When Dissatisfied Patients Seek Second Opinions
By Jean H. Ellis, MD
Argus, June, 1996
Fifteen percent of all OMIC closed cataract surgery-related cases involve an intraocular lens (IOL) problem: malpositioning, dislocation, wrong size or incorrect power. The majority of these cases are resolved without a payment to the plaintiff or with a relatively low indemnity payment of less than $50,000.
Patients who are symptomatic with IOL abnormalities need timely and proper medical and surgical intervention as well as openness and good communication about their particular problem. However, often the patient is asymptomatic and pleased with the surgical outcome following cataract surgery. In such cases, discussions about some lens implant abnormalities may be unnecessary and only serve to upset the patient or trigger a claim or lawsuit.
Most legal actions regarding implant abnormalities stem from a patient’s dissatisfaction with the results and/or a bad experience with the surgeon. Sometimes a patient may initiate a lawsuit in response to an evaluation by another ophthalmologist who may have criticized the implant, the eye’s appearance or the surgical technique.
In one OMIC case, a patient sued an insured ophthalmologist as a direct result of a colleague’s inadvertent critical comment about a lens implant. The patient had sought a second opinion from the other ophthalmologist regarding dry eye syndrome, a condition everyone admitted had pre-existed the cataract surgery. Before all the pertinent facts were identified, the second ophthalmologist informed the patient that the IOL was put in backwards. (The operating ophthalmologist was unaware that the lens was inverted.) The patient believed the inverted lens contributed to her eye irritation.
Despite a visual outcome of 20/25 in the operative eye, this case was settled with a small payment to the plaintiff. The plaintiff’s expert witness intended to testify that backward insertion of the lens increased the patient’s postoperative intraocular inflammation. The expert agreed that similar anterior chamber IOLs have been placed in the eye backwards by other surgeons, and that these patients achieved similar excellent visual recovery without irritation. However, it was felt that a jury might not understand that the malpositioned implant did not cause any harm.
Problems encountered with IOLs can also correlate to the surgical technique used, as with capsulorrhexis contracture syndrome. Surgeons now prefer using smaller IOL designs in an effort to reduce unwanted postoperative astigmatism. Smaller-sized optics can be associated with decreased patient tolerance in issues of lens centration. Understanding the surgical technique used is important when evaluating a cataract patient’s complaints.
When a dissatisfied patient seeks out a second opinion following cataract surgery, first collect all pertinent facts and data. This includes a thorough patient history, a comprehensive ocular examination, a review of the prior ophthalmologist’s medical and surgical records, and ideally, a discussion with the surgeon of possible etiologies for the patient’s symptomatic lens implant problems. Only after all this information has been gathered can the patient be properly diagnosed and informed. Often, sympathetic and careful management is enough to mitigate a patient’s dissatisfaction and avert unwarranted malpractice litigation.
Trends in the Duty of Informed Consent
By Paul Weber, JD
[EyeNet, November/December 1997]
A recent decision by the Supreme Court of Wisconsin has augmented the duty of informed consent to include disclosure to the patient of the physician’s level of experience and success rate for a given procedure. For now, this decision is applicable only to physicians in Wisconsin. However, this decision is noteworthy not only for the $6.2 million judgment against the defendant physician in the underlying lawsuit, but also for the debate it has ignited in the legal and medical communities regarding the trend of doctors having to disclose more information to patients, including their own level of experience with a procedure.
The Wisconsin Supreme Court decision arises from the case of Johnson v. Kokemoor. The patient, Donna Johnson, was referred to neurosurgeon Richard Kokemoor, MD, because of excruciating headaches. In the course of the exam he found an enlarging but unruptured aneurysm in the posterior of her brain. He recommended a basilar bifurcation aneurysm procedure. She recalls being told the procedure was safer than an angiogram, likening it to a tonsillectomy (Dr. Kokemoor denies saying this). He told the patient he had done this procedure “several times,” which he defined as “dozens” and “lots of times.” He also told the patient the mortality and morbidity rate was about two percent. It was undisputed that he told her of the risks of death, stroke, or blindness associated with this surgery. Ten days after first seeing Dr. Kokemoor, she had the procedure. As a consequence of the surgery, Ms Johnson, who had no neurological impairments prior to surgery, was rendered an incomplete quadriplegic.
