negligently damaging the levator muscle when performing the biopsy. The critical comment of “inadvertent biopsy” in the operative report of the subsequent treatment ophthalmologist fit neatly with the plaintiff’s strategy of showing that the levator muscle was damaged by the insured.

The patient’s grandmother tried to bolster the point of the insured damaging the levator muscle by testifying that after the sling operation the assisting resident stated to her and the baby’s mother that the surgeon had been unable to locate both ends of the eyelid muscle centrally. He allegedly stated that “the baby did not remove the muscle herself.” From this purposed statement of the resident, the grandmother and mother assumed that the insured had removed that portion of the muscle.

During the deposition of the ophthalmologist who performed the sling surgery, he testified that there were a number of errors, inconsistencies and unfortunate word choices in the operative report dictated by the resident such as the characterization that the gap in the levator muscle was “due to previous inadvertent biopsy”. He supported the insured’s decision to do the biopsy and had no criticism of his treatment of the patient.

Nevertheless, the plaintiff brought in three experts who were willing to testify that the insured negligently damaged the levator muscle. The testimony of these experts conflicted, however, and much of it was discredited during the trial. After a six-day trial, the jury took less than three hours to reach a verdict for the defendant.

Risk Management Principlesand Commentary

This case typifies the situation in which unintentional comment generates a lawsuit. When a plaintiff’s attorney investigates a possible claim for medical malpractice, he or she will have all the patient’s medical records copied and reviewed. A comment by a subsequent treater such as “due to inadvertent biopsy” is a red flag to a plaintiff’s attorney that there may be negligence and helps the attorney to form a theory of the case.

Next, the records are sent to experts who are requested to focus upon the theory of the “inadvertent biopsy.” They review the records and see an “unbiased” subsequent treater opining that the biopsy was “inadvertent.” Thus, they may feel more secure in finding evidence to support this theory of the case.

The sad irony of this case and others is that the ophthalmologist whose operative report was used to bolster the claim against the insured actually had no criticism of the insured’s care of the patient and did not consider the biopsy “inadvertent.” However, his signature as well as that of the resident appeared on the operative report.

Prior to signing records, an ophthalmologist should review them for inconsistencies and incompleteness in clinical facts, findings, test results and the like. Dictated notes and reports, especially those dictated by an assistant, must be proofread to ensure accuracy and completeness. As in this case, what is charted will be considered the opinion of the signing ophthalmologist.

Early Reporting of Claims Benefits All Insureds

Digest, Fall, 1995

Allegation

The insured ophthalmologist allegedly failed to properly advise a patient of the nature and risks of a surgical procedure and performed surgery to remove a right lower lid lesion in a negligent manner.

Disposition

Claim was dropped by the patient during the prelitigation stage and case was resolved without an indemnity payment.

Background

Early reporting of a claim allowed this OMIC insured to avoid being named as a defendant in a lawsuit. Because the insured gave OMIC the opportunity to respond to the plaintiff attorney before suit was filed, the physician avoided many of the frustrating and time-consuming efforts involved in preparing a full-blown legal defense. At the same time, the insurer was able to avoid expensive defense costs.

Case Summary

The patient was a 77-year-old male referred to the insured for evaluation of a lesion on his right lower lid. The patient reported that the lesion had been growing slowly for approximately a year. Upon examination, the insured described the lesion as a firm, fixed tumor at the lid margin umbilicated with pearly borders. She diagnosed probable basal cell carcinoma and recommended excision.

Several days later, the insured performed an excision of the tumor and reconstruction of the lid defect with a full thickness skin graft. Five days postoperatively the surgical wound completely dehisced. The insured removed all the sutures and offered the patient a Hughes flap reconstruction. The patient agreed to the Hughes flap, and it was performed the next day.

Postoperatively, the Hughes flap took well and the wound was healing nicely. After two postop visits, the patient suddenly informed the insured that he was changing physicians and had decided to be followed by a plastic surgeon rather than an ophthalmologist. The plastic surgeon subsequently performed a division and inset of the flap without complication, but a revision was later required to correct some residual contracture.

Analysis

Prior to filing a lawsuit, the patient’s attorney wrote to the insured physician alleging that the insured had provided negligent care and suggesting an out-of-court settlement. The insured promptly notified OMIC of the situation, and the claims representative opened a file and began an investigation accordingly. OMIC consulted with an oculoplastic specialist, who reviewed the pertinent medical records and opined that the surgical technique employed by the insured for both the initial tumor excision and the subsequent Hughes flap was within the standard of care. Armed with this supportive expert opinion, the claims representative was ultimately able to convince the patient’s attorney to drop the case before a lawsuit was filed.

The discussions between the OMIC claims representative and the patient’s attorney did not resolve this case overnight. The attorney had reviewed cases in the medical literature which recommended techniques somewhat different from that employed by the insured, particularly in literature authored by plastic surgeons rather than by ophthalmologists specializing in oculoplastics. Based on this research, the patient’s attorney was initially quite confident about the case and formulated a long laundry list of technical criticisms. It took several months of phone calls and correspondence to convince the attorney that the insured had not deviated from the standard of care and that OMIC was fully prepared to defend the case.