At trial, there was testimony that Dr. Kokemoor only operated on this type of aneurysm twice. Experts for plaintiff testified that the mortality and morbidity rate for this procedure was 11 percent for the world’s best aneurysm surgeons who had performed hundreds of these surgeries and 20 – 30 percent for surgeon’s with limited experience such as Dr. Kokemoor. The Wisconsin Supreme court held that evidence reflecting the surgeon’s failure to disclose his limited prior experience was admissible at trial and did not unduly or unfairly prejudice the doctor. The court stated “when different physicians have substantially different success rates with the same procedure (and that information is material) the court may admit this statistical evidence.” Finally, the court held that it was proper to admit evidence that Dr. Kokemoor should have advised the patient of the alternative of undergoing surgery at a tertiary care facility with a more experienced surgeon in a better equipped facility.
The Wisconsin court did not create a new informed consent standard. Most states already followed the trend towards a duty to disclose what a reasonable person in the patient’s position would want to know. To most physicians, that generally meant discussing complication rates about an invasive procedure; now it may mean discussing a physician’s own “track record.” What is unique about the Kokemoor case is that never before has the disclosure of the doctor’s experience (or failure to disclose such experience) been the primary subject of litigation. Because of this decision, there is now a precedent that plaintiff lawyers will not have to prove the doctor violated the standard of care, but only that the doctor failed to refer the patient to a colleague with a lower complication rate where the patient, presumably, would have had a better result.
One potential liability scenario that emerges as a result of the Kokemoor decision regards what to tell a patient when you are performing a recently learned procedure or technique. Due to technologic advances and marketplace demands, many ophthalmologists are learning new procedures such as refractive surgery or CO2 laser skin resurfacing. Sometimes, in order to be a provider in a managed care plan, an ophthalmologist may have to agree to see and treat patients that they normally would refer; e.g., pediatric strabismus patients. These technologic advances and changes in health care delivery not only create ethical dilemmas, but an informed consent issue regarding what patients need to know to make an intelligent and informed decision about whether or not to undergo a proposed therapy or treatment.
It is OMIC’s view that the current trend towards patients receiving more information compels the prudent ophthalmologist to inform the patient of his or her level of experience with a newly learned procedure or technique. How and whether an ophthalmologist’s “track record” is disclosed will vary depending on the surgeon’s experience with the technique or procedure. There is no “hard-and-fast” rule on when an ophthalmologist should talk about comparative risk with the patient and sometimes there might not be any “comparative data.” However, we can state that an ophthalmologist should attempt to see the procedure from the patient’s perspective and ask: “Would I want to know the level of expertise and experience of my physician if I was undergoing this particular procedure?” This is the question that will be asked if a lawsuit arises and jurors are trying to determine if this information would have been material to a patient’s decision about whether to undergo a particular treatment or procedure. If the answer is “yes,” then the ophthalmologist ought to discuss the issue of experience and comparative risk (if data exists) and document in the patient’s record that such a discussion did in fact take place. Failure to have such a discussion leaves wide open the possibility of a claim applying the ever-expanding duty of informed consent.
Informed Consent Revisited
By Paul Weber, JD
OMIC’s vice-president of risk management
Digest, Summer, 2001
Poor informed consent continues to be a frequent and serious allegation in claims and lawsuits against ophthalmologists. Despite the availability of procedure-specific informed consent documents from OMIC, an alarming number of insureds still do not use them and simply rely on the hospital or surgicenter’s consent form to cover their exposure. Unfortunately, these generic documents focus on the risks of anesthesia and rarely address ophthalmic-specific risks. Informed consent documentation is so critical to the successful defense of a malpractice claim that it bears revisiting.
Q What is the risk of not obtaining informed consent from a patient?
A The courts in most states have decided that if a physician performs a procedure or provides care without first informing the patient of the risks, complications, and alternatives and the patient has a known complication or side effect, the doctor must pay damages. (In some states, this decision has been codified into a statute.) This legal doctrine provides another avenue for patients to sue their physician and is often used in conjunction with claims of improper performance. The law in most states provides that: (1) In providing medical services, a physician must get informed consent; (2) Informed consent occurs after disclosure by the physician of factors a “reasonably well qualified” physician would disclose under similar circumstances; (3) Failure to obtain informed consent is negligence; (4) Expert testimony is needed to prove the sufficiency of disclosed risks/alternatives.
Q What must the plaintiff prove to prevail in an allegation of informed consent?
A The plaintiff must prove that: (1) The physician failed to inform the patient of the risks/alternatives another physician would have disclosed; (2) If these risks/alternatives were disclosed, a reasonable person would not have submitted to the procedure; (3) The patient was injured; (4) Failure to disclose these risks/alternatives was cause of injury.
Q What steps can I take to ensure that the patient is properly informed?
A The process of informed consent begins when the patient is first seen and given information to read and/or a video to view about his or her condition and its treatment. For risk management purposes, it is important to document that the patient received this information and/or viewed a video to help refute a claim of lack of informed consent.
Q When does informed consent “happen”?
A Some experts suggest that informed consent is an ongoing process rather than a seminal event. However, for medicolegal purposes, it is essential the ophthalmologist have a personal discussion with the patient about the risks, benefits, and alternatives to treatment and personally answer the patient’s questions. Only after this discussion can the patient give his or her informed consent. It is this discussion and subsequent patient agreement that constitutes “informed consent.” What comes next is the documentation or memorializing of the patient agreement.
Q Why is a procedure-specific informed consent document so important? Why isn’t a simple note in the chart sufficient?
A Without a document signed by the patient listing the risks specific to the procedure, the jury will be confronted with two entirely different versions of what was discussed. Unfortunately, it is quite rare that handwritten chart notes are as comprehensive as a procedure-specific informed consent document. However, such a note in the patient’s chart coupled with a procedure-specific informed consent document presents a formidable defense. Also document whenever the ophthalmologist spends a significant amount of time with a patient discussing a procedure, including how much time was spent. This helps refute claims that the physician was “in and out” of the room and did not seriously address the patient’s concerns.
Q What are some strategies surrounding the actual signing of the informed consent document?
A The patient should sign the document after having the discussion with the ophthalmologist. Many of these documents state that “the doctor has answered my questions.” This assumes that a discussion has taken place so if the patient signs the document before the discussion, it is inaccurate and may diminish the document’s effectiveness. Ask the patient to initial each page of a multi-page document or even specific paragraphs to avoid allegations that the patient was shown only the last page to sign and not given a chance to review the document in its entirety. Encourage the patient to take the document home prior to signing to digest the information and review it with a family member if necessary. The patient also may be given a copy of the document to keep.
Great Expectations Raise Stakes in Elective Surgery
By C. Gregory Tiemeier, Esq.
Mr. Tiemeier is an OMIC defense attorney and partner in the Denver law firms of Tiemeier & Hensen, P.C. He represents physicians and other health care providers in professional liability litigation.
Digest, Fall 2001
We’ve seen the ads for LASIK: An attractive couple frolicking in the tropical surf under the headline, “Live life to the fullest!” or “Throw away your glasses and contacts!” It’s an enticing message, guaranteed to spark patient interest and cause problems down the road if the patient is disappointed with the results. I have noticed several recurring themes in many of the ophthalmic malpractice cases I have defended that complicate the defense and increase the likelihood of an indemnity payment of the plaintiff. Defense issues can arise in any ophthalmic malpractice case, but some are unique to elective procedures.