Risk Management Principlesand Commentary

Some physicians mistakenly believe that the only time they should call their insurer is when a Summons and Complaint arrives at their door. While it is true that a lawsuit does not commence until a Complaint has been filed in court and served upon the defendant, the prelitigation stage of a claim should be taken seriously and used as an opportunity to try to avoid litigation.

It is not always possible to derail an impending lawsuit. However, OMIC does have the trained staff and procedures in place to deal with claimants and their attorneys directly in an effort to forestall a lawsuit. For these efforts to succeed, insureds must report potential lawsuits early. When successful, this early intervention benefits all policyholders by reducing defense costs that ultimately impact premiums.

False Advertising and Misrepresentation Hamper Defense in Laser Facial Surgery Case

Digest, Summer, 1996

ALLEGATION  Unsatisfactory results from laser facial surgery due to insured’s substandard technique, lack of informed consent, false advertising, and misrepresentation.

DISPOSITION  Case settled with indemnity payment to include the cost of subsequent repair surgery.

Case Summary

After reading an enticing ad in a local newspaper that suggested “youth was just a minor surgery away,” the plaintiff, a 59-year-old woman decided it was time to have her wrinkles removed. She set up a consultation meeting with the insured ophthalmologist and was assured that the new CO₂ laser technique was extremely safe and that the results were astounding. The insured also assured the patient that she had performed this procedure many times and that all her patients had been very satisfied.

Based on these reassurances and representations in the newspaper ad that this ophthalmologist “teaches other surgeons how to perform laser facial surgery,” the patient underwent a full face CO₂ laser resurfacing. There were no apparent complications during the procedure, and the patient was discharged from the surgicenter in stable condition. Her recovery was unremarkable for the most part; however, she suffered from extreme redness when the new skin appeared, which alarmed her. The insured tried to console her, explaining that this was a normal complication and that the redness could be expected to resolve in another two to three weeks. Unfortunately, the redness continued for three months before the patient was able to adequately conceal it with skin bleaches and makeup. In addition to the redness, the patient complained that the wrinkles under her eyes were not adequately removed and that the smile lines at the corners of her mouth had been altered and now were uneven. The insured offered further surgery to correct the smile lines to the patient’s satisfaction, but the patient declined.

The next communication from the patient was a letter from her attorney stating that she was bringing legal action against the insured for damages suffered by the substandard performance of laser surgery, lack of informed consent, false advertising, and misrepresentation.

Analysis

In the absence of the misleading advertisement, this case could have been defended on the merits of the medical facts. Two oculoplastic surgeons, both experienced in CO₂ laser resurfacing, reviewed the surgery, postop care, and the overall visual results of this patient and were supportive of the insured’s surgical technique and postoperative care. They were satisfied that the redness experienced by this patient was a known and expected complication and that the change in her smile lines was an expected result of the general tightening of the facial skin and would possibly relax over time.

The difficulty in defending this case came with the discovery that the insured actually had not been involved in instructing other physicians in the CO₂ laser technique and had in fact performed only six procedures prior to the plaintiff’s. The ad had been developed by a local marketing company after a brief interview with the insured. When it was presented for her approval prior to printing, the insured questioned the propriety of claiming she was “the surgeon who teaches other surgeons” since she knew she did not instruct other surgeons in this procedure; however, the marketing representative assured her that since she was a university professor she was qualified to make this claim. The marketing representative also pointed out that an eye-catching and enticing ad could be quite effective in attracting patients.

Unfortunately, the plaintiff attorney probed into the insured’s university standing and discovered that while she was indeed an assistant clinical professor in ophthalmology, she had no affiliation with plastic surgery or dermatology, which he erroneously thought was a necessary qualification to teach and perform this procedure. Even though the plaintiff attorney was misdirected in his initial investigation into specialties, it was inevitable that with further probing he would discover that the insured did not in fact teach other surgeons this procedure. Based on the perceived inability to defend the statements made in the newspaper ad, OMIC, in conjunction with the insured, decided to settle the case for a nominal amount rather than face the probable ramifications of further probing by the plaintiff attorney.

Risk Management Principles and Commentary

If the insured had heeded her uneasiness about the wording of the ad and insisted that it be modified, she might have avoided the subsequent legal action taken against her. When publishing an ad about one’s own professional expertise, it is the physician who must decide what can and cannot be said. Stretching the truth in a misleading way can be construed as misrepresentation and may result in a high jury award if a case goes to trial. Likewise, when the stakes at trial are so high, it can be difficult to reach a reasonable settlement.

During the informed consent process, it is extremely important for the physician who performs laser resurfacing not only to fully inform the patient of the known complications, such as excessive redness, but also to be honest about one’s level of experience with this procedure. If at a later date, the patient becomes unhappy with the results, and there has been a less than accurate disclosure of the physician’s actual experience with the procedure, or an overly optimistic promise of the outcome, the case will be extremely difficult to defend.