Advertisements that state or suggest that surgery will help patients feel good or better about themselves may be effective marketing, but they expose the surgeon to liability by implying a responsibility to the patient that ophthalmic elective surgery is not designed to fulfill. Advertising that promotes unreasonable expectations only makes the surgeon’s job harder and a lawsuit more difficult to defend. Surgery should not be represented as being able to do anything other than alter the patient’s appearance or visual acuity. Patient and surgeon need to agree and have a clear understanding in advance of what the change will be. A simple question on the intake form – “what do you hope to achieve with this surgery?” – can root out unreasonable expectations and allow them to be addressed. As long as the surgeon achieves the results that were agreed upon beforehand, the care is defensible, whether the person looks or feels better.
Some courts are scrutinizing whether a patient who wants elective surgery is capable of giving informed consent. In the summer of 2000, a New York judge permitted a lawsuit to go forward in which a patient alleged that her cosmetic surgeon should have known that she had a distorted body image and therefore was incapable of giving informed consent for cosmetic surgery. The lawsuit did not allege that the surgery was done poorly or failed to obtain the desired result, only that it never should have been done because the patient’s self-perception was so irrational that any surgery was improper.
The time to get to know a patient is during the preoperative discussion. Besides answering the patient’s questions, use this opportunity to ask yourself: Is this person a good candidate for surgery? Does he or she have reasonable expectations? Have there been problems with other physicians in the past? Does this person have a perfectionist personality such that he or she will not be satisfied with any result? It’s all right to delegate a portion of the preoperative counseling and screening process to your staff provided you listen to their comments and assessment of the patient. More than once I have heard a physician lament, “My staff told me that patient was going to be nothing but trouble. I should have listened.”
Avoid the White Knight Syndrome
In law school we were warned about clients who, having already been to several other attorneys, describe in harsh, unflattering terms the work done by them, and then appeal to your superlative skills to “help them out of the mess created by those incompetent legal hacks.” The same warning applies to patients who come to you with tales of woe about the poor skills of other surgeons. Before jumping to conclusions, obtain the patient’s medical records and talk to the previous surgeon. You may learn that the “bad result” the patient is complaining about is actually a remarkably good one when placed in context or that the patient has a history of noncompliance with postoperative instructions. Don’t fall victim to the “white knight syndrome.”
Physicians who make their patients feel special find that referrals follow. Aside from the business success it brings, making patients feel appreciated helps keep them out of their attorney’s office if there is a poor result. I frequently hear plaintiffs in their depositions complain that their physician wasn’t listening to them or did nothing to address their concerns. Often they are angry because they feel the physician was unwilling to tell them truthfully what happened and why. Patients who are frustrated because they cannot get answers from their physician in the exam room will attempt to get them in the courtroom. Notwithstanding the fact that sometimes a patient’s questions cannot be answered with certainty, the physician must always demonstrate concern for the surgical result and endeavor to help the patient understand how it came about.
This same attention to patient needs should be evident during the preoperative phase as well. Instruct your staff to make patients feel welcome and comfortable. Let patients know from the actions of you and your staff that their safety and satisfaction is important to you. Patients considering elective surgery are likely to have some anxieties or reservations and talking with someone about their fears is the best way to allay them. A patient who is tense and anxious going in to surgery who has no outlet for those anxieties will be looking for problems when it is over, even problems not caused by the surgery. I defended a blepharoplasty case a few years ago in which the patient noticed postoperative unilateral inferior visual field loss, probably from unrelated anterior ischemic optic neuropathy (AION) that may have been present before the surgery or could have been coincident with it. We couldn’t tell, though, because it was not until after the procedure that the plaintiff began paying close attention to what she could see. Unfortunately, there was no record of a preoperative visual field examination, something that I highly recommend as part of the work-up for oculoplastic surgery.
Don’t Make Promises You Can’t Keep
Sometimes a patient will make an appointment for a consultation for a certain procedure but would be better served with something else. The appointment may have been made on the basis of information received from an unreliable or misleading source, such as a competitor’s advertising. Explore what the patient really wants from surgery. Does the 50-year old presbyopic myope who comes in for LASIk know about monovision correction? Offer the patient an opportunity to try it out with contact lenses. Make sure they understand that they’ll be trading distance correction glasses or contact lenses for reading glasses after LASIK. Many people don’t understand that presbyopia is a problem of visual accommodation, not visual acuity. Document your monovision discussion with the patient’s decision.
If a patient is having second thoughts about a procedure, don’t try to exercise your powers of persuasion. Validate the patient’s concerns; don’t dismiss them. Encourage the patient to give it more thought and come back at a later time. Patients who feel they were talked into something they didn’t want are more likely to blame the surgeon if it doesn’t turn out well. On the other hand, patients who are allowed to decide for themselves and encouraged to think it over before proceeding are more inclined to take responsibility for any foreseeable side effects or untoward outcomes.
Neither the physician nor staff should attempt to allay a patient’s concerns with promises that there won’t be problems following surgery. Stick to the facts. “We’ve done 8,000 LASIK procedures, and the worst complication we’ve had is starbursting. We tell you about possible complications to help you understand that this is a surgical procedure, and therefore we cannot guarantee success. But the chances of you suffering one of these complications is very small.” Show the cosmetic surgery candidate before and after pictures of other patients – not just the successful ones, but also those that didn’t come out so well. The patient should understand that statistically rare complications can occur.
One of my most frustrating cases involved an RK overcorrection that occurred even though the operating surgeon used the correct data from the correct nomogram and performed the procedure flawlessly. The case was defensible; however, we had to settle because when I interviewed the defendant’s nurse about the plaintiff’s claim that a good result had been guaranteed, she admitted having told the patient, “Don’t worry, I promise you won’t have any problems with the surgery.” Her intentions may have been good, but from a legal standpoint, she created an all but insurmountable obstacle to defending the informed consent claim.
Be There For Your Patients
Occasionally, a lawsuit arises because a patient who should have been talking to the doctor was “screened” by the staff and a subtle, but significant, symptom was overlooked until serious consequences arose. Even if the nurse or receptionist can answer the question, a patient who calls with questions or complaints after surgery should be offered the opportunity to speak with the doctor. If handled tactfully, that patient may decide that it is not necessary to speak with the surgeon after all. For example, “I’d be happy to have Dr. Smith give you a call this afternoon, but just so you’re not worrying, you should know that pain or discomfort is to be expected after LASIK surgery.”
But the decision to speak with the doctor or not should be made by the patient, not the receptionist or nurse. This is especially true for patients who have suffered a poor outcome or complication. Although, not common, I have seen surgeons faced with a bad outcome try to discount the severity, ignore it, or even unfairly blame the patient. In fact, the physician and staff need to spend more time with unhappy patients to validate legitimate concerns and complaints and listen sympathetically to the others.
Some patients may request a refund of the surgery fee if they are unhappy with the results. Such requests should be considered on a case by case basis. Generally, it is better to show sympathy and concern for the patient than to refund fees. On the other hand, some successful surgeons have used a refund policy as part of their overall patient satisfaction guarantee.
There are some patients who will never be happy or whose unrealistic expectations could never be met. The vast majority of patients who have ophthalmic elective surgery are very satisfied with the results. When there is a problem, however, a jury will more closely scrutinize the care of the physician if the surgery was elective, rather than an emergency or life-saving procedure. Following these suggestions will help your attorney defend your case in this event. They may also have the added benefit of making your patients feel more appreciated and understood, which could be good for your business as well.
Don’t Be Afraid to Say You’re Sorry
By Paul Weber, JD,
OMIC’s vice-president of risk management
Digest, Spring 2001
Poor patient outcomes will occur during the career of even the most careful and skilled ophthalmologist. A long-standing debate in medicine concerns whether an overt statement of regret by a physician for a poor medical or surgical outcome could be perceived as an admission of guilt and catalyze a malpractice claim by the patient or be used in court as evidence of liability. But several studies and surveys show that a physician who sympathetically communicates and responds to a patient who has a poor outcome may actually minimize the risk of the patient filing a lawsuit.
Q Is an apology or expression of regret appropriate if a patient experiences a “known risk” of a procedure?
A One study found that more than 50% of malpractice lawsuits are precipitated by the physician’s unwillingness to spend time with the patient and failure to communicate effectively with the patient.1 An expression of regret is not an admission of fault or liability. A statement such as “I regret things didn’t end up the way we had hoped” or “I’m sorry things didn’t come out the way we had planned” conveys disappointment with the outcome but not the treatment itself. Avoid confessional or self-incriminating statements such as “I guess we blew it,” which focuses on the physician’s concerns about his or her performance and not on the patient’s concerns about the injury or loss.
Q What else can I do to minimize my risk of a claim when a patient has an adverse outcome?
A Four common complaints were identified in deposition transcripts of patients who sued their physician following a poor outcome: the physician deserted the patient, delivered information poorly, devalued the patient’s views, or failed to understand from the patient’s perspective.2 Following a poor outcome, set aside ample time to meet with the patient and family. Even though the outcome may be a known complication or side effect that was discussed before the procedure or treatment, assume the patient has only a vague understanding or recollection of the information provided at that time. Come prepared to review the same information now in small, easily understandable chunks. Do not delegate this responsibility as this gives the impression that you are avoiding or are indifferent to the patient’s concerns. Making time for the patient is probably the most effective way to show your concern.
Q How should I document these conversations?
A After explaining the nature of the poor outcome and the steps to remedy it or to help the patient adjust to a permanent loss, it is important to document that the patient appeared to understand and had all questions answered. If you spend a significant amount of time with a patient, document how much (“spent 20 minutes with patient’s family reviewing clinical outcome of surgery”). Recollections often fade as the amount of time actually spent counseling a patient if it is not in the record. Using the patient record to convey and document opinions that a poor outcome was the result of an error or omission by another provider will not help the patient and may reflect poorly on the person placing the blame. Contact OMIC to discuss how to keep confidential, privileged record of the chronology of events.
Q Should I waive my fee or refund money to a patient with a poor outcome?
A This issue has been addressed in previous risk management articles that can be accessed on OMIC’s website, www.omic.com.3,4 Contact Paul Weber at (800) 562-6642, ext. 603 or pweber@omic.com to discuss your options.
Q Can an apology or statement of regret be used as evidence in court?
A In most states, any discussion with a patient, including expressions of sympathy, can be used as evidence in court. Only a few states, such as California, have ruled it inadmissible to bring into evidence a benevolent gesture or expression of sympathy relating to the pain or suffering of a person involved in an “accident,” including medical incidents. No two situations or patients are alike so there will never be one foolproof approach to communicating with a patient who has has a poor outcome. That said, most patients want an ophthalmologist to recognize and respond to them not only as a patient with a clinical problem but also as a human being with emotions related to that problem.
Notes
- J. Kelley Avery, MD, “How the Medical ‘Lawsuit Pie’ is Cut – Lawyers Tell What Turns Some Patients Litigious,” Medical Malpractice Prevention, July/August 1986.
- Howard B. Beckman, et al., “The Doctor-Patient Relationship and Malpractice – Lessons from Plaintiff Depositions,” Archives of Internal Medicine, June 27, 1994, v.154.
- Paul Weber, JD, “When to Report ‘Free Servicing’ of Patients to Data Bank,” Argus, July 1995.
- Byron H. Demorest, MD, “Waiving Your Bill May Avert a Claim Following a Poor Clinical Outcome,” Argus, November 1992, (see “Waiving Your Bill May Avert a Claim Following a Poor Clinical Outcome,”)